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azzed
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bullturds
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cocaine
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cocainees
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crackwhore
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cum
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cumsluted
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cunthunterer
cunthunteres
cunthuntering
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cunthunters
cunting
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cuntlicked
cuntlicker
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dagos
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damn
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damneder
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dickbag
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dickbags
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dickdippered
dickdipperer
dickdipperes
dickdippering
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dicker
dickes
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dickfaceed
dickfaceer
dickfacees
dickfaceing
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dickflippered
dickflipperer
dickflipperes
dickflippering
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dickheaded
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dickheadser
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dingleed
dingleer
dinglees
dingleing
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dipship
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dipshipes
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dizzyed
dizzyer
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dizzying
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dizzys
doggiestyleed
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dopeyer
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drunker
drunkes
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dumass
dumassed
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dumasses
dumassing
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dumasss
dumbass
dumbassed
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dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
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dyke
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dykeer
dykees
dykeing
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erotic
eroticed
eroticer
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erotics
extacy
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extacying
extacyly
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extasy
extasyed
extasyer
extasyes
extasying
extasyly
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facked
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faged
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fagged
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faggoted
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fagoted
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faiged
faiger
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faigts
fannybandit
fannybandited
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fannybandits
farted
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fartknockered
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fartly
farts
felch
felched
felcher
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fellateer
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fellateing
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fellatio
fellatioed
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feltched
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floozy
floozyed
floozyer
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foad
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freexes
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friggaer
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fuckined
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fuckinged
fuckinger
fuckinges
fuckinging
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fuckings
fuckining
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Health care unaffordability common for pregnant/postpartum women
Financial hardship remains prevalent among pregnant and postpartum women, despite the implementation of the Affordable Care Act (ACA), according to new findings published in JAMA Network Open.
Nearly a quarter (24%) of pregnant and postpartum women reported having unmet health care needs, 60% had health care unaffordability, and 54% reported general financial stress. Notably, the type of insurance was associated with the ability to afford health care.
Those with private insurance, along with women with lower incomes, were more likely to experience unaffordable health care, compared to those covered by public insurance or who had higher incomes.
Senior study author Michelle H. Moniz, MD, assistant professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor, was surprised by multiple study findings. “The prevalence of financial hardship overall, and the three individual indicators of hardship, did not change over time from 2013 to 2018,” she said. “The ACA was enacted just prior to the study period, and while this policy had many benefits for women – especially around increasing insurance coverage – it does not seem to have improved financial hardship among pregnant and postpartum women.”
She emphasized that two groups were at the highest risk of health care unaffordability: those with private insurance and those living on low incomes. “This is notable, as we often think of private insurance as offering ‘Cadillac coverage,’ but our prior work suggests that privately insured women have strikingly high out-of-pocket costs for pregnancy and childbirth-related care,” Dr. Moniz said.
These expenses include deductibles, copays, and coinsurance payments, which come to about $4,500 on average. Medicaid plans, in contrast, have exceedingly low out-of-pocket costs for pregnant and postpartum women. “Findings from the current study call for targeted policy interventions to alleviate financial strain and remove financial barriers to health care access for privately insured families,” she said. “Similarly, families living on lower incomes were also at high risk of health care unaffordability. This may be because even small out-of-pocket costs, or health care–associated costs, account for a larger share of the family’s income.”
This finding for lower-income women calls for targeted policy interventions. “Sliding-scale deductibles, for example, are one solution that might mitigate economic hardship and remove cost-related barriers to health care for pregnant and postpartum women,” Dr. Moniz added.
Health care unaffordability high
In this study, Dr. Moniz and colleagues evaluated the prevalence of financial hardship among peripartum women over time, and how it was affected by their income level and the type of insurance coverage.
They conducted a cross-sectional study that included peripartum women between the ages of 18 and 45 years who reported being currently pregnant or pregnant in the past 12 months. The women were all participants in the National Health Interview Survey, which covers the period from 2013 to 2018, and the data were analyzed from January to May 2021.
The cohort included 3,509 peripartum women, and was weighted to represent 1,050,789 women, with a mean age of 29 years. In 2018, an estimated 39,017 of 184,018 (21.2%) were Black; 36,045 (19.6%) were Hispanic; and 97,366 (52.9%) were White. In the latter years of the study period, the participants tended to be older, more highly educated, and less likely to lack insurance.
When the authors compared the unadjusted reported financial hardship outcome by each study year, unmet health care need (2013: 27.9% [95% confidence interval, 24.4%-31.7%]; 2018: 23.7% [95% CI, 19.5%-28.6%]), health care unaffordability (2013: 65.7% [95% CI, 61.1%-70.0%]; 2018: 58.8% [95% CI, 53.4%-64.0%]), and general financial stress (2013: 60.6% [95% CI, 55.2%-65.8%]; 2018: 53.8% [95% CI, 47.8%-59.8%]) remained largely unchanged between 2013 and 2018.
When they looked at the relationship between insurance type, income, and financial difficulties, some degree of financial hardship was common across all groups; private insurance: 63.8% [95% CI, 61.1%-66.6%]; with public insurance: 49.9% [95% CI, 46.4%-53.4%]; with no insurance: 81.8% [95% CI, 76.4%-87.3%]; with income < 400% of the federal poverty level (FPL): 65.5% [95% CI, 62.1%-66.9%]; with income at least 400% of the FPL: 49.3% [95% CI,44.7%-53.9%]).
Those without any insurance had the highest odds of reporting unmet health care needs (adjusted OR [aOR], 4.40; 95% CI, 3.23-6.00) and health care unaffordability (aOR, 5.18; 95% CI, 3.49-7.70) compared with women who received public insurance.
But while women with private insurance had lower odds of reporting unmet health care needs (aOR, 0.67; 95% CI, 0.52-0.87), they faced higher odds of reporting health care unaffordability (aOR, 1.88; 95% CI, 1.49-2.36) compared to women who had public insurance.
Those with household incomes of less than 400% of the FPL had higher odds of reporting unmet health care need (aOR,1.50; 95% CI, 1.08-2.08) and health care unaffordability (aOR, 1.98; 95% CI, 1.54-2.55) versus women whose household incomes were at least 400% of FPL. The odds of general financial stress did not significantly differ by insurance status/type or income level.
Weighing in on the data
Jamie Daw, PhD, assistant professor of health policy and management, Columbia University Mailman School of Public Health, New York, noted that many people think of private insurance as “good coverage.”
“But the portion of medical costs that patients are required to pay under private plans has risen dramatically over the past decade,” she said. “Over half of the U.S. workforce is now enrolled in high-deductible plans, where the average deductible was $4,500 in 2020. The private insurance of today does not provide sufficient financial protection for most families, who would need to have the liquid assets to cover childbirth.”
Another expert agreed that the high out-of-pocket costs for women with private health insurance were probably responsible for making peripartum health care more unaffordable. These included costs for pregnancy care as well as for maternal and infant care during and after childbirth.
“This study reporting the high unmet medical needs and unaffordability of health care for peripartum women further underscores that the U.S. health care system is not meeting the needs of pregnant women, mothers, and their newborn infants,” said Lois K. Lee, MD, associate professor of pediatrics and emergency medicine at Harvard Medical School and associate director for public policy at the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion, Boston.
“It is imperative to optimize the health of pregnant mothers to optimize the health of infants, who are our future society,” she said. “Policies which would expand Medicaid coverage to a full 1-year postpartum across all states is one important strategy to improve health care access and affordability to peripartum women. However, this must be part of a multipronged approach addressing the social determinants of health, as insurance coverage alone will not fully address this important health issue of peripartum women, and their children.”
Dr Moniz reported receiving personal fees from the RAND Corporation, the Society of Family Planning outside the submitted work and grant K08 HS025465 from the Agency for Healthcare Research and Quality. Dr. Daw has no disclosures. Dr. Lee reports speaker fees from the American Academy of Pediatrics and SUNY Upstate Medical University. Coauthor Dr. Taylor was supported by the National Clinician Scholars Program at the University of Michigan. Dr Dalton was supported by grant R01 HS023784 from the Agency for Healthcare Research and Quality.
Financial hardship remains prevalent among pregnant and postpartum women, despite the implementation of the Affordable Care Act (ACA), according to new findings published in JAMA Network Open.
Nearly a quarter (24%) of pregnant and postpartum women reported having unmet health care needs, 60% had health care unaffordability, and 54% reported general financial stress. Notably, the type of insurance was associated with the ability to afford health care.
Those with private insurance, along with women with lower incomes, were more likely to experience unaffordable health care, compared to those covered by public insurance or who had higher incomes.
Senior study author Michelle H. Moniz, MD, assistant professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor, was surprised by multiple study findings. “The prevalence of financial hardship overall, and the three individual indicators of hardship, did not change over time from 2013 to 2018,” she said. “The ACA was enacted just prior to the study period, and while this policy had many benefits for women – especially around increasing insurance coverage – it does not seem to have improved financial hardship among pregnant and postpartum women.”
She emphasized that two groups were at the highest risk of health care unaffordability: those with private insurance and those living on low incomes. “This is notable, as we often think of private insurance as offering ‘Cadillac coverage,’ but our prior work suggests that privately insured women have strikingly high out-of-pocket costs for pregnancy and childbirth-related care,” Dr. Moniz said.
These expenses include deductibles, copays, and coinsurance payments, which come to about $4,500 on average. Medicaid plans, in contrast, have exceedingly low out-of-pocket costs for pregnant and postpartum women. “Findings from the current study call for targeted policy interventions to alleviate financial strain and remove financial barriers to health care access for privately insured families,” she said. “Similarly, families living on lower incomes were also at high risk of health care unaffordability. This may be because even small out-of-pocket costs, or health care–associated costs, account for a larger share of the family’s income.”
This finding for lower-income women calls for targeted policy interventions. “Sliding-scale deductibles, for example, are one solution that might mitigate economic hardship and remove cost-related barriers to health care for pregnant and postpartum women,” Dr. Moniz added.
Health care unaffordability high
In this study, Dr. Moniz and colleagues evaluated the prevalence of financial hardship among peripartum women over time, and how it was affected by their income level and the type of insurance coverage.
They conducted a cross-sectional study that included peripartum women between the ages of 18 and 45 years who reported being currently pregnant or pregnant in the past 12 months. The women were all participants in the National Health Interview Survey, which covers the period from 2013 to 2018, and the data were analyzed from January to May 2021.
The cohort included 3,509 peripartum women, and was weighted to represent 1,050,789 women, with a mean age of 29 years. In 2018, an estimated 39,017 of 184,018 (21.2%) were Black; 36,045 (19.6%) were Hispanic; and 97,366 (52.9%) were White. In the latter years of the study period, the participants tended to be older, more highly educated, and less likely to lack insurance.
When the authors compared the unadjusted reported financial hardship outcome by each study year, unmet health care need (2013: 27.9% [95% confidence interval, 24.4%-31.7%]; 2018: 23.7% [95% CI, 19.5%-28.6%]), health care unaffordability (2013: 65.7% [95% CI, 61.1%-70.0%]; 2018: 58.8% [95% CI, 53.4%-64.0%]), and general financial stress (2013: 60.6% [95% CI, 55.2%-65.8%]; 2018: 53.8% [95% CI, 47.8%-59.8%]) remained largely unchanged between 2013 and 2018.
When they looked at the relationship between insurance type, income, and financial difficulties, some degree of financial hardship was common across all groups; private insurance: 63.8% [95% CI, 61.1%-66.6%]; with public insurance: 49.9% [95% CI, 46.4%-53.4%]; with no insurance: 81.8% [95% CI, 76.4%-87.3%]; with income < 400% of the federal poverty level (FPL): 65.5% [95% CI, 62.1%-66.9%]; with income at least 400% of the FPL: 49.3% [95% CI,44.7%-53.9%]).
Those without any insurance had the highest odds of reporting unmet health care needs (adjusted OR [aOR], 4.40; 95% CI, 3.23-6.00) and health care unaffordability (aOR, 5.18; 95% CI, 3.49-7.70) compared with women who received public insurance.
But while women with private insurance had lower odds of reporting unmet health care needs (aOR, 0.67; 95% CI, 0.52-0.87), they faced higher odds of reporting health care unaffordability (aOR, 1.88; 95% CI, 1.49-2.36) compared to women who had public insurance.
Those with household incomes of less than 400% of the FPL had higher odds of reporting unmet health care need (aOR,1.50; 95% CI, 1.08-2.08) and health care unaffordability (aOR, 1.98; 95% CI, 1.54-2.55) versus women whose household incomes were at least 400% of FPL. The odds of general financial stress did not significantly differ by insurance status/type or income level.
Weighing in on the data
Jamie Daw, PhD, assistant professor of health policy and management, Columbia University Mailman School of Public Health, New York, noted that many people think of private insurance as “good coverage.”
“But the portion of medical costs that patients are required to pay under private plans has risen dramatically over the past decade,” she said. “Over half of the U.S. workforce is now enrolled in high-deductible plans, where the average deductible was $4,500 in 2020. The private insurance of today does not provide sufficient financial protection for most families, who would need to have the liquid assets to cover childbirth.”
Another expert agreed that the high out-of-pocket costs for women with private health insurance were probably responsible for making peripartum health care more unaffordable. These included costs for pregnancy care as well as for maternal and infant care during and after childbirth.
“This study reporting the high unmet medical needs and unaffordability of health care for peripartum women further underscores that the U.S. health care system is not meeting the needs of pregnant women, mothers, and their newborn infants,” said Lois K. Lee, MD, associate professor of pediatrics and emergency medicine at Harvard Medical School and associate director for public policy at the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion, Boston.
“It is imperative to optimize the health of pregnant mothers to optimize the health of infants, who are our future society,” she said. “Policies which would expand Medicaid coverage to a full 1-year postpartum across all states is one important strategy to improve health care access and affordability to peripartum women. However, this must be part of a multipronged approach addressing the social determinants of health, as insurance coverage alone will not fully address this important health issue of peripartum women, and their children.”
Dr Moniz reported receiving personal fees from the RAND Corporation, the Society of Family Planning outside the submitted work and grant K08 HS025465 from the Agency for Healthcare Research and Quality. Dr. Daw has no disclosures. Dr. Lee reports speaker fees from the American Academy of Pediatrics and SUNY Upstate Medical University. Coauthor Dr. Taylor was supported by the National Clinician Scholars Program at the University of Michigan. Dr Dalton was supported by grant R01 HS023784 from the Agency for Healthcare Research and Quality.
Financial hardship remains prevalent among pregnant and postpartum women, despite the implementation of the Affordable Care Act (ACA), according to new findings published in JAMA Network Open.
Nearly a quarter (24%) of pregnant and postpartum women reported having unmet health care needs, 60% had health care unaffordability, and 54% reported general financial stress. Notably, the type of insurance was associated with the ability to afford health care.
Those with private insurance, along with women with lower incomes, were more likely to experience unaffordable health care, compared to those covered by public insurance or who had higher incomes.
Senior study author Michelle H. Moniz, MD, assistant professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor, was surprised by multiple study findings. “The prevalence of financial hardship overall, and the three individual indicators of hardship, did not change over time from 2013 to 2018,” she said. “The ACA was enacted just prior to the study period, and while this policy had many benefits for women – especially around increasing insurance coverage – it does not seem to have improved financial hardship among pregnant and postpartum women.”
She emphasized that two groups were at the highest risk of health care unaffordability: those with private insurance and those living on low incomes. “This is notable, as we often think of private insurance as offering ‘Cadillac coverage,’ but our prior work suggests that privately insured women have strikingly high out-of-pocket costs for pregnancy and childbirth-related care,” Dr. Moniz said.
These expenses include deductibles, copays, and coinsurance payments, which come to about $4,500 on average. Medicaid plans, in contrast, have exceedingly low out-of-pocket costs for pregnant and postpartum women. “Findings from the current study call for targeted policy interventions to alleviate financial strain and remove financial barriers to health care access for privately insured families,” she said. “Similarly, families living on lower incomes were also at high risk of health care unaffordability. This may be because even small out-of-pocket costs, or health care–associated costs, account for a larger share of the family’s income.”
This finding for lower-income women calls for targeted policy interventions. “Sliding-scale deductibles, for example, are one solution that might mitigate economic hardship and remove cost-related barriers to health care for pregnant and postpartum women,” Dr. Moniz added.
Health care unaffordability high
In this study, Dr. Moniz and colleagues evaluated the prevalence of financial hardship among peripartum women over time, and how it was affected by their income level and the type of insurance coverage.
They conducted a cross-sectional study that included peripartum women between the ages of 18 and 45 years who reported being currently pregnant or pregnant in the past 12 months. The women were all participants in the National Health Interview Survey, which covers the period from 2013 to 2018, and the data were analyzed from January to May 2021.
