Randy Dotinga

One year into the implementation of the Mission Act, the US Department of Veterans Affairs (VA) continues to expand a wide-ranging third-party-administered program to boost the access of veterans to the civilian medical system, a VA official told colleagues at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO). “VA has given to the third-party administrators what they do well, which is payment of claims, and VA has taken back what we think we can do better—scheduling, care coordination, and customer service,” said Elizabeth Brill, MD, MBA, chief medical officer and senior adviser to the acting assistant undersecretary for Health for Community Care.

            The 2 third-party contractors that run the Community Care Network (CCN) are Optum and TriWest. Both companies now proces patients at all VA medical facilities in the continental US. Optum serves all the states that are entirely (or mainly) in the Central and Eastern Time Zones—except for Texas—plus Puerto Rico, Washington D.C., and the US Virgin Islands. TriWest serves Texas, Hawaii, and the states that are entirely (or mainly) in the Mountain and Pacific Time Zones. The VA has not yet assigned any contractor for Alaska, Guam, American Samoa, and the Northern Mariana Islands.

“We have tried to consolidate as much as possible into the Community Care Network, pulling in a lot of services that were not previously covered, but it’s still not covering 100% of all services that veterans need outside VA medical centers,” said Brill.

Although the VA continues to rely on Veterans Care Agreements, in which health care providers contract directly with the VA, “the main focus of community care is the Community Care Network.” Said Brill. In a pair of regions—encompassing the Midwest, Northeast, and a few other states—90% of private health services are now provided through the network, she said.

One benefit of the new system is a better experience for the health care providers who work with Optum and TriWest. These administrators are responsible for finding providers and providing them with credentials based on appropriate criteria, Brill said. “In prior days, VA paid community providers directly, and some of you may be familiar with the delays that occurred in the system,” she said. “In the new system, we have third-party administrators who pay the providers quickly, and then VA pays them.”

Urgent care services are now available through CCN in most of the continental US and will be expanded to Texas, the Mountain region and the West by the end of September, she said. “We’ve been very pleased to see the response.” Meanwhile, flu shots for enrolled veterans are now available through the system via 60,000 locations.

There are requirements for private health care providers: They must meet new training requirements and submit claims within 180 days. Patients also must meet standards to get community care. For example, patients are eligible for access if the VA can’t serve them within a 30-minute drive time for primary care and mental health care and a 60-minute drive time for specialty care. Similarly, veterans are eligible if they cannot get an appointment within 20 days for primary and mental health care and 28 days for specialty care.

However, Brill insisted, the Mission Act is “not a move toward privatization. Internal VA care is just as important as external VA care,” she said. “This just gives them more choice.”

Brill also noted that there’s more to the Mission Act than expanded access. For example, an expansion of the Program of Comprehensive Assistance for Family Caregivers Program “will start kicking in this fall and the winter,” she said. It will include families of veterans from all eras of service.

The act also is designed to improve infrastructure, although the coronavirus pandemic may disrupt timing, she said. And, she added, it will strengthen the VA’s ability to recruit and keep health care providers through projects like a new scholarship program and more access to medical education debt reduction. 

One year into the implementation of the Mission Act, the US Department of Veterans Affairs (VA) continues to expand a wide-ranging third-party-administered program to boost the access of veterans to the civilian medical system, a VA official told colleagues at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO). “VA has given to the third-party administrators what they do well, which is payment of claims, and VA has taken back what we think we can do better—scheduling, care coordination, and customer service,” said Elizabeth Brill, MD, MBA, chief medical officer and senior adviser to the acting assistant undersecretary for Health for Community Care.

            The 2 third-party contractors that run the Community Care Network (CCN) are Optum and TriWest. Both companies now proces patients at all VA medical facilities in the continental US. Optum serves all the states that are entirely (or mainly) in the Central and Eastern Time Zones—except for Texas—plus Puerto Rico, Washington D.C., and the US Virgin Islands. TriWest serves Texas, Hawaii, and the states that are entirely (or mainly) in the Mountain and Pacific Time Zones. The VA has not yet assigned any contractor for Alaska, Guam, American Samoa, and the Northern Mariana Islands.

“We have tried to consolidate as much as possible into the Community Care Network, pulling in a lot of services that were not previously covered, but it’s still not covering 100% of all services that veterans need outside VA medical centers,” said Brill.

Although the VA continues to rely on Veterans Care Agreements, in which health care providers contract directly with the VA, “the main focus of community care is the Community Care Network.” Said Brill. In a pair of regions—encompassing the Midwest, Northeast, and a few other states—90% of private health services are now provided through the network, she said.

One benefit of the new system is a better experience for the health care providers who work with Optum and TriWest. These administrators are responsible for finding providers and providing them with credentials based on appropriate criteria, Brill said. “In prior days, VA paid community providers directly, and some of you may be familiar with the delays that occurred in the system,” she said. “In the new system, we have third-party administrators who pay the providers quickly, and then VA pays them.”

Urgent care services are now available through CCN in most of the continental US and will be expanded to Texas, the Mountain region and the West by the end of September, she said. “We’ve been very pleased to see the response.” Meanwhile, flu shots for enrolled veterans are now available through the system via 60,000 locations.

There are requirements for private health care providers: They must meet new training requirements and submit claims within 180 days. Patients also must meet standards to get community care. For example, patients are eligible for access if the VA can’t serve them within a 30-minute drive time for primary care and mental health care and a 60-minute drive time for specialty care. Similarly, veterans are eligible if they cannot get an appointment within 20 days for primary and mental health care and 28 days for specialty care.

However, Brill insisted, the Mission Act is “not a move toward privatization. Internal VA care is just as important as external VA care,” she said. “This just gives them more choice.”

Brill also noted that there’s more to the Mission Act than expanded access. For example, an expansion of the Program of Comprehensive Assistance for Family Caregivers Program “will start kicking in this fall and the winter,” she said. It will include families of veterans from all eras of service.

The act also is designed to improve infrastructure, although the coronavirus pandemic may disrupt timing, she said. And, she added, it will strengthen the VA’s ability to recruit and keep health care providers through projects like a new scholarship program and more access to medical education debt reduction. 

One year into the implementation of the Mission Act, the US Department of Veterans Affairs (VA) continues to expand a wide-ranging third-party-administered program to boost the access of veterans to the civilian medical system, a VA official told colleagues at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO). “VA has given to the third-party administrators what they do well, which is payment of claims, and VA has taken back what we think we can do better—scheduling, care coordination, and customer service,” said Elizabeth Brill, MD, MBA, chief medical officer and senior adviser to the acting assistant undersecretary for Health for Community Care.

            The 2 third-party contractors that run the Community Care Network (CCN) are Optum and TriWest. Both companies now proces patients at all VA medical facilities in the continental US. Optum serves all the states that are entirely (or mainly) in the Central and Eastern Time Zones—except for Texas—plus Puerto Rico, Washington D.C., and the US Virgin Islands. TriWest serves Texas, Hawaii, and the states that are entirely (or mainly) in the Mountain and Pacific Time Zones. The VA has not yet assigned any contractor for Alaska, Guam, American Samoa, and the Northern Mariana Islands.

“We have tried to consolidate as much as possible into the Community Care Network, pulling in a lot of services that were not previously covered, but it’s still not covering 100% of all services that veterans need outside VA medical centers,” said Brill.

Although the VA continues to rely on Veterans Care Agreements, in which health care providers contract directly with the VA, “the main focus of community care is the Community Care Network.” Said Brill. In a pair of regions—encompassing the Midwest, Northeast, and a few other states—90% of private health services are now provided through the network, she said.

One benefit of the new system is a better experience for the health care providers who work with Optum and TriWest. These administrators are responsible for finding providers and providing them with credentials based on appropriate criteria, Brill said. “In prior days, VA paid community providers directly, and some of you may be familiar with the delays that occurred in the system,” she said. “In the new system, we have third-party administrators who pay the providers quickly, and then VA pays them.”

Urgent care services are now available through CCN in most of the continental US and will be expanded to Texas, the Mountain region and the West by the end of September, she said. “We’ve been very pleased to see the response.” Meanwhile, flu shots for enrolled veterans are now available through the system via 60,000 locations.

There are requirements for private health care providers: They must meet new training requirements and submit claims within 180 days. Patients also must meet standards to get community care. For example, patients are eligible for access if the VA can’t serve them within a 30-minute drive time for primary care and mental health care and a 60-minute drive time for specialty care. Similarly, veterans are eligible if they cannot get an appointment within 20 days for primary and mental health care and 28 days for specialty care.

However, Brill insisted, the Mission Act is “not a move toward privatization. Internal VA care is just as important as external VA care,” she said. “This just gives them more choice.”

Brill also noted that there’s more to the Mission Act than expanded access. For example, an expansion of the Program of Comprehensive Assistance for Family Caregivers Program “will start kicking in this fall and the winter,” she said. It will include families of veterans from all eras of service.

The act also is designed to improve infrastructure, although the coronavirus pandemic may disrupt timing, she said. And, she added, it will strengthen the VA’s ability to recruit and keep health care providers through projects like a new scholarship program and more access to medical education debt reduction. 

Human papilloma virus (HPV)-mediated squamous cell carcinoma of the head and neck is on the rise, and the lack of herd immunity in young people will ensure growth for many years to come. “We’re really looking at another 30 to 40 years of HPV and oropharynx cancer growth,” said head and neck cancer surgeon Joseph Califano, MD, deputy director of the Moores Cancer Center at the University of California at San Diego, at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO).

            Califano highlighted a 2019 study that estimated the number of diagnoses of oropharynx cancer cases in the US will grow by half to 30,000 by 2030, with the wide majority (about 25,000) in men. In 2016, the annual number of oropharynx cancer cases was 20,124. “The exponential increase in oropharynx cancer incidence in young white US men has ebbed, and modest increases are occurring/anticipated in cohorts born after 1955,” the study authors wrote.

            “Currently in the United States, we don't have adequate vaccine efficiency to provide herd immunity, particularly for young boys,” said Califano. He added that although HPV vaccinations may create herd immunity in 5 to 10 years, the cancers associated with HPV can take decades to develop so a dip in rates won’t come for many years.

            HPV-associated head and neck squamous cell cancer (HNSCC) affects people at a younger age when compared with other head and neck cancers—a decade or 2 earlier, according to Califano. Many patients are nonsmokers and nondrinkers, he said, and tumors may be painless and asymptomatic.

            It’s also becoming clear that the HPV-associated HNSCC can strike across a widespread area of the oropharynx, including the palatine and lingual tonsils, the nasal cavity, nasopharynx, and hypopharynx (the lower part of the voice box), he said. “It has an even larger footprint than we originally supposed when we realized HPV was a dominant mechanism for development of oropharyngeal cancer,” said Califano.

            Describing the extent of these cancers as an “epidemic,” Califono said a turning point in the understanding of HPV’s role in oropharynx cancers came in a “definitive” 2001 study that reported that HPV-positive patients were much more likely to develop oropharynx cancer (adjusted odds ratio, 14.4). Later research found that HPV-associated oropharynx cancers were more common than HPV-associated cervical cancer. Higher lifetime numbers of vaginal sex and oral sex partners are linked to higher risk of HPV-mediated HNSCC, he said, as is prolonged daily marijuana use.

            Califano emphasized the importance of counseling patients about sexual behaviors linked to the cancers, although it’s also important to consider that “the majority of patients don’t have these risk factors.”

            “The diagnosis is not an indication of infidelity or promiscuity,” he added, recalling that he saw at least one marriage dissolve because of “misunderstandings” regarding how the cancer is caused.  

            There are multiple treatment options. Early-stage oropharynx cancers can be treated with primary excision and staging neck dissection or radiotherapy. Multimodality therapy is appropriate for late-stage cancer and can include concurrent chemotherapy and radiation, primary excision, and treatment with concurrent cisplatinum, depending on the case. Also, “patients do really benefit if they’re enrolled in clinical trials.”

The good news is that HPV-positivity is associated with improved survival in oropharynx cancer, he said. He highlighted a 2019 study that said radiotherapy and cisplatin improve survival in HPV-positive oropharynx cancer patients. “This has become the de-facto standard of care for locally advanced, low-risk HPV-positive oropharynx cancer,” he said.

Califano reported no relevant disclosures.

Human papilloma virus (HPV)-mediated squamous cell carcinoma of the head and neck is on the rise, and the lack of herd immunity in young people will ensure growth for many years to come. “We’re really looking at another 30 to 40 years of HPV and oropharynx cancer growth,” said head and neck cancer surgeon Joseph Califano, MD, deputy director of the Moores Cancer Center at the University of California at San Diego, at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO).

            Califano highlighted a 2019 study that estimated the number of diagnoses of oropharynx cancer cases in the US will grow by half to 30,000 by 2030, with the wide majority (about 25,000) in men. In 2016, the annual number of oropharynx cancer cases was 20,124. “The exponential increase in oropharynx cancer incidence in young white US men has ebbed, and modest increases are occurring/anticipated in cohorts born after 1955,” the study authors wrote.

            “Currently in the United States, we don't have adequate vaccine efficiency to provide herd immunity, particularly for young boys,” said Califano. He added that although HPV vaccinations may create herd immunity in 5 to 10 years, the cancers associated with HPV can take decades to develop so a dip in rates won’t come for many years.

            HPV-associated head and neck squamous cell cancer (HNSCC) affects people at a younger age when compared with other head and neck cancers—a decade or 2 earlier, according to Califano. Many patients are nonsmokers and nondrinkers, he said, and tumors may be painless and asymptomatic.

            It’s also becoming clear that the HPV-associated HNSCC can strike across a widespread area of the oropharynx, including the palatine and lingual tonsils, the nasal cavity, nasopharynx, and hypopharynx (the lower part of the voice box), he said. “It has an even larger footprint than we originally supposed when we realized HPV was a dominant mechanism for development of oropharyngeal cancer,” said Califano.

            Describing the extent of these cancers as an “epidemic,” Califono said a turning point in the understanding of HPV’s role in oropharynx cancers came in a “definitive” 2001 study that reported that HPV-positive patients were much more likely to develop oropharynx cancer (adjusted odds ratio, 14.4). Later research found that HPV-associated oropharynx cancers were more common than HPV-associated cervical cancer. Higher lifetime numbers of vaginal sex and oral sex partners are linked to higher risk of HPV-mediated HNSCC, he said, as is prolonged daily marijuana use.

            Califano emphasized the importance of counseling patients about sexual behaviors linked to the cancers, although it’s also important to consider that “the majority of patients don’t have these risk factors.”

            “The diagnosis is not an indication of infidelity or promiscuity,” he added, recalling that he saw at least one marriage dissolve because of “misunderstandings” regarding how the cancer is caused.  

            There are multiple treatment options. Early-stage oropharynx cancers can be treated with primary excision and staging neck dissection or radiotherapy. Multimodality therapy is appropriate for late-stage cancer and can include concurrent chemotherapy and radiation, primary excision, and treatment with concurrent cisplatinum, depending on the case. Also, “patients do really benefit if they’re enrolled in clinical trials.”

The good news is that HPV-positivity is associated with improved survival in oropharynx cancer, he said. He highlighted a 2019 study that said radiotherapy and cisplatin improve survival in HPV-positive oropharynx cancer patients. “This has become the de-facto standard of care for locally advanced, low-risk HPV-positive oropharynx cancer,” he said.

Califano reported no relevant disclosures.

Human papilloma virus (HPV)-mediated squamous cell carcinoma of the head and neck is on the rise, and the lack of herd immunity in young people will ensure growth for many years to come. “We’re really looking at another 30 to 40 years of HPV and oropharynx cancer growth,” said head and neck cancer surgeon Joseph Califano, MD, deputy director of the Moores Cancer Center at the University of California at San Diego, at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO).

            Califano highlighted a 2019 study that estimated the number of diagnoses of oropharynx cancer cases in the US will grow by half to 30,000 by 2030, with the wide majority (about 25,000) in men. In 2016, the annual number of oropharynx cancer cases was 20,124. “The exponential increase in oropharynx cancer incidence in young white US men has ebbed, and modest increases are occurring/anticipated in cohorts born after 1955,” the study authors wrote.

            “Currently in the United States, we don't have adequate vaccine efficiency to provide herd immunity, particularly for young boys,” said Califano. He added that although HPV vaccinations may create herd immunity in 5 to 10 years, the cancers associated with HPV can take decades to develop so a dip in rates won’t come for many years.

            HPV-associated head and neck squamous cell cancer (HNSCC) affects people at a younger age when compared with other head and neck cancers—a decade or 2 earlier, according to Califano. Many patients are nonsmokers and nondrinkers, he said, and tumors may be painless and asymptomatic.

            It’s also becoming clear that the HPV-associated HNSCC can strike across a widespread area of the oropharynx, including the palatine and lingual tonsils, the nasal cavity, nasopharynx, and hypopharynx (the lower part of the voice box), he said. “It has an even larger footprint than we originally supposed when we realized HPV was a dominant mechanism for development of oropharyngeal cancer,” said Califano.

            Describing the extent of these cancers as an “epidemic,” Califono said a turning point in the understanding of HPV’s role in oropharynx cancers came in a “definitive” 2001 study that reported that HPV-positive patients were much more likely to develop oropharynx cancer (adjusted odds ratio, 14.4). Later research found that HPV-associated oropharynx cancers were more common than HPV-associated cervical cancer. Higher lifetime numbers of vaginal sex and oral sex partners are linked to higher risk of HPV-mediated HNSCC, he said, as is prolonged daily marijuana use.

