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WPATH removes age limits from transgender treatment guidelines
Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.
The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.
These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.
The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.
For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
The complexity of treating adolescents
WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.
Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.
The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.
However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.
The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.
Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.
The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.
“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.
WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”
Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.
SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.
And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.
It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”
SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”
And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”
Who uses WPATH to guide care? This is ‘a big unknown’
WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.
However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.
The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.
“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.
In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.
“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”
A version of this article first appeared on Medscape.com.
Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.
The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.
These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.
The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.
For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
The complexity of treating adolescents
WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.
Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.
The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.
However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.
The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.
Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.
The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.
“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.
WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”
Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.
SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.
And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.
It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”
SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”
And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”
Who uses WPATH to guide care? This is ‘a big unknown’
WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.
However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.
The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.
“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.
In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.
“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”
A version of this article first appeared on Medscape.com.
Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.
The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.
These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.
The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.
For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
The complexity of treating adolescents
WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.
Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.
The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.
However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.
The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.
Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.
The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.
“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.
WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”
Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.
SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.
And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.
It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”
SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”
And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”
Who uses WPATH to guide care? This is ‘a big unknown’
WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.
However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.
The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.
“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.
In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.
“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF TRANSGENDER HEALTH
Physicians can’t be bystanders in ‘silent scourge’ of medical bullying
Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.
“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.
She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.
The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”
The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.
“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”
She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”
Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.
Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
Physicians can’t be bystanders to bullying
This means transitioning from being a bystander to an upstander.”
She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”
Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”
Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.
The study authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.
“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.
She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.
The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”
The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.
“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”
She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”
Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.
Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
Physicians can’t be bystanders to bullying
This means transitioning from being a bystander to an upstander.”
She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”
Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”
Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.
The study authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.
“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.
She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.
The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”
The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.
“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”
She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”
Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.
Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
Physicians can’t be bystanders to bullying
This means transitioning from being a bystander to an upstander.”
She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”
Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”
Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.
The study authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
EHR: A progress report
I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason:
Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.
The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”
Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.
There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.
Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.
The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.
Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.
The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.
Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.
Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.
Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.
Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.
With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.
Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason:
Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.
The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”
Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.
There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.
Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.
The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.
Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.
The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.
Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.
Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.
Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.
Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.
With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.
Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason:
Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.
The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”
Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.
There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.
Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.
The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.
Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.
The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.
Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.
Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.
Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.
Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.
With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.
Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Quiet quitting: Are physicians dying inside bit by bit? Or setting healthy boundaries?
In the past few months, “quiet quitting” has garnered increasing traction across social media platforms. My morning review of social media revealed thousands of posts ranging from “Why doing less at work could be good for you – and your employer” to “After ‘quiet quitting’ here comes ‘quiet firing.’ ”
But quiet quitting is neither quiet nor quitting.
Quiet quitting is a misnomer. In addition, quiet quitters are firmer with their boundaries, do not take on work above and beyond clearly stated expectations, do not respond after hours, and do not feel like they are “not doing their job” when they are not immediately available.
Individuals who “quiet quit” continue to meet the demands of their job but reject the hustle-culture mentality that you must always be available for more work and, most importantly, that your value as person and self-worth are defined and determined by your work. Quiet quitters believe that it is possible to have good boundaries and yet remain productive, engaged, and active within the workplace.
Earlier this month, NPR’s posted tutorial on how to set better boundaries at work garnered 491,000 views, reflecting employees’ difficulties in communicating their needs, thoughts, and availability to their employers. Quiet quitting refers to not only rejecting the idea of going above and beyond in the workplace but also feeling confident that there will not be negative ramifications for not consistently working beyond the expected requirements.
A focus on balance, life, loves, and family is rarely addressed or emphasized by traditional employers; employees have little skill in addressing boundaries and clarifying their value and availability. For decades, “needing” flexibility of any kind or valuing activities as much as your job were viewed as negative attributes, making those individuals less-desired employees.
Data support the quiet quitting trend. Gallup data reveal that employee engagement has fallen for 2 consecutive years in the U.S. workforce. Across the first quarter of 2022, Generation Z and younger Millennials report the lowest engagement across populations at 31%. More than half of this cohort, 54%, classified as “not engaged” in their workplace.
Why is quiet quitting gaining prominence now? COVID may play a role.
Many suggest that self-evaluation and establishing firmer boundaries is a logical response to emotional sequelae caused by COVID. Quiet quitting appears to have been fueled by the pandemic. Employees were forced into crisis mode by COVID; the lines between work, life, and home evaporated, allowing or forcing workers to evaluate their efficacy and satisfaction. With the structural impact of COVID reducing and a return to more standard work practices, it is expected that the job “rules” once held as truths come under evaluation and scrutiny.
Perhaps COVID has forced, and provided, another opportunity for us to closely examine our routines and habits and take stock of what really matters. Generations expectedly differ in their values and definitions of success. COVID has set prior established rules on fire, by forcing patterns and expectations that were neither expected nor wanted, within the context of a global health crisis. Within this backdrop, should we really believe our worth is determined by our job?
The truth is, we are still grieving what we lost during COVID and we have expectedly not assimilated to “the new normal.” Psychology has long recognized that losing structures and supports, routines and habits, causes symptoms of significant discomfort.
The idea that we would return to prior workplace expectations is naive. The idea we would “return to life as it was” is naive. It seems expected, then, that both employers and employees should evaluate their goals and communicate more openly about how each can be met.
It is incumbent upon the employers to set up clear guidelines regarding expectations, including rewards for performance and expectations for time, both within and outside of the work schedule. Employers must recognize symptoms of detachment in their employees and engage in the process of continuing clarifying roles and expectations while providing necessities for employees to succeed at their highest level. Employees, in turn, must self-examine their goals, communicate their needs, meet their responsibilities fully, and take on the challenge of determining their own definition of balance.
Maybe instead of quiet quitting, we should call it this new movement “self-awareness, growth, and evolution.” Hmmm, there’s an intriguing thought.
Dr. Calvery is professor of pediatrics at the University of Louisville (Ky.) She disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
In the past few months, “quiet quitting” has garnered increasing traction across social media platforms. My morning review of social media revealed thousands of posts ranging from “Why doing less at work could be good for you – and your employer” to “After ‘quiet quitting’ here comes ‘quiet firing.’ ”
But quiet quitting is neither quiet nor quitting.
Quiet quitting is a misnomer. In addition, quiet quitters are firmer with their boundaries, do not take on work above and beyond clearly stated expectations, do not respond after hours, and do not feel like they are “not doing their job” when they are not immediately available.
Individuals who “quiet quit” continue to meet the demands of their job but reject the hustle-culture mentality that you must always be available for more work and, most importantly, that your value as person and self-worth are defined and determined by your work. Quiet quitters believe that it is possible to have good boundaries and yet remain productive, engaged, and active within the workplace.
Earlier this month, NPR’s posted tutorial on how to set better boundaries at work garnered 491,000 views, reflecting employees’ difficulties in communicating their needs, thoughts, and availability to their employers. Quiet quitting refers to not only rejecting the idea of going above and beyond in the workplace but also feeling confident that there will not be negative ramifications for not consistently working beyond the expected requirements.
A focus on balance, life, loves, and family is rarely addressed or emphasized by traditional employers; employees have little skill in addressing boundaries and clarifying their value and availability. For decades, “needing” flexibility of any kind or valuing activities as much as your job were viewed as negative attributes, making those individuals less-desired employees.
Data support the quiet quitting trend. Gallup data reveal that employee engagement has fallen for 2 consecutive years in the U.S. workforce. Across the first quarter of 2022, Generation Z and younger Millennials report the lowest engagement across populations at 31%. More than half of this cohort, 54%, classified as “not engaged” in their workplace.
Why is quiet quitting gaining prominence now? COVID may play a role.
Many suggest that self-evaluation and establishing firmer boundaries is a logical response to emotional sequelae caused by COVID. Quiet quitting appears to have been fueled by the pandemic. Employees were forced into crisis mode by COVID; the lines between work, life, and home evaporated, allowing or forcing workers to evaluate their efficacy and satisfaction. With the structural impact of COVID reducing and a return to more standard work practices, it is expected that the job “rules” once held as truths come under evaluation and scrutiny.
Perhaps COVID has forced, and provided, another opportunity for us to closely examine our routines and habits and take stock of what really matters. Generations expectedly differ in their values and definitions of success. COVID has set prior established rules on fire, by forcing patterns and expectations that were neither expected nor wanted, within the context of a global health crisis. Within this backdrop, should we really believe our worth is determined by our job?
The truth is, we are still grieving what we lost during COVID and we have expectedly not assimilated to “the new normal.” Psychology has long recognized that losing structures and supports, routines and habits, causes symptoms of significant discomfort.
The idea that we would return to prior workplace expectations is naive. The idea we would “return to life as it was” is naive. It seems expected, then, that both employers and employees should evaluate their goals and communicate more openly about how each can be met.
It is incumbent upon the employers to set up clear guidelines regarding expectations, including rewards for performance and expectations for time, both within and outside of the work schedule. Employers must recognize symptoms of detachment in their employees and engage in the process of continuing clarifying roles and expectations while providing necessities for employees to succeed at their highest level. Employees, in turn, must self-examine their goals, communicate their needs, meet their responsibilities fully, and take on the challenge of determining their own definition of balance.
Maybe instead of quiet quitting, we should call it this new movement “self-awareness, growth, and evolution.” Hmmm, there’s an intriguing thought.
Dr. Calvery is professor of pediatrics at the University of Louisville (Ky.) She disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
In the past few months, “quiet quitting” has garnered increasing traction across social media platforms. My morning review of social media revealed thousands of posts ranging from “Why doing less at work could be good for you – and your employer” to “After ‘quiet quitting’ here comes ‘quiet firing.’ ”
But quiet quitting is neither quiet nor quitting.
Quiet quitting is a misnomer. In addition, quiet quitters are firmer with their boundaries, do not take on work above and beyond clearly stated expectations, do not respond after hours, and do not feel like they are “not doing their job” when they are not immediately available.
Individuals who “quiet quit” continue to meet the demands of their job but reject the hustle-culture mentality that you must always be available for more work and, most importantly, that your value as person and self-worth are defined and determined by your work. Quiet quitters believe that it is possible to have good boundaries and yet remain productive, engaged, and active within the workplace.