The cohort included 3,509 peripartum women, and was weighted to represent 1,050,789 women, with a mean age of 29 years. In 2018, an estimated 39,017 of 184,018 (21.2%) were Black; 36,045 (19.6%) were Hispanic; and 97,366 (52.9%) were White. In the latter years of the study period, the participants tended to be older, more highly educated, and less likely to lack insurance.
When the authors compared the unadjusted reported financial hardship outcome by each study year, unmet health care need (2013: 27.9% [95% confidence interval, 24.4%-31.7%]; 2018: 23.7% [95% CI, 19.5%-28.6%]), health care unaffordability (2013: 65.7% [95% CI, 61.1%-70.0%]; 2018: 58.8% [95% CI, 53.4%-64.0%]), and general financial stress (2013: 60.6% [95% CI, 55.2%-65.8%]; 2018: 53.8% [95% CI, 47.8%-59.8%]) remained largely unchanged between 2013 and 2018.
When they looked at the relationship between insurance type, income, and financial difficulties, some degree of financial hardship was common across all groups; private insurance: 63.8% [95% CI, 61.1%-66.6%]; with public insurance: 49.9% [95% CI, 46.4%-53.4%]; with no insurance: 81.8% [95% CI, 76.4%-87.3%]; with income < 400% of the federal poverty level (FPL): 65.5% [95% CI, 62.1%-66.9%]; with income at least 400% of the FPL: 49.3% [95% CI,44.7%-53.9%]).
Those without any insurance had the highest odds of reporting unmet health care needs (adjusted OR [aOR], 4.40; 95% CI, 3.23-6.00) and health care unaffordability (aOR, 5.18; 95% CI, 3.49-7.70) compared with women who received public insurance.
But while women with private insurance had lower odds of reporting unmet health care needs (aOR, 0.67; 95% CI, 0.52-0.87), they faced higher odds of reporting health care unaffordability (aOR, 1.88; 95% CI, 1.49-2.36) compared to women who had public insurance.
Those with household incomes of less than 400% of the FPL had higher odds of reporting unmet health care need (aOR,1.50; 95% CI, 1.08-2.08) and health care unaffordability (aOR, 1.98; 95% CI, 1.54-2.55) versus women whose household incomes were at least 400% of FPL. The odds of general financial stress did not significantly differ by insurance status/type or income level.
Weighing in on the data
Jamie Daw, PhD, assistant professor of health policy and management, Columbia University Mailman School of Public Health, New York, noted that many people think of private insurance as “good coverage.”
“But the portion of medical costs that patients are required to pay under private plans has risen dramatically over the past decade,” she said. “Over half of the U.S. workforce is now enrolled in high-deductible plans, where the average deductible was $4,500 in 2020. The private insurance of today does not provide sufficient financial protection for most families, who would need to have the liquid assets to cover childbirth.”
Another expert agreed that the high out-of-pocket costs for women with private health insurance were probably responsible for making peripartum health care more unaffordable. These included costs for pregnancy care as well as for maternal and infant care during and after childbirth.
“This study reporting the high unmet medical needs and unaffordability of health care for peripartum women further underscores that the U.S. health care system is not meeting the needs of pregnant women, mothers, and their newborn infants,” said Lois K. Lee, MD, associate professor of pediatrics and emergency medicine at Harvard Medical School and associate director for public policy at the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion, Boston.
“It is imperative to optimize the health of pregnant mothers to optimize the health of infants, who are our future society,” she said. “Policies which would expand Medicaid coverage to a full 1-year postpartum across all states is one important strategy to improve health care access and affordability to peripartum women. However, this must be part of a multipronged approach addressing the social determinants of health, as insurance coverage alone will not fully address this important health issue of peripartum women, and their children.”
Dr Moniz reported receiving personal fees from the RAND Corporation, the Society of Family Planning outside the submitted work and grant K08 HS025465 from the Agency for Healthcare Research and Quality. Dr. Daw has no disclosures. Dr. Lee reports speaker fees from the American Academy of Pediatrics and SUNY Upstate Medical University. Coauthor Dr. Taylor was supported by the National Clinician Scholars Program at the University of Michigan. Dr Dalton was supported by grant R01 HS023784 from the Agency for Healthcare Research and Quality.
FROM JAMA NETWORK OPEN
CDC endorses Pfizer’s COVID-19 vaccine for young kids
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
Lesbian, gay, bisexual youth miss out on health care
Youth identifying as lesbian, gay, or bisexual were significantly less likely than were their peers to communicate with a physician or utilize health care in the past 12 months, according to data from a cohort study of approximately 4,000 adolescents.
Disparities in physical and mental health outcomes for individuals who identify as lesbian, gay, or bisexual (LGB) persist in the United States, and emerge in adolescents and young adults, wrote Sari L. Reisner, ScD, of Boston Children’s Hospital, and colleagues.
“LGB adult research indicates substantial unmet medical needs, including needed care and preventive care,” for reasons including “reluctance to disclose sexual identity to clinicians, lower health insurance rates, lack of culturally appropriate preventive services, and lack of clinician LGB care competence,” they said.
However, health use trends by adolescents who identify as LGB have not been well studied, they noted.
In a study published in JAMA Network Open, the researchers analyzed data from 4,256 participants in the third wave (10th grade) of adolescents in Healthy Passages, a longitudinal, observational cohort study of diverse public school students in Birmingham, Ala.; Houston; and Los Angeles County. Data were collected in grades 5, 7, and 10.
The study population included 640 youth who identified as LGB, and 3,616 non-LGB youth. Sexual status was based on responses to questions in the grade 10 youth survey. Health care use was based on the responses to questions about routine care, such as a regular checkup, and other care, such as a sick visit. Data on delayed care were collected from parents and youth. At baseline, the average age of the study participants in fifth grade was 11 years, 48.9% were female, 44.5% were Hispanic or Latino, and 28.9% were Black.
Overall, more LGB youth reported not receiving needed medical care when they thought they needed it within the past 12 months compared with non-LGB youth (42.4% of LGB vs. 30.2% of non-LGB youth; adjusted odds ratio 1.68). The most common conditions for which LGB youth did not seek care were sexually transmitted infections, contraception, and substance use.
Overall, the main reason given for not seeking medical care was that they thought the problem would go away (approximately 26% for LGB and non-LGB). Approximately twice as many LGB youth as non-LGB youth said they avoided medical care because they did not want their parents to know (14.5% vs. 9.4%).
Significantly more LGB youth than non-LGB youth reported difficulty communicating with their physicians in the past 12 months (15.3% vs. 9.4%; aOR 1.71). The main reasons for not communicating with a clinician about a topic of concern were that the adolescent did not want parents to know (40.7% of LGB and 30.2% of non-LGB) and that they were too embarrassed to talk about the topic (37.5% of LGB and 25.9% of non-LGB).
The researchers were not surprised that “LGB youth self-reported greater difficulty communicating with a clinician about topics they wanted to discuss,” but they found no significant differences in reasons for communication difficulty based on sexual orientation.
Approximately two-thirds (65.8%) of LGB youth reported feeling “a little or not at all comfortable” talking to a health care clinician about their sexual attractions, compared with approximately one-third (37.8%) of non-LGB youth.
Only 12.5% of the LGB youth said that their clinicians knew their sexual orientation, the researchers noted. However, clinicians need to know youths’ sexual orientation to provide appropriate and comprehensive care, they said, especially in light of the known negative health consequences of LGB internalized stigma, as well as the pertinence of certain sexual behaviors to preventive care and screening.
The study findings were limited by several factors including the cross-sectional design and inability to show causality, and by the incongruence of different dimensions of sexual orientation, the researchers noted. Other limitations included the use only of English and Spanish language, and a lack of complete information on disclosure of sexual orientation to parents, the researchers noted.
The results were strengthened by the diverse demographics, although they may not be generalizable to a wider population, they added.
However, the data show that responsive health care is needed to reduce disparities for LGB youth, they emphasized. “Care should be sensitive and respectful to sexual orientation for all youth, with clinicians taking time to ask adolescents about their sexual identity, attractions, and behaviors, particularly in sexual and reproductive health,” they concluded.
Adolescents suffer barriers similar to those of adults
“We know that significant health disparities exist for LGBTQ adults and adolescents,” Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “LGBTQ adults often have had poor experiences during health care encounters – ranging from poor interactions with inadequately trained clinicians to frank discrimination,” she said. “These experiences can prevent individuals from seeking health care in the future or disclosing important information during a medical visit, both of which can contribute to worsened health outcomes,” she emphasized.
Prior to this study, data to confirm similar patterns of decreased health care utilization in LGB youth were limited, Dr. Curran said. “Identifying and understanding barriers to health care for LGBTQ youth are essential to help address the disparities in this population,” she said.
Dr. Curran said she was not surprised by the study findings for adolescents, which reflect patterns seen in LGBTQ adults.
Overcoming barriers to encourage LGB youth to seek regular medical care involves “training health care professionals about LGBTQ health, teaching the skill of taking a nonjudgmental, inclusive history, and making health care facilities welcoming and inclusive, such as displaying a pride flag in clinic, and using forms asking for pronouns,” Dr. Curran said.
Dr. Curran said she thinks the trends in decreased health care use are similar for transgender youth. “I suspect, if anything, that transgender youth will have even further decreased health care utilization when compared to cisgender heterosexual peers and LGB peers,” she noted.
Going forward, it will be important to understand the reasons behind decreased health care use among LGB youth, such as poor experiences, discrimination, or fears about confidentiality, said Dr. Curran. “Additionally, it would be important to understand if this decreased health utilization also occurs with transgender youth,” she said.
The Healthy Passages Study was funded by the Centers for Disease Control and Prevention. One of the study coauthors disclosed funding from the Agency for Healthcare Research and Quality as part of the Harvard-wide Pediatric Health Services Research Fellowship Program. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
Youth identifying as lesbian, gay, or bisexual were significantly less likely than were their peers to communicate with a physician or utilize health care in the past 12 months, according to data from a cohort study of approximately 4,000 adolescents.
Disparities in physical and mental health outcomes for individuals who identify as lesbian, gay, or bisexual (LGB) persist in the United States, and emerge in adolescents and young adults, wrote Sari L. Reisner, ScD, of Boston Children’s Hospital, and colleagues.
“LGB adult research indicates substantial unmet medical needs, including needed care and preventive care,” for reasons including “reluctance to disclose sexual identity to clinicians, lower health insurance rates, lack of culturally appropriate preventive services, and lack of clinician LGB care competence,” they said.
However, health use trends by adolescents who identify as LGB have not been well studied, they noted.
In a study published in JAMA Network Open, the researchers analyzed data from 4,256 participants in the third wave (10th grade) of adolescents in Healthy Passages, a longitudinal, observational cohort study of diverse public school students in Birmingham, Ala.; Houston; and Los Angeles County. Data were collected in grades 5, 7, and 10.
The study population included 640 youth who identified as LGB, and 3,616 non-LGB youth. Sexual status was based on responses to questions in the grade 10 youth survey. Health care use was based on the responses to questions about routine care, such as a regular checkup, and other care, such as a sick visit. Data on delayed care were collected from parents and youth. At baseline, the average age of the study participants in fifth grade was 11 years, 48.9% were female, 44.5% were Hispanic or Latino, and 28.9% were Black.
Overall, more LGB youth reported not receiving needed medical care when they thought they needed it within the past 12 months compared with non-LGB youth (42.4% of LGB vs. 30.2% of non-LGB youth; adjusted odds ratio 1.68). The most common conditions for which LGB youth did not seek care were sexually transmitted infections, contraception, and substance use.
Overall, the main reason given for not seeking medical care was that they thought the problem would go away (approximately 26% for LGB and non-LGB). Approximately twice as many LGB youth as non-LGB youth said they avoided medical care because they did not want their parents to know (14.5% vs. 9.4%).
Significantly more LGB youth than non-LGB youth reported difficulty communicating with their physicians in the past 12 months (15.3% vs. 9.4%; aOR 1.71). The main reasons for not communicating with a clinician about a topic of concern were that the adolescent did not want parents to know (40.7% of LGB and 30.2% of non-LGB) and that they were too embarrassed to talk about the topic (37.5% of LGB and 25.9% of non-LGB).
The researchers were not surprised that “LGB youth self-reported greater difficulty communicating with a clinician about topics they wanted to discuss,” but they found no significant differences in reasons for communication difficulty based on sexual orientation.
Approximately two-thirds (65.8%) of LGB youth reported feeling “a little or not at all comfortable” talking to a health care clinician about their sexual attractions, compared with approximately one-third (37.8%) of non-LGB youth.
Only 12.5% of the LGB youth said that their clinicians knew their sexual orientation, the researchers noted. However, clinicians need to know youths’ sexual orientation to provide appropriate and comprehensive care, they said, especially in light of the known negative health consequences of LGB internalized stigma, as well as the pertinence of certain sexual behaviors to preventive care and screening.
The study findings were limited by several factors including the cross-sectional design and inability to show causality, and by the incongruence of different dimensions of sexual orientation, the researchers noted. Other limitations included the use only of English and Spanish language, and a lack of complete information on disclosure of sexual orientation to parents, the researchers noted.
The results were strengthened by the diverse demographics, although they may not be generalizable to a wider population, they added.
However, the data show that responsive health care is needed to reduce disparities for LGB youth, they emphasized. “Care should be sensitive and respectful to sexual orientation for all youth, with clinicians taking time to ask adolescents about their sexual identity, attractions, and behaviors, particularly in sexual and reproductive health,” they concluded.
Adolescents suffer barriers similar to those of adults
“We know that significant health disparities exist for LGBTQ adults and adolescents,” Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “LGBTQ adults often have had poor experiences during health care encounters – ranging from poor interactions with inadequately trained clinicians to frank discrimination,” she said. “These experiences can prevent individuals from seeking health care in the future or disclosing important information during a medical visit, both of which can contribute to worsened health outcomes,” she emphasized.
Prior to this study, data to confirm similar patterns of decreased health care utilization in LGB youth were limited, Dr. Curran said. “Identifying and understanding barriers to health care for LGBTQ youth are essential to help address the disparities in this population,” she said.
Dr. Curran said she was not surprised by the study findings for adolescents, which reflect patterns seen in LGBTQ adults.
Overcoming barriers to encourage LGB youth to seek regular medical care involves “training health care professionals about LGBTQ health, teaching the skill of taking a nonjudgmental, inclusive history, and making health care facilities welcoming and inclusive, such as displaying a pride flag in clinic, and using forms asking for pronouns,” Dr. Curran said.
Dr. Curran said she thinks the trends in decreased health care use are similar for transgender youth. “I suspect, if anything, that transgender youth will have even further decreased health care utilization when compared to cisgender heterosexual peers and LGB peers,” she noted.
Going forward, it will be important to understand the reasons behind decreased health care use among LGB youth, such as poor experiences, discrimination, or fears about confidentiality, said Dr. Curran. “Additionally, it would be important to understand if this decreased health utilization also occurs with transgender youth,” she said.
The Healthy Passages Study was funded by the Centers for Disease Control and Prevention. One of the study coauthors disclosed funding from the Agency for Healthcare Research and Quality as part of the Harvard-wide Pediatric Health Services Research Fellowship Program. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
Youth identifying as lesbian, gay, or bisexual were significantly less likely than were their peers to communicate with a physician or utilize health care in the past 12 months, according to data from a cohort study of approximately 4,000 adolescents.
Disparities in physical and mental health outcomes for individuals who identify as lesbian, gay, or bisexual (LGB) persist in the United States, and emerge in adolescents and young adults, wrote Sari L. Reisner, ScD, of Boston Children’s Hospital, and colleagues.
“LGB adult research indicates substantial unmet medical needs, including needed care and preventive care,” for reasons including “reluctance to disclose sexual identity to clinicians, lower health insurance rates, lack of culturally appropriate preventive services, and lack of clinician LGB care competence,” they said.
However, health use trends by adolescents who identify as LGB have not been well studied, they noted.
In a study published in JAMA Network Open, the researchers analyzed data from 4,256 participants in the third wave (10th grade) of adolescents in Healthy Passages, a longitudinal, observational cohort study of diverse public school students in Birmingham, Ala.; Houston; and Los Angeles County. Data were collected in grades 5, 7, and 10.
The study population included 640 youth who identified as LGB, and 3,616 non-LGB youth. Sexual status was based on responses to questions in the grade 10 youth survey. Health care use was based on the responses to questions about routine care, such as a regular checkup, and other care, such as a sick visit. Data on delayed care were collected from parents and youth. At baseline, the average age of the study participants in fifth grade was 11 years, 48.9% were female, 44.5% were Hispanic or Latino, and 28.9% were Black.
Overall, more LGB youth reported not receiving needed medical care when they thought they needed it within the past 12 months compared with non-LGB youth (42.4% of LGB vs. 30.2% of non-LGB youth; adjusted odds ratio 1.68). The most common conditions for which LGB youth did not seek care were sexually transmitted infections, contraception, and substance use.
