An independent expert panel within the Centers for Disease Control and Prevention (CDC) has studied the potential benefits and risks of the Pfizer-BioNTech COVID-19 vaccine and voted unanimously to recommend the shots for all Americans ages 16 and older.

All 14 members of the Advisory Committee on Immunization Practices (ACIP) voted ‘yes’ to recommend the vaccine for Americans ages 16 and up. The vaccine was fully approved by the U.S. Food and Drug Administration (FDA) last week.

The inoculation is still available to teens ages 12 to 15 under an emergency use authorization from the FDA.

ACIP now sends its recommendation to the CDC Director Rochelle Walensky, MD, for her sign off.

After reviewing the evidence behind the vaccine, panel member Sarah Long, MD, a professor of pediatrics at Drexel University College of Medicine, Philadelphia, said she couldn’t recall another instance where panelists had so much data on which to base their recommendation.

“This vaccine is worthy of the trust of the American people,” she said.

Doctors across the country use vaccines in line with the recommendations made by the ACIP. Their approval typically means that private and government insurers will cover the cost of the shots. In the case of the COVID-19 vaccines, the government is already picking up the tab.

Few surprises

The panel’s independent review of the vaccine’s effectiveness from nine studies held few surprises. 

They found the Pfizer vaccine prevented a COVID infection with symptoms about 90%–92% of the time, at least for the first 4 months after the second shot. Protection against hospitalization and death was even higher.

The vaccine was about 89% effective at preventing a COVID infection without symptoms, according to a pooled estimate of five studies.

The data included in the review was updated only through March 13 of this year, however, and does not reflect the impact of further waning of immunity or the impact of the Delta variant.

In making their recommendation, the panel got an update on the safety of the vaccines, which have now been used in the United States for about 9 months.

The rate of anaphylaxis has settled at around five cases for every million shots given, according to the ACIP’s review of the evidence. 

Cases of myocarditis and pericarditis were more common after getting a Pfizer-BioNTech vaccine than would be expected to happen naturally in the general population, but the risk was still very rare, and elevated primarily for men younger than age 30. 

Out of 17 million second doses of Pfizer-BioNTech vaccines in the United States, there have been 327 confirmed cases of myocarditis reported to the Vaccine Adverse Event Reporting System in people who are younger than age 30. The average hospital stay for a myocarditis cases is 1 to 2 days. 

So far, no one in the United States diagnosed with myocarditis after vaccination has died.

What’s more, the risk of myocarditis after vaccination was dwarfed by the risk of myocarditis after a COVID infection. The risk of myocarditis after a COVID infection was 6 to 34 times higher than the risk after receiving an mRNA vaccine.

About 11% of people who get the vaccine experience a serious reaction to the shot, compared with about 3% in the placebo group. Serious reactions were defined as pain; swelling or redness at the injection site that interferes with activity; needing to visit the hospital or ER for pain; tissue necrosis, or having skin slough off; high fever; vomiting that requires hydration; persistent diarrhea; severe headache;  or muscle pain/severe joint pain.

“Safe and effective”

After hearing a presentation on the state of the pandemic in the US, some panel members were struck and shaken that 38% of Americans who are eligible are still not fully vaccinated.

Pablo Sanchez, MD, a pediatrician at Nationwide Children’s Hospital in Columbus, Ohio, said, “We’re doing an abysmal job vaccinating the American people. The message has to go out that the vaccines are safe and effective.”



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

An independent expert panel within the Centers for Disease Control and Prevention (CDC) has studied the potential benefits and risks of the Pfizer-BioNTech COVID-19 vaccine and voted unanimously to recommend the shots for all Americans ages 16 and older.

All 14 members of the Advisory Committee on Immunization Practices (ACIP) voted ‘yes’ to recommend the vaccine for Americans ages 16 and up. The vaccine was fully approved by the U.S. Food and Drug Administration (FDA) last week.

The inoculation is still available to teens ages 12 to 15 under an emergency use authorization from the FDA.

ACIP now sends its recommendation to the CDC Director Rochelle Walensky, MD, for her sign off.

After reviewing the evidence behind the vaccine, panel member Sarah Long, MD, a professor of pediatrics at Drexel University College of Medicine, Philadelphia, said she couldn’t recall another instance where panelists had so much data on which to base their recommendation.

“This vaccine is worthy of the trust of the American people,” she said.

Doctors across the country use vaccines in line with the recommendations made by the ACIP. Their approval typically means that private and government insurers will cover the cost of the shots. In the case of the COVID-19 vaccines, the government is already picking up the tab.

Few surprises

The panel’s independent review of the vaccine’s effectiveness from nine studies held few surprises. 

They found the Pfizer vaccine prevented a COVID infection with symptoms about 90%–92% of the time, at least for the first 4 months after the second shot. Protection against hospitalization and death was even higher.

The vaccine was about 89% effective at preventing a COVID infection without symptoms, according to a pooled estimate of five studies.

The data included in the review was updated only through March 13 of this year, however, and does not reflect the impact of further waning of immunity or the impact of the Delta variant.

In making their recommendation, the panel got an update on the safety of the vaccines, which have now been used in the United States for about 9 months.

The rate of anaphylaxis has settled at around five cases for every million shots given, according to the ACIP’s review of the evidence. 

Cases of myocarditis and pericarditis were more common after getting a Pfizer-BioNTech vaccine than would be expected to happen naturally in the general population, but the risk was still very rare, and elevated primarily for men younger than age 30. 

Out of 17 million second doses of Pfizer-BioNTech vaccines in the United States, there have been 327 confirmed cases of myocarditis reported to the Vaccine Adverse Event Reporting System in people who are younger than age 30. The average hospital stay for a myocarditis cases is 1 to 2 days. 

So far, no one in the United States diagnosed with myocarditis after vaccination has died.

What’s more, the risk of myocarditis after vaccination was dwarfed by the risk of myocarditis after a COVID infection. The risk of myocarditis after a COVID infection was 6 to 34 times higher than the risk after receiving an mRNA vaccine.

About 11% of people who get the vaccine experience a serious reaction to the shot, compared with about 3% in the placebo group. Serious reactions were defined as pain; swelling or redness at the injection site that interferes with activity; needing to visit the hospital or ER for pain; tissue necrosis, or having skin slough off; high fever; vomiting that requires hydration; persistent diarrhea; severe headache;  or muscle pain/severe joint pain.

“Safe and effective”

After hearing a presentation on the state of the pandemic in the US, some panel members were struck and shaken that 38% of Americans who are eligible are still not fully vaccinated.

Pablo Sanchez, MD, a pediatrician at Nationwide Children’s Hospital in Columbus, Ohio, said, “We’re doing an abysmal job vaccinating the American people. The message has to go out that the vaccines are safe and effective.”



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

An independent expert panel within the Centers for Disease Control and Prevention (CDC) has studied the potential benefits and risks of the Pfizer-BioNTech COVID-19 vaccine and voted unanimously to recommend the shots for all Americans ages 16 and older.

All 14 members of the Advisory Committee on Immunization Practices (ACIP) voted ‘yes’ to recommend the vaccine for Americans ages 16 and up. The vaccine was fully approved by the U.S. Food and Drug Administration (FDA) last week.

The inoculation is still available to teens ages 12 to 15 under an emergency use authorization from the FDA.

ACIP now sends its recommendation to the CDC Director Rochelle Walensky, MD, for her sign off.

After reviewing the evidence behind the vaccine, panel member Sarah Long, MD, a professor of pediatrics at Drexel University College of Medicine, Philadelphia, said she couldn’t recall another instance where panelists had so much data on which to base their recommendation.

“This vaccine is worthy of the trust of the American people,” she said.

Doctors across the country use vaccines in line with the recommendations made by the ACIP. Their approval typically means that private and government insurers will cover the cost of the shots. In the case of the COVID-19 vaccines, the government is already picking up the tab.

Few surprises

The panel’s independent review of the vaccine’s effectiveness from nine studies held few surprises. 

They found the Pfizer vaccine prevented a COVID infection with symptoms about 90%–92% of the time, at least for the first 4 months after the second shot. Protection against hospitalization and death was even higher.

The vaccine was about 89% effective at preventing a COVID infection without symptoms, according to a pooled estimate of five studies.

The data included in the review was updated only through March 13 of this year, however, and does not reflect the impact of further waning of immunity or the impact of the Delta variant.

In making their recommendation, the panel got an update on the safety of the vaccines, which have now been used in the United States for about 9 months.

The rate of anaphylaxis has settled at around five cases for every million shots given, according to the ACIP’s review of the evidence. 

Cases of myocarditis and pericarditis were more common after getting a Pfizer-BioNTech vaccine than would be expected to happen naturally in the general population, but the risk was still very rare, and elevated primarily for men younger than age 30. 

Out of 17 million second doses of Pfizer-BioNTech vaccines in the United States, there have been 327 confirmed cases of myocarditis reported to the Vaccine Adverse Event Reporting System in people who are younger than age 30. The average hospital stay for a myocarditis cases is 1 to 2 days. 

So far, no one in the United States diagnosed with myocarditis after vaccination has died.

What’s more, the risk of myocarditis after vaccination was dwarfed by the risk of myocarditis after a COVID infection. The risk of myocarditis after a COVID infection was 6 to 34 times higher than the risk after receiving an mRNA vaccine.

About 11% of people who get the vaccine experience a serious reaction to the shot, compared with about 3% in the placebo group. Serious reactions were defined as pain; swelling or redness at the injection site that interferes with activity; needing to visit the hospital or ER for pain; tissue necrosis, or having skin slough off; high fever; vomiting that requires hydration; persistent diarrhea; severe headache;  or muscle pain/severe joint pain.

“Safe and effective”

After hearing a presentation on the state of the pandemic in the US, some panel members were struck and shaken that 38% of Americans who are eligible are still not fully vaccinated.

Pablo Sanchez, MD, a pediatrician at Nationwide Children’s Hospital in Columbus, Ohio, said, “We’re doing an abysmal job vaccinating the American people. The message has to go out that the vaccines are safe and effective.”



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

Receiving treatment with a biologic medication, compared with no biologic treatment, appeared to be associated with a lower risk for developing psoriatic arthritis (PsA) in patients with psoriasis.

That’s according to the results of a nested case-control study involving electronic medical record data from an Israeli health maintenance organization in Arthritis & Rheumatology. Compared with no biologic treatment, the risk for developing PsA among PsO patients was reduced by 39%.

This study shows “a statistically and clinically significant lower risk for developing PsA among patients receiving biologic medications for psoriasis treatment,” wrote Yael Shalev Rosenthal, MPH, of the Sackler Faculty of Medicine, Tel Aviv University and colleagues. “The results suggest considering treatment with biologic medications in patients [who] present with significant risk factors for PsA at an earlier stage of treatment.”

“It would be nice to believe this story, but I don’t think we can based on the evidence we’ve got so far,” commented Philip Helliwell, PhD, DM, in an interview.

Dr. Helliwell, who is professor of clinical rheumatology at the University of Leeds (England) and an Honorary Consultant Rheumatologist for the Leeds Teaching Hospitals and Bradford Teaching Hospitals NHS Trust, noted that there were several issues with the current evidence.

Aside from their often retrospective or nonrandomized nature, prior analyses, including the current one, were based on EMR data.

“There’s actually no face-to-face patient contact going on here. It’s all done on coding, and coding can be unreliable,” Dr. Helliwell said.

While the study’s findings are “in line with other studies that have looked at this, and suggest that if you get a biologic, you’re less likely to get PsA with your psoriasis, there could be lots of reasons why.”

The big problem here is confounding by indication. “You don’t get on a biologic unless you’ve got bad psoriasis,” Dr. Helliwell explained. The Israeli criteria for starting a biologic are much higher than in the United Kingdom, he added, requiring more than 50% of patients’ body surface area to be affected, or a Psoriasis Area and Severity Index score of more than 50. Moreover, people with bad psoriasis are more likely to get PsA. This, however, makes the results more impressive.

Confounding by indication is an issue with this study, agreed consultant rheumatologist Adewale Adebajo, PhD, in a separate interview. He acknowledged, however, that the study’s authors did try to account for this by limiting the timescale of their analysis to the first 10 years of biologic therapy. They also used the usual methods of propensity score matching and multivariate Cox regression analysis to hopefully iron out any differences between the two groups of patients.

Study details and results

Ms. Rosenthal and coauthors analyzed EMR data on patients with psoriasis but not PsA that were logged in the Maccabi Healthcare Services (MHS) database. The MHS is the second-largest health maintenance organization in Israel, insuring over 2 million members, the researchers said.

In all, 663 patients with psoriasis but not PsA before or at initiation of biologic treatment were included in their analysis and matched to a control group of 663 patients with psoriasis who had not received biologic treatment. Propensity score matching was used to iron out some differences in baseline characteristics that had been seen between the groups, such as older age at diagnosis, higher body mass index, and a longer time between diagnosis and treatment seen in patients treated without biologics.

After adjusting for multiple risk factors and confounders, “the control group still had a significantly higher risk for PsA, compared to the biological treatment group,” the researchers wrote. Indeed, the adjusted hazard ratio was 1.39, with a 95% confidence interval between 1.03 and 1.87.

An ‘intriguing study’

“This is a retrospective study, and it has all the faults of a retrospective study,” said Dr. Adebajo, associate medical director for research and development at Barnsley (England) NHS Foundation Trust. But “these were patients who hopefully hadn’t yet developed psoriatic arthritis, although it is difficult to exclude subclinical psoriatic arthritis.”

The ideal would of course be to look at patients prospectively, but a randomized clinical trial would be unlikely to ever be conducted, Dr. Helliwell noted. “It would be unfair to randomize people who have got bad psoriasis and need a biologic to placebo just to prove the point really,” he said. “Getting control groups in this arena is very difficult.”

That doesn’t mean that prospective evaluation is not possible. Dr. Adebajo noted that there were already cohorts of newly diagnosed patients who were being prospectively followed up and those could perhaps be used to look at the question again in the future.

“You’re then looking at the natural history, the natural outcome, and you don’t need to worry about confounding because you’re just collecting all of the information as you go along.”

The idea that biologics might slow or even prevent the onset of PsA is “an interesting and enchanting hypothesis,” Dr. Adebajo said. “The study doesn’t prove the hypothesis, but it’s an intriguing study because it doesn’t disprove the hypothesis either.

“It gives us food for thought and a basis for further studies,” as well as some “encouragement to perhaps use biologics earlier because there may be additional benefits of doing so.”

That’s still to be proven of course, as it has been reported that patients with psoriasis can develop PsA while taking biologics.

“Clinically, that’s what we see in the combined clinic. We get people referred with psoriasis [who are] already on a biologic who developed musculoskeletal problems,” Dr. Helliwell said.

“It would be nice to believe” that biologics prevent or slow PsA in patients with psoriasis, Dr. Helliwell added, but I’m not sure these data are conclusive. From this study we know nothing about the phenotype of psoriasis, which is important in the development of PsA. In addition, we know that of the 30% of people with psoriasis who develop PsA, about half of these are undiagnosed at the time of such studies. In that case, what the biologic is doing is just treating preexisting PsA. If you count those numbers up, some of the differences between the two groups seen in this study are accounted for. From registry data there is no way of checking this.”

No external funding was used for the study. One author acknowledged acting as an investigator, adviser, or consultant to several pharmaceutical companies including AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Coherus, Dexcel Pharma, Eli Lilly, Janssen, Novartis, and Pfizer. All other authors had nothing to disclose.

Dr. Helliwell and Dr. Adebajo had no conflicts of interest.

Receiving treatment with a biologic medication, compared with no biologic treatment, appeared to be associated with a lower risk for developing psoriatic arthritis (PsA) in patients with psoriasis.

That’s according to the results of a nested case-control study involving electronic medical record data from an Israeli health maintenance organization in Arthritis & Rheumatology. Compared with no biologic treatment, the risk for developing PsA among PsO patients was reduced by 39%.

This study shows “a statistically and clinically significant lower risk for developing PsA among patients receiving biologic medications for psoriasis treatment,” wrote Yael Shalev Rosenthal, MPH, of the Sackler Faculty of Medicine, Tel Aviv University and colleagues. “The results suggest considering treatment with biologic medications in patients [who] present with significant risk factors for PsA at an earlier stage of treatment.”

“It would be nice to believe this story, but I don’t think we can based on the evidence we’ve got so far,” commented Philip Helliwell, PhD, DM, in an interview.

Dr. Helliwell, who is professor of clinical rheumatology at the University of Leeds (England) and an Honorary Consultant Rheumatologist for the Leeds Teaching Hospitals and Bradford Teaching Hospitals NHS Trust, noted that there were several issues with the current evidence.

Aside from their often retrospective or nonrandomized nature, prior analyses, including the current one, were based on EMR data.