Earlier this month, NPR’s posted tutorial on how to set better boundaries at work garnered 491,000 views, reflecting employees’ difficulties in communicating their needs, thoughts, and availability to their employers. Quiet quitting refers to not only rejecting the idea of going above and beyond in the workplace but also feeling confident that there will not be negative ramifications for not consistently working beyond the expected requirements.
A focus on balance, life, loves, and family is rarely addressed or emphasized by traditional employers; employees have little skill in addressing boundaries and clarifying their value and availability. For decades, “needing” flexibility of any kind or valuing activities as much as your job were viewed as negative attributes, making those individuals less-desired employees.
Data support the quiet quitting trend. Gallup data reveal that employee engagement has fallen for 2 consecutive years in the U.S. workforce. Across the first quarter of 2022, Generation Z and younger Millennials report the lowest engagement across populations at 31%. More than half of this cohort, 54%, classified as “not engaged” in their workplace.
Why is quiet quitting gaining prominence now? COVID may play a role.
Many suggest that self-evaluation and establishing firmer boundaries is a logical response to emotional sequelae caused by COVID. Quiet quitting appears to have been fueled by the pandemic. Employees were forced into crisis mode by COVID; the lines between work, life, and home evaporated, allowing or forcing workers to evaluate their efficacy and satisfaction. With the structural impact of COVID reducing and a return to more standard work practices, it is expected that the job “rules” once held as truths come under evaluation and scrutiny.
Perhaps COVID has forced, and provided, another opportunity for us to closely examine our routines and habits and take stock of what really matters. Generations expectedly differ in their values and definitions of success. COVID has set prior established rules on fire, by forcing patterns and expectations that were neither expected nor wanted, within the context of a global health crisis. Within this backdrop, should we really believe our worth is determined by our job?
The truth is, we are still grieving what we lost during COVID and we have expectedly not assimilated to “the new normal.” Psychology has long recognized that losing structures and supports, routines and habits, causes symptoms of significant discomfort.
The idea that we would return to prior workplace expectations is naive. The idea we would “return to life as it was” is naive. It seems expected, then, that both employers and employees should evaluate their goals and communicate more openly about how each can be met.
It is incumbent upon the employers to set up clear guidelines regarding expectations, including rewards for performance and expectations for time, both within and outside of the work schedule. Employers must recognize symptoms of detachment in their employees and engage in the process of continuing clarifying roles and expectations while providing necessities for employees to succeed at their highest level. Employees, in turn, must self-examine their goals, communicate their needs, meet their responsibilities fully, and take on the challenge of determining their own definition of balance.
Maybe instead of quiet quitting, we should call it this new movement “self-awareness, growth, and evolution.” Hmmm, there’s an intriguing thought.
Dr. Calvery is professor of pediatrics at the University of Louisville (Ky.) She disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Polio in 2022: Some concerns but vaccine still works
Who would have thought we would need to refresh our knowledge on polio virus in 2022? Fate seems cruel to add this concern on the heels of SARS-CoV-2, monkeypox, abnormal seasons for RSV, acute flaccid myelitis (AFM) linked to enteroviruses, and a summer of parechovirus causing infant meningitis. But confirmation that indeed an adult had polio with paralytic disease raises concerns among public health groups and ordinary citizens alike, particularly those who remember polio in its heyday.
History: In the summer of 1952, polio was among the most feared diseases on the planet. Families were advised to not allow children to congregate in groups or use public swimming pools; little league baseball games were being canceled and there was talk of not opening schools for the fall. Every parent’s nightmare seemed to be the nonspecific febrile summer illness that led to paralytic sequelae. TV news included videos of the iron lung wards in hospitals across the country. Medical providers felt powerless, only able to give nonspecific preventive advice. There was no specific antiviral (there still isn’t) and vaccines seemed a long way off.
Then came the news that Dr. Jonas Salk’s group had gotten an inactivated polio vaccine (IPV) approved for general use in 1955. Families were excited to have their children vaccinated. Paralytic polio cases dropped like a rock from approximately 22,000/year in 1952 to approximately 2,200 in 1956. A surge to near 6,000 cases in 1959 led to Dr. Albert Sabin’s oral polio vaccine (OPV), which supplanted IPV in 1961. OPV had the advantages of: 1) Inducing mucosal as well as serum antibodies, 2) more durable responses, and 3) immunity in unvaccinated persons exposed to vaccine virus that had been shed in stools into wastewater and rivers.
By 1964, polio had nearly disappeared. The last wild-type indigenous U.S. case was in 1979. By 1994, all the Americas were declared polio free. Because the only U.S. paralytic polio cases thereafter were foreign imports or were associated with oral vaccine strains (so-called vaccine-associated paralytic polio [VAPP]), OPV was replaced by an enhanced IPV in 2000 to prevent further VAPP.
Polio facts: Polio is asymptomatic in about 70% of infections. Among the 30% with symptoms, paralysis occurs infrequently, with the overall rate of paralytic infections being 0.5% (rate varies by virus type with type 3 having the highest rate).1 Why then was the world so afraid of polio? If every person in a U.S. birth cohort (about 3.7 million) was unvaccinated and became infected with poliovirus, more than 18,000 would get paralytic polio and almost 1,300 would die. Of note, adults have a higher chance of paralytic polio after infection than children.
Concerns in 2022: Persons vaccinated with at least three doses of either IPV or OPV have historically been protected from paralytic polio (99% protection). But are we sure that the United States remains protected against polio after 2 decades of IPV being the only vaccine? Polio could be reintroduced at any time to the United States from countries with reported cases that likely arose because of low vaccination rates related to war, famine, or political upheavals (Malawi, Mozambique, Nigeria, Pakistan, and Afghanistan).2 The proof? The recent confirmed New York case.
International efforts resulted in global eradication of two polio wild-types viruses (type 2 in 2015 and type 3 in 2019). Nevertheless, vaccine-derived, virulent polio virus (VDPV) type 2 and VDPV-3 still circulate in some areas, particularly Africa (VDPV-2) and Israel (VDPV-3). The above-mentioned U.S. case is an unvaccinated adult traveler who went to an area where VDPV-2 circulates and developed disease after returning home.3 So, it was not an indigenous reappearance in the United States and it was not a breakthrough case in a vaccinated person. But it is sobering to realize that all who are unvaccinated remain at risk for paralytic polio in 2022, particularly because vaccination rates declined nearly everywhere during the initial COVID-19 pandemic. We are still catching up, with vaccination rates under 50% in some ZIP codes.4
Are VDPVs circulating in some parts of the United States? Interestingly, wastewater surveillance programs may be the most economical and practical way to perform polio surveillance. Such a program detected polio virus in London wastewater in June 2022.5 New York has recently detected polio in wastewater during testing begun because of the recent case.6
Good news: For paralytic polio, seropositivity at any titer indicates protection, so U.S. serosurveillance data would also be informative. How durable is polio protection in the IPV era? Available data suggest that even though we have used only IPV these past 20 years, seropositivity rates among vaccinees with at least three doses of either IPV or OPV should persist for decades and likely for life. Even before polio became a concern this year, the Centers for Disease Control and Prevention, being proactive, wanted to ensure that the enhanced IPV was producing durable immunity and that persons of all ages remained seropositive to the three polio virus types over 10 years after discontinuing OPV use in 2012.
The CDC collaborated with investigators in Kansas City, Mo., to evaluate titers and seropositivity to all three types in a 2- to 85-year-old otherwise healthy cohort with demographics that mirrored the 2010 census for the Kansas City region, which in turn mirrored the national 2021 census data.7 There were approximately 100 persons in each age cohort, with 200 below age 11 years (the cohort that had received only IPV). Serology was performed at the CDC.
Overall seropositivity rates were high, but lower for type 3 (83.3%) and type 2 (90.7%) than type 1 (94.4%). Of note, most of those seronegative for one or more types were among 2- to 3-year-olds who had not completed their full IPV series, with most seronegative results being against polio types 1 and 3. Further, five, who were confirmed as having received no polio vaccine, were seronegative for all three types. Two with no available vaccine records (over 18 years old) were also seronegative for all three types.
So, regardless of the era in which one got polio vaccine, vaccine protection appears to persist indefinitely after three doses. Even 80-year-olds were still seropositive if they had three doses. We can confidently reassure our patients that the vaccine still works; the persons who need to fear polio in 2022 are those who are not vaccinated or have had fewer than three doses, particularly if they travel to areas of persistent polio. Wild type 1 virus persists in a few countries as does VDPV type 2 and VDPV type 3. Importantly, wild type 2 and wild type 3 (with the lowest seropositivity in 2012 study) have been eliminated globally so the only circulating type 2 and type 3 polio virus is VDPV in a few countries. Travel to these countries warrants review of polio vaccine records and CDC or WHO current recommendations for travelers to those countries.
Dr. Harrison is a professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. Email him at pdnews@mdedge.com.
References
1. Poliomyelitis. World Health Organization fact sheet, 2022 Jul 4..
2. Franco-Paredes C et al. Lancet Infect Dis. 2022 Aug 16. doi: 10.1016/S1473-3099(22)00548-5.
3. Link-Gelles R et al. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1065-8.
4. “Polio vaccination rate for 2-year-olds is as low as 37% in parts of N.Y. county where paralysis case was found,” NBC News, Erika Edwards, 2022 Aug 16. 5. Vaccine-derived poliovirus type 2 (VDPV2) detected in environmental samples in London. Polioeradication.org. 2022 Jun 22.
6. “NYSDOH and NYCDOHMH wastewater monitoring identifies polio in New York City and urges unvaccinated New Yorkers to get vaccinated now,” nyc.gov. 2022 Aug 12.
7. Wallace GS et al. Hum Vaccin Immunother. 2017;13(4):776-83.
Who would have thought we would need to refresh our knowledge on polio virus in 2022? Fate seems cruel to add this concern on the heels of SARS-CoV-2, monkeypox, abnormal seasons for RSV, acute flaccid myelitis (AFM) linked to enteroviruses, and a summer of parechovirus causing infant meningitis. But confirmation that indeed an adult had polio with paralytic disease raises concerns among public health groups and ordinary citizens alike, particularly those who remember polio in its heyday.
History: In the summer of 1952, polio was among the most feared diseases on the planet. Families were advised to not allow children to congregate in groups or use public swimming pools; little league baseball games were being canceled and there was talk of not opening schools for the fall. Every parent’s nightmare seemed to be the nonspecific febrile summer illness that led to paralytic sequelae. TV news included videos of the iron lung wards in hospitals across the country. Medical providers felt powerless, only able to give nonspecific preventive advice. There was no specific antiviral (there still isn’t) and vaccines seemed a long way off.
