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A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows.

People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.

The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”

The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022. 

Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%. 

Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.

“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.

While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.

A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.

Four coauthors reported receiving grants and personal fees from various sources.

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

COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows.

People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.

The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”

The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022. 

Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%. 

Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.

“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.

While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.

A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.

Four coauthors reported receiving grants and personal fees from various sources.

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

COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows.

People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.

The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”

The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022. 

Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%. 

Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.

“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.

While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.

A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.

Four coauthors reported receiving grants and personal fees from various sources.

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

Treatment with the diabetes drug metformin shows a significant, dose-dependent effect in lowering SARS-CoV-2 viral load within days of administration, according to the latest analysis of the phase 3 COVID-OUT trial. These findings add to a multitude of benefits the drug has been shown to have in COVID infection.

COVID-OUT did not meet its primary endpoint, but it did show important secondary outcomes including a 42% reduction in ED visits and in hospitalizations and/or deaths by day 14, and a 58% reduction in hospitalizations/death by day 28. A further subanalysis has shown a 42% reduction in long COVID, compared with placebo.

“In this phase 3 randomized controlled trial, metformin showed prevention of severe COVID, prevention of long COVID, and an antiviral effect, and this is consistent with other data,” said coauthor Carolyn Bramante, MD, University of Minnesota, Minneapolis, in presenting the findings at the Conference on Retroviruses & Opportunistic Infections.
 

Study details

For the new subanalysis, the authors further evaluated the effects of metformin treatment on SARS-CoV-2 viral load.

A total of 1,323 patients in the study, enrolled at six centers, were randomized to treatment either with metformin 1,000 mg per day on days 2-5 and 1,500 mg per day on days 6 to 14 (n = 187), or to ivermectin 390-470 mcg/kg per day for 3 days (n = 187), fluvoxamine 50 mg twice daily for 14 days, and/or an exact-matching placebo in a 2 x 3 factorial trial design.

The subanalysis on viral load included 483 patients from the trial who were treated with metformin versus 462 who received placebo, who were all enrolled within 3 days of a documented SARS-CoV-2 infection and less than 7 days after symptom onset.

The patients had a median age of 46 years, and all had either overweight or obesity. Only about 2% had diabetes, and only patients considered low-risk were excluded from the trial, including those under age 30 and those with a body mass index under 25.

About half of patients had received a primary vaccine and about 5% had received a vaccine booster. SARS-CoV-2 variants that were prominent during the study included Alpha, Delta, and Omicron.

The viral samples available on days 1, 5, and 10 showed a mean change in viral load from baseline to follow-up; the viral load was significantly lower with metformin versus placebo (–0.64 log10 copies/mL), representing a 4.4-fold greater decrease in viral load with metformin.

The mean rate of undetectable SARS-CoV-2 viral load at day 5 was 49.9% in the metformin group versus 54.6% in the placebo group (odds ratio, 1.235), and the undetectable rate at day 10 was 14.3% in the metformin group and 22.6% in the placebo group (OR, 1.663; P = .003).

An increased antiviral effect corresponded with increases in metformin dosing on days 6 through 14. Furthermore, the antiviral effect became stronger when metformin was started earlier in the course of infection.

Of note, the antiviral effect was more pronounced among those who were not vaccinated (mean, –0.95 log copies/mL), compared with the vaccinated (mean, –0.39 log copies/mL).

The antiviral effect with metformin was similar to that seen with nirmatrelvir at day 5 and was greater than nirmatrelvir at day 10.

No similar relationships in SARS-CoV-2 viral load were observed between ivermectin or fluvoxamine and placebo.

The findings are consistent with results of other recent observational studies, including research showing metformin to be associated with reductions in COVID-19 severity in patients with prediabetes, Dr. Bramante noted.

The authors’ previous analysis looking at long COVID in the COVID-OUT study showed that metformin treatment during acute COVID significantly reduced the risk for a diagnosis of long COVID versus placebo at 300 days following randomization, with a hazard ratio of 0.59 after adjustment for the study drug and vaccination at baseline.

Dr. Bramante noted that metformin’s potential antiviral properties have long been speculated, with some of the earliest research on the drug suggesting less severe outcomes in influenza, and more recently, RNA assays suggesting effects against other RNA viruses, including the Zika virus.

In terms of COVID, Dr. Bramante noted that the drug has plenty of potentially favorable benefits.

“Metformin is very safe and is known to have very few contraindications, so the next steps could be to consider looking at this in terms of a combination therapy,” she said.
 

‘Data from other studies are conflicting’

Commenting on the study, Diane V. Havlir, MD, cautioned that “metformin is currently not recommended in treatment guidelines, [and] data from other studies are conflicting; side effects can be an issue, and the study presented here was in a select population,” she said in an interview.

However, “what is both new and interesting in this presentation is the reduction of viral load, which [was observed] in the samples collected not only on days 1-5, but also days 6-14,” said Dr. Havlir, who is professor and associate chair of clinical research, department of medicine, and chief of the division of HIV, infectious diseases and global medicine and director of the AIDS Research Institute at the University of California, San Francisco.

Key questions the findings raise include whether the results correlate with clinical outcomes or transmission, and whether the findings are generalizable to other populations and settings, Dr. Havlir said.

Ultimately, “we need to continue to pursue all aspects of outpatient treatments for COVID to address questions like these for new and existing agents,” she added.

The trial received funding from the Parsemus Foundation, the Rainwater Charitable Foundation, Fast Grants, and the United Health Group. The authors and Dr. Havlir disclosed no relevant financial relationships.

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

Treatment with the diabetes drug metformin shows a significant, dose-dependent effect in lowering SARS-CoV-2 viral load within days of administration, according to the latest analysis of the phase 3 COVID-OUT trial. These findings add to a multitude of benefits the drug has been shown to have in COVID infection.

COVID-OUT did not meet its primary endpoint, but it did show important secondary outcomes including a 42% reduction in ED visits and in hospitalizations and/or deaths by day 14, and a 58% reduction in hospitalizations/death by day 28. A further subanalysis has shown a 42% reduction in long COVID, compared with placebo.

“In this phase 3 randomized controlled trial, metformin showed prevention of severe COVID, prevention of long COVID, and an antiviral effect, and this is consistent with other data,” said coauthor Carolyn Bramante, MD, University of Minnesota, Minneapolis, in presenting the findings at the Conference on Retroviruses & Opportunistic Infections.
 

Study details

For the new subanalysis, the authors further evaluated the effects of metformin treatment on SARS-CoV-2 viral load.

A total of 1,323 patients in the study, enrolled at six centers, were randomized to treatment either with metformin 1,000 mg per day on days 2-5 and 1,500 mg per day on days 6 to 14 (n = 187), or to ivermectin 390-470 mcg/kg per day for 3 days (n = 187), fluvoxamine 50 mg twice daily for 14 days, and/or an exact-matching placebo in a 2 x 3 factorial trial design.

The subanalysis on viral load included 483 patients from the trial who were treated with metformin versus 462 who received placebo, who were all enrolled within 3 days of a documented SARS-CoV-2 infection and less than 7 days after symptom onset.

The patients had a median age of 46 years, and all had either overweight or obesity. Only about 2% had diabetes, and only patients considered low-risk were excluded from the trial, including those under age 30 and those with a body mass index under 25.

About half of patients had received a primary vaccine and about 5% had received a vaccine booster. SARS-CoV-2 variants that were prominent during the study included Alpha, Delta, and Omicron.

The viral samples available on days 1, 5, and 10 showed a mean change in viral load from baseline to follow-up; the viral load was significantly lower with metformin versus placebo (–0.64 log10 copies/mL), representing a 4.4-fold greater decrease in viral load with metformin.

The mean rate of undetectable SARS-CoV-2 viral load at day 5 was 49.9% in the metformin group versus 54.6% in the placebo group (odds ratio, 1.235), and the undetectable rate at day 10 was 14.3% in the metformin group and 22.6% in the placebo group (OR, 1.663; P = .003).

An increased antiviral effect corresponded with increases in metformin dosing on days 6 through 14. Furthermore, the antiviral effect became stronger when metformin was started earlier in the course of infection.

Of note, the antiviral effect was more pronounced among those who were not vaccinated (mean, –0.95 log copies/mL), compared with the vaccinated (mean, –0.39 log copies/mL).

The antiviral effect with metformin was similar to that seen with nirmatrelvir at day 5 and was greater than nirmatrelvir at day 10.

No similar relationships in SARS-CoV-2 viral load were observed between ivermectin or fluvoxamine and placebo.

The findings are consistent with results of other recent observational studies, including research showing metformin to be associated with reductions in COVID-19 severity in patients with prediabetes, Dr. Bramante noted.

The authors’ previous analysis looking at long COVID in the COVID-OUT study showed that metformin treatment during acute COVID significantly reduced the risk for a diagnosis of long COVID versus placebo at 300 days following randomization, with a hazard ratio of 0.59 after adjustment for the study drug and vaccination at baseline.

Dr. Bramante noted that metformin’s potential antiviral properties have long been speculated, with some of the earliest research on the drug suggesting less severe outcomes in influenza, and more recently, RNA assays suggesting effects against other RNA viruses, including the Zika virus.

In terms of COVID, Dr. Bramante noted that the drug has plenty of potentially favorable benefits.

“Metformin is very safe and is known to have very few contraindications, so the next steps could be to consider looking at this in terms of a combination therapy,” she said.
 

‘Data from other studies are conflicting’

Commenting on the study, Diane V. Havlir, MD, cautioned that “metformin is currently not recommended in treatment guidelines, [and] data from other studies are conflicting; side effects can be an issue, and the study presented here was in a select population,” she said in an interview.

However, “what is both new and interesting in this presentation is the reduction of viral load, which [was observed] in the samples collected not only on days 1-5, but also days 6-14,” said Dr. Havlir, who is professor and associate chair of clinical research, department of medicine, and chief of the division of HIV, infectious diseases and global medicine and director of the AIDS Research Institute at the University of California, San Francisco.

Key questions the findings raise include whether the results correlate with clinical outcomes or transmission, and whether the findings are generalizable to other populations and settings, Dr. Havlir said.

Ultimately, “we need to continue to pursue all aspects of outpatient treatments for COVID to address questions like these for new and existing agents,” she added.