Overall, the main reason given for not seeking medical care was that they thought the problem would go away (approximately 26% for LGB and non-LGB). Approximately twice as many LGB youth as non-LGB youth said they avoided medical care because they did not want their parents to know (14.5% vs. 9.4%).
Significantly more LGB youth than non-LGB youth reported difficulty communicating with their physicians in the past 12 months (15.3% vs. 9.4%; aOR 1.71). The main reasons for not communicating with a clinician about a topic of concern were that the adolescent did not want parents to know (40.7% of LGB and 30.2% of non-LGB) and that they were too embarrassed to talk about the topic (37.5% of LGB and 25.9% of non-LGB).
The researchers were not surprised that “LGB youth self-reported greater difficulty communicating with a clinician about topics they wanted to discuss,” but they found no significant differences in reasons for communication difficulty based on sexual orientation.
Approximately two-thirds (65.8%) of LGB youth reported feeling “a little or not at all comfortable” talking to a health care clinician about their sexual attractions, compared with approximately one-third (37.8%) of non-LGB youth.
Only 12.5% of the LGB youth said that their clinicians knew their sexual orientation, the researchers noted. However, clinicians need to know youths’ sexual orientation to provide appropriate and comprehensive care, they said, especially in light of the known negative health consequences of LGB internalized stigma, as well as the pertinence of certain sexual behaviors to preventive care and screening.
The study findings were limited by several factors including the cross-sectional design and inability to show causality, and by the incongruence of different dimensions of sexual orientation, the researchers noted. Other limitations included the use only of English and Spanish language, and a lack of complete information on disclosure of sexual orientation to parents, the researchers noted.
The results were strengthened by the diverse demographics, although they may not be generalizable to a wider population, they added.
However, the data show that responsive health care is needed to reduce disparities for LGB youth, they emphasized. “Care should be sensitive and respectful to sexual orientation for all youth, with clinicians taking time to ask adolescents about their sexual identity, attractions, and behaviors, particularly in sexual and reproductive health,” they concluded.
Adolescents suffer barriers similar to those of adults
“We know that significant health disparities exist for LGBTQ adults and adolescents,” Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “LGBTQ adults often have had poor experiences during health care encounters – ranging from poor interactions with inadequately trained clinicians to frank discrimination,” she said. “These experiences can prevent individuals from seeking health care in the future or disclosing important information during a medical visit, both of which can contribute to worsened health outcomes,” she emphasized.
Prior to this study, data to confirm similar patterns of decreased health care utilization in LGB youth were limited, Dr. Curran said. “Identifying and understanding barriers to health care for LGBTQ youth are essential to help address the disparities in this population,” she said.
Dr. Curran said she was not surprised by the study findings for adolescents, which reflect patterns seen in LGBTQ adults.
Overcoming barriers to encourage LGB youth to seek regular medical care involves “training health care professionals about LGBTQ health, teaching the skill of taking a nonjudgmental, inclusive history, and making health care facilities welcoming and inclusive, such as displaying a pride flag in clinic, and using forms asking for pronouns,” Dr. Curran said.
Dr. Curran said she thinks the trends in decreased health care use are similar for transgender youth. “I suspect, if anything, that transgender youth will have even further decreased health care utilization when compared to cisgender heterosexual peers and LGB peers,” she noted.
Going forward, it will be important to understand the reasons behind decreased health care use among LGB youth, such as poor experiences, discrimination, or fears about confidentiality, said Dr. Curran. “Additionally, it would be important to understand if this decreased health utilization also occurs with transgender youth,” she said.
The Healthy Passages Study was funded by the Centers for Disease Control and Prevention. One of the study coauthors disclosed funding from the Agency for Healthcare Research and Quality as part of the Harvard-wide Pediatric Health Services Research Fellowship Program. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
FROM JAMA NETWORK OPEN
HCV in pregnancy: One piece of a bigger problem
Mirroring the opioid crisis, maternal and newborn hepatitis C infections (HCV) more than doubled in the United States between 2009 and 2019, with disproportionate increases in people of White, American Indian, and Alaska Native race, especially those with less education, according to a cross-sectional study published in JAMA Health Forum. However, the level of risk within these populations was mitigated in counties with higher employment, reported Stephen W. Patrick, MD, of Vanderbilt University, in Nashville, Tenn., and coauthors.
“As we develop public health approaches to prevent HCV infections, connect to treatment, and monitor exposed infants, understanding these factors can be of critical importance to tailoring interventions,” Dr. Patrick said in an interview. “HCV is one more complication of the opioid crisis,” he added. “These data also enable us to step back a bit from HCV and look at the landscape of how the opioid crisis continues to grow in complexity and scope. Throughout the opioid crisis we have often failed to recognize and address the unique needs of pregnant people and infants.”
The study authors used data from the National Center for Health Statistics at the Centers for Disease Control and Prevention, and from the Area Health Resource File to examine maternal-infant HCV infection among all U.S. births between 2009 and 2019. The researchers also examined community-level risk factors including rurality, employment, and access to medical care.
In counties reporting HCV, there were 39,380,122 people who had live births, of whom 138,343 (0.4%) were diagnosed with HCV. The overall rate of maternal HCV infection increased from 1.8 to 5.1 per 1,000 live births between 2009 and 2019.
Infection rates were highest in American Indian/Alaska Native (AI/AN) and White people (adjusted odds ratio [aOR] 7.94 and 7.37, respectively) compared with Black people. They were higher among individuals without a 4-year degree compared to those with higher education (aOR, 3.19).
Among these groups considered to be at higher risk for HCV infection, high employment rates somewhat mitigated the risk. Specifically, in counties in the 10th percentile of employment, the predicted probability of HCV increased from 0.16% to 1.37%, between 2009 and 2019, whereas in counties at the 90th percentile of employment, the predicted probability remained similar, at 0.36% in 2009 and 0.48% in 2019.
“With constrained national resources, understanding both individual and community-level factors associated with HCV infections in pregnant people could inform strategies to mitigate its spread, such as harm reduction efforts (e.g., syringe service programs), improving access to treatment for [opioid use disorder] or increasing the obstetrical workforce in high-risk communities, HCV testing strategies in pregnant people and people of childbearing age, and treatment with novel antiviral therapies,” wrote the authors.
In the time since the authors began the study, universal HCV screening for every pregnancy has been recommended by a number of groups, including the U.S. Preventive Services Task Force, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (SMFM). However, Dr. Patrick says even though such recommendations are now adopted, it will be some time before they are fully operational, making knowledge of HCV risk factors important for obstetricians as well as pediatricians and family physicians. “We don’t know how if hospitals and clinicians have started universal screening for HCV and even when it is completely adopted, understanding individual and community-level factors associated with HCV in pregnant people is still of critical importance,” he explained. “In some of our previous work we have found that non-White HCV-exposed infants are less likely to be tested for HCV than are White infants, even after accounting for multiple individual and hospital-level factors. The pattern we are seeing in our research and in research in other groups is one of unequal treatment of pregnant people with substance use disorder in terms of being given evidence-based treatments, being tested for HCV, and even in child welfare outcomes like foster placement. It is important to know these issues are occurring, but we need specific equitable approaches to ensuring optimal outcomes for all families.
Jeffrey A. Kuller, MD, one of the authors of the SMFM’s new recommendations for universal HCV screening in pregnancy, agreed that until universal screening is widely adopted, awareness of maternal HCV risk factors is important, “to better determine who is at highest risk for hep C, barriers to care, and patients to better target.” This information also affects procedure at the time of delivery, added Dr. Kuller, professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke University, Durham, N.C. “We do not perform C-sections for the presence of hep C,” he told this publication. However, in labor, “we try to avoid internal fetal monitoring when possible, and early artificial rupture of membranes when possible, and avoid the use of routine episiotomy,” he said. “Hep C–positive patients should also be assessed for other sexually transmitted diseases including HIV, syphilis, gonorrhea, chlamydia, and hep B. “Although we do not typically treat hep C pharmacologically during pregnancy, we try to get the patient placed with a hepatologist for long-term management.”
The study has important implications for pediatric patients, added Audrey R. Lloyd, MD, a med-peds infectious disease fellow who is studying HCV in pregnancy at the University of Alabama at Birmingham. “In the setting of maternal HCV viremia, maternal-fetal transmission occurs in around 6% of exposed infants and around 10% if there is maternal HIV-HCV coinfection,” she said in an interview. “With the increasing rates of HCV in pregnant women described by Dr. Patrick et al., HCV infections among infants will also rise. Even when maternal HCV infection is documented, we often do not do a good job screening the infants for infection and linking them to treatment. This new data makes me worried we may see more complications of pediatric HCV infection in the future,” she added. She explained that safe and effective treatments for HCV infection are approved down to 3 years of age, but patients must first be diagnosed to receive treatment.
From whichever angle you approach it, tackling both the opioid epidemic and HCV infection in pregnancy will inevitably end up helping both parts of the mother-infant dyad, said Dr. Patrick. “Not too long ago I was caring for an opioid-exposed infant at the hospital where I practice who had transferred in from another center hours away. The mother had not been tested for HCV, so I tested the infant for HCV antibodies which were positive. Imagine that, determining a mother is HCV positive by testing the infant. There are so many layers of systems that should be fixed to make this not happen. And what are the chances the mother, after she found out, was able to access treatment for HCV? What about the infant being tested? The systems are just fragmented and we need to do better.”
The study was funded by the National Institute on Drug Abuse of the National Institutes of Health. Neither Dr. Patrick, Dr. Kuller, nor Dr. Lloyd reported any conflicts of interest.
Mirroring the opioid crisis, maternal and newborn hepatitis C infections (HCV) more than doubled in the United States between 2009 and 2019, with disproportionate increases in people of White, American Indian, and Alaska Native race, especially those with less education, according to a cross-sectional study published in JAMA Health Forum. However, the level of risk within these populations was mitigated in counties with higher employment, reported Stephen W. Patrick, MD, of Vanderbilt University, in Nashville, Tenn., and coauthors.
“As we develop public health approaches to prevent HCV infections, connect to treatment, and monitor exposed infants, understanding these factors can be of critical importance to tailoring interventions,” Dr. Patrick said in an interview. “HCV is one more complication of the opioid crisis,” he added. “These data also enable us to step back a bit from HCV and look at the landscape of how the opioid crisis continues to grow in complexity and scope. Throughout the opioid crisis we have often failed to recognize and address the unique needs of pregnant people and infants.”
The study authors used data from the National Center for Health Statistics at the Centers for Disease Control and Prevention, and from the Area Health Resource File to examine maternal-infant HCV infection among all U.S. births between 2009 and 2019. The researchers also examined community-level risk factors including rurality, employment, and access to medical care.
In counties reporting HCV, there were 39,380,122 people who had live births, of whom 138,343 (0.4%) were diagnosed with HCV. The overall rate of maternal HCV infection increased from 1.8 to 5.1 per 1,000 live births between 2009 and 2019.
Infection rates were highest in American Indian/Alaska Native (AI/AN) and White people (adjusted odds ratio [aOR] 7.94 and 7.37, respectively) compared with Black people. They were higher among individuals without a 4-year degree compared to those with higher education (aOR, 3.19).
Among these groups considered to be at higher risk for HCV infection, high employment rates somewhat mitigated the risk. Specifically, in counties in the 10th percentile of employment, the predicted probability of HCV increased from 0.16% to 1.37%, between 2009 and 2019, whereas in counties at the 90th percentile of employment, the predicted probability remained similar, at 0.36% in 2009 and 0.48% in 2019.
“With constrained national resources, understanding both individual and community-level factors associated with HCV infections in pregnant people could inform strategies to mitigate its spread, such as harm reduction efforts (e.g., syringe service programs), improving access to treatment for [opioid use disorder] or increasing the obstetrical workforce in high-risk communities, HCV testing strategies in pregnant people and people of childbearing age, and treatment with novel antiviral therapies,” wrote the authors.
In the time since the authors began the study, universal HCV screening for every pregnancy has been recommended by a number of groups, including the U.S. Preventive Services Task Force, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (SMFM). However, Dr. Patrick says even though such recommendations are now adopted, it will be some time before they are fully operational, making knowledge of HCV risk factors important for obstetricians as well as pediatricians and family physicians. “We don’t know how if hospitals and clinicians have started universal screening for HCV and even when it is completely adopted, understanding individual and community-level factors associated with HCV in pregnant people is still of critical importance,” he explained. “In some of our previous work we have found that non-White HCV-exposed infants are less likely to be tested for HCV than are White infants, even after accounting for multiple individual and hospital-level factors. The pattern we are seeing in our research and in research in other groups is one of unequal treatment of pregnant people with substance use disorder in terms of being given evidence-based treatments, being tested for HCV, and even in child welfare outcomes like foster placement. It is important to know these issues are occurring, but we need specific equitable approaches to ensuring optimal outcomes for all families.
Jeffrey A. Kuller, MD, one of the authors of the SMFM’s new recommendations for universal HCV screening in pregnancy, agreed that until universal screening is widely adopted, awareness of maternal HCV risk factors is important, “to better determine who is at highest risk for hep C, barriers to care, and patients to better target.” This information also affects procedure at the time of delivery, added Dr. Kuller, professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke University, Durham, N.C. “We do not perform C-sections for the presence of hep C,” he told this publication. However, in labor, “we try to avoid internal fetal monitoring when possible, and early artificial rupture of membranes when possible, and avoid the use of routine episiotomy,” he said. “Hep C–positive patients should also be assessed for other sexually transmitted diseases including HIV, syphilis, gonorrhea, chlamydia, and hep B. “Although we do not typically treat hep C pharmacologically during pregnancy, we try to get the patient placed with a hepatologist for long-term management.”
The study has important implications for pediatric patients, added Audrey R. Lloyd, MD, a med-peds infectious disease fellow who is studying HCV in pregnancy at the University of Alabama at Birmingham. “In the setting of maternal HCV viremia, maternal-fetal transmission occurs in around 6% of exposed infants and around 10% if there is maternal HIV-HCV coinfection,” she said in an interview. “With the increasing rates of HCV in pregnant women described by Dr. Patrick et al., HCV infections among infants will also rise. Even when maternal HCV infection is documented, we often do not do a good job screening the infants for infection and linking them to treatment. This new data makes me worried we may see more complications of pediatric HCV infection in the future,” she added. She explained that safe and effective treatments for HCV infection are approved down to 3 years of age, but patients must first be diagnosed to receive treatment.
From whichever angle you approach it, tackling both the opioid epidemic and HCV infection in pregnancy will inevitably end up helping both parts of the mother-infant dyad, said Dr. Patrick. “Not too long ago I was caring for an opioid-exposed infant at the hospital where I practice who had transferred in from another center hours away. The mother had not been tested for HCV, so I tested the infant for HCV antibodies which were positive. Imagine that, determining a mother is HCV positive by testing the infant. There are so many layers of systems that should be fixed to make this not happen. And what are the chances the mother, after she found out, was able to access treatment for HCV? What about the infant being tested? The systems are just fragmented and we need to do better.”
The study was funded by the National Institute on Drug Abuse of the National Institutes of Health. Neither Dr. Patrick, Dr. Kuller, nor Dr. Lloyd reported any conflicts of interest.
Mirroring the opioid crisis, maternal and newborn hepatitis C infections (HCV) more than doubled in the United States between 2009 and 2019, with disproportionate increases in people of White, American Indian, and Alaska Native race, especially those with less education, according to a cross-sectional study published in JAMA Health Forum. However, the level of risk within these populations was mitigated in counties with higher employment, reported Stephen W. Patrick, MD, of Vanderbilt University, in Nashville, Tenn., and coauthors.
“As we develop public health approaches to prevent HCV infections, connect to treatment, and monitor exposed infants, understanding these factors can be of critical importance to tailoring interventions,” Dr. Patrick said in an interview. “HCV is one more complication of the opioid crisis,” he added. “These data also enable us to step back a bit from HCV and look at the landscape of how the opioid crisis continues to grow in complexity and scope. Throughout the opioid crisis we have often failed to recognize and address the unique needs of pregnant people and infants.”
The study authors used data from the National Center for Health Statistics at the Centers for Disease Control and Prevention, and from the Area Health Resource File to examine maternal-infant HCV infection among all U.S. births between 2009 and 2019. The researchers also examined community-level risk factors including rurality, employment, and access to medical care.
In counties reporting HCV, there were 39,380,122 people who had live births, of whom 138,343 (0.4%) were diagnosed with HCV. The overall rate of maternal HCV infection increased from 1.8 to 5.1 per 1,000 live births between 2009 and 2019.
Infection rates were highest in American Indian/Alaska Native (AI/AN) and White people (adjusted odds ratio [aOR] 7.94 and 7.37, respectively) compared with Black people. They were higher among individuals without a 4-year degree compared to those with higher education (aOR, 3.19).
