MDedge Surgery

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

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

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

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

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

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

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.

“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.

“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.

“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”

The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
 

Taking job stress seriously

Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.

“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”

The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”

Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”

The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.

“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
 

Greatest COVID caseload

Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.

“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”

Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.

“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”

Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”

Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.

“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”

Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.

“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”

SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
 

The impact on women doctors

In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.¹

“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.

“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”

When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.

These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”

What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.

The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.

Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
 

What are the answers?

Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”

A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”

Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”

Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”

“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.

“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
 

Reference

1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.

Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.

“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.

“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.

“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”

The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
 

Taking job stress seriously

Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.

“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”

The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”

Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”

The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.

“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
 

Greatest COVID caseload

Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.

“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”

Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.

“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”

Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”

Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.

“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”

Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.

“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”

SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
 

The impact on women doctors

In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.¹

“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.

“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”

When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.

These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”

What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.

The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.

Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
 

What are the answers?

Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”

A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”

Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”

Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”

“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.

“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
 

Reference

1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.

Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.

“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.

“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.

“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”

The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
 

Taking job stress seriously

Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.

“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”

The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”

Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”

The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.

“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
 

Greatest COVID caseload

Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.

“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”

Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.

“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”

Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”

Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.

“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”

Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.

“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”

SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
 

The impact on women doctors

In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.¹

“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.

“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”

When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.

These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”

What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.

The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.

Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
 

What are the answers?

Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”

A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”

Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”

Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”

“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.

“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
 

Reference

1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.

European dermatologists shifted en masse to teledermatology during the first wave of the COVID-19 pandemic, and most of them disliked the videoconferencing experience intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.

“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).

The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.

The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.

Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.

Impact on professional practice

Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.

Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.

Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
 

Impact on dermatologists’ personal lives

About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.

Sixteen percent of dermatologists reported drinking more alcohol during sequestration.

But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.

Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.

“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.

A second EADV survey will be performed during the fall/winter wave of the pandemic.

Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
 

[email protected]

SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D

European dermatologists shifted en masse to teledermatology during the first wave of the COVID-19 pandemic, and most of them disliked the videoconferencing experience intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.

“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).

The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.

The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.

Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.

Impact on professional practice

Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.

Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.

Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
 

Impact on dermatologists’ personal lives

About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.

Sixteen percent of dermatologists reported drinking more alcohol during sequestration.

But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.

Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.

“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.

A second EADV survey will be performed during the fall/winter wave of the pandemic.

Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
 

[email protected]

SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D

European dermatologists shifted en masse to teledermatology during the first wave of the COVID-19 pandemic, and most of them disliked the videoconferencing experience intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.

“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).

The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.

The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.

Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.

Impact on professional practice

Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.

Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.

Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
 

Impact on dermatologists’ personal lives

About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.

Sixteen percent of dermatologists reported drinking more alcohol during sequestration.

But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.

Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.

“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.

A second EADV survey will be performed during the fall/winter wave of the pandemic.

Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
 

[email protected]

SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D

There were more new cases of COVID-19 reported in children during the week ending Oct. 29 than any other week during the pandemic, the American Academy of Pediatrics announced Nov. 2.

For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.

“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”

For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.

Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.

In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.

These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.

“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.

[email protected]

There were more new cases of COVID-19 reported in children during the week ending Oct. 29 than any other week during the pandemic, the American Academy of Pediatrics announced Nov. 2.

For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.

“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”

For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.

Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.

In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.

These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.

“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.

[email protected]

There were more new cases of COVID-19 reported in children during the week ending Oct. 29 than any other week during the pandemic, the American Academy of Pediatrics announced Nov. 2.

For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.

“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”

For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.

Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.

In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.

These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.

“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.

[email protected]

Biologic therapy for psoriasis may protect against severe COVID-19, according to two large observational studies from Italy and France presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

“Biologics seem to be very protective against severe, poor-prognosis COVID-19, but they do not prevent infection with the virus,” reported Giovanni Damiani, MD, a dermatologist at the University of Milan.

This apparent protective effect of biologic agents against severe and even fatal COVID-19 is all the more impressive because the psoriasis patients included in the Italian study – as is true of those elsewhere throughout the world – had relatively high rates of obesity, smoking, and chronic obstructive pulmonary disease, known risk factors for severe COVID-19, he added.

He presented a case-control study including 1,193 adult psoriasis patients on biologics or apremilast (Otezla) at Milan’s San Donato Hospital during the period from Feb. 21 to April 9, 2020. The control group comprised more than 10 million individuals, the entire adult population of the Lombardy region, of which Milan is the capital. This was the hardest-hit area in all of Italy during the first wave of COVID-19.

Twenty-two of the 1,193 psoriasis patients experienced confirmed COVID-19 during the study period. Seventeen were quarantined at home because their disease was mild. Five were hospitalized. But no psoriasis patients were placed in intensive care, and none died.

Psoriasis patients on biologics were significantly more likely than the general Lombardian population to test positive for COVID-19, with an unadjusted odds ratio of 3.43. They were at 9.05-fold increased risk of home quarantine for mild disease, and at 3.59-fold greater risk than controls for hospitalization for COVID-19. However, they were not at significantly increased risk of ICU admission. And while they actually had a 59% relative risk reduction for death, this didn’t achieve statistical significance.

Forty-five percent of the psoriasis patients were on an interleukin-17 (IL-17) inhibitor, 22% were on a tumor necrosis factor–alpha inhibitor, and 20% were taking an IL-12/23 inhibitor. Of note, none of 77 patients on apremilast developed COVID-19, even though it is widely considered a less potent psoriasis therapy than the injectable monoclonal antibody biologics.

The French experience

Anne-Claire Fougerousse, MD, and her French coinvestigators conducted a study designed to address a different question: Is it safe to start psoriasis patients on biologics or older conventional systemic agents such as methotrexate during the pandemic?

She presented a French national cross-sectional study of 1,418 adult psoriasis patients on a biologic or standard systemic therapy during a snapshot in time near the peak of the first wave of the pandemic in France: the period from April 27 to May 7, 2020. The group included 1,188 psoriasis patients on maintenance therapy and 230 who had initiated systemic treatment within the past 4 months. More than one-third of the patients had at least one risk factor for severe COVID-19.

Although testing wasn’t available to confirm all cases, 54 patients developed probable COVID-19 during the study period. Only five required hospitalization. None died. The two hospitalized psoriasis patients admitted to an ICU had obesity as a risk factor for severe COVID-19, as did another of the five hospitalized patients, reported Dr. Fougerousse, a dermatologist at the Bégin Military Teaching Hospital in Saint-Mandé, France. Hospitalization for COVID-19 was required in 0.43% of the French treatment initiators, not significantly different from the 0.34% rate in patients on maintenance systemic therapy. A study limitation was the lack of a control group.

Nonetheless, the data did answer the investigators’ main question: “This is the first data showing no increased incidence of severe COVID-19 in psoriasis patients receiving systemic therapy in the treatment initiation period compared to those on maintenance therapy. This may now allow physicians to initiate conventional systemic or biologic therapy in patients with severe psoriasis on a case-by-case basis in the context of the persistent COVID-19 pandemic,” Dr. Fougerousse concluded.


 

Proposed mechanism of benefit

The Italian study findings that biologics boost the risk of infection with the SARS-CoV-2 virus in psoriasis patients while potentially protecting them against ICU admission and death are backed by a biologically plausible albeit as yet unproven mechanism of action, Dr. Damiani asserted.

He elaborated: A vast body of high-quality clinical trials data demonstrates that these targeted immunosuppressive agents are associated with modestly increased risk of viral infections, including both skin and respiratory tract infections. So there is no reason to suppose these agents would offer protection against the first phase of COVID-19, involving SARS-CoV-2 infection, nor protect against the second (pulmonary phase), whose hallmarks are dyspnea with or without hypoxia. But progression to the third phase, involving hyperinflammation and hypercoagulation – dubbed the cytokine storm – could be a different matter.

“Of particular interest was that our patients on IL-17 inhibitors displayed a really great outcome. Interleukin-17 has procoagulant and prothrombotic effects, organizes bronchoalveolar remodeling, has a profibrotic effect, induces mitochondrial dysfunction, and encourages dendritic cell migration in peribronchial lymph nodes. Therefore, by antagonizing this interleukin, we may have a better prognosis, although further studies are needed to be certain,” Dr. Damiani commented.
 

Publication of his preliminary findings drew the attention of a group of highly respected thought leaders in psoriasis, including James G. Krueger, MD, head of the laboratory for investigative dermatology and codirector of the center for clinical and investigative science at Rockefeller University, New York.

The Italian report prompted them to analyze data from the phase 4, double-blind, randomized ObePso-S study investigating the effects of the IL-17 inhibitor secukinumab (Cosentyx) on systemic inflammatory markers and gene expression in psoriasis patients. The investigators demonstrated that IL-17–mediated inflammation in psoriasis patients was associated with increased expression of the angiotensin-converting enzyme 2 (ACE2) receptor in lesional skin, and that treatment with secukinumab dropped ACE2 expression to levels seen in nonlesional skin. Given that ACE2 is the chief portal of entry for SARS-CoV-2 and that IL-17 exerts systemic proinflammatory effects, it’s plausible that inhibition of IL-17–mediated inflammation via dampening of ACE2 expression in noncutaneous epithelia “could prove to be advantageous in patients with psoriasis who are at risk for SARS-CoV-2 infection,” according to Dr. Krueger and his coinvestigators in the Journal of Allergy and Clinical Immunology.

Dr. Damiani and Dr. Fougerousse reported having no financial conflicts regarding their studies. The secukinumab/ACE2 receptor study was funded by Novartis.
 

[email protected]

Biologic therapy for psoriasis may protect against severe COVID-19, according to two large observational studies from Italy and France presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

“Biologics seem to be very protective against severe, poor-prognosis COVID-19, but they do not prevent infection with the virus,” reported Giovanni Damiani, MD, a dermatologist at the University of Milan.

This apparent protective effect of biologic agents against severe and even fatal COVID-19 is all the more impressive because the psoriasis patients included in the Italian study – as is true of those elsewhere throughout the world – had relatively high rates of obesity, smoking, and chronic obstructive pulmonary disease, known risk factors for severe COVID-19, he added.

He presented a case-control study including 1,193 adult psoriasis patients on biologics or apremilast (Otezla) at Milan’s San Donato Hospital during the period from Feb. 21 to April 9, 2020. The control group comprised more than 10 million individuals, the entire adult population of the Lombardy region, of which Milan is the capital. This was the hardest-hit area in all of Italy during the first wave of COVID-19.

Twenty-two of the 1,193 psoriasis patients experienced confirmed COVID-19 during the study period. Seventeen were quarantined at home because their disease was mild. Five were hospitalized. But no psoriasis patients were placed in intensive care, and none died.

Psoriasis patients on biologics were significantly more likely than the general Lombardian population to test positive for COVID-19, with an unadjusted odds ratio of 3.43. They were at 9.05-fold increased risk of home quarantine for mild disease, and at 3.59-fold greater risk than controls for hospitalization for COVID-19. However, they were not at significantly increased risk of ICU admission. And while they actually had a 59% relative risk reduction for death, this didn’t achieve statistical significance.

Forty-five percent of the psoriasis patients were on an interleukin-17 (IL-17) inhibitor, 22% were on a tumor necrosis factor–alpha inhibitor, and 20% were taking an IL-12/23 inhibitor. Of note, none of 77 patients on apremilast developed COVID-19, even though it is widely considered a less potent psoriasis therapy than the injectable monoclonal antibody biologics.

The French experience

Anne-Claire Fougerousse, MD, and her French coinvestigators conducted a study designed to address a different question: Is it safe to start psoriasis patients on biologics or older conventional systemic agents such as methotrexate during the pandemic?

She presented a French national cross-sectional study of 1,418 adult psoriasis patients on a biologic or standard systemic therapy during a snapshot in time near the peak of the first wave of the pandemic in France: the period from April 27 to May 7, 2020. The group included 1,188 psoriasis patients on maintenance therapy and 230 who had initiated systemic treatment within the past 4 months. More than one-third of the patients had at least one risk factor for severe COVID-19.

Although testing wasn’t available to confirm all cases, 54 patients developed probable COVID-19 during the study period. Only five required hospitalization. None died. The two hospitalized psoriasis patients admitted to an ICU had obesity as a risk factor for severe COVID-19, as did another of the five hospitalized patients, reported Dr. Fougerousse, a dermatologist at the Bégin Military Teaching Hospital in Saint-Mandé, France. Hospitalization for COVID-19 was required in 0.43% of the French treatment initiators, not significantly different from the 0.34% rate in patients on maintenance systemic therapy. A study limitation was the lack of a control group.

Nonetheless, the data did answer the investigators’ main question: “This is the first data showing no increased incidence of severe COVID-19 in psoriasis patients receiving systemic therapy in the treatment initiation period compared to those on maintenance therapy. This may now allow physicians to initiate conventional systemic or biologic therapy in patients with severe psoriasis on a case-by-case basis in the context of the persistent COVID-19 pandemic,” Dr. Fougerousse concluded.


 

Proposed mechanism of benefit

The Italian study findings that biologics boost the risk of infection with the SARS-CoV-2 virus in psoriasis patients while potentially protecting them against ICU admission and death are backed by a biologically plausible albeit as yet unproven mechanism of action, Dr. Damiani asserted.

He elaborated: A vast body of high-quality clinical trials data demonstrates that these targeted immunosuppressive agents are associated with modestly increased risk of viral infections, including both skin and respiratory tract infections. So there is no reason to suppose these agents would offer protection against the first phase of COVID-19, involving SARS-CoV-2 infection, nor protect against the second (pulmonary phase), whose hallmarks are dyspnea with or without hypoxia. But progression to the third phase, involving hyperinflammation and hypercoagulation – dubbed the cytokine storm – could be a different matter.

“Of particular interest was that our patients on IL-17 inhibitors displayed a really great outcome. Interleukin-17 has procoagulant and prothrombotic effects, organizes bronchoalveolar remodeling, has a profibrotic effect, induces mitochondrial dysfunction, and encourages dendritic cell migration in peribronchial lymph nodes. Therefore, by antagonizing this interleukin, we may have a better prognosis, although further studies are needed to be certain,” Dr. Damiani commented.
 