Then came the news that Dr. Jonas Salk’s group had gotten an inactivated polio vaccine (IPV) approved for general use in 1955. Families were excited to have their children vaccinated. Paralytic polio cases dropped like a rock from approximately 22,000/year in 1952 to approximately 2,200 in 1956. A surge to near 6,000 cases in 1959 led to Dr. Albert Sabin’s oral polio vaccine (OPV), which supplanted IPV in 1961. OPV had the advantages of: 1) Inducing mucosal as well as serum antibodies, 2) more durable responses, and 3) immunity in unvaccinated persons exposed to vaccine virus that had been shed in stools into wastewater and rivers.
By 1964, polio had nearly disappeared. The last wild-type indigenous U.S. case was in 1979. By 1994, all the Americas were declared polio free. Because the only U.S. paralytic polio cases thereafter were foreign imports or were associated with oral vaccine strains (so-called vaccine-associated paralytic polio [VAPP]), OPV was replaced by an enhanced IPV in 2000 to prevent further VAPP.
Polio facts: Polio is asymptomatic in about 70% of infections. Among the 30% with symptoms, paralysis occurs infrequently, with the overall rate of paralytic infections being 0.5% (rate varies by virus type with type 3 having the highest rate).1 Why then was the world so afraid of polio? If every person in a U.S. birth cohort (about 3.7 million) was unvaccinated and became infected with poliovirus, more than 18,000 would get paralytic polio and almost 1,300 would die. Of note, adults have a higher chance of paralytic polio after infection than children.
Concerns in 2022: Persons vaccinated with at least three doses of either IPV or OPV have historically been protected from paralytic polio (99% protection). But are we sure that the United States remains protected against polio after 2 decades of IPV being the only vaccine? Polio could be reintroduced at any time to the United States from countries with reported cases that likely arose because of low vaccination rates related to war, famine, or political upheavals (Malawi, Mozambique, Nigeria, Pakistan, and Afghanistan).2 The proof? The recent confirmed New York case.
International efforts resulted in global eradication of two polio wild-types viruses (type 2 in 2015 and type 3 in 2019). Nevertheless, vaccine-derived, virulent polio virus (VDPV) type 2 and VDPV-3 still circulate in some areas, particularly Africa (VDPV-2) and Israel (VDPV-3). The above-mentioned U.S. case is an unvaccinated adult traveler who went to an area where VDPV-2 circulates and developed disease after returning home.3 So, it was not an indigenous reappearance in the United States and it was not a breakthrough case in a vaccinated person. But it is sobering to realize that all who are unvaccinated remain at risk for paralytic polio in 2022, particularly because vaccination rates declined nearly everywhere during the initial COVID-19 pandemic. We are still catching up, with vaccination rates under 50% in some ZIP codes.4
Are VDPVs circulating in some parts of the United States? Interestingly, wastewater surveillance programs may be the most economical and practical way to perform polio surveillance. Such a program detected polio virus in London wastewater in June 2022.5 New York has recently detected polio in wastewater during testing begun because of the recent case.6
Good news: For paralytic polio, seropositivity at any titer indicates protection, so U.S. serosurveillance data would also be informative. How durable is polio protection in the IPV era? Available data suggest that even though we have used only IPV these past 20 years, seropositivity rates among vaccinees with at least three doses of either IPV or OPV should persist for decades and likely for life. Even before polio became a concern this year, the Centers for Disease Control and Prevention, being proactive, wanted to ensure that the enhanced IPV was producing durable immunity and that persons of all ages remained seropositive to the three polio virus types over 10 years after discontinuing OPV use in 2012.
The CDC collaborated with investigators in Kansas City, Mo., to evaluate titers and seropositivity to all three types in a 2- to 85-year-old otherwise healthy cohort with demographics that mirrored the 2010 census for the Kansas City region, which in turn mirrored the national 2021 census data.7 There were approximately 100 persons in each age cohort, with 200 below age 11 years (the cohort that had received only IPV). Serology was performed at the CDC.
Overall seropositivity rates were high, but lower for type 3 (83.3%) and type 2 (90.7%) than type 1 (94.4%). Of note, most of those seronegative for one or more types were among 2- to 3-year-olds who had not completed their full IPV series, with most seronegative results being against polio types 1 and 3. Further, five, who were confirmed as having received no polio vaccine, were seronegative for all three types. Two with no available vaccine records (over 18 years old) were also seronegative for all three types.
So, regardless of the era in which one got polio vaccine, vaccine protection appears to persist indefinitely after three doses. Even 80-year-olds were still seropositive if they had three doses. We can confidently reassure our patients that the vaccine still works; the persons who need to fear polio in 2022 are those who are not vaccinated or have had fewer than three doses, particularly if they travel to areas of persistent polio. Wild type 1 virus persists in a few countries as does VDPV type 2 and VDPV type 3. Importantly, wild type 2 and wild type 3 (with the lowest seropositivity in 2012 study) have been eliminated globally so the only circulating type 2 and type 3 polio virus is VDPV in a few countries. Travel to these countries warrants review of polio vaccine records and CDC or WHO current recommendations for travelers to those countries.
Dr. Harrison is a professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. Email him at pdnews@mdedge.com.
References
1. Poliomyelitis. World Health Organization fact sheet, 2022 Jul 4..
2. Franco-Paredes C et al. Lancet Infect Dis. 2022 Aug 16. doi: 10.1016/S1473-3099(22)00548-5.
3. Link-Gelles R et al. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1065-8.
4. “Polio vaccination rate for 2-year-olds is as low as 37% in parts of N.Y. county where paralysis case was found,” NBC News, Erika Edwards, 2022 Aug 16. 5. Vaccine-derived poliovirus type 2 (VDPV2) detected in environmental samples in London. Polioeradication.org. 2022 Jun 22.
6. “NYSDOH and NYCDOHMH wastewater monitoring identifies polio in New York City and urges unvaccinated New Yorkers to get vaccinated now,” nyc.gov. 2022 Aug 12.
7. Wallace GS et al. Hum Vaccin Immunother. 2017;13(4):776-83.
Who would have thought we would need to refresh our knowledge on polio virus in 2022? Fate seems cruel to add this concern on the heels of SARS-CoV-2, monkeypox, abnormal seasons for RSV, acute flaccid myelitis (AFM) linked to enteroviruses, and a summer of parechovirus causing infant meningitis. But confirmation that indeed an adult had polio with paralytic disease raises concerns among public health groups and ordinary citizens alike, particularly those who remember polio in its heyday.
History: In the summer of 1952, polio was among the most feared diseases on the planet. Families were advised to not allow children to congregate in groups or use public swimming pools; little league baseball games were being canceled and there was talk of not opening schools for the fall. Every parent’s nightmare seemed to be the nonspecific febrile summer illness that led to paralytic sequelae. TV news included videos of the iron lung wards in hospitals across the country. Medical providers felt powerless, only able to give nonspecific preventive advice. There was no specific antiviral (there still isn’t) and vaccines seemed a long way off.
Then came the news that Dr. Jonas Salk’s group had gotten an inactivated polio vaccine (IPV) approved for general use in 1955. Families were excited to have their children vaccinated. Paralytic polio cases dropped like a rock from approximately 22,000/year in 1952 to approximately 2,200 in 1956. A surge to near 6,000 cases in 1959 led to Dr. Albert Sabin’s oral polio vaccine (OPV), which supplanted IPV in 1961. OPV had the advantages of: 1) Inducing mucosal as well as serum antibodies, 2) more durable responses, and 3) immunity in unvaccinated persons exposed to vaccine virus that had been shed in stools into wastewater and rivers.
By 1964, polio had nearly disappeared. The last wild-type indigenous U.S. case was in 1979. By 1994, all the Americas were declared polio free. Because the only U.S. paralytic polio cases thereafter were foreign imports or were associated with oral vaccine strains (so-called vaccine-associated paralytic polio [VAPP]), OPV was replaced by an enhanced IPV in 2000 to prevent further VAPP.
Polio facts: Polio is asymptomatic in about 70% of infections. Among the 30% with symptoms, paralysis occurs infrequently, with the overall rate of paralytic infections being 0.5% (rate varies by virus type with type 3 having the highest rate).1 Why then was the world so afraid of polio? If every person in a U.S. birth cohort (about 3.7 million) was unvaccinated and became infected with poliovirus, more than 18,000 would get paralytic polio and almost 1,300 would die. Of note, adults have a higher chance of paralytic polio after infection than children.
Concerns in 2022: Persons vaccinated with at least three doses of either IPV or OPV have historically been protected from paralytic polio (99% protection). But are we sure that the United States remains protected against polio after 2 decades of IPV being the only vaccine? Polio could be reintroduced at any time to the United States from countries with reported cases that likely arose because of low vaccination rates related to war, famine, or political upheavals (Malawi, Mozambique, Nigeria, Pakistan, and Afghanistan).2 The proof? The recent confirmed New York case.
International efforts resulted in global eradication of two polio wild-types viruses (type 2 in 2015 and type 3 in 2019). Nevertheless, vaccine-derived, virulent polio virus (VDPV) type 2 and VDPV-3 still circulate in some areas, particularly Africa (VDPV-2) and Israel (VDPV-3). The above-mentioned U.S. case is an unvaccinated adult traveler who went to an area where VDPV-2 circulates and developed disease after returning home.3 So, it was not an indigenous reappearance in the United States and it was not a breakthrough case in a vaccinated person. But it is sobering to realize that all who are unvaccinated remain at risk for paralytic polio in 2022, particularly because vaccination rates declined nearly everywhere during the initial COVID-19 pandemic. We are still catching up, with vaccination rates under 50% in some ZIP codes.4
Are VDPVs circulating in some parts of the United States? Interestingly, wastewater surveillance programs may be the most economical and practical way to perform polio surveillance. Such a program detected polio virus in London wastewater in June 2022.5 New York has recently detected polio in wastewater during testing begun because of the recent case.6
Good news: For paralytic polio, seropositivity at any titer indicates protection, so U.S. serosurveillance data would also be informative. How durable is polio protection in the IPV era? Available data suggest that even though we have used only IPV these past 20 years, seropositivity rates among vaccinees with at least three doses of either IPV or OPV should persist for decades and likely for life. Even before polio became a concern this year, the Centers for Disease Control and Prevention, being proactive, wanted to ensure that the enhanced IPV was producing durable immunity and that persons of all ages remained seropositive to the three polio virus types over 10 years after discontinuing OPV use in 2012.
