Mixed Topics

The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.

Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”

He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.

Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m² (range 15.8-36.5 kg/m²).

Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.

They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.

Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.

The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
 

‘Substantial’ effects

“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.

The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.

The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.

“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”

Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.

Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.

“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”

A version of this article first appeared on Medscape UK.

The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.

Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”

He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.

Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m² (range 15.8-36.5 kg/m²).

Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.

They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.

Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.

The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
 

‘Substantial’ effects

“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.

The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.

The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.

“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”

Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.

Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.

“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”

A version of this article first appeared on Medscape UK.

The notion that people get ‘hangry’ – irritable and short-tempered when they’re hungry – is such an established part of modern folklore that the word has even been added to the Oxford English Dictionary. Although experimental studies in the past have shown that low blood glucose levels increase impulsivity, anger, and aggression, there has been little solid evidence that this translates to real-life settings.

Now new research has confirmed that the phenomenon does really exist in everyday life. The study, published in the journal PLOS ONE, is the first to investigate how hunger affects people’s emotions on a day-to-day level. Lead author Viren Swami, professor of social psychology at Anglia Ruskin University, Cambridge, England, said: “Many of us are aware that being hungry can influence our emotions, but surprisingly little scientific research has focused on being ‘hangry’.”

He and coauthors from Karl Landsteiner University of Health Sciences in Krems an der Donau, Austria, recruited 64 participants from Central Europe who completed a 21-day experience sampling phase, in which they were prompted to report their feelings on a smartphone app five times a day. At each prompt, they reported their levels of hunger, anger, irritability, pleasure, and arousal on a visual analog scale.

Participants were on average 29.9 years old (range = 18-60), predominantly (81.3%) women, and had a mean body mass index of 23.8 kg/m² (range 15.8-36.5 kg/m²).

Anger was rated on a 5-point scale but the team explained that the effects of hunger are unlikely to be unique to anger per se, so they also asked about experiences of irritability and, in order to obtain a more holistic view of emotionality, also about pleasure and arousal, as indexed using Russell’s affect grid.

They also asked about eating behaviors over the previous 3 weeks, including frequency of main meals, snacking behavior, healthy eating, feeling hungry, and sense of satiety, and about dietary behaviors including restrictive eating, emotionally induced eating, and externally determined eating behavior.

Analysis of the resulting total of 9,142 responses showed that higher levels of self-reported hunger were associated with greater feelings of anger and irritability, and with lower levels of pleasure. These findings remained significant after accounting for participants’ sex, age, body mass index, dietary behaviors, and trait anger. However, associations with arousal were not significant.

The authors commented that the use of the app allowed data collection to take place in subjects’ everyday environments, such as their workplace and at home. “These results provide evidence that everyday levels of hunger are associated with negative emotionality and supports the notion of being ‘hangry.’ ”
 

‘Substantial’ effects

“The effects were substantial,” the team said, “even after taking into account demographic factors” such as age and sex, body mass index, dietary behavior, and individual personality traits. Hunger was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants.

The research also showed that the negative emotions – irritability, anger, and unpleasantness – were caused by both day-to-day fluctuations in hunger and residual levels of hunger measured by averages over the 3-week period.

The authors said their findings “suggest that the experience of being hangry is real, insofar as hunger was associated with greater anger and irritability, and lower pleasure, in our sample over a period of 3 weeks.

“These results may have important implications for understanding everyday experiences of emotions, and may also assist practitioners to more effectively ensure productive individual behaviors and interpersonal relationships (for example, by ensuring that no one goes hungry).”

Although the majority of participants (55%) said they paid attention to hunger pangs, only 23% said that they knew when they were full and then stopped eating, whereas 63% said they could tell when they were full but sometimes continued to eat. Few (4.7%) people said they could not tell when they were full and therefore oriented their eating based on the size of the meal, but 9% described frequent overeating because of not feeling satiated, and 13% stated they ate when they were stressed, upset, angry, or bored.

Professor Swami said: “Ours is the first study to examine being ‘hangry’ outside of a lab. By following people in their day-to-day lives, we found that hunger was related to levels of anger, irritability, and pleasure.