The trial received funding from the Parsemus Foundation, the Rainwater Charitable Foundation, Fast Grants, and the United Health Group. The authors and Dr. Havlir disclosed no relevant financial relationships.

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

Treatment with the diabetes drug metformin shows a significant, dose-dependent effect in lowering SARS-CoV-2 viral load within days of administration, according to the latest analysis of the phase 3 COVID-OUT trial. These findings add to a multitude of benefits the drug has been shown to have in COVID infection.

COVID-OUT did not meet its primary endpoint, but it did show important secondary outcomes including a 42% reduction in ED visits and in hospitalizations and/or deaths by day 14, and a 58% reduction in hospitalizations/death by day 28. A further subanalysis has shown a 42% reduction in long COVID, compared with placebo.

“In this phase 3 randomized controlled trial, metformin showed prevention of severe COVID, prevention of long COVID, and an antiviral effect, and this is consistent with other data,” said coauthor Carolyn Bramante, MD, University of Minnesota, Minneapolis, in presenting the findings at the Conference on Retroviruses & Opportunistic Infections.
 

Study details

For the new subanalysis, the authors further evaluated the effects of metformin treatment on SARS-CoV-2 viral load.

A total of 1,323 patients in the study, enrolled at six centers, were randomized to treatment either with metformin 1,000 mg per day on days 2-5 and 1,500 mg per day on days 6 to 14 (n = 187), or to ivermectin 390-470 mcg/kg per day for 3 days (n = 187), fluvoxamine 50 mg twice daily for 14 days, and/or an exact-matching placebo in a 2 x 3 factorial trial design.

The subanalysis on viral load included 483 patients from the trial who were treated with metformin versus 462 who received placebo, who were all enrolled within 3 days of a documented SARS-CoV-2 infection and less than 7 days after symptom onset.

The patients had a median age of 46 years, and all had either overweight or obesity. Only about 2% had diabetes, and only patients considered low-risk were excluded from the trial, including those under age 30 and those with a body mass index under 25.

About half of patients had received a primary vaccine and about 5% had received a vaccine booster. SARS-CoV-2 variants that were prominent during the study included Alpha, Delta, and Omicron.

The viral samples available on days 1, 5, and 10 showed a mean change in viral load from baseline to follow-up; the viral load was significantly lower with metformin versus placebo (–0.64 log10 copies/mL), representing a 4.4-fold greater decrease in viral load with metformin.

The mean rate of undetectable SARS-CoV-2 viral load at day 5 was 49.9% in the metformin group versus 54.6% in the placebo group (odds ratio, 1.235), and the undetectable rate at day 10 was 14.3% in the metformin group and 22.6% in the placebo group (OR, 1.663; P = .003).

An increased antiviral effect corresponded with increases in metformin dosing on days 6 through 14. Furthermore, the antiviral effect became stronger when metformin was started earlier in the course of infection.

Of note, the antiviral effect was more pronounced among those who were not vaccinated (mean, –0.95 log copies/mL), compared with the vaccinated (mean, –0.39 log copies/mL).

The antiviral effect with metformin was similar to that seen with nirmatrelvir at day 5 and was greater than nirmatrelvir at day 10.

No similar relationships in SARS-CoV-2 viral load were observed between ivermectin or fluvoxamine and placebo.

The findings are consistent with results of other recent observational studies, including research showing metformin to be associated with reductions in COVID-19 severity in patients with prediabetes, Dr. Bramante noted.

The authors’ previous analysis looking at long COVID in the COVID-OUT study showed that metformin treatment during acute COVID significantly reduced the risk for a diagnosis of long COVID versus placebo at 300 days following randomization, with a hazard ratio of 0.59 after adjustment for the study drug and vaccination at baseline.

Dr. Bramante noted that metformin’s potential antiviral properties have long been speculated, with some of the earliest research on the drug suggesting less severe outcomes in influenza, and more recently, RNA assays suggesting effects against other RNA viruses, including the Zika virus.

In terms of COVID, Dr. Bramante noted that the drug has plenty of potentially favorable benefits.

“Metformin is very safe and is known to have very few contraindications, so the next steps could be to consider looking at this in terms of a combination therapy,” she said.
 

‘Data from other studies are conflicting’

Commenting on the study, Diane V. Havlir, MD, cautioned that “metformin is currently not recommended in treatment guidelines, [and] data from other studies are conflicting; side effects can be an issue, and the study presented here was in a select population,” she said in an interview.

However, “what is both new and interesting in this presentation is the reduction of viral load, which [was observed] in the samples collected not only on days 1-5, but also days 6-14,” said Dr. Havlir, who is professor and associate chair of clinical research, department of medicine, and chief of the division of HIV, infectious diseases and global medicine and director of the AIDS Research Institute at the University of California, San Francisco.

Key questions the findings raise include whether the results correlate with clinical outcomes or transmission, and whether the findings are generalizable to other populations and settings, Dr. Havlir said.

Ultimately, “we need to continue to pursue all aspects of outpatient treatments for COVID to address questions like these for new and existing agents,” she added.

The trial received funding from the Parsemus Foundation, the Rainwater Charitable Foundation, Fast Grants, and the United Health Group. The authors and Dr. Havlir disclosed no relevant financial relationships.

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

On June 14, 2017, just before noon, a doctor made an incision near a patient’s groin. Kari Kirk, a representative for the world’s largest medical device company, Medtronic, looked on and began texting her colleague a play-by-play.

“Fixing both legs from the ankles,” she wrote.

It was a fairly common procedure at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, performed to treat blockages in the leg vessels.

Within reach were an array of Medtronic products: tubes with blades attached to shave hardened deposits off of artery walls; stents to widen blood vessels; balloons coated with therapeutic drugs.

Each time a doctor puts a foreign device in someone’s body, it carries a risk of complication, which can include clots or even require amputation. So medical experts, research and even Medtronic’s own device instructions urge doctors to use as few as are necessary.

But, as revealed in Kirk’s text messages, this doctor took an aggressive approach.

“Just used 12 [drug-coated balloons]!!” Kirk texted her colleague.

“Does that mean I owe u $$,” he responded.

“Thats what I’m thinking!!!” she said. “And now 14 balloons?!”

“but only one stent so far??”

“So far!”

As the texting continued, her colleague replied, “U are going to want to start going to the VA all the time.”

The messages, recently unsealed in an ongoing whistleblower lawsuit, give a window into the way money and medicine mingle in the booming business of peripheral artery disease, a condition that afflicts 6.5 million Americans over age 40 and is caused when fatty plaque builds up in arteries, blocking blood flow to the legs.

Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices. This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used.

The suit, filed in 2017 by a sales representative for a competing medical device firm, alleges an illegal kickback scheme between Medtronic and hospital employees. According to the complaint and documents released in the suit, between 2011 and 2018, VA health care workers received steakhouse dinners, Apple electronics, and NASCAR tickets, and in turn, Medtronic secured a lucrative contract with the hospital. Meanwhile, the company’s representatives allegedly “groomed and trained” physicians at the facility, who then deployed the company’s devices even when it was not medically indicated.

Independently from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively. While it’s not uncommon to deploy several devices, a medical expert on the investigation team found that the VA doctors sometimes used more than 15 at a time – one used 33 – deviating from the standard of care.

“It is unconscionable – there can be no valid medically acceptable basis to cram so many devices into a human being,” wrote attorneys representing the whistleblower in legal filings from January 2023. “This is not medical treatment. This is abuse.”

Dr. Kim Hodgson, former president of the Society for Vascular Surgery and an expert retained by the plaintiff, said the findings of the internal review of patient data raise “a high level of concern regarding necessity of treatment provided,” according to case documents.

Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic representative Kirk declined to respond to ProPublica’s request for comment.

The hospital investigation found that amputations increased sixfold in the same time frame as the procedures in question, according to internal emails, but made no conclusion about whether those two things were connected. ProPublica reached out to the VA to ask whether any patients had been harmed.

The VA is “conducting an extensive review of patient care” at the Kansas hospital, “including the number of devices used on patients – to make sure that Veterans were not harmed by any procedures,” press secretary Terrence Hayes said in a statement. So far, the VA’s investigation has found no “quality of care issues,” he said, and the investigation will continue “until every Veteran’s case has been reviewed.” (Read the full statement here.) Neither the department nor the hospital has taken formal action against the medical providers, Hayes said.

The medical group that had a contract with the VA for vascular interventions, Wichita Radiological Group, did not respond to ProPublica’s requests for comment, nor did the doctors named in the suit: Dr. Shaun Gonda, Dr. Bret Winblad, and Dr. Kermit Rust. It is unclear from the case documents which doctors conducted which procedures. Eric Barth, an attorney for the medical group, denied the allegations in recent legal filings, calling the claims “baseless” and the lawsuit a “witch hunt.”

The lawsuit comes amid growing concern about one of these procedures – atherectomies – after researchers and doctors have uncovered patterns of excessive and inappropriate use. Recent research has found that this procedure, a common but costly treatment to shave or laser plaque from blood vessels, is not more effective than cheaper alternatives and may even be associated with a higher risk of complications including amputation. In recent years, several doctors and clinics have been investigated for allegedly taking advantage of Medicare’s reimbursement rates, and one study found that many doctors are resorting to atherectomies in the earliest stages of peripheral artery disease, against best practices that urge noninvasive treatment.

“Atherectomy is important in certain settings. But it’s being used in a way that is entirely inappropriate and it’s largely driven by the incentive structure,” said Dr. Caitlin Hicks, the lead author of the study and an associate professor of surgery at Johns Hopkins University School of Medicine.

Although different payment structures govern the care of veterans, the whistleblower lawsuit alleges that outside physicians, paid hourly by the Dole VA, were motivated to conduct longer and more complex procedures that would earn them higher payment.

Under different circumstances, the patient in the procedure room on that summer day could have been done after 2 hours.

But, 150 minutes in, those Medtronic representatives were still texting. At that point, more than 15 of their vascular devices had been used, including stents, balloons, and those for atherectomy.

“Long case!” Kirk’s colleague texted. “Is it looking ok??”

“It is,” she said. “Thought we were done a few times! Now he’s going back in to cut again!”

A little while later, she texted: “....17!”

He texted back [with laughing emoticons].

Hospital leaders had been scrutinizing the use of these procedures at the Dole VA for years.