Publication of his preliminary findings drew the attention of a group of highly respected thought leaders in psoriasis, including James G. Krueger, MD, head of the laboratory for investigative dermatology and codirector of the center for clinical and investigative science at Rockefeller University, New York.

The Italian report prompted them to analyze data from the phase 4, double-blind, randomized ObePso-S study investigating the effects of the IL-17 inhibitor secukinumab (Cosentyx) on systemic inflammatory markers and gene expression in psoriasis patients. The investigators demonstrated that IL-17–mediated inflammation in psoriasis patients was associated with increased expression of the angiotensin-converting enzyme 2 (ACE2) receptor in lesional skin, and that treatment with secukinumab dropped ACE2 expression to levels seen in nonlesional skin. Given that ACE2 is the chief portal of entry for SARS-CoV-2 and that IL-17 exerts systemic proinflammatory effects, it’s plausible that inhibition of IL-17–mediated inflammation via dampening of ACE2 expression in noncutaneous epithelia “could prove to be advantageous in patients with psoriasis who are at risk for SARS-CoV-2 infection,” according to Dr. Krueger and his coinvestigators in the Journal of Allergy and Clinical Immunology.

Dr. Damiani and Dr. Fougerousse reported having no financial conflicts regarding their studies. The secukinumab/ACE2 receptor study was funded by Novartis.
 

[email protected]

Biologic therapy for psoriasis may protect against severe COVID-19, according to two large observational studies from Italy and France presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

“Biologics seem to be very protective against severe, poor-prognosis COVID-19, but they do not prevent infection with the virus,” reported Giovanni Damiani, MD, a dermatologist at the University of Milan.

This apparent protective effect of biologic agents against severe and even fatal COVID-19 is all the more impressive because the psoriasis patients included in the Italian study – as is true of those elsewhere throughout the world – had relatively high rates of obesity, smoking, and chronic obstructive pulmonary disease, known risk factors for severe COVID-19, he added.

He presented a case-control study including 1,193 adult psoriasis patients on biologics or apremilast (Otezla) at Milan’s San Donato Hospital during the period from Feb. 21 to April 9, 2020. The control group comprised more than 10 million individuals, the entire adult population of the Lombardy region, of which Milan is the capital. This was the hardest-hit area in all of Italy during the first wave of COVID-19.

Twenty-two of the 1,193 psoriasis patients experienced confirmed COVID-19 during the study period. Seventeen were quarantined at home because their disease was mild. Five were hospitalized. But no psoriasis patients were placed in intensive care, and none died.

Psoriasis patients on biologics were significantly more likely than the general Lombardian population to test positive for COVID-19, with an unadjusted odds ratio of 3.43. They were at 9.05-fold increased risk of home quarantine for mild disease, and at 3.59-fold greater risk than controls for hospitalization for COVID-19. However, they were not at significantly increased risk of ICU admission. And while they actually had a 59% relative risk reduction for death, this didn’t achieve statistical significance.

Forty-five percent of the psoriasis patients were on an interleukin-17 (IL-17) inhibitor, 22% were on a tumor necrosis factor–alpha inhibitor, and 20% were taking an IL-12/23 inhibitor. Of note, none of 77 patients on apremilast developed COVID-19, even though it is widely considered a less potent psoriasis therapy than the injectable monoclonal antibody biologics.

The French experience

Anne-Claire Fougerousse, MD, and her French coinvestigators conducted a study designed to address a different question: Is it safe to start psoriasis patients on biologics or older conventional systemic agents such as methotrexate during the pandemic?

She presented a French national cross-sectional study of 1,418 adult psoriasis patients on a biologic or standard systemic therapy during a snapshot in time near the peak of the first wave of the pandemic in France: the period from April 27 to May 7, 2020. The group included 1,188 psoriasis patients on maintenance therapy and 230 who had initiated systemic treatment within the past 4 months. More than one-third of the patients had at least one risk factor for severe COVID-19.

Although testing wasn’t available to confirm all cases, 54 patients developed probable COVID-19 during the study period. Only five required hospitalization. None died. The two hospitalized psoriasis patients admitted to an ICU had obesity as a risk factor for severe COVID-19, as did another of the five hospitalized patients, reported Dr. Fougerousse, a dermatologist at the Bégin Military Teaching Hospital in Saint-Mandé, France. Hospitalization for COVID-19 was required in 0.43% of the French treatment initiators, not significantly different from the 0.34% rate in patients on maintenance systemic therapy. A study limitation was the lack of a control group.

Nonetheless, the data did answer the investigators’ main question: “This is the first data showing no increased incidence of severe COVID-19 in psoriasis patients receiving systemic therapy in the treatment initiation period compared to those on maintenance therapy. This may now allow physicians to initiate conventional systemic or biologic therapy in patients with severe psoriasis on a case-by-case basis in the context of the persistent COVID-19 pandemic,” Dr. Fougerousse concluded.


 

Proposed mechanism of benefit

The Italian study findings that biologics boost the risk of infection with the SARS-CoV-2 virus in psoriasis patients while potentially protecting them against ICU admission and death are backed by a biologically plausible albeit as yet unproven mechanism of action, Dr. Damiani asserted.

He elaborated: A vast body of high-quality clinical trials data demonstrates that these targeted immunosuppressive agents are associated with modestly increased risk of viral infections, including both skin and respiratory tract infections. So there is no reason to suppose these agents would offer protection against the first phase of COVID-19, involving SARS-CoV-2 infection, nor protect against the second (pulmonary phase), whose hallmarks are dyspnea with or without hypoxia. But progression to the third phase, involving hyperinflammation and hypercoagulation – dubbed the cytokine storm – could be a different matter.

“Of particular interest was that our patients on IL-17 inhibitors displayed a really great outcome. Interleukin-17 has procoagulant and prothrombotic effects, organizes bronchoalveolar remodeling, has a profibrotic effect, induces mitochondrial dysfunction, and encourages dendritic cell migration in peribronchial lymph nodes. Therefore, by antagonizing this interleukin, we may have a better prognosis, although further studies are needed to be certain,” Dr. Damiani commented.
 

Publication of his preliminary findings drew the attention of a group of highly respected thought leaders in psoriasis, including James G. Krueger, MD, head of the laboratory for investigative dermatology and codirector of the center for clinical and investigative science at Rockefeller University, New York.

The Italian report prompted them to analyze data from the phase 4, double-blind, randomized ObePso-S study investigating the effects of the IL-17 inhibitor secukinumab (Cosentyx) on systemic inflammatory markers and gene expression in psoriasis patients. The investigators demonstrated that IL-17–mediated inflammation in psoriasis patients was associated with increased expression of the angiotensin-converting enzyme 2 (ACE2) receptor in lesional skin, and that treatment with secukinumab dropped ACE2 expression to levels seen in nonlesional skin. Given that ACE2 is the chief portal of entry for SARS-CoV-2 and that IL-17 exerts systemic proinflammatory effects, it’s plausible that inhibition of IL-17–mediated inflammation via dampening of ACE2 expression in noncutaneous epithelia “could prove to be advantageous in patients with psoriasis who are at risk for SARS-CoV-2 infection,” according to Dr. Krueger and his coinvestigators in the Journal of Allergy and Clinical Immunology.

Dr. Damiani and Dr. Fougerousse reported having no financial conflicts regarding their studies. The secukinumab/ACE2 receptor study was funded by Novartis.
 

[email protected]

The Pharmaceutical Research and Manufacturers of America led the health sector in spending on lobbying through the first three quarters of 2020, and health care as a whole spent more than any of the other 12 sectors of the U.S. economy, according to the Center for Responsive Politics.

PhRMA spent $20.7 million on lobbying through the end of September, good enough for third on the overall list of U.S. companies and organizations. Three other members of the health sector made the top 10: the American Hospital Association ($18.3 million), BlueCross/BlueShield ($16.3 million), and the American Medical Association ($15.2 million), the center reported.

Total spending by the health sector was $464 million from Jan. 1 to Sept. 30, topping the finance/insurance/real estate sector at $403 million, and miscellaneous business at $371 million. Miscellaneous business is the home of the U.S. Chamber of Commerce, the annual leader in such spending for the last 20 years, based on data from the Senate Office of Public Records.

The largest share of health sector spending came from pharmaceuticals/health products, with a total of almost $233 million, just slightly more than the sector’s four other constituents combined: hospitals/nursing homes ($80 million), health services/HMOs ($75 million), health professionals ($67 million), and miscellaneous health ($9.5 million), the center said on OpenSecrets.org.

Taking one step down from the sector level, that $233 million made pharmaceuticals/health products the highest spending of about 100 industries in 2020, nearly doubling the efforts of electronics manufacturing and equipment ($118 million), which came a distant second. Hospitals/nursing homes was eighth on the industry list, the center noted.

[email protected]

The Pharmaceutical Research and Manufacturers of America led the health sector in spending on lobbying through the first three quarters of 2020, and health care as a whole spent more than any of the other 12 sectors of the U.S. economy, according to the Center for Responsive Politics.

PhRMA spent $20.7 million on lobbying through the end of September, good enough for third on the overall list of U.S. companies and organizations. Three other members of the health sector made the top 10: the American Hospital Association ($18.3 million), BlueCross/BlueShield ($16.3 million), and the American Medical Association ($15.2 million), the center reported.

Total spending by the health sector was $464 million from Jan. 1 to Sept. 30, topping the finance/insurance/real estate sector at $403 million, and miscellaneous business at $371 million. Miscellaneous business is the home of the U.S. Chamber of Commerce, the annual leader in such spending for the last 20 years, based on data from the Senate Office of Public Records.

The largest share of health sector spending came from pharmaceuticals/health products, with a total of almost $233 million, just slightly more than the sector’s four other constituents combined: hospitals/nursing homes ($80 million), health services/HMOs ($75 million), health professionals ($67 million), and miscellaneous health ($9.5 million), the center said on OpenSecrets.org.

Taking one step down from the sector level, that $233 million made pharmaceuticals/health products the highest spending of about 100 industries in 2020, nearly doubling the efforts of electronics manufacturing and equipment ($118 million), which came a distant second. Hospitals/nursing homes was eighth on the industry list, the center noted.

[email protected]

The Pharmaceutical Research and Manufacturers of America led the health sector in spending on lobbying through the first three quarters of 2020, and health care as a whole spent more than any of the other 12 sectors of the U.S. economy, according to the Center for Responsive Politics.

PhRMA spent $20.7 million on lobbying through the end of September, good enough for third on the overall list of U.S. companies and organizations. Three other members of the health sector made the top 10: the American Hospital Association ($18.3 million), BlueCross/BlueShield ($16.3 million), and the American Medical Association ($15.2 million), the center reported.

Total spending by the health sector was $464 million from Jan. 1 to Sept. 30, topping the finance/insurance/real estate sector at $403 million, and miscellaneous business at $371 million. Miscellaneous business is the home of the U.S. Chamber of Commerce, the annual leader in such spending for the last 20 years, based on data from the Senate Office of Public Records.

The largest share of health sector spending came from pharmaceuticals/health products, with a total of almost $233 million, just slightly more than the sector’s four other constituents combined: hospitals/nursing homes ($80 million), health services/HMOs ($75 million), health professionals ($67 million), and miscellaneous health ($9.5 million), the center said on OpenSecrets.org.

Taking one step down from the sector level, that $233 million made pharmaceuticals/health products the highest spending of about 100 industries in 2020, nearly doubling the efforts of electronics manufacturing and equipment ($118 million), which came a distant second. Hospitals/nursing homes was eighth on the industry list, the center noted.

[email protected]

“I disapprove of what you say, but I will defend to the death your right to say it.” The choice of the secretary general of the European Association for Cardio-Thoracic Surgery to open with this quote was the first hint that the next presentation at the 2019 annual meeting would be anything but dull. The session chair followed with a reminder to keep the discussion polite and civil.

Presenter David Taggart, MD, PhD, did not disappoint. The professor of cardiovascular surgery at the University of Oxford (England) began with the announcement that he had withdrawn his name from a recent paper in the New England Journal of Medicine. He then proceeded to accuse his coinvestigators of misrepresenting the findings of a major clinical trial.

Dr. Taggart was chair of the surgical committee for the Abbott-sponsored EXCEL trial, which compared two procedures for patients who had blockages in their left main coronary artery: percutaneous coronary intervention (PCI) using coronary stents, and coronary artery bypass graft surgery (CABG). The investigators designed the trial to compare outcomes for the two treatments using a composite endpoint of death, stroke, and MI. The 3-year follow-up data had been published in NEJM without controversy – or, at least, without public controversy.

But when it came time to publish the 5-year follow-up, there was a significantly higher rate of death in the stent group, and both Dr. Taggart and the journal editors were concerned that this finding was being downplayed in the manuscript.

In their comments to the authors, the journal editors had recommended including the mortality difference (unless clearly trivial) ‘”in the concluding statement in the final paragraph.” Yet, the concluding statement of the published paper read that there “was no significant difference between PCI and CABG.”

In Dr. Taggart’s view, that claim was dangerous for patients, and so he was left with no choice but to remove himself as an author, a first for the academic with over 300 scientific papers to his name.

Earlier publications from the EXCEL trial had influenced European treatment guidelines. But subsequent allegations of misconduct and hidden data spurred the EACTS to repudiate those guidelines out of concern “that some results in the EXCEL trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice.”

The controversy pitted cardiothoracic surgeons against interventional cardiologists, who were seen as increasingly encroaching on the surgeons’ turf. Dr. Taggart was a long-time critic of the subspecialty.

Surgeons demanded an independent analysis of the EXCEL trial data – a demand that the investigators have yet to satisfy. Dr. Taggart was the first to speak publicly, but others had major reservations about the trial reporting and conduct years earlier.
 

Mortality data held back

One such person was Lars Wallentin, MD, a professor of cardiology at Uppsala (Sweden) University Hospital, who chaired the independent committee that monitored the safety and scientific validity of the EXCEL trial.

The committee, known as the data and safety monitoring board (DSMB), received a report on March 23, 2016, that showed that increasingly more patients who had received stents were dying, compared with the group of patients that had undergone CABG. A graph of the survival curves showed the gap between the two groups widening after 3 years (Figure 1).