The CDC collaborated with investigators in Kansas City, Mo., to evaluate titers and seropositivity to all three types in a 2- to 85-year-old otherwise healthy cohort with demographics that mirrored the 2010 census for the Kansas City region, which in turn mirrored the national 2021 census data.7 There were approximately 100 persons in each age cohort, with 200 below age 11 years (the cohort that had received only IPV). Serology was performed at the CDC.
Overall seropositivity rates were high, but lower for type 3 (83.3%) and type 2 (90.7%) than type 1 (94.4%). Of note, most of those seronegative for one or more types were among 2- to 3-year-olds who had not completed their full IPV series, with most seronegative results being against polio types 1 and 3. Further, five, who were confirmed as having received no polio vaccine, were seronegative for all three types. Two with no available vaccine records (over 18 years old) were also seronegative for all three types.
So, regardless of the era in which one got polio vaccine, vaccine protection appears to persist indefinitely after three doses. Even 80-year-olds were still seropositive if they had three doses. We can confidently reassure our patients that the vaccine still works; the persons who need to fear polio in 2022 are those who are not vaccinated or have had fewer than three doses, particularly if they travel to areas of persistent polio. Wild type 1 virus persists in a few countries as does VDPV type 2 and VDPV type 3. Importantly, wild type 2 and wild type 3 (with the lowest seropositivity in 2012 study) have been eliminated globally so the only circulating type 2 and type 3 polio virus is VDPV in a few countries. Travel to these countries warrants review of polio vaccine records and CDC or WHO current recommendations for travelers to those countries.
Dr. Harrison is a professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. Email him at pdnews@mdedge.com.
References
1. Poliomyelitis. World Health Organization fact sheet, 2022 Jul 4..
2. Franco-Paredes C et al. Lancet Infect Dis. 2022 Aug 16. doi: 10.1016/S1473-3099(22)00548-5.
3. Link-Gelles R et al. MMWR Morb Mortal Wkly Rep. 2022 Aug 19;71(33):1065-8.
4. “Polio vaccination rate for 2-year-olds is as low as 37% in parts of N.Y. county where paralysis case was found,” NBC News, Erika Edwards, 2022 Aug 16. 5. Vaccine-derived poliovirus type 2 (VDPV2) detected in environmental samples in London. Polioeradication.org. 2022 Jun 22.
6. “NYSDOH and NYCDOHMH wastewater monitoring identifies polio in New York City and urges unvaccinated New Yorkers to get vaccinated now,” nyc.gov. 2022 Aug 12.
7. Wallace GS et al. Hum Vaccin Immunother. 2017;13(4):776-83.
Pandemic has helped clinicians to gain better insight on pernio, expert says
PORTLAND, ORE. – while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.
“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”
Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.
Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.
In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.
In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.
Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.
“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”
Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.
In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”
According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.
“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”
Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.
“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.
Dr. Fox reported having no relevant disclosures.
PORTLAND, ORE. – while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.
“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”
Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.
Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.
In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.
In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.
Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.
“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”
Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.
In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”
According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.
“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”
Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.
“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.
Dr. Fox reported having no relevant disclosures.
PORTLAND, ORE. – while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.
“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”
Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.
Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.
In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.
In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.
Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.
“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”
Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.
In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”
According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.
“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”
Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.
“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.
Dr. Fox reported having no relevant disclosures.
AT PDA 2022
Talking to teens
After 15 years as a high school teacher at urban schools, I realized adults widely misunderstand that teenagers do not want to talk to them. In fact, most crave finding an adult they can trust and have serious conversations about issues like sex, drugs, and death. G was a sophomore who was going blind from a rare degenerative disease and one day sought my guidance about a sexual orgy he accidentally got in involved in. Was it wrong? Would God send him to hell? Why was he now so anxious after?
Because I was an openly gay teacher, students every semester would come out to me, asking what the “gay scene” was like, or how to deal with a homophobic family. Sometimes, students would seek counsel about an unplanned pregnancy, about abortion. In one instance, a student sought counsel about her violent thoughts, and eventually checked herself into a psychiatric ward. Five separate times, students in my class were murdered and I accompanied my classes through mourning.
Unlike many pediatricians, a teacher has a lot of time with these young adults: daily, sometimes over years. Students often admit they spend more time with their teachers than their parents. I can’t give you that time, but here are some general tips.
Attitude promoting trust
My guiding attitude toward teens was that they were my equals. I would “do unto them as I would have them do unto me.” Not less, but also not more – because sometimes “more” can cloak condescension. When I was a student, I trusted teachers who shared their fears and mistakes, not performing under a confessional spotlight, but to establish commonality, to flatten hierarchy. I also trusted those who could set boundaries and wield authority compassionately. Because sometimes I needed a firm hand. And so, as an adult I tried to give this to my students as well.
Although my students and I were equals, our situations are different. That is true with gender, race, and class, and it is also true with adults versus teens. The first step toward treating someone authentically as an equal when in a position of authority is to understand the unique stressors of their life. That means asking questions and listening to what they need.
Stressors in a teen’s life
A typical high school junior or senior goes to work 8-10 hours a day. Unpaid. They sit for hours at a small desk in a small room with sometimes 34 others. Most of the time they cannot eat or use their phone. If they need to pee, they need to ask permission. They have to ask permission to speak. And then when they go home, they sit at a small desk again for homework. They often do not even have their own room. They also have to ask for permission to buy something for themselves, for money, for a ride anywhere. Their values are often compromised so they won’t get kicked out of a house or a class. The life of a teen is not at all “carefree” but largely prescribed and with little control.
When I think about my youth and how little freedom, privacy, and control I had compared with now, it softens my attitude to even the rudest student. (Isn’t rudeness often a sign of resistance against an oppressive system?) But, some may say, these teens do not have to worry about bills. But if I think back honestly to my teen years, would I trade the responsibilities I have now for those supposed carefree years? Carefree is not how most teens describe their lives but a nostalgic rosy retrospection adults assign. Almost all teens I taught would rather work to gain some control over their lives. Which is why so many work 4-5 hours after school on top of homework, giving up their weekends, and binding themselves to a “carefree” 60- to 80-hour work week.
Talking about drugs, sex, and mental health
Drugs
It’s a good idea to first disarm teens of their fear of judgment or punishment, saying things like: “It’s normal to experiment with drugs, even hard ones.” The most successful, respected adults you see now have, so it’s not a reflection of who you are. Tell me what you’re worried about and it’ll be just between us.
After rapport is established, follow-up questions that elicit and affirm their feelings and thoughts can encourage more revelations: Do you think you have a problem? Why? How do you get your drugs and I’m curious only because finding that out can help us understand risks and solutions. What made you start? And keep on using?
Sex
Again, first disarm their fears: You can talk to me freely and confidently about sex: What you do, who you do it with, how you do it, and how often – I know that people are very different in their sexual interests and activities.
It is also good to set up clear boundaries. I had instances where students had romantic interest in me and would use these conversations as overtures. If you feel like your patient may be interested in you, then be explicit about boundaries: I’m a doctor who can point you to resources or offer treatments related to any sexual practice and its consequences, but that is all I am. Anything else is illegal and would end our patient-doctor relationship. (I would also immediately document the interaction and tell it to a witness.)
I never escalated incidences like this because I understood that most teens are naturally curious and often not taught about sexual boundaries, so I tried to make these encounters “teachable moments,” not punitive ones. Many teens are more aware of health consequences, like STDs or pregnancy, than psychological ones. So, it’s useful to ask: When you have sex outside your relationship, how does that make you feel? Does sex with multiple partners make you anxious or guilty afterwards? I like to use straightforward language and normalize taboo sexual practices with an even tone to allow teens to speak truthfully.
Suicide/depression
First, disarm and normalize: It is very common for people to have depression or thoughts of suicide. Most of the adults around you probably have and so have I (if that is true). Have you experienced this? Older teens often crave an intelligent open discussion about depression and suicide. If they look particularly distressed, I also tell them that I, and countless others, found strategies to deal with these thoughts. For most older teens, talking about causes of mental health issues and treatments is a breath of fresh air. This is especially true for teens from urban communities who have dealt precociously with death and violence, minority communities where mental health is often stigmatized, and young males whose machismo code can prevent them from acknowledging their feelings.
Some follow-up questions: Where do you think these thoughts come from? And if they don’t know: It’s perfectly normal for there to be no reason. The important thing is that they don’t last too long and that you know that. And if they do, then I can provide you resources and potential treatments.
Summary
Treating teens as equals by understanding their situation allows understanding and compassion for their stressors. This motivates an inquisitive and collaborative patient-centric approach that allows a sharing of sensitive topics like drugs, sex, and mental health.
Dr. Nguyen is a resident in psychiatry at the University of California, San Francisco.
*This story was updated on Nov. 3, 2022.
After 15 years as a high school teacher at urban schools, I realized adults widely misunderstand that teenagers do not want to talk to them. In fact, most crave finding an adult they can trust and have serious conversations about issues like sex, drugs, and death. G was a sophomore who was going blind from a rare degenerative disease and one day sought my guidance about a sexual orgy he accidentally got in involved in. Was it wrong? Would God send him to hell? Why was he now so anxious after?
Because I was an openly gay teacher, students every semester would come out to me, asking what the “gay scene” was like, or how to deal with a homophobic family. Sometimes, students would seek counsel about an unplanned pregnancy, about abortion. In one instance, a student sought counsel about her violent thoughts, and eventually checked herself into a psychiatric ward. Five separate times, students in my class were murdered and I accompanied my classes through mourning.
Unlike many pediatricians, a teacher has a lot of time with these young adults: daily, sometimes over years. Students often admit they spend more time with their teachers than their parents. I can’t give you that time, but here are some general tips.
Attitude promoting trust
My guiding attitude toward teens was that they were my equals. I would “do unto them as I would have them do unto me.” Not less, but also not more – because sometimes “more” can cloak condescension. When I was a student, I trusted teachers who shared their fears and mistakes, not performing under a confessional spotlight, but to establish commonality, to flatten hierarchy. I also trusted those who could set boundaries and wield authority compassionately. Because sometimes I needed a firm hand. And so, as an adult I tried to give this to my students as well.