            Califano emphasized the importance of counseling patients about sexual behaviors linked to the cancers, although it’s also important to consider that “the majority of patients don’t have these risk factors.”

            “The diagnosis is not an indication of infidelity or promiscuity,” he added, recalling that he saw at least one marriage dissolve because of “misunderstandings” regarding how the cancer is caused.  

            There are multiple treatment options. Early-stage oropharynx cancers can be treated with primary excision and staging neck dissection or radiotherapy. Multimodality therapy is appropriate for late-stage cancer and can include concurrent chemotherapy and radiation, primary excision, and treatment with concurrent cisplatinum, depending on the case. Also, “patients do really benefit if they’re enrolled in clinical trials.”

The good news is that HPV-positivity is associated with improved survival in oropharynx cancer, he said. He highlighted a 2019 study that said radiotherapy and cisplatin improve survival in HPV-positive oropharynx cancer patients. “This has become the de-facto standard of care for locally advanced, low-risk HPV-positive oropharynx cancer,” he said.

Califano reported no relevant disclosures.

Abnormal coagulation is a hallmark of COVID-19. Now, as we’re learning more about the high risk of thrombosis, physicians need to prescribe prophylaxis routinely in the hospital, stay alert, and act immediately when signs of trouble appear. “We must have a low suspicion for diagnosis and treatment of thrombosis,” said hematologist-oncologist Thomas DeLoughery, MD, professor of medicine at Oregon Health & Science University in Portland in a presentation at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Still, research is sparse, and there are disagreements about the best strategies to protect patients, said DeLoughery. Physicians recognized coagulation problems early on during the course of the COVID-19 pandemic, he said, and they’re very common. According to DeLoughery, most patients have abnormal coagulation, very high D-dimer test results, and very high fibrinogen levels—even to the extraordinary level of 1,500 mg/dL, he said. And unlike in typical patients with septic shock, patients with thrombosis have a higher risk than bleeding.

A high D-dimer level is a major prognostic indicator of thrombosis and bad outcomes. “It’s representative of widespread coagulation activation, and it can be a sign of pulmonary thrombosis and local thrombosis happening at the site of the COVID infection,” he said.

DeLoughery highlighted an April 2020 study that found that “patients with D‐dimer levels ≥ 2.0 µg/mL had a higher incidence of mortality when compared with those who with D‐dimer levels < 2.0 µg/mL (12/67 vs 1/267; P < .001; hazard ratio, 51.5; 95% CI, 12.9‐206.7).”

Research also suggests that “there's something about getting COVID and going to the intensive care unit (ICU) that dramatically raises the risk of thrombosis,” he said, and the risk goes up over time in the ICU. Venous thrombosis isn’t the only risk. Relatively young patients with COVID have suffered from arterial thrombosis, even though they have minimal to no respiratory symptoms and no cardiovascular risk factors.

As for treatments, DeLoughery noted that thrombosis can occur despite standard prophylaxis, and patients may show resistance to heparin and, therefore, need massive doses. Still, there’s consensus that every patient with COVID-19 in the hospital should get thromboprophylaxis with low-molecular-weight heparin (LMWH), he said, and unfractionated heparin is appropriate for those with renal failure.

“The problem is everything else is controversial,” he said. For example, hematologists are split evenly on whether heparin dosing should be increased beyond standard protocol for patients in the ICU with 1.5 to 3 times normal D-dimers levels. He agreed with this approach but notes that some centers set their D-dimer triggers higher—at 3 to 6 times the normal level.

“The problem is that there’s limited data,” he said. “We have lots of observational studies suggesting benefits from higher doses, but we have no randomized trial data, and the observational studies are not uniform in their recommendations.”

What about outpatient prophylaxis? It appears that risk of thrombosis is < 1% percent when patients are out of the hospital, he said. “This is very reassuring that once the patient gets better, their prothrombotic drive goes away.”

Dr. DeLoughery highlighted the protocol at Oregon Health & Science University:

• Prophylaxis. Everyone with COVID-19 admitted to the hospital receives enoxaparin 40 mg daily. If the patient’s body mass index > 40, it should be increased to twice daily. For patients with renal failure, use unfractionated heparin 5000 u twice daily or enoxaparin 30 mg daily.
• In the ICU. Screen for deep vein thrombosis at admission and every 4 to 5 days thereafter. Increase enoxaparin to 40 mg twice daily, and to 1 mg/kg twice daily if signs of thrombosis develop, such as sudden deterioration, respiratory failure, the patient is too unstable to get a computed tomography, or with D-dimer > 3.0 µg/mL. “People’s thresholds for initiating empiric therapy differ, but this is an option,” he said.

For outpatient patients who are likely to be immobile for a month, 40 mg enoxaparin or 10 mg rivaroxaban are appropriate. “We’re not as aggressive as we used to be about outpatient prophylaxis,” he said.

Moving forward, he said, “this is an area where we really need clinical trials. There's just so much uncertainty.”

DeLoughery reported no disclosures.

Abnormal coagulation is a hallmark of COVID-19. Now, as we’re learning more about the high risk of thrombosis, physicians need to prescribe prophylaxis routinely in the hospital, stay alert, and act immediately when signs of trouble appear. “We must have a low suspicion for diagnosis and treatment of thrombosis,” said hematologist-oncologist Thomas DeLoughery, MD, professor of medicine at Oregon Health & Science University in Portland in a presentation at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Still, research is sparse, and there are disagreements about the best strategies to protect patients, said DeLoughery. Physicians recognized coagulation problems early on during the course of the COVID-19 pandemic, he said, and they’re very common. According to DeLoughery, most patients have abnormal coagulation, very high D-dimer test results, and very high fibrinogen levels—even to the extraordinary level of 1,500 mg/dL, he said. And unlike in typical patients with septic shock, patients with thrombosis have a higher risk than bleeding.

A high D-dimer level is a major prognostic indicator of thrombosis and bad outcomes. “It’s representative of widespread coagulation activation, and it can be a sign of pulmonary thrombosis and local thrombosis happening at the site of the COVID infection,” he said.

DeLoughery highlighted an April 2020 study that found that “patients with D‐dimer levels ≥ 2.0 µg/mL had a higher incidence of mortality when compared with those who with D‐dimer levels < 2.0 µg/mL (12/67 vs 1/267; P < .001; hazard ratio, 51.5; 95% CI, 12.9‐206.7).”

Research also suggests that “there's something about getting COVID and going to the intensive care unit (ICU) that dramatically raises the risk of thrombosis,” he said, and the risk goes up over time in the ICU. Venous thrombosis isn’t the only risk. Relatively young patients with COVID have suffered from arterial thrombosis, even though they have minimal to no respiratory symptoms and no cardiovascular risk factors.

As for treatments, DeLoughery noted that thrombosis can occur despite standard prophylaxis, and patients may show resistance to heparin and, therefore, need massive doses. Still, there’s consensus that every patient with COVID-19 in the hospital should get thromboprophylaxis with low-molecular-weight heparin (LMWH), he said, and unfractionated heparin is appropriate for those with renal failure.

“The problem is everything else is controversial,” he said. For example, hematologists are split evenly on whether heparin dosing should be increased beyond standard protocol for patients in the ICU with 1.5 to 3 times normal D-dimers levels. He agreed with this approach but notes that some centers set their D-dimer triggers higher—at 3 to 6 times the normal level.

“The problem is that there’s limited data,” he said. “We have lots of observational studies suggesting benefits from higher doses, but we have no randomized trial data, and the observational studies are not uniform in their recommendations.”

What about outpatient prophylaxis? It appears that risk of thrombosis is < 1% percent when patients are out of the hospital, he said. “This is very reassuring that once the patient gets better, their prothrombotic drive goes away.”

Dr. DeLoughery highlighted the protocol at Oregon Health & Science University:

• Prophylaxis. Everyone with COVID-19 admitted to the hospital receives enoxaparin 40 mg daily. If the patient’s body mass index > 40, it should be increased to twice daily. For patients with renal failure, use unfractionated heparin 5000 u twice daily or enoxaparin 30 mg daily.
• In the ICU. Screen for deep vein thrombosis at admission and every 4 to 5 days thereafter. Increase enoxaparin to 40 mg twice daily, and to 1 mg/kg twice daily if signs of thrombosis develop, such as sudden deterioration, respiratory failure, the patient is too unstable to get a computed tomography, or with D-dimer > 3.0 µg/mL. “People’s thresholds for initiating empiric therapy differ, but this is an option,” he said.

For outpatient patients who are likely to be immobile for a month, 40 mg enoxaparin or 10 mg rivaroxaban are appropriate. “We’re not as aggressive as we used to be about outpatient prophylaxis,” he said.

Moving forward, he said, “this is an area where we really need clinical trials. There's just so much uncertainty.”

DeLoughery reported no disclosures.

Abnormal coagulation is a hallmark of COVID-19. Now, as we’re learning more about the high risk of thrombosis, physicians need to prescribe prophylaxis routinely in the hospital, stay alert, and act immediately when signs of trouble appear. “We must have a low suspicion for diagnosis and treatment of thrombosis,” said hematologist-oncologist Thomas DeLoughery, MD, professor of medicine at Oregon Health & Science University in Portland in a presentation at the virtual 2020 annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Still, research is sparse, and there are disagreements about the best strategies to protect patients, said DeLoughery. Physicians recognized coagulation problems early on during the course of the COVID-19 pandemic, he said, and they’re very common. According to DeLoughery, most patients have abnormal coagulation, very high D-dimer test results, and very high fibrinogen levels—even to the extraordinary level of 1,500 mg/dL, he said. And unlike in typical patients with septic shock, patients with thrombosis have a higher risk than bleeding.

A high D-dimer level is a major prognostic indicator of thrombosis and bad outcomes. “It’s representative of widespread coagulation activation, and it can be a sign of pulmonary thrombosis and local thrombosis happening at the site of the COVID infection,” he said.

DeLoughery highlighted an April 2020 study that found that “patients with D‐dimer levels ≥ 2.0 µg/mL had a higher incidence of mortality when compared with those who with D‐dimer levels < 2.0 µg/mL (12/67 vs 1/267; P < .001; hazard ratio, 51.5; 95% CI, 12.9‐206.7).”

Research also suggests that “there's something about getting COVID and going to the intensive care unit (ICU) that dramatically raises the risk of thrombosis,” he said, and the risk goes up over time in the ICU. Venous thrombosis isn’t the only risk. Relatively young patients with COVID have suffered from arterial thrombosis, even though they have minimal to no respiratory symptoms and no cardiovascular risk factors.

As for treatments, DeLoughery noted that thrombosis can occur despite standard prophylaxis, and patients may show resistance to heparin and, therefore, need massive doses. Still, there’s consensus that every patient with COVID-19 in the hospital should get thromboprophylaxis with low-molecular-weight heparin (LMWH), he said, and unfractionated heparin is appropriate for those with renal failure.

“The problem is everything else is controversial,” he said. For example, hematologists are split evenly on whether heparin dosing should be increased beyond standard protocol for patients in the ICU with 1.5 to 3 times normal D-dimers levels. He agreed with this approach but notes that some centers set their D-dimer triggers higher—at 3 to 6 times the normal level.

“The problem is that there’s limited data,” he said. “We have lots of observational studies suggesting benefits from higher doses, but we have no randomized trial data, and the observational studies are not uniform in their recommendations.”

What about outpatient prophylaxis? It appears that risk of thrombosis is < 1% percent when patients are out of the hospital, he said. “This is very reassuring that once the patient gets better, their prothrombotic drive goes away.”

Dr. DeLoughery highlighted the protocol at Oregon Health & Science University:

• Prophylaxis. Everyone with COVID-19 admitted to the hospital receives enoxaparin 40 mg daily. If the patient’s body mass index > 40, it should be increased to twice daily. For patients with renal failure, use unfractionated heparin 5000 u twice daily or enoxaparin 30 mg daily.
• In the ICU. Screen for deep vein thrombosis at admission and every 4 to 5 days thereafter. Increase enoxaparin to 40 mg twice daily, and to 1 mg/kg twice daily if signs of thrombosis develop, such as sudden deterioration, respiratory failure, the patient is too unstable to get a computed tomography, or with D-dimer > 3.0 µg/mL. “People’s thresholds for initiating empiric therapy differ, but this is an option,” he said.

For outpatient patients who are likely to be immobile for a month, 40 mg enoxaparin or 10 mg rivaroxaban are appropriate. “We’re not as aggressive as we used to be about outpatient prophylaxis,” he said.

Moving forward, he said, “this is an area where we really need clinical trials. There's just so much uncertainty.”

DeLoughery reported no disclosures.

The US Department of Veterans Affairs (VA) is embracing clinical trials with a focus on oncology, and patients will benefit from new priorities and programs, VA officials reported at the Association of VA Hematology/Oncology (AVAHO) virtual meeting. “The whole model is one that is far more proactive,” said Carolyn Clancy, MD, Under Secretary for Health for Discovery, Education, and Affiliate Networks.

According to Clancy, the department’s top research priority is to increase veteran access to high-quality clinical trials. “Priority number 2 is increasing the real-world impact of VA research,” she said. “Our commitment to veterans and the taxpayers is to reverse and shorten the [research-to-implementation] timeline. And the third priority is to put VA data to work for veterans, not just through people who work in VA and Veterans Health Administration, but through other researchers who can have access to them.”

To meet these goals, VA is engaging in multiple research programs and collaborations. Rachel B. Ramoni, DMD, ScD, the VA chief research and development officer, highlighted a number of the projects in a separate AVAHO meeting presentation, including:

• The National Cancer Institute and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE), an interagency collaboration between the VA and the National Cancer Institute (NCI). This program established a network of sites to help enrolled veterans take part in NCI-supported clinical trials. “It really got up and running in 2018, and I’m proud to say that over 250 veterans have been enrolled, and enrollment exceeds that at non-NAVIGATE sites,” Ramoni reported. “Clearly, the additional support that these sites are getting is really helping to achieve the outcome of getting more veterans access to these trials.” However, she said, some areas of the nation aren’t yet covered by the program.
• The Precision Oncology Program for Cancer of the Prostate (POPCaP), established through a partnership with the Prostate Cancer Foundation. The foundation provided a $50 million investment. “This program ensures that veterans, no matter where they are, get best-in-class prostate cancer care,” Ramoni explained. “The initial focus was ensuring that men get sequencing if they have metastatic prostate cancer, and that they get access to clinical trials. The really distinguishing factor about POPCaP is that it has built a vibrant community of clinicians, researchers and program offices. The whole is much greater than the sum of its parts.” More POPCaP hubs are in development, she said.
• PATCH (Prostate Cancer Analysis for Therapy Choice), a program funded by the VA and the Prostate Cancer Foundation. “The whole purpose of PATCH is to create this network of sites to systematically go through different clinical trials that are biomarker-driven,” Ramoni said. “One of the great things about PATCH is that it’s leveraging the genetics databases to help proactively identify men who might qualify for these trials and to find them wherever they might be across the system so they have access to these trials.” She also praised the program’s commitment to collaboration and mentorship. “If you’re new to putting together clinical trials concepts or to submitting merit proposals to VA for funding, PATCH is a great place to get into a community that’s supportive and wants to help you succeed.”
• The VA Phenomics Library. This library, based at the Boston VA Medical Center, focuses on improving the analysis of “messy” electronic health record data, Ramoni noted. “There are automated algorithms that go through and help you clean up that data to make sense of it,” she said. “The problem is that it’s really been an every-person-for-himself-or-herself system. Each researcher who needed these phenotypes was creating his or her own.” The Phenomics Library will promote sharing “so there’s not going to be as much wasted time duplicating effort,” she said. “By the end of fiscal year 2021, we will have over 1,000 curated phenotypes in there. We hope that will be a great resource for the oncology community as well as many other communities.”
• Access to Clinical Trials (ACT) for Veterans. “This program, which began a couple of years ago, has really succeeded,” Ramoni said. “We were focusing on decreasing the time it takes to start up multi-site industry trials. When we got started with ACT, it was taking over 200 days to get started. And now, just a couple years later, we are well under 100 days, which is within industry standards.” Also, she said, the VA established a Partnered Research Program office, “which serves to interact with our industry partners and really guide them through the VA system, which can be complex if you’re approaching it for the first time.”

In a separate presentation, Krissa Caroff, MS, CPC, program manager of the Partnered Research Program, said it had quickened the process of implementing clinical trials by tackling roadblocks such as the need for multiple master agreements to be signed. Central coordination has been key, she said, “and we are working closely to ensure that we when have a multisite trial, all the VA sites are utilizing the same single IRB [institutional review board]. We’ve also identified the critical information that we need to collect from industry in order for us to evaluate a trial.”

What’s next? “We really are going to be focusing on oncology trials,” Ramoni insisted. “This is a high priority for us.” She added: “Please share your feedback and experiences with us. And also please communicate amongst your colleagues within your organization to explain how we’re standardizing things within VA.”

The speakers reported no relevant disclosures.  

The US Department of Veterans Affairs (VA) is embracing clinical trials with a focus on oncology, and patients will benefit from new priorities and programs, VA officials reported at the Association of VA Hematology/Oncology (AVAHO) virtual meeting. “The whole model is one that is far more proactive,” said Carolyn Clancy, MD, Under Secretary for Health for Discovery, Education, and Affiliate Networks.

According to Clancy, the department’s top research priority is to increase veteran access to high-quality clinical trials. “Priority number 2 is increasing the real-world impact of VA research,” she said. “Our commitment to veterans and the taxpayers is to reverse and shorten the [research-to-implementation] timeline. And the third priority is to put VA data to work for veterans, not just through people who work in VA and Veterans Health Administration, but through other researchers who can have access to them.”