“There’s actually no face-to-face patient contact going on here. It’s all done on coding, and coding can be unreliable,” Dr. Helliwell said.

While the study’s findings are “in line with other studies that have looked at this, and suggest that if you get a biologic, you’re less likely to get PsA with your psoriasis, there could be lots of reasons why.”

The big problem here is confounding by indication. “You don’t get on a biologic unless you’ve got bad psoriasis,” Dr. Helliwell explained. The Israeli criteria for starting a biologic are much higher than in the United Kingdom, he added, requiring more than 50% of patients’ body surface area to be affected, or a Psoriasis Area and Severity Index score of more than 50. Moreover, people with bad psoriasis are more likely to get PsA. This, however, makes the results more impressive.

Confounding by indication is an issue with this study, agreed consultant rheumatologist Adewale Adebajo, PhD, in a separate interview. He acknowledged, however, that the study’s authors did try to account for this by limiting the timescale of their analysis to the first 10 years of biologic therapy. They also used the usual methods of propensity score matching and multivariate Cox regression analysis to hopefully iron out any differences between the two groups of patients.

Study details and results

Ms. Rosenthal and coauthors analyzed EMR data on patients with psoriasis but not PsA that were logged in the Maccabi Healthcare Services (MHS) database. The MHS is the second-largest health maintenance organization in Israel, insuring over 2 million members, the researchers said.

In all, 663 patients with psoriasis but not PsA before or at initiation of biologic treatment were included in their analysis and matched to a control group of 663 patients with psoriasis who had not received biologic treatment. Propensity score matching was used to iron out some differences in baseline characteristics that had been seen between the groups, such as older age at diagnosis, higher body mass index, and a longer time between diagnosis and treatment seen in patients treated without biologics.

After adjusting for multiple risk factors and confounders, “the control group still had a significantly higher risk for PsA, compared to the biological treatment group,” the researchers wrote. Indeed, the adjusted hazard ratio was 1.39, with a 95% confidence interval between 1.03 and 1.87.

An ‘intriguing study’

“This is a retrospective study, and it has all the faults of a retrospective study,” said Dr. Adebajo, associate medical director for research and development at Barnsley (England) NHS Foundation Trust. But “these were patients who hopefully hadn’t yet developed psoriatic arthritis, although it is difficult to exclude subclinical psoriatic arthritis.”

The ideal would of course be to look at patients prospectively, but a randomized clinical trial would be unlikely to ever be conducted, Dr. Helliwell noted. “It would be unfair to randomize people who have got bad psoriasis and need a biologic to placebo just to prove the point really,” he said. “Getting control groups in this arena is very difficult.”

That doesn’t mean that prospective evaluation is not possible. Dr. Adebajo noted that there were already cohorts of newly diagnosed patients who were being prospectively followed up and those could perhaps be used to look at the question again in the future.

“You’re then looking at the natural history, the natural outcome, and you don’t need to worry about confounding because you’re just collecting all of the information as you go along.”

The idea that biologics might slow or even prevent the onset of PsA is “an interesting and enchanting hypothesis,” Dr. Adebajo said. “The study doesn’t prove the hypothesis, but it’s an intriguing study because it doesn’t disprove the hypothesis either.

“It gives us food for thought and a basis for further studies,” as well as some “encouragement to perhaps use biologics earlier because there may be additional benefits of doing so.”

That’s still to be proven of course, as it has been reported that patients with psoriasis can develop PsA while taking biologics.

“Clinically, that’s what we see in the combined clinic. We get people referred with psoriasis [who are] already on a biologic who developed musculoskeletal problems,” Dr. Helliwell said.

“It would be nice to believe” that biologics prevent or slow PsA in patients with psoriasis, Dr. Helliwell added, but I’m not sure these data are conclusive. From this study we know nothing about the phenotype of psoriasis, which is important in the development of PsA. In addition, we know that of the 30% of people with psoriasis who develop PsA, about half of these are undiagnosed at the time of such studies. In that case, what the biologic is doing is just treating preexisting PsA. If you count those numbers up, some of the differences between the two groups seen in this study are accounted for. From registry data there is no way of checking this.”

No external funding was used for the study. One author acknowledged acting as an investigator, adviser, or consultant to several pharmaceutical companies including AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Coherus, Dexcel Pharma, Eli Lilly, Janssen, Novartis, and Pfizer. All other authors had nothing to disclose.

Dr. Helliwell and Dr. Adebajo had no conflicts of interest.

Receiving treatment with a biologic medication, compared with no biologic treatment, appeared to be associated with a lower risk for developing psoriatic arthritis (PsA) in patients with psoriasis.

That’s according to the results of a nested case-control study involving electronic medical record data from an Israeli health maintenance organization in Arthritis & Rheumatology. Compared with no biologic treatment, the risk for developing PsA among PsO patients was reduced by 39%.

This study shows “a statistically and clinically significant lower risk for developing PsA among patients receiving biologic medications for psoriasis treatment,” wrote Yael Shalev Rosenthal, MPH, of the Sackler Faculty of Medicine, Tel Aviv University and colleagues. “The results suggest considering treatment with biologic medications in patients [who] present with significant risk factors for PsA at an earlier stage of treatment.”

“It would be nice to believe this story, but I don’t think we can based on the evidence we’ve got so far,” commented Philip Helliwell, PhD, DM, in an interview.

Dr. Helliwell, who is professor of clinical rheumatology at the University of Leeds (England) and an Honorary Consultant Rheumatologist for the Leeds Teaching Hospitals and Bradford Teaching Hospitals NHS Trust, noted that there were several issues with the current evidence.

Aside from their often retrospective or nonrandomized nature, prior analyses, including the current one, were based on EMR data.

“There’s actually no face-to-face patient contact going on here. It’s all done on coding, and coding can be unreliable,” Dr. Helliwell said.

While the study’s findings are “in line with other studies that have looked at this, and suggest that if you get a biologic, you’re less likely to get PsA with your psoriasis, there could be lots of reasons why.”

The big problem here is confounding by indication. “You don’t get on a biologic unless you’ve got bad psoriasis,” Dr. Helliwell explained. The Israeli criteria for starting a biologic are much higher than in the United Kingdom, he added, requiring more than 50% of patients’ body surface area to be affected, or a Psoriasis Area and Severity Index score of more than 50. Moreover, people with bad psoriasis are more likely to get PsA. This, however, makes the results more impressive.

Confounding by indication is an issue with this study, agreed consultant rheumatologist Adewale Adebajo, PhD, in a separate interview. He acknowledged, however, that the study’s authors did try to account for this by limiting the timescale of their analysis to the first 10 years of biologic therapy. They also used the usual methods of propensity score matching and multivariate Cox regression analysis to hopefully iron out any differences between the two groups of patients.

Study details and results

Ms. Rosenthal and coauthors analyzed EMR data on patients with psoriasis but not PsA that were logged in the Maccabi Healthcare Services (MHS) database. The MHS is the second-largest health maintenance organization in Israel, insuring over 2 million members, the researchers said.

In all, 663 patients with psoriasis but not PsA before or at initiation of biologic treatment were included in their analysis and matched to a control group of 663 patients with psoriasis who had not received biologic treatment. Propensity score matching was used to iron out some differences in baseline characteristics that had been seen between the groups, such as older age at diagnosis, higher body mass index, and a longer time between diagnosis and treatment seen in patients treated without biologics.

After adjusting for multiple risk factors and confounders, “the control group still had a significantly higher risk for PsA, compared to the biological treatment group,” the researchers wrote. Indeed, the adjusted hazard ratio was 1.39, with a 95% confidence interval between 1.03 and 1.87.

An ‘intriguing study’

“This is a retrospective study, and it has all the faults of a retrospective study,” said Dr. Adebajo, associate medical director for research and development at Barnsley (England) NHS Foundation Trust. But “these were patients who hopefully hadn’t yet developed psoriatic arthritis, although it is difficult to exclude subclinical psoriatic arthritis.”

The ideal would of course be to look at patients prospectively, but a randomized clinical trial would be unlikely to ever be conducted, Dr. Helliwell noted. “It would be unfair to randomize people who have got bad psoriasis and need a biologic to placebo just to prove the point really,” he said. “Getting control groups in this arena is very difficult.”

That doesn’t mean that prospective evaluation is not possible. Dr. Adebajo noted that there were already cohorts of newly diagnosed patients who were being prospectively followed up and those could perhaps be used to look at the question again in the future.

“You’re then looking at the natural history, the natural outcome, and you don’t need to worry about confounding because you’re just collecting all of the information as you go along.”

The idea that biologics might slow or even prevent the onset of PsA is “an interesting and enchanting hypothesis,” Dr. Adebajo said. “The study doesn’t prove the hypothesis, but it’s an intriguing study because it doesn’t disprove the hypothesis either.

“It gives us food for thought and a basis for further studies,” as well as some “encouragement to perhaps use biologics earlier because there may be additional benefits of doing so.”

That’s still to be proven of course, as it has been reported that patients with psoriasis can develop PsA while taking biologics.

“Clinically, that’s what we see in the combined clinic. We get people referred with psoriasis [who are] already on a biologic who developed musculoskeletal problems,” Dr. Helliwell said.

“It would be nice to believe” that biologics prevent or slow PsA in patients with psoriasis, Dr. Helliwell added, but I’m not sure these data are conclusive. From this study we know nothing about the phenotype of psoriasis, which is important in the development of PsA. In addition, we know that of the 30% of people with psoriasis who develop PsA, about half of these are undiagnosed at the time of such studies. In that case, what the biologic is doing is just treating preexisting PsA. If you count those numbers up, some of the differences between the two groups seen in this study are accounted for. From registry data there is no way of checking this.”

No external funding was used for the study. One author acknowledged acting as an investigator, adviser, or consultant to several pharmaceutical companies including AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Coherus, Dexcel Pharma, Eli Lilly, Janssen, Novartis, and Pfizer. All other authors had nothing to disclose.

Dr. Helliwell and Dr. Adebajo had no conflicts of interest.

Epithelial and immune cells of the upper airways of children are preactivated and primed to detect SARS-CoV-2 infection, which may contribute to stronger early immune responses to SARS-CoV-2 infection than adults, new research suggests.

The findings may help to explain why children have a lower risk of developing severe COVID-19 illness or becoming infected with SARS-CoV-2 in the first place, the researchers say.

The study was published online Aug. 18 in Nature Biotechnology.
 

Primed for action

Children appear to be better able than adults to control SARS-CoV-2 infection, but, until now, the exact molecular mechanisms have been unclear.

A team of investigators from Germany did an in-depth analysis of nasal swab samples obtained from 24 children and 21 adults who tested positive for SARS-CoV-2, as well as a control group of 18 children and 23 adults who tested negative for SARS-CoV-2.

“We wanted to understand why viral defense appears to work so much better in children than in adults,” Irina Lehmann, PhD, head of the molecular epidemiology unit at the Berlin Institute of Health Charité – Universitätsmedizin Berlin, explained in a news release. 

Single-cell sequencing showed that children had higher baseline levels of certain RNA-sensing receptors that are relevant to SARS-CoV-2 detection, such as MDA5 and RIG-I, in the epithelial and immune cells of their noses.

This differential expression led to stronger early immune responses to SARS-CoV-2 infection in children than in adults.

Children were also more likely than adults to have distinct immune cell subpopulations, including KLRC1+ cytotoxic T cells, involved in fighting infection, and memory CD8+ T cells, associated with the development of long-lasting immunity.
 

‘Clear evidence’

The study provides “clear evidence” that upper-airway immune cells of children are “primed for virus sensing, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults,” the investigators say.

Primed virus sensing and a preactivated innate immune response in children leads to efficient early production of interferons (IFNs) in the infected airways, likely mediating substantial antiviral effects, they note.

Ultimately, this may lead to lower viral replication and faster clearance in children. In fact, several studies have already shown that children eliminate the virus more quickly than adults, consistent with the concept that they shut down viral replication earlier, the study team says.

Weighing in on the findings for this news organization, John Wherry, PhD, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, said this “interesting study highlights potential differences in innate immunity and possibly geographic immunity in the upper respiratory tract in children versus adults.”

“We know there are differences in innate immunity over a lifespan, but exactly how these differences might relate to viral infection remains unclear,” said Dr. Wherry, who was not involved in the study.

“Children, of course, often have more respiratory infections than adults [but] whether this is due to exposure [i.e., daycare, schools, etc.] or susceptibility [lack of accumulated adaptive immunity over a greater number of years of exposure] is unclear,” Dr. Wherry noted.

“These data may help reveal what kinds of innate immune responses in the upper respiratory tract might help restrain SARS-CoV-2 and [perhaps partially] explain why children typically have milder COVID-19 disease,” he added.

The study was supported by the Berlin Institute of Health COVID-19 research program and fightCOVID@DKFZ initiative, European Commission, German Federal Ministry for Education and Research (BMBF), and German Research Foundation. Dr. Lehmann and Dr. Wherry have reported no relevant financial relationships.

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

Epithelial and immune cells of the upper airways of children are preactivated and primed to detect SARS-CoV-2 infection, which may contribute to stronger early immune responses to SARS-CoV-2 infection than adults, new research suggests.

The findings may help to explain why children have a lower risk of developing severe COVID-19 illness or becoming infected with SARS-CoV-2 in the first place, the researchers say.

The study was published online Aug. 18 in Nature Biotechnology.
 

Primed for action

Children appear to be better able than adults to control SARS-CoV-2 infection, but, until now, the exact molecular mechanisms have been unclear.

A team of investigators from Germany did an in-depth analysis of nasal swab samples obtained from 24 children and 21 adults who tested positive for SARS-CoV-2, as well as a control group of 18 children and 23 adults who tested negative for SARS-CoV-2.

“We wanted to understand why viral defense appears to work so much better in children than in adults,” Irina Lehmann, PhD, head of the molecular epidemiology unit at the Berlin Institute of Health Charité – Universitätsmedizin Berlin, explained in a news release. 

Single-cell sequencing showed that children had higher baseline levels of certain RNA-sensing receptors that are relevant to SARS-CoV-2 detection, such as MDA5 and RIG-I, in the epithelial and immune cells of their noses.

This differential expression led to stronger early immune responses to SARS-CoV-2 infection in children than in adults.

Children were also more likely than adults to have distinct immune cell subpopulations, including KLRC1+ cytotoxic T cells, involved in fighting infection, and memory CD8+ T cells, associated with the development of long-lasting immunity.
 

‘Clear evidence’

The study provides “clear evidence” that upper-airway immune cells of children are “primed for virus sensing, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults,” the investigators say.

Primed virus sensing and a preactivated innate immune response in children leads to efficient early production of interferons (IFNs) in the infected airways, likely mediating substantial antiviral effects, they note.

Ultimately, this may lead to lower viral replication and faster clearance in children. In fact, several studies have already shown that children eliminate the virus more quickly than adults, consistent with the concept that they shut down viral replication earlier, the study team says.

Weighing in on the findings for this news organization, John Wherry, PhD, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, said this “interesting study highlights potential differences in innate immunity and possibly geographic immunity in the upper respiratory tract in children versus adults.”

“We know there are differences in innate immunity over a lifespan, but exactly how these differences might relate to viral infection remains unclear,” said Dr. Wherry, who was not involved in the study.

“Children, of course, often have more respiratory infections than adults [but] whether this is due to exposure [i.e., daycare, schools, etc.] or susceptibility [lack of accumulated adaptive immunity over a greater number of years of exposure] is unclear,” Dr. Wherry noted.

“These data may help reveal what kinds of innate immune responses in the upper respiratory tract might help restrain SARS-CoV-2 and [perhaps partially] explain why children typically have milder COVID-19 disease,” he added.

The study was supported by the Berlin Institute of Health COVID-19 research program and fightCOVID@DKFZ initiative, European Commission, German Federal Ministry for Education and Research (BMBF), and German Research Foundation. Dr. Lehmann and Dr. Wherry have reported no relevant financial relationships.

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

Epithelial and immune cells of the upper airways of children are preactivated and primed to detect SARS-CoV-2 infection, which may contribute to stronger early immune responses to SARS-CoV-2 infection than adults, new research suggests.

The findings may help to explain why children have a lower risk of developing severe COVID-19 illness or becoming infected with SARS-CoV-2 in the first place, the researchers say.

The study was published online Aug. 18 in Nature Biotechnology.
 

Primed for action

Children appear to be better able than adults to control SARS-CoV-2 infection, but, until now, the exact molecular mechanisms have been unclear.

A team of investigators from Germany did an in-depth analysis of nasal swab samples obtained from 24 children and 21 adults who tested positive for SARS-CoV-2, as well as a control group of 18 children and 23 adults who tested negative for SARS-CoV-2.

“We wanted to understand why viral defense appears to work so much better in children than in adults,” Irina Lehmann, PhD, head of the molecular epidemiology unit at the Berlin Institute of Health Charité – Universitätsmedizin Berlin, explained in a news release. 