Although my students and I were equals, our situations are different. That is true with gender, race, and class, and it is also true with adults versus teens. The first step toward treating someone authentically as an equal when in a position of authority is to understand the unique stressors of their life. That means asking questions and listening to what they need.
Stressors in a teen’s life
A typical high school junior or senior goes to work 8-10 hours a day. Unpaid. They sit for hours at a small desk in a small room with sometimes 34 others. Most of the time they cannot eat or use their phone. If they need to pee, they need to ask permission. They have to ask permission to speak. And then when they go home, they sit at a small desk again for homework. They often do not even have their own room. They also have to ask for permission to buy something for themselves, for money, for a ride anywhere. Their values are often compromised so they won’t get kicked out of a house or a class. The life of a teen is not at all “carefree” but largely prescribed and with little control.
When I think about my youth and how little freedom, privacy, and control I had compared with now, it softens my attitude to even the rudest student. (Isn’t rudeness often a sign of resistance against an oppressive system?) But, some may say, these teens do not have to worry about bills. But if I think back honestly to my teen years, would I trade the responsibilities I have now for those supposed carefree years? Carefree is not how most teens describe their lives but a nostalgic rosy retrospection adults assign. Almost all teens I taught would rather work to gain some control over their lives. Which is why so many work 4-5 hours after school on top of homework, giving up their weekends, and binding themselves to a “carefree” 60- to 80-hour work week.
Talking about drugs, sex, and mental health
Drugs
It’s a good idea to first disarm teens of their fear of judgment or punishment, saying things like: “It’s normal to experiment with drugs, even hard ones.” The most successful, respected adults you see now have, so it’s not a reflection of who you are. Tell me what you’re worried about and it’ll be just between us.
After rapport is established, follow-up questions that elicit and affirm their feelings and thoughts can encourage more revelations: Do you think you have a problem? Why? How do you get your drugs and I’m curious only because finding that out can help us understand risks and solutions. What made you start? And keep on using?
Sex
Again, first disarm their fears: You can talk to me freely and confidently about sex: What you do, who you do it with, how you do it, and how often – I know that people are very different in their sexual interests and activities.
It is also good to set up clear boundaries. I had instances where students had romantic interest in me and would use these conversations as overtures. If you feel like your patient may be interested in you, then be explicit about boundaries: I’m a doctor who can point you to resources or offer treatments related to any sexual practice and its consequences, but that is all I am. Anything else is illegal and would end our patient-doctor relationship. (I would also immediately document the interaction and tell it to a witness.)
I never escalated incidences like this because I understood that most teens are naturally curious and often not taught about sexual boundaries, so I tried to make these encounters “teachable moments,” not punitive ones. Many teens are more aware of health consequences, like STDs or pregnancy, than psychological ones. So, it’s useful to ask: When you have sex outside your relationship, how does that make you feel? Does sex with multiple partners make you anxious or guilty afterwards? I like to use straightforward language and normalize taboo sexual practices with an even tone to allow teens to speak truthfully.
Suicide/depression
First, disarm and normalize: It is very common for people to have depression or thoughts of suicide. Most of the adults around you probably have and so have I (if that is true). Have you experienced this? Older teens often crave an intelligent open discussion about depression and suicide. If they look particularly distressed, I also tell them that I, and countless others, found strategies to deal with these thoughts. For most older teens, talking about causes of mental health issues and treatments is a breath of fresh air. This is especially true for teens from urban communities who have dealt precociously with death and violence, minority communities where mental health is often stigmatized, and young males whose machismo code can prevent them from acknowledging their feelings.
Some follow-up questions: Where do you think these thoughts come from? And if they don’t know: It’s perfectly normal for there to be no reason. The important thing is that they don’t last too long and that you know that. And if they do, then I can provide you resources and potential treatments.
Summary
Treating teens as equals by understanding their situation allows understanding and compassion for their stressors. This motivates an inquisitive and collaborative patient-centric approach that allows a sharing of sensitive topics like drugs, sex, and mental health.
Dr. Nguyen is a resident in psychiatry at the University of California, San Francisco.
*This story was updated on Nov. 3, 2022.
After 15 years as a high school teacher at urban schools, I realized adults widely misunderstand that teenagers do not want to talk to them. In fact, most crave finding an adult they can trust and have serious conversations about issues like sex, drugs, and death. G was a sophomore who was going blind from a rare degenerative disease and one day sought my guidance about a sexual orgy he accidentally got in involved in. Was it wrong? Would God send him to hell? Why was he now so anxious after?
Because I was an openly gay teacher, students every semester would come out to me, asking what the “gay scene” was like, or how to deal with a homophobic family. Sometimes, students would seek counsel about an unplanned pregnancy, about abortion. In one instance, a student sought counsel about her violent thoughts, and eventually checked herself into a psychiatric ward. Five separate times, students in my class were murdered and I accompanied my classes through mourning.
Unlike many pediatricians, a teacher has a lot of time with these young adults: daily, sometimes over years. Students often admit they spend more time with their teachers than their parents. I can’t give you that time, but here are some general tips.
Attitude promoting trust
My guiding attitude toward teens was that they were my equals. I would “do unto them as I would have them do unto me.” Not less, but also not more – because sometimes “more” can cloak condescension. When I was a student, I trusted teachers who shared their fears and mistakes, not performing under a confessional spotlight, but to establish commonality, to flatten hierarchy. I also trusted those who could set boundaries and wield authority compassionately. Because sometimes I needed a firm hand. And so, as an adult I tried to give this to my students as well.
Although my students and I were equals, our situations are different. That is true with gender, race, and class, and it is also true with adults versus teens. The first step toward treating someone authentically as an equal when in a position of authority is to understand the unique stressors of their life. That means asking questions and listening to what they need.
Stressors in a teen’s life
A typical high school junior or senior goes to work 8-10 hours a day. Unpaid. They sit for hours at a small desk in a small room with sometimes 34 others. Most of the time they cannot eat or use their phone. If they need to pee, they need to ask permission. They have to ask permission to speak. And then when they go home, they sit at a small desk again for homework. They often do not even have their own room. They also have to ask for permission to buy something for themselves, for money, for a ride anywhere. Their values are often compromised so they won’t get kicked out of a house or a class. The life of a teen is not at all “carefree” but largely prescribed and with little control.
When I think about my youth and how little freedom, privacy, and control I had compared with now, it softens my attitude to even the rudest student. (Isn’t rudeness often a sign of resistance against an oppressive system?) But, some may say, these teens do not have to worry about bills. But if I think back honestly to my teen years, would I trade the responsibilities I have now for those supposed carefree years? Carefree is not how most teens describe their lives but a nostalgic rosy retrospection adults assign. Almost all teens I taught would rather work to gain some control over their lives. Which is why so many work 4-5 hours after school on top of homework, giving up their weekends, and binding themselves to a “carefree” 60- to 80-hour work week.
Talking about drugs, sex, and mental health
Drugs
It’s a good idea to first disarm teens of their fear of judgment or punishment, saying things like: “It’s normal to experiment with drugs, even hard ones.” The most successful, respected adults you see now have, so it’s not a reflection of who you are. Tell me what you’re worried about and it’ll be just between us.
After rapport is established, follow-up questions that elicit and affirm their feelings and thoughts can encourage more revelations: Do you think you have a problem? Why? How do you get your drugs and I’m curious only because finding that out can help us understand risks and solutions. What made you start? And keep on using?
Sex
Again, first disarm their fears: You can talk to me freely and confidently about sex: What you do, who you do it with, how you do it, and how often – I know that people are very different in their sexual interests and activities.
It is also good to set up clear boundaries. I had instances where students had romantic interest in me and would use these conversations as overtures. If you feel like your patient may be interested in you, then be explicit about boundaries: I’m a doctor who can point you to resources or offer treatments related to any sexual practice and its consequences, but that is all I am. Anything else is illegal and would end our patient-doctor relationship. (I would also immediately document the interaction and tell it to a witness.)
I never escalated incidences like this because I understood that most teens are naturally curious and often not taught about sexual boundaries, so I tried to make these encounters “teachable moments,” not punitive ones. Many teens are more aware of health consequences, like STDs or pregnancy, than psychological ones. So, it’s useful to ask: When you have sex outside your relationship, how does that make you feel? Does sex with multiple partners make you anxious or guilty afterwards? I like to use straightforward language and normalize taboo sexual practices with an even tone to allow teens to speak truthfully.
Suicide/depression
First, disarm and normalize: It is very common for people to have depression or thoughts of suicide. Most of the adults around you probably have and so have I (if that is true). Have you experienced this? Older teens often crave an intelligent open discussion about depression and suicide. If they look particularly distressed, I also tell them that I, and countless others, found strategies to deal with these thoughts. For most older teens, talking about causes of mental health issues and treatments is a breath of fresh air. This is especially true for teens from urban communities who have dealt precociously with death and violence, minority communities where mental health is often stigmatized, and young males whose machismo code can prevent them from acknowledging their feelings.
Some follow-up questions: Where do you think these thoughts come from? And if they don’t know: It’s perfectly normal for there to be no reason. The important thing is that they don’t last too long and that you know that. And if they do, then I can provide you resources and potential treatments.
Summary
Treating teens as equals by understanding their situation allows understanding and compassion for their stressors. This motivates an inquisitive and collaborative patient-centric approach that allows a sharing of sensitive topics like drugs, sex, and mental health.
Dr. Nguyen is a resident in psychiatry at the University of California, San Francisco.
*This story was updated on Nov. 3, 2022.
Newborns get routine heel blood tests, but should states keep those samples?
Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.
But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.
Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.
In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.
Philip L. Ellison, an attorney in Hemlock, Mich., who is spearheading the suit, said he became aware of the issue when his son was born 5 years ago. Mr. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Mr. Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.
The unexpected request set off alarm bells for Mr. Ellison.
“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement.”
Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.
Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used deidentified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.
Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.
Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.
Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.
Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.
“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’ ” to having their newborns’ leftover blood used in research, said Beth Tarini, MD, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”
In Michigan, 64% of parents consented to participate, according to court documents in Mr. Ellison’s case.
Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the United States.
“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Kyle Brothers, MD, PhD, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Ky.
After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.
Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.
To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.
In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.
The lawsuit seeks to find out how often in the past 5 years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”
New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.
Ms. Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use.”
The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Ms. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.
A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.
In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Ms. Wuth said. “Typically, this means someone has been killed or gone missing,” she added.