By September of that year, Dr. Wallentin and other members of the DSMB were anxious to share the concerning mortality difference with the broader medical community.

They were aware that EACTS and the European Society of Cardiology had started the process of updating their guidelines on myocardial revascularization, and were keen for the guideline writing committee to see all of the data.

Meanwhile, the trial investigators, led by principal investigator Gregg Stone, MD, then at New York–Presbyterian Hospital and Columbia University Medical Center, were preparing to publish a report of the 3-year outcomes. Recruitment for EXCEL started in September 2010, so at the time of the 3-year analysis in 2016, some patients had been followed up for over 5 years. But the data, published in NEJM in October 2016, were capped at 3 years (Figure 2). It didn’t show the widening gap in late mortality that Dr. Wallentin and the rest of the DSMB had seen.

When asked about this, the investigators said they were transparent about their plans to cap the data at 3 years in an amendment to the study protocol. Stone’s coprincipal investigators were interventional cardiologist Patrick Serruys, MD, then of Imperial College London; and two surgeons: Joseph Sabik, MD, then of the Cleveland Clinic Foundation, and A. Pieter Kappetein, MD, PhD, then at Erasmus Medical Center, Rotterdam. The four principal investigators all declared financial payments from stent manufacturers either to themselves or their institutions.

Study sponsor Abbott has distanced itself from the decisions made and has referred all questions about the trial to the EXCEL investigators. Charles Simonton, chief medical officer at Abbott (now at Abiomed) was a coauthor on both the 3- and 5-year papers. Dr. Wallentin believes that the sponsor must have been aware of the DSMB’s concerns.
 

Continuing DSMB concerns

A year later, the DSMB was still troubled. Dr. Wallentin emailed Dr. Stone in September 2017 asking for an updated analysis of the mortality data without any capping in time.

Dr. Wallentin added that he didn’t think that unblinding the mortality results would be an issue at that stage because these were late deaths in a trial where the interventions were long completed. But, he warned, “it might be very concerning if, in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community.”

The investigators took a month to respond. They declined the request, saying that the trial was not statistically powered to measure mortality. In his email to Dr. Wallentin, Dr. Stone stressed that they were committed to complete disclosure of all of the EXCEL data and that the responsible time point to unblind was after 4 years. His coprincipal investigators (Dr. Serruys, Dr. Sabik, and Dr. Kappetein) as well as EXCEL statistical committee chair Stuart Pocock, PhD, and Mr. Simonton were all copied on the email.

Dr. Wallentin deferred to the principal investigators’ arguments.
 

Missing MI data

Death was not the only outcome of the EXCEL trial to draw scrutiny.

The EXCEL investigators used a unique definition of MI that was almost exclusively based on a rise in the cardiac biomarker CK-MB. This protocol definition of MI was later adapted into the Society for Cardiovascular Angiography and Interventions definition in a paper coauthored by Dr. Stone. The investigators agreed to also measure MIs that met the more commonly used Third Universal Definition as a secondary endpoint. The Third Universal Definition of Myocardial Infarction uses a change in biomarkers – preferably troponin or alternatively CK-MB – coupled with other clinical signs.

It is standard practice to report secondary endpoints in any analysis of the main findings of a study. Yet, the EXCEL investigators did not report the universal definition of MI in either the 3-year or 5-year publications.

This is critical because MI according to one definition may not count according to the other, and the final tally could tip the trial results positive, negative, or neutral for coronary stents.

In Dr. Taggart’s opinion, the protocol definition puts CABG at a disadvantage because it uses the same biomarker threshold for procedural-related MI for both PCI and CABG. Because surgery involves more manipulation of the heart, cardiac enzyme levels will naturally be higher after CABG than PCI. These procedure-related enzyme elevations are not “true clinical MIs,” according to Dr. Taggart and others.

Late last year, a dataset containing the 3-year follow-up of EXCEL, including the information on the universal definition of MI, was leaked to the BBC. Working with biostatisticians, the BBC confirmed that according to this definition, there were more MIs in the stent group.

Originally, the investigators disputed the finding, calling the BBC data “imaginary.” They claimed that they were unable to calculate a rate of MI according to the universal definition because they lacked routine collection of troponins, although the universal definition also allows use of CK-MB. They have since published an analysis of 5-year MI data according to the universal definition, which showed twice the rate of MI in the PCI group.

From the leaked data, the BBC calculated the main composite endpoint of death, stroke, and MI using the universal definition of MI. Now the results swung in favor of CABG.
 

Impact on guidelines

None of this was known at the time the European cardiology societies convened a committee to write their new guidelines on myocardial revascularization. The writing panel disagreed about whether PCI and CABG were equivalent for patients with left main coronary artery disease (CAD).

Besides EXCEL, another study, the NOBLE trial, compared PCI and CABG in left main CAD and came to opposite conclusions – conclusions that matched the leaked data. In that trial, European investigators chose a slightly different primary endpoint: a composite of death, MI, stroke, and the need for a repeat procedure. They used the universal definition of MI exclusively, and notably, they omitted procedural MI from their clinical event count. The results, published at the same time as the EXCEL 3-year findings, suggested that CABG was better.

Given the discrepant findings of two large trials, the guideline committee considered all of the available data comparing the two methods of revascularization for left main CAD. But even then, things weren’t clear-cut. One draft meta-analysis, supported by the National Institute for Health Research, suggested that results were worse for first- and second-generation drug-eluting coronary stents – including those used in EXCEL – compared with surgery.

Another meta-analysis, later published in The Lancet, drew a different conclusion and found that PCI was just as good as surgery. The main author, Stuart Head, a cardiothoracic surgeon on the ESC/EACTS guideline committee, was a research fellow with EXCEL investigator Dr. Kappetein at Erasmus. EXCEL investigators Dr. Stone, Dr. Kappetein, and Dr. Serruys were coauthors of the Lancet meta-analysis.

There was heated discussion about the committee’s draft recommendations, which gave both CABG and PCI a Class IA recommendation in patients with left main CAD and low anatomical complexity. In October 2017, the ESC commissioned an anonymous external reviewer to weigh in. James Brophy, MD, PhD, a cardiologist and professor of medicine and epidemiology at McGill University, Montreal, confirmed that he was the reviewer after he published an updated version in June 2020.

Looking at all of the data available at the time comparing the procedures for left main CAD, Dr. Brophy’s analysis suggested a 73% chance that the excess in death, stroke, or MI represents at least two excess events per 100 patients treated with PCI rather than CABG.

Dr. Brophy thought that most patients would find these differences clinically meaningful and advised against giving both procedures the same class of recommendation. He was also concerned that many readers will skip to the summary recommendation table without reading the entire guideline document.

“I feel this is misleading in its present form,” he wrote in 2017.

Despite Dr. Brophy’s review, the guideline committee stuck with its original recommendations. The final 2018 ESC/EACTS Guidelines on myocardial revascularization gave equal weight to both CABG and PCI in patients with left main CAD and low anatomical complexity. In contrast, US guidelines do not put PCI and CABG on the same footing for any group of patients with left main CAD.

The lead author of the ESC/EACTS guidelines section on left main disease, and around a third of those on the writing task force, all declared financial payments from stent manufacturers either to themselves or their institutions. The EXCEL principal investigator, Dr. Kappetein, was secretary general of EACTS and oversaw the guidelines process for the surgical organization. He left to work for Medtronic midway through the process and was later joined there by his former research fellow, Stuart Head.

Dr. Brophy said in an interview that given the final guideline recommendations, he assumed that the committee had other reviews and went with the majority opinion.

But not everyone involved in the guidelines saw Dr. Brophy’s review. Nick Freemantle, a statistical reviewer appointed by EACTS, expected to see it but didn’t. This omission calls into question the neutrality of the whole process, in his view.

Mr. Freemantle believes that the deck was stacked so that he only saw the pieces of evidence that supported the conclusions that were already decided and that he was not shown “the bits that don’t fit that neatly.”

“And without that narrative, it all feels a bit grubby, to be honest,” he said.

Professor Barbara Casadei, ESC president, disputed this, saying that the guidelines were approved by all surgical members, including the EACTS council.

Missing from Dr. Brophy’s review were the later data from EXCEL. As he had told the DSMB in 2017, Stone presented the 4-year data from EXCEL at the TCT conference in September 2018. At this point, the analysis showed that 10.3% of people had died after PCI and 7.4% after CABG.

But this presentation was not given much prominence at the conference, which Dr. Stone organized, and occurred during a didactic session in a small room rather than on one of the main stages where the 3-year data from EXCEL were announced with much fanfare. The presentation also took place 3 weeks after the European guidelines were published.
 

Surgeons withdraw support

After the BBC report last year that the universal definition of MI data had been collected but not published in the 3-year follow-up manuscript, and showed more MI in the PCI group than the protocol definition, the EACTS withdrew its support for the guidelines. The ESC continued to uphold the guidelines «until there is robust scientific evidence (as opposed to allegations) indicating we should do otherwise,” said Ms. Casadei.

A spokesperson for NEJM said the journal stood by the EXCEL papers because “there is no credible harm to patients from the publication of the paper and accurate reporting of trial results.” NEJM has since conducted a review and published a series of letters in response. The letters have reinvigorated rather than appeased the dissenters, as reported by Medscape.

A number of cardiologists and researchers started a petition on change.org to revise the EACTS/ESC left main CAD guidelines, and surgical societies across the globe have written to the editor of NEJM asking him to retract or amend the EXCEL papers.

This has not happened. The journal’s editor maintains that the letters containing the analyses are “sufficient information” to allow readers and guideline authors to “evaluate the trial findings.”

Dr. Taggart was dismissive of that response. “There is still no recognition or acknowledgment that failure to publish these data in 2016 ‘misled’ the guideline writers for the ESC/EACTS guidelines, and there is still no formal correction of the 2016 and 2019 NEJM manuscripts.”

Over a year after the BBC received the leaked data, the EXCEL investigators published an analysis of the primary outcome using the universal definition of MI data in the Journal of the American College of Cardiology.

It shows 141 events in the PCI arm, compared with 102 in the CABG arm. The investigators acknowledge that the rates of procedural MI differ depending on the definition used. According to their analysis, the protocol definition was predictive of mortality after both treatments, whereas the universal definition of procedural MI was predictive of mortality only after CABG. Not everyone agrees with this interpretation, and an accompanying editorial questioned these conclusions.

For Dr. Wallentin, it’s a relief that these data are in the public domain so that their interpretation and clinical consequences can be “openly discussed.” He hoped that the whole experience will result in something constructive and useful for the future.

As for the guidelines, the tide may be turning.

In a joint statement with EACTS on Oct. 6, 2020, the ESC agreed to review its guidelines for left main disease in the light of emerging, longer-term outcome data from the trials of CABG versus PCI.

Dr. Taggart has no regrets about speaking out despite this being “an exceedingly painful and bruising experience.”

The saga, he said, “reflects very badly on our specialty, the investigators, industry, and the world’s ‘leading’ medical journal.”

This article first appeared on Medscape.com.

“I disapprove of what you say, but I will defend to the death your right to say it.” The choice of the secretary general of the European Association for Cardio-Thoracic Surgery to open with this quote was the first hint that the next presentation at the 2019 annual meeting would be anything but dull. The session chair followed with a reminder to keep the discussion polite and civil.

Presenter David Taggart, MD, PhD, did not disappoint. The professor of cardiovascular surgery at the University of Oxford (England) began with the announcement that he had withdrawn his name from a recent paper in the New England Journal of Medicine. He then proceeded to accuse his coinvestigators of misrepresenting the findings of a major clinical trial.

Dr. Taggart was chair of the surgical committee for the Abbott-sponsored EXCEL trial, which compared two procedures for patients who had blockages in their left main coronary artery: percutaneous coronary intervention (PCI) using coronary stents, and coronary artery bypass graft surgery (CABG). The investigators designed the trial to compare outcomes for the two treatments using a composite endpoint of death, stroke, and MI. The 3-year follow-up data had been published in NEJM without controversy – or, at least, without public controversy.

But when it came time to publish the 5-year follow-up, there was a significantly higher rate of death in the stent group, and both Dr. Taggart and the journal editors were concerned that this finding was being downplayed in the manuscript.

In their comments to the authors, the journal editors had recommended including the mortality difference (unless clearly trivial) ‘”in the concluding statement in the final paragraph.” Yet, the concluding statement of the published paper read that there “was no significant difference between PCI and CABG.”

In Dr. Taggart’s view, that claim was dangerous for patients, and so he was left with no choice but to remove himself as an author, a first for the academic with over 300 scientific papers to his name.

Earlier publications from the EXCEL trial had influenced European treatment guidelines. But subsequent allegations of misconduct and hidden data spurred the EACTS to repudiate those guidelines out of concern “that some results in the EXCEL trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice.”

The controversy pitted cardiothoracic surgeons against interventional cardiologists, who were seen as increasingly encroaching on the surgeons’ turf. Dr. Taggart was a long-time critic of the subspecialty.

Surgeons demanded an independent analysis of the EXCEL trial data – a demand that the investigators have yet to satisfy. Dr. Taggart was the first to speak publicly, but others had major reservations about the trial reporting and conduct years earlier.
 

Mortality data held back

One such person was Lars Wallentin, MD, a professor of cardiology at Uppsala (Sweden) University Hospital, who chaired the independent committee that monitored the safety and scientific validity of the EXCEL trial.

The committee, known as the data and safety monitoring board (DSMB), received a report on March 23, 2016, that showed that increasingly more patients who had received stents were dying, compared with the group of patients that had undergone CABG. A graph of the survival curves showed the gap between the two groups widening after 3 years (Figure 1).

By September of that year, Dr. Wallentin and other members of the DSMB were anxious to share the concerning mortality difference with the broader medical community.

They were aware that EACTS and the European Society of Cardiology had started the process of updating their guidelines on myocardial revascularization, and were keen for the guideline writing committee to see all of the data.

Meanwhile, the trial investigators, led by principal investigator Gregg Stone, MD, then at New York–Presbyterian Hospital and Columbia University Medical Center, were preparing to publish a report of the 3-year outcomes. Recruitment for EXCEL started in September 2010, so at the time of the 3-year analysis in 2016, some patients had been followed up for over 5 years. But the data, published in NEJM in October 2016, were capped at 3 years (Figure 2). It didn’t show the widening gap in late mortality that Dr. Wallentin and the rest of the DSMB had seen.