Single-cell sequencing showed that children had higher baseline levels of certain RNA-sensing receptors that are relevant to SARS-CoV-2 detection, such as MDA5 and RIG-I, in the epithelial and immune cells of their noses.

This differential expression led to stronger early immune responses to SARS-CoV-2 infection in children than in adults.

Children were also more likely than adults to have distinct immune cell subpopulations, including KLRC1+ cytotoxic T cells, involved in fighting infection, and memory CD8+ T cells, associated with the development of long-lasting immunity.
 

‘Clear evidence’

The study provides “clear evidence” that upper-airway immune cells of children are “primed for virus sensing, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults,” the investigators say.

Primed virus sensing and a preactivated innate immune response in children leads to efficient early production of interferons (IFNs) in the infected airways, likely mediating substantial antiviral effects, they note.

Ultimately, this may lead to lower viral replication and faster clearance in children. In fact, several studies have already shown that children eliminate the virus more quickly than adults, consistent with the concept that they shut down viral replication earlier, the study team says.

Weighing in on the findings for this news organization, John Wherry, PhD, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, said this “interesting study highlights potential differences in innate immunity and possibly geographic immunity in the upper respiratory tract in children versus adults.”

“We know there are differences in innate immunity over a lifespan, but exactly how these differences might relate to viral infection remains unclear,” said Dr. Wherry, who was not involved in the study.

“Children, of course, often have more respiratory infections than adults [but] whether this is due to exposure [i.e., daycare, schools, etc.] or susceptibility [lack of accumulated adaptive immunity over a greater number of years of exposure] is unclear,” Dr. Wherry noted.

“These data may help reveal what kinds of innate immune responses in the upper respiratory tract might help restrain SARS-CoV-2 and [perhaps partially] explain why children typically have milder COVID-19 disease,” he added.

The study was supported by the Berlin Institute of Health COVID-19 research program and fightCOVID@DKFZ initiative, European Commission, German Federal Ministry for Education and Research (BMBF), and German Research Foundation. Dr. Lehmann and Dr. Wherry have reported no relevant financial relationships.

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

A handful of studies have suggested that for newly infected COVID-19 patients, risk for serious illness may be reduced with a short course of fluvoxamine (Luvox), a decades-old pill typically prescribed for depression or obsessive-compulsive disorder (OCD). But those were small studies involving just a few hundred people.

This week, researchers reported promising data from a large, randomized phase 3 trial that enrolled COVID-19 patients from 11 sites in Brazil. In this study, in which 1,472 people were assigned to receive either a 10-day course of fluvoxamine or placebo pills, the antidepressant cut emergency department and hospital admissions by 29%.

Findings from the new study, which have not yet been peer reviewed, were published August 23 in MedRxiv.

Around the globe, particularly in countries without access to vaccines, “treatment options that are cheap and available and supported by good-quality evidence are the only hope we’ve got to reduce mortality within high-risk populations,” said Edward Mills, PhD, professor in the department of health research methods, evidence, and impact, McMaster University, Hamilton, Ont.

The new findings came from TOGETHER, a large platform trial coordinated by Dr. Mills and colleagues to evaluate the use of fluvoxamine and other repurposed drug candidates for symptomatic, high-risk, adult outpatients with confirmed cases of COVID-19.

The trial’s adaptive format allows multiple agents to be added and tested alongside placebo in a single master protocol – similar to the United Kingdom’s Recovery trial, which found that the common steroid dexamethasone could reduce deaths among hospitalized COVID-19 patients.

In platform trials, treatment arms can be dropped for futility, as was the case with hydroxychloroquine and lopinavir-ritonavir, neither of which did better than placebo at preventing hospitalization in an earlier TOGETHER trial analysis.
 

Study details

In the newly reported analysis, patients were randomly assigned to receive fluvoxamine or placebo between January and August 2021. Participants took fluvoxamine 100 mg twice daily for 10 days. By comparison, the U.S. Food and Drug Administration recommends a maximum daily dose of 300 mg of fluvoxamine for patients with OCD; full psychiatric benefits occur after 6 weeks.

For the primary outcome, the investigators assessed whether the conditions of patients with COVID worsened over a 28-day period so as to require either hospitalization or observation in the emergency department for more than 6 hours. In the placebo group, 108 of 733 patients’ conditions deteriorated to this extent (14.7%); by contrast, only 77 of 739 patients in the fluvoxamine group (10.4%) met these primary criteria – a relative risk reduction of 29%.

The treatment effect was greater (34%) in the per protocol analysis of participants who completed their course of pills.

The investigators also collected data on vital signs, including temperature and oxygen saturation, as well as adverse events reported at clinic visits or through video conferencing, phone calls, or social media applications. Side effects were mild, most commonly nausea and fatigue, and did not differ significantly between active treatment and control groups, Dr. Mills said in an interview.

Amid scores of studies evaluating repurposed drugs for COVID-19, the data on fluvoxamine are “looking much more favorable than anyone could have guessed – at least anyone in infectious disease,” said Paul Sax, MD, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

The new TOGETHER trial results augment supportive data published in JAMA last November from a phase 2 randomized trial that was small but “very well done,” Dr. Sax told this news organization.

Those results got a boost from a subsequent study of 65 racetrack workers who chose to take fluvoxamine during a COVID-19 outbreak in the San Francisco Bay area. Forty-eight persons opted against taking the drug. In this small, nonrandomized study, “the people who chose to be treated with fluvoxamine were sicker [at baseline] than the people who didn’t go on it, and yet the [treated group] ended up better,” said Dr. Sax, who discussed accumulating data on the use of fluvoxamine for COVID-19 in a recent New England Journal of Medicine blog post.
 

Anti-inflammatory effect?

After reviewing the new findings, Frank Domino, MD, professor of family medicine and community health at the University of Massachusetts, Worcester, said he would encourage patients with high-risk COVID-19 to consider taking fluvoxamine to lower their risk of being hospitalized. “But I would make it clear this was not a ‘cure,’ “ he said, “and we are unsure how it helps.”

At this point, U.S. treatment guidelines do not recommend fluvoxamine as the standard of care for nonhospitalized COVID-19 patients, but the National Institutes of Health is “very aware of the data,” Dr. Sax told this news organization.

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) – a class of drugs that includes the more commonly prescribed antidepressant fluoxetine (Prozac). If prescribed off-label to COVID-19 patients, fluvoxamine should not be used within 2 weeks of starting treatment with other SSRI or monoamine oxidase inhibitor antidepressants and should be used with caution with other QT-interval prolonging medications, Dr. Sax said.

In addition, fluvoxamine can enhance the effect of antiplatelet and anticoagulant drugs, potentially triggering bleeding.

On the basis of in vitro and mouse studies of fluvoxamine, “we think it has an anti-inflammatory effect,” said child psychiatrist Angela Reiersen, MD, of Washington University, St. Louis, who came up with the idea for testing fluvoxamine in last year’s phase 2 trial and coauthored a recent article describing the drug’s potential mechanisms of action in COVID-19.

She and other researchers believe fluvoxamine’s anti-inflammatory effects derive from the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, which regulates cellular responses to stress and infection.

Fluvoxamine also inhibits the activation of platelets. “In COVID-19, there does seem to be a problem with hyperactivation of platelets and excessive blood clots forming, so it is possible this could be another mechanism where it might be helping,” Dr. Reiersen said.

If sigma-1 activation turns out to be the main mechanism underlying fluvoxamine’s benefits in COVID-19, other sigma-1 agonists, such as fluoxetine, may also help. In a retrospective analysis of thousands of adults hospitalized for COVID-19 in France early in the pandemic, those who were taking antidepressants had a 44% lower risk for intubation or death.

And in a study under review, researchers at Stanford (Calif.) University and the University of California, San Francisco, analyzed electronic health records to explore a potential link between fluoxetine use and COVID outcomes among more than 80,000 patients from over 80 institutions across the United States. Other research suggests that antipsychotics could also have protective effects for patients with COVID-19.
 

Long COVID, long-term challenges

On the basis of its potential mechanisms of action, fluvoxamine may be able to prevent or treat long COVID, Dr. Reiersen said. That possibility will be assessed among other secondary endpoints in two ongoing studies of repurposed drugs: the NIH’s ACTIV-6, and the University of Minnesota’s COVID-OUT, an at-home trial of ivermectin, metformin, and fluvoxamine.

Dr. Reiersen and Washington University colleagues are also analyzing longer-term outcomes of participants in their own phase 3 trial of fluvoxamine (Stop COVID 2), which was discontinued when enrollment slowed to a trickle during the U.S. vaccine rollout. Logistical hurdles and scant funding have greatly hampered efforts to test the use of off-patent drugs for COVID-19 outpatients during the pandemic.

U.S. efforts face other obstacles as well. Elsewhere in the world – including Brazil, where the TOGETHER trial was run – vaccines are scarce, and there are no monoclonal antibodies.

“People have a great sense of community duty, and they’re participating in the trials,” Dr. Mills said. “You’re in a much more political environment in the U.S. on these outpatient trials.”

The TOGETHER trial was funded by Fast Grants and the Rainwater Foundation. Dr. Reiersen is an inventor on a patent application related to methods of treating COVID-19, which was filed by Washington University, St. Louis. Dr. Mills, Dr. Domino, and Dr. Sax report no relevant financial relationships.

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

A handful of studies have suggested that for newly infected COVID-19 patients, risk for serious illness may be reduced with a short course of fluvoxamine (Luvox), a decades-old pill typically prescribed for depression or obsessive-compulsive disorder (OCD). But those were small studies involving just a few hundred people.

This week, researchers reported promising data from a large, randomized phase 3 trial that enrolled COVID-19 patients from 11 sites in Brazil. In this study, in which 1,472 people were assigned to receive either a 10-day course of fluvoxamine or placebo pills, the antidepressant cut emergency department and hospital admissions by 29%.

Findings from the new study, which have not yet been peer reviewed, were published August 23 in MedRxiv.

Around the globe, particularly in countries without access to vaccines, “treatment options that are cheap and available and supported by good-quality evidence are the only hope we’ve got to reduce mortality within high-risk populations,” said Edward Mills, PhD, professor in the department of health research methods, evidence, and impact, McMaster University, Hamilton, Ont.

The new findings came from TOGETHER, a large platform trial coordinated by Dr. Mills and colleagues to evaluate the use of fluvoxamine and other repurposed drug candidates for symptomatic, high-risk, adult outpatients with confirmed cases of COVID-19.

The trial’s adaptive format allows multiple agents to be added and tested alongside placebo in a single master protocol – similar to the United Kingdom’s Recovery trial, which found that the common steroid dexamethasone could reduce deaths among hospitalized COVID-19 patients.

In platform trials, treatment arms can be dropped for futility, as was the case with hydroxychloroquine and lopinavir-ritonavir, neither of which did better than placebo at preventing hospitalization in an earlier TOGETHER trial analysis.
 

Study details

In the newly reported analysis, patients were randomly assigned to receive fluvoxamine or placebo between January and August 2021. Participants took fluvoxamine 100 mg twice daily for 10 days. By comparison, the U.S. Food and Drug Administration recommends a maximum daily dose of 300 mg of fluvoxamine for patients with OCD; full psychiatric benefits occur after 6 weeks.

For the primary outcome, the investigators assessed whether the conditions of patients with COVID worsened over a 28-day period so as to require either hospitalization or observation in the emergency department for more than 6 hours. In the placebo group, 108 of 733 patients’ conditions deteriorated to this extent (14.7%); by contrast, only 77 of 739 patients in the fluvoxamine group (10.4%) met these primary criteria – a relative risk reduction of 29%.

The treatment effect was greater (34%) in the per protocol analysis of participants who completed their course of pills.

The investigators also collected data on vital signs, including temperature and oxygen saturation, as well as adverse events reported at clinic visits or through video conferencing, phone calls, or social media applications. Side effects were mild, most commonly nausea and fatigue, and did not differ significantly between active treatment and control groups, Dr. Mills said in an interview.

Amid scores of studies evaluating repurposed drugs for COVID-19, the data on fluvoxamine are “looking much more favorable than anyone could have guessed – at least anyone in infectious disease,” said Paul Sax, MD, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

The new TOGETHER trial results augment supportive data published in JAMA last November from a phase 2 randomized trial that was small but “very well done,” Dr. Sax told this news organization.

Those results got a boost from a subsequent study of 65 racetrack workers who chose to take fluvoxamine during a COVID-19 outbreak in the San Francisco Bay area. Forty-eight persons opted against taking the drug. In this small, nonrandomized study, “the people who chose to be treated with fluvoxamine were sicker [at baseline] than the people who didn’t go on it, and yet the [treated group] ended up better,” said Dr. Sax, who discussed accumulating data on the use of fluvoxamine for COVID-19 in a recent New England Journal of Medicine blog post.
 

Anti-inflammatory effect?

After reviewing the new findings, Frank Domino, MD, professor of family medicine and community health at the University of Massachusetts, Worcester, said he would encourage patients with high-risk COVID-19 to consider taking fluvoxamine to lower their risk of being hospitalized. “But I would make it clear this was not a ‘cure,’ “ he said, “and we are unsure how it helps.”

At this point, U.S. treatment guidelines do not recommend fluvoxamine as the standard of care for nonhospitalized COVID-19 patients, but the National Institutes of Health is “very aware of the data,” Dr. Sax told this news organization.

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) – a class of drugs that includes the more commonly prescribed antidepressant fluoxetine (Prozac). If prescribed off-label to COVID-19 patients, fluvoxamine should not be used within 2 weeks of starting treatment with other SSRI or monoamine oxidase inhibitor antidepressants and should be used with caution with other QT-interval prolonging medications, Dr. Sax said.

In addition, fluvoxamine can enhance the effect of antiplatelet and anticoagulant drugs, potentially triggering bleeding.

On the basis of in vitro and mouse studies of fluvoxamine, “we think it has an anti-inflammatory effect,” said child psychiatrist Angela Reiersen, MD, of Washington University, St. Louis, who came up with the idea for testing fluvoxamine in last year’s phase 2 trial and coauthored a recent article describing the drug’s potential mechanisms of action in COVID-19.

She and other researchers believe fluvoxamine’s anti-inflammatory effects derive from the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, which regulates cellular responses to stress and infection.

Fluvoxamine also inhibits the activation of platelets. “In COVID-19, there does seem to be a problem with hyperactivation of platelets and excessive blood clots forming, so it is possible this could be another mechanism where it might be helping,” Dr. Reiersen said.

If sigma-1 activation turns out to be the main mechanism underlying fluvoxamine’s benefits in COVID-19, other sigma-1 agonists, such as fluoxetine, may also help. In a retrospective analysis of thousands of adults hospitalized for COVID-19 in France early in the pandemic, those who were taking antidepressants had a 44% lower risk for intubation or death.

And in a study under review, researchers at Stanford (Calif.) University and the University of California, San Francisco, analyzed electronic health records to explore a potential link between fluoxetine use and COVID outcomes among more than 80,000 patients from over 80 institutions across the United States. Other research suggests that antipsychotics could also have protective effects for patients with COVID-19.
 

Long COVID, long-term challenges

On the basis of its potential mechanisms of action, fluvoxamine may be able to prevent or treat long COVID, Dr. Reiersen said. That possibility will be assessed among other secondary endpoints in two ongoing studies of repurposed drugs: the NIH’s ACTIV-6, and the University of Minnesota’s COVID-OUT, an at-home trial of ivermectin, metformin, and fluvoxamine.

Dr. Reiersen and Washington University colleagues are also analyzing longer-term outcomes of participants in their own phase 3 trial of fluvoxamine (Stop COVID 2), which was discontinued when enrollment slowed to a trickle during the U.S. vaccine rollout. Logistical hurdles and scant funding have greatly hampered efforts to test the use of off-patent drugs for COVID-19 outpatients during the pandemic.

U.S. efforts face other obstacles as well. Elsewhere in the world – including Brazil, where the TOGETHER trial was run – vaccines are scarce, and there are no monoclonal antibodies.

“People have a great sense of community duty, and they’re participating in the trials,” Dr. Mills said. “You’re in a much more political environment in the U.S. on these outpatient trials.”

The TOGETHER trial was funded by Fast Grants and the Rainwater Foundation. Dr. Reiersen is an inventor on a patent application related to methods of treating COVID-19, which was filed by Washington University, St. Louis. Dr. Mills, Dr. Domino, and Dr. Sax report no relevant financial relationships.

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

A handful of studies have suggested that for newly infected COVID-19 patients, risk for serious illness may be reduced with a short course of fluvoxamine (Luvox), a decades-old pill typically prescribed for depression or obsessive-compulsive disorder (OCD). But those were small studies involving just a few hundred people.