“Although our study doesn’t present ways to mitigate negative hunger-induced emotions, research suggests that being able to label an emotion can help people to regulate it, such as by recognizing that we feel angry simply because we are hungry. Therefore, greater awareness of being ‘hangry’ could reduce the likelihood that hunger results in negative emotions and behaviors in individuals.”

A version of this article first appeared on Medscape UK.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Sitting at his desk in Sea Girt, N.J., John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.

The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.

This fall, Mr. Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.

After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Dr. Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health & Human Services.

Like the rest of us, Dr. Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.

The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).

While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Dr. Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
 

Preview of masks to come

“We’ve seen some really amazing things,” Dr. Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”

One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
 

And the finalists are ...

ReadiMask 365: “I can wear this all day long,” Mr. Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”

He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”

ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Mr. Hsu says.

“Being able to work with BARDA and getting their wisdom is invaluable,” he says.

The makers of ClearMask think masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless,” said Mr. Hsu. He predicts health care settings will become stricter about wearing masks.

“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.

4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.

Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability, and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she says. It went on the market in November 2020.

Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Mr. Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Mr. Ngo said.

Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.

Levi Strauss: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.

Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.

SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.

StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
 

Bye-bye N95?

“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Dr. Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.

“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.

Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
 

Getting from 1,500 to 10

In the first phase of the challenge, Dr. Lippold says, “the goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.

Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Dr. Lippold says.

The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.

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

Sitting at his desk in Sea Girt, N.J., John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.

The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.

This fall, Mr. Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.

After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Dr. Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health & Human Services.

Like the rest of us, Dr. Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.

The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).

While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Dr. Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
 

Preview of masks to come

“We’ve seen some really amazing things,” Dr. Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”

One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
 

And the finalists are ...

ReadiMask 365: “I can wear this all day long,” Mr. Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”

He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”

ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Mr. Hsu says.

“Being able to work with BARDA and getting their wisdom is invaluable,” he says.

The makers of ClearMask think masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless,” said Mr. Hsu. He predicts health care settings will become stricter about wearing masks.

“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.

4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.

Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability, and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she says. It went on the market in November 2020.

Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Mr. Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Mr. Ngo said.

Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.

Levi Strauss: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.

Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.

SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.

StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
 

Bye-bye N95?

“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Dr. Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.

“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.

Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
 

Getting from 1,500 to 10

In the first phase of the challenge, Dr. Lippold says, “the goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.

Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Dr. Lippold says.

The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.

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

Sitting at his desk in Sea Girt, N.J., John Schwind is eager to demonstrate his ReadiMask 365. He holds up what looks like a white sheet of memo paper, peels off a protective liner, and sticks the mask first to his nose. He glides his fingers down his face, over his cheeks, and to his chin, sealing the mask and then demonstrating how easy it is to talk with it in place.

The mask’s medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn’t let air leak and won’t fog his glasses. It’s strapless, so it won’t hurt his ears or make them stick out.

This fall, Mr. Schwind, the CEO of Global Safety First, is hoping to take home $150,000 as one of the two top winners of the federal Mask Innovation Challenge. He has made it to the top 10 but realizes he still has a ton of competition.

After the challenge launched in late 2021, nearly 1,500 submissions were received, says Kumiko Lippold, PhD, a health scientist and manager of the Mask Innovation Challenge. The challenge is run by Dr. Lippold and others at the Division of Research, Innovation, and Ventures (DRIVe), which is part of the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health & Human Services.

Like the rest of us, Dr. Lippold knows that masks desperately need a makeover. The point of the challenge is to inspire and design masks that are comfortable, even with long wear, and that provide excellent protection. The aim is not only to get us through this pandemic but also future pandemics and other public health emergencies. “We are focused on building masks for the next pandemic, the next wildfires,” she says.

The project is a partnership among BARDA’s DRIVe, the National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technology (NIST).

While NIOSH is a partner in the challenge, giving feedback to mask developers, “the mask challenge is entirely separate from the NIOSH approval process,” Dr. Lippold says. Companies can then pursue NIOSH approval on their own, later, if they wish. The agency certifies only masks and respirators.
 

Preview of masks to come

“We’ve seen some really amazing things,” Dr. Lippold said of the new designs. She didn’t want to play favorites, so she gave an overview of innovations. Some designs have transparent materials, or partially see-through materials, so facial expressions can be read. “We’ve also seen really unique bio-based materials that are derived from natural products. We’ve seen sensors in some.”