When asked about this, the investigators said they were transparent about their plans to cap the data at 3 years in an amendment to the study protocol. Stone’s coprincipal investigators were interventional cardiologist Patrick Serruys, MD, then of Imperial College London; and two surgeons: Joseph Sabik, MD, then of the Cleveland Clinic Foundation, and A. Pieter Kappetein, MD, PhD, then at Erasmus Medical Center, Rotterdam. The four principal investigators all declared financial payments from stent manufacturers either to themselves or their institutions.

Study sponsor Abbott has distanced itself from the decisions made and has referred all questions about the trial to the EXCEL investigators. Charles Simonton, chief medical officer at Abbott (now at Abiomed) was a coauthor on both the 3- and 5-year papers. Dr. Wallentin believes that the sponsor must have been aware of the DSMB’s concerns.
 

Continuing DSMB concerns

A year later, the DSMB was still troubled. Dr. Wallentin emailed Dr. Stone in September 2017 asking for an updated analysis of the mortality data without any capping in time.

Dr. Wallentin added that he didn’t think that unblinding the mortality results would be an issue at that stage because these were late deaths in a trial where the interventions were long completed. But, he warned, “it might be very concerning if, in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community.”

The investigators took a month to respond. They declined the request, saying that the trial was not statistically powered to measure mortality. In his email to Dr. Wallentin, Dr. Stone stressed that they were committed to complete disclosure of all of the EXCEL data and that the responsible time point to unblind was after 4 years. His coprincipal investigators (Dr. Serruys, Dr. Sabik, and Dr. Kappetein) as well as EXCEL statistical committee chair Stuart Pocock, PhD, and Mr. Simonton were all copied on the email.

Dr. Wallentin deferred to the principal investigators’ arguments.
 

Missing MI data

Death was not the only outcome of the EXCEL trial to draw scrutiny.

The EXCEL investigators used a unique definition of MI that was almost exclusively based on a rise in the cardiac biomarker CK-MB. This protocol definition of MI was later adapted into the Society for Cardiovascular Angiography and Interventions definition in a paper coauthored by Dr. Stone. The investigators agreed to also measure MIs that met the more commonly used Third Universal Definition as a secondary endpoint. The Third Universal Definition of Myocardial Infarction uses a change in biomarkers – preferably troponin or alternatively CK-MB – coupled with other clinical signs.

It is standard practice to report secondary endpoints in any analysis of the main findings of a study. Yet, the EXCEL investigators did not report the universal definition of MI in either the 3-year or 5-year publications.

This is critical because MI according to one definition may not count according to the other, and the final tally could tip the trial results positive, negative, or neutral for coronary stents.

In Dr. Taggart’s opinion, the protocol definition puts CABG at a disadvantage because it uses the same biomarker threshold for procedural-related MI for both PCI and CABG. Because surgery involves more manipulation of the heart, cardiac enzyme levels will naturally be higher after CABG than PCI. These procedure-related enzyme elevations are not “true clinical MIs,” according to Dr. Taggart and others.

Late last year, a dataset containing the 3-year follow-up of EXCEL, including the information on the universal definition of MI, was leaked to the BBC. Working with biostatisticians, the BBC confirmed that according to this definition, there were more MIs in the stent group.

Originally, the investigators disputed the finding, calling the BBC data “imaginary.” They claimed that they were unable to calculate a rate of MI according to the universal definition because they lacked routine collection of troponins, although the universal definition also allows use of CK-MB. They have since published an analysis of 5-year MI data according to the universal definition, which showed twice the rate of MI in the PCI group.

From the leaked data, the BBC calculated the main composite endpoint of death, stroke, and MI using the universal definition of MI. Now the results swung in favor of CABG.
 

Impact on guidelines

None of this was known at the time the European cardiology societies convened a committee to write their new guidelines on myocardial revascularization. The writing panel disagreed about whether PCI and CABG were equivalent for patients with left main coronary artery disease (CAD).

Besides EXCEL, another study, the NOBLE trial, compared PCI and CABG in left main CAD and came to opposite conclusions – conclusions that matched the leaked data. In that trial, European investigators chose a slightly different primary endpoint: a composite of death, MI, stroke, and the need for a repeat procedure. They used the universal definition of MI exclusively, and notably, they omitted procedural MI from their clinical event count. The results, published at the same time as the EXCEL 3-year findings, suggested that CABG was better.

Given the discrepant findings of two large trials, the guideline committee considered all of the available data comparing the two methods of revascularization for left main CAD. But even then, things weren’t clear-cut. One draft meta-analysis, supported by the National Institute for Health Research, suggested that results were worse for first- and second-generation drug-eluting coronary stents – including those used in EXCEL – compared with surgery.

Another meta-analysis, later published in The Lancet, drew a different conclusion and found that PCI was just as good as surgery. The main author, Stuart Head, a cardiothoracic surgeon on the ESC/EACTS guideline committee, was a research fellow with EXCEL investigator Dr. Kappetein at Erasmus. EXCEL investigators Dr. Stone, Dr. Kappetein, and Dr. Serruys were coauthors of the Lancet meta-analysis.

There was heated discussion about the committee’s draft recommendations, which gave both CABG and PCI a Class IA recommendation in patients with left main CAD and low anatomical complexity. In October 2017, the ESC commissioned an anonymous external reviewer to weigh in. James Brophy, MD, PhD, a cardiologist and professor of medicine and epidemiology at McGill University, Montreal, confirmed that he was the reviewer after he published an updated version in June 2020.

Looking at all of the data available at the time comparing the procedures for left main CAD, Dr. Brophy’s analysis suggested a 73% chance that the excess in death, stroke, or MI represents at least two excess events per 100 patients treated with PCI rather than CABG.

Dr. Brophy thought that most patients would find these differences clinically meaningful and advised against giving both procedures the same class of recommendation. He was also concerned that many readers will skip to the summary recommendation table without reading the entire guideline document.

“I feel this is misleading in its present form,” he wrote in 2017.

Despite Dr. Brophy’s review, the guideline committee stuck with its original recommendations. The final 2018 ESC/EACTS Guidelines on myocardial revascularization gave equal weight to both CABG and PCI in patients with left main CAD and low anatomical complexity. In contrast, US guidelines do not put PCI and CABG on the same footing for any group of patients with left main CAD.

The lead author of the ESC/EACTS guidelines section on left main disease, and around a third of those on the writing task force, all declared financial payments from stent manufacturers either to themselves or their institutions. The EXCEL principal investigator, Dr. Kappetein, was secretary general of EACTS and oversaw the guidelines process for the surgical organization. He left to work for Medtronic midway through the process and was later joined there by his former research fellow, Stuart Head.

Dr. Brophy said in an interview that given the final guideline recommendations, he assumed that the committee had other reviews and went with the majority opinion.

But not everyone involved in the guidelines saw Dr. Brophy’s review. Nick Freemantle, a statistical reviewer appointed by EACTS, expected to see it but didn’t. This omission calls into question the neutrality of the whole process, in his view.

Mr. Freemantle believes that the deck was stacked so that he only saw the pieces of evidence that supported the conclusions that were already decided and that he was not shown “the bits that don’t fit that neatly.”

“And without that narrative, it all feels a bit grubby, to be honest,” he said.

Professor Barbara Casadei, ESC president, disputed this, saying that the guidelines were approved by all surgical members, including the EACTS council.

Missing from Dr. Brophy’s review were the later data from EXCEL. As he had told the DSMB in 2017, Stone presented the 4-year data from EXCEL at the TCT conference in September 2018. At this point, the analysis showed that 10.3% of people had died after PCI and 7.4% after CABG.

But this presentation was not given much prominence at the conference, which Dr. Stone organized, and occurred during a didactic session in a small room rather than on one of the main stages where the 3-year data from EXCEL were announced with much fanfare. The presentation also took place 3 weeks after the European guidelines were published.
 

Surgeons withdraw support

After the BBC report last year that the universal definition of MI data had been collected but not published in the 3-year follow-up manuscript, and showed more MI in the PCI group than the protocol definition, the EACTS withdrew its support for the guidelines. The ESC continued to uphold the guidelines «until there is robust scientific evidence (as opposed to allegations) indicating we should do otherwise,” said Ms. Casadei.

A spokesperson for NEJM said the journal stood by the EXCEL papers because “there is no credible harm to patients from the publication of the paper and accurate reporting of trial results.” NEJM has since conducted a review and published a series of letters in response. The letters have reinvigorated rather than appeased the dissenters, as reported by Medscape.

A number of cardiologists and researchers started a petition on change.org to revise the EACTS/ESC left main CAD guidelines, and surgical societies across the globe have written to the editor of NEJM asking him to retract or amend the EXCEL papers.

This has not happened. The journal’s editor maintains that the letters containing the analyses are “sufficient information” to allow readers and guideline authors to “evaluate the trial findings.”

Dr. Taggart was dismissive of that response. “There is still no recognition or acknowledgment that failure to publish these data in 2016 ‘misled’ the guideline writers for the ESC/EACTS guidelines, and there is still no formal correction of the 2016 and 2019 NEJM manuscripts.”

Over a year after the BBC received the leaked data, the EXCEL investigators published an analysis of the primary outcome using the universal definition of MI data in the Journal of the American College of Cardiology.

It shows 141 events in the PCI arm, compared with 102 in the CABG arm. The investigators acknowledge that the rates of procedural MI differ depending on the definition used. According to their analysis, the protocol definition was predictive of mortality after both treatments, whereas the universal definition of procedural MI was predictive of mortality only after CABG. Not everyone agrees with this interpretation, and an accompanying editorial questioned these conclusions.

For Dr. Wallentin, it’s a relief that these data are in the public domain so that their interpretation and clinical consequences can be “openly discussed.” He hoped that the whole experience will result in something constructive and useful for the future.

As for the guidelines, the tide may be turning.

In a joint statement with EACTS on Oct. 6, 2020, the ESC agreed to review its guidelines for left main disease in the light of emerging, longer-term outcome data from the trials of CABG versus PCI.

Dr. Taggart has no regrets about speaking out despite this being “an exceedingly painful and bruising experience.”

The saga, he said, “reflects very badly on our specialty, the investigators, industry, and the world’s ‘leading’ medical journal.”

This article first appeared on Medscape.com.

“I disapprove of what you say, but I will defend to the death your right to say it.” The choice of the secretary general of the European Association for Cardio-Thoracic Surgery to open with this quote was the first hint that the next presentation at the 2019 annual meeting would be anything but dull. The session chair followed with a reminder to keep the discussion polite and civil.

Presenter David Taggart, MD, PhD, did not disappoint. The professor of cardiovascular surgery at the University of Oxford (England) began with the announcement that he had withdrawn his name from a recent paper in the New England Journal of Medicine. He then proceeded to accuse his coinvestigators of misrepresenting the findings of a major clinical trial.

Dr. Taggart was chair of the surgical committee for the Abbott-sponsored EXCEL trial, which compared two procedures for patients who had blockages in their left main coronary artery: percutaneous coronary intervention (PCI) using coronary stents, and coronary artery bypass graft surgery (CABG). The investigators designed the trial to compare outcomes for the two treatments using a composite endpoint of death, stroke, and MI. The 3-year follow-up data had been published in NEJM without controversy – or, at least, without public controversy.

But when it came time to publish the 5-year follow-up, there was a significantly higher rate of death in the stent group, and both Dr. Taggart and the journal editors were concerned that this finding was being downplayed in the manuscript.

In their comments to the authors, the journal editors had recommended including the mortality difference (unless clearly trivial) ‘”in the concluding statement in the final paragraph.” Yet, the concluding statement of the published paper read that there “was no significant difference between PCI and CABG.”

In Dr. Taggart’s view, that claim was dangerous for patients, and so he was left with no choice but to remove himself as an author, a first for the academic with over 300 scientific papers to his name.

Earlier publications from the EXCEL trial had influenced European treatment guidelines. But subsequent allegations of misconduct and hidden data spurred the EACTS to repudiate those guidelines out of concern “that some results in the EXCEL trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice.”

The controversy pitted cardiothoracic surgeons against interventional cardiologists, who were seen as increasingly encroaching on the surgeons’ turf. Dr. Taggart was a long-time critic of the subspecialty.

Surgeons demanded an independent analysis of the EXCEL trial data – a demand that the investigators have yet to satisfy. Dr. Taggart was the first to speak publicly, but others had major reservations about the trial reporting and conduct years earlier.
 

Mortality data held back

One such person was Lars Wallentin, MD, a professor of cardiology at Uppsala (Sweden) University Hospital, who chaired the independent committee that monitored the safety and scientific validity of the EXCEL trial.

The committee, known as the data and safety monitoring board (DSMB), received a report on March 23, 2016, that showed that increasingly more patients who had received stents were dying, compared with the group of patients that had undergone CABG. A graph of the survival curves showed the gap between the two groups widening after 3 years (Figure 1).

By September of that year, Dr. Wallentin and other members of the DSMB were anxious to share the concerning mortality difference with the broader medical community.

They were aware that EACTS and the European Society of Cardiology had started the process of updating their guidelines on myocardial revascularization, and were keen for the guideline writing committee to see all of the data.

Meanwhile, the trial investigators, led by principal investigator Gregg Stone, MD, then at New York–Presbyterian Hospital and Columbia University Medical Center, were preparing to publish a report of the 3-year outcomes. Recruitment for EXCEL started in September 2010, so at the time of the 3-year analysis in 2016, some patients had been followed up for over 5 years. But the data, published in NEJM in October 2016, were capped at 3 years (Figure 2). It didn’t show the widening gap in late mortality that Dr. Wallentin and the rest of the DSMB had seen.

When asked about this, the investigators said they were transparent about their plans to cap the data at 3 years in an amendment to the study protocol. Stone’s coprincipal investigators were interventional cardiologist Patrick Serruys, MD, then of Imperial College London; and two surgeons: Joseph Sabik, MD, then of the Cleveland Clinic Foundation, and A. Pieter Kappetein, MD, PhD, then at Erasmus Medical Center, Rotterdam. The four principal investigators all declared financial payments from stent manufacturers either to themselves or their institutions.