This week, researchers reported promising data from a large, randomized phase 3 trial that enrolled COVID-19 patients from 11 sites in Brazil. In this study, in which 1,472 people were assigned to receive either a 10-day course of fluvoxamine or placebo pills, the antidepressant cut emergency department and hospital admissions by 29%.

Findings from the new study, which have not yet been peer reviewed, were published August 23 in MedRxiv.

Around the globe, particularly in countries without access to vaccines, “treatment options that are cheap and available and supported by good-quality evidence are the only hope we’ve got to reduce mortality within high-risk populations,” said Edward Mills, PhD, professor in the department of health research methods, evidence, and impact, McMaster University, Hamilton, Ont.

The new findings came from TOGETHER, a large platform trial coordinated by Dr. Mills and colleagues to evaluate the use of fluvoxamine and other repurposed drug candidates for symptomatic, high-risk, adult outpatients with confirmed cases of COVID-19.

The trial’s adaptive format allows multiple agents to be added and tested alongside placebo in a single master protocol – similar to the United Kingdom’s Recovery trial, which found that the common steroid dexamethasone could reduce deaths among hospitalized COVID-19 patients.

In platform trials, treatment arms can be dropped for futility, as was the case with hydroxychloroquine and lopinavir-ritonavir, neither of which did better than placebo at preventing hospitalization in an earlier TOGETHER trial analysis.
 

Study details

In the newly reported analysis, patients were randomly assigned to receive fluvoxamine or placebo between January and August 2021. Participants took fluvoxamine 100 mg twice daily for 10 days. By comparison, the U.S. Food and Drug Administration recommends a maximum daily dose of 300 mg of fluvoxamine for patients with OCD; full psychiatric benefits occur after 6 weeks.

For the primary outcome, the investigators assessed whether the conditions of patients with COVID worsened over a 28-day period so as to require either hospitalization or observation in the emergency department for more than 6 hours. In the placebo group, 108 of 733 patients’ conditions deteriorated to this extent (14.7%); by contrast, only 77 of 739 patients in the fluvoxamine group (10.4%) met these primary criteria – a relative risk reduction of 29%.

The treatment effect was greater (34%) in the per protocol analysis of participants who completed their course of pills.

The investigators also collected data on vital signs, including temperature and oxygen saturation, as well as adverse events reported at clinic visits or through video conferencing, phone calls, or social media applications. Side effects were mild, most commonly nausea and fatigue, and did not differ significantly between active treatment and control groups, Dr. Mills said in an interview.

Amid scores of studies evaluating repurposed drugs for COVID-19, the data on fluvoxamine are “looking much more favorable than anyone could have guessed – at least anyone in infectious disease,” said Paul Sax, MD, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

The new TOGETHER trial results augment supportive data published in JAMA last November from a phase 2 randomized trial that was small but “very well done,” Dr. Sax told this news organization.

Those results got a boost from a subsequent study of 65 racetrack workers who chose to take fluvoxamine during a COVID-19 outbreak in the San Francisco Bay area. Forty-eight persons opted against taking the drug. In this small, nonrandomized study, “the people who chose to be treated with fluvoxamine were sicker [at baseline] than the people who didn’t go on it, and yet the [treated group] ended up better,” said Dr. Sax, who discussed accumulating data on the use of fluvoxamine for COVID-19 in a recent New England Journal of Medicine blog post.
 

Anti-inflammatory effect?

After reviewing the new findings, Frank Domino, MD, professor of family medicine and community health at the University of Massachusetts, Worcester, said he would encourage patients with high-risk COVID-19 to consider taking fluvoxamine to lower their risk of being hospitalized. “But I would make it clear this was not a ‘cure,’ “ he said, “and we are unsure how it helps.”

At this point, U.S. treatment guidelines do not recommend fluvoxamine as the standard of care for nonhospitalized COVID-19 patients, but the National Institutes of Health is “very aware of the data,” Dr. Sax told this news organization.

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) – a class of drugs that includes the more commonly prescribed antidepressant fluoxetine (Prozac). If prescribed off-label to COVID-19 patients, fluvoxamine should not be used within 2 weeks of starting treatment with other SSRI or monoamine oxidase inhibitor antidepressants and should be used with caution with other QT-interval prolonging medications, Dr. Sax said.

In addition, fluvoxamine can enhance the effect of antiplatelet and anticoagulant drugs, potentially triggering bleeding.

On the basis of in vitro and mouse studies of fluvoxamine, “we think it has an anti-inflammatory effect,” said child psychiatrist Angela Reiersen, MD, of Washington University, St. Louis, who came up with the idea for testing fluvoxamine in last year’s phase 2 trial and coauthored a recent article describing the drug’s potential mechanisms of action in COVID-19.

She and other researchers believe fluvoxamine’s anti-inflammatory effects derive from the molecule’s binding to the sigma-1 receptor in the endoplasmic reticulum, which regulates cellular responses to stress and infection.

Fluvoxamine also inhibits the activation of platelets. “In COVID-19, there does seem to be a problem with hyperactivation of platelets and excessive blood clots forming, so it is possible this could be another mechanism where it might be helping,” Dr. Reiersen said.

If sigma-1 activation turns out to be the main mechanism underlying fluvoxamine’s benefits in COVID-19, other sigma-1 agonists, such as fluoxetine, may also help. In a retrospective analysis of thousands of adults hospitalized for COVID-19 in France early in the pandemic, those who were taking antidepressants had a 44% lower risk for intubation or death.

And in a study under review, researchers at Stanford (Calif.) University and the University of California, San Francisco, analyzed electronic health records to explore a potential link between fluoxetine use and COVID outcomes among more than 80,000 patients from over 80 institutions across the United States. Other research suggests that antipsychotics could also have protective effects for patients with COVID-19.
 

Long COVID, long-term challenges

On the basis of its potential mechanisms of action, fluvoxamine may be able to prevent or treat long COVID, Dr. Reiersen said. That possibility will be assessed among other secondary endpoints in two ongoing studies of repurposed drugs: the NIH’s ACTIV-6, and the University of Minnesota’s COVID-OUT, an at-home trial of ivermectin, metformin, and fluvoxamine.

Dr. Reiersen and Washington University colleagues are also analyzing longer-term outcomes of participants in their own phase 3 trial of fluvoxamine (Stop COVID 2), which was discontinued when enrollment slowed to a trickle during the U.S. vaccine rollout. Logistical hurdles and scant funding have greatly hampered efforts to test the use of off-patent drugs for COVID-19 outpatients during the pandemic.

U.S. efforts face other obstacles as well. Elsewhere in the world – including Brazil, where the TOGETHER trial was run – vaccines are scarce, and there are no monoclonal antibodies.

“People have a great sense of community duty, and they’re participating in the trials,” Dr. Mills said. “You’re in a much more political environment in the U.S. on these outpatient trials.”

The TOGETHER trial was funded by Fast Grants and the Rainwater Foundation. Dr. Reiersen is an inventor on a patent application related to methods of treating COVID-19, which was filed by Washington University, St. Louis. Dr. Mills, Dr. Domino, and Dr. Sax report no relevant financial relationships.

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

The first global trial to compare the cardiovascular (CV) safety of two therapies for prostate cancer proved inconclusive because of inadequate enrollment and events, but the study is a harbinger of growth in the emerging specialty of cardio-oncology, according to experts.

European Society of Cardiology

“Many new cancer agents have extended patient survival, yet some of these agents have significant potential cardiovascular toxicity,” said Renato D. Lopes, MD, in presenting a study at the annual congress of the European Society of Cardiology.

In the context of improving survival in patients with or at risk for both cancer and cardiovascular disease, he suggested that the prostate cancer study he led could be “a model for interdisciplinary collaboration” needed to address the relative and sometimes competing risks of these disease states.

This point was seconded by several pioneers in cardio-oncology who participated in the discussion of the results of the trial, called PRONOUNCE.

“We know many drugs in oncology increase cardiovascular risk, so these are the types of trials we need,” according Thomas M. Suter, MD, who leads the cardio-oncology service at the University Hospital, Berne, Switzerland. He was the ESC-invited discussant for PRONOUNCE.
 

More than 100 centers in 12 countries involved

In PRONOUNCE, 545 patients with prostate cancer and established atherosclerotic cardiovascular disease were randomized to degarelix, a gonadotropin-releasing hormone antagonist, or leuprolide, a GnRH agonist. The patients were enrolled at 113 participating centers in 12 countries. All of the patients had an indication for an androgen-deprivation therapy (ADT).

In numerous previous studies, “ADT has been associated with higher CV morbidity and mortality, particularly in men with preexisting CV disease,” explained Dr. Lopes, but the relative cardiovascular safety of GnRH agonists relative to GnRH antagonists has been “controversial.”

The PRONOUNCE study was designed to resolve this issue, but the study was terminated early because of slow enrollment (not related to the COVID-19 pandemic). The planned enrollment was 900 patients.

In addition, the rate of major adverse cardiovascular events (MACE), defined as myocardial infarction, stroke, or death, was lower over the course of follow-up than anticipated in the study design.
 

No significant difference on primary endpoint

At the end of 12 months, MACE occurred in 11 (4.1%) of patients randomized to leuprolide and 15 (5.5%) of those randomized to degarelix. The greater hazard ratio for MACE in the degarelix group did not approach statistical significance (hazard ratio, 1.28; P = .53).

As a result, the question of the relative CV safety of these drugs “remains unresolved,” according to Dr. Lopes, professor of medicine at Duke University Medical Center, Durham, N.C.

This does not diminish the need to answer this question. In the addition to the fact that cancer is a malignancy primarily of advancing age when CV disease is prevalent – the mean age in this study was 73 years and 44% were over age 75 – it is often an indolent disease with long periods of survival, according to Dr. Lopes. About half of prostate cancer patients have concomitant CV disease, and about half will receive ADT at some point in their treatment.

In patients receiving ADT, leuprolide is far more commonly used than GnRH antagonists, which are offered in only about 4% of patients, according to data cited by Dr. Lopes. The underlying hypothesis of this study was that leuprolide is associated with greater CV risk, which might have been relevant to a risk-benefit calculation, if the hypothesis had been confirmed.
 

Cancer drugs can increase CV risk

Based on experimental data, “there is concern the leuprolide is involved in plaque destabilization,” said Dr. Lopes, but he noted that ADTs in general are associated with adverse metabolic changes, including increases in LDL cholesterol, insulin resistance, and body fat, all of which could be relevant to CV risk.

It is the improving rates of survival for prostate cancer as well for other types of cancer that have increased attention to the potential for cancer drugs to increase CV risk, another major cause of early mortality. For these competing risks, objective data are needed to evaluate a relative risk-to-benefit ratio for treatment choices.

This dilemma led the ESC to recently establish its Council on Cardio-Oncology, and many centers around the world are also creating interdisciplinary groups to guide treatment choices for patients with both diseases.

“You will certainly get a lot of referrals,” said Rudolf de Boer, MD, professor of translational cardiology, University Medical Center, Groningen, Netherlands. Basing his remark on his own experience starting a cardio-oncology clinic at his institution, he called this work challenging and agreed that the need for objective data is urgent.

“We need data to provide common ground on which to judge relative risks,” Dr. de Boer said. He also praised the PRONOUNCE investigators for their efforts even if the data failed to answer the question posed.

The PRONOUNCE results were published online in Circulation at the time of Dr. Lopes’s presentation.

The study received funding from Ferring Pharmaceuticals. Dr. Lopes reports financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. Dr. Suter reports financial relationships with Boehringer Ingelheim, GlaxoSmithKline, and Roche. Dr. de Boer reports financial relationships with AstraZeneca, Abbott, Bristol-Myers Squibb, Novartis, Novo Nordisk, and Roche.

The first global trial to compare the cardiovascular (CV) safety of two therapies for prostate cancer proved inconclusive because of inadequate enrollment and events, but the study is a harbinger of growth in the emerging specialty of cardio-oncology, according to experts.

European Society of Cardiology

“Many new cancer agents have extended patient survival, yet some of these agents have significant potential cardiovascular toxicity,” said Renato D. Lopes, MD, in presenting a study at the annual congress of the European Society of Cardiology.

In the context of improving survival in patients with or at risk for both cancer and cardiovascular disease, he suggested that the prostate cancer study he led could be “a model for interdisciplinary collaboration” needed to address the relative and sometimes competing risks of these disease states.

This point was seconded by several pioneers in cardio-oncology who participated in the discussion of the results of the trial, called PRONOUNCE.

“We know many drugs in oncology increase cardiovascular risk, so these are the types of trials we need,” according Thomas M. Suter, MD, who leads the cardio-oncology service at the University Hospital, Berne, Switzerland. He was the ESC-invited discussant for PRONOUNCE.
 

More than 100 centers in 12 countries involved

In PRONOUNCE, 545 patients with prostate cancer and established atherosclerotic cardiovascular disease were randomized to degarelix, a gonadotropin-releasing hormone antagonist, or leuprolide, a GnRH agonist. The patients were enrolled at 113 participating centers in 12 countries. All of the patients had an indication for an androgen-deprivation therapy (ADT).

In numerous previous studies, “ADT has been associated with higher CV morbidity and mortality, particularly in men with preexisting CV disease,” explained Dr. Lopes, but the relative cardiovascular safety of GnRH agonists relative to GnRH antagonists has been “controversial.”

The PRONOUNCE study was designed to resolve this issue, but the study was terminated early because of slow enrollment (not related to the COVID-19 pandemic). The planned enrollment was 900 patients.

In addition, the rate of major adverse cardiovascular events (MACE), defined as myocardial infarction, stroke, or death, was lower over the course of follow-up than anticipated in the study design.
 

No significant difference on primary endpoint

At the end of 12 months, MACE occurred in 11 (4.1%) of patients randomized to leuprolide and 15 (5.5%) of those randomized to degarelix. The greater hazard ratio for MACE in the degarelix group did not approach statistical significance (hazard ratio, 1.28; P = .53).

As a result, the question of the relative CV safety of these drugs “remains unresolved,” according to Dr. Lopes, professor of medicine at Duke University Medical Center, Durham, N.C.

This does not diminish the need to answer this question. In the addition to the fact that cancer is a malignancy primarily of advancing age when CV disease is prevalent – the mean age in this study was 73 years and 44% were over age 75 – it is often an indolent disease with long periods of survival, according to Dr. Lopes. About half of prostate cancer patients have concomitant CV disease, and about half will receive ADT at some point in their treatment.

In patients receiving ADT, leuprolide is far more commonly used than GnRH antagonists, which are offered in only about 4% of patients, according to data cited by Dr. Lopes. The underlying hypothesis of this study was that leuprolide is associated with greater CV risk, which might have been relevant to a risk-benefit calculation, if the hypothesis had been confirmed.
 

Cancer drugs can increase CV risk

Based on experimental data, “there is concern the leuprolide is involved in plaque destabilization,” said Dr. Lopes, but he noted that ADTs in general are associated with adverse metabolic changes, including increases in LDL cholesterol, insulin resistance, and body fat, all of which could be relevant to CV risk.

It is the improving rates of survival for prostate cancer as well for other types of cancer that have increased attention to the potential for cancer drugs to increase CV risk, another major cause of early mortality. For these competing risks, objective data are needed to evaluate a relative risk-to-benefit ratio for treatment choices.

This dilemma led the ESC to recently establish its Council on Cardio-Oncology, and many centers around the world are also creating interdisciplinary groups to guide treatment choices for patients with both diseases.

“You will certainly get a lot of referrals,” said Rudolf de Boer, MD, professor of translational cardiology, University Medical Center, Groningen, Netherlands. Basing his remark on his own experience starting a cardio-oncology clinic at his institution, he called this work challenging and agreed that the need for objective data is urgent.

“We need data to provide common ground on which to judge relative risks,” Dr. de Boer said. He also praised the PRONOUNCE investigators for their efforts even if the data failed to answer the question posed.

The PRONOUNCE results were published online in Circulation at the time of Dr. Lopes’s presentation.

The study received funding from Ferring Pharmaceuticals. Dr. Lopes reports financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. Dr. Suter reports financial relationships with Boehringer Ingelheim, GlaxoSmithKline, and Roche. Dr. de Boer reports financial relationships with AstraZeneca, Abbott, Bristol-Myers Squibb, Novartis, Novo Nordisk, and Roche.

The first global trial to compare the cardiovascular (CV) safety of two therapies for prostate cancer proved inconclusive because of inadequate enrollment and events, but the study is a harbinger of growth in the emerging specialty of cardio-oncology, according to experts.

European Society of Cardiology

“Many new cancer agents have extended patient survival, yet some of these agents have significant potential cardiovascular toxicity,” said Renato D. Lopes, MD, in presenting a study at the annual congress of the European Society of Cardiology.

In the context of improving survival in patients with or at risk for both cancer and cardiovascular disease, he suggested that the prostate cancer study he led could be “a model for interdisciplinary collaboration” needed to address the relative and sometimes competing risks of these disease states.