One mask model has origami folds, which increase overall surface and breathing area. Some 3D-printed masks promise a custom fit and take into account whether a person’s nose bridge is low or high.
 

And the finalists are ...

ReadiMask 365: “I can wear this all day long,” Mr. Schwind said of his new design. It has a nano fiber filter and is flexible. Besides the one in the BARDA challenge, the company has other ReadiMasks on the market. “The most important thing is comfort,” he says. “Second is protection. If they don’t feel they have a good seal, users don’t have confidence in the mask.”

He offers various sizes of ReadiMasks, from small sizes designed for women with smaller faces to extra-large, “for NFL linemen.”

ClearMask: “We are the original clear mask,” says Aaron Hsu, CEO and co-founder of ClearMask in Baltimore. The company began in 2017, and the clear design was inspired by a company co-founder who is deaf. She was scheduled to have surgery, and her sign language interpreter did not show up, leaving her to try to communicate in the operating room with masked health care providers. There were no transparent masks available then, Mr. Hsu says.

“Being able to work with BARDA and getting their wisdom is invaluable,” he says.

The makers of ClearMask think masks are here to stay, at least for some. “I think a certain percentage of the population will continue to wear them, regardless,” said Mr. Hsu. He predicts health care settings will become stricter about wearing masks.

“Even now, when you even walk in to a hospital, you might be required to wear a mask,” he says, even as a visitor. His company’s masks are easy to adjust and are secured around the head, so your ears don’t get sore, he says.

4C Air: The BreSafe transparent mask is semi-transparent and is made of a nanomaterial that provides high levels of filtration and breathability with some transparency.

Air99: Based on origami principles, the Airgami mask is meant to improve fit, breathability, and aesthetics over existing masks. “Airgami fits better, works better and looks better,” says Min Xiao, a company spokesperson. “It won’t fall off the nose or collapse onto the mouth, and eyeglasses fog less, she says. Voices are less muffled.” It’s also reusable, rinseable and can be heat disinfected, she says. It went on the market in November 2020.

Air Flo Labs: Flo Mask Pro, like the company’s other designs, conducted over 100 3D facial scans across many ethnicities to produce a better fit, says Kevin Ngo, its creator. For the adult masks, two nose bridge sizes are offered. And users can choose a Pro Filter, with 99% filtration, or an Everyday, which is meant to be much more breathable than other masks. “Our silicone gasket is incredibly soft and gentle on the skin,” Mr. Ngo says. “In addition,we offer indents for glasses, which prevent any fogging.” The company began shipping in May; several thousand masks are in use now, Mr. Ngo said.

Georgetown University: This team’s smart mask is made of metallic foams that can be cleaned and reused.

Levi Strauss: The form of the mask can be made by any basic garment factory. It aims to activate the apparel supply chain as another source of low-cost, high-performance masks.

Matregenix: This mask, made of a transparent nanofiber, allows for easier communication while having high filtration.

SEAL Lab: The SINEW mask stands for Smart, Individualized, Near-Face, Extended Wear. The mask used technology to overcome flaws of traditional respirators, with the same degree of protection. It doesn’t make contact with the skin of the wearer’s face.

StaySafeNow: A team from Harvard University developed Crystal Guard, a reusable, cost-effective clear mask. Its developers say it’s meant to be especially useful for essential workers, teachers, and others who have to communicate to do their work.
 

Bye-bye N95?

“From our perspective, our goal with the mask challenge was not to replace the N95 respirator,” Dr. Lippold says. N95 masks, which NIOSH certifies, are valuable and protect people in high-risk settings. “With the mask challenge, our goal was really to provide the public with a comparable alternative that really meets their specific level of risk.” Working in a health care setting carries a different risk, she says, than going to the grocery store.

“A common complaint with the N95 is that they are very uncomfortable.” It’s a major barrier to compliance, “and we wanted to address that gap. We didn’t directly compare [the entries] to an N95,” she says, although their testing was similar to NIOSH’s. A number of finalists say they will pursue NIOSH approval, she says.

Meanwhile, some of the finalists’ masks are for sale. Air Flo Labs, for instance, has its Flo Mask Pro for sale online, noting that BARDA allowed it to release the test results from NIOSH and NIST.
 

