CHEST Physician

Lower doses of linezolid in the BPaL drug regimen (bedaquiline, pretomanid, and linezolid) significantly reduce the adverse events associated with the treatment for patients with highly drug-resistant tuberculosis (TB) without compromising its high efficacy, new research shows.

“The ZeNix trial shows that reduced doses and/or shorter durations of linezolid appear to have high efficacy and improved safety,” said first author Francesca Conradie, MB, BCh, of the clinical HIV research unit, faculty of health sciences, University of Witwatersrand, Johannesburg, South Africa, in presenting the findings at the virtual meeting of the International AIDS Society conference.

As recently reported in the pivotal Nix-TB trial, the BPaL regimen yielded a 90% treatment success rate among people with highly drug-resistant forms of TB.

However, a 6-month regimen that included linezolid 1,200 mg resulted in toxic effects: 81% of patients in the study experienced peripheral neuropathy, and myelosuppression occurred in 48%. These effects often led to dose reductions or treatment interruption.

Adjustments in the dose of linezolid in the new ZeNix trial substantially reduced peripheral neuropathy to 13% and myelosuppression to 7%, with no significant reduction in the treatment response.

Importantly, the results were similar among patients with and those without HIV. This is of note because TB is the leading cause of death among patients with HIV.

“In the ZeNix trial, only 20% of patients were HIV infected, but in the [previous] Nix-TB trial, 30% were infected, so we have experience now in about 70 patients who were infected, and the outcomes were no different,” Dr. Conradie said in an interview.

Experts say the findings represent an important turn in the steep challenge of tackling highly resistant TB.

“In our opinion, these are exciting results that could change treatment guidelines for highly drug-resistant tuberculosis, with real benefits for the patients,” said Hendrik Streeck, MD, International AIDS Society cochair and director of the Institute of Virology and the Institute for HIV Research at the University Bonn (Germany), in a press conference.

Payam Nahid, MD, MPH, director of the Center for Tuberculosis at theUniversity of California, San Francisco, agreed.

“The results of this trial will impact global practices in treating drug-resistant TB as well as the design and conduct of future TB clinical trials,” Dr. Nahid said in an interview.
 

ZeNix trial

The phase 3 ZeNix trial included 181 patients with highly resistant TB in South Africa, Russia, Georgia, and Moldova. The mean age of the patients was 37 years; 67.4% were men, 63.5% were White, and 19.9% were HIV positive.

All patients were treated for 6 months with bedaquiline 200 mg daily for 8 weeks followed by 100 mg daily for 18 weeks, as well as pretomanid 200 mg daily.

The patients were randomly assigned to receive one of four daily doses of linezolid: 1,200 mg for 6 months (the original dose from the Nix-TB trial; n = 45) or 2 months (n = 46), or 600 mg for 6 or 2 months (45 patients each).

Percentages of patients with HIV were equal among the four groups, at about 20% each.

The primary outcomes – resolution of clinical disease and a negative culture status after 6 months – were observed across all linezolid dose groups. The success rate was 93% for those receiving 1,200 mg for 6 months, 89% for those receiving 1,200 mg for 2 months, 91% for those receiving 600 mg for 6 months, and 84% for those receiving 600 mg for 2 months.

With regard to the key adverse events of peripheral neuropathy and myelosuppression, manifested as anemia, the highest rates were among those who received linezolid 1,200 mg for 6 month, at 38% and 22%, respectively, compared with 24% and 17.4% among those who received 1,200 mg for 2 months, 24% and 2% among those who received 600 mg for 6 months, and 13% and 6.7% among those who received 600 mg for 2 months.

Four cases of optic neuropathy occurred among those who received 1,200 mg for 6 months; all cases resolved.

Patients who received 1,200 mg for 6 months required the highest number of linezolid dose modifications; 51% required changes that included reduction, interruption, or discontinuation, compared with 28% among those who received 1,200 mg for 2 months and 13% each in the other two groups.

On the basis of these results, “my personal opinion is that 600 mg at 6 months [of linezolid] is most likely the best strategy for the treatment of this highly resistant treatment population group,” Dr. Conradie told this news organization.
 