In 2017, shortly after Rick Ament was hired to lead the facility, he noticed something was amiss. While the longtime hospital administrator was poring over the finances, he was alarmed to discover that the relatively small Dole VA had one of the most expensive cardiac programs in the country. As Ament dug deeper, he realized vascular interventions were the reason.

“It just did not make sense that the acuity level of our patients would generate such extreme cost variances from the norm,” he testified in December, in a deposition for the whistleblower case. “It was so significant, we needed to get to the bottom of it.”

Ament, a second generation Air Force veteran, quietly assembled a task force to investigate why the facility had purchased so many medical devices for these procedures. After they examined inventory records, calculating the total number of medical devices and the cost of devices per patient, they grew concerned.

“We were more expensive than, I believe it was, the top 10 hospitals in the VA combined,” he said. “My feeling was that we either had very, very bad providers or we had product walking out the door.”

Ament enlisted experts from other VA hospitals to help his team investigate, including an administrative officer who could understand finances and a respected interventional radiologist who could examine records. The task force gathered a list of patients from 2016 to 2018, according to internal emails, and analyzed their medical charts.

According to internal VA documents released through the whistleblower suit, the review found a number of clinical failings: Evidence-based medicine had not been followed in the majority of cases reviewed. Procedures were over-aggressive, treating lesions that should have been left alone. And there was a total disregard for established best practices for treating peripheral artery disease.

One of the experts on the investigative team explained to Ament that while it was not uncommon for doctors to use a couple of devices in one intervention, the total number of devices in many of the procedures at his facility went into the double digits, sometimes five times the expected amount.

In one encounter, a doctor deployed 33 devices in one procedure – 3 atherectomy devices, 9 stents, and 21 balloons.

This use of devices was exorbitant, Ament came to understand. “I want to say the term ‘egregious’ was used,” he testified. “It was kind of like validation, but I really wish I was wrong.”

“Did it make you concerned for patient care?” a lawyer asked during the deposition.

“It did,” Ament replied.

A member of his task force pulled data for veterans who had leg amputations due to vascular disease. Over 5 years, the number of veterans who had amputations increased, from about 6 in 2013 to 38 in 2018, according to internal emails released in the suit. The VA did not respond to ProPublica’s questions about the rise in amputations or whether it was due to complications from the procedures.

Even though Ament testified in December 2022 that he became aware of the excessive use of devices during his investigation that began about 5 years ago, neither he nor the VA have publicly acknowledged these findings outside of the lawsuit. It is unclear whether VA representatives informed the patients whose records were reviewed about their findings. ProPublica reached out to more than half a dozen veteran community groups in the Wichita area and none were aware of the investigation nor the allegations of overuse of vascular procedures at the facility.

The VA says that if its ongoing review finds instances of substandard care, it will reach out to affected patients and inform them about possible complications and benefits they may be entitled to. The press secretary said the review will take several months. Ament declined to respond to ProPublica’s questions, citing the ongoing case.

In 2018, Ament turned over his findings to the criminal division of the VA’s Office of Inspector General. He also shut down interventional radiology procedures at the facility’s catheter lab.

Federal agents separately opened an investigation into the same unit in the facility, looking into allegations of kickbacks.

More than 40 pages of expense reports from Medtronic, revealed in the whistleblower case, show sales representatives treating Dole health care workers to hundreds of meals over several years – lunches at Dempsey’s Biscuit Co.; business meals at the Scotch & Sirloin steakhouse; dinner at Chester’s Chophouse & Wine Bar, price per attendee: $122.39.

Federal agents obtained the receipts.

“Robert J. Dole VAMC employees may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic,” Nathen Howard, a special agent in the VA OIG, wrote in an investigation memo from February 2019.

This kind of relationship could violate VA policy, which forbids federal employees from receiving any gifts, including meals, from people who do business or seek to do business with a federal institution. For health care workers, violating this policy could have serious implications for patients. Numerous studies have shown that even modest industry-sponsored gifts, including meals, may influence prescribing or treatment behavior of health care professionals.

The agents opened their investigation into kickbacks at the Wichita facility in response to the whistleblower lawsuit, which was filed by Thomas Schroeder in 2017. The VA OIG would not confirm or deny whether it was continuing to investigate kickbacks at the facility. The VA did not directly answer ProPublica’s questions about kickbacks at the Dole VA, but it said that every employee must complete an annual ethics training, which covers gift rules.

In recent years, Medtronic has settled a handful of other cases that have alleged kickbacks between company representatives and health care professionals.

In 2018, Medtronic’s subsidiary Covidien paid $13 million to settle claims with the U.S. Department of Justice that it paid kickbacks to health care institutions that used its mechanical blood clot devices. In 2019, the same subsidiary paid $17 million to resolve allegations that it provided in-kind marketing support to doctors using its vein products. And in 2020, Medtronic paid more than $8 million to settle claims that representatives had paid kickbacks to a neurosurgeon, including scores of lavish meals at a restaurant that the doctor owned, to induce him to purchase the company’s medication pumps.

Schroeder’s lawsuit is not the first time Medtronic’s vascular devices were named in an alleged kickback scheme. In early 2015, Medtronic acquired Covidien, and shortly after the merger, its subsidiary ev3 Inc. agreed to pay $1.25 million to resolve allegations that it had paid doctors who were “high volume users” of its atherectomy devices to act as evangelists for the company, and had provided physicians with company shares to participate in clinical trials for their tools.

The whistleblower in this earlier case, a former sales representative for the company, also alleged that the subsidiary was gaming Medicare’s payment system. Hospitals were often hesitant to conduct atherectomy procedures because of the low reimbursement rates. According to the suit, sales representatives encouraged doctors to admit patients for longer stays to reap greater reimbursements and make a profit, even though such stays were often not medically indicated.

“Medical device makers that try to boost their profits by causing patients to be admitted for unnecessary and expensive inpatient hospital stays will be held accountable,” special agent Thomas O’Donnell, from the Office of Inspector General at the U.S. Department of Health and Human Services, said in a press release for the settlement. “Both patients and taxpayers deserve to have medical decisions made based on what is medically appropriate.”

Medtronic spokesperson Xiong said that in each case, the company “cooperated fully with the DOJ to resolve its concerns and, where wrongdoing was found, took appropriate remedial action.”

Seton Hall Law School professor Jacob Elberg, a former assistant U.S. attorney for the District of New Jersey who led its health care and government fraud unit, is concerned by the frequency of such settlements in the last 2 decades. “There are, at this point, real questions as to whether the sanctions imposed by DOJ are sufficient to deter wrongdoing and to lead to meaningful change, especially within the medical device industry.”

Although the Department of Justice has declined to intervene in the lawsuit involving the Dole VA at this time, the case is ongoing and further depositions with Medtronic sales representatives and a former VA employee are scheduled for this month.

VA employees and doctors named in the suit declined to comment or did not respond to ProPublica’s questions about the alleged kickbacks and whether sales representatives may have influenced veterans’ treatment plans. In interviews with federal investigators, according to released transcripts, several of the employees who were questioned denied receiving frequent meals from sales representatives, contradicting Medtronic’s expense reports.

Their statements also stand in contrast to Medtronic representative Kari Kirk’s final text messages during that procedure in June 2017, which ultimately lasted more than 3 hours.

“Now u done??” her colleague asked.

“Just finished,” she texted. “Running to get them lunch!”

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

On June 14, 2017, just before noon, a doctor made an incision near a patient’s groin. Kari Kirk, a representative for the world’s largest medical device company, Medtronic, looked on and began texting her colleague a play-by-play.

“Fixing both legs from the ankles,” she wrote.

It was a fairly common procedure at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, performed to treat blockages in the leg vessels.

Within reach were an array of Medtronic products: tubes with blades attached to shave hardened deposits off of artery walls; stents to widen blood vessels; balloons coated with therapeutic drugs.

Each time a doctor puts a foreign device in someone’s body, it carries a risk of complication, which can include clots or even require amputation. So medical experts, research and even Medtronic’s own device instructions urge doctors to use as few as are necessary.

But, as revealed in Kirk’s text messages, this doctor took an aggressive approach.

“Just used 12 [drug-coated balloons]!!” Kirk texted her colleague.

“Does that mean I owe u $$,” he responded.

“Thats what I’m thinking!!!” she said. “And now 14 balloons?!”

“but only one stent so far??”

“So far!”

As the texting continued, her colleague replied, “U are going to want to start going to the VA all the time.”

The messages, recently unsealed in an ongoing whistleblower lawsuit, give a window into the way money and medicine mingle in the booming business of peripheral artery disease, a condition that afflicts 6.5 million Americans over age 40 and is caused when fatty plaque builds up in arteries, blocking blood flow to the legs.

Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices. This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used.

The suit, filed in 2017 by a sales representative for a competing medical device firm, alleges an illegal kickback scheme between Medtronic and hospital employees. According to the complaint and documents released in the suit, between 2011 and 2018, VA health care workers received steakhouse dinners, Apple electronics, and NASCAR tickets, and in turn, Medtronic secured a lucrative contract with the hospital. Meanwhile, the company’s representatives allegedly “groomed and trained” physicians at the facility, who then deployed the company’s devices even when it was not medically indicated.

Independently from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively. While it’s not uncommon to deploy several devices, a medical expert on the investigation team found that the VA doctors sometimes used more than 15 at a time – one used 33 – deviating from the standard of care.

“It is unconscionable – there can be no valid medically acceptable basis to cram so many devices into a human being,” wrote attorneys representing the whistleblower in legal filings from January 2023. “This is not medical treatment. This is abuse.”

Dr. Kim Hodgson, former president of the Society for Vascular Surgery and an expert retained by the plaintiff, said the findings of the internal review of patient data raise “a high level of concern regarding necessity of treatment provided,” according to case documents.

Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic representative Kirk declined to respond to ProPublica’s request for comment.

The hospital investigation found that amputations increased sixfold in the same time frame as the procedures in question, according to internal emails, but made no conclusion about whether those two things were connected. ProPublica reached out to the VA to ask whether any patients had been harmed.

The VA is “conducting an extensive review of patient care” at the Kansas hospital, “including the number of devices used on patients – to make sure that Veterans were not harmed by any procedures,” press secretary Terrence Hayes said in a statement. So far, the VA’s investigation has found no “quality of care issues,” he said, and the investigation will continue “until every Veteran’s case has been reviewed.” (Read the full statement here.) Neither the department nor the hospital has taken formal action against the medical providers, Hayes said.