To meet these goals, VA is engaging in multiple research programs and collaborations. Rachel B. Ramoni, DMD, ScD, the VA chief research and development officer, highlighted a number of the projects in a separate AVAHO meeting presentation, including:

• The National Cancer Institute and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE), an interagency collaboration between the VA and the National Cancer Institute (NCI). This program established a network of sites to help enrolled veterans take part in NCI-supported clinical trials. “It really got up and running in 2018, and I’m proud to say that over 250 veterans have been enrolled, and enrollment exceeds that at non-NAVIGATE sites,” Ramoni reported. “Clearly, the additional support that these sites are getting is really helping to achieve the outcome of getting more veterans access to these trials.” However, she said, some areas of the nation aren’t yet covered by the program.
• The Precision Oncology Program for Cancer of the Prostate (POPCaP), established through a partnership with the Prostate Cancer Foundation. The foundation provided a $50 million investment. “This program ensures that veterans, no matter where they are, get best-in-class prostate cancer care,” Ramoni explained. “The initial focus was ensuring that men get sequencing if they have metastatic prostate cancer, and that they get access to clinical trials. The really distinguishing factor about POPCaP is that it has built a vibrant community of clinicians, researchers and program offices. The whole is much greater than the sum of its parts.” More POPCaP hubs are in development, she said.
• PATCH (Prostate Cancer Analysis for Therapy Choice), a program funded by the VA and the Prostate Cancer Foundation. “The whole purpose of PATCH is to create this network of sites to systematically go through different clinical trials that are biomarker-driven,” Ramoni said. “One of the great things about PATCH is that it’s leveraging the genetics databases to help proactively identify men who might qualify for these trials and to find them wherever they might be across the system so they have access to these trials.” She also praised the program’s commitment to collaboration and mentorship. “If you’re new to putting together clinical trials concepts or to submitting merit proposals to VA for funding, PATCH is a great place to get into a community that’s supportive and wants to help you succeed.”
• The VA Phenomics Library. This library, based at the Boston VA Medical Center, focuses on improving the analysis of “messy” electronic health record data, Ramoni noted. “There are automated algorithms that go through and help you clean up that data to make sense of it,” she said. “The problem is that it’s really been an every-person-for-himself-or-herself system. Each researcher who needed these phenotypes was creating his or her own.” The Phenomics Library will promote sharing “so there’s not going to be as much wasted time duplicating effort,” she said. “By the end of fiscal year 2021, we will have over 1,000 curated phenotypes in there. We hope that will be a great resource for the oncology community as well as many other communities.”
• Access to Clinical Trials (ACT) for Veterans. “This program, which began a couple of years ago, has really succeeded,” Ramoni said. “We were focusing on decreasing the time it takes to start up multi-site industry trials. When we got started with ACT, it was taking over 200 days to get started. And now, just a couple years later, we are well under 100 days, which is within industry standards.” Also, she said, the VA established a Partnered Research Program office, “which serves to interact with our industry partners and really guide them through the VA system, which can be complex if you’re approaching it for the first time.”

In a separate presentation, Krissa Caroff, MS, CPC, program manager of the Partnered Research Program, said it had quickened the process of implementing clinical trials by tackling roadblocks such as the need for multiple master agreements to be signed. Central coordination has been key, she said, “and we are working closely to ensure that we when have a multisite trial, all the VA sites are utilizing the same single IRB [institutional review board]. We’ve also identified the critical information that we need to collect from industry in order for us to evaluate a trial.”

What’s next? “We really are going to be focusing on oncology trials,” Ramoni insisted. “This is a high priority for us.” She added: “Please share your feedback and experiences with us. And also please communicate amongst your colleagues within your organization to explain how we’re standardizing things within VA.”

The speakers reported no relevant disclosures.  

The US Department of Veterans Affairs (VA) is embracing clinical trials with a focus on oncology, and patients will benefit from new priorities and programs, VA officials reported at the Association of VA Hematology/Oncology (AVAHO) virtual meeting. “The whole model is one that is far more proactive,” said Carolyn Clancy, MD, Under Secretary for Health for Discovery, Education, and Affiliate Networks.

According to Clancy, the department’s top research priority is to increase veteran access to high-quality clinical trials. “Priority number 2 is increasing the real-world impact of VA research,” she said. “Our commitment to veterans and the taxpayers is to reverse and shorten the [research-to-implementation] timeline. And the third priority is to put VA data to work for veterans, not just through people who work in VA and Veterans Health Administration, but through other researchers who can have access to them.”

To meet these goals, VA is engaging in multiple research programs and collaborations. Rachel B. Ramoni, DMD, ScD, the VA chief research and development officer, highlighted a number of the projects in a separate AVAHO meeting presentation, including:

• The National Cancer Institute and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE), an interagency collaboration between the VA and the National Cancer Institute (NCI). This program established a network of sites to help enrolled veterans take part in NCI-supported clinical trials. “It really got up and running in 2018, and I’m proud to say that over 250 veterans have been enrolled, and enrollment exceeds that at non-NAVIGATE sites,” Ramoni reported. “Clearly, the additional support that these sites are getting is really helping to achieve the outcome of getting more veterans access to these trials.” However, she said, some areas of the nation aren’t yet covered by the program.
• The Precision Oncology Program for Cancer of the Prostate (POPCaP), established through a partnership with the Prostate Cancer Foundation. The foundation provided a $50 million investment. “This program ensures that veterans, no matter where they are, get best-in-class prostate cancer care,” Ramoni explained. “The initial focus was ensuring that men get sequencing if they have metastatic prostate cancer, and that they get access to clinical trials. The really distinguishing factor about POPCaP is that it has built a vibrant community of clinicians, researchers and program offices. The whole is much greater than the sum of its parts.” More POPCaP hubs are in development, she said.
• PATCH (Prostate Cancer Analysis for Therapy Choice), a program funded by the VA and the Prostate Cancer Foundation. “The whole purpose of PATCH is to create this network of sites to systematically go through different clinical trials that are biomarker-driven,” Ramoni said. “One of the great things about PATCH is that it’s leveraging the genetics databases to help proactively identify men who might qualify for these trials and to find them wherever they might be across the system so they have access to these trials.” She also praised the program’s commitment to collaboration and mentorship. “If you’re new to putting together clinical trials concepts or to submitting merit proposals to VA for funding, PATCH is a great place to get into a community that’s supportive and wants to help you succeed.”
• The VA Phenomics Library. This library, based at the Boston VA Medical Center, focuses on improving the analysis of “messy” electronic health record data, Ramoni noted. “There are automated algorithms that go through and help you clean up that data to make sense of it,” she said. “The problem is that it’s really been an every-person-for-himself-or-herself system. Each researcher who needed these phenotypes was creating his or her own.” The Phenomics Library will promote sharing “so there’s not going to be as much wasted time duplicating effort,” she said. “By the end of fiscal year 2021, we will have over 1,000 curated phenotypes in there. We hope that will be a great resource for the oncology community as well as many other communities.”
• Access to Clinical Trials (ACT) for Veterans. “This program, which began a couple of years ago, has really succeeded,” Ramoni said. “We were focusing on decreasing the time it takes to start up multi-site industry trials. When we got started with ACT, it was taking over 200 days to get started. And now, just a couple years later, we are well under 100 days, which is within industry standards.” Also, she said, the VA established a Partnered Research Program office, “which serves to interact with our industry partners and really guide them through the VA system, which can be complex if you’re approaching it for the first time.”

In a separate presentation, Krissa Caroff, MS, CPC, program manager of the Partnered Research Program, said it had quickened the process of implementing clinical trials by tackling roadblocks such as the need for multiple master agreements to be signed. Central coordination has been key, she said, “and we are working closely to ensure that we when have a multisite trial, all the VA sites are utilizing the same single IRB [institutional review board]. We’ve also identified the critical information that we need to collect from industry in order for us to evaluate a trial.”

What’s next? “We really are going to be focusing on oncology trials,” Ramoni insisted. “This is a high priority for us.” She added: “Please share your feedback and experiences with us. And also please communicate amongst your colleagues within your organization to explain how we’re standardizing things within VA.”

The speakers reported no relevant disclosures.  

Serious side effects make up the majority of adverse effects of rituximab and ocrelizumab in patients with multiple sclerosis (MS), a new postmarketing analysis finds, and AE-related deaths were not unusual. Serious AEs, and those linked to death, were more common in the rituximab group, although the reported infection rate was higher in the ocrelizumab group.

The analysis, published Aug. 21 in the Multiple Sclerosis Journal, highlights the importance of monitoring patients for infections and encouraging them to do the same, the authors said.

“This report points out the impact of treatments in terms of unrecognized or underappreciated complications,” said Mark Gudesblatt, MD, medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Patchogue, N.Y., who reviewed the study findings. “These medications have a significant downside.”

Lead author Natalia Gonzalez Caldito, MD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues analyzed AEs for the drugs in the Food and Drug Administration’s Adverse Event Reporting System. They only included cases in which the drugs were solely used to treat MS and were indicated as the cause of the AEs.

Rituximab (Rituxan) and ocrelizumab (Ocrevus) are both monoclonal antibodies. Rituximab is not FDA approved for MS but is used off label; ocrelizumab is approved for the relapsing forms of MS and primary progressive MS.

The researchers found 623 AE reports and 1,466 total AEs for rituximab and 7,948 and 23,613, respectively, for ocrelizumab. The average ages for the groups were 48.76 versus 43.89, respectively, (P < .001), and 71% in each group were women.

Among total AEs, serious AEs were more common in the rituximab group versus the ocrelizumab group (64.8% vs. 56.3%, respectively, P < .001). Adverse events that caused death were also more common in the rituximab group versus the ocrelizumab group (5.75% vs. 2.11%, P < .001).

Infections and infestations were more common in the ocrelizumab group than the rituximab group (21.93% vs. 11.05%, respectively, P < .001). However, certain AEs were more common in the rituximab group than the ocrelizumab group: Those in the blood and lymphatic system category (2.86% vs. 0.91%, respectively, P < .001), and those in the neoplasms category (4.02% vs. 1.28%, P < .001, respectively).

Researchers found a highly strong association between rituximab and a rare side effects – ear pruritus (itching, 0.8%). They also identified signals for infusion-related reaction (4.82%), throat irritation (4.01%) and throat tightness (1.44%), malignant melanoma (0.8%), breast cancer (1.77%) and neutropenia (2.57%).

Among the ocrelizumab AEs, researchers found the strongest association with oral herpes (2.21%), and they found other signals for herpes zoster (2.89%), urinary tract infection (10.52%), nasopharyngitis (9.79%), infusion-related reaction (4.76%), throat irritation (3.08%), and notably MS relapses (4.1%).

“Additional pharmacovigilance studies are needed to explore and further characterize these findings,” the researchers wrote. “Furthermore, these observations suggest that the AE profile of other second-generation anti-CD20 [monoclonal antibodies] may also differ from those of rituximab and ocrelizumab.”

Dr. Gudesblatt praised the analysis and said the findings make sense. “Use of B-cell–depleting agents lead to accumulative immune deficiency in routine care, which leads to higher rates of infection,” he said. He added that, “in the clinical trials for ocrelizumab, patients with IgG and IgM deficiency were excluded, but there is no advisement to exclude such patients in real care. The rates of infection in those patients with MS who have preexisting immune deficiencies and who are treated with these agents are unknown.”

The prospect of AEs is especially worrisome, he said, since “this information is only short term. Who knows what effect the prolonged use of unopposed B-cell depletion will have on infections in the long run?”

Neurologist Mitchell Wallin, MD, MPH, of George Washington University, Washington, and the University of Maryland, Baltimore County, said in an interview that the analysis is rigorous and especially useful because it includes a wider array of subjects – including those who are older and sicker – than took part in earlier clinical trials. “It’s really important to look at this real-world evidence,” he said, “and basically put this in the back of your head when you follow up with your patients.”

No study funding was reported. The corresponding author reported various disclosures. Dr. Gudesblatt and Dr. Wallin reported no disclosures.

SOURCE: Gonzalez Caldito N et al. Mult Scler J. 2020 Aug 21. doi: 10.1177/1352458520949986.

Serious side effects make up the majority of adverse effects of rituximab and ocrelizumab in patients with multiple sclerosis (MS), a new postmarketing analysis finds, and AE-related deaths were not unusual. Serious AEs, and those linked to death, were more common in the rituximab group, although the reported infection rate was higher in the ocrelizumab group.

The analysis, published Aug. 21 in the Multiple Sclerosis Journal, highlights the importance of monitoring patients for infections and encouraging them to do the same, the authors said.

“This report points out the impact of treatments in terms of unrecognized or underappreciated complications,” said Mark Gudesblatt, MD, medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Patchogue, N.Y., who reviewed the study findings. “These medications have a significant downside.”

Lead author Natalia Gonzalez Caldito, MD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues analyzed AEs for the drugs in the Food and Drug Administration’s Adverse Event Reporting System. They only included cases in which the drugs were solely used to treat MS and were indicated as the cause of the AEs.

Rituximab (Rituxan) and ocrelizumab (Ocrevus) are both monoclonal antibodies. Rituximab is not FDA approved for MS but is used off label; ocrelizumab is approved for the relapsing forms of MS and primary progressive MS.

The researchers found 623 AE reports and 1,466 total AEs for rituximab and 7,948 and 23,613, respectively, for ocrelizumab. The average ages for the groups were 48.76 versus 43.89, respectively, (P < .001), and 71% in each group were women.

Among total AEs, serious AEs were more common in the rituximab group versus the ocrelizumab group (64.8% vs. 56.3%, respectively, P < .001). Adverse events that caused death were also more common in the rituximab group versus the ocrelizumab group (5.75% vs. 2.11%, P < .001).

Infections and infestations were more common in the ocrelizumab group than the rituximab group (21.93% vs. 11.05%, respectively, P < .001). However, certain AEs were more common in the rituximab group than the ocrelizumab group: Those in the blood and lymphatic system category (2.86% vs. 0.91%, respectively, P < .001), and those in the neoplasms category (4.02% vs. 1.28%, P < .001, respectively).

Researchers found a highly strong association between rituximab and a rare side effects – ear pruritus (itching, 0.8%). They also identified signals for infusion-related reaction (4.82%), throat irritation (4.01%) and throat tightness (1.44%), malignant melanoma (0.8%), breast cancer (1.77%) and neutropenia (2.57%).

Among the ocrelizumab AEs, researchers found the strongest association with oral herpes (2.21%), and they found other signals for herpes zoster (2.89%), urinary tract infection (10.52%), nasopharyngitis (9.79%), infusion-related reaction (4.76%), throat irritation (3.08%), and notably MS relapses (4.1%).

“Additional pharmacovigilance studies are needed to explore and further characterize these findings,” the researchers wrote. “Furthermore, these observations suggest that the AE profile of other second-generation anti-CD20 [monoclonal antibodies] may also differ from those of rituximab and ocrelizumab.”

Dr. Gudesblatt praised the analysis and said the findings make sense. “Use of B-cell–depleting agents lead to accumulative immune deficiency in routine care, which leads to higher rates of infection,” he said. He added that, “in the clinical trials for ocrelizumab, patients with IgG and IgM deficiency were excluded, but there is no advisement to exclude such patients in real care. The rates of infection in those patients with MS who have preexisting immune deficiencies and who are treated with these agents are unknown.”

The prospect of AEs is especially worrisome, he said, since “this information is only short term. Who knows what effect the prolonged use of unopposed B-cell depletion will have on infections in the long run?”

Neurologist Mitchell Wallin, MD, MPH, of George Washington University, Washington, and the University of Maryland, Baltimore County, said in an interview that the analysis is rigorous and especially useful because it includes a wider array of subjects – including those who are older and sicker – than took part in earlier clinical trials. “It’s really important to look at this real-world evidence,” he said, “and basically put this in the back of your head when you follow up with your patients.”

No study funding was reported. The corresponding author reported various disclosures. Dr. Gudesblatt and Dr. Wallin reported no disclosures.

SOURCE: Gonzalez Caldito N et al. Mult Scler J. 2020 Aug 21. doi: 10.1177/1352458520949986.

Serious side effects make up the majority of adverse effects of rituximab and ocrelizumab in patients with multiple sclerosis (MS), a new postmarketing analysis finds, and AE-related deaths were not unusual. Serious AEs, and those linked to death, were more common in the rituximab group, although the reported infection rate was higher in the ocrelizumab group.

The analysis, published Aug. 21 in the Multiple Sclerosis Journal, highlights the importance of monitoring patients for infections and encouraging them to do the same, the authors said.

“This report points out the impact of treatments in terms of unrecognized or underappreciated complications,” said Mark Gudesblatt, MD, medical director of the Comprehensive MS Care Center at South Shore Neurologic Associates in Patchogue, N.Y., who reviewed the study findings. “These medications have a significant downside.”

Lead author Natalia Gonzalez Caldito, MD, of the University of Texas Southwestern Medical Center, Dallas, and colleagues analyzed AEs for the drugs in the Food and Drug Administration’s Adverse Event Reporting System. They only included cases in which the drugs were solely used to treat MS and were indicated as the cause of the AEs.

Rituximab (Rituxan) and ocrelizumab (Ocrevus) are both monoclonal antibodies. Rituximab is not FDA approved for MS but is used off label; ocrelizumab is approved for the relapsing forms of MS and primary progressive MS.

The researchers found 623 AE reports and 1,466 total AEs for rituximab and 7,948 and 23,613, respectively, for ocrelizumab. The average ages for the groups were 48.76 versus 43.89, respectively, (P < .001), and 71% in each group were women.