Findings represent ‘great news’ in addressing concerns

Dr. Nahid further commented that the results are highly encouraging in light of the ongoing concerns about the effects of linezolid in the BPaL regimen.

“This is great news,” he said. “The ZeNix trial addresses a key concern that providers and patients have had regarding the safety and tolerability of taking 6 months of linezolid at 1200 mg/d as part of the BPaL regimen.

“The findings that doses lower and durations shorter than the current 1,200 mg linezolid daily for 6 months will significantly expand the usability of the BPaL regimen worldwide.”

The inclusion of patients with HIV was essential in the trial, he noted.

“There are drug-drug interactions to be considered, among other factors that impact drug exposure,” Dr. Nahid said.

“Inclusion of patients living with HIV in this study means that any modifications to the BPaL regimen considered by the WHO [World Health Organization] and other policy decision makers will include data from this key population,” he said. “Of course, more data are needed on safety, tolerability, and efficacy on BPaL in general, and there are international cohorts and demonstration projects underway that will enhance our understanding of the regimen in HIV and in other special populations.”

The authors, Dr. Streeck, and Dr. Nahid have disclosed no relevant financial relationships.

This article was updated 7/21/21.

Lower doses of linezolid in the BPaL drug regimen (bedaquiline, pretomanid, and linezolid) significantly reduce the adverse events associated with the treatment for patients with highly drug-resistant tuberculosis (TB) without compromising its high efficacy, new research shows.

“The ZeNix trial shows that reduced doses and/or shorter durations of linezolid appear to have high efficacy and improved safety,” said first author Francesca Conradie, MB, BCh, of the clinical HIV research unit, faculty of health sciences, University of Witwatersrand, Johannesburg, South Africa, in presenting the findings at the virtual meeting of the International AIDS Society conference.

As recently reported in the pivotal Nix-TB trial, the BPaL regimen yielded a 90% treatment success rate among people with highly drug-resistant forms of TB.

However, a 6-month regimen that included linezolid 1,200 mg resulted in toxic effects: 81% of patients in the study experienced peripheral neuropathy, and myelosuppression occurred in 48%. These effects often led to dose reductions or treatment interruption.

Adjustments in the dose of linezolid in the new ZeNix trial substantially reduced peripheral neuropathy to 13% and myelosuppression to 7%, with no significant reduction in the treatment response.

Importantly, the results were similar among patients with and those without HIV. This is of note because TB is the leading cause of death among patients with HIV.

“In the ZeNix trial, only 20% of patients were HIV infected, but in the [previous] Nix-TB trial, 30% were infected, so we have experience now in about 70 patients who were infected, and the outcomes were no different,” Dr. Conradie said in an interview.

Experts say the findings represent an important turn in the steep challenge of tackling highly resistant TB.

“In our opinion, these are exciting results that could change treatment guidelines for highly drug-resistant tuberculosis, with real benefits for the patients,” said Hendrik Streeck, MD, International AIDS Society cochair and director of the Institute of Virology and the Institute for HIV Research at the University Bonn (Germany), in a press conference.

Payam Nahid, MD, MPH, director of the Center for Tuberculosis at theUniversity of California, San Francisco, agreed.

“The results of this trial will impact global practices in treating drug-resistant TB as well as the design and conduct of future TB clinical trials,” Dr. Nahid said in an interview.
 

ZeNix trial

The phase 3 ZeNix trial included 181 patients with highly resistant TB in South Africa, Russia, Georgia, and Moldova. The mean age of the patients was 37 years; 67.4% were men, 63.5% were White, and 19.9% were HIV positive.

All patients were treated for 6 months with bedaquiline 200 mg daily for 8 weeks followed by 100 mg daily for 18 weeks, as well as pretomanid 200 mg daily.

The patients were randomly assigned to receive one of four daily doses of linezolid: 1,200 mg for 6 months (the original dose from the Nix-TB trial; n = 45) or 2 months (n = 46), or 600 mg for 6 or 2 months (45 patients each).

Percentages of patients with HIV were equal among the four groups, at about 20% each.