The medical group that had a contract with the VA for vascular interventions, Wichita Radiological Group, did not respond to ProPublica’s requests for comment, nor did the doctors named in the suit: Dr. Shaun Gonda, Dr. Bret Winblad, and Dr. Kermit Rust. It is unclear from the case documents which doctors conducted which procedures. Eric Barth, an attorney for the medical group, denied the allegations in recent legal filings, calling the claims “baseless” and the lawsuit a “witch hunt.”

The lawsuit comes amid growing concern about one of these procedures – atherectomies – after researchers and doctors have uncovered patterns of excessive and inappropriate use. Recent research has found that this procedure, a common but costly treatment to shave or laser plaque from blood vessels, is not more effective than cheaper alternatives and may even be associated with a higher risk of complications including amputation. In recent years, several doctors and clinics have been investigated for allegedly taking advantage of Medicare’s reimbursement rates, and one study found that many doctors are resorting to atherectomies in the earliest stages of peripheral artery disease, against best practices that urge noninvasive treatment.

“Atherectomy is important in certain settings. But it’s being used in a way that is entirely inappropriate and it’s largely driven by the incentive structure,” said Dr. Caitlin Hicks, the lead author of the study and an associate professor of surgery at Johns Hopkins University School of Medicine.

Although different payment structures govern the care of veterans, the whistleblower lawsuit alleges that outside physicians, paid hourly by the Dole VA, were motivated to conduct longer and more complex procedures that would earn them higher payment.

Under different circumstances, the patient in the procedure room on that summer day could have been done after 2 hours.

But, 150 minutes in, those Medtronic representatives were still texting. At that point, more than 15 of their vascular devices had been used, including stents, balloons, and those for atherectomy.

“Long case!” Kirk’s colleague texted. “Is it looking ok??”

“It is,” she said. “Thought we were done a few times! Now he’s going back in to cut again!”

A little while later, she texted: “....17!”

He texted back [with laughing emoticons].

Hospital leaders had been scrutinizing the use of these procedures at the Dole VA for years.

In 2017, shortly after Rick Ament was hired to lead the facility, he noticed something was amiss. While the longtime hospital administrator was poring over the finances, he was alarmed to discover that the relatively small Dole VA had one of the most expensive cardiac programs in the country. As Ament dug deeper, he realized vascular interventions were the reason.

“It just did not make sense that the acuity level of our patients would generate such extreme cost variances from the norm,” he testified in December, in a deposition for the whistleblower case. “It was so significant, we needed to get to the bottom of it.”

Ament, a second generation Air Force veteran, quietly assembled a task force to investigate why the facility had purchased so many medical devices for these procedures. After they examined inventory records, calculating the total number of medical devices and the cost of devices per patient, they grew concerned.

“We were more expensive than, I believe it was, the top 10 hospitals in the VA combined,” he said. “My feeling was that we either had very, very bad providers or we had product walking out the door.”

Ament enlisted experts from other VA hospitals to help his team investigate, including an administrative officer who could understand finances and a respected interventional radiologist who could examine records. The task force gathered a list of patients from 2016 to 2018, according to internal emails, and analyzed their medical charts.

According to internal VA documents released through the whistleblower suit, the review found a number of clinical failings: Evidence-based medicine had not been followed in the majority of cases reviewed. Procedures were over-aggressive, treating lesions that should have been left alone. And there was a total disregard for established best practices for treating peripheral artery disease.

One of the experts on the investigative team explained to Ament that while it was not uncommon for doctors to use a couple of devices in one intervention, the total number of devices in many of the procedures at his facility went into the double digits, sometimes five times the expected amount.

In one encounter, a doctor deployed 33 devices in one procedure – 3 atherectomy devices, 9 stents, and 21 balloons.

This use of devices was exorbitant, Ament came to understand. “I want to say the term ‘egregious’ was used,” he testified. “It was kind of like validation, but I really wish I was wrong.”

“Did it make you concerned for patient care?” a lawyer asked during the deposition.

“It did,” Ament replied.

A member of his task force pulled data for veterans who had leg amputations due to vascular disease. Over 5 years, the number of veterans who had amputations increased, from about 6 in 2013 to 38 in 2018, according to internal emails released in the suit. The VA did not respond to ProPublica’s questions about the rise in amputations or whether it was due to complications from the procedures.

Even though Ament testified in December 2022 that he became aware of the excessive use of devices during his investigation that began about 5 years ago, neither he nor the VA have publicly acknowledged these findings outside of the lawsuit. It is unclear whether VA representatives informed the patients whose records were reviewed about their findings. ProPublica reached out to more than half a dozen veteran community groups in the Wichita area and none were aware of the investigation nor the allegations of overuse of vascular procedures at the facility.

The VA says that if its ongoing review finds instances of substandard care, it will reach out to affected patients and inform them about possible complications and benefits they may be entitled to. The press secretary said the review will take several months. Ament declined to respond to ProPublica’s questions, citing the ongoing case.

In 2018, Ament turned over his findings to the criminal division of the VA’s Office of Inspector General. He also shut down interventional radiology procedures at the facility’s catheter lab.

Federal agents separately opened an investigation into the same unit in the facility, looking into allegations of kickbacks.

More than 40 pages of expense reports from Medtronic, revealed in the whistleblower case, show sales representatives treating Dole health care workers to hundreds of meals over several years – lunches at Dempsey’s Biscuit Co.; business meals at the Scotch & Sirloin steakhouse; dinner at Chester’s Chophouse & Wine Bar, price per attendee: $122.39.

Federal agents obtained the receipts.

“Robert J. Dole VAMC employees may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic,” Nathen Howard, a special agent in the VA OIG, wrote in an investigation memo from February 2019.

This kind of relationship could violate VA policy, which forbids federal employees from receiving any gifts, including meals, from people who do business or seek to do business with a federal institution. For health care workers, violating this policy could have serious implications for patients. Numerous studies have shown that even modest industry-sponsored gifts, including meals, may influence prescribing or treatment behavior of health care professionals.

The agents opened their investigation into kickbacks at the Wichita facility in response to the whistleblower lawsuit, which was filed by Thomas Schroeder in 2017. The VA OIG would not confirm or deny whether it was continuing to investigate kickbacks at the facility. The VA did not directly answer ProPublica’s questions about kickbacks at the Dole VA, but it said that every employee must complete an annual ethics training, which covers gift rules.

In recent years, Medtronic has settled a handful of other cases that have alleged kickbacks between company representatives and health care professionals.

In 2018, Medtronic’s subsidiary Covidien paid $13 million to settle claims with the U.S. Department of Justice that it paid kickbacks to health care institutions that used its mechanical blood clot devices. In 2019, the same subsidiary paid $17 million to resolve allegations that it provided in-kind marketing support to doctors using its vein products. And in 2020, Medtronic paid more than $8 million to settle claims that representatives had paid kickbacks to a neurosurgeon, including scores of lavish meals at a restaurant that the doctor owned, to induce him to purchase the company’s medication pumps.

Schroeder’s lawsuit is not the first time Medtronic’s vascular devices were named in an alleged kickback scheme. In early 2015, Medtronic acquired Covidien, and shortly after the merger, its subsidiary ev3 Inc. agreed to pay $1.25 million to resolve allegations that it had paid doctors who were “high volume users” of its atherectomy devices to act as evangelists for the company, and had provided physicians with company shares to participate in clinical trials for their tools.

The whistleblower in this earlier case, a former sales representative for the company, also alleged that the subsidiary was gaming Medicare’s payment system. Hospitals were often hesitant to conduct atherectomy procedures because of the low reimbursement rates. According to the suit, sales representatives encouraged doctors to admit patients for longer stays to reap greater reimbursements and make a profit, even though such stays were often not medically indicated.

“Medical device makers that try to boost their profits by causing patients to be admitted for unnecessary and expensive inpatient hospital stays will be held accountable,” special agent Thomas O’Donnell, from the Office of Inspector General at the U.S. Department of Health and Human Services, said in a press release for the settlement. “Both patients and taxpayers deserve to have medical decisions made based on what is medically appropriate.”

Medtronic spokesperson Xiong said that in each case, the company “cooperated fully with the DOJ to resolve its concerns and, where wrongdoing was found, took appropriate remedial action.”

Seton Hall Law School professor Jacob Elberg, a former assistant U.S. attorney for the District of New Jersey who led its health care and government fraud unit, is concerned by the frequency of such settlements in the last 2 decades. “There are, at this point, real questions as to whether the sanctions imposed by DOJ are sufficient to deter wrongdoing and to lead to meaningful change, especially within the medical device industry.”

Although the Department of Justice has declined to intervene in the lawsuit involving the Dole VA at this time, the case is ongoing and further depositions with Medtronic sales representatives and a former VA employee are scheduled for this month.

VA employees and doctors named in the suit declined to comment or did not respond to ProPublica’s questions about the alleged kickbacks and whether sales representatives may have influenced veterans’ treatment plans. In interviews with federal investigators, according to released transcripts, several of the employees who were questioned denied receiving frequent meals from sales representatives, contradicting Medtronic’s expense reports.

Their statements also stand in contrast to Medtronic representative Kari Kirk’s final text messages during that procedure in June 2017, which ultimately lasted more than 3 hours.

“Now u done??” her colleague asked.

“Just finished,” she texted. “Running to get them lunch!”

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

On June 14, 2017, just before noon, a doctor made an incision near a patient’s groin. Kari Kirk, a representative for the world’s largest medical device company, Medtronic, looked on and began texting her colleague a play-by-play.

“Fixing both legs from the ankles,” she wrote.

It was a fairly common procedure at the Robert J. Dole Veterans Affairs Medical Center in Wichita, Kansas, performed to treat blockages in the leg vessels.

Within reach were an array of Medtronic products: tubes with blades attached to shave hardened deposits off of artery walls; stents to widen blood vessels; balloons coated with therapeutic drugs.

Each time a doctor puts a foreign device in someone’s body, it carries a risk of complication, which can include clots or even require amputation. So medical experts, research and even Medtronic’s own device instructions urge doctors to use as few as are necessary.

But, as revealed in Kirk’s text messages, this doctor took an aggressive approach.

“Just used 12 [drug-coated balloons]!!” Kirk texted her colleague.