Getting from 1,500 to 10

In the first phase of the challenge, Dr. Lippold says, “the goal was to engage as wide an audience as possible.” With the second phase, the bar was set a bit higher. Instead of just submitting ideas on paper, companies had to submit prototypes for lab testing. “We got about 80 submissions,” she says.

Those 80 were whittled down to 10 finalists. Teams had sent prototypes, and experts, including those from NIOSH and NIST, rated them, sometimes looking at multiple copies of the masks. Experts looked at how well the masks filtered the air, how breathable they were, and other data. Once the feedback was given to the mask companies, they entered a redesign period. “Scientists can take this data and basically make these prototypes better,” Dr. Lippold says.

The final round of testing will be in September, and the winners will be announced in the fall. The opportunity allowed companies to have their products go through testing they might not otherwise have been able to get, she says.

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

The stress of losing a family member can hasten the death of patients with heart failure, suggests a large Swedish study that points to the need for greater integration of psychosocial risk factors in the treatment of HF.

The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).

The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).

“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”

The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.

“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”

A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.

“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.

“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.

Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.

The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.

Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.

No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.

An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).

The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.

Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”

The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.

“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”

Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”

Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.

“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”

The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.

The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.

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

The stress of losing a family member can hasten the death of patients with heart failure, suggests a large Swedish study that points to the need for greater integration of psychosocial risk factors in the treatment of HF.

The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).

The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).

“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”

The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.

“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”

A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.

“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.

“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.

Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.

The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.

Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.

No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.

An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).

The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.

Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”

The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.

“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”

Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”

Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.

“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”

The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.

The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.

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

The stress of losing a family member can hasten the death of patients with heart failure, suggests a large Swedish study that points to the need for greater integration of psychosocial risk factors in the treatment of HF.

The adjusted relative risk of dying was nearly 30% higher among bereaved patients with HF (1.29; 95% confidence interval, 1.27-1.30) and slightly higher for those grieving the loss of more than one family member (RR, 1.35).

The highest risk was in the first week after the loss (RR, 1.78) but persisted after 5 years of follow-up (RR, 1.30).

“Heart failure is a very difficult condition and has a very poor prognosis comparable to many, many cancers,” senior author Krisztina László, PhD, Karolinska Institutet, Stockholm, said in an interview. “So it’s important for us to be aware of these increased risks and to understand them better.”

The early risk for death could be related to stress-induced cardiomyopathy, or Takotsubo syndrome, as well as activation of the hypothalamic-pituitary-adrenal axis, the renin-angiotensin-aldosterone system, and sympathetic nervous system, she explained. Higher long-term risks may reflect chronic stress, leading to poorly managed disease and an unhealthy lifestyle.

“If we understand better the underlying mechanisms maybe we can give more specific advice,” Dr. László said. “At this stage, I think having an awareness of the risk and trying to follow patients or at least not let them fall out of usual care, asking questions, trying to understand what their needs are, maybe that is what we can do well.”

A recent position paper by the European Association of Preventive Cardiology pointed out that psychosocial risk factors, like depression and social isolation, can exacerbate heart failure and calls for better integration of psychosocial factors in the treatment of patients with chronic HF.

“We don’t do a very good job of it, but I think they are very important,” observed Stuart D. Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., and was not involved in the study.

“When we hear about a spouse dying, we might call and give condolences, but it’s probably a group of patients that for the next 6 months or so we need to watch more closely and see if there are things we can impact both medically as well as socially to perhaps prevent some of this increase in mortality,” he told this news organization.

Although several studies have linked bereavement with adverse health outcomes, this is just one of two studies to look specifically at its role in HF prognosis, Dr. László noted. A 2013 study of 66,000 male veterans reported that widowers had nearly a 38% higher all-cause mortality risk than did married veterans.

The present study extends those findings to 490,527 patients in the Swedish Heart Failure Registry between 2000 and 2018 and/or in the Swedish Patient Register with a primary diagnosis of HF between 1987 and 2018. During a mean follow-up of 3.7 years, 12% of participants had a family member die, and 383,674 participants died.

Results showed the HF mortality risk increased 10% after the death of a child, 20% with the death of a spouse/partner, 13% with a sibling’s death, and 5% with the death of a grandchild.

No increased risk was seen after the death of a parent, which is likely owed to a median patient age of about 75 years and “is in line with our expectations of the life cycle,” Dr. László said.