Among these groups considered to be at higher risk for HCV infection, high employment rates somewhat mitigated the risk. Specifically, in counties in the 10th percentile of employment, the predicted probability of HCV increased from 0.16% to 1.37%, between 2009 and 2019, whereas in counties at the 90th percentile of employment, the predicted probability remained similar, at 0.36% in 2009 and 0.48% in 2019.
“With constrained national resources, understanding both individual and community-level factors associated with HCV infections in pregnant people could inform strategies to mitigate its spread, such as harm reduction efforts (e.g., syringe service programs), improving access to treatment for [opioid use disorder] or increasing the obstetrical workforce in high-risk communities, HCV testing strategies in pregnant people and people of childbearing age, and treatment with novel antiviral therapies,” wrote the authors.
In the time since the authors began the study, universal HCV screening for every pregnancy has been recommended by a number of groups, including the U.S. Preventive Services Task Force, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (SMFM). However, Dr. Patrick says even though such recommendations are now adopted, it will be some time before they are fully operational, making knowledge of HCV risk factors important for obstetricians as well as pediatricians and family physicians. “We don’t know how if hospitals and clinicians have started universal screening for HCV and even when it is completely adopted, understanding individual and community-level factors associated with HCV in pregnant people is still of critical importance,” he explained. “In some of our previous work we have found that non-White HCV-exposed infants are less likely to be tested for HCV than are White infants, even after accounting for multiple individual and hospital-level factors. The pattern we are seeing in our research and in research in other groups is one of unequal treatment of pregnant people with substance use disorder in terms of being given evidence-based treatments, being tested for HCV, and even in child welfare outcomes like foster placement. It is important to know these issues are occurring, but we need specific equitable approaches to ensuring optimal outcomes for all families.
Jeffrey A. Kuller, MD, one of the authors of the SMFM’s new recommendations for universal HCV screening in pregnancy, agreed that until universal screening is widely adopted, awareness of maternal HCV risk factors is important, “to better determine who is at highest risk for hep C, barriers to care, and patients to better target.” This information also affects procedure at the time of delivery, added Dr. Kuller, professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke University, Durham, N.C. “We do not perform C-sections for the presence of hep C,” he told this publication. However, in labor, “we try to avoid internal fetal monitoring when possible, and early artificial rupture of membranes when possible, and avoid the use of routine episiotomy,” he said. “Hep C–positive patients should also be assessed for other sexually transmitted diseases including HIV, syphilis, gonorrhea, chlamydia, and hep B. “Although we do not typically treat hep C pharmacologically during pregnancy, we try to get the patient placed with a hepatologist for long-term management.”
The study has important implications for pediatric patients, added Audrey R. Lloyd, MD, a med-peds infectious disease fellow who is studying HCV in pregnancy at the University of Alabama at Birmingham. “In the setting of maternal HCV viremia, maternal-fetal transmission occurs in around 6% of exposed infants and around 10% if there is maternal HIV-HCV coinfection,” she said in an interview. “With the increasing rates of HCV in pregnant women described by Dr. Patrick et al., HCV infections among infants will also rise. Even when maternal HCV infection is documented, we often do not do a good job screening the infants for infection and linking them to treatment. This new data makes me worried we may see more complications of pediatric HCV infection in the future,” she added. She explained that safe and effective treatments for HCV infection are approved down to 3 years of age, but patients must first be diagnosed to receive treatment.
From whichever angle you approach it, tackling both the opioid epidemic and HCV infection in pregnancy will inevitably end up helping both parts of the mother-infant dyad, said Dr. Patrick. “Not too long ago I was caring for an opioid-exposed infant at the hospital where I practice who had transferred in from another center hours away. The mother had not been tested for HCV, so I tested the infant for HCV antibodies which were positive. Imagine that, determining a mother is HCV positive by testing the infant. There are so many layers of systems that should be fixed to make this not happen. And what are the chances the mother, after she found out, was able to access treatment for HCV? What about the infant being tested? The systems are just fragmented and we need to do better.”
The study was funded by the National Institute on Drug Abuse of the National Institutes of Health. Neither Dr. Patrick, Dr. Kuller, nor Dr. Lloyd reported any conflicts of interest.
FROM JAMA HEALTH FORUM
Majority of justices seem receptive to bid to stop Texas abortion law
During over 3 hours of oral arguments on Nov. 1,
They seemed less certain about whether the federal government — which is also challenging the law — was within its rights to sue Texas.
Senate Bill 8, which went into effect September 1, allows any private citizen to file suit anywhere in the state against anyone who performs, induces, or “aids or abets” an abortion. If successful in court, the plaintiff is entitled to at least $10,000 and does not have to pay attorneys’ fees; rather, defendants are required to pay all legal costs.
In September, most justices denied an emergency request to stop the law but agreed to quickly hear the challenges in person.
At the Nov. 1 hearing, it appeared that a few justices who had let the law stand — notably conservatives Amy Coney Barrett and Brett Kavanaugh — were now agreeing that its challengers, in particular the abortion provider Whole Woman’s Health, might have a legal basis to move forward.
“I think it’s pretty likely the Court is going to do something that allows ‘someone’s’ suit against SB 8 to go ahead,” tweeted Raffi Melkonian, a Houston attorney, after the hearing. “I don’t know when they’re going to do that.”
The Supreme Court usually issues its opinions months after arguments. Since these two challenges — Whole Woman’s Health v. Jackson and US v. Texas — were heard on a faster schedule, there’s speculation that a decision could also come quickly.
“The court clearly is in a hurry,” wrote Florida State University law professor Mary Ziegler before the hearing in a post on court-tracking site SCOTUSblog. She said the court seems to be taking the abortion issue as seriously as most Americans, and that the justices could rule before it hears oral arguments on December 1 in a Mississippi case directly challenging Roe v. Wade.
In addition, data shows abortions have been severely curtailed in Texas since the law took effect — by as much as 50% according to researchers at the University of Texas at Austin. They reported that 2,164 abortions were provided in September 2021, compared with 4,313 in September 2020.
“The actual provisions in this law have prevented every woman in Texas from exercising a constitutional right as declared by this court,” said Justice Elena Kagan, clarifying that it was every woman who had not made a decision by 6 weeks.
“Usually, in these chilling effect cases, we’re kind of guessing,” she said. “Here, we’re not guessing. We know exactly what has happened as a result of this law. It has chilled everybody on the ground.”
Judge Edward Stone II, an attorney with the Texas Attorney General’s Office who argued for the state, denied Justice Kagan’s assertion.
Nineteen medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, American Academy of Pediatrics, and the American College of Physicians, filed a friend of the court brief supporting both challenges, saying the Texas law allows legislators to interfere with the patient–doctor relationship and that it limits treatment options.
Texas argued that the only way to challenge the law at the federal level would be to be sued first.
Marc A. Hearron, a lawyer with the Center for Reproductive Rights who argued for Whole Woman’s Health, said that was untenable.
“What my friends on the other side are saying is that clinics should just violate the law,” and “subject themselves to the risk that they will be forced to close their doors,” said Mr. Hearron.
But even if providers decide to violate the law, “they may not find physicians, nurses, ultrasound technicians, staff members willing to work behind the desk, because this law targets all of them,” he said.
Plus, clinics run the risk of becoming permanent defendants because the law does not prohibit multiple suits, he said.
Whole Woman’s Health asked the justices to stop the law by preventing the state’s clerks from filing cases.
Federal standing not as clear
The U.S. Department of Justice sued Texas on September 9, saying the law negated the constitutional right to an abortion.
“The Act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said at the time.
At the court, U.S. Solicitor General Elizabeth B. Prelogar called it a “brazen attack” on the supremacy of federal law and said it would open the door to other states mounting similar challenges.
Justice Kagan seemed to agree.
“The entire point of this law, its purpose, and its effect is to find the chink in the armor of Ex parte Young,” a 1908 law that “set out a basic principle of how our government is supposed to work and how people can seek review of unconstitutional state laws,” she said, decrying that “after all these many years, some geniuses came up with a way to evade the commands of that decision.”
Judge Stone waved off the concerns. “Nothing in this law even pretends that Texas courts could evade that because it can’t,” he said.
“Essentially, we would be inviting states, all 50 of them, with respect to their unpreferred constitutional rights, to try to nullify the law — that this Court has laid down as to the content of those rights,” said Justice Kagan.
Justice Kavanaugh also seemed concerned about that possibility.
“It could be free speech rights. It could be free exercise of religion rights. It could be Second Amendment rights if this position is accepted here,” he said, citing a brief submitted by the Firearms Policy Coalition that supported the Whole Woman’s Health challenge.
Justice Neil Gorsuch seemed dubious that the Texas law would undercut anybody’s right to challenge.
“Often constitutional rights, of course, can only be enforced in a defensive posture, when an individual is faced either with potential liability, punitive damages, but also, of course, civil fines — fines and even criminal sanction, including prison time,” he said.
Judge Stone argued that the U.S. government is “not a proper plaintiff” and did not have the right to sue Texas or any of its officials because none were involved in enforcing the law. If the federal government didn’t like the law, it should ask Congress to fix it, said Judge Stone.
After the hearing, Texas Attorney General Ken Paxton reiterated that position.
“The Biden Administration does not have the power to sue a state, such as Texas, just because it disagrees with a state law that protects the unborn,” he said in a statement.
A ruling on the challenges will not put an end to the litigation over SB 8.
“Even if the Supreme Court does rule that the abortion provider plaintiffs are allowed to sue, it is likely that there will still need to be more litigation in a federal trial court before SB 8 is actually determined to be unconstitutional and is blocked by a court order,” wrote Ian Millhiser, a Supreme Court scholar, after the hearing.
A federal judge in Austin did approve the Department of Justice’s request for a temporary halt to the law in October, but days later, the Fifth Circuit Court of Appeals ruled it could go back into effect while the legal questions were being pondered in the courts.
A version of this article first appeared on Medscape.com.
During over 3 hours of oral arguments on Nov. 1,
They seemed less certain about whether the federal government — which is also challenging the law — was within its rights to sue Texas.
Senate Bill 8, which went into effect September 1, allows any private citizen to file suit anywhere in the state against anyone who performs, induces, or “aids or abets” an abortion. If successful in court, the plaintiff is entitled to at least $10,000 and does not have to pay attorneys’ fees; rather, defendants are required to pay all legal costs.
In September, most justices denied an emergency request to stop the law but agreed to quickly hear the challenges in person.
At the Nov. 1 hearing, it appeared that a few justices who had let the law stand — notably conservatives Amy Coney Barrett and Brett Kavanaugh — were now agreeing that its challengers, in particular the abortion provider Whole Woman’s Health, might have a legal basis to move forward.
“I think it’s pretty likely the Court is going to do something that allows ‘someone’s’ suit against SB 8 to go ahead,” tweeted Raffi Melkonian, a Houston attorney, after the hearing. “I don’t know when they’re going to do that.”
The Supreme Court usually issues its opinions months after arguments. Since these two challenges — Whole Woman’s Health v. Jackson and US v. Texas — were heard on a faster schedule, there’s speculation that a decision could also come quickly.
“The court clearly is in a hurry,” wrote Florida State University law professor Mary Ziegler before the hearing in a post on court-tracking site SCOTUSblog. She said the court seems to be taking the abortion issue as seriously as most Americans, and that the justices could rule before it hears oral arguments on December 1 in a Mississippi case directly challenging Roe v. Wade.
In addition, data shows abortions have been severely curtailed in Texas since the law took effect — by as much as 50% according to researchers at the University of Texas at Austin. They reported that 2,164 abortions were provided in September 2021, compared with 4,313 in September 2020.
“The actual provisions in this law have prevented every woman in Texas from exercising a constitutional right as declared by this court,” said Justice Elena Kagan, clarifying that it was every woman who had not made a decision by 6 weeks.
“Usually, in these chilling effect cases, we’re kind of guessing,” she said. “Here, we’re not guessing. We know exactly what has happened as a result of this law. It has chilled everybody on the ground.”
Judge Edward Stone II, an attorney with the Texas Attorney General’s Office who argued for the state, denied Justice Kagan’s assertion.
Nineteen medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, American Academy of Pediatrics, and the American College of Physicians, filed a friend of the court brief supporting both challenges, saying the Texas law allows legislators to interfere with the patient–doctor relationship and that it limits treatment options.
Texas argued that the only way to challenge the law at the federal level would be to be sued first.
Marc A. Hearron, a lawyer with the Center for Reproductive Rights who argued for Whole Woman’s Health, said that was untenable.
“What my friends on the other side are saying is that clinics should just violate the law,” and “subject themselves to the risk that they will be forced to close their doors,” said Mr. Hearron.
But even if providers decide to violate the law, “they may not find physicians, nurses, ultrasound technicians, staff members willing to work behind the desk, because this law targets all of them,” he said.
Plus, clinics run the risk of becoming permanent defendants because the law does not prohibit multiple suits, he said.
Whole Woman’s Health asked the justices to stop the law by preventing the state’s clerks from filing cases.
Federal standing not as clear
The U.S. Department of Justice sued Texas on September 9, saying the law negated the constitutional right to an abortion.
“The Act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said at the time.
At the court, U.S. Solicitor General Elizabeth B. Prelogar called it a “brazen attack” on the supremacy of federal law and said it would open the door to other states mounting similar challenges.
Justice Kagan seemed to agree.
“The entire point of this law, its purpose, and its effect is to find the chink in the armor of Ex parte Young,” a 1908 law that “set out a basic principle of how our government is supposed to work and how people can seek review of unconstitutional state laws,” she said, decrying that “after all these many years, some geniuses came up with a way to evade the commands of that decision.”
Judge Stone waved off the concerns. “Nothing in this law even pretends that Texas courts could evade that because it can’t,” he said.
“Essentially, we would be inviting states, all 50 of them, with respect to their unpreferred constitutional rights, to try to nullify the law — that this Court has laid down as to the content of those rights,” said Justice Kagan.
Justice Kavanaugh also seemed concerned about that possibility.
“It could be free speech rights. It could be free exercise of religion rights. It could be Second Amendment rights if this position is accepted here,” he said, citing a brief submitted by the Firearms Policy Coalition that supported the Whole Woman’s Health challenge.
Justice Neil Gorsuch seemed dubious that the Texas law would undercut anybody’s right to challenge.
“Often constitutional rights, of course, can only be enforced in a defensive posture, when an individual is faced either with potential liability, punitive damages, but also, of course, civil fines — fines and even criminal sanction, including prison time,” he said.
Judge Stone argued that the U.S. government is “not a proper plaintiff” and did not have the right to sue Texas or any of its officials because none were involved in enforcing the law. If the federal government didn’t like the law, it should ask Congress to fix it, said Judge Stone.
After the hearing, Texas Attorney General Ken Paxton reiterated that position.
“The Biden Administration does not have the power to sue a state, such as Texas, just because it disagrees with a state law that protects the unborn,” he said in a statement.
A ruling on the challenges will not put an end to the litigation over SB 8.
“Even if the Supreme Court does rule that the abortion provider plaintiffs are allowed to sue, it is likely that there will still need to be more litigation in a federal trial court before SB 8 is actually determined to be unconstitutional and is blocked by a court order,” wrote Ian Millhiser, a Supreme Court scholar, after the hearing.
A federal judge in Austin did approve the Department of Justice’s request for a temporary halt to the law in October, but days later, the Fifth Circuit Court of Appeals ruled it could go back into effect while the legal questions were being pondered in the courts.
A version of this article first appeared on Medscape.com.
During over 3 hours of oral arguments on Nov. 1,
They seemed less certain about whether the federal government — which is also challenging the law — was within its rights to sue Texas.
Senate Bill 8, which went into effect September 1, allows any private citizen to file suit anywhere in the state against anyone who performs, induces, or “aids or abets” an abortion. If successful in court, the plaintiff is entitled to at least $10,000 and does not have to pay attorneys’ fees; rather, defendants are required to pay all legal costs.
In September, most justices denied an emergency request to stop the law but agreed to quickly hear the challenges in person.
At the Nov. 1 hearing, it appeared that a few justices who had let the law stand — notably conservatives Amy Coney Barrett and Brett Kavanaugh — were now agreeing that its challengers, in particular the abortion provider Whole Woman’s Health, might have a legal basis to move forward.
“I think it’s pretty likely the Court is going to do something that allows ‘someone’s’ suit against SB 8 to go ahead,” tweeted Raffi Melkonian, a Houston attorney, after the hearing. “I don’t know when they’re going to do that.”
The Supreme Court usually issues its opinions months after arguments. Since these two challenges — Whole Woman’s Health v. Jackson and US v. Texas — were heard on a faster schedule, there’s speculation that a decision could also come quickly.
“The court clearly is in a hurry,” wrote Florida State University law professor Mary Ziegler before the hearing in a post on court-tracking site SCOTUSblog. She said the court seems to be taking the abortion issue as seriously as most Americans, and that the justices could rule before it hears oral arguments on December 1 in a Mississippi case directly challenging Roe v. Wade.