Among total AEs, serious AEs were more common in the rituximab group versus the ocrelizumab group (64.8% vs. 56.3%, respectively, P < .001). Adverse events that caused death were also more common in the rituximab group versus the ocrelizumab group (5.75% vs. 2.11%, P < .001).

Infections and infestations were more common in the ocrelizumab group than the rituximab group (21.93% vs. 11.05%, respectively, P < .001). However, certain AEs were more common in the rituximab group than the ocrelizumab group: Those in the blood and lymphatic system category (2.86% vs. 0.91%, respectively, P < .001), and those in the neoplasms category (4.02% vs. 1.28%, P < .001, respectively).

Researchers found a highly strong association between rituximab and a rare side effects – ear pruritus (itching, 0.8%). They also identified signals for infusion-related reaction (4.82%), throat irritation (4.01%) and throat tightness (1.44%), malignant melanoma (0.8%), breast cancer (1.77%) and neutropenia (2.57%).

Among the ocrelizumab AEs, researchers found the strongest association with oral herpes (2.21%), and they found other signals for herpes zoster (2.89%), urinary tract infection (10.52%), nasopharyngitis (9.79%), infusion-related reaction (4.76%), throat irritation (3.08%), and notably MS relapses (4.1%).

“Additional pharmacovigilance studies are needed to explore and further characterize these findings,” the researchers wrote. “Furthermore, these observations suggest that the AE profile of other second-generation anti-CD20 [monoclonal antibodies] may also differ from those of rituximab and ocrelizumab.”

Dr. Gudesblatt praised the analysis and said the findings make sense. “Use of B-cell–depleting agents lead to accumulative immune deficiency in routine care, which leads to higher rates of infection,” he said. He added that, “in the clinical trials for ocrelizumab, patients with IgG and IgM deficiency were excluded, but there is no advisement to exclude such patients in real care. The rates of infection in those patients with MS who have preexisting immune deficiencies and who are treated with these agents are unknown.”

The prospect of AEs is especially worrisome, he said, since “this information is only short term. Who knows what effect the prolonged use of unopposed B-cell depletion will have on infections in the long run?”

Neurologist Mitchell Wallin, MD, MPH, of George Washington University, Washington, and the University of Maryland, Baltimore County, said in an interview that the analysis is rigorous and especially useful because it includes a wider array of subjects – including those who are older and sicker – than took part in earlier clinical trials. “It’s really important to look at this real-world evidence,” he said, “and basically put this in the back of your head when you follow up with your patients.”

No study funding was reported. The corresponding author reported various disclosures. Dr. Gudesblatt and Dr. Wallin reported no disclosures.

SOURCE: Gonzalez Caldito N et al. Mult Scler J. 2020 Aug 21. doi: 10.1177/1352458520949986.

A new analysis of existing research confirms a stark link between excess weight and COVID-19: People with obesity are much more likely to be diagnosed with the novel coronavirus, undergo hospitalization and ICU admission, and die.

Obese patients faced the greatest bump in risk on the hospitalization front, with their odds of being admitted listed as 113% higher. The odds of diagnosis, ICU admission, and death were 46% higher (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.30-1.65; P < .0001); 74% higher (OR, 1.74, CI, 1.46-2.08, P < .0001); 48% (OR, 1.48, CI, 1.22–1.80, P < .001, all pooled analyses and 95% CI), respectively. All differences were highly significantly different, investigators reported in a systematic review and meta-analysis published online Aug. 26 in Obesity Reviews.

“Essentially, these are pretty scary statistics,” nutrition researcher and study lead author Barry M. Popkin, PhD, of the University of North Carolina at Chapel Hill School of Public Health, said in an interview. “Other studies have talked about an increase in mortality, and we were thinking there’d be a little increase like 10% – nothing like 48%.”

According to the Johns Hopkins University of Medicine tracker, nearly 6 million people in the United States had been diagnosed with COVID-19 as of Aug. 30. The number of deaths had surpassed 183,000.

The authors of the new review launched their project to better understand the link between obesity and COVID-19 “all the way from being diagnosed to death,” Dr. Popkin said, adding that the meta-analysis is the largest of its kind to examine the link.

Dr. Popkin and colleagues analyzed 75 studies during January to June 2020 that tracked 399,461 patients (55% of whom were male) diagnosed with COVID-19. They found that 18 of 20 studies linked obesity with a 46% higher risk of diagnosis, but Dr. Popkin cautioned that this may be misleading. “I suspect it’s because they’re sicker and getting tested more for COVID,” he said. “I don’t think obesity enhances your likelihood of getting COVID. We don’t have a biological rationale for that.”

The researchers examined 19 studies that explored a link between obesity and hospitalization; all 19 found a higher risk of hospitalization in patients with obesity (pooled OR, 2.13). Twenty-one of 22 studies that looked at ICU admissions discovered a higher risk for patients with obesity (pooled OR, 1.74). And 27 of 35 studies that examined COVID-19 mortality found a higher death rate in patients with obesity (pooled OR, 1.48).

The review also looked at 14 studies that examined links between obesity and administration of invasive mechanical ventilation. All the studies found a higher risk for patients with obesity (pooled OR, 1.66; 95% CI, 1.38-1.99; P < .0001).

Could socioeconomic factors explain the difference in risk for people with obesity? It’s not clear. According to Dr. Popkin, most of the studies don’t examine factors such as income. While he believes physical factors are the key to the higher risk, he said “there’s clearly a social side to this.”

On the biological front, it appears that “the immune system is much weaker if you’re obese,” he said, and excess weight may worsen the course of a respiratory disease such as COVID-19 because of lung disorders such as sleep apnea.

In addition to highlighting inflammation and a weakened immune system, the review offers multiple explanations for why patients with obesity face worse outcomes in COVID-19. It may be more difficult for medical professionals to care for them in the hospital because of their weight, the authors wrote, and “obesity may also impair therapeutic treatments during COVID-19 infections.” The authors noted that ACE inhibitors may worsen COVID-19 in patients with type 2 diabetes.

The researchers noted that “potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.” They pointed to research that suggests T-cell responses are weaker and antibody titers wane at a faster rate in people with obesity who are vaccinated against influenza.

SOURCE: Popkin BM et al. Obes Rev. 2020 Aug 26. doi: 10.1111/obr.13128.

A new analysis of existing research confirms a stark link between excess weight and COVID-19: People with obesity are much more likely to be diagnosed with the novel coronavirus, undergo hospitalization and ICU admission, and die.

Obese patients faced the greatest bump in risk on the hospitalization front, with their odds of being admitted listed as 113% higher. The odds of diagnosis, ICU admission, and death were 46% higher (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.30-1.65; P < .0001); 74% higher (OR, 1.74, CI, 1.46-2.08, P < .0001); 48% (OR, 1.48, CI, 1.22–1.80, P < .001, all pooled analyses and 95% CI), respectively. All differences were highly significantly different, investigators reported in a systematic review and meta-analysis published online Aug. 26 in Obesity Reviews.

“Essentially, these are pretty scary statistics,” nutrition researcher and study lead author Barry M. Popkin, PhD, of the University of North Carolina at Chapel Hill School of Public Health, said in an interview. “Other studies have talked about an increase in mortality, and we were thinking there’d be a little increase like 10% – nothing like 48%.”

According to the Johns Hopkins University of Medicine tracker, nearly 6 million people in the United States had been diagnosed with COVID-19 as of Aug. 30. The number of deaths had surpassed 183,000.

The authors of the new review launched their project to better understand the link between obesity and COVID-19 “all the way from being diagnosed to death,” Dr. Popkin said, adding that the meta-analysis is the largest of its kind to examine the link.

Dr. Popkin and colleagues analyzed 75 studies during January to June 2020 that tracked 399,461 patients (55% of whom were male) diagnosed with COVID-19. They found that 18 of 20 studies linked obesity with a 46% higher risk of diagnosis, but Dr. Popkin cautioned that this may be misleading. “I suspect it’s because they’re sicker and getting tested more for COVID,” he said. “I don’t think obesity enhances your likelihood of getting COVID. We don’t have a biological rationale for that.”

The researchers examined 19 studies that explored a link between obesity and hospitalization; all 19 found a higher risk of hospitalization in patients with obesity (pooled OR, 2.13). Twenty-one of 22 studies that looked at ICU admissions discovered a higher risk for patients with obesity (pooled OR, 1.74). And 27 of 35 studies that examined COVID-19 mortality found a higher death rate in patients with obesity (pooled OR, 1.48).

The review also looked at 14 studies that examined links between obesity and administration of invasive mechanical ventilation. All the studies found a higher risk for patients with obesity (pooled OR, 1.66; 95% CI, 1.38-1.99; P < .0001).

Could socioeconomic factors explain the difference in risk for people with obesity? It’s not clear. According to Dr. Popkin, most of the studies don’t examine factors such as income. While he believes physical factors are the key to the higher risk, he said “there’s clearly a social side to this.”

On the biological front, it appears that “the immune system is much weaker if you’re obese,” he said, and excess weight may worsen the course of a respiratory disease such as COVID-19 because of lung disorders such as sleep apnea.

In addition to highlighting inflammation and a weakened immune system, the review offers multiple explanations for why patients with obesity face worse outcomes in COVID-19. It may be more difficult for medical professionals to care for them in the hospital because of their weight, the authors wrote, and “obesity may also impair therapeutic treatments during COVID-19 infections.” The authors noted that ACE inhibitors may worsen COVID-19 in patients with type 2 diabetes.

The researchers noted that “potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.” They pointed to research that suggests T-cell responses are weaker and antibody titers wane at a faster rate in people with obesity who are vaccinated against influenza.

SOURCE: Popkin BM et al. Obes Rev. 2020 Aug 26. doi: 10.1111/obr.13128.

A new analysis of existing research confirms a stark link between excess weight and COVID-19: People with obesity are much more likely to be diagnosed with the novel coronavirus, undergo hospitalization and ICU admission, and die.

Obese patients faced the greatest bump in risk on the hospitalization front, with their odds of being admitted listed as 113% higher. The odds of diagnosis, ICU admission, and death were 46% higher (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.30-1.65; P < .0001); 74% higher (OR, 1.74, CI, 1.46-2.08, P < .0001); 48% (OR, 1.48, CI, 1.22–1.80, P < .001, all pooled analyses and 95% CI), respectively. All differences were highly significantly different, investigators reported in a systematic review and meta-analysis published online Aug. 26 in Obesity Reviews.

“Essentially, these are pretty scary statistics,” nutrition researcher and study lead author Barry M. Popkin, PhD, of the University of North Carolina at Chapel Hill School of Public Health, said in an interview. “Other studies have talked about an increase in mortality, and we were thinking there’d be a little increase like 10% – nothing like 48%.”

According to the Johns Hopkins University of Medicine tracker, nearly 6 million people in the United States had been diagnosed with COVID-19 as of Aug. 30. The number of deaths had surpassed 183,000.

The authors of the new review launched their project to better understand the link between obesity and COVID-19 “all the way from being diagnosed to death,” Dr. Popkin said, adding that the meta-analysis is the largest of its kind to examine the link.

Dr. Popkin and colleagues analyzed 75 studies during January to June 2020 that tracked 399,461 patients (55% of whom were male) diagnosed with COVID-19. They found that 18 of 20 studies linked obesity with a 46% higher risk of diagnosis, but Dr. Popkin cautioned that this may be misleading. “I suspect it’s because they’re sicker and getting tested more for COVID,” he said. “I don’t think obesity enhances your likelihood of getting COVID. We don’t have a biological rationale for that.”

The researchers examined 19 studies that explored a link between obesity and hospitalization; all 19 found a higher risk of hospitalization in patients with obesity (pooled OR, 2.13). Twenty-one of 22 studies that looked at ICU admissions discovered a higher risk for patients with obesity (pooled OR, 1.74). And 27 of 35 studies that examined COVID-19 mortality found a higher death rate in patients with obesity (pooled OR, 1.48).

The review also looked at 14 studies that examined links between obesity and administration of invasive mechanical ventilation. All the studies found a higher risk for patients with obesity (pooled OR, 1.66; 95% CI, 1.38-1.99; P < .0001).

Could socioeconomic factors explain the difference in risk for people with obesity? It’s not clear. According to Dr. Popkin, most of the studies don’t examine factors such as income. While he believes physical factors are the key to the higher risk, he said “there’s clearly a social side to this.”

On the biological front, it appears that “the immune system is much weaker if you’re obese,” he said, and excess weight may worsen the course of a respiratory disease such as COVID-19 because of lung disorders such as sleep apnea.

In addition to highlighting inflammation and a weakened immune system, the review offers multiple explanations for why patients with obesity face worse outcomes in COVID-19. It may be more difficult for medical professionals to care for them in the hospital because of their weight, the authors wrote, and “obesity may also impair therapeutic treatments during COVID-19 infections.” The authors noted that ACE inhibitors may worsen COVID-19 in patients with type 2 diabetes.

The researchers noted that “potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.” They pointed to research that suggests T-cell responses are weaker and antibody titers wane at a faster rate in people with obesity who are vaccinated against influenza.

SOURCE: Popkin BM et al. Obes Rev. 2020 Aug 26. doi: 10.1111/obr.13128.

A new report recommends the surgical closure of patent foramen ovale (PFO) in high-risk divers, but physicians in the United States urged caution about widespread use of the procedure in this population.

“PFO closure is recommended in divers with a high-grade PFO, with a history of unprovoked decompression sickness [DCS], or at the diver’s preference. Besides protection from DCS, PFO closure also offers the diver life-long protection from PFO-associated stroke,” write the authors of an analysis of the DIVE-PFO Registry.

The investigators, led by Jakub Honêk, MD, PhD, of Motol University Hospital in Prague, based that advice on results of their analysis, which compared two groups of divers with high-grade PFO: 55 who underwent catheter-based PFO closure, and 98 who were urged to dive cautiously.

Over a mean of about 7 years, the divers who underwent catheter-based PFO closure had no unprovoked decompression sickness (DCS), while the condition occurred in 11% of those who hadn’t had the procedure, according to the report, a research letter published online in the Journal of the American College of Cardiology.Decompression sickness, also known as the bends, can occur as gas bubbles pass through the circulatory system as divers ascend. In divers with PFO, which affects about 25% of the population, the bubbles can bypass filtration in the lungs and cause strokes, said neurologist David Thaler, MD, PhD, of Tufts Medical Center, Boston.

PFO closure via surgery is one option for divers with PFO, but there’s debate over whether the procedure should be widespread. For the new research letter, researchers prospectively tracked 748 divers in the DIVE-PFO (Decompression Illness Prevention in Divers with a Patent Foramen Ovale) registry during 2006-2018. Twenty-two percent had high-grade PFO.

In divers with PFO of grade 3 or above, procedures were performed if patients had a history of DCS or if they couldn’t adapt to conservative diving recommendations. The researchers said this population included commercial divers.

The groups that did or didn’t undergo surgery were similar in age (40.0 and 37.3 years, respectively, P = 0.079), and sex (78.2% and 79.6% male, respectively, P = 0.893), but differed in number of new dives (30,684 vs. 25,328, respectively, P < 0.001,), ). They were tracked for a mean of 7.1 years and 6.5 years, respectively.

It’s not clear whether the divers who underwent the closure procedure had fewer DCSs because they were more cautious about dive safety than the other diver group. The research letter doesn’t mention whether strokes occurred in divers in the two groups.

The study authors write that the results are consistent with previous findings that “PFO closure eliminates arterial gas emboli, “PFO is a major risk factor for unprovoked DCS,” and “PFO closure is a safe procedure with a very low complication rate.”

In interviews, physicians who are familiar with diver safety questioned the value of the findings and said medical professionals shouldn’t change practice.
 

Not so fast, experts say

Dr. Thaler, the Tufts Medical Center neurologist, questioned why the report explored a link between PFO and DCS. Overall, he said, the findings are too incomplete to inform practice. Anesthesiologist Richard Moon, MD, of Duke University, Durham, N.C., also questioned the study’s examination of DCS. “Most DCS cases are uncorrelated with PFO. It is only serious cases, a minority, that could conceivably be related to PFO, and even then, many serious cases that occur in divers with PFO are unrelated to it.” He added that “numerous divers with mild DCS ... have been mistakenly evaluated for PFO. Such practice is unsubstantiated by data.”

Should more closures be performed in this population? “I would be hesitant to make the recommended closures in divers,” said cardiologist David C. Peritz, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. “There are probably other ways that you can decrease your chances of getting decompression illness and make your dives more safe.”

Cardiologist Clifford J. Kavinsky, MD, PhD, of Rush University Medical Center, Chicago, said the closure procedure is “relatively safe” when performed by experienced surgeons. He noted that it is “only approved to prevent recurrent ischemic stroke in patients predominantly between the ages of 18 and 60 years who have experienced a cortical stroke presumed to be of embolic nature and for which no obvious cause can be found.”

As for high-risk divers, he said PFO closures “can be considered, but the data as yet are not strong enough to strongly recommend it.”

The Czech Republic’s Ministry of Health funded the study. The authors report no relevant disclosures. Dr. Thaler, Dr. Kavinsky, Dr. Moon and Dr. Peritz report no relevant disclosures.

SOURCE: Honěk J et al. J Am Coll Cardiol. 2020 Sep 1;76(9):1149-50.

A new report recommends the surgical closure of patent foramen ovale (PFO) in high-risk divers, but physicians in the United States urged caution about widespread use of the procedure in this population.