The primary outcomes – resolution of clinical disease and a negative culture status after 6 months – were observed across all linezolid dose groups. The success rate was 93% for those receiving 1,200 mg for 6 months, 89% for those receiving 1,200 mg for 2 months, 91% for those receiving 600 mg for 6 months, and 84% for those receiving 600 mg for 2 months.

With regard to the key adverse events of peripheral neuropathy and myelosuppression, manifested as anemia, the highest rates were among those who received linezolid 1,200 mg for 6 month, at 38% and 22%, respectively, compared with 24% and 17.4% among those who received 1,200 mg for 2 months, 24% and 2% among those who received 600 mg for 6 months, and 13% and 6.7% among those who received 600 mg for 2 months.

Four cases of optic neuropathy occurred among those who received 1,200 mg for 6 months; all cases resolved.

Patients who received 1,200 mg for 6 months required the highest number of linezolid dose modifications; 51% required changes that included reduction, interruption, or discontinuation, compared with 28% among those who received 1,200 mg for 2 months and 13% each in the other two groups.

On the basis of these results, “my personal opinion is that 600 mg at 6 months [of linezolid] is most likely the best strategy for the treatment of this highly resistant treatment population group,” Dr. Conradie told this news organization.
 

Findings represent ‘great news’ in addressing concerns

Dr. Nahid further commented that the results are highly encouraging in light of the ongoing concerns about the effects of linezolid in the BPaL regimen.

“This is great news,” he said. “The ZeNix trial addresses a key concern that providers and patients have had regarding the safety and tolerability of taking 6 months of linezolid at 1200 mg/d as part of the BPaL regimen.

“The findings that doses lower and durations shorter than the current 1,200 mg linezolid daily for 6 months will significantly expand the usability of the BPaL regimen worldwide.”

The inclusion of patients with HIV was essential in the trial, he noted.

“There are drug-drug interactions to be considered, among other factors that impact drug exposure,” Dr. Nahid said.

“Inclusion of patients living with HIV in this study means that any modifications to the BPaL regimen considered by the WHO [World Health Organization] and other policy decision makers will include data from this key population,” he said. “Of course, more data are needed on safety, tolerability, and efficacy on BPaL in general, and there are international cohorts and demonstration projects underway that will enhance our understanding of the regimen in HIV and in other special populations.”

The authors, Dr. Streeck, and Dr. Nahid have disclosed no relevant financial relationships.

This article was updated 7/21/21.

Lower doses of linezolid in the BPaL drug regimen (bedaquiline, pretomanid, and linezolid) significantly reduce the adverse events associated with the treatment for patients with highly drug-resistant tuberculosis (TB) without compromising its high efficacy, new research shows.

“The ZeNix trial shows that reduced doses and/or shorter durations of linezolid appear to have high efficacy and improved safety,” said first author Francesca Conradie, MB, BCh, of the clinical HIV research unit, faculty of health sciences, University of Witwatersrand, Johannesburg, South Africa, in presenting the findings at the virtual meeting of the International AIDS Society conference.

As recently reported in the pivotal Nix-TB trial, the BPaL regimen yielded a 90% treatment success rate among people with highly drug-resistant forms of TB.

However, a 6-month regimen that included linezolid 1,200 mg resulted in toxic effects: 81% of patients in the study experienced peripheral neuropathy, and myelosuppression occurred in 48%. These effects often led to dose reductions or treatment interruption.

Adjustments in the dose of linezolid in the new ZeNix trial substantially reduced peripheral neuropathy to 13% and myelosuppression to 7%, with no significant reduction in the treatment response.

Importantly, the results were similar among patients with and those without HIV. This is of note because TB is the leading cause of death among patients with HIV.

“In the ZeNix trial, only 20% of patients were HIV infected, but in the [previous] Nix-TB trial, 30% were infected, so we have experience now in about 70 patients who were infected, and the outcomes were no different,” Dr. Conradie said in an interview.

Experts say the findings represent an important turn in the steep challenge of tackling highly resistant TB.

“In our opinion, these are exciting results that could change treatment guidelines for highly drug-resistant tuberculosis, with real benefits for the patients,” said Hendrik Streeck, MD, International AIDS Society cochair and director of the Institute of Virology and the Institute for HIV Research at the University Bonn (Germany), in a press conference.