In addition, data shows abortions have been severely curtailed in Texas since the law took effect — by as much as 50% according to researchers at the University of Texas at Austin. They reported that 2,164 abortions were provided in September 2021, compared with 4,313 in September 2020.
“The actual provisions in this law have prevented every woman in Texas from exercising a constitutional right as declared by this court,” said Justice Elena Kagan, clarifying that it was every woman who had not made a decision by 6 weeks.
“Usually, in these chilling effect cases, we’re kind of guessing,” she said. “Here, we’re not guessing. We know exactly what has happened as a result of this law. It has chilled everybody on the ground.”
Judge Edward Stone II, an attorney with the Texas Attorney General’s Office who argued for the state, denied Justice Kagan’s assertion.
Nineteen medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, American Academy of Pediatrics, and the American College of Physicians, filed a friend of the court brief supporting both challenges, saying the Texas law allows legislators to interfere with the patient–doctor relationship and that it limits treatment options.
Texas argued that the only way to challenge the law at the federal level would be to be sued first.
Marc A. Hearron, a lawyer with the Center for Reproductive Rights who argued for Whole Woman’s Health, said that was untenable.
“What my friends on the other side are saying is that clinics should just violate the law,” and “subject themselves to the risk that they will be forced to close their doors,” said Mr. Hearron.
But even if providers decide to violate the law, “they may not find physicians, nurses, ultrasound technicians, staff members willing to work behind the desk, because this law targets all of them,” he said.
Plus, clinics run the risk of becoming permanent defendants because the law does not prohibit multiple suits, he said.
Whole Woman’s Health asked the justices to stop the law by preventing the state’s clerks from filing cases.
Federal standing not as clear
The U.S. Department of Justice sued Texas on September 9, saying the law negated the constitutional right to an abortion.
“The Act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said at the time.
At the court, U.S. Solicitor General Elizabeth B. Prelogar called it a “brazen attack” on the supremacy of federal law and said it would open the door to other states mounting similar challenges.
Justice Kagan seemed to agree.
“The entire point of this law, its purpose, and its effect is to find the chink in the armor of Ex parte Young,” a 1908 law that “set out a basic principle of how our government is supposed to work and how people can seek review of unconstitutional state laws,” she said, decrying that “after all these many years, some geniuses came up with a way to evade the commands of that decision.”
Judge Stone waved off the concerns. “Nothing in this law even pretends that Texas courts could evade that because it can’t,” he said.
“Essentially, we would be inviting states, all 50 of them, with respect to their unpreferred constitutional rights, to try to nullify the law — that this Court has laid down as to the content of those rights,” said Justice Kagan.
Justice Kavanaugh also seemed concerned about that possibility.
“It could be free speech rights. It could be free exercise of religion rights. It could be Second Amendment rights if this position is accepted here,” he said, citing a brief submitted by the Firearms Policy Coalition that supported the Whole Woman’s Health challenge.
Justice Neil Gorsuch seemed dubious that the Texas law would undercut anybody’s right to challenge.
“Often constitutional rights, of course, can only be enforced in a defensive posture, when an individual is faced either with potential liability, punitive damages, but also, of course, civil fines — fines and even criminal sanction, including prison time,” he said.
Judge Stone argued that the U.S. government is “not a proper plaintiff” and did not have the right to sue Texas or any of its officials because none were involved in enforcing the law. If the federal government didn’t like the law, it should ask Congress to fix it, said Judge Stone.
After the hearing, Texas Attorney General Ken Paxton reiterated that position.
“The Biden Administration does not have the power to sue a state, such as Texas, just because it disagrees with a state law that protects the unborn,” he said in a statement.
A ruling on the challenges will not put an end to the litigation over SB 8.
“Even if the Supreme Court does rule that the abortion provider plaintiffs are allowed to sue, it is likely that there will still need to be more litigation in a federal trial court before SB 8 is actually determined to be unconstitutional and is blocked by a court order,” wrote Ian Millhiser, a Supreme Court scholar, after the hearing.
A federal judge in Austin did approve the Department of Justice’s request for a temporary halt to the law in October, but days later, the Fifth Circuit Court of Appeals ruled it could go back into effect while the legal questions were being pondered in the courts.
A version of this article first appeared on Medscape.com.
COVID-19 vaccines provide 5 times the protection of natural immunity, CDC study says
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
, according to aThe research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
Hair follicle miniaturization common in persistent chemo-induced alopecia, case series suggests
and treatment with minoxidil (sometimes with antiandrogen therapy) was associated with improved hair density, according to a recently published retrospective case series.
“An improvement in hair density was observed in most of the patients treated with topical minoxidil or LDOM [low-dose oral minoxidil], with a more favorable outcome seen with LDOM with or without antiandrogens,” reported Bevin Bhoyrul, MBBS, of Sinclair Dermatology in Melbourne and coauthors from the United Kingdom and Germany.
The findings, published in JAMA Dermatology, suggest that pCIA “may be at least partly reversible,” they wrote.
The investigators analyzed the clinicopathologic characteristics of pCIA in 100 patients presenting to the hair clinics, as well as the results of trichoscopy performed in 90 of the patients and biopsies in 18. The researchers also assessed the effectiveness of treatment in 49 of these patients who met their criteria of completing at least 6 months of therapy with minoxidil.
Almost all patients in their series – 92% – were treated with taxanes and had more severe alopecia than those who weren’t exposed to taxanes (a median Sinclair scale grade of 4 vs. 2). Defined as absent or incomplete hair regrowth 6 months or more after completion of chemotherapy, pCIA has been increasingly reported in the literature, the authors note.
Of the 100 patients, all but one of whom were women, 39 had globally-reduced hair density that also involved the occipital area (diffuse alopecia), and 55 patients had thinning of the centroparietal scalp hair in a female pattern hair loss (FPHL) distribution. Patients presented between November 2011 and February 2020 and had a mean age of 54. The Sinclair scale, which grades from 1 to 5, was used to assess the severity of hair loss in these patients.
Five female patients had bitemporal recession or balding of the crown in a male pattern hair loss (MPHL) distribution, and the one male patient had extensive baldness resembling Hamilton-Norwood type VII.
The vast majority of patients who had trichoscopy performed – 88% – had trichoscopic features that were “indistinguishable from those of androgenetic alopecia,” most commonly hair shaft diameter variability, increased vellus hairs, and predominant single-hair follicular units, the authors reported.
Of the 18 patients who had biopsies, 14 had androgenetic alopecia-like features with decreased terminal hairs, increased vellus hairs, and fibrous streamers. The reduced terminal-to-vellus ratio characterizes hair follicle miniaturization, a hallmark of androgenetic alopecia, they said. (Two patients had cicatricial alopecia, and two had features of both.)
“The predominant phenotypes of pCIA show prominent vellus hairs both clinically and histologically, suggesting that terminal hair follicles undergo miniaturization,” Dr. Bhoyrul and coauthors wrote. Among the 49 patients who completed 6 months or more of treatment, the median Sinclair grade improved from 4 to 3 in 21 patients who received topical minoxidil for a median duration of 17 months; from 4 to 2.5 in 18 patients who received LDOM for a median duration of 29 months; and from 5 to 3 in 10 patients who received LDOM combined with an antiandrogen, such as spironolactone, for a median of 33 months.
Almost three-quarters of the patients in the series received adjuvant hormone therapy, which is independently associated with hair loss, the authors noted. However, there was no statistically significant difference in the pattern or severity of alopecia between patients who were treated with endocrine therapy and those who weren’t.
Asked to comment on the study and on the care of patients with pCIA, Maria K. Hordinsky, MD, professor and chair of dermatology at the University of Minnesota, Minneapolis, and an expert in hair diseases, said the case series points to the value of biopsies in patients with pCIA.
“Some patients really do have a loss of hair follicles,” she said. “But if you do a biopsy and see this miniaturization of the hair follicles, then we have tools to stimulate the hair follicles to become more normal. ... These patients can be successfully treated.”
For patients who do not want to do a biopsy, a therapeutic trial is acceptable. “But knowing helps set expectations for people,” she said. “If the follicles are really small, it will take months [of therapy].”
In addition to topical minoxidil, which she said “is always a good tool,” and LDOM, which is “becoming very popular,” Dr. Hordinsky has used low-level laser light successfully. She cautioned against the use of spironolactone and other hair-growth promoting therapies with potentially significant hormonal impacts unless there is discussion between the dermatologist, oncologist, and patient.
The authors of the case series called in their conclusion for wider use of hair-protective strategies such as scalp hypothermia. But Dr. Hordinsky said that, in the United States, there are divergent opinions among oncologists and among cancer centers on the use of scalp cooling and whether or not it might lessen response to chemotherapy.
More research is needed, she noted, on chemotherapy-induced hair loss in patients of different races and ethnicities. Of the 100 patients in the case series, 91 were European; others were Afro Caribbean, Middle Eastern, and South Asian.
Dr. Bhoyrul is supported by the Geoffrey Dowling Fellowship from the British Association of Dermatologists. One coauthor disclosed serving as a principal investigator and/or scientific board member for various pharmaceutical companies, outside of the submitted study. There were no other disclosures reported. Dr. Hordinsky, the immediate past president of the American Hair Research Society and a section editor for hair diseases in UpToDate, had no relevant disclosures.
and treatment with minoxidil (sometimes with antiandrogen therapy) was associated with improved hair density, according to a recently published retrospective case series.
“An improvement in hair density was observed in most of the patients treated with topical minoxidil or LDOM [low-dose oral minoxidil], with a more favorable outcome seen with LDOM with or without antiandrogens,” reported Bevin Bhoyrul, MBBS, of Sinclair Dermatology in Melbourne and coauthors from the United Kingdom and Germany.
The findings, published in JAMA Dermatology, suggest that pCIA “may be at least partly reversible,” they wrote.
The investigators analyzed the clinicopathologic characteristics of pCIA in 100 patients presenting to the hair clinics, as well as the results of trichoscopy performed in 90 of the patients and biopsies in 18. The researchers also assessed the effectiveness of treatment in 49 of these patients who met their criteria of completing at least 6 months of therapy with minoxidil.
Almost all patients in their series – 92% – were treated with taxanes and had more severe alopecia than those who weren’t exposed to taxanes (a median Sinclair scale grade of 4 vs. 2). Defined as absent or incomplete hair regrowth 6 months or more after completion of chemotherapy, pCIA has been increasingly reported in the literature, the authors note.
Of the 100 patients, all but one of whom were women, 39 had globally-reduced hair density that also involved the occipital area (diffuse alopecia), and 55 patients had thinning of the centroparietal scalp hair in a female pattern hair loss (FPHL) distribution. Patients presented between November 2011 and February 2020 and had a mean age of 54. The Sinclair scale, which grades from 1 to 5, was used to assess the severity of hair loss in these patients.
Five female patients had bitemporal recession or balding of the crown in a male pattern hair loss (MPHL) distribution, and the one male patient had extensive baldness resembling Hamilton-Norwood type VII.
The vast majority of patients who had trichoscopy performed – 88% – had trichoscopic features that were “indistinguishable from those of androgenetic alopecia,” most commonly hair shaft diameter variability, increased vellus hairs, and predominant single-hair follicular units, the authors reported.
Of the 18 patients who had biopsies, 14 had androgenetic alopecia-like features with decreased terminal hairs, increased vellus hairs, and fibrous streamers. The reduced terminal-to-vellus ratio characterizes hair follicle miniaturization, a hallmark of androgenetic alopecia, they said. (Two patients had cicatricial alopecia, and two had features of both.)
“The predominant phenotypes of pCIA show prominent vellus hairs both clinically and histologically, suggesting that terminal hair follicles undergo miniaturization,” Dr. Bhoyrul and coauthors wrote. Among the 49 patients who completed 6 months or more of treatment, the median Sinclair grade improved from 4 to 3 in 21 patients who received topical minoxidil for a median duration of 17 months; from 4 to 2.5 in 18 patients who received LDOM for a median duration of 29 months; and from 5 to 3 in 10 patients who received LDOM combined with an antiandrogen, such as spironolactone, for a median of 33 months.
Almost three-quarters of the patients in the series received adjuvant hormone therapy, which is independently associated with hair loss, the authors noted. However, there was no statistically significant difference in the pattern or severity of alopecia between patients who were treated with endocrine therapy and those who weren’t.
Asked to comment on the study and on the care of patients with pCIA, Maria K. Hordinsky, MD, professor and chair of dermatology at the University of Minnesota, Minneapolis, and an expert in hair diseases, said the case series points to the value of biopsies in patients with pCIA.
“Some patients really do have a loss of hair follicles,” she said. “But if you do a biopsy and see this miniaturization of the hair follicles, then we have tools to stimulate the hair follicles to become more normal. ... These patients can be successfully treated.”
For patients who do not want to do a biopsy, a therapeutic trial is acceptable. “But knowing helps set expectations for people,” she said. “If the follicles are really small, it will take months [of therapy].”
In addition to topical minoxidil, which she said “is always a good tool,” and LDOM, which is “becoming very popular,” Dr. Hordinsky has used low-level laser light successfully. She cautioned against the use of spironolactone and other hair-growth promoting therapies with potentially significant hormonal impacts unless there is discussion between the dermatologist, oncologist, and patient.
The authors of the case series called in their conclusion for wider use of hair-protective strategies such as scalp hypothermia. But Dr. Hordinsky said that, in the United States, there are divergent opinions among oncologists and among cancer centers on the use of scalp cooling and whether or not it might lessen response to chemotherapy.
More research is needed, she noted, on chemotherapy-induced hair loss in patients of different races and ethnicities. Of the 100 patients in the case series, 91 were European; others were Afro Caribbean, Middle Eastern, and South Asian.
Dr. Bhoyrul is supported by the Geoffrey Dowling Fellowship from the British Association of Dermatologists. One coauthor disclosed serving as a principal investigator and/or scientific board member for various pharmaceutical companies, outside of the submitted study. There were no other disclosures reported. Dr. Hordinsky, the immediate past president of the American Hair Research Society and a section editor for hair diseases in UpToDate, had no relevant disclosures.
and treatment with minoxidil (sometimes with antiandrogen therapy) was associated with improved hair density, according to a recently published retrospective case series.
“An improvement in hair density was observed in most of the patients treated with topical minoxidil or LDOM [low-dose oral minoxidil], with a more favorable outcome seen with LDOM with or without antiandrogens,” reported Bevin Bhoyrul, MBBS, of Sinclair Dermatology in Melbourne and coauthors from the United Kingdom and Germany.
The findings, published in JAMA Dermatology, suggest that pCIA “may be at least partly reversible,” they wrote.
The investigators analyzed the clinicopathologic characteristics of pCIA in 100 patients presenting to the hair clinics, as well as the results of trichoscopy performed in 90 of the patients and biopsies in 18. The researchers also assessed the effectiveness of treatment in 49 of these patients who met their criteria of completing at least 6 months of therapy with minoxidil.
Almost all patients in their series – 92% – were treated with taxanes and had more severe alopecia than those who weren’t exposed to taxanes (a median Sinclair scale grade of 4 vs. 2). Defined as absent or incomplete hair regrowth 6 months or more after completion of chemotherapy, pCIA has been increasingly reported in the literature, the authors note.
Of the 100 patients, all but one of whom were women, 39 had globally-reduced hair density that also involved the occipital area (diffuse alopecia), and 55 patients had thinning of the centroparietal scalp hair in a female pattern hair loss (FPHL) distribution. Patients presented between November 2011 and February 2020 and had a mean age of 54. The Sinclair scale, which grades from 1 to 5, was used to assess the severity of hair loss in these patients.
Five female patients had bitemporal recession or balding of the crown in a male pattern hair loss (MPHL) distribution, and the one male patient had extensive baldness resembling Hamilton-Norwood type VII.
The vast majority of patients who had trichoscopy performed – 88% – had trichoscopic features that were “indistinguishable from those of androgenetic alopecia,” most commonly hair shaft diameter variability, increased vellus hairs, and predominant single-hair follicular units, the authors reported.
Of the 18 patients who had biopsies, 14 had androgenetic alopecia-like features with decreased terminal hairs, increased vellus hairs, and fibrous streamers. The reduced terminal-to-vellus ratio characterizes hair follicle miniaturization, a hallmark of androgenetic alopecia, they said. (Two patients had cicatricial alopecia, and two had features of both.)
“The predominant phenotypes of pCIA show prominent vellus hairs both clinically and histologically, suggesting that terminal hair follicles undergo miniaturization,” Dr. Bhoyrul and coauthors wrote. Among the 49 patients who completed 6 months or more of treatment, the median Sinclair grade improved from 4 to 3 in 21 patients who received topical minoxidil for a median duration of 17 months; from 4 to 2.5 in 18 patients who received LDOM for a median duration of 29 months; and from 5 to 3 in 10 patients who received LDOM combined with an antiandrogen, such as spironolactone, for a median of 33 months.