“PFO closure is recommended in divers with a high-grade PFO, with a history of unprovoked decompression sickness [DCS], or at the diver’s preference. Besides protection from DCS, PFO closure also offers the diver life-long protection from PFO-associated stroke,” write the authors of an analysis of the DIVE-PFO Registry.

The investigators, led by Jakub Honêk, MD, PhD, of Motol University Hospital in Prague, based that advice on results of their analysis, which compared two groups of divers with high-grade PFO: 55 who underwent catheter-based PFO closure, and 98 who were urged to dive cautiously.

Over a mean of about 7 years, the divers who underwent catheter-based PFO closure had no unprovoked decompression sickness (DCS), while the condition occurred in 11% of those who hadn’t had the procedure, according to the report, a research letter published online in the Journal of the American College of Cardiology.Decompression sickness, also known as the bends, can occur as gas bubbles pass through the circulatory system as divers ascend. In divers with PFO, which affects about 25% of the population, the bubbles can bypass filtration in the lungs and cause strokes, said neurologist David Thaler, MD, PhD, of Tufts Medical Center, Boston.

PFO closure via surgery is one option for divers with PFO, but there’s debate over whether the procedure should be widespread. For the new research letter, researchers prospectively tracked 748 divers in the DIVE-PFO (Decompression Illness Prevention in Divers with a Patent Foramen Ovale) registry during 2006-2018. Twenty-two percent had high-grade PFO.

In divers with PFO of grade 3 or above, procedures were performed if patients had a history of DCS or if they couldn’t adapt to conservative diving recommendations. The researchers said this population included commercial divers.

The groups that did or didn’t undergo surgery were similar in age (40.0 and 37.3 years, respectively, P = 0.079), and sex (78.2% and 79.6% male, respectively, P = 0.893), but differed in number of new dives (30,684 vs. 25,328, respectively, P < 0.001,), ). They were tracked for a mean of 7.1 years and 6.5 years, respectively.

It’s not clear whether the divers who underwent the closure procedure had fewer DCSs because they were more cautious about dive safety than the other diver group. The research letter doesn’t mention whether strokes occurred in divers in the two groups.

The study authors write that the results are consistent with previous findings that “PFO closure eliminates arterial gas emboli, “PFO is a major risk factor for unprovoked DCS,” and “PFO closure is a safe procedure with a very low complication rate.”

In interviews, physicians who are familiar with diver safety questioned the value of the findings and said medical professionals shouldn’t change practice.
 

Not so fast, experts say

Dr. Thaler, the Tufts Medical Center neurologist, questioned why the report explored a link between PFO and DCS. Overall, he said, the findings are too incomplete to inform practice. Anesthesiologist Richard Moon, MD, of Duke University, Durham, N.C., also questioned the study’s examination of DCS. “Most DCS cases are uncorrelated with PFO. It is only serious cases, a minority, that could conceivably be related to PFO, and even then, many serious cases that occur in divers with PFO are unrelated to it.” He added that “numerous divers with mild DCS ... have been mistakenly evaluated for PFO. Such practice is unsubstantiated by data.”

Should more closures be performed in this population? “I would be hesitant to make the recommended closures in divers,” said cardiologist David C. Peritz, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. “There are probably other ways that you can decrease your chances of getting decompression illness and make your dives more safe.”

Cardiologist Clifford J. Kavinsky, MD, PhD, of Rush University Medical Center, Chicago, said the closure procedure is “relatively safe” when performed by experienced surgeons. He noted that it is “only approved to prevent recurrent ischemic stroke in patients predominantly between the ages of 18 and 60 years who have experienced a cortical stroke presumed to be of embolic nature and for which no obvious cause can be found.”

As for high-risk divers, he said PFO closures “can be considered, but the data as yet are not strong enough to strongly recommend it.”

The Czech Republic’s Ministry of Health funded the study. The authors report no relevant disclosures. Dr. Thaler, Dr. Kavinsky, Dr. Moon and Dr. Peritz report no relevant disclosures.

SOURCE: Honěk J et al. J Am Coll Cardiol. 2020 Sep 1;76(9):1149-50.

A new report recommends the surgical closure of patent foramen ovale (PFO) in high-risk divers, but physicians in the United States urged caution about widespread use of the procedure in this population.

“PFO closure is recommended in divers with a high-grade PFO, with a history of unprovoked decompression sickness [DCS], or at the diver’s preference. Besides protection from DCS, PFO closure also offers the diver life-long protection from PFO-associated stroke,” write the authors of an analysis of the DIVE-PFO Registry.

The investigators, led by Jakub Honêk, MD, PhD, of Motol University Hospital in Prague, based that advice on results of their analysis, which compared two groups of divers with high-grade PFO: 55 who underwent catheter-based PFO closure, and 98 who were urged to dive cautiously.

Over a mean of about 7 years, the divers who underwent catheter-based PFO closure had no unprovoked decompression sickness (DCS), while the condition occurred in 11% of those who hadn’t had the procedure, according to the report, a research letter published online in the Journal of the American College of Cardiology.Decompression sickness, also known as the bends, can occur as gas bubbles pass through the circulatory system as divers ascend. In divers with PFO, which affects about 25% of the population, the bubbles can bypass filtration in the lungs and cause strokes, said neurologist David Thaler, MD, PhD, of Tufts Medical Center, Boston.

PFO closure via surgery is one option for divers with PFO, but there’s debate over whether the procedure should be widespread. For the new research letter, researchers prospectively tracked 748 divers in the DIVE-PFO (Decompression Illness Prevention in Divers with a Patent Foramen Ovale) registry during 2006-2018. Twenty-two percent had high-grade PFO.

In divers with PFO of grade 3 or above, procedures were performed if patients had a history of DCS or if they couldn’t adapt to conservative diving recommendations. The researchers said this population included commercial divers.

The groups that did or didn’t undergo surgery were similar in age (40.0 and 37.3 years, respectively, P = 0.079), and sex (78.2% and 79.6% male, respectively, P = 0.893), but differed in number of new dives (30,684 vs. 25,328, respectively, P < 0.001,), ). They were tracked for a mean of 7.1 years and 6.5 years, respectively.

It’s not clear whether the divers who underwent the closure procedure had fewer DCSs because they were more cautious about dive safety than the other diver group. The research letter doesn’t mention whether strokes occurred in divers in the two groups.

The study authors write that the results are consistent with previous findings that “PFO closure eliminates arterial gas emboli, “PFO is a major risk factor for unprovoked DCS,” and “PFO closure is a safe procedure with a very low complication rate.”

In interviews, physicians who are familiar with diver safety questioned the value of the findings and said medical professionals shouldn’t change practice.
 

Not so fast, experts say

Dr. Thaler, the Tufts Medical Center neurologist, questioned why the report explored a link between PFO and DCS. Overall, he said, the findings are too incomplete to inform practice. Anesthesiologist Richard Moon, MD, of Duke University, Durham, N.C., also questioned the study’s examination of DCS. “Most DCS cases are uncorrelated with PFO. It is only serious cases, a minority, that could conceivably be related to PFO, and even then, many serious cases that occur in divers with PFO are unrelated to it.” He added that “numerous divers with mild DCS ... have been mistakenly evaluated for PFO. Such practice is unsubstantiated by data.”

Should more closures be performed in this population? “I would be hesitant to make the recommended closures in divers,” said cardiologist David C. Peritz, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. “There are probably other ways that you can decrease your chances of getting decompression illness and make your dives more safe.”

Cardiologist Clifford J. Kavinsky, MD, PhD, of Rush University Medical Center, Chicago, said the closure procedure is “relatively safe” when performed by experienced surgeons. He noted that it is “only approved to prevent recurrent ischemic stroke in patients predominantly between the ages of 18 and 60 years who have experienced a cortical stroke presumed to be of embolic nature and for which no obvious cause can be found.”

As for high-risk divers, he said PFO closures “can be considered, but the data as yet are not strong enough to strongly recommend it.”

The Czech Republic’s Ministry of Health funded the study. The authors report no relevant disclosures. Dr. Thaler, Dr. Kavinsky, Dr. Moon and Dr. Peritz report no relevant disclosures.

SOURCE: Honěk J et al. J Am Coll Cardiol. 2020 Sep 1;76(9):1149-50.

Compared with their counterparts who get more relief, patients with difficult-to-treat migraine are more likely to delay acute treatment and take over-the-counter and opioid painkillers. They are also more likely to have depression and impairment. Overall, insufficient responders—patients less likely to get relief shortly after acute treatment—are “more medically and psychosocially complex,” wrote the authors of the study, which appeared in the July/August issue of Headache.

Common characteristics of insufficient responders

The researchers, led by Louise Lombard, M Nutr, of Eli Lilly and Company, analyzed data from a 2014 cross-sectional survey. They tracked 583 patients with migraine, including 200 (34%) who were considered insufficient responders because they failed to achieve freedom from pain within 2 hours of acute treatment in at least four of five attacks.

The insufficient and sufficient responder groups were similar in age (mean = 40 for both) and gender (80% and 75% female, respectively, P = .170) and race (72% and 77% white, P = .279).

However, insufficient responders were clearly more affected by headaches, multiple treatments, and other burdens. Compared with those who had better responses to treatment, they were more likely to have four or more migraine headache days per month (46% vs. 31%), rebound or medication-overuse headaches (16% vs. 7%) and chronic migraine (12% vs. 5%, all P < .05).

They were also more likely have comorbid depression (38% vs. 22%) and psychological conditions other than depression and anxiety (8% vs. 4%, all P < .05).

As for treatment, insufficient response was higher in patients who waited until the appearance of pain to take medication (odds ratio = 1.83, 95% confidence interval [CI] 1.15–2.92, P = .011, after adjustment for covariates). And insufficient responders were more likely to have been prescribed at least three unique preventive regimens (12% vs. 6%), to take over-the-counter medications (50% vs. 38%) and to take opioid painkillers (16% vs. 8%, all P < .05).

The authors, who caution that the study does not prove cause and effect, wrote that insufficient responders “may benefit from education on how and when to use current treatments.”
 

Managing insufficient responders

Neurology Reviews editor-in-chief Alan M. Rapoport, MD, said the study “confirms a lot of what we knew.” Dr, Rapoport, who was not involved in the study, is clinical professor of neurology at the University of California, Los Angeles.

“As expected, the insufficient responders used more opioids and over-the-counter medications, which is not the ideal way to treat migraine,” he said. “That probably caused them to have medication-overuse headache, which might have caused them to respond poorly to even the best treatment regimen. They also had more severe symptoms, more comorbidities, and a poorer quality of life. They also had more impairment and greater impact on work, with more of them unemployed.”

The insufficient responders also “took medication at the time or after the pain began, rather than before it when they thought the attack was beginning due to premonitory symptoms,” he said.

Dr. Rapoport also noted a surprising and unusual finding: Patients who did not report sensitivity to light as their most bothersome symptom were more likely to be insufficient responders (OR = 2.3, 95% CI [1.21–4.37], P = .011). “In all recent migraine studies,” he said, “the majority of patients selected photophobia as their most bothersome symptom.”

In the big picture, he said, the study suggests that “a third triptan does not seem to work better than the first two, patients with medication-overuse headache and chronic migraine and those not on preventive medication do not respond that well to acute care treatment, and the same is true when depression is present.”

No study funding was reported. Four study authors reported ties with Eli Lilly, and two reported employment by Adelphi Real World, which provided the survey results..

SOURCE: Lombard L et al. Headache. 2020;60(7):1325-39. doi: 10.1111/head.13835.

Compared with their counterparts who get more relief, patients with difficult-to-treat migraine are more likely to delay acute treatment and take over-the-counter and opioid painkillers. They are also more likely to have depression and impairment. Overall, insufficient responders—patients less likely to get relief shortly after acute treatment—are “more medically and psychosocially complex,” wrote the authors of the study, which appeared in the July/August issue of Headache.

Common characteristics of insufficient responders

The researchers, led by Louise Lombard, M Nutr, of Eli Lilly and Company, analyzed data from a 2014 cross-sectional survey. They tracked 583 patients with migraine, including 200 (34%) who were considered insufficient responders because they failed to achieve freedom from pain within 2 hours of acute treatment in at least four of five attacks.

The insufficient and sufficient responder groups were similar in age (mean = 40 for both) and gender (80% and 75% female, respectively, P = .170) and race (72% and 77% white, P = .279).

However, insufficient responders were clearly more affected by headaches, multiple treatments, and other burdens. Compared with those who had better responses to treatment, they were more likely to have four or more migraine headache days per month (46% vs. 31%), rebound or medication-overuse headaches (16% vs. 7%) and chronic migraine (12% vs. 5%, all P < .05).

They were also more likely have comorbid depression (38% vs. 22%) and psychological conditions other than depression and anxiety (8% vs. 4%, all P < .05).

As for treatment, insufficient response was higher in patients who waited until the appearance of pain to take medication (odds ratio = 1.83, 95% confidence interval [CI] 1.15–2.92, P = .011, after adjustment for covariates). And insufficient responders were more likely to have been prescribed at least three unique preventive regimens (12% vs. 6%), to take over-the-counter medications (50% vs. 38%) and to take opioid painkillers (16% vs. 8%, all P < .05).

The authors, who caution that the study does not prove cause and effect, wrote that insufficient responders “may benefit from education on how and when to use current treatments.”
 

Managing insufficient responders

Neurology Reviews editor-in-chief Alan M. Rapoport, MD, said the study “confirms a lot of what we knew.” Dr, Rapoport, who was not involved in the study, is clinical professor of neurology at the University of California, Los Angeles.

“As expected, the insufficient responders used more opioids and over-the-counter medications, which is not the ideal way to treat migraine,” he said. “That probably caused them to have medication-overuse headache, which might have caused them to respond poorly to even the best treatment regimen. They also had more severe symptoms, more comorbidities, and a poorer quality of life. They also had more impairment and greater impact on work, with more of them unemployed.”

The insufficient responders also “took medication at the time or after the pain began, rather than before it when they thought the attack was beginning due to premonitory symptoms,” he said.

Dr. Rapoport also noted a surprising and unusual finding: Patients who did not report sensitivity to light as their most bothersome symptom were more likely to be insufficient responders (OR = 2.3, 95% CI [1.21–4.37], P = .011). “In all recent migraine studies,” he said, “the majority of patients selected photophobia as their most bothersome symptom.”

In the big picture, he said, the study suggests that “a third triptan does not seem to work better than the first two, patients with medication-overuse headache and chronic migraine and those not on preventive medication do not respond that well to acute care treatment, and the same is true when depression is present.”

No study funding was reported. Four study authors reported ties with Eli Lilly, and two reported employment by Adelphi Real World, which provided the survey results..

SOURCE: Lombard L et al. Headache. 2020;60(7):1325-39. doi: 10.1111/head.13835.

Compared with their counterparts who get more relief, patients with difficult-to-treat migraine are more likely to delay acute treatment and take over-the-counter and opioid painkillers. They are also more likely to have depression and impairment. Overall, insufficient responders—patients less likely to get relief shortly after acute treatment—are “more medically and psychosocially complex,” wrote the authors of the study, which appeared in the July/August issue of Headache.

Common characteristics of insufficient responders

The researchers, led by Louise Lombard, M Nutr, of Eli Lilly and Company, analyzed data from a 2014 cross-sectional survey. They tracked 583 patients with migraine, including 200 (34%) who were considered insufficient responders because they failed to achieve freedom from pain within 2 hours of acute treatment in at least four of five attacks.

The insufficient and sufficient responder groups were similar in age (mean = 40 for both) and gender (80% and 75% female, respectively, P = .170) and race (72% and 77% white, P = .279).

However, insufficient responders were clearly more affected by headaches, multiple treatments, and other burdens. Compared with those who had better responses to treatment, they were more likely to have four or more migraine headache days per month (46% vs. 31%), rebound or medication-overuse headaches (16% vs. 7%) and chronic migraine (12% vs. 5%, all P < .05).

They were also more likely have comorbid depression (38% vs. 22%) and psychological conditions other than depression and anxiety (8% vs. 4%, all P < .05).

As for treatment, insufficient response was higher in patients who waited until the appearance of pain to take medication (odds ratio = 1.83, 95% confidence interval [CI] 1.15–2.92, P = .011, after adjustment for covariates). And insufficient responders were more likely to have been prescribed at least three unique preventive regimens (12% vs. 6%), to take over-the-counter medications (50% vs. 38%) and to take opioid painkillers (16% vs. 8%, all P < .05).

The authors, who caution that the study does not prove cause and effect, wrote that insufficient responders “may benefit from education on how and when to use current treatments.”
 

Managing insufficient responders

Neurology Reviews editor-in-chief Alan M. Rapoport, MD, said the study “confirms a lot of what we knew.” Dr, Rapoport, who was not involved in the study, is clinical professor of neurology at the University of California, Los Angeles.

“As expected, the insufficient responders used more opioids and over-the-counter medications, which is not the ideal way to treat migraine,” he said. “That probably caused them to have medication-overuse headache, which might have caused them to respond poorly to even the best treatment regimen. They also had more severe symptoms, more comorbidities, and a poorer quality of life. They also had more impairment and greater impact on work, with more of them unemployed.”

The insufficient responders also “took medication at the time or after the pain began, rather than before it when they thought the attack was beginning due to premonitory symptoms,” he said.

Dr. Rapoport also noted a surprising and unusual finding: Patients who did not report sensitivity to light as their most bothersome symptom were more likely to be insufficient responders (OR = 2.3, 95% CI [1.21–4.37], P = .011). “In all recent migraine studies,” he said, “the majority of patients selected photophobia as their most bothersome symptom.”