Study sponsor Abbott has distanced itself from the decisions made and has referred all questions about the trial to the EXCEL investigators. Charles Simonton, chief medical officer at Abbott (now at Abiomed) was a coauthor on both the 3- and 5-year papers. Dr. Wallentin believes that the sponsor must have been aware of the DSMB’s concerns.
 

Continuing DSMB concerns

A year later, the DSMB was still troubled. Dr. Wallentin emailed Dr. Stone in September 2017 asking for an updated analysis of the mortality data without any capping in time.

Dr. Wallentin added that he didn’t think that unblinding the mortality results would be an issue at that stage because these were late deaths in a trial where the interventions were long completed. But, he warned, “it might be very concerning if, in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community.”

The investigators took a month to respond. They declined the request, saying that the trial was not statistically powered to measure mortality. In his email to Dr. Wallentin, Dr. Stone stressed that they were committed to complete disclosure of all of the EXCEL data and that the responsible time point to unblind was after 4 years. His coprincipal investigators (Dr. Serruys, Dr. Sabik, and Dr. Kappetein) as well as EXCEL statistical committee chair Stuart Pocock, PhD, and Mr. Simonton were all copied on the email.

Dr. Wallentin deferred to the principal investigators’ arguments.
 

Missing MI data

Death was not the only outcome of the EXCEL trial to draw scrutiny.

The EXCEL investigators used a unique definition of MI that was almost exclusively based on a rise in the cardiac biomarker CK-MB. This protocol definition of MI was later adapted into the Society for Cardiovascular Angiography and Interventions definition in a paper coauthored by Dr. Stone. The investigators agreed to also measure MIs that met the more commonly used Third Universal Definition as a secondary endpoint. The Third Universal Definition of Myocardial Infarction uses a change in biomarkers – preferably troponin or alternatively CK-MB – coupled with other clinical signs.

It is standard practice to report secondary endpoints in any analysis of the main findings of a study. Yet, the EXCEL investigators did not report the universal definition of MI in either the 3-year or 5-year publications.

This is critical because MI according to one definition may not count according to the other, and the final tally could tip the trial results positive, negative, or neutral for coronary stents.

In Dr. Taggart’s opinion, the protocol definition puts CABG at a disadvantage because it uses the same biomarker threshold for procedural-related MI for both PCI and CABG. Because surgery involves more manipulation of the heart, cardiac enzyme levels will naturally be higher after CABG than PCI. These procedure-related enzyme elevations are not “true clinical MIs,” according to Dr. Taggart and others.

Late last year, a dataset containing the 3-year follow-up of EXCEL, including the information on the universal definition of MI, was leaked to the BBC. Working with biostatisticians, the BBC confirmed that according to this definition, there were more MIs in the stent group.

Originally, the investigators disputed the finding, calling the BBC data “imaginary.” They claimed that they were unable to calculate a rate of MI according to the universal definition because they lacked routine collection of troponins, although the universal definition also allows use of CK-MB. They have since published an analysis of 5-year MI data according to the universal definition, which showed twice the rate of MI in the PCI group.

From the leaked data, the BBC calculated the main composite endpoint of death, stroke, and MI using the universal definition of MI. Now the results swung in favor of CABG.
 

Impact on guidelines

None of this was known at the time the European cardiology societies convened a committee to write their new guidelines on myocardial revascularization. The writing panel disagreed about whether PCI and CABG were equivalent for patients with left main coronary artery disease (CAD).

Besides EXCEL, another study, the NOBLE trial, compared PCI and CABG in left main CAD and came to opposite conclusions – conclusions that matched the leaked data. In that trial, European investigators chose a slightly different primary endpoint: a composite of death, MI, stroke, and the need for a repeat procedure. They used the universal definition of MI exclusively, and notably, they omitted procedural MI from their clinical event count. The results, published at the same time as the EXCEL 3-year findings, suggested that CABG was better.

Given the discrepant findings of two large trials, the guideline committee considered all of the available data comparing the two methods of revascularization for left main CAD. But even then, things weren’t clear-cut. One draft meta-analysis, supported by the National Institute for Health Research, suggested that results were worse for first- and second-generation drug-eluting coronary stents – including those used in EXCEL – compared with surgery.

Another meta-analysis, later published in The Lancet, drew a different conclusion and found that PCI was just as good as surgery. The main author, Stuart Head, a cardiothoracic surgeon on the ESC/EACTS guideline committee, was a research fellow with EXCEL investigator Dr. Kappetein at Erasmus. EXCEL investigators Dr. Stone, Dr. Kappetein, and Dr. Serruys were coauthors of the Lancet meta-analysis.

There was heated discussion about the committee’s draft recommendations, which gave both CABG and PCI a Class IA recommendation in patients with left main CAD and low anatomical complexity. In October 2017, the ESC commissioned an anonymous external reviewer to weigh in. James Brophy, MD, PhD, a cardiologist and professor of medicine and epidemiology at McGill University, Montreal, confirmed that he was the reviewer after he published an updated version in June 2020.

Looking at all of the data available at the time comparing the procedures for left main CAD, Dr. Brophy’s analysis suggested a 73% chance that the excess in death, stroke, or MI represents at least two excess events per 100 patients treated with PCI rather than CABG.

Dr. Brophy thought that most patients would find these differences clinically meaningful and advised against giving both procedures the same class of recommendation. He was also concerned that many readers will skip to the summary recommendation table without reading the entire guideline document.

“I feel this is misleading in its present form,” he wrote in 2017.

Despite Dr. Brophy’s review, the guideline committee stuck with its original recommendations. The final 2018 ESC/EACTS Guidelines on myocardial revascularization gave equal weight to both CABG and PCI in patients with left main CAD and low anatomical complexity. In contrast, US guidelines do not put PCI and CABG on the same footing for any group of patients with left main CAD.

The lead author of the ESC/EACTS guidelines section on left main disease, and around a third of those on the writing task force, all declared financial payments from stent manufacturers either to themselves or their institutions. The EXCEL principal investigator, Dr. Kappetein, was secretary general of EACTS and oversaw the guidelines process for the surgical organization. He left to work for Medtronic midway through the process and was later joined there by his former research fellow, Stuart Head.

Dr. Brophy said in an interview that given the final guideline recommendations, he assumed that the committee had other reviews and went with the majority opinion.

But not everyone involved in the guidelines saw Dr. Brophy’s review. Nick Freemantle, a statistical reviewer appointed by EACTS, expected to see it but didn’t. This omission calls into question the neutrality of the whole process, in his view.

Mr. Freemantle believes that the deck was stacked so that he only saw the pieces of evidence that supported the conclusions that were already decided and that he was not shown “the bits that don’t fit that neatly.”

“And without that narrative, it all feels a bit grubby, to be honest,” he said.

Professor Barbara Casadei, ESC president, disputed this, saying that the guidelines were approved by all surgical members, including the EACTS council.

Missing from Dr. Brophy’s review were the later data from EXCEL. As he had told the DSMB in 2017, Stone presented the 4-year data from EXCEL at the TCT conference in September 2018. At this point, the analysis showed that 10.3% of people had died after PCI and 7.4% after CABG.

But this presentation was not given much prominence at the conference, which Dr. Stone organized, and occurred during a didactic session in a small room rather than on one of the main stages where the 3-year data from EXCEL were announced with much fanfare. The presentation also took place 3 weeks after the European guidelines were published.
 

Surgeons withdraw support

After the BBC report last year that the universal definition of MI data had been collected but not published in the 3-year follow-up manuscript, and showed more MI in the PCI group than the protocol definition, the EACTS withdrew its support for the guidelines. The ESC continued to uphold the guidelines «until there is robust scientific evidence (as opposed to allegations) indicating we should do otherwise,” said Ms. Casadei.

A spokesperson for NEJM said the journal stood by the EXCEL papers because “there is no credible harm to patients from the publication of the paper and accurate reporting of trial results.” NEJM has since conducted a review and published a series of letters in response. The letters have reinvigorated rather than appeased the dissenters, as reported by Medscape.

A number of cardiologists and researchers started a petition on change.org to revise the EACTS/ESC left main CAD guidelines, and surgical societies across the globe have written to the editor of NEJM asking him to retract or amend the EXCEL papers.

This has not happened. The journal’s editor maintains that the letters containing the analyses are “sufficient information” to allow readers and guideline authors to “evaluate the trial findings.”

Dr. Taggart was dismissive of that response. “There is still no recognition or acknowledgment that failure to publish these data in 2016 ‘misled’ the guideline writers for the ESC/EACTS guidelines, and there is still no formal correction of the 2016 and 2019 NEJM manuscripts.”

Over a year after the BBC received the leaked data, the EXCEL investigators published an analysis of the primary outcome using the universal definition of MI data in the Journal of the American College of Cardiology.

It shows 141 events in the PCI arm, compared with 102 in the CABG arm. The investigators acknowledge that the rates of procedural MI differ depending on the definition used. According to their analysis, the protocol definition was predictive of mortality after both treatments, whereas the universal definition of procedural MI was predictive of mortality only after CABG. Not everyone agrees with this interpretation, and an accompanying editorial questioned these conclusions.

For Dr. Wallentin, it’s a relief that these data are in the public domain so that their interpretation and clinical consequences can be “openly discussed.” He hoped that the whole experience will result in something constructive and useful for the future.

As for the guidelines, the tide may be turning.

In a joint statement with EACTS on Oct. 6, 2020, the ESC agreed to review its guidelines for left main disease in the light of emerging, longer-term outcome data from the trials of CABG versus PCI.

Dr. Taggart has no regrets about speaking out despite this being “an exceedingly painful and bruising experience.”

The saga, he said, “reflects very badly on our specialty, the investigators, industry, and the world’s ‘leading’ medical journal.”

This article first appeared on Medscape.com.

Dr. G, a New York surgeon, was only a couple years into practice when he faced his first lawsuit.

After undergoing liposuction surgery on the area of her calf and ankle, a patient claimed she had developed a severe allergic reaction, characterized by small areas of necrosis on the lower extremities, said Dr. G, who asked to remain anonymous. However, the alleged injury seemed suspicious, said Dr. G, considering that 3 weeks after the surgery, the area had shown a successful result with minimal swelling.

Six months into the suit, Dr. G received a shocking phone call. It was the patient’s estranged husband, who revealed that his wife was having an affair with another man, a physician. In recorded phone calls, the patient and her paramour had discussed causing an injury near the patient’s calf in an attempt to sue and get rich, the husband relayed. Dr. G immediately contacted his insurance carrier with the news, but his attorney said the information would not be admissible in court. Instead, the insurer settled with the patient, who received about $125,000.

At the time, Dr. G did not have a consent-to-settle clause in his contract, so the insurer was able to settle without his approval.

In legal practice, a frivolous claim is defined as one that lacks a supporting legal argument or any factual basis. A claim issued with the intent of disturbing, annoying, or harassing the opposing party can also be described as legally frivolous, said Michael Stinson, vice president of government relations and public policy for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

However, when most physicians refer to “frivolous claims,” they often mean a claim in which there is no attributable negligence. Such suits represent a second category of claims – nonmeritorious lawsuits.

“I think people intermix nonmeritorious and frivolous all the time,” Mr. Stinson said. “In the vast majority of nonmeritorious claims, the patient has suffered an adverse outcome, it’s just that it wasn’t the result of negligence, whereas with a frivolous lawsuit, they really haven’t suffered any damage, so they’ve got no business filing a lawsuit on any level.”

A third type of so-called frivolous suit is that of a fraudulent or fake claim, in which, as Dr. G experienced, a patient causes a self-injury or lies about a condition to craft a false claim against a physician.

If a patient files a claim that the patient knows is false, the patient commits fraud and may be subject to counterclaims for malicious prosecution or abuse of process, said Jeffrey Segal, MD, JD, a neurosurgeon and health law attorney. Further, the patient would be testifying under oath, and such testimony can be considered perjury, a criminal offense with criminal penalties.

Sadly, Dr. G was the target of another frivolous lawsuit years later. In that suit, a patient claimed the surgeon had left a piece of sponge in her breast cavity during surgery. The case was dismissed when medical records proved the patient knew that the foreign body resulted from an unrelated procedure she had undergone years earlier.

“There is so much abuse in the court system,” Dr. G said. “You really don’t think stuff like that will happen to you, especially if you honor the profession. It’s unfortunate. It’s left a very bitter taste in my mouth.”

Frivolous claims have long been a subject of debate. Tort reform advocates often contend that such claims are pervasive. They cite them as key reasons for high health care costs and say that they have led to the rise of defensive medicine. Plaintiffs’ attorneys counter that the rate of frivolous claims is widely exaggerated and argue that the pursuit of frivolous claims would be “bad business” for legal firms. The debate begs the question: Do frivolous cases still exist, and if so, how common are they?

“I have never seen a frivolous malpractice claim,” says Malcolm P. McConnell III, JD, a Richmond, Va., medical malpractice attorney and chair of the Medical Malpractice Legislative Subcommittee for the Virginia Trial Lawyers Association. “I cannot say that such things never happen, but any lawyer bringing such a thing is foolish, because there is no reward for it.”
 

Are shotgun lawsuits frivolous?

To many physicians, being dragged into a lawsuit over a complaint or medical outcome in which they were not involved is frivolous, said Stanislaw Stawicki, MD, a trauma surgeon and researcher based in Bethlehem, Pa. Dr. Stawicki was named in a lawsuit along with a long list of medical staff who interacted in some way with the plaintiff. Dr. Stawicki himself saw the patient once and made a note in the chart but had nothing to do with the patient’s surgery or with any critical decisions regarding his care, he said.

“Nothing really prepares you for seeing your name on a legal complaint,” Dr. Stawicki said. “It’s traumatic. I had to block out entire days to give depositions, which were really kind of pointless. Questions like, ‘Is this really your name? Where did you train? Were you there that morning?’ Stuff that was really not consequential to the fact that someone had surgery a month earlier and had some sort of complication.”

Dr. Stawicki was eventually dropped from the claim, but not before a nearly year-long ordeal of legal proceedings, meetings, and paperwork.