Many clinicians and bioethicists say that standards for the use of blood spots need to be set.
“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.
But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.
Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.
In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.
Philip L. Ellison, an attorney in Hemlock, Mich., who is spearheading the suit, said he became aware of the issue when his son was born 5 years ago. Mr. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Mr. Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.
The unexpected request set off alarm bells for Mr. Ellison.
“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement.”
Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.
Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used deidentified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.
Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.
Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.
Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.
Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.
“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’ ” to having their newborns’ leftover blood used in research, said Beth Tarini, MD, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”
In Michigan, 64% of parents consented to participate, according to court documents in Mr. Ellison’s case.
Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the United States.
“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Kyle Brothers, MD, PhD, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Ky.
After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.
Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.
To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.
In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.
The lawsuit seeks to find out how often in the past 5 years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”
New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.
Ms. Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use.”
The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Ms. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.
A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.
In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Ms. Wuth said. “Typically, this means someone has been killed or gone missing,” she added.
Many clinicians and bioethicists say that standards for the use of blood spots need to be set.
“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.
But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.
Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.
In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.
Philip L. Ellison, an attorney in Hemlock, Mich., who is spearheading the suit, said he became aware of the issue when his son was born 5 years ago. Mr. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Mr. Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.
The unexpected request set off alarm bells for Mr. Ellison.
“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement.”
Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.
Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used deidentified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.
Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.
Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.
Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.
Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.
“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’ ” to having their newborns’ leftover blood used in research, said Beth Tarini, MD, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”
In Michigan, 64% of parents consented to participate, according to court documents in Mr. Ellison’s case.
Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the United States.
“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Kyle Brothers, MD, PhD, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Ky.
After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.
Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.
To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.
In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.
The lawsuit seeks to find out how often in the past 5 years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”
New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.
Ms. Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use.”
The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Ms. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.
A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.
In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Ms. Wuth said. “Typically, this means someone has been killed or gone missing,” she added.
Many clinicians and bioethicists say that standards for the use of blood spots need to be set.
“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Two states aim to curb diet pill sales to minors
California and New York are on the cusp of going further than the Food and Drug Administration in restricting the sale of nonprescription diet pills to minors as pediatricians and public health advocates try to protect kids from extreme weight-loss gimmicks online.
A bill before Gov. Gavin Newsom would bar anyone under 18 in California from buying over-the-counter weight-loss supplements – whether online or in shops – without a prescription. A similar bill passed by New York lawmakers is on Gov. Kathy Hochul’s desk. Neither Democrat has indicated how he or she will act.
If both bills are signed into law, proponents hope the momentum will build to restrict diet pill sales to children in more states. Massachusetts, New Jersey, and Missouri have introduced similar bills and backers plan to continue their push next year.
Nearly 30 million people in the United States will have an eating disorder in their lifetime; 95% of them are aged between 12 and 25, according to Johns Hopkins All Children’s Hospital. The hospital added that eating disorders pose the highest risk of mortality of any mental health disorder. And it has become easier than ever for minors to get pills that are sold online or on drugstore shelves. All dietary supplements, which include those for weight loss, accounted for nearly 35% of the $63 billion over-the-counter health products industry in 2021, according to Vision Research Reports, a market research firm.
Dietary supplements, which encompass a broad range of vitamins, herbs, and minerals, are classified by the FDA as food and don’t undergo scientific and safety testing as prescription drugs and over-the-counter medicines do.
Public health advocates want to keep weight-loss products – with ads that may promise to “Drop 5 pounds a week!” and pill names like Slim Sense – away from young people, particularly girls, since some research has linked some products to eating disorders. A study in the American Journal of Public Health, which followed more than 10,000 women aged 14-36 over 15 years, found that “those who used diet pills had more than 5 times higher adjusted odds of receiving an eating disorder diagnosis from a health care provider within 1-3 years than those who did not.”
Many pills have been found tainted with banned and dangerous ingredients that may cause cancer, heart attacks, strokes, and other ailments. For example, the FDA advised the public to avoid Slim Sense by Dr. Reade because it contains lorcaserin, which has been found to cause psychiatric disturbances and impairments in attention or memory. The FDA ordered it discontinued and the company couldn’t be reached for comment.
“Unscrupulous manufacturers are willing to take risks with consumers’ health – and they are lacing their products with illegal pharmaceuticals, banned pharmaceuticals, steroids, excessive stimulants, even experimental stimulants,” said S. Bryn Austin, ScD, founding director of the Strategic Training Initiative for the Prevention of Eating Disorders, or STRIPED, which supports the restrictions. “Consumers have no idea that this is what’s in these types of products.”
STRIPED is a public health initiative based at the Harvard School of Public Health, Boston, and Boston Children’s Hospital.
An industry trade group, the Natural Products Association, disputes that diet pills cause eating disorders, citing the lack of consumer complaints to the FDA of adverse events from their members’ products. “According to FDA data, there is no association between the two,” said Kyle Turk, the association’s director of government affairs.
The association contends that its members adhere to safe manufacturing processes, random product testing, and appropriate marketing guidelines. Representatives also worry that if minors can’t buy supplements over the counter, they may buy them from “crooks” on the black market and undermine the integrity of the industry. Under the bills, minors purchasing weight-loss products must show identification along with a prescription.
Not all business groups oppose the ban. The American Herbal Products Association, a trade group representing dietary supplement manufacturers and retailers, dropped its opposition to California’s bill once it was amended to remove ingredient categories that are found in non-diet supplements and vitamins, according to Robert Marriott, director of regulatory affairs.
Children’s advocates have found worrisome trends among young people who envision their ideal body type based on what they see on social media. According to a study commissioned by Fairplay, a nonprofit that seeks to stop harmful marketing practices targeting children, kids as young as 9 were found to be following three or more eating disorder accounts on Instagram, while the median age was 19. The authors called it a “pro–eating disorder bubble.”
Meta, which owns Instagram and Facebook, said the report lacks nuance, such as recognizing the human need to share life’s difficult moments. The company argues that blanket censorship isn’t the answer. “Experts and safety organizations have told us it’s important to strike a balance and allow people to share their personal stories while removing any content that encourages or promotes eating disorders,” Liza Crenshaw, a Meta spokesperson, said in an email.
Jason Nagata, MD, a pediatrician who cares for children and young adults with life-threatening eating disorders, believes that easy access to diet pills contributes to his patients’ conditions at UCSF Benioff Children’s Hospital in San Francisco. That was the case for one of his patients, an emaciated 11-year-old girl.
“She had basically entered a starvation state because she was not getting enough nutrition,” said Dr. Nagata, who provided supporting testimony for the California bill. “She was taking these pills and using other kinds of extreme behaviors to lose weight.”
Dr. Nagata said the number of patients he sees with eating disorders has tripled since the pandemic began. They are desperate to get diet pills, some with modest results. “We’ve had patients who have been so dependent on these products that they will be hospitalized and they’re still ordering these products on Amazon,” he said.
Public health advocates turned to state legislatures in response to the federal government’s limited authority to regulate diet pills. Under a 1994 federal law known as the Dietary Supplement Health and Education Act, the FDA “cannot step in until after there is a clear issue of harm to consumers,” said Dr. Austin.
No match for the supplement industry’s heavy lobbying on Capitol Hill, public health advocates shifted to a state-by-state approach.
There is, however, a push for the FDA to improve oversight of what goes into diet pills. Sen. Dick Durbin (D-Ill.) in April introduced a bill that would require dietary supplement manufacturers to register their products – along with the ingredients – with the regulator.
Proponents say the change is needed because manufacturers have been known to include dangerous ingredients. C. Michael White, PharmD, of the University of Connecticut, Storrs, found 35% of tainted health products came from weight-loss supplements in a review of a health fraud database.
A few ingredients have been banned, including sibutramine, a stimulant. “It was a very commonly used weight-loss supplement that ended up being removed from the U.S. market because of its elevated risk of causing things like heart attacks, strokes, and arrhythmias,” Dr. White said.
Another ingredient was phenolphthalein, which was used in laxatives until it was identified as a suspected carcinogen and banned in 1999. “To think,” he said, “that that product would still be on the U.S. market is just unconscionable.”
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
California and New York are on the cusp of going further than the Food and Drug Administration in restricting the sale of nonprescription diet pills to minors as pediatricians and public health advocates try to protect kids from extreme weight-loss gimmicks online.
A bill before Gov. Gavin Newsom would bar anyone under 18 in California from buying over-the-counter weight-loss supplements – whether online or in shops – without a prescription. A similar bill passed by New York lawmakers is on Gov. Kathy Hochul’s desk. Neither Democrat has indicated how he or she will act.
If both bills are signed into law, proponents hope the momentum will build to restrict diet pill sales to children in more states. Massachusetts, New Jersey, and Missouri have introduced similar bills and backers plan to continue their push next year.
Nearly 30 million people in the United States will have an eating disorder in their lifetime; 95% of them are aged between 12 and 25, according to Johns Hopkins All Children’s Hospital. The hospital added that eating disorders pose the highest risk of mortality of any mental health disorder. And it has become easier than ever for minors to get pills that are sold online or on drugstore shelves. All dietary supplements, which include those for weight loss, accounted for nearly 35% of the $63 billion over-the-counter health products industry in 2021, according to Vision Research Reports, a market research firm.
Dietary supplements, which encompass a broad range of vitamins, herbs, and minerals, are classified by the FDA as food and don’t undergo scientific and safety testing as prescription drugs and over-the-counter medicines do.
Public health advocates want to keep weight-loss products – with ads that may promise to “Drop 5 pounds a week!” and pill names like Slim Sense – away from young people, particularly girls, since some research has linked some products to eating disorders. A study in the American Journal of Public Health, which followed more than 10,000 women aged 14-36 over 15 years, found that “those who used diet pills had more than 5 times higher adjusted odds of receiving an eating disorder diagnosis from a health care provider within 1-3 years than those who did not.”
Many pills have been found tainted with banned and dangerous ingredients that may cause cancer, heart attacks, strokes, and other ailments. For example, the FDA advised the public to avoid Slim Sense by Dr. Reade because it contains lorcaserin, which has been found to cause psychiatric disturbances and impairments in attention or memory. The FDA ordered it discontinued and the company couldn’t be reached for comment.