Almost three-quarters of the patients in the series received adjuvant hormone therapy, which is independently associated with hair loss, the authors noted. However, there was no statistically significant difference in the pattern or severity of alopecia between patients who were treated with endocrine therapy and those who weren’t.
Asked to comment on the study and on the care of patients with pCIA, Maria K. Hordinsky, MD, professor and chair of dermatology at the University of Minnesota, Minneapolis, and an expert in hair diseases, said the case series points to the value of biopsies in patients with pCIA.
“Some patients really do have a loss of hair follicles,” she said. “But if you do a biopsy and see this miniaturization of the hair follicles, then we have tools to stimulate the hair follicles to become more normal. ... These patients can be successfully treated.”
For patients who do not want to do a biopsy, a therapeutic trial is acceptable. “But knowing helps set expectations for people,” she said. “If the follicles are really small, it will take months [of therapy].”
In addition to topical minoxidil, which she said “is always a good tool,” and LDOM, which is “becoming very popular,” Dr. Hordinsky has used low-level laser light successfully. She cautioned against the use of spironolactone and other hair-growth promoting therapies with potentially significant hormonal impacts unless there is discussion between the dermatologist, oncologist, and patient.
The authors of the case series called in their conclusion for wider use of hair-protective strategies such as scalp hypothermia. But Dr. Hordinsky said that, in the United States, there are divergent opinions among oncologists and among cancer centers on the use of scalp cooling and whether or not it might lessen response to chemotherapy.
More research is needed, she noted, on chemotherapy-induced hair loss in patients of different races and ethnicities. Of the 100 patients in the case series, 91 were European; others were Afro Caribbean, Middle Eastern, and South Asian.
Dr. Bhoyrul is supported by the Geoffrey Dowling Fellowship from the British Association of Dermatologists. One coauthor disclosed serving as a principal investigator and/or scientific board member for various pharmaceutical companies, outside of the submitted study. There were no other disclosures reported. Dr. Hordinsky, the immediate past president of the American Hair Research Society and a section editor for hair diseases in UpToDate, had no relevant disclosures.
FROM JAMA DERMATOLOGY
ERs are swamped with seriously ill patients, although many don’t have COVID
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
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. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
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. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Inside the emergency department at Sparrow Hospital in Lansing, Mich., staff members are struggling to care for patients showing up much sicker than they’ve ever seen.
Tiffani Dusang, the ER’s nursing director, practically vibrates with pent-up anxiety, looking at patients lying on a long line of stretchers pushed up against the beige walls of the hospital hallways. “It’s hard to watch,” she said in a warm Texas twang.
But there’s nothing she can do. The ER’s 72 rooms are already filled.
“I always feel very, very bad when I walk down the hallway and see that people are in pain, or needing to sleep, or needing quiet. But they have to be in the hallway with, as you can see, 10 or 15 people walking by every minute,” Ms. Dusang said.
The scene is a stark contrast to where this emergency department — and thousands of others — were at the start of the pandemic. Except for initial hot spots like New York City, in spring 2020 many ERs across the country were often eerily empty. Terrified of contracting COVID-19, people who were sick with other things did their best to stay away from hospitals. Visits to emergency rooms dropped to half their typical levels, according to the Epic Health Research Network, and didn’t fully rebound until this summer.
But now, they’re too full.
Months of treatment delays have exacerbated chronic conditions and worsened symptoms. Doctors and nurses say the severity of illness ranges widely and includes abdominal pain, respiratory problems, blood clots, heart conditions and suicide attempts, among other conditions.
But they can hardly be accommodated. Emergency departments, ideally, are meant to be brief ports in a storm, with patients staying just long enough to be sent home with instructions to follow up with primary care physicians, or sufficiently stabilized to be transferred “upstairs” to inpatient or intensive care units.
Except now those long-term care floors are full too, with a mix of covid and non-covid patients. People coming to the ER get warehoused for hours, even days, forcing ER staffers to perform long-term care roles they weren’t trained to do.
At Sparrow, space is a valuable commodity in the ER: A separate section of the hospital was turned into an overflow unit. Stretchers stack up in halls. A row of brown reclining chairs lines a wall, intended for patients who aren’t sick enough for a stretcher but are too sick to stay in the main waiting room.
Forget privacy, Alejos Perrientoz learned when he arrived. He came to the ER because his arm had been tingling and painful for over a week. He couldn’t hold a cup of coffee. A nurse gave him a full physical exam in a brown recliner, which made him self-conscious about having his shirt lifted in front of strangers. “I felt a little uncomfortable,” he whispered. “But I have no choice, you know? I’m in the hallway. There’s no rooms.
“We could have done the physical in the parking lot,” he added, managing a laugh.
Even patients who arrive by ambulance are not guaranteed a room: One nurse runs triage, screening those who absolutely need a bed, and those who can be put in the waiting area.
“I hate that we even have to make that determination,” MS. Dusang said. Lately, staff members have been pulling out some patients already in the ER’s rooms when others arrive who are more critically ill. “No one likes to take someone out of the privacy of their room and say, ‘We’re going to put you in a hallway because we need to get care to someone else.’”
ER patients have grown sicker
“We are hearing from members in every part of the country,” said Dr. Lisa Moreno, president of the American Academy of Emergency Medicine. “The Midwest, the South, the Northeast, the West … they are seeing this exact same phenomenon.”
Although the number of ER visits returned to pre-COVID levels this summer, admission rates, from the ER to the hospital’s inpatient floors, are still almost 20% higher. That’s according to the most recent analysis by the Epic Health Research Network, which pulls data from more than 120 million patients across the country.
“It’s an early indicator that what’s happening in the ED is that we’re seeing more acute cases than we were pre-pandemic,” said Caleb Cox, a data scientist at Epic.
Less acute cases, such as people with health issues like rashes or conjunctivitis, still aren’t going to the ER as much as they used to. Instead, they may be opting for an urgent care center or their primary care doctor, Mr. Cox explained. Meanwhile, there has been an increase in people coming to the ER with more serious conditions, like strokes and heart attacks.
So, even though the total number of patients coming to ERs is about the same as before the pandemic, “that’s absolutely going to feel like [if I’m an ER doctor or nurse] I’m seeing more patients and I’m seeing more acute patients,” Mr. Cox said.
Dr. Moreno, the AAEM president, works at an emergency department in New Orleans. She said the level of illness, and the inability to admit patients quickly and move them to beds upstairs, has created a level of chaos she described as “not even humane.”
At the beginning of a recent shift, she heard a patient crying nearby and went to investigate. It was a paraplegic man who’d recently had surgery for colon cancer. His large post-operative wound was sealed with a device called a wound vac, which pulls fluid from the wound into a drainage tube attached to a portable vacuum pump.
But the wound vac had malfunctioned, which is why he had come to the ER. Staffers were so busy, however, that by the time Dr. Moreno came in, the fluid from his wound was leaking everywhere.
“When I went in, the bed was covered,” she recalled. “I mean, he was lying in a puddle of secretions from this wound. And he was crying, because he said to me, ‘I’m paralyzed. I can’t move to get away from all these secretions, and I know I’m going to end up getting an infection. I know I’m going to end up getting an ulcer. I’ve been laying in this for, like, eight or nine hours.’”
The nurse in charge of his care told Dr. Moreno she simply hadn’t had time to help this patient yet. “She said, ‘I’ve had so many patients to take care of, and so many critical patients. I started [an IV] drip on this person. This person is on a cardiac monitor. I just didn’t have time to get in there.’”
“This is not humane care,” Dr. Moreno said. “This is horrible care.”
But it’s what can happen when emergency department staffers don’t have the resources they need to deal with the onslaught of competing demands.
“All the nurses and doctors had the highest level of intent to do the right thing for the person,” Dr. Moreno said. “But because of the high acuity of … a large number of patients, the staffing ratio of nurse to patient, even the staffing ratio of doctor to patient, this guy did not get the care that he deserved to get, just as a human being.”
The instance of unintended neglect that Dr. Moreno saw is extreme, and not the experience of most patients who arrive at ERs these days. But the problem is not new: Even before the pandemic, ER overcrowding had been a “widespread problem and a source of patient harm, according to a recent commentary in NEJM Catalyst Innovations in Care Delivery.
“ED crowding is not an issue of inconvenience,” the authors wrote. “There is incontrovertible evidence that ED crowding leads to significant patient harm, including morbidity and mortality related to consequential delays of treatment for both high- and low-acuity patients.”
And already-overwhelmed staffers are burning out.
Burnout feeds staffing shortages, and vice versa
Every morning, Tiffani Dusang wakes up and checks her Sparrow email with one singular hope: that she will not see yet another nurse resignation letter in her inbox.
“I cannot tell you how many of them [the nurses] tell me they went home crying” after their shifts, she said.
Despite Ms. Dusang’s best efforts to support her staffers, they’re leaving too fast to be replaced, either to take higher-paying gigs as a travel nurse, to try a less-stressful type of nursing, or simply walking away from the profession entirely.
Kelly Spitz has been an emergency department nurse at Sparrow for 10 years. But, lately, she has also fantasized about leaving. “It has crossed my mind several times,” she said, and yet she continues to come back. “Because I have a team here. And I love what I do.” But then she started to cry. The issue is not the hard work, or even the stress. She struggles with not being able to give her patients the kind of care and attention she wants to give them, and that they need and deserve, she said.
She often thinks about a patient whose test results revealed terminal cancer, she said. Ms. Spitz spent all day working the phones, hustling case managers, trying to get hospice care set up in the man’s home. He was going to die, and she just didn’t want him to have to die in the hospital, where only one visitor was allowed. She wanted to get him home, and back with his family.
Finally, after many hours, they found an ambulance to take him home.
Three days later, the man’s family members called Ms. Spitz: He had died surrounded by family. They were calling to thank her.
“I felt like I did my job there, because I got him home,” she said. But that’s a rare feeling these days. “I just hope it gets better. I hope it gets better soon.”
Around 4 p.m. at Sparrow Hospital as one shift approached its end, Ms. Dusang faced a new crisis: The overnight shift was more short-staffed than usual.
“Can we get two inpatient nurses?” she asked, hoping to borrow two nurses from one of the hospital floors upstairs.
“Already tried,” replied nurse Troy Latunski.
Without more staff, it’s going to be hard to care for new patients who come in overnight — from car crashes to seizures or other emergencies.
But Mr. Latunski had a plan: He would go home, snatch a few hours of sleep and return at 11 p.m. to work the overnight shift in the ER’s overflow unit. That meant he would be largely caring for eight patients, alone. On just a few short hours of sleep. But lately that seemed to be their only, and best, option.
Ms. Dusang considered for a moment, took a deep breath and nodded. “OK,” she said.
“Go home. Get some sleep. Thank you,” she added, shooting Mr. Latunski a grateful smile. And then she pivoted, because another nurse was approaching with an urgent question. On to the next crisis.
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. This story is part of a partnership that includes Michigan Radio, NPR and KHN.
Boxed warnings: Legal risks that many physicians never see coming
Almost all physicians write prescriptions, and each prescription requires a physician to assess the risks and benefits of the drug. If an adverse drug reaction occurs, physicians may be called on to defend their risk-benefit assessment in court.
The assessment of risk is complicated when there is a boxed warning that describes potentially serious and life-threatening adverse reactions associated with a drug. Some of our most commonly prescribed drugs have boxed warnings, and drugs that were initially approved by the Food and Drug Administration without boxed warnings may have them added years later.
One serious problem with boxed warnings is that there are no reliable mechanisms for making sure that physicians are aware of them. The warnings are typically not seen by physicians as printed product labels, just as physicians often don’t see the pills and capsules that they prescribe. Pharmacists who receive packaged drugs from manufacturers may be the only ones to see an actual printed boxed warning, but even those pharmacists have little reason to read each label and note changes when handling many bulk packages.
This problem is aggravated by misperceptions that many physicians have about boxed warnings and the increasingly intense scrutiny given to them by mass media and the courts. Lawyers can use boxed warnings to make a drug look dangerous, even when it’s not, and to make physicians look reckless when prescribing it. Therefore, it is important for physicians to understand what boxed warnings are, what they are not, the problems they cause, and how to minimize these problems.
What is a ‘boxed warning’?
The marketing and sale of drugs in the United States requires approval by the FDA. Approval requires manufacturers to prepare a document containing “Full Prescribing Information” for the drug and to include a printed copy in every package of the drug that is sold. This document is commonly called a “package insert,” but the FDA designates this document as the manufacturer’s product “label.”
In 1979, the FDA began requiring some labels to appear within thick, black rectangular borders; these have come to be known as boxed warnings. Boxed warnings are usually placed at the beginning of a label. They may be added to the label of a previously approved drug already on the market or included in the product label when first approved and marketed.
The requirement for a boxed warning most often arises when a signal appears during review of postmarketing surveillance data suggesting a possible and plausible association between a drug and an adverse reaction. Warnings may also be initiated in response to petitions from public interest groups, or upon the discovery of serious toxicity in animals. Regardless of their origin, the intent of a boxed warning is to highlight information that may have important therapeutic consequences and warrants heightened awareness among physicians.
What a boxed warning is not
A boxed warning is not “issued” by the FDA; it is merely required by the FDA. Specific wording or a template may be suggested by the FDA, but product labels and boxed warnings are written and issued by the manufacturer. This distinction may seem minor, but extensive litigation has occurred over whether manufacturers have met their duty to warn consumers about possible risks when using their products, and this duty cannot be shifted to the FDA.
A boxed warning may not be added to a product label at the option of a manufacturer. The FDA allows a boxed warning only if it requires the warning, to preserve its impact. It should be noted that some medical information sources (e.g., PDR.net) may include a “BOXED WARNING” in their drug monographs, but monographs not written by a manufacturer are not regulated by the FDA, and the text of their boxed warnings do not always correspond to the boxed warning that was approved by the FDA.
A boxed warning is not an indication that revocation of FDA approval is being considered or that it is likely to be revoked. FDA approval is subject to ongoing review and may be revoked at any time, without a prior boxed warning.
A boxed warning is not the highest level of warning. The FDA may require a manufacturer to send out a “Dear Health Care Provider” (DHCP) letter when an even higher or more urgent level of warning is deemed necessary. DHCP letters are usually accompanied by revisions of the product label, but most label revisions – and even most boxed warnings – are not accompanied by DHCP letters.
A boxed warning is not a statement about causation. Most warnings describe an “association” between a drug and an adverse effect, or “increased risk,” or instances of a particular adverse effect that “have been reported” in persons taking a drug. The words in a boxed warning are carefully chosen and require careful reading; in most cases they refrain from stating that a drug actually causes an adverse effect. The postmarketing surveillance data on which most warnings are based generally cannot provide the kind of evidence required to establish causation, and an association may be nothing more than an uncommon manifestation of the disorder for which the drug has been prescribed.
A boxed warning is not a statement about the probability of an adverse reaction occurring. The requirement for a boxed warning correlates better to the new recognition of a possible association than to the probability of an association. For example, penicillin has long been known to cause fatal anaphylaxis in 1/100,000 first-time administrations, but it does not have a boxed warning. The adverse consequences described in boxed warnings are often far less frequent – so much so that most physicians will never see them.
A boxed warning does not define the standard of care. The warning is a requirement imposed on the manufacturer, not on the practice of medicine. For legal purposes, the “standard of care” for the practice of medicine is defined state by state and is typically cast in terms such as “what most physicians would do in similar circumstances.” Physicians often prescribe drugs in spite of boxed warnings, just as they often prescribe drugs for “off label” indications, always balancing risk versus benefit.
A boxed warning does not constitute a contraindication to the use of a medication. Some warnings state that a drug is contraindicated in some situations, but product labels have another mandated section for listing contraindications, and most boxed warnings have no corresponding entry in that section.
A boxed warning does not necessarily constitute current information, nor is it always updated when new or contrary information becomes available. Revisions to boxed warnings, and to product labels in general, are made only after detailed review at the FDA, and the process of deciding whether an existing boxed warning continues to be appropriate may divert limited regulatory resources from more urgent priorities. Consequently, revisions to a boxed warning may lag behind the data that justify a revision by months or years. Revisions may never occur if softening or eliminating a boxed warning is deemed to be not worth the cost by a manufacturer.
Boxed warning problems for physicians
There is no reliable mechanism for manufacturers or the FDA to communicate boxed warnings directly to physicians, so it’s not clear how physicians are expected to stay informed about the issuance or revision of boxed warnings. They may first learn about new or revised warnings in the mass media, which is paying ever-increasing attention to press releases from the FDA. However, it can be difficult for the media to accurately convey the subtle and complex nature of a boxed warning in nontechnical terms.
Many physicians subscribe to various medical news alerts and attend continuing medical education (CME) programs, which often do an excellent job of highlighting new warnings, while hospitals, clinics, and pharmacies may broadcast news about boxed warnings in newsletters or other notices. But these notifications are ephemeral and may be missed by physicians who are overwhelmed by email, notices, newsletters, and CME programs.