It is common practice for plaintiffs’ attorneys to add codefendants in the early stages of a claim, said David M. Studdert, ScD, a leading health law researcher and a professor of law at Stanford (Calif.) Law School. Defendants are gradually dismissed as the case moves forward and details of the incident become clearer, he said.

“Plaintiffs’ attorneys have strong incentives to try and choose claims that will be successful,” Dr. Studdert said. “However, in the early point in the process, neither the patient nor the attorney may have a good idea what has actually happened with care. So sometimes, filing a lawsuit may be the only way to begin the process of opening up that information.”

A study by Dr. Studdert in which medical malpractice claims, errors, and compensation payments were analyzed found that, out of 1,452 claims, about one-third (37%) did not involve errors.

“Many physicians might call those frivolous lawsuits, but in fact, most of those don’t go on to receive compensation,” he said. “We suspect that in many instances, those claims are simply dropped once it becomes apparent that there wasn’t error involved.

“They can still be burdensome, anxiety provoking, and time consuming for physicians who are named in those suits, so I don’t want to suggest that claims that don’t involve errors are not a problem,” said Dr. Studdert. “However, I think it’s wrong to assume, as many people do when they use the term ‘frivolous lawsuit,’ that this is really an extortionary effort by a plaintiffs’ attorney to try to get money out of a hospital or a physician for care that was really unproblematic.”
 

Certain ‘frivolous’ cases more common than others

Nonmeritorious claims still occur relatively frequently today, according to data from the Medical Professional Liability Association’s Data Sharing Project. Of about 18,000 liability claims reported from 2016 to 2018, 65% were dropped, withdrawn, or dismissed. Of the 6% of claims that went before a jury, more than 85% resulted in a verdict for the defendant, the researchers found.

“Basically, any claim that does not result in a payment because the underlying claim of negligence on the part of a health professional had been demonstrated, proven, or adjudicated false is one we would describe as nonmeritorious,” Mr. Stinson said.

The MPL Association does not track cases that meet the legal definition of frivolous, said Mr. Stinson, and they “don’t see truly frivolous lawsuits very often.”

Malpractice claims are risky, expensive, and aggressively defended, says Mr. McConnell, the plaintiffs’ attorney. Mr. McConnell, who has been practicing for 30 years, said his own claim selection process is very rigorous and that he cannot afford to pursue claims that aren’t well supported by science and medicine.

“Pursuing frivolous cases would bankrupt me and ruin my reputation,” he said. “A lawyer I know once said he would write a check for $10,000 to anyone who could show him a lawyer who makes a living pursuing frivolous medical malpractice cases. It’s a fair challenge. The economics and the practices of liability carriers and defense lawyers make frivolous cases a dead end for plaintiff lawyers.”

Most medical malpractice cases are taken on a contingency fee basis, Mr. McConnell noted, meaning that the plaintiff’s lawyer is not paid unless the claim is successful.

“This means that the plaintiff’s lawyer is risking 2 years of intensive labor on a case which may yield no fee at all,” he said. “Obviously, any reasonable lawyer is going to want to minimize that risk. The only way to minimize that risk is for the case to be solid, not weak, and certainly not frivolous.”

But Dr. Segal, the health law attorney, says that plenty of frivolous liability claims are levied each year, with attorneys willing to pursue them.

It’s true that seasoned plaintiffs’ attorneys generally screen for merit and damages, Dr. Segal said, but in some instances, attorneys who are not trained in malpractice law accept frivolous claims and take them forward. In some cases, they are slip-and-fall accident attorneys accustomed to receiving modest amounts from insurance companies quickly, said Dr. Segal, founder of Medical Justice, a company that helps deter frivolous lawsuits against physicians.

“If we lived in a perfectly rational universe where plaintiffs’ attorneys screened cases well and only took the meritorious cases forward, we would see less frivolous cases filed, but that’s not the universe I live in,” Dr. Segal said. “There are well over a million attorneys in this country, and some are hungrier than others. The attorneys may frequently get burned in the end, and maybe that attorney won’t move another malpractice case forward, but there’s always someone else willing to take their place.”

Medical Justice has twice run a Most Frivolous Lawsuit Contest on its website, one in 2008 and one in late 2018. The first contest drew 30 entries, and the second garnered nearly 40 submissions, primarily from physicians who were defendants in the cases, according to Dr. Segal. (Dr. G’s lawsuit was highlighted in the most recent contest.)

In one case, an emergency physician was drawn into litigation by the family of a deceased patient. The patient experienced sudden cardiac arrythmia at home, and paramedics were unable to intubate her or establish IV access. She was transferred to the hospital, where resuscitation efforts continued, but she remained in asystole and was pronounced dead after 15 minutes.

At the hospital, blood tests were conducted. They showed that her serum potassium concentration was elevated to about 12 mEq/L, Dr. Segal said. The family initiated a claim in which they accused the emergency physician of failure to diagnose hyperkalemia. They alleged that had the hyperkalemia been discovered sooner, the patient’s death could have been prevented.

“If you had no other facts about this, you would wonder how a person with potassium that high would even be alive,” Dr. Segal said. “But what they were looking at was the body decomposing and all the potassium in the cells being released into the bloodstream. It wasn’t the cause of the problem, it was an effect of the problem. She really was dead on arrival, and she was probably dead at home.”

The case was eventually dropped.

Although the outcome for the patient was tragic, says Dr. Segal, the case is one of many types of frivolous claims that exist today.

“Yes, frivolous cases are out there,” he said.
 

Fraudulent claims uncommon

As for fraudulent medical liability claims, legal experts say they’re rare. J. Richard Moore, JD, an Indianapolis-based medical liability defense attorney, said he’s never personally encountered a medical malpractice claim in which he believed a plaintiff caused an injury or an illness and attempted to blame it on a physician.

However, Mr. Moore has defended many claims in which the illness or condition the plaintiff claimed was caused or was made worse through medical negligence was actually a preexisting condition or a preexisting condition that worsened and was not related to any medical negligence, Mr. Moore said.

“Although I have often felt in such cases that the plaintiff really knew that the condition was not affected by any alleged medical negligence, I would not put that in the ‘fraudulent claim’ category because it can be very difficult to establish a person’s subjective state of mind,” he said. “Usually in those cases, the plaintiff just denies memory of previous medical records or claims that the previous doctor who treated him or her for the same condition ‘got it wrong.’ In those cases, it is generally left to the jury whether to believe the plaintiff or not.”

Mr. Stinson also says he has not come across a truly fraudulent medical liability case. He noted that such a claim might be similar to a person falsely claiming a soft-tissue injury following an alleged slip-and-fall accident.

“Clearly, a fraudulent claim could be viewed as riskier from the plaintiff’s perspective because they could face criminal prosecution for insurance fraud, whereas if a claim is merely frivolous, they probably only run the risk of court-issued fine, if even that. That may be why we don’t often see fraudulent MPL claims.”
 

Ways to prevent or fight frivolous lawsuits

Since Dr. Stawicki’s legal nightmare as a resident, rules have tightened in Pennsylvania, and it is now more difficult to file frivolous claims, he said.

Pennsylvania is one of at least 28 states that require a certificate of merit in order for a medical liability claim to move forward. The provisions generally state that an appropriately licensed professional must supply a written statement attesting that the care the patient received failed to meet acceptable professional standards and that such conduct was a cause in the alleged harm.

“There is now a much greater burden of proof regarding what can proceed,” Dr. Stawicki said. “I’ve been involved in a couple cases that did not proceed because there was no certificate of merit.”

Although these reforms may help, not all merit rules are created equal. Some states require that the expert who signs the affidavit be knowledgeable in the relevant issues involved in the action. Other states have looser requirements. In one of the cases featured in Medical Justice’s Most Frivolous Lawsuit Contest, a podiatrist signed a supporting declaration for a claim related to obstetric care.

For physicians facing a frivolous claim, fighting it out in court depends on a number of factors. Without a consent-to-settle clause in the contract, an insurer can make the final decision on whether to defend or settle a case.

Resolving a malpractice claim is generally a business decision for the insurer, Dr. Studdert said.

“When the claim is for a relatively low amount of money, the costs of moving forward to defend that claim may be much more than the costs of simply settling it would be,” he said. “On the other hand, liability insurers and their lawyers are repeat players here, as are the plaintiffs’ attorneys. They don’t want to incentivize plaintiffs’ attorneys to bring questionable claims, and if they settle quickly, that may do so.”

Mr. Stinson, of the MPL Association, said a truly frivolous claim – one with no legal basis – is highly unlikely to be settled, “especially by MPL Association members who go beyond having a purely financial interest in their insureds to also focus on their professional reputation/integrity.” MPL Association members insure nearly 2 million health care professionals globally, including 2,500 hospitals and more than two-thirds of America’s physicians who are in private practice.

Physicians should make sure they know what is and what is not included in their policy, Dr. Segal said.

“The broker should sit down with the doctor, ideally before initial purchase or renewal, and explain in clear terms what the carrier’s obligations are and what the physician’s obligations are,” he said. “Know what type of protection is being purchased and what conditions might trigger a surprising and unhappy outcome.”
 

Should I countersue?

For truly frivolous claims, physicians have the legal right to sue for damages caused by the unfounded complaint.

Perhaps the most well-known case of a successful malpractice countersuit is that of Louisville neurosurgeon John Guarnaschelli, MD, who in 2000 won $72,000 in damages against a plaintiffs’ attorney for malicious prosecution.

The physician’s countersuit followed the dismissal of a negligence claim against Dr. Guarnaschelli by a patient who contracted meningitis. The plaintiffs’ attorney had made little effort to gather evidence to connect Dr. Guarnaschelli to the patient’s injuries and had consulted only one other physician, a client of his, before filing the lawsuit, according to a summary of the case in the American Bar Association Journal.

Malicious prosecution is the most common legal theory of recovery for physicians in countersuits, according to a review of successful countersuits by doctors. Dr. Stawicki is a coauthor of that review. Other legal theories that physicians can raise include abuse of process, negligence, defamation, invasion of privacy, and infliction of emotional distress. Of the 13 cases evaluated in the article by Dr. Stawicki and colleagues, damages awarded to physicians ranged from about $13,000 to $125,000.

Although some doctors have success, pursuing a counterclaim can be a difficult feat, said Benjamin Braslow, MD, a trauma surgeon and professor of clinical surgery at the University of Pennsylvania in Philadelphia.

“The main takeaways were it’s an uphill battle often met with not only resistance but diminishing returns to countersue,” said Dr. Braslow, a coauthor of the countersuits analysis. “You have to meet very specific criteria regarding leveling the suit, and it may end up being a costly, time-consuming battle.”

To prove malicious prosecution, for example, a physician must show that a claim was instituted without probable cause, that the suing party acted maliciously in instituting the action, and that the doctor was damaged by the action, among other essential elements.

As for Dr. G, the surgeon, he now has a contract with a consent-to-settle clause and has taken other legal precautions since his lawsuits. He requires that his patients sign an agreement that any negligence claims they levy go to arbitration. If an arbitrator finds in the patient’s favor, the case may proceed to court, he said. However, he requires another agreement such that if patients lose in court, they are responsible for his legal fees.

“I’m just more careful,” he said. “I ask all my staff in the office to use their judgment, however superficial, if they feel something is wrong with an individual to tell me so. I’d rather send them away than operate on them and have it result in a lawsuit.”
 

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

Dr. G, a New York surgeon, was only a couple years into practice when he faced his first lawsuit.

After undergoing liposuction surgery on the area of her calf and ankle, a patient claimed she had developed a severe allergic reaction, characterized by small areas of necrosis on the lower extremities, said Dr. G, who asked to remain anonymous. However, the alleged injury seemed suspicious, said Dr. G, considering that 3 weeks after the surgery, the area had shown a successful result with minimal swelling.

Six months into the suit, Dr. G received a shocking phone call. It was the patient’s estranged husband, who revealed that his wife was having an affair with another man, a physician. In recorded phone calls, the patient and her paramour had discussed causing an injury near the patient’s calf in an attempt to sue and get rich, the husband relayed. Dr. G immediately contacted his insurance carrier with the news, but his attorney said the information would not be admissible in court. Instead, the insurer settled with the patient, who received about $125,000.

At the time, Dr. G did not have a consent-to-settle clause in his contract, so the insurer was able to settle without his approval.

In legal practice, a frivolous claim is defined as one that lacks a supporting legal argument or any factual basis. A claim issued with the intent of disturbing, annoying, or harassing the opposing party can also be described as legally frivolous, said Michael Stinson, vice president of government relations and public policy for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

However, when most physicians refer to “frivolous claims,” they often mean a claim in which there is no attributable negligence. Such suits represent a second category of claims – nonmeritorious lawsuits.

“I think people intermix nonmeritorious and frivolous all the time,” Mr. Stinson said. “In the vast majority of nonmeritorious claims, the patient has suffered an adverse outcome, it’s just that it wasn’t the result of negligence, whereas with a frivolous lawsuit, they really haven’t suffered any damage, so they’ve got no business filing a lawsuit on any level.”

A third type of so-called frivolous suit is that of a fraudulent or fake claim, in which, as Dr. G experienced, a patient causes a self-injury or lies about a condition to craft a false claim against a physician.

If a patient files a claim that the patient knows is false, the patient commits fraud and may be subject to counterclaims for malicious prosecution or abuse of process, said Jeffrey Segal, MD, JD, a neurosurgeon and health law attorney. Further, the patient would be testifying under oath, and such testimony can be considered perjury, a criminal offense with criminal penalties.

Sadly, Dr. G was the target of another frivolous lawsuit years later. In that suit, a patient claimed the surgeon had left a piece of sponge in her breast cavity during surgery. The case was dismissed when medical records proved the patient knew that the foreign body resulted from an unrelated procedure she had undergone years earlier.

“There is so much abuse in the court system,” Dr. G said. “You really don’t think stuff like that will happen to you, especially if you honor the profession. It’s unfortunate. It’s left a very bitter taste in my mouth.”

Frivolous claims have long been a subject of debate. Tort reform advocates often contend that such claims are pervasive. They cite them as key reasons for high health care costs and say that they have led to the rise of defensive medicine. Plaintiffs’ attorneys counter that the rate of frivolous claims is widely exaggerated and argue that the pursuit of frivolous claims would be “bad business” for legal firms. The debate begs the question: Do frivolous cases still exist, and if so, how common are they?