An association between bereavement and mortality risk was observed in cases of loss caused by cardiovascular disease (RR, 1.34) and other natural causes (RR, 1.27) but also in cases of unnatural deaths, such as suicide (RR, 1.13).

The overall findings were similar regardless of left ventricular ejection fraction and New York Heart Association functional class and were not affected by sex or country of birth.

Dr. Russell agreed that the death of a parent would be expected among these older patients with HF but said that “if the mechanism of this truly is kind of this increased stress hormones and Takotsubo-type mechanism, you’d think it would be worse if it was your kid that died. That shocked me a bit.”

The strong association between mortality and the loss of a spouse or partner was not surprising, given that they’re an important source of mutual social support, he added.

“If it’s a 75-year-old whose spouse dies, we need to make sure that we have the children’s phone number or other people that we can reach out to and say: ‘Can you check on them?’ ” he said. “And we need to make sure that somebody else is coming in with them because I would guess that probably at least half of what patients hear in a clinic visit goes in one ear and out the other and it’s going to make that much better. So we need to find who that new support person is for the patient.”

Asked whether there are efforts underway to incorporate psychosocial factors into current U.S. guidelines, Dr. Russell replied, “certainly within heart failure, I don’t think we’re really discussing it and, that may be the best part of this paper. It really makes us think about a different way of approaching these older patients.”

Dr. László said that future studies are needed to investigate whether less severe sources of stress may also contribute to poor HF prognosis.

“In our population, 12% of patients were affected, which is quite high, but there are patients with heart failure who experience on a daily basis other sources of stress, which are less severe but chronic and affect large numbers,” she said. “This may also have important public health implications and will be an important next step.”

The authors noted that they were unable to eliminate residual confounding by genetic factors or unmeasured socioeconomic-, lifestyle-, or health-related factors shared by family members. Other limitations are limited power to detect a modest effect in some of the subanalyses and that the findings may be generalizable only to countries with social and cultural contexts and health-related factors similar to those of Sweden.

The study was supported by grants from the Swedish Council for Working Life and Social Research, the Karolinska Institutet’s Research Foundation, and the China Scholarship Council. Dr. László is also supported by a grant from the Heart and Lung Foundation. All other authors and Dr. Russell reported no relevant financial relationships.

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

Falsely elevated pulse oximeter readings are leading to less oxygen supplementation for people of color, a recent study finds.

The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.

“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO₂ readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”

Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
 

‘We’re not providing equal care’

Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).

Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO₂ readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.

Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO₂ and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.

“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”

The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.

Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.

“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.

Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”

While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
 

Black patients 3X more likely to have hidden hypoxia than White patients

Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.

The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.

“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”

Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.

“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.

“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”

Yet Dr. Sjoding entertained the possibility that other factors may have been at play.

“I think definitely there’s a social commentary on prioritization of research,” he said.

The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.

Falsely elevated pulse oximeter readings are leading to less oxygen supplementation for people of color, a recent study finds.

The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.

“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO₂ readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”

Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
 

‘We’re not providing equal care’

Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).

Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO₂ readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.

Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO₂ and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.

“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”

The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.

Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.

“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.

Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”

While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
 

Black patients 3X more likely to have hidden hypoxia than White patients

Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.

The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.

“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”

Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.

“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.

“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”

Yet Dr. Sjoding entertained the possibility that other factors may have been at play.

“I think definitely there’s a social commentary on prioritization of research,” he said.

The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.

Falsely elevated pulse oximeter readings are leading to less oxygen supplementation for people of color, a recent study finds.

The new research suggests that skin color–related differences in pulse oximeter readings are in fact impacting clinical decision-making, lead author Eric R. Gottlieb, MD, of Brigham and Women’s Hospital and Massachusetts Institute of Technology, both in Boston, and colleagues wrote. This suggests that technology needs to updated to improve health equity, they continued, in their paper published in JAMA Internal Medicine.

“It has been known for decades that these readings are affected by various surface pigmentations, including nail polish and skin melanin, which may affect light absorption and scattering,” the investigators wrote. “This increases the risk of hidden hypoxemia [among patients with darker skin], in which patients have falsely elevated SpO₂ readings, usually defined as 92% or greater, with a blood hemoglobin oxygen saturation less than 88%.”