This point was seconded by several pioneers in cardio-oncology who participated in the discussion of the results of the trial, called PRONOUNCE.

“We know many drugs in oncology increase cardiovascular risk, so these are the types of trials we need,” according Thomas M. Suter, MD, who leads the cardio-oncology service at the University Hospital, Berne, Switzerland. He was the ESC-invited discussant for PRONOUNCE.
 

More than 100 centers in 12 countries involved

In PRONOUNCE, 545 patients with prostate cancer and established atherosclerotic cardiovascular disease were randomized to degarelix, a gonadotropin-releasing hormone antagonist, or leuprolide, a GnRH agonist. The patients were enrolled at 113 participating centers in 12 countries. All of the patients had an indication for an androgen-deprivation therapy (ADT).

In numerous previous studies, “ADT has been associated with higher CV morbidity and mortality, particularly in men with preexisting CV disease,” explained Dr. Lopes, but the relative cardiovascular safety of GnRH agonists relative to GnRH antagonists has been “controversial.”

The PRONOUNCE study was designed to resolve this issue, but the study was terminated early because of slow enrollment (not related to the COVID-19 pandemic). The planned enrollment was 900 patients.

In addition, the rate of major adverse cardiovascular events (MACE), defined as myocardial infarction, stroke, or death, was lower over the course of follow-up than anticipated in the study design.
 

No significant difference on primary endpoint

At the end of 12 months, MACE occurred in 11 (4.1%) of patients randomized to leuprolide and 15 (5.5%) of those randomized to degarelix. The greater hazard ratio for MACE in the degarelix group did not approach statistical significance (hazard ratio, 1.28; P = .53).

As a result, the question of the relative CV safety of these drugs “remains unresolved,” according to Dr. Lopes, professor of medicine at Duke University Medical Center, Durham, N.C.

This does not diminish the need to answer this question. In the addition to the fact that cancer is a malignancy primarily of advancing age when CV disease is prevalent – the mean age in this study was 73 years and 44% were over age 75 – it is often an indolent disease with long periods of survival, according to Dr. Lopes. About half of prostate cancer patients have concomitant CV disease, and about half will receive ADT at some point in their treatment.

In patients receiving ADT, leuprolide is far more commonly used than GnRH antagonists, which are offered in only about 4% of patients, according to data cited by Dr. Lopes. The underlying hypothesis of this study was that leuprolide is associated with greater CV risk, which might have been relevant to a risk-benefit calculation, if the hypothesis had been confirmed.
 

Cancer drugs can increase CV risk

Based on experimental data, “there is concern the leuprolide is involved in plaque destabilization,” said Dr. Lopes, but he noted that ADTs in general are associated with adverse metabolic changes, including increases in LDL cholesterol, insulin resistance, and body fat, all of which could be relevant to CV risk.

It is the improving rates of survival for prostate cancer as well for other types of cancer that have increased attention to the potential for cancer drugs to increase CV risk, another major cause of early mortality. For these competing risks, objective data are needed to evaluate a relative risk-to-benefit ratio for treatment choices.

This dilemma led the ESC to recently establish its Council on Cardio-Oncology, and many centers around the world are also creating interdisciplinary groups to guide treatment choices for patients with both diseases.

“You will certainly get a lot of referrals,” said Rudolf de Boer, MD, professor of translational cardiology, University Medical Center, Groningen, Netherlands. Basing his remark on his own experience starting a cardio-oncology clinic at his institution, he called this work challenging and agreed that the need for objective data is urgent.

“We need data to provide common ground on which to judge relative risks,” Dr. de Boer said. He also praised the PRONOUNCE investigators for their efforts even if the data failed to answer the question posed.

The PRONOUNCE results were published online in Circulation at the time of Dr. Lopes’s presentation.

The study received funding from Ferring Pharmaceuticals. Dr. Lopes reports financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. Dr. Suter reports financial relationships with Boehringer Ingelheim, GlaxoSmithKline, and Roche. Dr. de Boer reports financial relationships with AstraZeneca, Abbott, Bristol-Myers Squibb, Novartis, Novo Nordisk, and Roche.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Breast cancer screening rates at community health centers (CHCs) in the United States declined during the pandemic, particularly among Black and uninsured individuals, based on a retrospective look at 32 sites.

Still, drops in screening were less dramatic than national declines previously reported, possibly because of the American Cancer Society–directed CHANGE program, which was simultaneously underway at the CHCs involved, reported lead author Stacey A. Fedewa, PhD, senior principal scientist at the ACS in Atlanta, and colleagues.

“This is one of the first studies to examine breast cancer screening rates during the pandemic specifically among clinics providing care to communities of color and lower income populations, a group with lower utilization of and greater barriers to [breast cancer] screening,” the investigators wrote in Cancer. “This is important because these populations have longstanding barriers to accessing care, lower breast screening rates, higher breast cancer mortality rates, and are especially vulnerable to health care disruptions.”

According to a previous analysis of electronic health records by Mast and Munoz del Rio, breast cancer screening rates in the United States dropped 94% in March/April 2020, when the COVID-19 pandemic was declared a national emergency. Although a recent follow-up report showed a rebound in breast cancer screening, the estimated rate remains 13% below average.

The present study evaluated data from 32 out of 1,385 CHCs in the United States. All centers were involved in the ACS-run CHANGE grant program, which funded the clinics for 2 years, during which time they implemented at least three evidence-based provider and client interventions, such as patient navigation or electronic medical record enhancements. The clinics reported breast cancer screening rates on a routine basis throughout the 2-year period, beginning August 2018.

Breast cancer screening rate was defined as the percentage of women aged 50-74 years who had a screening mammogram within the past 27 months, out of a total pool of women who had a medical visit within the past year. For 2018, 2019, and 2020, respectively, 142,207; 142,003; and 150,630 women had a medical visit. Screening rates were compared across years in either June or July. Findings were further characterized by demographic characteristics, urban/rural status, and clinic region.

From 2018 to 2019 breast cancer screening rates rose 18%, from 45.8% to 53.9%. This increase was followed by an 8% decline during the 2019-2020 period, from 53.9% to 49.6%.

The investigators estimated the number of missed mammograms and breast cancer diagnoses for two comparative, hypothetical scenarios: first, if the rising trend from 2018 to 2019 had continued through 2020, and second, if the rate had plateaued at 53.9%.

The rising trend model suggested that 47,517 fewer mammograms than normal were conducted during 2019-2020, resulting in 242 missed breast cancer diagnoses, of which 166 were invasive and 76 were ductal carcinoma in situ. The plateau model suggested that 6,477 fewer mammograms were conducted, leading to 33 missed diagnoses.

Compared with the 8% decline in screening overall, the rate among Black patients dropped 12%, while rates at clinics with a lower proportion of uninsured patients dropped an average of 15%. In contrast, clinics in the South did not have a significant reduction in screening, “possibly reflecting lower baseline rates or impact of stay-at-home orders,” the investigators wrote.

Dr. Fedewa and colleagues also noted that their findings were less dramatic than those reported by Mast and Munoz del Rio. They suggested that the CHANGE program may have softened the blow dealt by the pandemic.

“The CHANGE program–funded interventions – that were established before and continued through 2020 – may have mitigated the pandemic’s effects on breast cancer screening services among the 32 CHCs that were studied,” they wrote. “Further investigation of breast cancer screening rates among additional CHCs will further inform where targeted interventions (e.g., client reminders, education on return to screening) are most needed.”

According to Madeline Sutton, MD, assistant professor of obstetrics and gynecology at Morehouse School of Medicine, Atlanta, “Progress seen with the CHANGE program should be duplicated in other clinical venues based on improvements seen in numbers of mammograms and breast cancers detected.”

Still, Dr. Sutton noted that the racial/ethnic disparities remain cause for concern.

“This study has implications for persons served at CHCs, especially if breast cancer racial/ethnic disparities are unintentionally widened during this pandemic,” Dr. Sutton said in a written comment. “Policy-level changes that decrease BCSR [breast cancer screen rate] gaps for women are warranted.”

Ana Velázquez Mañana, MD, a medical oncology fellow at the University of California, San Francisco, suggested that the effects of the pandemic may have been even more pronounced among medically underserved patients in whom interventions to increase screening were not being conducted, as they were through the CHANGE program.

“One must wonder to what degree these interventions reduced the decline in screening mammography rates observed during the pandemic and to what degree could disparities in screening be magnified in community health centers with less resources,” Dr. Velázquez said in a written comment. “Therefore, understanding barriers to breast cancer screening among our specific health care systems is key to guide resource allocation and the development of evidence-based multilevel interventions that can address these barriers, and ultimately increase screening rates.”

Dr. Velázquez also noted that the study by Dr. Fedewa and colleagues may have missed drops in screening among vulnerable populations that occurred later in the pandemic and in geographic hotspots. In a recent JAMA Network Open study, Dr. Velázquez reported a 41% drop in breast cancer screening at a safety-net hospital in San Francisco during the first stay-at-home order, which lasted from Feb. 1, 2020 to May 31, 2020.

The Breast Health Equity CHANGE grant was funded by the National Football League in partnership with the American Cancer Society. The investigators reported employment by the American Cancer Society. Dr. Wehling and Dr. Wysocki disclosed grants from Pfizer unrelated to this research. Dr. Sutton and Dr. Velázquez disclosed no conflicts of interest.

Loretta J. Colvin, APRN, ACNP-BC, is a Nurse Practitioner at Sleep Services, SSM Health Medical Group, specializing in the treatment of sleep disorders. Her focus is on insomnia, narcolepsy, obstructive sleep apnea, parasomnias, periodic leg movement disorder, restless leg syndrome, sleep disorders, snoring and telehealth.  

Q: As a nurse practitioner and a specialist at a clinic focused on identifying sleep related disorders, what do you feel is the overall value of such a clinic as a therapeutic need for patients?

Ms. Colvin: Well, for us in sleep, we've experienced a growth in our field, and anticipate further growth. We know that many people remain undiagnosed with their sleep disorders. So, we see our role as filling a need for the public in providing more personalized and specialized care for those that have a sleep problem.

Patients get to us via many routes, including self-referral or referral by their primary care provider or specialist.  We help these patients identify their sleep problems, guide them in testing and treatment decisions, and provide on-going treatment support.

Currently, there are two areas in which there is a particular need. With current stressors impacting our society, there is an increased need for patients to discuss their insomnia or sleep difficulty concerns with a healthcare provider.  We are seeing more patients bring up insomnia concerns to their primary care providers or coming directly to our sleep clinic for discussion of these concerns.   As the recognition of the importance of diagnosing and treatment sleep apnea continues to grow, we see more patients coming to us for care, including those with less obvious symptoms but high risk of sleep apnea due to their comorbid diseases.     

Q: Given current predictions that the outpatient health care structure will change and the number of APRNs and PAs will increase, what is your perspective on role and utilization of APPs, as well as the need to plan for the future care of patients with sleep disorders?

Ms. Colvin: First, let me talk about the national landscape with regards to structure. Nationally, the APP role and the number of professionals in that role is growing, so that's going to help meet some of the needs of our society for providing health care, whether it be primary care or specialty care, like I do, or acute care in the hospital. At present, there are a significant number of places where we fill a needed role but within the area of sleep, there is a likely to be an  increase in need for APPs as a result of attrition in the field as well as a shift in how many physicians are available to provide care in our ever-expanding specialty. What we then need to do is figure out how do we train these Providers in a specialty? This is not a specialty that is a large part of our basic education, so how do we train people into that specialty? And how do we prepare them for their role and ensure that we are offering opportunities to expand their capabilities over time?

An example of this can be seen with regards to the opportunities now being offered in telehealth in behavioral sleep medicine and in working with conditions like insomnia, or with people who have difficulty in trying to adjust to Continuous Positive Airway Pressure (CPAP) therapy and might need additional assistance and coaching.

Within my organization, physicians will refer patients directly to me who have struggled to use PAP in the past.  With specialized guidance, these past struggles can often be overcome thanks to improvements in our equipment and technology, patient knowledge and acceptance combined with personalized specialty care. I have had good success with helping patients who were not successful using PAP 10 or 20 years ago to become successful through guidance and coaching.  When we encounter anxiety or claustrophobia with PAP, we can incorporate behavioral sleep principles into the patient’s care to help them better acclimate to PAP therapy or consider alternative therapies.

Q: With more than 70 million US adults affected by sleep disorders and a growing number of clinicians and sleep practitioners gaining expertise in virtual models for diagnosis and treatments, what is your approach to using the telehealth to provide the same level of support, education, and therapy at home versus in the office?

Ms. Colvin: The pandemic definitely pushed us farther along in how we use telehealth. Before the pandemic, I was utilizing it in small increments, but there were some limits as a result of either regulation or reimbursement that caused it to not be included as a larger part of our program. However, now that we've experienced this shift with the pandemic, our health system has invested more in technology, and exposed more patients to the experience, I think telehealth and our usage of it will be different once we come out on the other side of this public health crisis. So, now we must decide, how are we going to use this mode as an alternative model of care?

I see two main focuses for us in sleep—expanding patient access and patient convenience. As technology improves, it will expand access for patients with less accessibility to technology and the internet, such as those in rural areas. And with smartphones becoming even more readily available and more capable of doing virtual care, we see potential to reach out and treat patients who we would otherwise not be able to offer treatment to.

Patient convenience is also very important. With virtual visits, we may be able to keep patients from having to leave work as they may be able to just ‘pop out’ at lunch, have a visit, and then go right back to work. Doing so also helps if patients have care giving responsibilities as they don't have to, for example, find a babysitter to come in for an office visit as they can make the necessary arrangements from home.

In lockstep with patient access and convenience, I am interested to see how telehealth, over time, manifests for patients with disabilities but we are already seeing the benefits of its application within this population.

I have a patient who is confined to a wheelchair so for this patient to get to a visit requires significant planning time to get into the van and be driven to the clinic by his caregiver, who has to schedule time off from work. So, it is not an easy process for this patient to come in and see me for a quick visit. With telehealth, this simple visit doesn’t have to be a whole- or half-day affair as it can be a quick check-in. If an in-person visit is warranted, we can always arrange that but usually we can accomplish what we need to on video and audio.

Another example is with those patients with hearing impairments. Depending on the impairment, certain patients may be able to use Bluetooth or audio enhancement with their hearing aids and can actually hear me better in a video environment than they can in the clinic; especially at this point in time as we are masked when in the office.

Q: In what ways do you think the telemedicine diagnosis process might be impacted post-pandemic?

Ms. Colvin: At-home sleep testing became available several years ago, but it has a limited role as it is specifically for the diagnosis of sleep apnea in the uncomplicated patient. Telehealth offers some convenience in enabling patients to be tested in their home and it is also more affordable for the patient and for insurance. In fact, this is seen as one of the disruptors in our field that will continue to expand in the appropriate patient populations. But we will always have to acknowledge that it won't serve all patient needs because our more complex patients still need to come in for in-person testing.

Q: Overall, in what ways do sleep professionals support the value of having a specialist care model versus a generalist PCP model to perform patient care within the US as well as other countries?

Ms. Colvin: From my view, I see that our PCPs are already stretched thin in their ability to provide easily accessible care and I think it would be difficult for them to also provide the specialty care that patients with sleep disorders need. Some of the less complex patients might be able to stay within a primary care environment but as technology, as well as the software training that is required to be able to communicate with the devices our patients use for treatment or for diagnosis, continues to become more complex, it can become difficult to manage through the primary care environment.

The question then goes back to, how can we be as accessible as possible in an underserved area or where the specialty clinic is not easy to access? I think this is where telehealth may give us new options for expanding access to patients who can use the technology that is available.

Loretta J. Colvin, APRN, ACNP-BC, is a Nurse Practitioner at Sleep Services, SSM Health Medical Group, specializing in the treatment of sleep disorders. Her focus is on insomnia, narcolepsy, obstructive sleep apnea, parasomnias, periodic leg movement disorder, restless leg syndrome, sleep disorders, snoring and telehealth.  

Q: As a nurse practitioner and a specialist at a clinic focused on identifying sleep related disorders, what do you feel is the overall value of such a clinic as a therapeutic need for patients?

Ms. Colvin: Well, for us in sleep, we've experienced a growth in our field, and anticipate further growth. We know that many people remain undiagnosed with their sleep disorders. So, we see our role as filling a need for the public in providing more personalized and specialized care for those that have a sleep problem.

Patients get to us via many routes, including self-referral or referral by their primary care provider or specialist.  We help these patients identify their sleep problems, guide them in testing and treatment decisions, and provide on-going treatment support.