“I have never seen a frivolous malpractice claim,” says Malcolm P. McConnell III, JD, a Richmond, Va., medical malpractice attorney and chair of the Medical Malpractice Legislative Subcommittee for the Virginia Trial Lawyers Association. “I cannot say that such things never happen, but any lawyer bringing such a thing is foolish, because there is no reward for it.”
 

Are shotgun lawsuits frivolous?

To many physicians, being dragged into a lawsuit over a complaint or medical outcome in which they were not involved is frivolous, said Stanislaw Stawicki, MD, a trauma surgeon and researcher based in Bethlehem, Pa. Dr. Stawicki was named in a lawsuit along with a long list of medical staff who interacted in some way with the plaintiff. Dr. Stawicki himself saw the patient once and made a note in the chart but had nothing to do with the patient’s surgery or with any critical decisions regarding his care, he said.

“Nothing really prepares you for seeing your name on a legal complaint,” Dr. Stawicki said. “It’s traumatic. I had to block out entire days to give depositions, which were really kind of pointless. Questions like, ‘Is this really your name? Where did you train? Were you there that morning?’ Stuff that was really not consequential to the fact that someone had surgery a month earlier and had some sort of complication.”

Dr. Stawicki was eventually dropped from the claim, but not before a nearly year-long ordeal of legal proceedings, meetings, and paperwork.

It is common practice for plaintiffs’ attorneys to add codefendants in the early stages of a claim, said David M. Studdert, ScD, a leading health law researcher and a professor of law at Stanford (Calif.) Law School. Defendants are gradually dismissed as the case moves forward and details of the incident become clearer, he said.

“Plaintiffs’ attorneys have strong incentives to try and choose claims that will be successful,” Dr. Studdert said. “However, in the early point in the process, neither the patient nor the attorney may have a good idea what has actually happened with care. So sometimes, filing a lawsuit may be the only way to begin the process of opening up that information.”

A study by Dr. Studdert in which medical malpractice claims, errors, and compensation payments were analyzed found that, out of 1,452 claims, about one-third (37%) did not involve errors.

“Many physicians might call those frivolous lawsuits, but in fact, most of those don’t go on to receive compensation,” he said. “We suspect that in many instances, those claims are simply dropped once it becomes apparent that there wasn’t error involved.

“They can still be burdensome, anxiety provoking, and time consuming for physicians who are named in those suits, so I don’t want to suggest that claims that don’t involve errors are not a problem,” said Dr. Studdert. “However, I think it’s wrong to assume, as many people do when they use the term ‘frivolous lawsuit,’ that this is really an extortionary effort by a plaintiffs’ attorney to try to get money out of a hospital or a physician for care that was really unproblematic.”
 

Certain ‘frivolous’ cases more common than others

Nonmeritorious claims still occur relatively frequently today, according to data from the Medical Professional Liability Association’s Data Sharing Project. Of about 18,000 liability claims reported from 2016 to 2018, 65% were dropped, withdrawn, or dismissed. Of the 6% of claims that went before a jury, more than 85% resulted in a verdict for the defendant, the researchers found.

“Basically, any claim that does not result in a payment because the underlying claim of negligence on the part of a health professional had been demonstrated, proven, or adjudicated false is one we would describe as nonmeritorious,” Mr. Stinson said.

The MPL Association does not track cases that meet the legal definition of frivolous, said Mr. Stinson, and they “don’t see truly frivolous lawsuits very often.”

Malpractice claims are risky, expensive, and aggressively defended, says Mr. McConnell, the plaintiffs’ attorney. Mr. McConnell, who has been practicing for 30 years, said his own claim selection process is very rigorous and that he cannot afford to pursue claims that aren’t well supported by science and medicine.

“Pursuing frivolous cases would bankrupt me and ruin my reputation,” he said. “A lawyer I know once said he would write a check for $10,000 to anyone who could show him a lawyer who makes a living pursuing frivolous medical malpractice cases. It’s a fair challenge. The economics and the practices of liability carriers and defense lawyers make frivolous cases a dead end for plaintiff lawyers.”

Most medical malpractice cases are taken on a contingency fee basis, Mr. McConnell noted, meaning that the plaintiff’s lawyer is not paid unless the claim is successful.

“This means that the plaintiff’s lawyer is risking 2 years of intensive labor on a case which may yield no fee at all,” he said. “Obviously, any reasonable lawyer is going to want to minimize that risk. The only way to minimize that risk is for the case to be solid, not weak, and certainly not frivolous.”

But Dr. Segal, the health law attorney, says that plenty of frivolous liability claims are levied each year, with attorneys willing to pursue them.

It’s true that seasoned plaintiffs’ attorneys generally screen for merit and damages, Dr. Segal said, but in some instances, attorneys who are not trained in malpractice law accept frivolous claims and take them forward. In some cases, they are slip-and-fall accident attorneys accustomed to receiving modest amounts from insurance companies quickly, said Dr. Segal, founder of Medical Justice, a company that helps deter frivolous lawsuits against physicians.

“If we lived in a perfectly rational universe where plaintiffs’ attorneys screened cases well and only took the meritorious cases forward, we would see less frivolous cases filed, but that’s not the universe I live in,” Dr. Segal said. “There are well over a million attorneys in this country, and some are hungrier than others. The attorneys may frequently get burned in the end, and maybe that attorney won’t move another malpractice case forward, but there’s always someone else willing to take their place.”

Medical Justice has twice run a Most Frivolous Lawsuit Contest on its website, one in 2008 and one in late 2018. The first contest drew 30 entries, and the second garnered nearly 40 submissions, primarily from physicians who were defendants in the cases, according to Dr. Segal. (Dr. G’s lawsuit was highlighted in the most recent contest.)

In one case, an emergency physician was drawn into litigation by the family of a deceased patient. The patient experienced sudden cardiac arrythmia at home, and paramedics were unable to intubate her or establish IV access. She was transferred to the hospital, where resuscitation efforts continued, but she remained in asystole and was pronounced dead after 15 minutes.

At the hospital, blood tests were conducted. They showed that her serum potassium concentration was elevated to about 12 mEq/L, Dr. Segal said. The family initiated a claim in which they accused the emergency physician of failure to diagnose hyperkalemia. They alleged that had the hyperkalemia been discovered sooner, the patient’s death could have been prevented.

“If you had no other facts about this, you would wonder how a person with potassium that high would even be alive,” Dr. Segal said. “But what they were looking at was the body decomposing and all the potassium in the cells being released into the bloodstream. It wasn’t the cause of the problem, it was an effect of the problem. She really was dead on arrival, and she was probably dead at home.”

The case was eventually dropped.

Although the outcome for the patient was tragic, says Dr. Segal, the case is one of many types of frivolous claims that exist today.

“Yes, frivolous cases are out there,” he said.
 

Fraudulent claims uncommon

As for fraudulent medical liability claims, legal experts say they’re rare. J. Richard Moore, JD, an Indianapolis-based medical liability defense attorney, said he’s never personally encountered a medical malpractice claim in which he believed a plaintiff caused an injury or an illness and attempted to blame it on a physician.

However, Mr. Moore has defended many claims in which the illness or condition the plaintiff claimed was caused or was made worse through medical negligence was actually a preexisting condition or a preexisting condition that worsened and was not related to any medical negligence, Mr. Moore said.

“Although I have often felt in such cases that the plaintiff really knew that the condition was not affected by any alleged medical negligence, I would not put that in the ‘fraudulent claim’ category because it can be very difficult to establish a person’s subjective state of mind,” he said. “Usually in those cases, the plaintiff just denies memory of previous medical records or claims that the previous doctor who treated him or her for the same condition ‘got it wrong.’ In those cases, it is generally left to the jury whether to believe the plaintiff or not.”

Mr. Stinson also says he has not come across a truly fraudulent medical liability case. He noted that such a claim might be similar to a person falsely claiming a soft-tissue injury following an alleged slip-and-fall accident.

“Clearly, a fraudulent claim could be viewed as riskier from the plaintiff’s perspective because they could face criminal prosecution for insurance fraud, whereas if a claim is merely frivolous, they probably only run the risk of court-issued fine, if even that. That may be why we don’t often see fraudulent MPL claims.”
 

Ways to prevent or fight frivolous lawsuits

Since Dr. Stawicki’s legal nightmare as a resident, rules have tightened in Pennsylvania, and it is now more difficult to file frivolous claims, he said.

Pennsylvania is one of at least 28 states that require a certificate of merit in order for a medical liability claim to move forward. The provisions generally state that an appropriately licensed professional must supply a written statement attesting that the care the patient received failed to meet acceptable professional standards and that such conduct was a cause in the alleged harm.

“There is now a much greater burden of proof regarding what can proceed,” Dr. Stawicki said. “I’ve been involved in a couple cases that did not proceed because there was no certificate of merit.”

Although these reforms may help, not all merit rules are created equal. Some states require that the expert who signs the affidavit be knowledgeable in the relevant issues involved in the action. Other states have looser requirements. In one of the cases featured in Medical Justice’s Most Frivolous Lawsuit Contest, a podiatrist signed a supporting declaration for a claim related to obstetric care.

For physicians facing a frivolous claim, fighting it out in court depends on a number of factors. Without a consent-to-settle clause in the contract, an insurer can make the final decision on whether to defend or settle a case.

Resolving a malpractice claim is generally a business decision for the insurer, Dr. Studdert said.

“When the claim is for a relatively low amount of money, the costs of moving forward to defend that claim may be much more than the costs of simply settling it would be,” he said. “On the other hand, liability insurers and their lawyers are repeat players here, as are the plaintiffs’ attorneys. They don’t want to incentivize plaintiffs’ attorneys to bring questionable claims, and if they settle quickly, that may do so.”

Mr. Stinson, of the MPL Association, said a truly frivolous claim – one with no legal basis – is highly unlikely to be settled, “especially by MPL Association members who go beyond having a purely financial interest in their insureds to also focus on their professional reputation/integrity.” MPL Association members insure nearly 2 million health care professionals globally, including 2,500 hospitals and more than two-thirds of America’s physicians who are in private practice.

Physicians should make sure they know what is and what is not included in their policy, Dr. Segal said.

“The broker should sit down with the doctor, ideally before initial purchase or renewal, and explain in clear terms what the carrier’s obligations are and what the physician’s obligations are,” he said. “Know what type of protection is being purchased and what conditions might trigger a surprising and unhappy outcome.”
 

Should I countersue?

For truly frivolous claims, physicians have the legal right to sue for damages caused by the unfounded complaint.

Perhaps the most well-known case of a successful malpractice countersuit is that of Louisville neurosurgeon John Guarnaschelli, MD, who in 2000 won $72,000 in damages against a plaintiffs’ attorney for malicious prosecution.

The physician’s countersuit followed the dismissal of a negligence claim against Dr. Guarnaschelli by a patient who contracted meningitis. The plaintiffs’ attorney had made little effort to gather evidence to connect Dr. Guarnaschelli to the patient’s injuries and had consulted only one other physician, a client of his, before filing the lawsuit, according to a summary of the case in the American Bar Association Journal.

Malicious prosecution is the most common legal theory of recovery for physicians in countersuits, according to a review of successful countersuits by doctors. Dr. Stawicki is a coauthor of that review. Other legal theories that physicians can raise include abuse of process, negligence, defamation, invasion of privacy, and infliction of emotional distress. Of the 13 cases evaluated in the article by Dr. Stawicki and colleagues, damages awarded to physicians ranged from about $13,000 to $125,000.

Although some doctors have success, pursuing a counterclaim can be a difficult feat, said Benjamin Braslow, MD, a trauma surgeon and professor of clinical surgery at the University of Pennsylvania in Philadelphia.

“The main takeaways were it’s an uphill battle often met with not only resistance but diminishing returns to countersue,” said Dr. Braslow, a coauthor of the countersuits analysis. “You have to meet very specific criteria regarding leveling the suit, and it may end up being a costly, time-consuming battle.”

To prove malicious prosecution, for example, a physician must show that a claim was instituted without probable cause, that the suing party acted maliciously in instituting the action, and that the doctor was damaged by the action, among other essential elements.

As for Dr. G, the surgeon, he now has a contract with a consent-to-settle clause and has taken other legal precautions since his lawsuits. He requires that his patients sign an agreement that any negligence claims they levy go to arbitration. If an arbitrator finds in the patient’s favor, the case may proceed to court, he said. However, he requires another agreement such that if patients lose in court, they are responsible for his legal fees.

“I’m just more careful,” he said. “I ask all my staff in the office to use their judgment, however superficial, if they feel something is wrong with an individual to tell me so. I’d rather send them away than operate on them and have it result in a lawsuit.”
 

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

Dr. G, a New York surgeon, was only a couple years into practice when he faced his first lawsuit.

After undergoing liposuction surgery on the area of her calf and ankle, a patient claimed she had developed a severe allergic reaction, characterized by small areas of necrosis on the lower extremities, said Dr. G, who asked to remain anonymous. However, the alleged injury seemed suspicious, said Dr. G, considering that 3 weeks after the surgery, the area had shown a successful result with minimal swelling.

Six months into the suit, Dr. G received a shocking phone call. It was the patient’s estranged husband, who revealed that his wife was having an affair with another man, a physician. In recorded phone calls, the patient and her paramour had discussed causing an injury near the patient’s calf in an attempt to sue and get rich, the husband relayed. Dr. G immediately contacted his insurance carrier with the news, but his attorney said the information would not be admissible in court. Instead, the insurer settled with the patient, who received about $125,000.

At the time, Dr. G did not have a consent-to-settle clause in his contract, so the insurer was able to settle without his approval.

In legal practice, a frivolous claim is defined as one that lacks a supporting legal argument or any factual basis. A claim issued with the intent of disturbing, annoying, or harassing the opposing party can also be described as legally frivolous, said Michael Stinson, vice president of government relations and public policy for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

However, when most physicians refer to “frivolous claims,” they often mean a claim in which there is no attributable negligence. Such suits represent a second category of claims – nonmeritorious lawsuits.