Although published reports on this phenomenon date back to the 1980s, clinical significance has been largely discounted, they said, citing a 2008 paper on the topic, which stated that “oximetry need not have exact accuracy” to determine if a patient needs oxygen supplementation.
 

‘We’re not providing equal care’

Questioning the validity of this statement, Dr. Gottlieb and colleagues conducted a retrospective cohort study involving 3,069 patients admitted to intensive care at the Beth Israel Deaconess Medical Center in Boston between 2008 and 2019, thereby excluding patients treated during the COVID-19 pandemic. The population consisted of four races/ethnicities: White (87%), Black (7%), Hispanic (4%), and Asian (3%).

Aligning with previous studies, multivariable linear regression analyses showed that Asian, Black, and Hispanic patients had significantly higher SpO₂ readings than White patients in relation to hemoglobin oxygen saturation values, suggesting falsely elevated readings.

Further modeling showed that these same patient groups also received lower oxygen delivery rates, which were not explained directly by race/ethnicity, but instead were mediated by the discrepancy between SpO₂ and hemoglobin oxygen saturation values. In other words, physicians were responding consistently to pulse oximetry readings, rather than exhibiting a direct racial/ethnic bias in their clinical decision-making.

“We’re not providing equal care,” Dr. Gottlieb said in an interview. “It’s not that the patients are sicker, or have other socioeconomic explanations for why this happens to them. It’s us. It’s our technology. And that’s something that really has to be fixed.”

The investigators offered a cautionary view of corrective algorithms, as these “have exacerbated disparities and are subject to ethical concerns;” for example, with glomerular filtration rate estimations in Black patients.

Dr. Gottlieb also cautioned against action by individual physicians, who may now be inclined to change how they interpret pulse oximeter readings based on a patient’s race or ethnicity.

“I don’t think that we can expect physicians, every time they see a patient, to be second guessing whether the number basically reflects the truth,” he said.

Instead, Dr. Gottlieb suggested that the burden of change rests upon the shoulders of institutions, including hospitals and device manufacturers, both of which “really need to take the responsibility” for making sure that pulse oximeters are “equitable and have similar performance across races.”

While Dr. Gottlieb said that skin color likely plays the greatest role in measurement discrepancies, he encouraged stakeholders “to think broadly about this, and not just assume that it’s entirely skin color,” noting a small amount of evidence indicating that blood chemistry may also play a role. Still, he predicted that colorimetry – the direct measurement of skin color – will probably be incorporated into pulse oximeters of the future.
 

Black patients 3X more likely to have hidden hypoxia than White patients

Michael Sjoding, MD, of the University of Michigan, Ann Arbor, was one of the first to raise awareness of skin color–related issues with pulse oximeters during the throes of the COVID-19 pandemic. His study, which involved more than 10,000 patients, showed that Black patients were threefold more likely to have hidden hypoxia than White patients.

The present study shows that such discrepancies are indeed clinically significant, Dr. Sjoding said in an interview. And these data are needed, he added, to bring about change.

“What is being asked is potentially a big deal,” Dr. Sjoding said. “Pulse oximeters are everywhere, and it would be a big undertaking to redesign pulse oximeters and purchase new pulse oximeters. You need a compelling body of evidence to do that. I think it’s there now, clearly. So I’m hopeful that we’re going to finally move forward, towards having devices that we are confident work accurately in everyone.”

Why it has taken so long to gather this evidence, however, is a thornier topic, considering race-related discrepancies in pulse oximeter readings were first documented more than 3 decades ago.

“We sort of rediscovered something that had been known and had been described in the past,” Dr. Sjoding said. He explained how he and many of his colleagues had completed pulmonary fellowships, yet none of them knew of these potential issues with pulse oximeters until they began to observe differences in their own patients during the pandemic.

“I’ll give previous generations of researchers the benefit of the doubt,” Dr. Sjoding said, pointing out that techniques in data gathering and analysis have advanced considerably over the years. “The types of studies that were done before were very different than what we did.”

Yet Dr. Sjoding entertained the possibility that other factors may have been at play.

“I think definitely there’s a social commentary on prioritization of research,” he said.

The study was supported by grants from the National Institutes of Health. The investigators and Dr. Sjoding reported no conflicts of interest.

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.