The warnings that pop up in electronic medical records systems are often so numerous that physicians become trained to ignore them. Printed advertisements in professional journals must include mandated boxed warnings, but their visibility is waning as physicians increasingly read journals online.
Another conundrum is how to inform the public about boxed warnings.
Manufacturers are prohibited from direct-to-consumer advertising of drugs with boxed warnings, although the warnings are easily found on the Internet. Some patients expect and welcome detailed information from their physicians, so it’s a good policy to always and repeatedly review this information with them, especially if they are members of an identified risk group. However, that policy may be counterproductive if it dissuades anxious patients from needed therapy despite risk-benefit considerations that strongly favor it. Boxed warnings are well known to have “spillover effects” in which the aspersions cast by a boxed warning for a relatively small subgroup of patients causes use of a drug to decline among all patients.
Compounding this conundrum is that physicians rarely have sufficient information to gauge the magnitude of a risk, given that boxed warnings are often based on information from surveillance systems that cannot accurately quantify the risk or even establish a causal relationship. The text of a boxed warning generally does not provide the information needed for evidence-based clinical practice such as a quantitative estimate of effect, information about source and trustworthiness of the evidence, and guidance on implementation. For these and other reasons, FDA policies about various boxed warnings have been the target of significant criticism.
Medication guides are one mechanism to address the challenge of informing patients about the risks of drugs they are taking. FDA-approved medication guides are available for most drugs dispensed as outpatient prescriptions, they’re written in plain language for the consumer, and they include paraphrased versions of any boxed warning. Ideally, patients review these guides with their physicians or pharmacists, but the guides may be lengthy and raise questions that may not be answerable (e.g., about incidence rates). Patients may decline to review this information when a drug is prescribed or dispensed, and they may discard printed copies given to them without reading.
What can physicians do to minimize boxed warning problems?
Physicians should periodically review the product labels for drugs they commonly prescribe, including drugs they’ve prescribed for a long time. Prescription renewal requests can be used as a prompt to check for changes in a patient’s condition or other medications that might place a patient in the target population of a boxed warning. Physicians can subscribe to newsletters that announce and discuss significant product label changes, including alerts directly from the FDA. Physicians may also enlist their office staff to find and review boxed warnings for drugs being prescribed, noting which ones should require a conversation with any patient who has been or will be receiving this drug. They may want to make explicit mention in their encounter record that a boxed warning, medication guide, or overall risk-benefit assessment has been discussed.
Summary
The nature of boxed warnings, the means by which they are disseminated, and their role in clinical practice are all in great need of improvement. Until that occurs, boxed warnings offer some, but only very limited, help to patients and physicians who struggle to understand the risks of medications.
Dr. Axelsen is professor in the departments of pharmacology, biochemistry, and biophysics, and of medicine, infectious diseases section, University of Pennsylvania, Philadelphia. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
Almost all physicians write prescriptions, and each prescription requires a physician to assess the risks and benefits of the drug. If an adverse drug reaction occurs, physicians may be called on to defend their risk-benefit assessment in court.
The assessment of risk is complicated when there is a boxed warning that describes potentially serious and life-threatening adverse reactions associated with a drug. Some of our most commonly prescribed drugs have boxed warnings, and drugs that were initially approved by the Food and Drug Administration without boxed warnings may have them added years later.
One serious problem with boxed warnings is that there are no reliable mechanisms for making sure that physicians are aware of them. The warnings are typically not seen by physicians as printed product labels, just as physicians often don’t see the pills and capsules that they prescribe. Pharmacists who receive packaged drugs from manufacturers may be the only ones to see an actual printed boxed warning, but even those pharmacists have little reason to read each label and note changes when handling many bulk packages.
This problem is aggravated by misperceptions that many physicians have about boxed warnings and the increasingly intense scrutiny given to them by mass media and the courts. Lawyers can use boxed warnings to make a drug look dangerous, even when it’s not, and to make physicians look reckless when prescribing it. Therefore, it is important for physicians to understand what boxed warnings are, what they are not, the problems they cause, and how to minimize these problems.
What is a ‘boxed warning’?
The marketing and sale of drugs in the United States requires approval by the FDA. Approval requires manufacturers to prepare a document containing “Full Prescribing Information” for the drug and to include a printed copy in every package of the drug that is sold. This document is commonly called a “package insert,” but the FDA designates this document as the manufacturer’s product “label.”
In 1979, the FDA began requiring some labels to appear within thick, black rectangular borders; these have come to be known as boxed warnings. Boxed warnings are usually placed at the beginning of a label. They may be added to the label of a previously approved drug already on the market or included in the product label when first approved and marketed.
The requirement for a boxed warning most often arises when a signal appears during review of postmarketing surveillance data suggesting a possible and plausible association between a drug and an adverse reaction. Warnings may also be initiated in response to petitions from public interest groups, or upon the discovery of serious toxicity in animals. Regardless of their origin, the intent of a boxed warning is to highlight information that may have important therapeutic consequences and warrants heightened awareness among physicians.
What a boxed warning is not
A boxed warning is not “issued” by the FDA; it is merely required by the FDA. Specific wording or a template may be suggested by the FDA, but product labels and boxed warnings are written and issued by the manufacturer. This distinction may seem minor, but extensive litigation has occurred over whether manufacturers have met their duty to warn consumers about possible risks when using their products, and this duty cannot be shifted to the FDA.
A boxed warning may not be added to a product label at the option of a manufacturer. The FDA allows a boxed warning only if it requires the warning, to preserve its impact. It should be noted that some medical information sources (e.g., PDR.net) may include a “BOXED WARNING” in their drug monographs, but monographs not written by a manufacturer are not regulated by the FDA, and the text of their boxed warnings do not always correspond to the boxed warning that was approved by the FDA.
A boxed warning is not an indication that revocation of FDA approval is being considered or that it is likely to be revoked. FDA approval is subject to ongoing review and may be revoked at any time, without a prior boxed warning.
A boxed warning is not the highest level of warning. The FDA may require a manufacturer to send out a “Dear Health Care Provider” (DHCP) letter when an even higher or more urgent level of warning is deemed necessary. DHCP letters are usually accompanied by revisions of the product label, but most label revisions – and even most boxed warnings – are not accompanied by DHCP letters.
A boxed warning is not a statement about causation. Most warnings describe an “association” between a drug and an adverse effect, or “increased risk,” or instances of a particular adverse effect that “have been reported” in persons taking a drug. The words in a boxed warning are carefully chosen and require careful reading; in most cases they refrain from stating that a drug actually causes an adverse effect. The postmarketing surveillance data on which most warnings are based generally cannot provide the kind of evidence required to establish causation, and an association may be nothing more than an uncommon manifestation of the disorder for which the drug has been prescribed.
A boxed warning is not a statement about the probability of an adverse reaction occurring. The requirement for a boxed warning correlates better to the new recognition of a possible association than to the probability of an association. For example, penicillin has long been known to cause fatal anaphylaxis in 1/100,000 first-time administrations, but it does not have a boxed warning. The adverse consequences described in boxed warnings are often far less frequent – so much so that most physicians will never see them.
A boxed warning does not define the standard of care. The warning is a requirement imposed on the manufacturer, not on the practice of medicine. For legal purposes, the “standard of care” for the practice of medicine is defined state by state and is typically cast in terms such as “what most physicians would do in similar circumstances.” Physicians often prescribe drugs in spite of boxed warnings, just as they often prescribe drugs for “off label” indications, always balancing risk versus benefit.
A boxed warning does not constitute a contraindication to the use of a medication. Some warnings state that a drug is contraindicated in some situations, but product labels have another mandated section for listing contraindications, and most boxed warnings have no corresponding entry in that section.
A boxed warning does not necessarily constitute current information, nor is it always updated when new or contrary information becomes available. Revisions to boxed warnings, and to product labels in general, are made only after detailed review at the FDA, and the process of deciding whether an existing boxed warning continues to be appropriate may divert limited regulatory resources from more urgent priorities. Consequently, revisions to a boxed warning may lag behind the data that justify a revision by months or years. Revisions may never occur if softening or eliminating a boxed warning is deemed to be not worth the cost by a manufacturer.
Boxed warning problems for physicians
There is no reliable mechanism for manufacturers or the FDA to communicate boxed warnings directly to physicians, so it’s not clear how physicians are expected to stay informed about the issuance or revision of boxed warnings. They may first learn about new or revised warnings in the mass media, which is paying ever-increasing attention to press releases from the FDA. However, it can be difficult for the media to accurately convey the subtle and complex nature of a boxed warning in nontechnical terms.
Many physicians subscribe to various medical news alerts and attend continuing medical education (CME) programs, which often do an excellent job of highlighting new warnings, while hospitals, clinics, and pharmacies may broadcast news about boxed warnings in newsletters or other notices. But these notifications are ephemeral and may be missed by physicians who are overwhelmed by email, notices, newsletters, and CME programs.
The warnings that pop up in electronic medical records systems are often so numerous that physicians become trained to ignore them. Printed advertisements in professional journals must include mandated boxed warnings, but their visibility is waning as physicians increasingly read journals online.
Another conundrum is how to inform the public about boxed warnings.
Manufacturers are prohibited from direct-to-consumer advertising of drugs with boxed warnings, although the warnings are easily found on the Internet. Some patients expect and welcome detailed information from their physicians, so it’s a good policy to always and repeatedly review this information with them, especially if they are members of an identified risk group. However, that policy may be counterproductive if it dissuades anxious patients from needed therapy despite risk-benefit considerations that strongly favor it. Boxed warnings are well known to have “spillover effects” in which the aspersions cast by a boxed warning for a relatively small subgroup of patients causes use of a drug to decline among all patients.
Compounding this conundrum is that physicians rarely have sufficient information to gauge the magnitude of a risk, given that boxed warnings are often based on information from surveillance systems that cannot accurately quantify the risk or even establish a causal relationship. The text of a boxed warning generally does not provide the information needed for evidence-based clinical practice such as a quantitative estimate of effect, information about source and trustworthiness of the evidence, and guidance on implementation. For these and other reasons, FDA policies about various boxed warnings have been the target of significant criticism.
Medication guides are one mechanism to address the challenge of informing patients about the risks of drugs they are taking. FDA-approved medication guides are available for most drugs dispensed as outpatient prescriptions, they’re written in plain language for the consumer, and they include paraphrased versions of any boxed warning. Ideally, patients review these guides with their physicians or pharmacists, but the guides may be lengthy and raise questions that may not be answerable (e.g., about incidence rates). Patients may decline to review this information when a drug is prescribed or dispensed, and they may discard printed copies given to them without reading.
What can physicians do to minimize boxed warning problems?
Physicians should periodically review the product labels for drugs they commonly prescribe, including drugs they’ve prescribed for a long time. Prescription renewal requests can be used as a prompt to check for changes in a patient’s condition or other medications that might place a patient in the target population of a boxed warning. Physicians can subscribe to newsletters that announce and discuss significant product label changes, including alerts directly from the FDA. Physicians may also enlist their office staff to find and review boxed warnings for drugs being prescribed, noting which ones should require a conversation with any patient who has been or will be receiving this drug. They may want to make explicit mention in their encounter record that a boxed warning, medication guide, or overall risk-benefit assessment has been discussed.
Summary
The nature of boxed warnings, the means by which they are disseminated, and their role in clinical practice are all in great need of improvement. Until that occurs, boxed warnings offer some, but only very limited, help to patients and physicians who struggle to understand the risks of medications.
Dr. Axelsen is professor in the departments of pharmacology, biochemistry, and biophysics, and of medicine, infectious diseases section, University of Pennsylvania, Philadelphia. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
Almost all physicians write prescriptions, and each prescription requires a physician to assess the risks and benefits of the drug. If an adverse drug reaction occurs, physicians may be called on to defend their risk-benefit assessment in court.
The assessment of risk is complicated when there is a boxed warning that describes potentially serious and life-threatening adverse reactions associated with a drug. Some of our most commonly prescribed drugs have boxed warnings, and drugs that were initially approved by the Food and Drug Administration without boxed warnings may have them added years later.
One serious problem with boxed warnings is that there are no reliable mechanisms for making sure that physicians are aware of them. The warnings are typically not seen by physicians as printed product labels, just as physicians often don’t see the pills and capsules that they prescribe. Pharmacists who receive packaged drugs from manufacturers may be the only ones to see an actual printed boxed warning, but even those pharmacists have little reason to read each label and note changes when handling many bulk packages.
This problem is aggravated by misperceptions that many physicians have about boxed warnings and the increasingly intense scrutiny given to them by mass media and the courts. Lawyers can use boxed warnings to make a drug look dangerous, even when it’s not, and to make physicians look reckless when prescribing it. Therefore, it is important for physicians to understand what boxed warnings are, what they are not, the problems they cause, and how to minimize these problems.
What is a ‘boxed warning’?
The marketing and sale of drugs in the United States requires approval by the FDA. Approval requires manufacturers to prepare a document containing “Full Prescribing Information” for the drug and to include a printed copy in every package of the drug that is sold. This document is commonly called a “package insert,” but the FDA designates this document as the manufacturer’s product “label.”
In 1979, the FDA began requiring some labels to appear within thick, black rectangular borders; these have come to be known as boxed warnings. Boxed warnings are usually placed at the beginning of a label. They may be added to the label of a previously approved drug already on the market or included in the product label when first approved and marketed.
The requirement for a boxed warning most often arises when a signal appears during review of postmarketing surveillance data suggesting a possible and plausible association between a drug and an adverse reaction. Warnings may also be initiated in response to petitions from public interest groups, or upon the discovery of serious toxicity in animals. Regardless of their origin, the intent of a boxed warning is to highlight information that may have important therapeutic consequences and warrants heightened awareness among physicians.
What a boxed warning is not
A boxed warning is not “issued” by the FDA; it is merely required by the FDA. Specific wording or a template may be suggested by the FDA, but product labels and boxed warnings are written and issued by the manufacturer. This distinction may seem minor, but extensive litigation has occurred over whether manufacturers have met their duty to warn consumers about possible risks when using their products, and this duty cannot be shifted to the FDA.
A boxed warning may not be added to a product label at the option of a manufacturer. The FDA allows a boxed warning only if it requires the warning, to preserve its impact. It should be noted that some medical information sources (e.g., PDR.net) may include a “BOXED WARNING” in their drug monographs, but monographs not written by a manufacturer are not regulated by the FDA, and the text of their boxed warnings do not always correspond to the boxed warning that was approved by the FDA.
A boxed warning is not an indication that revocation of FDA approval is being considered or that it is likely to be revoked. FDA approval is subject to ongoing review and may be revoked at any time, without a prior boxed warning.
A boxed warning is not the highest level of warning. The FDA may require a manufacturer to send out a “Dear Health Care Provider” (DHCP) letter when an even higher or more urgent level of warning is deemed necessary. DHCP letters are usually accompanied by revisions of the product label, but most label revisions – and even most boxed warnings – are not accompanied by DHCP letters.
A boxed warning is not a statement about causation. Most warnings describe an “association” between a drug and an adverse effect, or “increased risk,” or instances of a particular adverse effect that “have been reported” in persons taking a drug. The words in a boxed warning are carefully chosen and require careful reading; in most cases they refrain from stating that a drug actually causes an adverse effect. The postmarketing surveillance data on which most warnings are based generally cannot provide the kind of evidence required to establish causation, and an association may be nothing more than an uncommon manifestation of the disorder for which the drug has been prescribed.
A boxed warning is not a statement about the probability of an adverse reaction occurring. The requirement for a boxed warning correlates better to the new recognition of a possible association than to the probability of an association. For example, penicillin has long been known to cause fatal anaphylaxis in 1/100,000 first-time administrations, but it does not have a boxed warning. The adverse consequences described in boxed warnings are often far less frequent – so much so that most physicians will never see them.
A boxed warning does not define the standard of care. The warning is a requirement imposed on the manufacturer, not on the practice of medicine. For legal purposes, the “standard of care” for the practice of medicine is defined state by state and is typically cast in terms such as “what most physicians would do in similar circumstances.” Physicians often prescribe drugs in spite of boxed warnings, just as they often prescribe drugs for “off label” indications, always balancing risk versus benefit.
A boxed warning does not constitute a contraindication to the use of a medication. Some warnings state that a drug is contraindicated in some situations, but product labels have another mandated section for listing contraindications, and most boxed warnings have no corresponding entry in that section.
A boxed warning does not necessarily constitute current information, nor is it always updated when new or contrary information becomes available. Revisions to boxed warnings, and to product labels in general, are made only after detailed review at the FDA, and the process of deciding whether an existing boxed warning continues to be appropriate may divert limited regulatory resources from more urgent priorities. Consequently, revisions to a boxed warning may lag behind the data that justify a revision by months or years. Revisions may never occur if softening or eliminating a boxed warning is deemed to be not worth the cost by a manufacturer.