Currently, there are two areas in which there is a particular need. With current stressors impacting our society, there is an increased need for patients to discuss their insomnia or sleep difficulty concerns with a healthcare provider.  We are seeing more patients bring up insomnia concerns to their primary care providers or coming directly to our sleep clinic for discussion of these concerns.   As the recognition of the importance of diagnosing and treatment sleep apnea continues to grow, we see more patients coming to us for care, including those with less obvious symptoms but high risk of sleep apnea due to their comorbid diseases.     

Q: Given current predictions that the outpatient health care structure will change and the number of APRNs and PAs will increase, what is your perspective on role and utilization of APPs, as well as the need to plan for the future care of patients with sleep disorders?

Ms. Colvin: First, let me talk about the national landscape with regards to structure. Nationally, the APP role and the number of professionals in that role is growing, so that's going to help meet some of the needs of our society for providing health care, whether it be primary care or specialty care, like I do, or acute care in the hospital. At present, there are a significant number of places where we fill a needed role but within the area of sleep, there is a likely to be an  increase in need for APPs as a result of attrition in the field as well as a shift in how many physicians are available to provide care in our ever-expanding specialty. What we then need to do is figure out how do we train these Providers in a specialty? This is not a specialty that is a large part of our basic education, so how do we train people into that specialty? And how do we prepare them for their role and ensure that we are offering opportunities to expand their capabilities over time?

An example of this can be seen with regards to the opportunities now being offered in telehealth in behavioral sleep medicine and in working with conditions like insomnia, or with people who have difficulty in trying to adjust to Continuous Positive Airway Pressure (CPAP) therapy and might need additional assistance and coaching.

Within my organization, physicians will refer patients directly to me who have struggled to use PAP in the past.  With specialized guidance, these past struggles can often be overcome thanks to improvements in our equipment and technology, patient knowledge and acceptance combined with personalized specialty care. I have had good success with helping patients who were not successful using PAP 10 or 20 years ago to become successful through guidance and coaching.  When we encounter anxiety or claustrophobia with PAP, we can incorporate behavioral sleep principles into the patient’s care to help them better acclimate to PAP therapy or consider alternative therapies.

Q: With more than 70 million US adults affected by sleep disorders and a growing number of clinicians and sleep practitioners gaining expertise in virtual models for diagnosis and treatments, what is your approach to using the telehealth to provide the same level of support, education, and therapy at home versus in the office?

Ms. Colvin: The pandemic definitely pushed us farther along in how we use telehealth. Before the pandemic, I was utilizing it in small increments, but there were some limits as a result of either regulation or reimbursement that caused it to not be included as a larger part of our program. However, now that we've experienced this shift with the pandemic, our health system has invested more in technology, and exposed more patients to the experience, I think telehealth and our usage of it will be different once we come out on the other side of this public health crisis. So, now we must decide, how are we going to use this mode as an alternative model of care?

I see two main focuses for us in sleep—expanding patient access and patient convenience. As technology improves, it will expand access for patients with less accessibility to technology and the internet, such as those in rural areas. And with smartphones becoming even more readily available and more capable of doing virtual care, we see potential to reach out and treat patients who we would otherwise not be able to offer treatment to.

Patient convenience is also very important. With virtual visits, we may be able to keep patients from having to leave work as they may be able to just ‘pop out’ at lunch, have a visit, and then go right back to work. Doing so also helps if patients have care giving responsibilities as they don't have to, for example, find a babysitter to come in for an office visit as they can make the necessary arrangements from home.

In lockstep with patient access and convenience, I am interested to see how telehealth, over time, manifests for patients with disabilities but we are already seeing the benefits of its application within this population.

I have a patient who is confined to a wheelchair so for this patient to get to a visit requires significant planning time to get into the van and be driven to the clinic by his caregiver, who has to schedule time off from work. So, it is not an easy process for this patient to come in and see me for a quick visit. With telehealth, this simple visit doesn’t have to be a whole- or half-day affair as it can be a quick check-in. If an in-person visit is warranted, we can always arrange that but usually we can accomplish what we need to on video and audio.

Another example is with those patients with hearing impairments. Depending on the impairment, certain patients may be able to use Bluetooth or audio enhancement with their hearing aids and can actually hear me better in a video environment than they can in the clinic; especially at this point in time as we are masked when in the office.

Q: In what ways do you think the telemedicine diagnosis process might be impacted post-pandemic?

Ms. Colvin: At-home sleep testing became available several years ago, but it has a limited role as it is specifically for the diagnosis of sleep apnea in the uncomplicated patient. Telehealth offers some convenience in enabling patients to be tested in their home and it is also more affordable for the patient and for insurance. In fact, this is seen as one of the disruptors in our field that will continue to expand in the appropriate patient populations. But we will always have to acknowledge that it won't serve all patient needs because our more complex patients still need to come in for in-person testing.

Q: Overall, in what ways do sleep professionals support the value of having a specialist care model versus a generalist PCP model to perform patient care within the US as well as other countries?

Ms. Colvin: From my view, I see that our PCPs are already stretched thin in their ability to provide easily accessible care and I think it would be difficult for them to also provide the specialty care that patients with sleep disorders need. Some of the less complex patients might be able to stay within a primary care environment but as technology, as well as the software training that is required to be able to communicate with the devices our patients use for treatment or for diagnosis, continues to become more complex, it can become difficult to manage through the primary care environment.

The question then goes back to, how can we be as accessible as possible in an underserved area or where the specialty clinic is not easy to access? I think this is where telehealth may give us new options for expanding access to patients who can use the technology that is available.

Loretta J. Colvin, APRN, ACNP-BC, is a Nurse Practitioner at Sleep Services, SSM Health Medical Group, specializing in the treatment of sleep disorders. Her focus is on insomnia, narcolepsy, obstructive sleep apnea, parasomnias, periodic leg movement disorder, restless leg syndrome, sleep disorders, snoring and telehealth.  

Q: As a nurse practitioner and a specialist at a clinic focused on identifying sleep related disorders, what do you feel is the overall value of such a clinic as a therapeutic need for patients?

Ms. Colvin: Well, for us in sleep, we've experienced a growth in our field, and anticipate further growth. We know that many people remain undiagnosed with their sleep disorders. So, we see our role as filling a need for the public in providing more personalized and specialized care for those that have a sleep problem.

Patients get to us via many routes, including self-referral or referral by their primary care provider or specialist.  We help these patients identify their sleep problems, guide them in testing and treatment decisions, and provide on-going treatment support.

Currently, there are two areas in which there is a particular need. With current stressors impacting our society, there is an increased need for patients to discuss their insomnia or sleep difficulty concerns with a healthcare provider.  We are seeing more patients bring up insomnia concerns to their primary care providers or coming directly to our sleep clinic for discussion of these concerns.   As the recognition of the importance of diagnosing and treatment sleep apnea continues to grow, we see more patients coming to us for care, including those with less obvious symptoms but high risk of sleep apnea due to their comorbid diseases.     

Q: Given current predictions that the outpatient health care structure will change and the number of APRNs and PAs will increase, what is your perspective on role and utilization of APPs, as well as the need to plan for the future care of patients with sleep disorders?

Ms. Colvin: First, let me talk about the national landscape with regards to structure. Nationally, the APP role and the number of professionals in that role is growing, so that's going to help meet some of the needs of our society for providing health care, whether it be primary care or specialty care, like I do, or acute care in the hospital. At present, there are a significant number of places where we fill a needed role but within the area of sleep, there is a likely to be an  increase in need for APPs as a result of attrition in the field as well as a shift in how many physicians are available to provide care in our ever-expanding specialty. What we then need to do is figure out how do we train these Providers in a specialty? This is not a specialty that is a large part of our basic education, so how do we train people into that specialty? And how do we prepare them for their role and ensure that we are offering opportunities to expand their capabilities over time?

An example of this can be seen with regards to the opportunities now being offered in telehealth in behavioral sleep medicine and in working with conditions like insomnia, or with people who have difficulty in trying to adjust to Continuous Positive Airway Pressure (CPAP) therapy and might need additional assistance and coaching.

Within my organization, physicians will refer patients directly to me who have struggled to use PAP in the past.  With specialized guidance, these past struggles can often be overcome thanks to improvements in our equipment and technology, patient knowledge and acceptance combined with personalized specialty care. I have had good success with helping patients who were not successful using PAP 10 or 20 years ago to become successful through guidance and coaching.  When we encounter anxiety or claustrophobia with PAP, we can incorporate behavioral sleep principles into the patient’s care to help them better acclimate to PAP therapy or consider alternative therapies.

Q: With more than 70 million US adults affected by sleep disorders and a growing number of clinicians and sleep practitioners gaining expertise in virtual models for diagnosis and treatments, what is your approach to using the telehealth to provide the same level of support, education, and therapy at home versus in the office?

Ms. Colvin: The pandemic definitely pushed us farther along in how we use telehealth. Before the pandemic, I was utilizing it in small increments, but there were some limits as a result of either regulation or reimbursement that caused it to not be included as a larger part of our program. However, now that we've experienced this shift with the pandemic, our health system has invested more in technology, and exposed more patients to the experience, I think telehealth and our usage of it will be different once we come out on the other side of this public health crisis. So, now we must decide, how are we going to use this mode as an alternative model of care?

I see two main focuses for us in sleep—expanding patient access and patient convenience. As technology improves, it will expand access for patients with less accessibility to technology and the internet, such as those in rural areas. And with smartphones becoming even more readily available and more capable of doing virtual care, we see potential to reach out and treat patients who we would otherwise not be able to offer treatment to.

Patient convenience is also very important. With virtual visits, we may be able to keep patients from having to leave work as they may be able to just ‘pop out’ at lunch, have a visit, and then go right back to work. Doing so also helps if patients have care giving responsibilities as they don't have to, for example, find a babysitter to come in for an office visit as they can make the necessary arrangements from home.

In lockstep with patient access and convenience, I am interested to see how telehealth, over time, manifests for patients with disabilities but we are already seeing the benefits of its application within this population.

I have a patient who is confined to a wheelchair so for this patient to get to a visit requires significant planning time to get into the van and be driven to the clinic by his caregiver, who has to schedule time off from work. So, it is not an easy process for this patient to come in and see me for a quick visit. With telehealth, this simple visit doesn’t have to be a whole- or half-day affair as it can be a quick check-in. If an in-person visit is warranted, we can always arrange that but usually we can accomplish what we need to on video and audio.

Another example is with those patients with hearing impairments. Depending on the impairment, certain patients may be able to use Bluetooth or audio enhancement with their hearing aids and can actually hear me better in a video environment than they can in the clinic; especially at this point in time as we are masked when in the office.

Q: In what ways do you think the telemedicine diagnosis process might be impacted post-pandemic?

Ms. Colvin: At-home sleep testing became available several years ago, but it has a limited role as it is specifically for the diagnosis of sleep apnea in the uncomplicated patient. Telehealth offers some convenience in enabling patients to be tested in their home and it is also more affordable for the patient and for insurance. In fact, this is seen as one of the disruptors in our field that will continue to expand in the appropriate patient populations. But we will always have to acknowledge that it won't serve all patient needs because our more complex patients still need to come in for in-person testing.

Q: Overall, in what ways do sleep professionals support the value of having a specialist care model versus a generalist PCP model to perform patient care within the US as well as other countries?

Ms. Colvin: From my view, I see that our PCPs are already stretched thin in their ability to provide easily accessible care and I think it would be difficult for them to also provide the specialty care that patients with sleep disorders need. Some of the less complex patients might be able to stay within a primary care environment but as technology, as well as the software training that is required to be able to communicate with the devices our patients use for treatment or for diagnosis, continues to become more complex, it can become difficult to manage through the primary care environment.

The question then goes back to, how can we be as accessible as possible in an underserved area or where the specialty clinic is not easy to access? I think this is where telehealth may give us new options for expanding access to patients who can use the technology that is available.

Officer Scott Davis is a passionate man who thinks and talks quickly. As a member of the Special Events Team for Montgomery County, Maryland, he was already staging in Rockville, outside of Washington, D.C., when the call came in last Jan. 6 to move their unit to the U.S. Capitol. 

Courtesy Scott Davis

“It was surreal,” said Mr. Davis. “There were people from all different groups at the Capitol that day. Many people were trying to get out, but others surrounded us. They called us ‘human race traitors.’ And then I heard someone say, ‘It’s good you brought your shields, we’ll carry your bodies out on them.’”

Mr. Davis described hours of mayhem during which he was hit with bear spray, a brick, a chair, and a metal rod. One of the members of Mr. Davis’ unit remains on leave with a head injury nearly 9 months after the siege.  

“It went on for 3 hours, but it felt like 15 minutes. Then, all of a sudden, it was over.”

For the members of law enforcement at the Capitol that day, the repercussions are still being felt, perhaps most notably in the case of the four officers who subsequently died of suicide. Three of the officers were with the Metropolitan Police Department of the District of Columbia and one worked for the Capitol Police Department.

Police officers are subjected to traumas on a regular basis and often placed in circumstances where their lives are in danger. Yet four suicides within a short time – all connected to a single event – is particularly shocking and tragic, even more so for how little attention it has garnered to date.  
 

What contributes to the high rate of suicide among officers?

Scott Silverii, PhD, a former police officer and author of Broken and Blue: A Policeman’s Guide to Health, Hope, and Healing, commented that he “wouldn’t be surprised if there are more suicides to come.” This stems not only from the experiences of that day but also the elevated risk for suicide that law enforcement officers already experienced prior to the Capitol riots. Suicide remains a rare event, with a national all-population average of 13.9 per 100,000 citizens. But as Dr. Silverii noted, more officers die by suicide each year than are killed in the line of duty. 

“Suicide is a big part of police culture – officers are doers and fixers, and it is seen as being more honorable to take yourself out of the equation than it is to ask for help,” he said. “Most officers come in with past pain, and this is a situation where they are being overwhelmed and under-respected. At the same time, police culture is a closed culture, and it is not friendly to researchers.”

Another contributor is the frequency with which law enforcement officers are exposed to trauma, according to Vernon Herron, Director of Officer Safety and Wellness for the Baltimore City Police. 

“Suicide can be a direct result of trauma, and at some point you just can’t absorb it, and it leads to problems,” Mr. Herron said, citing the psychiatric and addiction issues that officers commonly experience.
 

Protecting the protectors

Mr. Herron and others are working to address these problems head-on.

“We are trying to identify employees exposed to trauma and to offer counseling and intervention,” he said, “Otherwise, everything else will fall short.”

Yet implementing such measures is no easy task, given the lack of a central oversight organization for law enforcement, said Sheldon Greenberg, PhD, a former police officer and professor of management in the School of Education at Johns Hopkins University, Baltimore.

“In the United States there is no such thing as ‘The Police.’ There is no one in a position to set policy, standards, or training mandates nationally,” he said. “There are approximately 18,000 police and sheriff departments in the country, and many of them are small. No one can compel law enforcement agencies to implement officer wellness and suicide prevention programs, make counseling available to officers, or train supervisors and peers to identify suicide ideation.”

Dr. Greenberg said a further barrier to helping police officers considering self-harm is posed by the fact that even if they do seek out counseling, there is no guarantee that it will remain confidential. 

“Support personnel have an obligation to report an officer who is thinking about committing suicide,” he said. “Many officers are concerned about this lack of confidentiality and that they may be branded if they seek help.”

Although Dr. Greenberg said many police officers are self-professed “action junkies,” even their unusually high capacity for stress is often tested by the realities of the job.  

“Increasing demands for service, shortages of personnel, misinformation about police, COVID-19, talk about restructuring policing with little concrete direction, increased exposure to violence, greater numbers of vulnerable people, and more take a toll over time,” he lamented. “In addition, we are in a recruiting crisis in law enforcement, and there are no standards to ensure the quality of psychological screening provided to applicants. Many officers will go through their entire career and never be screened again. We know little about the stresses and strains that officers bring to the job.”
 

After the siege

It is not clear how many police officers were present at the Capitol on Jan. 6. During the chaos of the day, reinforcements to the Capitol Police Department arrived from Washington D.C., Maryland, and Virginia, but no official numbers on responders were obtained; Mr. Davis thought it was likely that there were at least 1,000 law enforcement officers present. Those who did respond sustained an estimated 100 injuries, including an officer who died the next day. Of the officers who died by suicide, one died 3 days after, another died 9 days later, and two more died in July – numbers that contradict the notion that this is some coincidence. Officer Alexander Kettering, a colleague of Mr. Davis who has been with Montgomery County Police for 15 years, was among those tasked with protecting the Capitol on Jan. 6. The chaos, violence, and destruction of the day has stuck with him and continues to occupy his thoughts.

“I had a front-row seat to the whole thing. It was overwhelming, and I’ve never seen people this angry,” said Mr. Kettering. “There were people up on the veranda and on the scaffolding set up for the inauguration. They were smashing windows and throwing things into the crowd. It was insane. There were decent people coming up to us and saying they would pray for us, then others calling us traitors, telling us to stand down and join them.”