In the big picture, he said, the study suggests that “a third triptan does not seem to work better than the first two, patients with medication-overuse headache and chronic migraine and those not on preventive medication do not respond that well to acute care treatment, and the same is true when depression is present.”

No study funding was reported. Four study authors reported ties with Eli Lilly, and two reported employment by Adelphi Real World, which provided the survey results..

SOURCE: Lombard L et al. Headache. 2020;60(7):1325-39. doi: 10.1111/head.13835.

Amanda Calhoun, MD, recalls noticing a distinct empathy gap while she trained at a youth psychiatric unit.

Courtesy Dr. Amanda Calhoun

A White male patient hurled the N-word at a Black patient, and the majority White staff did nothing. “And then [they] told me the White patient was struggling and that’s why they allowed it, even though he was aggressive,” said Dr. Calhoun, psychiatry resident at Yale University in New Haven, Conn. But Dr. Calhoun noticed less restraint on the part of her colleagues while she was treating an angry female Black Latinx patient.

“I remember staff saying she was a nightmare; they called her the B-word; she was ‘a terror.’ How is that this patient isn’t viewed as struggling, where the other patient is? I don’t understand the difference here.”

And, Dr. Calhoun said, “when a patient can complain that they feel they were treated differently based on skin color, [the White majority staff] would just say they have borderline personality disorder or they’re depressed.

“When the staff is not diverse, I really see differential treatment in who gets the benefit of the doubt and their empathy.”

Psychiatrists such as Dr. Calhoun can list countless other examples of institutional racism, interpersonal racism, and prejudice in psychiatry. They see signs of institutional racism in clinical care, academia, and in research. Some are questioning the American Psychiatric Association decision to put on hiatus the Institute on Psychiatric Services, its fall annual meeting that has traditionally served as a vehicle for examining the treatment of underserved communities.

Against that backdrop – and after the killing of George Floyd and amid the disproportionate impact of COVID-19 on communities of color – the APA launched an effort the group says is aimed at reforming itself and psychiatry as a whole. In June, the APA announced the formation of the Presidential Task Force to Address Structural Racism Throughout Psychiatry, and the panel – focused on anti-Black racism – has begun its yearlong work.

A specialty with inherent contradictions

Jeffrey Geller, MD, MPH, the APA’s president, acknowledged in an interview that racism in psychiatry is older than the APA – which celebrated its 175th anniversary as an association last year.

As Dr. Geller pointed out recently, Benjamin Rush, MD, a founding father of the United States and the father of American psychiatry, was an abolitionist who owned one enslaved man – and thought the intelligence and morality of Black people were equal to that of their White counterparts.¹ Dr. Rush also thought the skin color of Black people was a manifestation of a type of leprosy that he called “Negritude.”² “Rush was a remarkable mix of contradictions,” Dr. Geller wrote.

Many of the kinds of contradictions that animated Dr. Rush can be found within psychiatry.

Altha J. Stewart, MD, the first and only Black president of the APA, declined to be interviewed for this article.

But as Dr. Stewart was wrapping up her term as president, she reportedly³ said that a 1970 paper titled “Dimensions of Institutional Racism in Psychiatry” by the late Melvin Sabshin, MD, and associates was essentially a blueprint for moving the specialty forward.

That paper, published in the American Journal of Psychiatry, took psychiatry to task on many levels. One of the barriers that Black psychiatric patients must overcome, according to Dr. Sabshin and associates, is the “biases of the White therapist, who must overcome his cultural blind spots, reactive guilt, and unconscious prejudice.” They called community psychiatry paternalistic. Furthermore, Dr. Sabshin, who would later serve as medical director of the APA for almost 25 years, criticized White mental health professionals for viewing Black communities as “seething cauldrons of psychopathology”:

“They create stereotypes of absent fathers, primitive rage, psychopathy, self-depreciation, promiscuity, deficits in intellectual capacity, and lack of psychological sensitivity,” Dr. Sabshin and his associates wrote. “Gross pathological caricaturization ignores the enormous variation of behavior in black communities. ... The obsession with black psychopathology has been so great that it has retarded serious consideration of racism as it pertains to white psychopathology.”⁴

In other words, White American psychiatrists adopted the prevailing views of society at large toward Black people. More recently, “there was a period in this country where Black people were thought to be at higher risk of developing issues like schizophrenia⁵ instead of depression,” said Gregory Scott Brown, MD, of the Center for Green Psychiatry and the University of Texas in Austin.

Courtesy Dr. Gregory Scott Brown

“Pharmaceutical companies developed ads for antipsychotic medications that portrayed angry Black men or women. This got into the heads of who may have been conditioned without knowing it,” he said.

In addition, psychiatry has failed to diversify its ranks. To this day, Dr. Geller said, “Black psychiatrists are underrepresented in academic settings, leadership positions, hospitals, and clinics. Black patients are suffering because of inequities in access to care in treatment, and even those who receive treatment are often misdiagnosed since we don’t account for the extended community’s trauma.” About 2% of U.S. psychiatrists are Black, and Black people make up 13% of the U.S. population.⁶

The low percentage of Black psychiatrists hurts the field for many reasons, said task force member Steven Starks, MD, clinical assistant professor of psychiatry at the University of Houston, and not solely because the gap forces many Black patients to be treated by non-Black psychiatrists. “The association has a large, broad impact on our field and profession through the DSM, and work in areas like government relations and access to care and insurance,” Dr. Starks said.
 

Task force gets mixed reviews

After the announcement, Dr. Geller named the psychiatrists who will serve, and the task force, chaired by Cheryl D. Wills, MD, assistant professor of psychiatry at Case Western Reserve University in Cleveland, got to work quickly.

The task force has conducted an online town hall and will conduct another one on Aug. 24. It also released the results of a survey of nearly 500 members about the top three areas that the task force should address.

“Access to Healthcare/Mental Healthcare” received the most votes (97) as the recommended top priority, followed by “Socio-Economic Conditions and Factors” (49). These two areas also received the most first-, second- and third-priority votes overall (173 and 166, respectively).

The other areas with high numbers of first priority votes were “Lack of Minority Psychiatrists, Faculty and Leaders” and “Education for Psychiatrists,” both tied at 46. Those areas received 142 and 122 total votes supporting them as first, second, and third priorities.

Thirty-seven members said “Racism within the APA/APA Actions” should be the top priority. A small number of respondents appeared to doubt the need for such a task force: Nineteen thought the top priority should be “Questioning the Concept of Structural Racism/Task Force.”

Meanwhile, some psychiatrists are raising questions about the task force’s makeup.

Ruth S. Shim, MD, MPH, the Luke & Grace Kim Professor of Cultural Psychiatry at the University of California, Davis, said that she was disappointed by the task force’s membership. Specifically, Dr. Shim said, the task force does not include enough APA members she sees as qualified to address structural racism.

“While many of the Black psychiatrists who are members of the task force are experts in issues of diversity, inclusion, and equity, other members of the board of trustees who were appointed to this task force do not have any expertise in this area,” said Dr. Shim, who wrote a scathing commentary⁷ in July about the APA’s failures regarding structural racism. “I believe the selection of members could have been more thoughtful and more inclusive of diverse perspectives and voices.”

Dr. Geller countered that the task force includes a mix of APA board members and non–board members with various types of expertise. “Certain board members were chosen because their colleagues on the board “were already involved in task forces and other projects,” he said.

How the task force is envisioned

Dr. Geller’s goals for the task force, which will operate at least through his 1-year term as president, are ambitious.

“I hope the task force will identify structural racism wherever it’s taking place – where psychiatrists practice, within the APA itself,” Dr. Geller said. “It will be an educational process so we can inform members and ourselves about clear and subtle structural racism. Then we’re going to proffer solutions in several areas that can rectify some of what we’ve been doing and the negative outcomes that have resulted in areas of leadership such as access to care, treatment, hospital and clinic administration, health insurance, and academia. It’s clear that this is a massive undertaking.”

For her part, Dr. Shim thinks the task force might chip around the edges of the structural problems in the specialty – rather than focusing on the roots. “The task force is set up to fail,” she said. “To truly dismantle structural racism in the APA, the leadership of the organization – the CEO, the executive committee, and the board of trustees – must do the hard work of deep self-reflection and self-study to recognize the role that they have played in perpetuating and upholding White supremacy in the organization.

“I do not believe the task force will be capable of doing this, as this is not what they have been tasked to do,” Dr. Shim said.

Task force member Dr. Starks said he believes there is potential for progress within the APA. While Black members have been frustrated by an APA power structure that seems both harmful and unchangeable, he said, “this is an opportunity for us to re-root and achieve equity in mental health.”

He added that the priorities of the task force are not set in stone. “Those things that are listed on the website may change and evolve over time as we report back to the board and develop our functions internally,” said Dr. Starks, who praised Dr. Shim’s commentary as “courageous.”

The website lists these initial charges for the task force:

• Providing education and resources on APA’s and psychiatry’s history regarding structural racism.
• Explaining the current impact of structural racism on the mental health of our patients and colleagues.
• Developing achievable and actionable recommendations for change to eliminate structural racism in the APA and psychiatry now and in the future.
• Providing reports with specific recommendations for achievable actions to the APA board of trustees at each of its meetings through May 2021.
• Monitoring the implementation of tasks.

Meanwhile, the task force is reporting to the APA board of directors each month. The entity is tied to the 1-year presidential term of Dr. Geller, which ends in spring 2021, but Dr. Starks said he hopes it will continue in another form – such as a formal committee.
 

Importance of cultural competence

Dr. Brown highlighted the importance of cultural competence – “making sure that we are looking at patients in the context of their cultural background, their religion, their race, so we can make informed decisions without jumping to conclusions too soon.”

For example, if an African American man or woman talks about hearing God’s voice, “we shouldn’t necessarily brush it off or diminish it as psychiatric illness if it’s in the context of that person’s religious background,” Dr. Brown said.

Francis G. Lu, MD, agreed. He said the task force should explore cultural competency on both clinical and systems levels.

“An antidote to structural racism would be systems cultural competence involving organizations, clinics, and teams looking beyond patient care issues,” said Dr. Lu, the Luke & Grace Kim Professor in Cultural Psychiatry Emeritus at the University of California, Davis. A good starting point, he said, is the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care, also known as the National CLAS Standards.

Looking forward, Olusola Ajilore, MD, PhD, called for a focus on targeted efforts aimed at encouraging more minority medical students to become psychiatrists.

“We have a field with a lot of crucial questions that have yet to be answered,” said Dr. Ajilore, associate director of residency training and education at the University of Illinois at Chicago. “With more Black psychiatrists, we might be more aware of some of the research questions that affect our community, such as the mental health consequences of exposure to racism and prejudice.”

However, the role of White psychiatrists cannot be overemphasized, said Constance E. Dunlap, MD, clinical professor of psychiatry and behavioral sciences at George Washington University in Washington.

“Whites can make a difference by acknowledging the racial hierarchy that ‘unfairly disadvantages some ... and unfairly advantages others’ – to use the language⁸ offered by Dr. Camara Phyllis Jones, said Dr. Dunlap.

“As psychiatrists – as physicians – we are obligated to help patients see themselves and the world more clearly. This starts with our own self-appraisal and extends to our work, whether it is in a psychodynamic space or a community psychiatry setting,” Dr. Dunlap said. “Bottom line, instead of focusing on guilt, I tell my White colleagues and patients: You have privilege, use it constructively to benefit the world.”

Dr. Calhoun said she hopes to see mandated integration of training about racism into psychiatric education. “Rather than a special racism lecture, I’d like to see instruction implemented throughout. It should be essential for psychiatrists to learn about the historical racism of psychiatry and the current racial inequities that exist among psychiatric patients.”

The practice of community psychiatry,⁹ almost by definition, is uniquely positioned to break through some of those structural issues. “The community psychiatry approach to treatment is not specific to any race or cultural group – because each person is treated as an individual,” said Stephanie Le Melle, MD, MS, director of public psychiatry education at Columbia University and the New York Psychiatric Institute. “The social determinants of health, culture, and social justice experience of each person is taken into consideration,” said Dr. Le Melle.

“Community psychiatry steps outside of the traditional medical model of symptoms and illness, and focuses on understanding the person’s strengths and goals – and helps them to live their best lives.”

Dr. Le Melle also views diversifying the psychiatric workforce as imperative.

“For many African American, Latinx, and other marginalized populations that have had to deal with systemic and structural racism, discrimination, and historical abuse at the hands of psychiatry, it can be difficult to establish trust,” said Dr. Le Melle. “Therefore, diversity of our workforce and cultural humility are also crucial for engagement.”

The APA’s decision to not go forward with this year’s Institute on Psychiatric Services: The Mental Health Services Conference undermines the group’s credibility on these issues, according to some psychiatrists.

The IPS meeting, founded in 1948, is “where we traditionally teach and present about the social determinants of health and racism,” said Dr. Le Melle. “If the APA is serious about addressing the social determinants of health, bias, and discrimination against marginalized people and cultural humility, it needs to embrace and grow community psychiatry, not cut it.”

When asked about the IPS conference, Dr. Geller said that it has been scheduled for October 2021 in New York City. He also said the decision to skip the 2020 conference was made 2 years ago. The conference’s organizing committee decided to cancel the event when hotel space in the preferred city could not be arranged, Dr. Geller said.

Meanwhile, in a widely circulated letter that was sent to the APA board of trustees on Aug. 7, numerous leaders in psychiatry from across the country are citing steps they say the APA must take from “continuing impacts of structural racism that will greatly harm underserved patients, [minority and underrepresented] (M/UR) psychiatrists, and the APA as a whole.”

One step the leaders asked the APA to take was to hire an independent entity to investigate the organization’s “workplace culture, staff morale, and experiences of staff members and M/UR psychiatrists who support and/or work at the organization or have previously been dismissed or departed.”

Dr. Calhoun said she agrees that an internal examination would be productive.

“I’d like to see multiple people in positions of power (in the APA) in order to forward agendas,” Dr. Calhoun said. “Unless we do, we’ll have no way to achieve the goal of getting rid of structural racism.”
 

Dr. Calhoun, Dr. Geller, Dr. Brown, Dr. Starks, Dr. Lu, Dr. Ajilore, Dr. Dunlap, and Dr. Le Melle reported no relevant disclosures. Dr. Shim disclosed receiving royalties from American Psychiatric Association Publishing. Dr. Stewart is a coeditor of “Black Mental Health: Patients, Providers, and Systems” (American Psychiatric Association Publishing, 2018).

References

1. Geller J. Psychiatric News. 2020 Jun 23.

2. Washington HA. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present. (New York: Doubleday), 2006.

3. ”Stewart brings a robust and eventful presidential year to a close.” Psychiatric News Daily. 2019 May 18.

4. Sabshin M et al. Am J Psychiatry. 1970 Dec;127:6.

5. Metzl JM. The Protest Psychosis: How Schizophrenia Became a Black Disease. (Boston: Beacon Press), 2009.

6. U.S. Census Bureau. Population estimates. 2019 Jul 1.

7. Shim RS. “Structural racism is why I’m leaving organized psychiatry. statnews.com. 2020 Jul 1.

8. Jones CP. Ethn Dis;28(Suppl):231-4.

9. Ewalt JR and Ewalt PA. Am J Psychiatry. 2006 Apr 1. doi: 10.1176/ajp.126.1.43.

Amanda Calhoun, MD, recalls noticing a distinct empathy gap while she trained at a youth psychiatric unit.

Courtesy Dr. Amanda Calhoun

A White male patient hurled the N-word at a Black patient, and the majority White staff did nothing. “And then [they] told me the White patient was struggling and that’s why they allowed it, even though he was aggressive,” said Dr. Calhoun, psychiatry resident at Yale University in New Haven, Conn. But Dr. Calhoun noticed less restraint on the part of her colleagues while she was treating an angry female Black Latinx patient.

“I remember staff saying she was a nightmare; they called her the B-word; she was ‘a terror.’ How is that this patient isn’t viewed as struggling, where the other patient is? I don’t understand the difference here.”

And, Dr. Calhoun said, “when a patient can complain that they feel they were treated differently based on skin color, [the White majority staff] would just say they have borderline personality disorder or they’re depressed.

“When the staff is not diverse, I really see differential treatment in who gets the benefit of the doubt and their empathy.”

Psychiatrists such as Dr. Calhoun can list countless other examples of institutional racism, interpersonal racism, and prejudice in psychiatry. They see signs of institutional racism in clinical care, academia, and in research. Some are questioning the American Psychiatric Association decision to put on hiatus the Institute on Psychiatric Services, its fall annual meeting that has traditionally served as a vehicle for examining the treatment of underserved communities.

Against that backdrop – and after the killing of George Floyd and amid the disproportionate impact of COVID-19 on communities of color – the APA launched an effort the group says is aimed at reforming itself and psychiatry as a whole. In June, the APA announced the formation of the Presidential Task Force to Address Structural Racism Throughout Psychiatry, and the panel – focused on anti-Black racism – has begun its yearlong work.

A specialty with inherent contradictions

Jeffrey Geller, MD, MPH, the APA’s president, acknowledged in an interview that racism in psychiatry is older than the APA – which celebrated its 175th anniversary as an association last year.

As Dr. Geller pointed out recently, Benjamin Rush, MD, a founding father of the United States and the father of American psychiatry, was an abolitionist who owned one enslaved man – and thought the intelligence and morality of Black people were equal to that of their White counterparts.¹ Dr. Rush also thought the skin color of Black people was a manifestation of a type of leprosy that he called “Negritude.”² “Rush was a remarkable mix of contradictions,” Dr. Geller wrote.

Many of the kinds of contradictions that animated Dr. Rush can be found within psychiatry.