“Does that mean I owe u $$,” he responded.

“Thats what I’m thinking!!!” she said. “And now 14 balloons?!”

“but only one stent so far??”

“So far!”

As the texting continued, her colleague replied, “U are going to want to start going to the VA all the time.”

The messages, recently unsealed in an ongoing whistleblower lawsuit, give a window into the way money and medicine mingle in the booming business of peripheral artery disease, a condition that afflicts 6.5 million Americans over age 40 and is caused when fatty plaque builds up in arteries, blocking blood flow to the legs.

Representatives from companies are often present during vascular procedures to guide doctors on how to use their complex devices. This kind of access has the potential to influence treatment plans, as companies and their representatives profit when more of their product is used.

The suit, filed in 2017 by a sales representative for a competing medical device firm, alleges an illegal kickback scheme between Medtronic and hospital employees. According to the complaint and documents released in the suit, between 2011 and 2018, VA health care workers received steakhouse dinners, Apple electronics, and NASCAR tickets, and in turn, Medtronic secured a lucrative contract with the hospital. Meanwhile, the company’s representatives allegedly “groomed and trained” physicians at the facility, who then deployed the company’s devices even when it was not medically indicated.

Independently from the whistleblower suit, internal investigators at the Wichita facility have also examined the treatment patterns of its vascular patients in recent years and found numerous cases where medical devices were used excessively. While it’s not uncommon to deploy several devices, a medical expert on the investigation team found that the VA doctors sometimes used more than 15 at a time – one used 33 – deviating from the standard of care.

“It is unconscionable – there can be no valid medically acceptable basis to cram so many devices into a human being,” wrote attorneys representing the whistleblower in legal filings from January 2023. “This is not medical treatment. This is abuse.”

Dr. Kim Hodgson, former president of the Society for Vascular Surgery and an expert retained by the plaintiff, said the findings of the internal review of patient data raise “a high level of concern regarding necessity of treatment provided,” according to case documents.

Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic representative Kirk declined to respond to ProPublica’s request for comment.

The hospital investigation found that amputations increased sixfold in the same time frame as the procedures in question, according to internal emails, but made no conclusion about whether those two things were connected. ProPublica reached out to the VA to ask whether any patients had been harmed.

The VA is “conducting an extensive review of patient care” at the Kansas hospital, “including the number of devices used on patients – to make sure that Veterans were not harmed by any procedures,” press secretary Terrence Hayes said in a statement. So far, the VA’s investigation has found no “quality of care issues,” he said, and the investigation will continue “until every Veteran’s case has been reviewed.” (Read the full statement here.) Neither the department nor the hospital has taken formal action against the medical providers, Hayes said.

The medical group that had a contract with the VA for vascular interventions, Wichita Radiological Group, did not respond to ProPublica’s requests for comment, nor did the doctors named in the suit: Dr. Shaun Gonda, Dr. Bret Winblad, and Dr. Kermit Rust. It is unclear from the case documents which doctors conducted which procedures. Eric Barth, an attorney for the medical group, denied the allegations in recent legal filings, calling the claims “baseless” and the lawsuit a “witch hunt.”

The lawsuit comes amid growing concern about one of these procedures – atherectomies – after researchers and doctors have uncovered patterns of excessive and inappropriate use. Recent research has found that this procedure, a common but costly treatment to shave or laser plaque from blood vessels, is not more effective than cheaper alternatives and may even be associated with a higher risk of complications including amputation. In recent years, several doctors and clinics have been investigated for allegedly taking advantage of Medicare’s reimbursement rates, and one study found that many doctors are resorting to atherectomies in the earliest stages of peripheral artery disease, against best practices that urge noninvasive treatment.

“Atherectomy is important in certain settings. But it’s being used in a way that is entirely inappropriate and it’s largely driven by the incentive structure,” said Dr. Caitlin Hicks, the lead author of the study and an associate professor of surgery at Johns Hopkins University School of Medicine.

Although different payment structures govern the care of veterans, the whistleblower lawsuit alleges that outside physicians, paid hourly by the Dole VA, were motivated to conduct longer and more complex procedures that would earn them higher payment.

Under different circumstances, the patient in the procedure room on that summer day could have been done after 2 hours.

But, 150 minutes in, those Medtronic representatives were still texting. At that point, more than 15 of their vascular devices had been used, including stents, balloons, and those for atherectomy.

“Long case!” Kirk’s colleague texted. “Is it looking ok??”

“It is,” she said. “Thought we were done a few times! Now he’s going back in to cut again!”

A little while later, she texted: “....17!”

He texted back [with laughing emoticons].

Hospital leaders had been scrutinizing the use of these procedures at the Dole VA for years.

In 2017, shortly after Rick Ament was hired to lead the facility, he noticed something was amiss. While the longtime hospital administrator was poring over the finances, he was alarmed to discover that the relatively small Dole VA had one of the most expensive cardiac programs in the country. As Ament dug deeper, he realized vascular interventions were the reason.

“It just did not make sense that the acuity level of our patients would generate such extreme cost variances from the norm,” he testified in December, in a deposition for the whistleblower case. “It was so significant, we needed to get to the bottom of it.”

Ament, a second generation Air Force veteran, quietly assembled a task force to investigate why the facility had purchased so many medical devices for these procedures. After they examined inventory records, calculating the total number of medical devices and the cost of devices per patient, they grew concerned.

“We were more expensive than, I believe it was, the top 10 hospitals in the VA combined,” he said. “My feeling was that we either had very, very bad providers or we had product walking out the door.”

Ament enlisted experts from other VA hospitals to help his team investigate, including an administrative officer who could understand finances and a respected interventional radiologist who could examine records. The task force gathered a list of patients from 2016 to 2018, according to internal emails, and analyzed their medical charts.

According to internal VA documents released through the whistleblower suit, the review found a number of clinical failings: Evidence-based medicine had not been followed in the majority of cases reviewed. Procedures were over-aggressive, treating lesions that should have been left alone. And there was a total disregard for established best practices for treating peripheral artery disease.

One of the experts on the investigative team explained to Ament that while it was not uncommon for doctors to use a couple of devices in one intervention, the total number of devices in many of the procedures at his facility went into the double digits, sometimes five times the expected amount.

In one encounter, a doctor deployed 33 devices in one procedure – 3 atherectomy devices, 9 stents, and 21 balloons.

This use of devices was exorbitant, Ament came to understand. “I want to say the term ‘egregious’ was used,” he testified. “It was kind of like validation, but I really wish I was wrong.”

“Did it make you concerned for patient care?” a lawyer asked during the deposition.

“It did,” Ament replied.

A member of his task force pulled data for veterans who had leg amputations due to vascular disease. Over 5 years, the number of veterans who had amputations increased, from about 6 in 2013 to 38 in 2018, according to internal emails released in the suit. The VA did not respond to ProPublica’s questions about the rise in amputations or whether it was due to complications from the procedures.

Even though Ament testified in December 2022 that he became aware of the excessive use of devices during his investigation that began about 5 years ago, neither he nor the VA have publicly acknowledged these findings outside of the lawsuit. It is unclear whether VA representatives informed the patients whose records were reviewed about their findings. ProPublica reached out to more than half a dozen veteran community groups in the Wichita area and none were aware of the investigation nor the allegations of overuse of vascular procedures at the facility.

The VA says that if its ongoing review finds instances of substandard care, it will reach out to affected patients and inform them about possible complications and benefits they may be entitled to. The press secretary said the review will take several months. Ament declined to respond to ProPublica’s questions, citing the ongoing case.

In 2018, Ament turned over his findings to the criminal division of the VA’s Office of Inspector General. He also shut down interventional radiology procedures at the facility’s catheter lab.

Federal agents separately opened an investigation into the same unit in the facility, looking into allegations of kickbacks.

More than 40 pages of expense reports from Medtronic, revealed in the whistleblower case, show sales representatives treating Dole health care workers to hundreds of meals over several years – lunches at Dempsey’s Biscuit Co.; business meals at the Scotch & Sirloin steakhouse; dinner at Chester’s Chophouse & Wine Bar, price per attendee: $122.39.

Federal agents obtained the receipts.

“Robert J. Dole VAMC employees may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic,” Nathen Howard, a special agent in the VA OIG, wrote in an investigation memo from February 2019.

This kind of relationship could violate VA policy, which forbids federal employees from receiving any gifts, including meals, from people who do business or seek to do business with a federal institution. For health care workers, violating this policy could have serious implications for patients. Numerous studies have shown that even modest industry-sponsored gifts, including meals, may influence prescribing or treatment behavior of health care professionals.

The agents opened their investigation into kickbacks at the Wichita facility in response to the whistleblower lawsuit, which was filed by Thomas Schroeder in 2017. The VA OIG would not confirm or deny whether it was continuing to investigate kickbacks at the facility. The VA did not directly answer ProPublica’s questions about kickbacks at the Dole VA, but it said that every employee must complete an annual ethics training, which covers gift rules.

In recent years, Medtronic has settled a handful of other cases that have alleged kickbacks between company representatives and health care professionals.

In 2018, Medtronic’s subsidiary Covidien paid $13 million to settle claims with the U.S. Department of Justice that it paid kickbacks to health care institutions that used its mechanical blood clot devices. In 2019, the same subsidiary paid $17 million to resolve allegations that it provided in-kind marketing support to doctors using its vein products. And in 2020, Medtronic paid more than $8 million to settle claims that representatives had paid kickbacks to a neurosurgeon, including scores of lavish meals at a restaurant that the doctor owned, to induce him to purchase the company’s medication pumps.

Schroeder’s lawsuit is not the first time Medtronic’s vascular devices were named in an alleged kickback scheme. In early 2015, Medtronic acquired Covidien, and shortly after the merger, its subsidiary ev3 Inc. agreed to pay $1.25 million to resolve allegations that it had paid doctors who were “high volume users” of its atherectomy devices to act as evangelists for the company, and had provided physicians with company shares to participate in clinical trials for their tools.

The whistleblower in this earlier case, a former sales representative for the company, also alleged that the subsidiary was gaming Medicare’s payment system. Hospitals were often hesitant to conduct atherectomy procedures because of the low reimbursement rates. According to the suit, sales representatives encouraged doctors to admit patients for longer stays to reap greater reimbursements and make a profit, even though such stays were often not medically indicated.