In the aftermath of the Capitol siege, Mr. Kettering watched in dismay as the narrative of the day’s events began to warp.

“At first there was a consensus that what happened was so wrong, and then the politics took over. People were saying it wasn’t as bad as the media said, that it really wasn’t that violent and those speaking out are traitors or political operatives. I relive it every day, and it’s hard to escape, even in casual conversation.”

He added that the days’ events were compounded by the already heightened tensions surrounding the national debate around policing.

“It’s been 18 months of stress, of anti-police movements, and there is a fine line between addressing police brutality and being anti-police,” Mr. Kettering said, noting that the aforementioned issues have all contributed to the ongoing struggles his fellow officers are experiencing. 

“It’s not a thing for cops to talk about how an event affected them,” he said. “A lot of officers have just shut down. People have careers and pensions to protect, and every time we stop a motorist, something could go wrong, even if we do everything right. There are mixed signals: They tell us, ‘Defend but don’t defend.’” 

His colleague, Mr. Davis, said that officers “need more support from politicians,” noting that he felt particularly insulted by a comment made by a Montgomery County public official who accused the officers present at the Capitol of racism. “And finally, we feel a little betrayed by the public.”
 

More questions than answers from the Capitol’s day of chaos

What about the events of Jan. 6 led to the suicides of four law enforcement officers and what can be done to prevent more deaths in the future? There are the individual factors of each man’s personal history, circumstances, and vulnerabilities, including the sense of being personally endangered, witnessing trauma, and direct injury – one officer who died of suicide had sustained a head injury that day.

We don’t know if the officers went into the event with preexisting mental illness or addiction or if the day’s events precipitated psychiatric episodes. And with all the partisan anger surrounding the presidential election, we don’t know if each officer’s political beliefs amplified his distress over what occurred in a social media climate where police are being faulted by all sides.

When multiple suicides occur in a community, there is always concern about a “copycat” phenomena. These concerns are made more difficult to address, however, given the police culture of taboo and stigma associated with getting professional help, difficulty accessing care, and career repercussions for speaking openly about suicidal thoughts and mental health issues.

Finally, there is the current political agenda that leaves officers feeling unsupported, fearful of negative outcomes, and unappreciated. The Capitol siege in particular embodied a great deal of national distress and confusion over basic issues of truth, justice, and perceptions of reality in our polarized society.  

Can we move to a place where those who enforce laws have easy access to treatment, free from stigma? Can we encourage a culture that does not tolerate brutality or racism, while also refusing to label all police as bad and lending support to their mission? Can we be more attuned to the repercussions of circumstances where officers are witnesses to trauma, are endangered themselves, and would benefit from acknowledgment of their distress? 

Time will tell if our anti-police pendulum swings back. In the meantime, these four suicides among people defending our country remain tragically overlooked.
 

Dinah Miller, MD, is coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016). She has a private practice in Baltimore and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University. A version of this article first appeared on Medscape.com.

Officer Scott Davis is a passionate man who thinks and talks quickly. As a member of the Special Events Team for Montgomery County, Maryland, he was already staging in Rockville, outside of Washington, D.C., when the call came in last Jan. 6 to move their unit to the U.S. Capitol. 

Courtesy Scott Davis

“It was surreal,” said Mr. Davis. “There were people from all different groups at the Capitol that day. Many people were trying to get out, but others surrounded us. They called us ‘human race traitors.’ And then I heard someone say, ‘It’s good you brought your shields, we’ll carry your bodies out on them.’”

Mr. Davis described hours of mayhem during which he was hit with bear spray, a brick, a chair, and a metal rod. One of the members of Mr. Davis’ unit remains on leave with a head injury nearly 9 months after the siege.  

“It went on for 3 hours, but it felt like 15 minutes. Then, all of a sudden, it was over.”

For the members of law enforcement at the Capitol that day, the repercussions are still being felt, perhaps most notably in the case of the four officers who subsequently died of suicide. Three of the officers were with the Metropolitan Police Department of the District of Columbia and one worked for the Capitol Police Department.

Police officers are subjected to traumas on a regular basis and often placed in circumstances where their lives are in danger. Yet four suicides within a short time – all connected to a single event – is particularly shocking and tragic, even more so for how little attention it has garnered to date.  
 

What contributes to the high rate of suicide among officers?

Scott Silverii, PhD, a former police officer and author of Broken and Blue: A Policeman’s Guide to Health, Hope, and Healing, commented that he “wouldn’t be surprised if there are more suicides to come.” This stems not only from the experiences of that day but also the elevated risk for suicide that law enforcement officers already experienced prior to the Capitol riots. Suicide remains a rare event, with a national all-population average of 13.9 per 100,000 citizens. But as Dr. Silverii noted, more officers die by suicide each year than are killed in the line of duty. 

“Suicide is a big part of police culture – officers are doers and fixers, and it is seen as being more honorable to take yourself out of the equation than it is to ask for help,” he said. “Most officers come in with past pain, and this is a situation where they are being overwhelmed and under-respected. At the same time, police culture is a closed culture, and it is not friendly to researchers.”

Another contributor is the frequency with which law enforcement officers are exposed to trauma, according to Vernon Herron, Director of Officer Safety and Wellness for the Baltimore City Police. 

“Suicide can be a direct result of trauma, and at some point you just can’t absorb it, and it leads to problems,” Mr. Herron said, citing the psychiatric and addiction issues that officers commonly experience.
 

Protecting the protectors

Mr. Herron and others are working to address these problems head-on.

“We are trying to identify employees exposed to trauma and to offer counseling and intervention,” he said, “Otherwise, everything else will fall short.”

Yet implementing such measures is no easy task, given the lack of a central oversight organization for law enforcement, said Sheldon Greenberg, PhD, a former police officer and professor of management in the School of Education at Johns Hopkins University, Baltimore.

“In the United States there is no such thing as ‘The Police.’ There is no one in a position to set policy, standards, or training mandates nationally,” he said. “There are approximately 18,000 police and sheriff departments in the country, and many of them are small. No one can compel law enforcement agencies to implement officer wellness and suicide prevention programs, make counseling available to officers, or train supervisors and peers to identify suicide ideation.”

Dr. Greenberg said a further barrier to helping police officers considering self-harm is posed by the fact that even if they do seek out counseling, there is no guarantee that it will remain confidential. 

“Support personnel have an obligation to report an officer who is thinking about committing suicide,” he said. “Many officers are concerned about this lack of confidentiality and that they may be branded if they seek help.”

Although Dr. Greenberg said many police officers are self-professed “action junkies,” even their unusually high capacity for stress is often tested by the realities of the job.  

“Increasing demands for service, shortages of personnel, misinformation about police, COVID-19, talk about restructuring policing with little concrete direction, increased exposure to violence, greater numbers of vulnerable people, and more take a toll over time,” he lamented. “In addition, we are in a recruiting crisis in law enforcement, and there are no standards to ensure the quality of psychological screening provided to applicants. Many officers will go through their entire career and never be screened again. We know little about the stresses and strains that officers bring to the job.”
 

After the siege

It is not clear how many police officers were present at the Capitol on Jan. 6. During the chaos of the day, reinforcements to the Capitol Police Department arrived from Washington D.C., Maryland, and Virginia, but no official numbers on responders were obtained; Mr. Davis thought it was likely that there were at least 1,000 law enforcement officers present. Those who did respond sustained an estimated 100 injuries, including an officer who died the next day. Of the officers who died by suicide, one died 3 days after, another died 9 days later, and two more died in July – numbers that contradict the notion that this is some coincidence. Officer Alexander Kettering, a colleague of Mr. Davis who has been with Montgomery County Police for 15 years, was among those tasked with protecting the Capitol on Jan. 6. The chaos, violence, and destruction of the day has stuck with him and continues to occupy his thoughts.

“I had a front-row seat to the whole thing. It was overwhelming, and I’ve never seen people this angry,” said Mr. Kettering. “There were people up on the veranda and on the scaffolding set up for the inauguration. They were smashing windows and throwing things into the crowd. It was insane. There were decent people coming up to us and saying they would pray for us, then others calling us traitors, telling us to stand down and join them.”

In the aftermath of the Capitol siege, Mr. Kettering watched in dismay as the narrative of the day’s events began to warp.

“At first there was a consensus that what happened was so wrong, and then the politics took over. People were saying it wasn’t as bad as the media said, that it really wasn’t that violent and those speaking out are traitors or political operatives. I relive it every day, and it’s hard to escape, even in casual conversation.”

He added that the days’ events were compounded by the already heightened tensions surrounding the national debate around policing.

“It’s been 18 months of stress, of anti-police movements, and there is a fine line between addressing police brutality and being anti-police,” Mr. Kettering said, noting that the aforementioned issues have all contributed to the ongoing struggles his fellow officers are experiencing. 

“It’s not a thing for cops to talk about how an event affected them,” he said. “A lot of officers have just shut down. People have careers and pensions to protect, and every time we stop a motorist, something could go wrong, even if we do everything right. There are mixed signals: They tell us, ‘Defend but don’t defend.’” 

His colleague, Mr. Davis, said that officers “need more support from politicians,” noting that he felt particularly insulted by a comment made by a Montgomery County public official who accused the officers present at the Capitol of racism. “And finally, we feel a little betrayed by the public.”
 

More questions than answers from the Capitol’s day of chaos

What about the events of Jan. 6 led to the suicides of four law enforcement officers and what can be done to prevent more deaths in the future? There are the individual factors of each man’s personal history, circumstances, and vulnerabilities, including the sense of being personally endangered, witnessing trauma, and direct injury – one officer who died of suicide had sustained a head injury that day.

We don’t know if the officers went into the event with preexisting mental illness or addiction or if the day’s events precipitated psychiatric episodes. And with all the partisan anger surrounding the presidential election, we don’t know if each officer’s political beliefs amplified his distress over what occurred in a social media climate where police are being faulted by all sides.

When multiple suicides occur in a community, there is always concern about a “copycat” phenomena. These concerns are made more difficult to address, however, given the police culture of taboo and stigma associated with getting professional help, difficulty accessing care, and career repercussions for speaking openly about suicidal thoughts and mental health issues.

Finally, there is the current political agenda that leaves officers feeling unsupported, fearful of negative outcomes, and unappreciated. The Capitol siege in particular embodied a great deal of national distress and confusion over basic issues of truth, justice, and perceptions of reality in our polarized society.  

Can we move to a place where those who enforce laws have easy access to treatment, free from stigma? Can we encourage a culture that does not tolerate brutality or racism, while also refusing to label all police as bad and lending support to their mission? Can we be more attuned to the repercussions of circumstances where officers are witnesses to trauma, are endangered themselves, and would benefit from acknowledgment of their distress? 

Time will tell if our anti-police pendulum swings back. In the meantime, these four suicides among people defending our country remain tragically overlooked.
 

Dinah Miller, MD, is coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016). She has a private practice in Baltimore and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University. A version of this article first appeared on Medscape.com.

Officer Scott Davis is a passionate man who thinks and talks quickly. As a member of the Special Events Team for Montgomery County, Maryland, he was already staging in Rockville, outside of Washington, D.C., when the call came in last Jan. 6 to move their unit to the U.S. Capitol. 

Courtesy Scott Davis

“It was surreal,” said Mr. Davis. “There were people from all different groups at the Capitol that day. Many people were trying to get out, but others surrounded us. They called us ‘human race traitors.’ And then I heard someone say, ‘It’s good you brought your shields, we’ll carry your bodies out on them.’”

Mr. Davis described hours of mayhem during which he was hit with bear spray, a brick, a chair, and a metal rod. One of the members of Mr. Davis’ unit remains on leave with a head injury nearly 9 months after the siege.  

“It went on for 3 hours, but it felt like 15 minutes. Then, all of a sudden, it was over.”

For the members of law enforcement at the Capitol that day, the repercussions are still being felt, perhaps most notably in the case of the four officers who subsequently died of suicide. Three of the officers were with the Metropolitan Police Department of the District of Columbia and one worked for the Capitol Police Department.

Police officers are subjected to traumas on a regular basis and often placed in circumstances where their lives are in danger. Yet four suicides within a short time – all connected to a single event – is particularly shocking and tragic, even more so for how little attention it has garnered to date.  
 

What contributes to the high rate of suicide among officers?

Scott Silverii, PhD, a former police officer and author of Broken and Blue: A Policeman’s Guide to Health, Hope, and Healing, commented that he “wouldn’t be surprised if there are more suicides to come.” This stems not only from the experiences of that day but also the elevated risk for suicide that law enforcement officers already experienced prior to the Capitol riots. Suicide remains a rare event, with a national all-population average of 13.9 per 100,000 citizens. But as Dr. Silverii noted, more officers die by suicide each year than are killed in the line of duty. 

“Suicide is a big part of police culture – officers are doers and fixers, and it is seen as being more honorable to take yourself out of the equation than it is to ask for help,” he said. “Most officers come in with past pain, and this is a situation where they are being overwhelmed and under-respected. At the same time, police culture is a closed culture, and it is not friendly to researchers.”

Another contributor is the frequency with which law enforcement officers are exposed to trauma, according to Vernon Herron, Director of Officer Safety and Wellness for the Baltimore City Police. 

“Suicide can be a direct result of trauma, and at some point you just can’t absorb it, and it leads to problems,” Mr. Herron said, citing the psychiatric and addiction issues that officers commonly experience.
 

Protecting the protectors

Mr. Herron and others are working to address these problems head-on.

“We are trying to identify employees exposed to trauma and to offer counseling and intervention,” he said, “Otherwise, everything else will fall short.”

Yet implementing such measures is no easy task, given the lack of a central oversight organization for law enforcement, said Sheldon Greenberg, PhD, a former police officer and professor of management in the School of Education at Johns Hopkins University, Baltimore.

“In the United States there is no such thing as ‘The Police.’ There is no one in a position to set policy, standards, or training mandates nationally,” he said. “There are approximately 18,000 police and sheriff departments in the country, and many of them are small. No one can compel law enforcement agencies to implement officer wellness and suicide prevention programs, make counseling available to officers, or train supervisors and peers to identify suicide ideation.”

Dr. Greenberg said a further barrier to helping police officers considering self-harm is posed by the fact that even if they do seek out counseling, there is no guarantee that it will remain confidential. 

“Support personnel have an obligation to report an officer who is thinking about committing suicide,” he said. “Many officers are concerned about this lack of confidentiality and that they may be branded if they seek help.”

Although Dr. Greenberg said many police officers are self-professed “action junkies,” even their unusually high capacity for stress is often tested by the realities of the job.  

“Increasing demands for service, shortages of personnel, misinformation about police, COVID-19, talk about restructuring policing with little concrete direction, increased exposure to violence, greater numbers of vulnerable people, and more take a toll over time,” he lamented. “In addition, we are in a recruiting crisis in law enforcement, and there are no standards to ensure the quality of psychological screening provided to applicants. Many officers will go through their entire career and never be screened again. We know little about the stresses and strains that officers bring to the job.”
 

After the siege

It is not clear how many police officers were present at the Capitol on Jan. 6. During the chaos of the day, reinforcements to the Capitol Police Department arrived from Washington D.C., Maryland, and Virginia, but no official numbers on responders were obtained; Mr. Davis thought it was likely that there were at least 1,000 law enforcement officers present. Those who did respond sustained an estimated 100 injuries, including an officer who died the next day. Of the officers who died by suicide, one died 3 days after, another died 9 days later, and two more died in July – numbers that contradict the notion that this is some coincidence. Officer Alexander Kettering, a colleague of Mr. Davis who has been with Montgomery County Police for 15 years, was among those tasked with protecting the Capitol on Jan. 6. The chaos, violence, and destruction of the day has stuck with him and continues to occupy his thoughts.

“I had a front-row seat to the whole thing. It was overwhelming, and I’ve never seen people this angry,” said Mr. Kettering. “There were people up on the veranda and on the scaffolding set up for the inauguration. They were smashing windows and throwing things into the crowd. It was insane. There were decent people coming up to us and saying they would pray for us, then others calling us traitors, telling us to stand down and join them.”

In the aftermath of the Capitol siege, Mr. Kettering watched in dismay as the narrative of the day’s events began to warp.

“At first there was a consensus that what happened was so wrong, and then the politics took over. People were saying it wasn’t as bad as the media said, that it really wasn’t that violent and those speaking out are traitors or political operatives. I relive it every day, and it’s hard to escape, even in casual conversation.”

He added that the days’ events were compounded by the already heightened tensions surrounding the national debate around policing.

“It’s been 18 months of stress, of anti-police movements, and there is a fine line between addressing police brutality and being anti-police,” Mr. Kettering said, noting that the aforementioned issues have all contributed to the ongoing struggles his fellow officers are experiencing. 

“It’s not a thing for cops to talk about how an event affected them,” he said. “A lot of officers have just shut down. People have careers and pensions to protect, and every time we stop a motorist, something could go wrong, even if we do everything right. There are mixed signals: They tell us, ‘Defend but don’t defend.’” 