“Unscrupulous manufacturers are willing to take risks with consumers’ health – and they are lacing their products with illegal pharmaceuticals, banned pharmaceuticals, steroids, excessive stimulants, even experimental stimulants,” said S. Bryn Austin, ScD, founding director of the Strategic Training Initiative for the Prevention of Eating Disorders, or STRIPED, which supports the restrictions. “Consumers have no idea that this is what’s in these types of products.”
STRIPED is a public health initiative based at the Harvard School of Public Health, Boston, and Boston Children’s Hospital.
An industry trade group, the Natural Products Association, disputes that diet pills cause eating disorders, citing the lack of consumer complaints to the FDA of adverse events from their members’ products. “According to FDA data, there is no association between the two,” said Kyle Turk, the association’s director of government affairs.
The association contends that its members adhere to safe manufacturing processes, random product testing, and appropriate marketing guidelines. Representatives also worry that if minors can’t buy supplements over the counter, they may buy them from “crooks” on the black market and undermine the integrity of the industry. Under the bills, minors purchasing weight-loss products must show identification along with a prescription.
Not all business groups oppose the ban. The American Herbal Products Association, a trade group representing dietary supplement manufacturers and retailers, dropped its opposition to California’s bill once it was amended to remove ingredient categories that are found in non-diet supplements and vitamins, according to Robert Marriott, director of regulatory affairs.
Children’s advocates have found worrisome trends among young people who envision their ideal body type based on what they see on social media. According to a study commissioned by Fairplay, a nonprofit that seeks to stop harmful marketing practices targeting children, kids as young as 9 were found to be following three or more eating disorder accounts on Instagram, while the median age was 19. The authors called it a “pro–eating disorder bubble.”
Meta, which owns Instagram and Facebook, said the report lacks nuance, such as recognizing the human need to share life’s difficult moments. The company argues that blanket censorship isn’t the answer. “Experts and safety organizations have told us it’s important to strike a balance and allow people to share their personal stories while removing any content that encourages or promotes eating disorders,” Liza Crenshaw, a Meta spokesperson, said in an email.
Jason Nagata, MD, a pediatrician who cares for children and young adults with life-threatening eating disorders, believes that easy access to diet pills contributes to his patients’ conditions at UCSF Benioff Children’s Hospital in San Francisco. That was the case for one of his patients, an emaciated 11-year-old girl.
“She had basically entered a starvation state because she was not getting enough nutrition,” said Dr. Nagata, who provided supporting testimony for the California bill. “She was taking these pills and using other kinds of extreme behaviors to lose weight.”
Dr. Nagata said the number of patients he sees with eating disorders has tripled since the pandemic began. They are desperate to get diet pills, some with modest results. “We’ve had patients who have been so dependent on these products that they will be hospitalized and they’re still ordering these products on Amazon,” he said.
Public health advocates turned to state legislatures in response to the federal government’s limited authority to regulate diet pills. Under a 1994 federal law known as the Dietary Supplement Health and Education Act, the FDA “cannot step in until after there is a clear issue of harm to consumers,” said Dr. Austin.
No match for the supplement industry’s heavy lobbying on Capitol Hill, public health advocates shifted to a state-by-state approach.
There is, however, a push for the FDA to improve oversight of what goes into diet pills. Sen. Dick Durbin (D-Ill.) in April introduced a bill that would require dietary supplement manufacturers to register their products – along with the ingredients – with the regulator.
Proponents say the change is needed because manufacturers have been known to include dangerous ingredients. C. Michael White, PharmD, of the University of Connecticut, Storrs, found 35% of tainted health products came from weight-loss supplements in a review of a health fraud database.
A few ingredients have been banned, including sibutramine, a stimulant. “It was a very commonly used weight-loss supplement that ended up being removed from the U.S. market because of its elevated risk of causing things like heart attacks, strokes, and arrhythmias,” Dr. White said.
Another ingredient was phenolphthalein, which was used in laxatives until it was identified as a suspected carcinogen and banned in 1999. “To think,” he said, “that that product would still be on the U.S. market is just unconscionable.”
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
California and New York are on the cusp of going further than the Food and Drug Administration in restricting the sale of nonprescription diet pills to minors as pediatricians and public health advocates try to protect kids from extreme weight-loss gimmicks online.
A bill before Gov. Gavin Newsom would bar anyone under 18 in California from buying over-the-counter weight-loss supplements – whether online or in shops – without a prescription. A similar bill passed by New York lawmakers is on Gov. Kathy Hochul’s desk. Neither Democrat has indicated how he or she will act.
If both bills are signed into law, proponents hope the momentum will build to restrict diet pill sales to children in more states. Massachusetts, New Jersey, and Missouri have introduced similar bills and backers plan to continue their push next year.
Nearly 30 million people in the United States will have an eating disorder in their lifetime; 95% of them are aged between 12 and 25, according to Johns Hopkins All Children’s Hospital. The hospital added that eating disorders pose the highest risk of mortality of any mental health disorder. And it has become easier than ever for minors to get pills that are sold online or on drugstore shelves. All dietary supplements, which include those for weight loss, accounted for nearly 35% of the $63 billion over-the-counter health products industry in 2021, according to Vision Research Reports, a market research firm.
Dietary supplements, which encompass a broad range of vitamins, herbs, and minerals, are classified by the FDA as food and don’t undergo scientific and safety testing as prescription drugs and over-the-counter medicines do.
Public health advocates want to keep weight-loss products – with ads that may promise to “Drop 5 pounds a week!” and pill names like Slim Sense – away from young people, particularly girls, since some research has linked some products to eating disorders. A study in the American Journal of Public Health, which followed more than 10,000 women aged 14-36 over 15 years, found that “those who used diet pills had more than 5 times higher adjusted odds of receiving an eating disorder diagnosis from a health care provider within 1-3 years than those who did not.”
Many pills have been found tainted with banned and dangerous ingredients that may cause cancer, heart attacks, strokes, and other ailments. For example, the FDA advised the public to avoid Slim Sense by Dr. Reade because it contains lorcaserin, which has been found to cause psychiatric disturbances and impairments in attention or memory. The FDA ordered it discontinued and the company couldn’t be reached for comment.
“Unscrupulous manufacturers are willing to take risks with consumers’ health – and they are lacing their products with illegal pharmaceuticals, banned pharmaceuticals, steroids, excessive stimulants, even experimental stimulants,” said S. Bryn Austin, ScD, founding director of the Strategic Training Initiative for the Prevention of Eating Disorders, or STRIPED, which supports the restrictions. “Consumers have no idea that this is what’s in these types of products.”
STRIPED is a public health initiative based at the Harvard School of Public Health, Boston, and Boston Children’s Hospital.
An industry trade group, the Natural Products Association, disputes that diet pills cause eating disorders, citing the lack of consumer complaints to the FDA of adverse events from their members’ products. “According to FDA data, there is no association between the two,” said Kyle Turk, the association’s director of government affairs.
The association contends that its members adhere to safe manufacturing processes, random product testing, and appropriate marketing guidelines. Representatives also worry that if minors can’t buy supplements over the counter, they may buy them from “crooks” on the black market and undermine the integrity of the industry. Under the bills, minors purchasing weight-loss products must show identification along with a prescription.
Not all business groups oppose the ban. The American Herbal Products Association, a trade group representing dietary supplement manufacturers and retailers, dropped its opposition to California’s bill once it was amended to remove ingredient categories that are found in non-diet supplements and vitamins, according to Robert Marriott, director of regulatory affairs.
Children’s advocates have found worrisome trends among young people who envision their ideal body type based on what they see on social media. According to a study commissioned by Fairplay, a nonprofit that seeks to stop harmful marketing practices targeting children, kids as young as 9 were found to be following three or more eating disorder accounts on Instagram, while the median age was 19. The authors called it a “pro–eating disorder bubble.”
Meta, which owns Instagram and Facebook, said the report lacks nuance, such as recognizing the human need to share life’s difficult moments. The company argues that blanket censorship isn’t the answer. “Experts and safety organizations have told us it’s important to strike a balance and allow people to share their personal stories while removing any content that encourages or promotes eating disorders,” Liza Crenshaw, a Meta spokesperson, said in an email.
Jason Nagata, MD, a pediatrician who cares for children and young adults with life-threatening eating disorders, believes that easy access to diet pills contributes to his patients’ conditions at UCSF Benioff Children’s Hospital in San Francisco. That was the case for one of his patients, an emaciated 11-year-old girl.
“She had basically entered a starvation state because she was not getting enough nutrition,” said Dr. Nagata, who provided supporting testimony for the California bill. “She was taking these pills and using other kinds of extreme behaviors to lose weight.”
Dr. Nagata said the number of patients he sees with eating disorders has tripled since the pandemic began. They are desperate to get diet pills, some with modest results. “We’ve had patients who have been so dependent on these products that they will be hospitalized and they’re still ordering these products on Amazon,” he said.
Public health advocates turned to state legislatures in response to the federal government’s limited authority to regulate diet pills. Under a 1994 federal law known as the Dietary Supplement Health and Education Act, the FDA “cannot step in until after there is a clear issue of harm to consumers,” said Dr. Austin.
No match for the supplement industry’s heavy lobbying on Capitol Hill, public health advocates shifted to a state-by-state approach.
There is, however, a push for the FDA to improve oversight of what goes into diet pills. Sen. Dick Durbin (D-Ill.) in April introduced a bill that would require dietary supplement manufacturers to register their products – along with the ingredients – with the regulator.
Proponents say the change is needed because manufacturers have been known to include dangerous ingredients. C. Michael White, PharmD, of the University of Connecticut, Storrs, found 35% of tainted health products came from weight-loss supplements in a review of a health fraud database.
A few ingredients have been banned, including sibutramine, a stimulant. “It was a very commonly used weight-loss supplement that ended up being removed from the U.S. market because of its elevated risk of causing things like heart attacks, strokes, and arrhythmias,” Dr. White said.
Another ingredient was phenolphthalein, which was used in laxatives until it was identified as a suspected carcinogen and banned in 1999. “To think,” he said, “that that product would still be on the U.S. market is just unconscionable.”
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Mental health in America: ‘The kids are not alright’
A new report shines a light on the toll the pandemic and other stressors have taken on the mental health of U.S. children and adolescents over the last 6 years.
The report shows a dramatic increase in use of acute care services for depression, anxiety, and other mental health conditions, especially among teens and preteens.
The report – The Kids Are Not Alright: Pediatric Mental Health Care Utilization from 2016-2021 – is the work of researchers at the Clarify Health Institute, the research arm of Clarify Health.