“Medical device makers that try to boost their profits by causing patients to be admitted for unnecessary and expensive inpatient hospital stays will be held accountable,” special agent Thomas O’Donnell, from the Office of Inspector General at the U.S. Department of Health and Human Services, said in a press release for the settlement. “Both patients and taxpayers deserve to have medical decisions made based on what is medically appropriate.”

Medtronic spokesperson Xiong said that in each case, the company “cooperated fully with the DOJ to resolve its concerns and, where wrongdoing was found, took appropriate remedial action.”

Seton Hall Law School professor Jacob Elberg, a former assistant U.S. attorney for the District of New Jersey who led its health care and government fraud unit, is concerned by the frequency of such settlements in the last 2 decades. “There are, at this point, real questions as to whether the sanctions imposed by DOJ are sufficient to deter wrongdoing and to lead to meaningful change, especially within the medical device industry.”

Although the Department of Justice has declined to intervene in the lawsuit involving the Dole VA at this time, the case is ongoing and further depositions with Medtronic sales representatives and a former VA employee are scheduled for this month.

VA employees and doctors named in the suit declined to comment or did not respond to ProPublica’s questions about the alleged kickbacks and whether sales representatives may have influenced veterans’ treatment plans. In interviews with federal investigators, according to released transcripts, several of the employees who were questioned denied receiving frequent meals from sales representatives, contradicting Medtronic’s expense reports.

Their statements also stand in contrast to Medtronic representative Kari Kirk’s final text messages during that procedure in June 2017, which ultimately lasted more than 3 hours.

“Now u done??” her colleague asked.

“Just finished,” she texted. “Running to get them lunch!”

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

The natural immunity provided by a COVID infection protects a person against severe illness on a par with two doses of mRNA vaccine, a new study says. 

People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet. 

The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported. 

But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.

They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied. 

The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News. 

“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”

The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.

This was the largest meta-analysis of immunity following infection to date, NBC News reports.

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

The natural immunity provided by a COVID infection protects a person against severe illness on a par with two doses of mRNA vaccine, a new study says. 

People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet. 

The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported. 

But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.

They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied. 

The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News. 

“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”

The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.

This was the largest meta-analysis of immunity following infection to date, NBC News reports.

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

The natural immunity provided by a COVID infection protects a person against severe illness on a par with two doses of mRNA vaccine, a new study says. 

People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet. 

The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported. 

But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.

They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied. 

The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News. 

“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”

The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.

This was the largest meta-analysis of immunity following infection to date, NBC News reports.

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

Approximately one in four patients with untreated COVID-19 experience symptom relapse, while almost one in three exhibits relapse of viral load, a recent study finds.

These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.

“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.

To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).

From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.

“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.

Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.

The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.

Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.

This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.

This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
 

Paxlovid may not be to blame for COVID-19 rebound

“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.

Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.

“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
 

Longer antiviral therapy deserves investigation

This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.

“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.

This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.

“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”

That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,

“We need further study of longer-term therapies,” he said.

An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.

“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”

While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.

The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.

Approximately one in four patients with untreated COVID-19 experience symptom relapse, while almost one in three exhibits relapse of viral load, a recent study finds.

These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.

“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.

To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).

From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.

“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.

Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.

The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.

Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.

This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.

This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
 

Paxlovid may not be to blame for COVID-19 rebound

“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.

Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.

“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
 

Longer antiviral therapy deserves investigation

This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.

“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.

This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.

“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”

That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,

“We need further study of longer-term therapies,” he said.

An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.

“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”

While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.

The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.

Approximately one in four patients with untreated COVID-19 experience symptom relapse, while almost one in three exhibits relapse of viral load, a recent study finds.

These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.

“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.

To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).

From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.

“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.

Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.

The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.

Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.

This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.

This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
 

Paxlovid may not be to blame for COVID-19 rebound

“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.

Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.

“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
 

Longer antiviral therapy deserves investigation

This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.

“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.

This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.

“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”

That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,

“We need further study of longer-term therapies,” he said.

An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.

“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”

While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.

The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.

A diagnostic workup for pulmonary embolism (PE) should be performed in all patients with recent onset of exertional dyspnea, according to the authors of an article published in the Journal of Thrombosis and Haemostasis. That conclusion emerged from an analysis of PE prevalence in 417 patients with recent marked exertional dyspnea performing previously well-tolerated physical activities.

Exertional dyspnea is a frequently encountered complaint in clinical practice. Missteps in both diagnosis and early management, however, have been found to be prevalent in emergency department practices. PE diagnosis can be delayed or altogether missed through nonspecific clinical manifestations or the absence of typical signs and symptoms, with a complicated clinical course or mortality as a consequence, stated the researchers. Also, failure to diagnose PE is a common malpractice allegation.

Noting that the prevalence of PE among patients with dyspnea on exertion has not been reported, the authors hypothesized: “PE might be a frequent underlying condition in patients presenting for care complaining of marked dyspnea on exertion of recent onset.”

In a multicenter prospective, cross-sectional study among 14 university or hospital centers in Italy, patients who were referred for outpatient evaluation with recent (< 1 month) dyspnea on exertion with a severity of 3 or 4 on the modified Medical Research Council dyspnea scale were potentially eligible for the study. Prior deep-vein thrombosis (DVT), PE, and use of therapeutic anticoagulation were among exclusion criteria. All patients aged 75 years or younger with recent (< 1 month) marked exertional dyspnea had a systematic workup for PE, irrespective of concomitant signs or symptoms of venous thromboembolism and alternative explanations for dyspnea. The main study outcome was prevalence of PE in the entire cohort of patients with recent marked dyspnea on exertion.

When about 400 patients had been enrolled after an interim analysis in which the preestablished stopping rule (if the lower limit of the 95% confidence interval of the prevalence of PE exceeds 20%) was met, the study was prematurely terminated. PE was found, after exclusion of 134 patients based on low PE clinical probability and normal D-dimer, in 134 (47.3%) of the remaining 283 patients. The overall PE prevalence was 32.1% (95% confidence interval, 27.8-36.8).

PE was present in 40 of 204 (19.6%) patients without other findings suspicious for PE and in 94 of 213 patients (44.1%) with PE-suspicious findings. PE involved a main pulmonary artery in 37% and multiple lobes in 87% of the patients.

The researchers pointed out that, while the prevalence of PE was highest (44%) in patients who had concomitant signs or symptoms suspicious of PE or underlying DVT, PE was detected in almost 20% of patients without concomitant PE signs and symptoms. Also, the detected pulmonary emboli were deemed significant.

“Our findings suggest that, regardless of the diagnostic algorithm in use, physicians should rule in or out PE in patients who solely report recent onset of marked dyspnea on exertion,” they concluded.

Agreeing with the authors’ conclusions, Mary Jo S. Farmer, MD, PhD, of the department of medicine at University of Massachusetts, Worcester, stated in an interview, “The results of the current study support a diagnostic workup for pulmonary embolus in all patients with recent onset of exertional dyspnea.” She added, “Pulmonary emboli detected were significant as almost all were segmental or more proximal emboli involving multiple lobes. The observed overall prevalence of pulmonary embolus of 32% may seem high when compared with the low prevalence of 7%-13% reported in other studies of patients with suspected pulmonary embolus. However, the prevalence of pulmonary embolus among emergency department cohorts in European countries is generally higher, as is the diagnostic yield from [CT pulmonary angiogram] compared to North American countries. This could be explained by differences in applied thresholds for suspicion of pulmonary embolus. The incidence of COVID-19 and association with thrombosis was not reported.

“It has been reported that nonspecific clinical manifestations and absence of typical signs and symptoms can result in delay in diagnosis of pulmonary embolus or result in pulmonary embolus being missed, an unfortunate situation that could result in malpractice allegation.” Dr. Farmer concluded.

Among limitations of the study, the authors noted that their results are not applicable to patients older than 75 years or patients with chronic (more than 1 month) symptoms of dyspnea or less severe dyspnea (modified Medical Research Council dyspnea score of 2 or lower). Also, no attempt to stratify the clinical relevance of PE was made.

The study was funded by the Arianna Foundation on Anticoagulation, Bologna, Italy. The authors reported that they had no potential conflicts. Dr. Farmer also declared she had no relevant conflicts.

A diagnostic workup for pulmonary embolism (PE) should be performed in all patients with recent onset of exertional dyspnea, according to the authors of an article published in the Journal of Thrombosis and Haemostasis. That conclusion emerged from an analysis of PE prevalence in 417 patients with recent marked exertional dyspnea performing previously well-tolerated physical activities.

Exertional dyspnea is a frequently encountered complaint in clinical practice. Missteps in both diagnosis and early management, however, have been found to be prevalent in emergency department practices. PE diagnosis can be delayed or altogether missed through nonspecific clinical manifestations or the absence of typical signs and symptoms, with a complicated clinical course or mortality as a consequence, stated the researchers. Also, failure to diagnose PE is a common malpractice allegation.

Noting that the prevalence of PE among patients with dyspnea on exertion has not been reported, the authors hypothesized: “PE might be a frequent underlying condition in patients presenting for care complaining of marked dyspnea on exertion of recent onset.”

In a multicenter prospective, cross-sectional study among 14 university or hospital centers in Italy, patients who were referred for outpatient evaluation with recent (< 1 month) dyspnea on exertion with a severity of 3 or 4 on the modified Medical Research Council dyspnea scale were potentially eligible for the study. Prior deep-vein thrombosis (DVT), PE, and use of therapeutic anticoagulation were among exclusion criteria. All patients aged 75 years or younger with recent (< 1 month) marked exertional dyspnea had a systematic workup for PE, irrespective of concomitant signs or symptoms of venous thromboembolism and alternative explanations for dyspnea. The main study outcome was prevalence of PE in the entire cohort of patients with recent marked dyspnea on exertion.

When about 400 patients had been enrolled after an interim analysis in which the preestablished stopping rule (if the lower limit of the 95% confidence interval of the prevalence of PE exceeds 20%) was met, the study was prematurely terminated. PE was found, after exclusion of 134 patients based on low PE clinical probability and normal D-dimer, in 134 (47.3%) of the remaining 283 patients. The overall PE prevalence was 32.1% (95% confidence interval, 27.8-36.8).