Altha J. Stewart, MD, the first and only Black president of the APA, declined to be interviewed for this article.

But as Dr. Stewart was wrapping up her term as president, she reportedly³ said that a 1970 paper titled “Dimensions of Institutional Racism in Psychiatry” by the late Melvin Sabshin, MD, and associates was essentially a blueprint for moving the specialty forward.

That paper, published in the American Journal of Psychiatry, took psychiatry to task on many levels. One of the barriers that Black psychiatric patients must overcome, according to Dr. Sabshin and associates, is the “biases of the White therapist, who must overcome his cultural blind spots, reactive guilt, and unconscious prejudice.” They called community psychiatry paternalistic. Furthermore, Dr. Sabshin, who would later serve as medical director of the APA for almost 25 years, criticized White mental health professionals for viewing Black communities as “seething cauldrons of psychopathology”:

“They create stereotypes of absent fathers, primitive rage, psychopathy, self-depreciation, promiscuity, deficits in intellectual capacity, and lack of psychological sensitivity,” Dr. Sabshin and his associates wrote. “Gross pathological caricaturization ignores the enormous variation of behavior in black communities. ... The obsession with black psychopathology has been so great that it has retarded serious consideration of racism as it pertains to white psychopathology.”⁴

In other words, White American psychiatrists adopted the prevailing views of society at large toward Black people. More recently, “there was a period in this country where Black people were thought to be at higher risk of developing issues like schizophrenia⁵ instead of depression,” said Gregory Scott Brown, MD, of the Center for Green Psychiatry and the University of Texas in Austin.

Courtesy Dr. Gregory Scott Brown

“Pharmaceutical companies developed ads for antipsychotic medications that portrayed angry Black men or women. This got into the heads of who may have been conditioned without knowing it,” he said.

In addition, psychiatry has failed to diversify its ranks. To this day, Dr. Geller said, “Black psychiatrists are underrepresented in academic settings, leadership positions, hospitals, and clinics. Black patients are suffering because of inequities in access to care in treatment, and even those who receive treatment are often misdiagnosed since we don’t account for the extended community’s trauma.” About 2% of U.S. psychiatrists are Black, and Black people make up 13% of the U.S. population.⁶

The low percentage of Black psychiatrists hurts the field for many reasons, said task force member Steven Starks, MD, clinical assistant professor of psychiatry at the University of Houston, and not solely because the gap forces many Black patients to be treated by non-Black psychiatrists. “The association has a large, broad impact on our field and profession through the DSM, and work in areas like government relations and access to care and insurance,” Dr. Starks said.
 

Task force gets mixed reviews

After the announcement, Dr. Geller named the psychiatrists who will serve, and the task force, chaired by Cheryl D. Wills, MD, assistant professor of psychiatry at Case Western Reserve University in Cleveland, got to work quickly.

The task force has conducted an online town hall and will conduct another one on Aug. 24. It also released the results of a survey of nearly 500 members about the top three areas that the task force should address.

“Access to Healthcare/Mental Healthcare” received the most votes (97) as the recommended top priority, followed by “Socio-Economic Conditions and Factors” (49). These two areas also received the most first-, second- and third-priority votes overall (173 and 166, respectively).

The other areas with high numbers of first priority votes were “Lack of Minority Psychiatrists, Faculty and Leaders” and “Education for Psychiatrists,” both tied at 46. Those areas received 142 and 122 total votes supporting them as first, second, and third priorities.

Thirty-seven members said “Racism within the APA/APA Actions” should be the top priority. A small number of respondents appeared to doubt the need for such a task force: Nineteen thought the top priority should be “Questioning the Concept of Structural Racism/Task Force.”

Meanwhile, some psychiatrists are raising questions about the task force’s makeup.

Ruth S. Shim, MD, MPH, the Luke & Grace Kim Professor of Cultural Psychiatry at the University of California, Davis, said that she was disappointed by the task force’s membership. Specifically, Dr. Shim said, the task force does not include enough APA members she sees as qualified to address structural racism.

“While many of the Black psychiatrists who are members of the task force are experts in issues of diversity, inclusion, and equity, other members of the board of trustees who were appointed to this task force do not have any expertise in this area,” said Dr. Shim, who wrote a scathing commentary⁷ in July about the APA’s failures regarding structural racism. “I believe the selection of members could have been more thoughtful and more inclusive of diverse perspectives and voices.”

Dr. Geller countered that the task force includes a mix of APA board members and non–board members with various types of expertise. “Certain board members were chosen because their colleagues on the board “were already involved in task forces and other projects,” he said.

How the task force is envisioned

Dr. Geller’s goals for the task force, which will operate at least through his 1-year term as president, are ambitious.

“I hope the task force will identify structural racism wherever it’s taking place – where psychiatrists practice, within the APA itself,” Dr. Geller said. “It will be an educational process so we can inform members and ourselves about clear and subtle structural racism. Then we’re going to proffer solutions in several areas that can rectify some of what we’ve been doing and the negative outcomes that have resulted in areas of leadership such as access to care, treatment, hospital and clinic administration, health insurance, and academia. It’s clear that this is a massive undertaking.”

For her part, Dr. Shim thinks the task force might chip around the edges of the structural problems in the specialty – rather than focusing on the roots. “The task force is set up to fail,” she said. “To truly dismantle structural racism in the APA, the leadership of the organization – the CEO, the executive committee, and the board of trustees – must do the hard work of deep self-reflection and self-study to recognize the role that they have played in perpetuating and upholding White supremacy in the organization.

“I do not believe the task force will be capable of doing this, as this is not what they have been tasked to do,” Dr. Shim said.

Task force member Dr. Starks said he believes there is potential for progress within the APA. While Black members have been frustrated by an APA power structure that seems both harmful and unchangeable, he said, “this is an opportunity for us to re-root and achieve equity in mental health.”

He added that the priorities of the task force are not set in stone. “Those things that are listed on the website may change and evolve over time as we report back to the board and develop our functions internally,” said Dr. Starks, who praised Dr. Shim’s commentary as “courageous.”

The website lists these initial charges for the task force:

• Providing education and resources on APA’s and psychiatry’s history regarding structural racism.
• Explaining the current impact of structural racism on the mental health of our patients and colleagues.
• Developing achievable and actionable recommendations for change to eliminate structural racism in the APA and psychiatry now and in the future.
• Providing reports with specific recommendations for achievable actions to the APA board of trustees at each of its meetings through May 2021.
• Monitoring the implementation of tasks.

Meanwhile, the task force is reporting to the APA board of directors each month. The entity is tied to the 1-year presidential term of Dr. Geller, which ends in spring 2021, but Dr. Starks said he hopes it will continue in another form – such as a formal committee.
 

Importance of cultural competence

Dr. Brown highlighted the importance of cultural competence – “making sure that we are looking at patients in the context of their cultural background, their religion, their race, so we can make informed decisions without jumping to conclusions too soon.”

For example, if an African American man or woman talks about hearing God’s voice, “we shouldn’t necessarily brush it off or diminish it as psychiatric illness if it’s in the context of that person’s religious background,” Dr. Brown said.

Francis G. Lu, MD, agreed. He said the task force should explore cultural competency on both clinical and systems levels.

“An antidote to structural racism would be systems cultural competence involving organizations, clinics, and teams looking beyond patient care issues,” said Dr. Lu, the Luke & Grace Kim Professor in Cultural Psychiatry Emeritus at the University of California, Davis. A good starting point, he said, is the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care, also known as the National CLAS Standards.

Looking forward, Olusola Ajilore, MD, PhD, called for a focus on targeted efforts aimed at encouraging more minority medical students to become psychiatrists.

“We have a field with a lot of crucial questions that have yet to be answered,” said Dr. Ajilore, associate director of residency training and education at the University of Illinois at Chicago. “With more Black psychiatrists, we might be more aware of some of the research questions that affect our community, such as the mental health consequences of exposure to racism and prejudice.”

However, the role of White psychiatrists cannot be overemphasized, said Constance E. Dunlap, MD, clinical professor of psychiatry and behavioral sciences at George Washington University in Washington.

“Whites can make a difference by acknowledging the racial hierarchy that ‘unfairly disadvantages some ... and unfairly advantages others’ – to use the language⁸ offered by Dr. Camara Phyllis Jones, said Dr. Dunlap.

“As psychiatrists – as physicians – we are obligated to help patients see themselves and the world more clearly. This starts with our own self-appraisal and extends to our work, whether it is in a psychodynamic space or a community psychiatry setting,” Dr. Dunlap said. “Bottom line, instead of focusing on guilt, I tell my White colleagues and patients: You have privilege, use it constructively to benefit the world.”

Dr. Calhoun said she hopes to see mandated integration of training about racism into psychiatric education. “Rather than a special racism lecture, I’d like to see instruction implemented throughout. It should be essential for psychiatrists to learn about the historical racism of psychiatry and the current racial inequities that exist among psychiatric patients.”

The practice of community psychiatry,⁹ almost by definition, is uniquely positioned to break through some of those structural issues. “The community psychiatry approach to treatment is not specific to any race or cultural group – because each person is treated as an individual,” said Stephanie Le Melle, MD, MS, director of public psychiatry education at Columbia University and the New York Psychiatric Institute. “The social determinants of health, culture, and social justice experience of each person is taken into consideration,” said Dr. Le Melle.

“Community psychiatry steps outside of the traditional medical model of symptoms and illness, and focuses on understanding the person’s strengths and goals – and helps them to live their best lives.”

Dr. Le Melle also views diversifying the psychiatric workforce as imperative.

“For many African American, Latinx, and other marginalized populations that have had to deal with systemic and structural racism, discrimination, and historical abuse at the hands of psychiatry, it can be difficult to establish trust,” said Dr. Le Melle. “Therefore, diversity of our workforce and cultural humility are also crucial for engagement.”

The APA’s decision to not go forward with this year’s Institute on Psychiatric Services: The Mental Health Services Conference undermines the group’s credibility on these issues, according to some psychiatrists.

The IPS meeting, founded in 1948, is “where we traditionally teach and present about the social determinants of health and racism,” said Dr. Le Melle. “If the APA is serious about addressing the social determinants of health, bias, and discrimination against marginalized people and cultural humility, it needs to embrace and grow community psychiatry, not cut it.”

When asked about the IPS conference, Dr. Geller said that it has been scheduled for October 2021 in New York City. He also said the decision to skip the 2020 conference was made 2 years ago. The conference’s organizing committee decided to cancel the event when hotel space in the preferred city could not be arranged, Dr. Geller said.

Meanwhile, in a widely circulated letter that was sent to the APA board of trustees on Aug. 7, numerous leaders in psychiatry from across the country are citing steps they say the APA must take from “continuing impacts of structural racism that will greatly harm underserved patients, [minority and underrepresented] (M/UR) psychiatrists, and the APA as a whole.”

One step the leaders asked the APA to take was to hire an independent entity to investigate the organization’s “workplace culture, staff morale, and experiences of staff members and M/UR psychiatrists who support and/or work at the organization or have previously been dismissed or departed.”

Dr. Calhoun said she agrees that an internal examination would be productive.

“I’d like to see multiple people in positions of power (in the APA) in order to forward agendas,” Dr. Calhoun said. “Unless we do, we’ll have no way to achieve the goal of getting rid of structural racism.”
 

Dr. Calhoun, Dr. Geller, Dr. Brown, Dr. Starks, Dr. Lu, Dr. Ajilore, Dr. Dunlap, and Dr. Le Melle reported no relevant disclosures. Dr. Shim disclosed receiving royalties from American Psychiatric Association Publishing. Dr. Stewart is a coeditor of “Black Mental Health: Patients, Providers, and Systems” (American Psychiatric Association Publishing, 2018).

References

1. Geller J. Psychiatric News. 2020 Jun 23.

2. Washington HA. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present. (New York: Doubleday), 2006.

3. ”Stewart brings a robust and eventful presidential year to a close.” Psychiatric News Daily. 2019 May 18.

4. Sabshin M et al. Am J Psychiatry. 1970 Dec;127:6.

5. Metzl JM. The Protest Psychosis: How Schizophrenia Became a Black Disease. (Boston: Beacon Press), 2009.

6. U.S. Census Bureau. Population estimates. 2019 Jul 1.

7. Shim RS. “Structural racism is why I’m leaving organized psychiatry. statnews.com. 2020 Jul 1.

8. Jones CP. Ethn Dis;28(Suppl):231-4.

9. Ewalt JR and Ewalt PA. Am J Psychiatry. 2006 Apr 1. doi: 10.1176/ajp.126.1.43.

Amanda Calhoun, MD, recalls noticing a distinct empathy gap while she trained at a youth psychiatric unit.

Courtesy Dr. Amanda Calhoun

A White male patient hurled the N-word at a Black patient, and the majority White staff did nothing. “And then [they] told me the White patient was struggling and that’s why they allowed it, even though he was aggressive,” said Dr. Calhoun, psychiatry resident at Yale University in New Haven, Conn. But Dr. Calhoun noticed less restraint on the part of her colleagues while she was treating an angry female Black Latinx patient.

“I remember staff saying she was a nightmare; they called her the B-word; she was ‘a terror.’ How is that this patient isn’t viewed as struggling, where the other patient is? I don’t understand the difference here.”

And, Dr. Calhoun said, “when a patient can complain that they feel they were treated differently based on skin color, [the White majority staff] would just say they have borderline personality disorder or they’re depressed.

“When the staff is not diverse, I really see differential treatment in who gets the benefit of the doubt and their empathy.”

Psychiatrists such as Dr. Calhoun can list countless other examples of institutional racism, interpersonal racism, and prejudice in psychiatry. They see signs of institutional racism in clinical care, academia, and in research. Some are questioning the American Psychiatric Association decision to put on hiatus the Institute on Psychiatric Services, its fall annual meeting that has traditionally served as a vehicle for examining the treatment of underserved communities.

Against that backdrop – and after the killing of George Floyd and amid the disproportionate impact of COVID-19 on communities of color – the APA launched an effort the group says is aimed at reforming itself and psychiatry as a whole. In June, the APA announced the formation of the Presidential Task Force to Address Structural Racism Throughout Psychiatry, and the panel – focused on anti-Black racism – has begun its yearlong work.

A specialty with inherent contradictions

Jeffrey Geller, MD, MPH, the APA’s president, acknowledged in an interview that racism in psychiatry is older than the APA – which celebrated its 175th anniversary as an association last year.

As Dr. Geller pointed out recently, Benjamin Rush, MD, a founding father of the United States and the father of American psychiatry, was an abolitionist who owned one enslaved man – and thought the intelligence and morality of Black people were equal to that of their White counterparts.¹ Dr. Rush also thought the skin color of Black people was a manifestation of a type of leprosy that he called “Negritude.”² “Rush was a remarkable mix of contradictions,” Dr. Geller wrote.

Many of the kinds of contradictions that animated Dr. Rush can be found within psychiatry.

Altha J. Stewart, MD, the first and only Black president of the APA, declined to be interviewed for this article.

But as Dr. Stewart was wrapping up her term as president, she reportedly³ said that a 1970 paper titled “Dimensions of Institutional Racism in Psychiatry” by the late Melvin Sabshin, MD, and associates was essentially a blueprint for moving the specialty forward.

That paper, published in the American Journal of Psychiatry, took psychiatry to task on many levels. One of the barriers that Black psychiatric patients must overcome, according to Dr. Sabshin and associates, is the “biases of the White therapist, who must overcome his cultural blind spots, reactive guilt, and unconscious prejudice.” They called community psychiatry paternalistic. Furthermore, Dr. Sabshin, who would later serve as medical director of the APA for almost 25 years, criticized White mental health professionals for viewing Black communities as “seething cauldrons of psychopathology”:

“They create stereotypes of absent fathers, primitive rage, psychopathy, self-depreciation, promiscuity, deficits in intellectual capacity, and lack of psychological sensitivity,” Dr. Sabshin and his associates wrote. “Gross pathological caricaturization ignores the enormous variation of behavior in black communities. ... The obsession with black psychopathology has been so great that it has retarded serious consideration of racism as it pertains to white psychopathology.”⁴

In other words, White American psychiatrists adopted the prevailing views of society at large toward Black people. More recently, “there was a period in this country where Black people were thought to be at higher risk of developing issues like schizophrenia⁵ instead of depression,” said Gregory Scott Brown, MD, of the Center for Green Psychiatry and the University of Texas in Austin.

Courtesy Dr. Gregory Scott Brown

“Pharmaceutical companies developed ads for antipsychotic medications that portrayed angry Black men or women. This got into the heads of who may have been conditioned without knowing it,” he said.

In addition, psychiatry has failed to diversify its ranks. To this day, Dr. Geller said, “Black psychiatrists are underrepresented in academic settings, leadership positions, hospitals, and clinics. Black patients are suffering because of inequities in access to care in treatment, and even those who receive treatment are often misdiagnosed since we don’t account for the extended community’s trauma.” About 2% of U.S. psychiatrists are Black, and Black people make up 13% of the U.S. population.⁶

The low percentage of Black psychiatrists hurts the field for many reasons, said task force member Steven Starks, MD, clinical assistant professor of psychiatry at the University of Houston, and not solely because the gap forces many Black patients to be treated by non-Black psychiatrists. “The association has a large, broad impact on our field and profession through the DSM, and work in areas like government relations and access to care and insurance,” Dr. Starks said.
 

Task force gets mixed reviews

After the announcement, Dr. Geller named the psychiatrists who will serve, and the task force, chaired by Cheryl D. Wills, MD, assistant professor of psychiatry at Case Western Reserve University in Cleveland, got to work quickly.