Boxed warning problems for physicians
There is no reliable mechanism for manufacturers or the FDA to communicate boxed warnings directly to physicians, so it’s not clear how physicians are expected to stay informed about the issuance or revision of boxed warnings. They may first learn about new or revised warnings in the mass media, which is paying ever-increasing attention to press releases from the FDA. However, it can be difficult for the media to accurately convey the subtle and complex nature of a boxed warning in nontechnical terms.
Many physicians subscribe to various medical news alerts and attend continuing medical education (CME) programs, which often do an excellent job of highlighting new warnings, while hospitals, clinics, and pharmacies may broadcast news about boxed warnings in newsletters or other notices. But these notifications are ephemeral and may be missed by physicians who are overwhelmed by email, notices, newsletters, and CME programs.
The warnings that pop up in electronic medical records systems are often so numerous that physicians become trained to ignore them. Printed advertisements in professional journals must include mandated boxed warnings, but their visibility is waning as physicians increasingly read journals online.
Another conundrum is how to inform the public about boxed warnings.
Manufacturers are prohibited from direct-to-consumer advertising of drugs with boxed warnings, although the warnings are easily found on the Internet. Some patients expect and welcome detailed information from their physicians, so it’s a good policy to always and repeatedly review this information with them, especially if they are members of an identified risk group. However, that policy may be counterproductive if it dissuades anxious patients from needed therapy despite risk-benefit considerations that strongly favor it. Boxed warnings are well known to have “spillover effects” in which the aspersions cast by a boxed warning for a relatively small subgroup of patients causes use of a drug to decline among all patients.
Compounding this conundrum is that physicians rarely have sufficient information to gauge the magnitude of a risk, given that boxed warnings are often based on information from surveillance systems that cannot accurately quantify the risk or even establish a causal relationship. The text of a boxed warning generally does not provide the information needed for evidence-based clinical practice such as a quantitative estimate of effect, information about source and trustworthiness of the evidence, and guidance on implementation. For these and other reasons, FDA policies about various boxed warnings have been the target of significant criticism.
Medication guides are one mechanism to address the challenge of informing patients about the risks of drugs they are taking. FDA-approved medication guides are available for most drugs dispensed as outpatient prescriptions, they’re written in plain language for the consumer, and they include paraphrased versions of any boxed warning. Ideally, patients review these guides with their physicians or pharmacists, but the guides may be lengthy and raise questions that may not be answerable (e.g., about incidence rates). Patients may decline to review this information when a drug is prescribed or dispensed, and they may discard printed copies given to them without reading.
What can physicians do to minimize boxed warning problems?
Physicians should periodically review the product labels for drugs they commonly prescribe, including drugs they’ve prescribed for a long time. Prescription renewal requests can be used as a prompt to check for changes in a patient’s condition or other medications that might place a patient in the target population of a boxed warning. Physicians can subscribe to newsletters that announce and discuss significant product label changes, including alerts directly from the FDA. Physicians may also enlist their office staff to find and review boxed warnings for drugs being prescribed, noting which ones should require a conversation with any patient who has been or will be receiving this drug. They may want to make explicit mention in their encounter record that a boxed warning, medication guide, or overall risk-benefit assessment has been discussed.
Summary
The nature of boxed warnings, the means by which they are disseminated, and their role in clinical practice are all in great need of improvement. Until that occurs, boxed warnings offer some, but only very limited, help to patients and physicians who struggle to understand the risks of medications.
Dr. Axelsen is professor in the departments of pharmacology, biochemistry, and biophysics, and of medicine, infectious diseases section, University of Pennsylvania, Philadelphia. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
80% of Americans research recommendations post-visit
Confusion over health information and doctor advice is even higher among people who care for patients than among those who don’t provide care to their loved ones, the nationally representative survey from the AHIMA Foundation found.
The survey also shows that 80% of Americans – and an even higher portion of caregivers – are likely to research medical recommendations online after a doctor’s visit. But 1 in 4 people don’t know how to access their own medical records or find it difficult to do so.
The findings reflect the same low level of health literacy in the U.S. population that earlier surveys did. The results also indicate that little has changed since the Department of Health and Human Services released a National Action Plan to Improve Health Literacy in 2010.
That plan emphasized the need to develop and share accurate health information that helps people make decisions; to promote changes in the health care system that improve health information, communication, informed decision-making, and access to health services; and to increase the sharing and use of evidence-based health literacy practices.
According to the AHIMA Foundation report, 62% of Americans are not sure they understand their doctor’s advice and the health information discussed during a visit. Twenty-four percent say they don’t comprehend any of it, and 31% can’t remember what was said during the visit. Fifteen percent of those surveyed said they were more confused about their health than they were before the encounter with their doctor.
Caregivers have special issues
Forty-three percent of Americans are caregivers, the report notes, and 91% of those play an active role in managing someone else’s health. Millennials (65%) and Gen Xers (50%) are significantly more likely than Gen Zers (39%) and Boomers (20%) to be a caregiver.
Most caregivers have concerns about their loved ones’ ability to manage their own health. Most of them believe that doctors provide enough information, but 38% don’t believe a doctor can communicate effectively with the patient if the caregiver is not present.
Forty-three percent of caretakers don’t think their loved ones can understand medical information on their own. On the other hand, caregivers are more likely than people who don’t provide care to say the doctor confused them and to research the doctor’s advice after an appointment.
For many patients and caregivers, communications break down when they are with their health care provider. Twenty-two percent of Americans say they do not feel comfortable asking their doctor certain health questions. This inability to have a satisfactory dialogue with their doctor means that many patients leave their appointments without getting clear answers to their questions (24%) or without having an opportunity to ask any questions at all (17%).
This is not surprising, considering that a 2018 study found that doctors spend only 11 seconds, on average, listening to patients before interrupting them.
Depending on the internet
Overall, the AHIMA survey found, 42% of Americans research their doctor’s recommendations after an appointment. A higher percentage of caregivers than noncaregiver peers do so (47% vs. 38%). Eighty percent of respondents say they are “likely” to research their doctor’s advice online after a visit.
When they have a medical problem or a question about their condition, just as many Americans (59%) turn to the internet for an answer as contact their doctor directly, the survey found. Twenty-nine percent of the respondents consult friends, family, or colleagues; 23% look up medical records if they’re easily accessible; 19% ask pharmacists for advice; and 6% call an unspecified 800 number.
Americans feel secure in the health information they find on the internet. Among those who go online to look up information, 86% are confident that it is credible. And 42% report feeling relieved that they can find a lot of information about their health concerns. Respondents also say that the information they gather allows them to feel more confident in their doctor’s recommendations (35%) and that they feel better after having learned more on the internet than their doctor had told them (39%). Men are more likely than women to say that their confidence in their doctor’s recommendations increased after doing online research (40% vs. 30%).
Access to health records
Access to medical records would help people better understand their condition or diagnosis. But nearly half of Americans (48%) admit they don’t usually review their medical records until long after an appointment, and 52% say they rarely access their records at all.
One in four Americans say that they don’t know where to go to access their health information or that they didn’t find the process easy. More than half of those who have never had to find their records think the process would be difficult if they had to try.
Eighty-one percent of Americans use an online platform or portal to access their medical records or health information. Two-thirds of Americans who use an online portal trust that their medical information is kept safe and not shared with other people or organizations.
Four in five respondents agree that if they had access to all of their health information, including medical records, recommendations, conditions, and test results, they’d see an improvement in their health management. Fifty-nine percent of them believe they’d also be more confident about understanding their health, and 47% say they’d have greater trust in their doctor’s recommendations. Higher percentages of caregivers than noncaregivers say the same.
Younger people, those with a high school degree or less, and those who earn less than $50,000 are less likely than older, better educated, and more affluent people to understand their doctor’s health information and to ask questions of their providers.
People of color struggle with their relationships with doctors, are less satisfied than white people with the information they receive during visits, and are more likely than white peers to feel that if they had access to all their health information, they’d manage their health better and be more confident in their doctors’ recommendations, the survey found.
A version of this article first appeared on WebMD.com.
Confusion over health information and doctor advice is even higher among people who care for patients than among those who don’t provide care to their loved ones, the nationally representative survey from the AHIMA Foundation found.
The survey also shows that 80% of Americans – and an even higher portion of caregivers – are likely to research medical recommendations online after a doctor’s visit. But 1 in 4 people don’t know how to access their own medical records or find it difficult to do so.
The findings reflect the same low level of health literacy in the U.S. population that earlier surveys did. The results also indicate that little has changed since the Department of Health and Human Services released a National Action Plan to Improve Health Literacy in 2010.
That plan emphasized the need to develop and share accurate health information that helps people make decisions; to promote changes in the health care system that improve health information, communication, informed decision-making, and access to health services; and to increase the sharing and use of evidence-based health literacy practices.
According to the AHIMA Foundation report, 62% of Americans are not sure they understand their doctor’s advice and the health information discussed during a visit. Twenty-four percent say they don’t comprehend any of it, and 31% can’t remember what was said during the visit. Fifteen percent of those surveyed said they were more confused about their health than they were before the encounter with their doctor.
Caregivers have special issues
Forty-three percent of Americans are caregivers, the report notes, and 91% of those play an active role in managing someone else’s health. Millennials (65%) and Gen Xers (50%) are significantly more likely than Gen Zers (39%) and Boomers (20%) to be a caregiver.
Most caregivers have concerns about their loved ones’ ability to manage their own health. Most of them believe that doctors provide enough information, but 38% don’t believe a doctor can communicate effectively with the patient if the caregiver is not present.
Forty-three percent of caretakers don’t think their loved ones can understand medical information on their own. On the other hand, caregivers are more likely than people who don’t provide care to say the doctor confused them and to research the doctor’s advice after an appointment.
For many patients and caregivers, communications break down when they are with their health care provider. Twenty-two percent of Americans say they do not feel comfortable asking their doctor certain health questions. This inability to have a satisfactory dialogue with their doctor means that many patients leave their appointments without getting clear answers to their questions (24%) or without having an opportunity to ask any questions at all (17%).
This is not surprising, considering that a 2018 study found that doctors spend only 11 seconds, on average, listening to patients before interrupting them.
Depending on the internet
Overall, the AHIMA survey found, 42% of Americans research their doctor’s recommendations after an appointment. A higher percentage of caregivers than noncaregiver peers do so (47% vs. 38%). Eighty percent of respondents say they are “likely” to research their doctor’s advice online after a visit.
When they have a medical problem or a question about their condition, just as many Americans (59%) turn to the internet for an answer as contact their doctor directly, the survey found. Twenty-nine percent of the respondents consult friends, family, or colleagues; 23% look up medical records if they’re easily accessible; 19% ask pharmacists for advice; and 6% call an unspecified 800 number.
Americans feel secure in the health information they find on the internet. Among those who go online to look up information, 86% are confident that it is credible. And 42% report feeling relieved that they can find a lot of information about their health concerns. Respondents also say that the information they gather allows them to feel more confident in their doctor’s recommendations (35%) and that they feel better after having learned more on the internet than their doctor had told them (39%). Men are more likely than women to say that their confidence in their doctor’s recommendations increased after doing online research (40% vs. 30%).
Access to health records
Access to medical records would help people better understand their condition or diagnosis. But nearly half of Americans (48%) admit they don’t usually review their medical records until long after an appointment, and 52% say they rarely access their records at all.
One in four Americans say that they don’t know where to go to access their health information or that they didn’t find the process easy. More than half of those who have never had to find their records think the process would be difficult if they had to try.
Eighty-one percent of Americans use an online platform or portal to access their medical records or health information. Two-thirds of Americans who use an online portal trust that their medical information is kept safe and not shared with other people or organizations.
Four in five respondents agree that if they had access to all of their health information, including medical records, recommendations, conditions, and test results, they’d see an improvement in their health management. Fifty-nine percent of them believe they’d also be more confident about understanding their health, and 47% say they’d have greater trust in their doctor’s recommendations. Higher percentages of caregivers than noncaregivers say the same.
Younger people, those with a high school degree or less, and those who earn less than $50,000 are less likely than older, better educated, and more affluent people to understand their doctor’s health information and to ask questions of their providers.
People of color struggle with their relationships with doctors, are less satisfied than white people with the information they receive during visits, and are more likely than white peers to feel that if they had access to all their health information, they’d manage their health better and be more confident in their doctors’ recommendations, the survey found.
A version of this article first appeared on WebMD.com.
Confusion over health information and doctor advice is even higher among people who care for patients than among those who don’t provide care to their loved ones, the nationally representative survey from the AHIMA Foundation found.
The survey also shows that 80% of Americans – and an even higher portion of caregivers – are likely to research medical recommendations online after a doctor’s visit. But 1 in 4 people don’t know how to access their own medical records or find it difficult to do so.
The findings reflect the same low level of health literacy in the U.S. population that earlier surveys did. The results also indicate that little has changed since the Department of Health and Human Services released a National Action Plan to Improve Health Literacy in 2010.
That plan emphasized the need to develop and share accurate health information that helps people make decisions; to promote changes in the health care system that improve health information, communication, informed decision-making, and access to health services; and to increase the sharing and use of evidence-based health literacy practices.
According to the AHIMA Foundation report, 62% of Americans are not sure they understand their doctor’s advice and the health information discussed during a visit. Twenty-four percent say they don’t comprehend any of it, and 31% can’t remember what was said during the visit. Fifteen percent of those surveyed said they were more confused about their health than they were before the encounter with their doctor.
Caregivers have special issues
Forty-three percent of Americans are caregivers, the report notes, and 91% of those play an active role in managing someone else’s health. Millennials (65%) and Gen Xers (50%) are significantly more likely than Gen Zers (39%) and Boomers (20%) to be a caregiver.
Most caregivers have concerns about their loved ones’ ability to manage their own health. Most of them believe that doctors provide enough information, but 38% don’t believe a doctor can communicate effectively with the patient if the caregiver is not present.
Forty-three percent of caretakers don’t think their loved ones can understand medical information on their own. On the other hand, caregivers are more likely than people who don’t provide care to say the doctor confused them and to research the doctor’s advice after an appointment.
For many patients and caregivers, communications break down when they are with their health care provider. Twenty-two percent of Americans say they do not feel comfortable asking their doctor certain health questions. This inability to have a satisfactory dialogue with their doctor means that many patients leave their appointments without getting clear answers to their questions (24%) or without having an opportunity to ask any questions at all (17%).
This is not surprising, considering that a 2018 study found that doctors spend only 11 seconds, on average, listening to patients before interrupting them.
Depending on the internet
Overall, the AHIMA survey found, 42% of Americans research their doctor’s recommendations after an appointment. A higher percentage of caregivers than noncaregiver peers do so (47% vs. 38%). Eighty percent of respondents say they are “likely” to research their doctor’s advice online after a visit.
When they have a medical problem or a question about their condition, just as many Americans (59%) turn to the internet for an answer as contact their doctor directly, the survey found. Twenty-nine percent of the respondents consult friends, family, or colleagues; 23% look up medical records if they’re easily accessible; 19% ask pharmacists for advice; and 6% call an unspecified 800 number.
Americans feel secure in the health information they find on the internet. Among those who go online to look up information, 86% are confident that it is credible. And 42% report feeling relieved that they can find a lot of information about their health concerns. Respondents also say that the information they gather allows them to feel more confident in their doctor’s recommendations (35%) and that they feel better after having learned more on the internet than their doctor had told them (39%). Men are more likely than women to say that their confidence in their doctor’s recommendations increased after doing online research (40% vs. 30%).
Access to health records
Access to medical records would help people better understand their condition or diagnosis. But nearly half of Americans (48%) admit they don’t usually review their medical records until long after an appointment, and 52% say they rarely access their records at all.
One in four Americans say that they don’t know where to go to access their health information or that they didn’t find the process easy. More than half of those who have never had to find their records think the process would be difficult if they had to try.
Eighty-one percent of Americans use an online platform or portal to access their medical records or health information. Two-thirds of Americans who use an online portal trust that their medical information is kept safe and not shared with other people or organizations.
Four in five respondents agree that if they had access to all of their health information, including medical records, recommendations, conditions, and test results, they’d see an improvement in their health management. Fifty-nine percent of them believe they’d also be more confident about understanding their health, and 47% say they’d have greater trust in their doctor’s recommendations. Higher percentages of caregivers than noncaregivers say the same.
Younger people, those with a high school degree or less, and those who earn less than $50,000 are less likely than older, better educated, and more affluent people to understand their doctor’s health information and to ask questions of their providers.
People of color struggle with their relationships with doctors, are less satisfied than white people with the information they receive during visits, and are more likely than white peers to feel that if they had access to all their health information, they’d manage their health better and be more confident in their doctors’ recommendations, the survey found.
A version of this article first appeared on WebMD.com.