PE was present in 40 of 204 (19.6%) patients without other findings suspicious for PE and in 94 of 213 patients (44.1%) with PE-suspicious findings. PE involved a main pulmonary artery in 37% and multiple lobes in 87% of the patients.

The researchers pointed out that, while the prevalence of PE was highest (44%) in patients who had concomitant signs or symptoms suspicious of PE or underlying DVT, PE was detected in almost 20% of patients without concomitant PE signs and symptoms. Also, the detected pulmonary emboli were deemed significant.

“Our findings suggest that, regardless of the diagnostic algorithm in use, physicians should rule in or out PE in patients who solely report recent onset of marked dyspnea on exertion,” they concluded.

Agreeing with the authors’ conclusions, Mary Jo S. Farmer, MD, PhD, of the department of medicine at University of Massachusetts, Worcester, stated in an interview, “The results of the current study support a diagnostic workup for pulmonary embolus in all patients with recent onset of exertional dyspnea.” She added, “Pulmonary emboli detected were significant as almost all were segmental or more proximal emboli involving multiple lobes. The observed overall prevalence of pulmonary embolus of 32% may seem high when compared with the low prevalence of 7%-13% reported in other studies of patients with suspected pulmonary embolus. However, the prevalence of pulmonary embolus among emergency department cohorts in European countries is generally higher, as is the diagnostic yield from [CT pulmonary angiogram] compared to North American countries. This could be explained by differences in applied thresholds for suspicion of pulmonary embolus. The incidence of COVID-19 and association with thrombosis was not reported.

“It has been reported that nonspecific clinical manifestations and absence of typical signs and symptoms can result in delay in diagnosis of pulmonary embolus or result in pulmonary embolus being missed, an unfortunate situation that could result in malpractice allegation.” Dr. Farmer concluded.

Among limitations of the study, the authors noted that their results are not applicable to patients older than 75 years or patients with chronic (more than 1 month) symptoms of dyspnea or less severe dyspnea (modified Medical Research Council dyspnea score of 2 or lower). Also, no attempt to stratify the clinical relevance of PE was made.

The study was funded by the Arianna Foundation on Anticoagulation, Bologna, Italy. The authors reported that they had no potential conflicts. Dr. Farmer also declared she had no relevant conflicts.

A diagnostic workup for pulmonary embolism (PE) should be performed in all patients with recent onset of exertional dyspnea, according to the authors of an article published in the Journal of Thrombosis and Haemostasis. That conclusion emerged from an analysis of PE prevalence in 417 patients with recent marked exertional dyspnea performing previously well-tolerated physical activities.

Exertional dyspnea is a frequently encountered complaint in clinical practice. Missteps in both diagnosis and early management, however, have been found to be prevalent in emergency department practices. PE diagnosis can be delayed or altogether missed through nonspecific clinical manifestations or the absence of typical signs and symptoms, with a complicated clinical course or mortality as a consequence, stated the researchers. Also, failure to diagnose PE is a common malpractice allegation.

Noting that the prevalence of PE among patients with dyspnea on exertion has not been reported, the authors hypothesized: “PE might be a frequent underlying condition in patients presenting for care complaining of marked dyspnea on exertion of recent onset.”

In a multicenter prospective, cross-sectional study among 14 university or hospital centers in Italy, patients who were referred for outpatient evaluation with recent (< 1 month) dyspnea on exertion with a severity of 3 or 4 on the modified Medical Research Council dyspnea scale were potentially eligible for the study. Prior deep-vein thrombosis (DVT), PE, and use of therapeutic anticoagulation were among exclusion criteria. All patients aged 75 years or younger with recent (< 1 month) marked exertional dyspnea had a systematic workup for PE, irrespective of concomitant signs or symptoms of venous thromboembolism and alternative explanations for dyspnea. The main study outcome was prevalence of PE in the entire cohort of patients with recent marked dyspnea on exertion.

When about 400 patients had been enrolled after an interim analysis in which the preestablished stopping rule (if the lower limit of the 95% confidence interval of the prevalence of PE exceeds 20%) was met, the study was prematurely terminated. PE was found, after exclusion of 134 patients based on low PE clinical probability and normal D-dimer, in 134 (47.3%) of the remaining 283 patients. The overall PE prevalence was 32.1% (95% confidence interval, 27.8-36.8).

PE was present in 40 of 204 (19.6%) patients without other findings suspicious for PE and in 94 of 213 patients (44.1%) with PE-suspicious findings. PE involved a main pulmonary artery in 37% and multiple lobes in 87% of the patients.

The researchers pointed out that, while the prevalence of PE was highest (44%) in patients who had concomitant signs or symptoms suspicious of PE or underlying DVT, PE was detected in almost 20% of patients without concomitant PE signs and symptoms. Also, the detected pulmonary emboli were deemed significant.

“Our findings suggest that, regardless of the diagnostic algorithm in use, physicians should rule in or out PE in patients who solely report recent onset of marked dyspnea on exertion,” they concluded.

Agreeing with the authors’ conclusions, Mary Jo S. Farmer, MD, PhD, of the department of medicine at University of Massachusetts, Worcester, stated in an interview, “The results of the current study support a diagnostic workup for pulmonary embolus in all patients with recent onset of exertional dyspnea.” She added, “Pulmonary emboli detected were significant as almost all were segmental or more proximal emboli involving multiple lobes. The observed overall prevalence of pulmonary embolus of 32% may seem high when compared with the low prevalence of 7%-13% reported in other studies of patients with suspected pulmonary embolus. However, the prevalence of pulmonary embolus among emergency department cohorts in European countries is generally higher, as is the diagnostic yield from [CT pulmonary angiogram] compared to North American countries. This could be explained by differences in applied thresholds for suspicion of pulmonary embolus. The incidence of COVID-19 and association with thrombosis was not reported.

“It has been reported that nonspecific clinical manifestations and absence of typical signs and symptoms can result in delay in diagnosis of pulmonary embolus or result in pulmonary embolus being missed, an unfortunate situation that could result in malpractice allegation.” Dr. Farmer concluded.

Among limitations of the study, the authors noted that their results are not applicable to patients older than 75 years or patients with chronic (more than 1 month) symptoms of dyspnea or less severe dyspnea (modified Medical Research Council dyspnea score of 2 or lower). Also, no attempt to stratify the clinical relevance of PE was made.

The study was funded by the Arianna Foundation on Anticoagulation, Bologna, Italy. The authors reported that they had no potential conflicts. Dr. Farmer also declared she had no relevant conflicts.

In patients with acute ischemic stroke who have not received thrombolysis or thrombectomy, early antihypertensive treatment compared with delayed antihypertensive treatment did not reduce the likelihood of death and major disability at 3 months in the CATIS-2 trial.

The trial was presented by Liping Liu, MD, Beijing Tiantan Hospital, at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

“Antihypertensive treatment can be delayed for at least 7 days following ischemic stroke onset, unless there are severe acute comorbidities that demand emergency blood pressure reduction to prevent serious complications,” Dr. Liu concluded.

But he acknowledged that the optimal BP management strategy in these patients remains uncertain and should be the focus of future research.

Discussing the trial at an ISC 2023 Highlights session, Lauren Sansing, MD, Yale University, New Haven, Conn., and ISC program vice chair, said: “These results seem to support waiting for a week or so before treating blood pressure in these patients.”

But Tudor Jovin, MD, Cooper Neurological Institute, Cherry Hill, N.J., and ISC program chair, countered: “To me, it’s kind of a neutral result, so what I take home from this is that you don’t necessarily have to wait.”

Dr. Jovin continued: “We used to think that it was mandatory not to treat blood pressure early because of the risk of deceasing the perfusion pressure, but this trial suggests the effects are neutral and there is probably as much benefit from lowering blood pressure for other reasons that offsets the potential harm.

“I think these are good data to rely on when we make these kinds of treatment decisions. Personally, I am a bit more aggressive with early blood pressure management and it’s good to see that you don’t get punished for that,” he added.

In his presentation, Dr. Liu explained that increased BP is common in acute stroke and is strongly associated with poor functional outcome and recurrence of ischemic stroke, but the optimal blood pressure management strategy in acute ischemic stroke remains controversial.

In the first CATIS trial (China Antihypertensive Trial in Acute Ischemic Stroke), which compared antihypertensive treatment within 48 hours of stroke onset with no antihypertensive treatment in ischemic stroke patients not receiving thrombolysis, the main results suggested that BP reduction with antihypertensive medications did not reduce the likelihood of death and major disability at 14 days or hospital discharge. But a subgroup analysis found that initiating antihypertensive treatment between 24 and 48 hours of stroke onset showed a beneficial effect on reducing death or major disability.

Current AHA/ASA guidelines suggest that, in patients with BP greater than 220/120 mm Hg who have not received thrombolysis or thrombectomy and have no comorbid conditions requiring urgent antihypertensive treatment, the benefit of initiating or reinitiating antihypertensive treatment within the first 48-72 hours is uncertain, although the guidelines say it might be reasonable to lower BP by around 15% during the first 24 hours after stroke onset, Dr. Liu noted.

The CATIS-2 trial was a multicenter, randomized, open-label, blinded-endpoints trial conducted at 106 centers in China that enrolled 4810 patients within 24-48 hours of onset of acute ischemic stroke who had elevated BP. Patients had not received thrombolytic therapy or mechanical thrombectomy.

Patients were randomly assigned to early antihypertensive therapy (initiated after randomization and aiming for a 10%-20% reduction in systolic BP) or delayed antihypertensive therapy (restarted antihypertensive therapy on day 8 of randomization, aiming for a BP of < 140/90 mm Hg).

The median age of the patients was 64 years, 65% were male, 80% had a history of hypertension, and the median National Institutes of Health Stroke Scale score was 3. Baseline BP averaged 163/92 mm Hg in both groups. The median time from stroke onset to antihypertensive treatment was 1.5 days in the early group and 8.5 days in the delayed group.

BP results showed that, at 24 hours after randomization, mean systolic pressure was reduced by 16.4 mm Hg (9.7%) in the early-treatment group and by 8.6 mm Hg (4.9%) in the delayed-treatment group (difference, –7.8 mm Hg; P < .0001).

At day 7, mean systolic pressure was 139.1 mm Hg in the early-treatment group, compared with 150.9 mm Hg in the delayed-treatment group, with a net difference in systolic BP of –11.9 mm Hg (P < .0001).