“I think people intermix nonmeritorious and frivolous all the time,” Mr. Stinson said. “In the vast majority of nonmeritorious claims, the patient has suffered an adverse outcome, it’s just that it wasn’t the result of negligence, whereas with a frivolous lawsuit, they really haven’t suffered any damage, so they’ve got no business filing a lawsuit on any level.”

A third type of so-called frivolous suit is that of a fraudulent or fake claim, in which, as Dr. G experienced, a patient causes a self-injury or lies about a condition to craft a false claim against a physician.

If a patient files a claim that the patient knows is false, the patient commits fraud and may be subject to counterclaims for malicious prosecution or abuse of process, said Jeffrey Segal, MD, JD, a neurosurgeon and health law attorney. Further, the patient would be testifying under oath, and such testimony can be considered perjury, a criminal offense with criminal penalties.

Sadly, Dr. G was the target of another frivolous lawsuit years later. In that suit, a patient claimed the surgeon had left a piece of sponge in her breast cavity during surgery. The case was dismissed when medical records proved the patient knew that the foreign body resulted from an unrelated procedure she had undergone years earlier.

“There is so much abuse in the court system,” Dr. G said. “You really don’t think stuff like that will happen to you, especially if you honor the profession. It’s unfortunate. It’s left a very bitter taste in my mouth.”

Frivolous claims have long been a subject of debate. Tort reform advocates often contend that such claims are pervasive. They cite them as key reasons for high health care costs and say that they have led to the rise of defensive medicine. Plaintiffs’ attorneys counter that the rate of frivolous claims is widely exaggerated and argue that the pursuit of frivolous claims would be “bad business” for legal firms. The debate begs the question: Do frivolous cases still exist, and if so, how common are they?

“I have never seen a frivolous malpractice claim,” says Malcolm P. McConnell III, JD, a Richmond, Va., medical malpractice attorney and chair of the Medical Malpractice Legislative Subcommittee for the Virginia Trial Lawyers Association. “I cannot say that such things never happen, but any lawyer bringing such a thing is foolish, because there is no reward for it.”
 

Are shotgun lawsuits frivolous?

To many physicians, being dragged into a lawsuit over a complaint or medical outcome in which they were not involved is frivolous, said Stanislaw Stawicki, MD, a trauma surgeon and researcher based in Bethlehem, Pa. Dr. Stawicki was named in a lawsuit along with a long list of medical staff who interacted in some way with the plaintiff. Dr. Stawicki himself saw the patient once and made a note in the chart but had nothing to do with the patient’s surgery or with any critical decisions regarding his care, he said.

“Nothing really prepares you for seeing your name on a legal complaint,” Dr. Stawicki said. “It’s traumatic. I had to block out entire days to give depositions, which were really kind of pointless. Questions like, ‘Is this really your name? Where did you train? Were you there that morning?’ Stuff that was really not consequential to the fact that someone had surgery a month earlier and had some sort of complication.”

Dr. Stawicki was eventually dropped from the claim, but not before a nearly year-long ordeal of legal proceedings, meetings, and paperwork.

It is common practice for plaintiffs’ attorneys to add codefendants in the early stages of a claim, said David M. Studdert, ScD, a leading health law researcher and a professor of law at Stanford (Calif.) Law School. Defendants are gradually dismissed as the case moves forward and details of the incident become clearer, he said.

“Plaintiffs’ attorneys have strong incentives to try and choose claims that will be successful,” Dr. Studdert said. “However, in the early point in the process, neither the patient nor the attorney may have a good idea what has actually happened with care. So sometimes, filing a lawsuit may be the only way to begin the process of opening up that information.”

A study by Dr. Studdert in which medical malpractice claims, errors, and compensation payments were analyzed found that, out of 1,452 claims, about one-third (37%) did not involve errors.

“Many physicians might call those frivolous lawsuits, but in fact, most of those don’t go on to receive compensation,” he said. “We suspect that in many instances, those claims are simply dropped once it becomes apparent that there wasn’t error involved.

“They can still be burdensome, anxiety provoking, and time consuming for physicians who are named in those suits, so I don’t want to suggest that claims that don’t involve errors are not a problem,” said Dr. Studdert. “However, I think it’s wrong to assume, as many people do when they use the term ‘frivolous lawsuit,’ that this is really an extortionary effort by a plaintiffs’ attorney to try to get money out of a hospital or a physician for care that was really unproblematic.”
 

Certain ‘frivolous’ cases more common than others

Nonmeritorious claims still occur relatively frequently today, according to data from the Medical Professional Liability Association’s Data Sharing Project. Of about 18,000 liability claims reported from 2016 to 2018, 65% were dropped, withdrawn, or dismissed. Of the 6% of claims that went before a jury, more than 85% resulted in a verdict for the defendant, the researchers found.

“Basically, any claim that does not result in a payment because the underlying claim of negligence on the part of a health professional had been demonstrated, proven, or adjudicated false is one we would describe as nonmeritorious,” Mr. Stinson said.

The MPL Association does not track cases that meet the legal definition of frivolous, said Mr. Stinson, and they “don’t see truly frivolous lawsuits very often.”

Malpractice claims are risky, expensive, and aggressively defended, says Mr. McConnell, the plaintiffs’ attorney. Mr. McConnell, who has been practicing for 30 years, said his own claim selection process is very rigorous and that he cannot afford to pursue claims that aren’t well supported by science and medicine.

“Pursuing frivolous cases would bankrupt me and ruin my reputation,” he said. “A lawyer I know once said he would write a check for $10,000 to anyone who could show him a lawyer who makes a living pursuing frivolous medical malpractice cases. It’s a fair challenge. The economics and the practices of liability carriers and defense lawyers make frivolous cases a dead end for plaintiff lawyers.”

Most medical malpractice cases are taken on a contingency fee basis, Mr. McConnell noted, meaning that the plaintiff’s lawyer is not paid unless the claim is successful.

“This means that the plaintiff’s lawyer is risking 2 years of intensive labor on a case which may yield no fee at all,” he said. “Obviously, any reasonable lawyer is going to want to minimize that risk. The only way to minimize that risk is for the case to be solid, not weak, and certainly not frivolous.”

But Dr. Segal, the health law attorney, says that plenty of frivolous liability claims are levied each year, with attorneys willing to pursue them.

It’s true that seasoned plaintiffs’ attorneys generally screen for merit and damages, Dr. Segal said, but in some instances, attorneys who are not trained in malpractice law accept frivolous claims and take them forward. In some cases, they are slip-and-fall accident attorneys accustomed to receiving modest amounts from insurance companies quickly, said Dr. Segal, founder of Medical Justice, a company that helps deter frivolous lawsuits against physicians.

“If we lived in a perfectly rational universe where plaintiffs’ attorneys screened cases well and only took the meritorious cases forward, we would see less frivolous cases filed, but that’s not the universe I live in,” Dr. Segal said. “There are well over a million attorneys in this country, and some are hungrier than others. The attorneys may frequently get burned in the end, and maybe that attorney won’t move another malpractice case forward, but there’s always someone else willing to take their place.”

Medical Justice has twice run a Most Frivolous Lawsuit Contest on its website, one in 2008 and one in late 2018. The first contest drew 30 entries, and the second garnered nearly 40 submissions, primarily from physicians who were defendants in the cases, according to Dr. Segal. (Dr. G’s lawsuit was highlighted in the most recent contest.)

In one case, an emergency physician was drawn into litigation by the family of a deceased patient. The patient experienced sudden cardiac arrythmia at home, and paramedics were unable to intubate her or establish IV access. She was transferred to the hospital, where resuscitation efforts continued, but she remained in asystole and was pronounced dead after 15 minutes.

At the hospital, blood tests were conducted. They showed that her serum potassium concentration was elevated to about 12 mEq/L, Dr. Segal said. The family initiated a claim in which they accused the emergency physician of failure to diagnose hyperkalemia. They alleged that had the hyperkalemia been discovered sooner, the patient’s death could have been prevented.

“If you had no other facts about this, you would wonder how a person with potassium that high would even be alive,” Dr. Segal said. “But what they were looking at was the body decomposing and all the potassium in the cells being released into the bloodstream. It wasn’t the cause of the problem, it was an effect of the problem. She really was dead on arrival, and she was probably dead at home.”

The case was eventually dropped.

Although the outcome for the patient was tragic, says Dr. Segal, the case is one of many types of frivolous claims that exist today.

“Yes, frivolous cases are out there,” he said.
 

Fraudulent claims uncommon

As for fraudulent medical liability claims, legal experts say they’re rare. J. Richard Moore, JD, an Indianapolis-based medical liability defense attorney, said he’s never personally encountered a medical malpractice claim in which he believed a plaintiff caused an injury or an illness and attempted to blame it on a physician.

However, Mr. Moore has defended many claims in which the illness or condition the plaintiff claimed was caused or was made worse through medical negligence was actually a preexisting condition or a preexisting condition that worsened and was not related to any medical negligence, Mr. Moore said.

“Although I have often felt in such cases that the plaintiff really knew that the condition was not affected by any alleged medical negligence, I would not put that in the ‘fraudulent claim’ category because it can be very difficult to establish a person’s subjective state of mind,” he said. “Usually in those cases, the plaintiff just denies memory of previous medical records or claims that the previous doctor who treated him or her for the same condition ‘got it wrong.’ In those cases, it is generally left to the jury whether to believe the plaintiff or not.”

Mr. Stinson also says he has not come across a truly fraudulent medical liability case. He noted that such a claim might be similar to a person falsely claiming a soft-tissue injury following an alleged slip-and-fall accident.

“Clearly, a fraudulent claim could be viewed as riskier from the plaintiff’s perspective because they could face criminal prosecution for insurance fraud, whereas if a claim is merely frivolous, they probably only run the risk of court-issued fine, if even that. That may be why we don’t often see fraudulent MPL claims.”
 

Ways to prevent or fight frivolous lawsuits

Since Dr. Stawicki’s legal nightmare as a resident, rules have tightened in Pennsylvania, and it is now more difficult to file frivolous claims, he said.

Pennsylvania is one of at least 28 states that require a certificate of merit in order for a medical liability claim to move forward. The provisions generally state that an appropriately licensed professional must supply a written statement attesting that the care the patient received failed to meet acceptable professional standards and that such conduct was a cause in the alleged harm.

“There is now a much greater burden of proof regarding what can proceed,” Dr. Stawicki said. “I’ve been involved in a couple cases that did not proceed because there was no certificate of merit.”

Although these reforms may help, not all merit rules are created equal. Some states require that the expert who signs the affidavit be knowledgeable in the relevant issues involved in the action. Other states have looser requirements. In one of the cases featured in Medical Justice’s Most Frivolous Lawsuit Contest, a podiatrist signed a supporting declaration for a claim related to obstetric care.

For physicians facing a frivolous claim, fighting it out in court depends on a number of factors. Without a consent-to-settle clause in the contract, an insurer can make the final decision on whether to defend or settle a case.

Resolving a malpractice claim is generally a business decision for the insurer, Dr. Studdert said.

“When the claim is for a relatively low amount of money, the costs of moving forward to defend that claim may be much more than the costs of simply settling it would be,” he said. “On the other hand, liability insurers and their lawyers are repeat players here, as are the plaintiffs’ attorneys. They don’t want to incentivize plaintiffs’ attorneys to bring questionable claims, and if they settle quickly, that may do so.”

Mr. Stinson, of the MPL Association, said a truly frivolous claim – one with no legal basis – is highly unlikely to be settled, “especially by MPL Association members who go beyond having a purely financial interest in their insureds to also focus on their professional reputation/integrity.” MPL Association members insure nearly 2 million health care professionals globally, including 2,500 hospitals and more than two-thirds of America’s physicians who are in private practice.

Physicians should make sure they know what is and what is not included in their policy, Dr. Segal said.

“The broker should sit down with the doctor, ideally before initial purchase or renewal, and explain in clear terms what the carrier’s obligations are and what the physician’s obligations are,” he said. “Know what type of protection is being purchased and what conditions might trigger a surprising and unhappy outcome.”
 

Should I countersue?

For truly frivolous claims, physicians have the legal right to sue for damages caused by the unfounded complaint.

Perhaps the most well-known case of a successful malpractice countersuit is that of Louisville neurosurgeon John Guarnaschelli, MD, who in 2000 won $72,000 in damages against a plaintiffs’ attorney for malicious prosecution.

The physician’s countersuit followed the dismissal of a negligence claim against Dr. Guarnaschelli by a patient who contracted meningitis. The plaintiffs’ attorney had made little effort to gather evidence to connect Dr. Guarnaschelli to the patient’s injuries and had consulted only one other physician, a client of his, before filing the lawsuit, according to a summary of the case in the American Bar Association Journal.

Malicious prosecution is the most common legal theory of recovery for physicians in countersuits, according to a review of successful countersuits by doctors. Dr. Stawicki is a coauthor of that review. Other legal theories that physicians can raise include abuse of process, negligence, defamation, invasion of privacy, and infliction of emotional distress. Of the 13 cases evaluated in the article by Dr. Stawicki and colleagues, damages awarded to physicians ranged from about $13,000 to $125,000.

Although some doctors have success, pursuing a counterclaim can be a difficult feat, said Benjamin Braslow, MD, a trauma surgeon and professor of clinical surgery at the University of Pennsylvania in Philadelphia.

“The main takeaways were it’s an uphill battle often met with not only resistance but diminishing returns to countersue,” said Dr. Braslow, a coauthor of the countersuits analysis. “You have to meet very specific criteria regarding leveling the suit, and it may end up being a costly, time-consuming battle.”

To prove malicious prosecution, for example, a physician must show that a claim was instituted without probable cause, that the suing party acted maliciously in instituting the action, and that the doctor was damaged by the action, among other essential elements.

As for Dr. G, the surgeon, he now has a contract with a consent-to-settle clause and has taken other legal precautions since his lawsuits. He requires that his patients sign an agreement that any negligence claims they levy go to arbitration. If an arbitrator finds in the patient’s favor, the case may proceed to court, he said. However, he requires another agreement such that if patients lose in court, they are responsible for his legal fees.

“I’m just more careful,” he said. “I ask all my staff in the office to use their judgment, however superficial, if they feel something is wrong with an individual to tell me so. I’d rather send them away than operate on them and have it result in a lawsuit.”
 

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