His colleague, Mr. Davis, said that officers “need more support from politicians,” noting that he felt particularly insulted by a comment made by a Montgomery County public official who accused the officers present at the Capitol of racism. “And finally, we feel a little betrayed by the public.”
 

More questions than answers from the Capitol’s day of chaos

What about the events of Jan. 6 led to the suicides of four law enforcement officers and what can be done to prevent more deaths in the future? There are the individual factors of each man’s personal history, circumstances, and vulnerabilities, including the sense of being personally endangered, witnessing trauma, and direct injury – one officer who died of suicide had sustained a head injury that day.

We don’t know if the officers went into the event with preexisting mental illness or addiction or if the day’s events precipitated psychiatric episodes. And with all the partisan anger surrounding the presidential election, we don’t know if each officer’s political beliefs amplified his distress over what occurred in a social media climate where police are being faulted by all sides.

When multiple suicides occur in a community, there is always concern about a “copycat” phenomena. These concerns are made more difficult to address, however, given the police culture of taboo and stigma associated with getting professional help, difficulty accessing care, and career repercussions for speaking openly about suicidal thoughts and mental health issues.

Finally, there is the current political agenda that leaves officers feeling unsupported, fearful of negative outcomes, and unappreciated. The Capitol siege in particular embodied a great deal of national distress and confusion over basic issues of truth, justice, and perceptions of reality in our polarized society.  

Can we move to a place where those who enforce laws have easy access to treatment, free from stigma? Can we encourage a culture that does not tolerate brutality or racism, while also refusing to label all police as bad and lending support to their mission? Can we be more attuned to the repercussions of circumstances where officers are witnesses to trauma, are endangered themselves, and would benefit from acknowledgment of their distress? 

Time will tell if our anti-police pendulum swings back. In the meantime, these four suicides among people defending our country remain tragically overlooked.
 

Dinah Miller, MD, is coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016). She has a private practice in Baltimore and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University. A version of this article first appeared on Medscape.com.

As governors and legislatures in states such as Texas, Florida, South Carolina, and Arkansas have banned schools and other entities from implementing mask mandates, disability rights advocates have pushed back. In federal civil rights lawsuits, they argue that bans on mask mandates violate antidiscrimination laws protecting people with disabilities.

OsakaWayne Studios/Moment

For unvaccinated and immunosuppressed individuals, masks can provide crucial protection from SARS-CoV-2.

People who are immunocompromised can harness the power of the Americans With Disabilities Act to fight against bans on mask mandates and protect themselves in their workplaces, argues Mical Raz, MD, PhD, a professor at the University of Rochester (N.Y.) and a physician at Strong Memorial Hospital, also in Rochester, New York, in an article published in JAMA with coauthor Doron Dorfman, LLB, JSD.

This news organization talked with Dr. Raz about approaching mask requirements as disability accommodation during the COVID-19 pandemic. The following interview was lightly edited for length and clarity.
 

How did you come to think about mask requirements as a form of disability accommodation?

I saw a tweet from a professor at a university who said they couldn’t ask students about their vaccination status or to wear a mask. All agency was removed from the professor to take care of and protect themselves. I thought, well, that can’t be right. And ostensibly, that would be particularly dangerous for somebody with immunosuppression for whom the vaccine is not adequately protective. So, I called my friend, Doron Dorfman, and asked him to help me think through the legal part of this. We fleshed it out and wrote the article that same night.
 

How novel is it to view accommodations for people who are immunosuppressed through the lens of disability accommodation?

I think there has not been enough focus during the pandemic on individuals with disabilities or on how disability law can be mobilized during this pandemic to help supplement the public health law. This framework should be used a lot more because it’s good for everybody, not just for individuals with disabilities.

For example, take what’s called the “curb effect.” If you expand sidewalks, yes, it helps individuals who use a wheelchair. But it also helps me as a mom with a stroller. It helps somebody with a shopping cart, or a kid with a bike. If we adopt policies that are inclusive to those who are disadvantaged, it’s good for everybody. We should always strive to be an inclusive society, not just because it’s the right thing to do but because it really makes our society better.
 

How can mask requirements be used as a form of disability accommodation, as you argue in the JAMA article?

The ADA requires employers to provide reasonable accommodations for disability. In this case, the disability is your immunosuppressive status. We have an abundance of evidence showing individuals who are immunocompromised and vaccinated are still inadequately protected from the SARS-CoV-2 virus. So, there is absolute data to show individuals with immunosuppression have a disability that requires accommodation.

The ADA has a mandate requiring employers to adjust or modify policies in order to accommodate a disability. There are certain situations in which you cannot or do not need to accommodate a disability, when it would fundamentally alter the kind of employment you offer or if it’s an undue burden or hardship. But given that we’ve been wearing masks and working remotely for a year now, arguing that somehow these accommodations are no longer possible seems disingenuous.

In that way, allowing a person who’s immunocompromised to require those around them to mask is a form of modified protective policies. And in this case, those policies line up with a public health good, masking in the face of the highly contagious Delta variant ravaging our country right now.
 

In your view, can this argument be used in the mask debates happening right now across the country?

This argument can and should be useful for a couple of different lawsuits that are now underway in different states. I hope our article will provide further support for those suits. And I hope in school board hearings, when parents and teachers are talking about their concerns, this could be one way to argue for why we should allow mask mandates in classes. I’ve received emails from parents who said they’re going to bring this article to their school board hearing.

I also hope this could shift the narrative around the pandemic. Instead of focusing on individual responsibility – I got my vaccine shot so I’m fine – let’s focus on how we create an inclusive environment where we protect everybody, including those who cannot be vaccinated because of age or disability, or those who are vaccinated but inadequately protected because of their underlying conditions.
 

In the JAMA article, you talk about how our pandemic response has focused on individual health and how that individual focus can be ableist. Can you explain that point?

I think this idea that we just make our choices – like whether to get vaccinated or wear a mask, or not – and live with it really perpetuates a highly individualistic and ableist mindset. It doesn’t consider the people I admit to the hospital who are vaccinated but have a heart transplant and didn’t mount the sufficient immune response. Or even the people who chose not to be vaccinated because they were exposed to hours and hours of misinformation on TV.

We like to individualize everything, focusing on personal responsibility and choices, but a pandemic is one of those moments where everybody’s choices affect everybody else. Laying responsibility at the doorstep of each person, rather than thinking about what steps we as a society could be taking, is cheap and politically expedient. There is no public health rationale behind the bans on mask requirements in states like Texas, Iowa, and Florida. These choices are about politics. And the price is always borne by the most disadvantaged among us.

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

As governors and legislatures in states such as Texas, Florida, South Carolina, and Arkansas have banned schools and other entities from implementing mask mandates, disability rights advocates have pushed back. In federal civil rights lawsuits, they argue that bans on mask mandates violate antidiscrimination laws protecting people with disabilities.

OsakaWayne Studios/Moment

For unvaccinated and immunosuppressed individuals, masks can provide crucial protection from SARS-CoV-2.

People who are immunocompromised can harness the power of the Americans With Disabilities Act to fight against bans on mask mandates and protect themselves in their workplaces, argues Mical Raz, MD, PhD, a professor at the University of Rochester (N.Y.) and a physician at Strong Memorial Hospital, also in Rochester, New York, in an article published in JAMA with coauthor Doron Dorfman, LLB, JSD.

This news organization talked with Dr. Raz about approaching mask requirements as disability accommodation during the COVID-19 pandemic. The following interview was lightly edited for length and clarity.
 

How did you come to think about mask requirements as a form of disability accommodation?

I saw a tweet from a professor at a university who said they couldn’t ask students about their vaccination status or to wear a mask. All agency was removed from the professor to take care of and protect themselves. I thought, well, that can’t be right. And ostensibly, that would be particularly dangerous for somebody with immunosuppression for whom the vaccine is not adequately protective. So, I called my friend, Doron Dorfman, and asked him to help me think through the legal part of this. We fleshed it out and wrote the article that same night.
 

How novel is it to view accommodations for people who are immunosuppressed through the lens of disability accommodation?

I think there has not been enough focus during the pandemic on individuals with disabilities or on how disability law can be mobilized during this pandemic to help supplement the public health law. This framework should be used a lot more because it’s good for everybody, not just for individuals with disabilities.

For example, take what’s called the “curb effect.” If you expand sidewalks, yes, it helps individuals who use a wheelchair. But it also helps me as a mom with a stroller. It helps somebody with a shopping cart, or a kid with a bike. If we adopt policies that are inclusive to those who are disadvantaged, it’s good for everybody. We should always strive to be an inclusive society, not just because it’s the right thing to do but because it really makes our society better.
 

How can mask requirements be used as a form of disability accommodation, as you argue in the JAMA article?

The ADA requires employers to provide reasonable accommodations for disability. In this case, the disability is your immunosuppressive status. We have an abundance of evidence showing individuals who are immunocompromised and vaccinated are still inadequately protected from the SARS-CoV-2 virus. So, there is absolute data to show individuals with immunosuppression have a disability that requires accommodation.

The ADA has a mandate requiring employers to adjust or modify policies in order to accommodate a disability. There are certain situations in which you cannot or do not need to accommodate a disability, when it would fundamentally alter the kind of employment you offer or if it’s an undue burden or hardship. But given that we’ve been wearing masks and working remotely for a year now, arguing that somehow these accommodations are no longer possible seems disingenuous.

In that way, allowing a person who’s immunocompromised to require those around them to mask is a form of modified protective policies. And in this case, those policies line up with a public health good, masking in the face of the highly contagious Delta variant ravaging our country right now.
 

In your view, can this argument be used in the mask debates happening right now across the country?

This argument can and should be useful for a couple of different lawsuits that are now underway in different states. I hope our article will provide further support for those suits. And I hope in school board hearings, when parents and teachers are talking about their concerns, this could be one way to argue for why we should allow mask mandates in classes. I’ve received emails from parents who said they’re going to bring this article to their school board hearing.

I also hope this could shift the narrative around the pandemic. Instead of focusing on individual responsibility – I got my vaccine shot so I’m fine – let’s focus on how we create an inclusive environment where we protect everybody, including those who cannot be vaccinated because of age or disability, or those who are vaccinated but inadequately protected because of their underlying conditions.
 

In the JAMA article, you talk about how our pandemic response has focused on individual health and how that individual focus can be ableist. Can you explain that point?

I think this idea that we just make our choices – like whether to get vaccinated or wear a mask, or not – and live with it really perpetuates a highly individualistic and ableist mindset. It doesn’t consider the people I admit to the hospital who are vaccinated but have a heart transplant and didn’t mount the sufficient immune response. Or even the people who chose not to be vaccinated because they were exposed to hours and hours of misinformation on TV.

We like to individualize everything, focusing on personal responsibility and choices, but a pandemic is one of those moments where everybody’s choices affect everybody else. Laying responsibility at the doorstep of each person, rather than thinking about what steps we as a society could be taking, is cheap and politically expedient. There is no public health rationale behind the bans on mask requirements in states like Texas, Iowa, and Florida. These choices are about politics. And the price is always borne by the most disadvantaged among us.

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

As governors and legislatures in states such as Texas, Florida, South Carolina, and Arkansas have banned schools and other entities from implementing mask mandates, disability rights advocates have pushed back. In federal civil rights lawsuits, they argue that bans on mask mandates violate antidiscrimination laws protecting people with disabilities.

OsakaWayne Studios/Moment

For unvaccinated and immunosuppressed individuals, masks can provide crucial protection from SARS-CoV-2.

People who are immunocompromised can harness the power of the Americans With Disabilities Act to fight against bans on mask mandates and protect themselves in their workplaces, argues Mical Raz, MD, PhD, a professor at the University of Rochester (N.Y.) and a physician at Strong Memorial Hospital, also in Rochester, New York, in an article published in JAMA with coauthor Doron Dorfman, LLB, JSD.

This news organization talked with Dr. Raz about approaching mask requirements as disability accommodation during the COVID-19 pandemic. The following interview was lightly edited for length and clarity.
 

How did you come to think about mask requirements as a form of disability accommodation?

I saw a tweet from a professor at a university who said they couldn’t ask students about their vaccination status or to wear a mask. All agency was removed from the professor to take care of and protect themselves. I thought, well, that can’t be right. And ostensibly, that would be particularly dangerous for somebody with immunosuppression for whom the vaccine is not adequately protective. So, I called my friend, Doron Dorfman, and asked him to help me think through the legal part of this. We fleshed it out and wrote the article that same night.
 

How novel is it to view accommodations for people who are immunosuppressed through the lens of disability accommodation?

I think there has not been enough focus during the pandemic on individuals with disabilities or on how disability law can be mobilized during this pandemic to help supplement the public health law. This framework should be used a lot more because it’s good for everybody, not just for individuals with disabilities.

For example, take what’s called the “curb effect.” If you expand sidewalks, yes, it helps individuals who use a wheelchair. But it also helps me as a mom with a stroller. It helps somebody with a shopping cart, or a kid with a bike. If we adopt policies that are inclusive to those who are disadvantaged, it’s good for everybody. We should always strive to be an inclusive society, not just because it’s the right thing to do but because it really makes our society better.
 

How can mask requirements be used as a form of disability accommodation, as you argue in the JAMA article?

The ADA requires employers to provide reasonable accommodations for disability. In this case, the disability is your immunosuppressive status. We have an abundance of evidence showing individuals who are immunocompromised and vaccinated are still inadequately protected from the SARS-CoV-2 virus. So, there is absolute data to show individuals with immunosuppression have a disability that requires accommodation.

The ADA has a mandate requiring employers to adjust or modify policies in order to accommodate a disability. There are certain situations in which you cannot or do not need to accommodate a disability, when it would fundamentally alter the kind of employment you offer or if it’s an undue burden or hardship. But given that we’ve been wearing masks and working remotely for a year now, arguing that somehow these accommodations are no longer possible seems disingenuous.

In that way, allowing a person who’s immunocompromised to require those around them to mask is a form of modified protective policies. And in this case, those policies line up with a public health good, masking in the face of the highly contagious Delta variant ravaging our country right now.
 

In your view, can this argument be used in the mask debates happening right now across the country?

This argument can and should be useful for a couple of different lawsuits that are now underway in different states. I hope our article will provide further support for those suits. And I hope in school board hearings, when parents and teachers are talking about their concerns, this could be one way to argue for why we should allow mask mandates in classes. I’ve received emails from parents who said they’re going to bring this article to their school board hearing.

I also hope this could shift the narrative around the pandemic. Instead of focusing on individual responsibility – I got my vaccine shot so I’m fine – let’s focus on how we create an inclusive environment where we protect everybody, including those who cannot be vaccinated because of age or disability, or those who are vaccinated but inadequately protected because of their underlying conditions.
 

In the JAMA article, you talk about how our pandemic response has focused on individual health and how that individual focus can be ableist. Can you explain that point?

I think this idea that we just make our choices – like whether to get vaccinated or wear a mask, or not – and live with it really perpetuates a highly individualistic and ableist mindset. It doesn’t consider the people I admit to the hospital who are vaccinated but have a heart transplant and didn’t mount the sufficient immune response. Or even the people who chose not to be vaccinated because they were exposed to hours and hours of misinformation on TV.

We like to individualize everything, focusing on personal responsibility and choices, but a pandemic is one of those moments where everybody’s choices affect everybody else. Laying responsibility at the doorstep of each person, rather than thinking about what steps we as a society could be taking, is cheap and politically expedient. There is no public health rationale behind the bans on mask requirements in states like Texas, Iowa, and Florida. These choices are about politics. And the price is always borne by the most disadvantaged among us.

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

After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.

During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.

We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.

Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
 

This kind of abuse is persistent

Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.

Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.

Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.

These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
 

COVID and the increase in violence against health care workers

The specter of COVID-19 has not only increased the problem of violence toward health care workers but has accelerated it at an alarming rate. As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.

In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.

This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.

The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
 

Standing united against health care worker abuse

Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.

First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.

In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.

HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.

Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.

The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.

Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.

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

After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.

During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.

We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.

Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
 

This kind of abuse is persistent

Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.

Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.

Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.

These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
 

COVID and the increase in violence against health care workers

The specter of COVID-19 has not only increased the problem of violence toward health care workers but has accelerated it at an alarming rate. As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.

In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.

This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.

The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
 

Standing united against health care worker abuse

Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.

First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.

In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.

HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.

Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.

The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.

Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.

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

After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.

During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.

We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.

Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
 

This kind of abuse is persistent

Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.

Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.

Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.

These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
 

COVID and the increase in violence against health care workers

The specter of COVID-19 has not only increased the problem of violence toward health care workers but has accelerated it at an alarming rate. As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.

In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.

This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.

The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
 

Standing united against health care worker abuse

Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.

First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.

In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.

HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.

Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.

The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.

Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.

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