The primary outcome was the composite of death and major disability (modified Rankin Scale ≥ 3) at 3 months. This did not differ between the groups, occurring in 12.1% in the early antihypertensive treatment group versus 10.5% in the delayed antihypertensive treatment group (risk ratio, 1.15; P = .08).

There was also no difference in the major secondary outcome of shift in scores of mRS at 3 months, with a common odds ratio of 1.05 (95% confidence interval, 0.95-1.17).

There was no interaction with the composite outcome of death or major disability at 90 days in the prespecified subgroups.

Dr. Liu pointed out several limitations of the study. These included an observed primary outcome rate substantially lower than expected; the BP reduction seen within the first 7 days in the early-treatment group was moderate; and the results of the study cannot be applied to patients treated with thrombolysis or thrombectomy.

Dr. Liu has disclosed no relevant financial relationships.

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

In patients with acute ischemic stroke who have not received thrombolysis or thrombectomy, early antihypertensive treatment compared with delayed antihypertensive treatment did not reduce the likelihood of death and major disability at 3 months in the CATIS-2 trial.

The trial was presented by Liping Liu, MD, Beijing Tiantan Hospital, at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

“Antihypertensive treatment can be delayed for at least 7 days following ischemic stroke onset, unless there are severe acute comorbidities that demand emergency blood pressure reduction to prevent serious complications,” Dr. Liu concluded.

But he acknowledged that the optimal BP management strategy in these patients remains uncertain and should be the focus of future research.

Discussing the trial at an ISC 2023 Highlights session, Lauren Sansing, MD, Yale University, New Haven, Conn., and ISC program vice chair, said: “These results seem to support waiting for a week or so before treating blood pressure in these patients.”

But Tudor Jovin, MD, Cooper Neurological Institute, Cherry Hill, N.J., and ISC program chair, countered: “To me, it’s kind of a neutral result, so what I take home from this is that you don’t necessarily have to wait.”

Dr. Jovin continued: “We used to think that it was mandatory not to treat blood pressure early because of the risk of deceasing the perfusion pressure, but this trial suggests the effects are neutral and there is probably as much benefit from lowering blood pressure for other reasons that offsets the potential harm.

“I think these are good data to rely on when we make these kinds of treatment decisions. Personally, I am a bit more aggressive with early blood pressure management and it’s good to see that you don’t get punished for that,” he added.

In his presentation, Dr. Liu explained that increased BP is common in acute stroke and is strongly associated with poor functional outcome and recurrence of ischemic stroke, but the optimal blood pressure management strategy in acute ischemic stroke remains controversial.

In the first CATIS trial (China Antihypertensive Trial in Acute Ischemic Stroke), which compared antihypertensive treatment within 48 hours of stroke onset with no antihypertensive treatment in ischemic stroke patients not receiving thrombolysis, the main results suggested that BP reduction with antihypertensive medications did not reduce the likelihood of death and major disability at 14 days or hospital discharge. But a subgroup analysis found that initiating antihypertensive treatment between 24 and 48 hours of stroke onset showed a beneficial effect on reducing death or major disability.

Current AHA/ASA guidelines suggest that, in patients with BP greater than 220/120 mm Hg who have not received thrombolysis or thrombectomy and have no comorbid conditions requiring urgent antihypertensive treatment, the benefit of initiating or reinitiating antihypertensive treatment within the first 48-72 hours is uncertain, although the guidelines say it might be reasonable to lower BP by around 15% during the first 24 hours after stroke onset, Dr. Liu noted.

The CATIS-2 trial was a multicenter, randomized, open-label, blinded-endpoints trial conducted at 106 centers in China that enrolled 4810 patients within 24-48 hours of onset of acute ischemic stroke who had elevated BP. Patients had not received thrombolytic therapy or mechanical thrombectomy.

Patients were randomly assigned to early antihypertensive therapy (initiated after randomization and aiming for a 10%-20% reduction in systolic BP) or delayed antihypertensive therapy (restarted antihypertensive therapy on day 8 of randomization, aiming for a BP of < 140/90 mm Hg).

The median age of the patients was 64 years, 65% were male, 80% had a history of hypertension, and the median National Institutes of Health Stroke Scale score was 3. Baseline BP averaged 163/92 mm Hg in both groups. The median time from stroke onset to antihypertensive treatment was 1.5 days in the early group and 8.5 days in the delayed group.

BP results showed that, at 24 hours after randomization, mean systolic pressure was reduced by 16.4 mm Hg (9.7%) in the early-treatment group and by 8.6 mm Hg (4.9%) in the delayed-treatment group (difference, –7.8 mm Hg; P < .0001).

At day 7, mean systolic pressure was 139.1 mm Hg in the early-treatment group, compared with 150.9 mm Hg in the delayed-treatment group, with a net difference in systolic BP of –11.9 mm Hg (P < .0001).

The primary outcome was the composite of death and major disability (modified Rankin Scale ≥ 3) at 3 months. This did not differ between the groups, occurring in 12.1% in the early antihypertensive treatment group versus 10.5% in the delayed antihypertensive treatment group (risk ratio, 1.15; P = .08).

There was also no difference in the major secondary outcome of shift in scores of mRS at 3 months, with a common odds ratio of 1.05 (95% confidence interval, 0.95-1.17).

There was no interaction with the composite outcome of death or major disability at 90 days in the prespecified subgroups.

Dr. Liu pointed out several limitations of the study. These included an observed primary outcome rate substantially lower than expected; the BP reduction seen within the first 7 days in the early-treatment group was moderate; and the results of the study cannot be applied to patients treated with thrombolysis or thrombectomy.

Dr. Liu has disclosed no relevant financial relationships.

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

In patients with acute ischemic stroke who have not received thrombolysis or thrombectomy, early antihypertensive treatment compared with delayed antihypertensive treatment did not reduce the likelihood of death and major disability at 3 months in the CATIS-2 trial.

The trial was presented by Liping Liu, MD, Beijing Tiantan Hospital, at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

“Antihypertensive treatment can be delayed for at least 7 days following ischemic stroke onset, unless there are severe acute comorbidities that demand emergency blood pressure reduction to prevent serious complications,” Dr. Liu concluded.

But he acknowledged that the optimal BP management strategy in these patients remains uncertain and should be the focus of future research.

Discussing the trial at an ISC 2023 Highlights session, Lauren Sansing, MD, Yale University, New Haven, Conn., and ISC program vice chair, said: “These results seem to support waiting for a week or so before treating blood pressure in these patients.”

But Tudor Jovin, MD, Cooper Neurological Institute, Cherry Hill, N.J., and ISC program chair, countered: “To me, it’s kind of a neutral result, so what I take home from this is that you don’t necessarily have to wait.”

Dr. Jovin continued: “We used to think that it was mandatory not to treat blood pressure early because of the risk of deceasing the perfusion pressure, but this trial suggests the effects are neutral and there is probably as much benefit from lowering blood pressure for other reasons that offsets the potential harm.

“I think these are good data to rely on when we make these kinds of treatment decisions. Personally, I am a bit more aggressive with early blood pressure management and it’s good to see that you don’t get punished for that,” he added.

In his presentation, Dr. Liu explained that increased BP is common in acute stroke and is strongly associated with poor functional outcome and recurrence of ischemic stroke, but the optimal blood pressure management strategy in acute ischemic stroke remains controversial.

In the first CATIS trial (China Antihypertensive Trial in Acute Ischemic Stroke), which compared antihypertensive treatment within 48 hours of stroke onset with no antihypertensive treatment in ischemic stroke patients not receiving thrombolysis, the main results suggested that BP reduction with antihypertensive medications did not reduce the likelihood of death and major disability at 14 days or hospital discharge. But a subgroup analysis found that initiating antihypertensive treatment between 24 and 48 hours of stroke onset showed a beneficial effect on reducing death or major disability.

Current AHA/ASA guidelines suggest that, in patients with BP greater than 220/120 mm Hg who have not received thrombolysis or thrombectomy and have no comorbid conditions requiring urgent antihypertensive treatment, the benefit of initiating or reinitiating antihypertensive treatment within the first 48-72 hours is uncertain, although the guidelines say it might be reasonable to lower BP by around 15% during the first 24 hours after stroke onset, Dr. Liu noted.

The CATIS-2 trial was a multicenter, randomized, open-label, blinded-endpoints trial conducted at 106 centers in China that enrolled 4810 patients within 24-48 hours of onset of acute ischemic stroke who had elevated BP. Patients had not received thrombolytic therapy or mechanical thrombectomy.

Patients were randomly assigned to early antihypertensive therapy (initiated after randomization and aiming for a 10%-20% reduction in systolic BP) or delayed antihypertensive therapy (restarted antihypertensive therapy on day 8 of randomization, aiming for a BP of < 140/90 mm Hg).

The median age of the patients was 64 years, 65% were male, 80% had a history of hypertension, and the median National Institutes of Health Stroke Scale score was 3. Baseline BP averaged 163/92 mm Hg in both groups. The median time from stroke onset to antihypertensive treatment was 1.5 days in the early group and 8.5 days in the delayed group.

BP results showed that, at 24 hours after randomization, mean systolic pressure was reduced by 16.4 mm Hg (9.7%) in the early-treatment group and by 8.6 mm Hg (4.9%) in the delayed-treatment group (difference, –7.8 mm Hg; P < .0001).

At day 7, mean systolic pressure was 139.1 mm Hg in the early-treatment group, compared with 150.9 mm Hg in the delayed-treatment group, with a net difference in systolic BP of –11.9 mm Hg (P < .0001).

The primary outcome was the composite of death and major disability (modified Rankin Scale ≥ 3) at 3 months. This did not differ between the groups, occurring in 12.1% in the early antihypertensive treatment group versus 10.5% in the delayed antihypertensive treatment group (risk ratio, 1.15; P = .08).

There was also no difference in the major secondary outcome of shift in scores of mRS at 3 months, with a common odds ratio of 1.05 (95% confidence interval, 0.95-1.17).

There was no interaction with the composite outcome of death or major disability at 90 days in the prespecified subgroups.

Dr. Liu pointed out several limitations of the study. These included an observed primary outcome rate substantially lower than expected; the BP reduction seen within the first 7 days in the early-treatment group was moderate; and the results of the study cannot be applied to patients treated with thrombolysis or thrombectomy.

Dr. Liu has disclosed no relevant financial relationships.

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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