The results are “deeply concerning” and should “spark a conversation” around the need to improve access, utilization, and quality of pediatric behavioral health services, Niall Brennan, chief analytics and privacy officer for the Clarify Health Institute, told this news organization.
‘Startling’ trends
Leveraging an observational, national sample of insurance claims from more than 20 million children aged 1-19 years annually, the researchers observed several disturbing trends in mental health care.
From 2016 to 2021, inpatient (IP) admissions rose 61% (from 30 to 48 visits annually per 1,000) and emergency department visits rose 20% (from 55 to 66 visits annually per 1,000).
Mental health IP admissions ranged from a low of 27% in the West North Central region to a high of 137% in the Middle Atlantic region.
There were substantial increases from 2016 to 2021 in mental health IP admissions among children of all age groups, but particularly among adolescents 12 to 15 years old, increasing 84% among girls and 83% among boys in this age group.
There was also a sharp increase in mental health ED visits among girls and boys aged 12-15 years, increasing 20% overall during the study period.
Mental health IP use grew faster from 2016 to 2021 among children with commercial insurance than among those with Medicaid (103% vs. 40%).
In contrast, mental health–specific ED visits declined 10% among children with commercial insurance and increased by 20% among those with Medicaid.
ED utilization rates in 2021 were nearly twice as high in the Medicaid population, compared with those for children with commercial insurance.
These are “startling” increases, Mr. Brennan said in an interview.
These trends “reinforce health care leaders’ responsibility to address children’s mental health, especially when considering that half of all mental health conditions onset during adolescence and carry into adulthood,” Jean Drouin, MD, Clarify Health’s chief executive office and cofounder, adds in a news release.
“With a growing consensus that mental, behavioral, and physical health intersect, this research report aims to spark a conversation about the overall wellbeing of America’s next generation,” Dr. Drouin says.
Concern for the future
Commenting on the new report, Anish Dube, MD, chair of the American Psychiatric Association’s Council on Children, Adolescents, and their Families, said the findings are “concerning, though unsurprising.”
“They confirm what those of us in clinical practice have experienced in the last several years. The need for mental health services continues to rise every year, while access to adequate help remains lacking,” Dr. Dube said.
“With the recent COVID-19 pandemic, concerns about the effects of climate change, global political uncertainty, and a rapidly changing employment landscape, young people in particular are vulnerable to worries about their future and feelings of helplessness and hopelessness,” he added.
Dr. Dube said there is no one right solution, and addressing this problem must consider individual and local factors.
However, some of the broader interventions needed to tackle the problem include increasing access to care by enforcing mental health parity and increasing the number of trained and qualified mental health professionals, such as child and adolescent psychiatrists, who can assess and treat these conditions in young people before they become major crises and lead to acute interventions like inpatient hospitalization.
“Public health interventions aimed at schools and families in raising awareness of mental health and well-being, and simple, cost-effective interventions to practice mental wellness will also help reduce the burden of mental illness in young people,” Dr. Dube added.
“The APA continues to fight for mental health parity enforcement and for meaningful access to mental health care for children, adolescents, and their families,” Dr. Dube said.
This research was conducted by the Clarify Health Institute. Mr. Brennan and Dr. Dube report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new report shines a light on the toll the pandemic and other stressors have taken on the mental health of U.S. children and adolescents over the last 6 years.
The report shows a dramatic increase in use of acute care services for depression, anxiety, and other mental health conditions, especially among teens and preteens.
The report – The Kids Are Not Alright: Pediatric Mental Health Care Utilization from 2016-2021 – is the work of researchers at the Clarify Health Institute, the research arm of Clarify Health.
The results are “deeply concerning” and should “spark a conversation” around the need to improve access, utilization, and quality of pediatric behavioral health services, Niall Brennan, chief analytics and privacy officer for the Clarify Health Institute, told this news organization.
‘Startling’ trends
Leveraging an observational, national sample of insurance claims from more than 20 million children aged 1-19 years annually, the researchers observed several disturbing trends in mental health care.
From 2016 to 2021, inpatient (IP) admissions rose 61% (from 30 to 48 visits annually per 1,000) and emergency department visits rose 20% (from 55 to 66 visits annually per 1,000).
Mental health IP admissions ranged from a low of 27% in the West North Central region to a high of 137% in the Middle Atlantic region.
There were substantial increases from 2016 to 2021 in mental health IP admissions among children of all age groups, but particularly among adolescents 12 to 15 years old, increasing 84% among girls and 83% among boys in this age group.
There was also a sharp increase in mental health ED visits among girls and boys aged 12-15 years, increasing 20% overall during the study period.
Mental health IP use grew faster from 2016 to 2021 among children with commercial insurance than among those with Medicaid (103% vs. 40%).
In contrast, mental health–specific ED visits declined 10% among children with commercial insurance and increased by 20% among those with Medicaid.
ED utilization rates in 2021 were nearly twice as high in the Medicaid population, compared with those for children with commercial insurance.
These are “startling” increases, Mr. Brennan said in an interview.
These trends “reinforce health care leaders’ responsibility to address children’s mental health, especially when considering that half of all mental health conditions onset during adolescence and carry into adulthood,” Jean Drouin, MD, Clarify Health’s chief executive office and cofounder, adds in a news release.
“With a growing consensus that mental, behavioral, and physical health intersect, this research report aims to spark a conversation about the overall wellbeing of America’s next generation,” Dr. Drouin says.
Concern for the future
Commenting on the new report, Anish Dube, MD, chair of the American Psychiatric Association’s Council on Children, Adolescents, and their Families, said the findings are “concerning, though unsurprising.”
“They confirm what those of us in clinical practice have experienced in the last several years. The need for mental health services continues to rise every year, while access to adequate help remains lacking,” Dr. Dube said.
“With the recent COVID-19 pandemic, concerns about the effects of climate change, global political uncertainty, and a rapidly changing employment landscape, young people in particular are vulnerable to worries about their future and feelings of helplessness and hopelessness,” he added.
Dr. Dube said there is no one right solution, and addressing this problem must consider individual and local factors.
However, some of the broader interventions needed to tackle the problem include increasing access to care by enforcing mental health parity and increasing the number of trained and qualified mental health professionals, such as child and adolescent psychiatrists, who can assess and treat these conditions in young people before they become major crises and lead to acute interventions like inpatient hospitalization.
“Public health interventions aimed at schools and families in raising awareness of mental health and well-being, and simple, cost-effective interventions to practice mental wellness will also help reduce the burden of mental illness in young people,” Dr. Dube added.
“The APA continues to fight for mental health parity enforcement and for meaningful access to mental health care for children, adolescents, and their families,” Dr. Dube said.
This research was conducted by the Clarify Health Institute. Mr. Brennan and Dr. Dube report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new report shines a light on the toll the pandemic and other stressors have taken on the mental health of U.S. children and adolescents over the last 6 years.
The report shows a dramatic increase in use of acute care services for depression, anxiety, and other mental health conditions, especially among teens and preteens.
The report – The Kids Are Not Alright: Pediatric Mental Health Care Utilization from 2016-2021 – is the work of researchers at the Clarify Health Institute, the research arm of Clarify Health.
The results are “deeply concerning” and should “spark a conversation” around the need to improve access, utilization, and quality of pediatric behavioral health services, Niall Brennan, chief analytics and privacy officer for the Clarify Health Institute, told this news organization.
‘Startling’ trends
Leveraging an observational, national sample of insurance claims from more than 20 million children aged 1-19 years annually, the researchers observed several disturbing trends in mental health care.
From 2016 to 2021, inpatient (IP) admissions rose 61% (from 30 to 48 visits annually per 1,000) and emergency department visits rose 20% (from 55 to 66 visits annually per 1,000).
Mental health IP admissions ranged from a low of 27% in the West North Central region to a high of 137% in the Middle Atlantic region.
There were substantial increases from 2016 to 2021 in mental health IP admissions among children of all age groups, but particularly among adolescents 12 to 15 years old, increasing 84% among girls and 83% among boys in this age group.
There was also a sharp increase in mental health ED visits among girls and boys aged 12-15 years, increasing 20% overall during the study period.
Mental health IP use grew faster from 2016 to 2021 among children with commercial insurance than among those with Medicaid (103% vs. 40%).
In contrast, mental health–specific ED visits declined 10% among children with commercial insurance and increased by 20% among those with Medicaid.
ED utilization rates in 2021 were nearly twice as high in the Medicaid population, compared with those for children with commercial insurance.
These are “startling” increases, Mr. Brennan said in an interview.
These trends “reinforce health care leaders’ responsibility to address children’s mental health, especially when considering that half of all mental health conditions onset during adolescence and carry into adulthood,” Jean Drouin, MD, Clarify Health’s chief executive office and cofounder, adds in a news release.
“With a growing consensus that mental, behavioral, and physical health intersect, this research report aims to spark a conversation about the overall wellbeing of America’s next generation,” Dr. Drouin says.
Concern for the future
Commenting on the new report, Anish Dube, MD, chair of the American Psychiatric Association’s Council on Children, Adolescents, and their Families, said the findings are “concerning, though unsurprising.”
“They confirm what those of us in clinical practice have experienced in the last several years. The need for mental health services continues to rise every year, while access to adequate help remains lacking,” Dr. Dube said.
“With the recent COVID-19 pandemic, concerns about the effects of climate change, global political uncertainty, and a rapidly changing employment landscape, young people in particular are vulnerable to worries about their future and feelings of helplessness and hopelessness,” he added.
Dr. Dube said there is no one right solution, and addressing this problem must consider individual and local factors.
However, some of the broader interventions needed to tackle the problem include increasing access to care by enforcing mental health parity and increasing the number of trained and qualified mental health professionals, such as child and adolescent psychiatrists, who can assess and treat these conditions in young people before they become major crises and lead to acute interventions like inpatient hospitalization.
“Public health interventions aimed at schools and families in raising awareness of mental health and well-being, and simple, cost-effective interventions to practice mental wellness will also help reduce the burden of mental illness in young people,” Dr. Dube added.
“The APA continues to fight for mental health parity enforcement and for meaningful access to mental health care for children, adolescents, and their families,” Dr. Dube said.
This research was conducted by the Clarify Health Institute. Mr. Brennan and Dr. Dube report no relevant financial relationships.
A version of this article first appeared on Medscape.com.