Payam Nahid, MD, MPH, director of the Center for Tuberculosis at theUniversity of California, San Francisco, agreed.

“The results of this trial will impact global practices in treating drug-resistant TB as well as the design and conduct of future TB clinical trials,” Dr. Nahid said in an interview.
 

ZeNix trial

The phase 3 ZeNix trial included 181 patients with highly resistant TB in South Africa, Russia, Georgia, and Moldova. The mean age of the patients was 37 years; 67.4% were men, 63.5% were White, and 19.9% were HIV positive.

All patients were treated for 6 months with bedaquiline 200 mg daily for 8 weeks followed by 100 mg daily for 18 weeks, as well as pretomanid 200 mg daily.

The patients were randomly assigned to receive one of four daily doses of linezolid: 1,200 mg for 6 months (the original dose from the Nix-TB trial; n = 45) or 2 months (n = 46), or 600 mg for 6 or 2 months (45 patients each).

Percentages of patients with HIV were equal among the four groups, at about 20% each.

The primary outcomes – resolution of clinical disease and a negative culture status after 6 months – were observed across all linezolid dose groups. The success rate was 93% for those receiving 1,200 mg for 6 months, 89% for those receiving 1,200 mg for 2 months, 91% for those receiving 600 mg for 6 months, and 84% for those receiving 600 mg for 2 months.

With regard to the key adverse events of peripheral neuropathy and myelosuppression, manifested as anemia, the highest rates were among those who received linezolid 1,200 mg for 6 month, at 38% and 22%, respectively, compared with 24% and 17.4% among those who received 1,200 mg for 2 months, 24% and 2% among those who received 600 mg for 6 months, and 13% and 6.7% among those who received 600 mg for 2 months.

Four cases of optic neuropathy occurred among those who received 1,200 mg for 6 months; all cases resolved.

Patients who received 1,200 mg for 6 months required the highest number of linezolid dose modifications; 51% required changes that included reduction, interruption, or discontinuation, compared with 28% among those who received 1,200 mg for 2 months and 13% each in the other two groups.

On the basis of these results, “my personal opinion is that 600 mg at 6 months [of linezolid] is most likely the best strategy for the treatment of this highly resistant treatment population group,” Dr. Conradie told this news organization.
 

Findings represent ‘great news’ in addressing concerns

Dr. Nahid further commented that the results are highly encouraging in light of the ongoing concerns about the effects of linezolid in the BPaL regimen.

“This is great news,” he said. “The ZeNix trial addresses a key concern that providers and patients have had regarding the safety and tolerability of taking 6 months of linezolid at 1200 mg/d as part of the BPaL regimen.

“The findings that doses lower and durations shorter than the current 1,200 mg linezolid daily for 6 months will significantly expand the usability of the BPaL regimen worldwide.”

The inclusion of patients with HIV was essential in the trial, he noted.

“There are drug-drug interactions to be considered, among other factors that impact drug exposure,” Dr. Nahid said.

“Inclusion of patients living with HIV in this study means that any modifications to the BPaL regimen considered by the WHO [World Health Organization] and other policy decision makers will include data from this key population,” he said. “Of course, more data are needed on safety, tolerability, and efficacy on BPaL in general, and there are international cohorts and demonstration projects underway that will enhance our understanding of the regimen in HIV and in other special populations.”

The authors, Dr. Streeck, and Dr. Nahid have disclosed no relevant financial relationships.

This article was updated 7/21/21.

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

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

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

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

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.

A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.

Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.

Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.

Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.

Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.

Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.

“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”

Source: Medscape.com

At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.

Results also indicate a favorable safety profile for dupilumab.

James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”

Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.

“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.

More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.

Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”

Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.

“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.

Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.

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

Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.

A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.

Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.

Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.

Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.

Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.

Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.

“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”

Source: Medscape.com

At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.

Results also indicate a favorable safety profile for dupilumab.

James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”

Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.

“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.

More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.

Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”

Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.

“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.

Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.

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

Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.

A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.

Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.

Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.

Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.

Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.

Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.

“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”

Source: Medscape.com

At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.

Results also indicate a favorable safety profile for dupilumab.

James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”

Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.

“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.

More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.

Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”

Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.

“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.

Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.

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

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.