The task force has conducted an online town hall and will conduct another one on Aug. 24. It also released the results of a survey of nearly 500 members about the top three areas that the task force should address.

“Access to Healthcare/Mental Healthcare” received the most votes (97) as the recommended top priority, followed by “Socio-Economic Conditions and Factors” (49). These two areas also received the most first-, second- and third-priority votes overall (173 and 166, respectively).

The other areas with high numbers of first priority votes were “Lack of Minority Psychiatrists, Faculty and Leaders” and “Education for Psychiatrists,” both tied at 46. Those areas received 142 and 122 total votes supporting them as first, second, and third priorities.

Thirty-seven members said “Racism within the APA/APA Actions” should be the top priority. A small number of respondents appeared to doubt the need for such a task force: Nineteen thought the top priority should be “Questioning the Concept of Structural Racism/Task Force.”

Meanwhile, some psychiatrists are raising questions about the task force’s makeup.

Ruth S. Shim, MD, MPH, the Luke & Grace Kim Professor of Cultural Psychiatry at the University of California, Davis, said that she was disappointed by the task force’s membership. Specifically, Dr. Shim said, the task force does not include enough APA members she sees as qualified to address structural racism.

“While many of the Black psychiatrists who are members of the task force are experts in issues of diversity, inclusion, and equity, other members of the board of trustees who were appointed to this task force do not have any expertise in this area,” said Dr. Shim, who wrote a scathing commentary⁷ in July about the APA’s failures regarding structural racism. “I believe the selection of members could have been more thoughtful and more inclusive of diverse perspectives and voices.”

Dr. Geller countered that the task force includes a mix of APA board members and non–board members with various types of expertise. “Certain board members were chosen because their colleagues on the board “were already involved in task forces and other projects,” he said.

How the task force is envisioned

Dr. Geller’s goals for the task force, which will operate at least through his 1-year term as president, are ambitious.

“I hope the task force will identify structural racism wherever it’s taking place – where psychiatrists practice, within the APA itself,” Dr. Geller said. “It will be an educational process so we can inform members and ourselves about clear and subtle structural racism. Then we’re going to proffer solutions in several areas that can rectify some of what we’ve been doing and the negative outcomes that have resulted in areas of leadership such as access to care, treatment, hospital and clinic administration, health insurance, and academia. It’s clear that this is a massive undertaking.”

For her part, Dr. Shim thinks the task force might chip around the edges of the structural problems in the specialty – rather than focusing on the roots. “The task force is set up to fail,” she said. “To truly dismantle structural racism in the APA, the leadership of the organization – the CEO, the executive committee, and the board of trustees – must do the hard work of deep self-reflection and self-study to recognize the role that they have played in perpetuating and upholding White supremacy in the organization.

“I do not believe the task force will be capable of doing this, as this is not what they have been tasked to do,” Dr. Shim said.

Task force member Dr. Starks said he believes there is potential for progress within the APA. While Black members have been frustrated by an APA power structure that seems both harmful and unchangeable, he said, “this is an opportunity for us to re-root and achieve equity in mental health.”

He added that the priorities of the task force are not set in stone. “Those things that are listed on the website may change and evolve over time as we report back to the board and develop our functions internally,” said Dr. Starks, who praised Dr. Shim’s commentary as “courageous.”

The website lists these initial charges for the task force:

• Providing education and resources on APA’s and psychiatry’s history regarding structural racism.
• Explaining the current impact of structural racism on the mental health of our patients and colleagues.
• Developing achievable and actionable recommendations for change to eliminate structural racism in the APA and psychiatry now and in the future.
• Providing reports with specific recommendations for achievable actions to the APA board of trustees at each of its meetings through May 2021.
• Monitoring the implementation of tasks.

Meanwhile, the task force is reporting to the APA board of directors each month. The entity is tied to the 1-year presidential term of Dr. Geller, which ends in spring 2021, but Dr. Starks said he hopes it will continue in another form – such as a formal committee.
 

Importance of cultural competence

Dr. Brown highlighted the importance of cultural competence – “making sure that we are looking at patients in the context of their cultural background, their religion, their race, so we can make informed decisions without jumping to conclusions too soon.”

For example, if an African American man or woman talks about hearing God’s voice, “we shouldn’t necessarily brush it off or diminish it as psychiatric illness if it’s in the context of that person’s religious background,” Dr. Brown said.

Francis G. Lu, MD, agreed. He said the task force should explore cultural competency on both clinical and systems levels.

“An antidote to structural racism would be systems cultural competence involving organizations, clinics, and teams looking beyond patient care issues,” said Dr. Lu, the Luke & Grace Kim Professor in Cultural Psychiatry Emeritus at the University of California, Davis. A good starting point, he said, is the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care, also known as the National CLAS Standards.

Looking forward, Olusola Ajilore, MD, PhD, called for a focus on targeted efforts aimed at encouraging more minority medical students to become psychiatrists.

“We have a field with a lot of crucial questions that have yet to be answered,” said Dr. Ajilore, associate director of residency training and education at the University of Illinois at Chicago. “With more Black psychiatrists, we might be more aware of some of the research questions that affect our community, such as the mental health consequences of exposure to racism and prejudice.”

However, the role of White psychiatrists cannot be overemphasized, said Constance E. Dunlap, MD, clinical professor of psychiatry and behavioral sciences at George Washington University in Washington.

“Whites can make a difference by acknowledging the racial hierarchy that ‘unfairly disadvantages some ... and unfairly advantages others’ – to use the language⁸ offered by Dr. Camara Phyllis Jones, said Dr. Dunlap.

“As psychiatrists – as physicians – we are obligated to help patients see themselves and the world more clearly. This starts with our own self-appraisal and extends to our work, whether it is in a psychodynamic space or a community psychiatry setting,” Dr. Dunlap said. “Bottom line, instead of focusing on guilt, I tell my White colleagues and patients: You have privilege, use it constructively to benefit the world.”

Dr. Calhoun said she hopes to see mandated integration of training about racism into psychiatric education. “Rather than a special racism lecture, I’d like to see instruction implemented throughout. It should be essential for psychiatrists to learn about the historical racism of psychiatry and the current racial inequities that exist among psychiatric patients.”

The practice of community psychiatry,⁹ almost by definition, is uniquely positioned to break through some of those structural issues. “The community psychiatry approach to treatment is not specific to any race or cultural group – because each person is treated as an individual,” said Stephanie Le Melle, MD, MS, director of public psychiatry education at Columbia University and the New York Psychiatric Institute. “The social determinants of health, culture, and social justice experience of each person is taken into consideration,” said Dr. Le Melle.

“Community psychiatry steps outside of the traditional medical model of symptoms and illness, and focuses on understanding the person’s strengths and goals – and helps them to live their best lives.”

Dr. Le Melle also views diversifying the psychiatric workforce as imperative.

“For many African American, Latinx, and other marginalized populations that have had to deal with systemic and structural racism, discrimination, and historical abuse at the hands of psychiatry, it can be difficult to establish trust,” said Dr. Le Melle. “Therefore, diversity of our workforce and cultural humility are also crucial for engagement.”

The APA’s decision to not go forward with this year’s Institute on Psychiatric Services: The Mental Health Services Conference undermines the group’s credibility on these issues, according to some psychiatrists.

The IPS meeting, founded in 1948, is “where we traditionally teach and present about the social determinants of health and racism,” said Dr. Le Melle. “If the APA is serious about addressing the social determinants of health, bias, and discrimination against marginalized people and cultural humility, it needs to embrace and grow community psychiatry, not cut it.”

When asked about the IPS conference, Dr. Geller said that it has been scheduled for October 2021 in New York City. He also said the decision to skip the 2020 conference was made 2 years ago. The conference’s organizing committee decided to cancel the event when hotel space in the preferred city could not be arranged, Dr. Geller said.

Meanwhile, in a widely circulated letter that was sent to the APA board of trustees on Aug. 7, numerous leaders in psychiatry from across the country are citing steps they say the APA must take from “continuing impacts of structural racism that will greatly harm underserved patients, [minority and underrepresented] (M/UR) psychiatrists, and the APA as a whole.”

One step the leaders asked the APA to take was to hire an independent entity to investigate the organization’s “workplace culture, staff morale, and experiences of staff members and M/UR psychiatrists who support and/or work at the organization or have previously been dismissed or departed.”

Dr. Calhoun said she agrees that an internal examination would be productive.

“I’d like to see multiple people in positions of power (in the APA) in order to forward agendas,” Dr. Calhoun said. “Unless we do, we’ll have no way to achieve the goal of getting rid of structural racism.”
 

Dr. Calhoun, Dr. Geller, Dr. Brown, Dr. Starks, Dr. Lu, Dr. Ajilore, Dr. Dunlap, and Dr. Le Melle reported no relevant disclosures. Dr. Shim disclosed receiving royalties from American Psychiatric Association Publishing. Dr. Stewart is a coeditor of “Black Mental Health: Patients, Providers, and Systems” (American Psychiatric Association Publishing, 2018).

References

1. Geller J. Psychiatric News. 2020 Jun 23.

2. Washington HA. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present. (New York: Doubleday), 2006.

3. ”Stewart brings a robust and eventful presidential year to a close.” Psychiatric News Daily. 2019 May 18.

4. Sabshin M et al. Am J Psychiatry. 1970 Dec;127:6.

5. Metzl JM. The Protest Psychosis: How Schizophrenia Became a Black Disease. (Boston: Beacon Press), 2009.

6. U.S. Census Bureau. Population estimates. 2019 Jul 1.

7. Shim RS. “Structural racism is why I’m leaving organized psychiatry. statnews.com. 2020 Jul 1.

8. Jones CP. Ethn Dis;28(Suppl):231-4.

9. Ewalt JR and Ewalt PA. Am J Psychiatry. 2006 Apr 1. doi: 10.1176/ajp.126.1.43.

Italian patients with diabetic foot ulceration (DFUs) suffered mightily during the height of the coronavirus pandemic in that country, according to a newly published study.

Phalinn Ooi/CC-BY-2.0

Amid a mandatory national lockdown, the rates of amputations skyrocketed at a hospital far from the hardest-hit region as many patients developed gangrene.

The findings offer critical lessons for the United States, said wound care specialist William H. Tettelbach, MD, of Western Peaks Specialty Hospital near Salt Lake City. “It’s become more obvious that outpatient wound care is a critical care need for the community because of the risk of ignoring these chronic wounds and letting them remain open. We cannot let these services be closed down like some were when the pandemic started.”

The study, led by Paola Caruso, MD, of the University of Campania Luigi Vanvitelli in Naples, appeared in Diabetes Care.

The researchers launched the study to understand how patients with diabetes and DFU fared during the height of the pandemic in Italy, where tens of thousands of people died, mainly in the northern region of the country. They focused on patients in the southern region who were admitted to the division of endocrinology and metabolic diseases at the Teaching Hospital at the University of Campania Luigi Vanvitelli.

The study compared 25 patients who were admitted from March 9 to May 18, 2020, with 38 patients who were admitted from a longer period between January and May 2019. The demographics of the groups are similar, with average ages in the early 60s and more men than women (21:4, respectively, in 2020 and 23:15, respectively, in 2019.)

The results reveal high numbers of emergent and serious cases in 2020. Compared with 2019, fewer were outpatients (16% vs. 45%, P = .028) and more were emergency patients (76% vs. 26%, P < .001).

Clinically, gangrene was much more common in the 2020 group, compared with the 2019 group (64% vs. 29%, P = .009), as was amputation (60% vs. 18%, P = .001).

The researchers determined that amputation was more than three times more likely in the 2020 versus the 2019 group (relative risk, 3.26; 95% confidence interval, 1.55-6.84) even though the 2019 period was longer. After adjustment for gender, the heightened risk in 2020 was 2.50 (95% CI, 1.18-5.29).

There was no statistically significant increase in the risk of revascularization.

“The COVID-19 lockdown may have had a detrimental impact on amputation risk because of the sudden interruption of DFU care and lower-limb preservation pathways, resulting in delayed diagnosis and treatment,” the researchers wrote. “DFU is often characterized by progressive clinical course, which can rapidly lead patients to critical worsening of their ulcers.”

They added that “the higher risk of amputation observed during COVID-19 lockdown confirms the need for proper and timely management of DFU patients to prevent dramatic outcomes responsible for a reduction of quality of life and increased morbidity and mortality.”

The study authors didn’t discuss why more patients seemed to have stayed home and not gotten proper care. It’s not clear if they were scared to get treatment or couldn’t obtain it because of the national shutdown.

Both have been factors affecting diabetic foot care in the United States during the pandemic, said Dr. Tettelbach. He called the study “timely and pertinent,” and said it highlights how wound care is “a critical need” that must remain available even when other medical services such as elective surgeries are shut down.

Infection-control protocols such as allowing patients to wait for appointments in their cars instead of waiting rooms will alleviate the fears of certain patients about seeking in-person care during the pandemic, he said. But some patients will be afraid to come in no matter what, he said, and home health may be the best solution for their care.

Several of the study authors reported various disclosures. Dr. Tettelbach reported no relevant disclosures.

SOURCE: Caruso P et al. Diabetes Care. 2020 Jul 23. doi:10.2337/dc20-1347.

Italian patients with diabetic foot ulceration (DFUs) suffered mightily during the height of the coronavirus pandemic in that country, according to a newly published study.

Phalinn Ooi/CC-BY-2.0

Amid a mandatory national lockdown, the rates of amputations skyrocketed at a hospital far from the hardest-hit region as many patients developed gangrene.

The findings offer critical lessons for the United States, said wound care specialist William H. Tettelbach, MD, of Western Peaks Specialty Hospital near Salt Lake City. “It’s become more obvious that outpatient wound care is a critical care need for the community because of the risk of ignoring these chronic wounds and letting them remain open. We cannot let these services be closed down like some were when the pandemic started.”

The study, led by Paola Caruso, MD, of the University of Campania Luigi Vanvitelli in Naples, appeared in Diabetes Care.

The researchers launched the study to understand how patients with diabetes and DFU fared during the height of the pandemic in Italy, where tens of thousands of people died, mainly in the northern region of the country. They focused on patients in the southern region who were admitted to the division of endocrinology and metabolic diseases at the Teaching Hospital at the University of Campania Luigi Vanvitelli.

The study compared 25 patients who were admitted from March 9 to May 18, 2020, with 38 patients who were admitted from a longer period between January and May 2019. The demographics of the groups are similar, with average ages in the early 60s and more men than women (21:4, respectively, in 2020 and 23:15, respectively, in 2019.)

The results reveal high numbers of emergent and serious cases in 2020. Compared with 2019, fewer were outpatients (16% vs. 45%, P = .028) and more were emergency patients (76% vs. 26%, P < .001).

Clinically, gangrene was much more common in the 2020 group, compared with the 2019 group (64% vs. 29%, P = .009), as was amputation (60% vs. 18%, P = .001).

The researchers determined that amputation was more than three times more likely in the 2020 versus the 2019 group (relative risk, 3.26; 95% confidence interval, 1.55-6.84) even though the 2019 period was longer. After adjustment for gender, the heightened risk in 2020 was 2.50 (95% CI, 1.18-5.29).

There was no statistically significant increase in the risk of revascularization.

“The COVID-19 lockdown may have had a detrimental impact on amputation risk because of the sudden interruption of DFU care and lower-limb preservation pathways, resulting in delayed diagnosis and treatment,” the researchers wrote. “DFU is often characterized by progressive clinical course, which can rapidly lead patients to critical worsening of their ulcers.”

They added that “the higher risk of amputation observed during COVID-19 lockdown confirms the need for proper and timely management of DFU patients to prevent dramatic outcomes responsible for a reduction of quality of life and increased morbidity and mortality.”

The study authors didn’t discuss why more patients seemed to have stayed home and not gotten proper care. It’s not clear if they were scared to get treatment or couldn’t obtain it because of the national shutdown.

Both have been factors affecting diabetic foot care in the United States during the pandemic, said Dr. Tettelbach. He called the study “timely and pertinent,” and said it highlights how wound care is “a critical need” that must remain available even when other medical services such as elective surgeries are shut down.

Infection-control protocols such as allowing patients to wait for appointments in their cars instead of waiting rooms will alleviate the fears of certain patients about seeking in-person care during the pandemic, he said. But some patients will be afraid to come in no matter what, he said, and home health may be the best solution for their care.

Several of the study authors reported various disclosures. Dr. Tettelbach reported no relevant disclosures.

SOURCE: Caruso P et al. Diabetes Care. 2020 Jul 23. doi:10.2337/dc20-1347.

Italian patients with diabetic foot ulceration (DFUs) suffered mightily during the height of the coronavirus pandemic in that country, according to a newly published study.

Phalinn Ooi/CC-BY-2.0

Amid a mandatory national lockdown, the rates of amputations skyrocketed at a hospital far from the hardest-hit region as many patients developed gangrene.

The findings offer critical lessons for the United States, said wound care specialist William H. Tettelbach, MD, of Western Peaks Specialty Hospital near Salt Lake City. “It’s become more obvious that outpatient wound care is a critical care need for the community because of the risk of ignoring these chronic wounds and letting them remain open. We cannot let these services be closed down like some were when the pandemic started.”

The study, led by Paola Caruso, MD, of the University of Campania Luigi Vanvitelli in Naples, appeared in Diabetes Care.

The researchers launched the study to understand how patients with diabetes and DFU fared during the height of the pandemic in Italy, where tens of thousands of people died, mainly in the northern region of the country. They focused on patients in the southern region who were admitted to the division of endocrinology and metabolic diseases at the Teaching Hospital at the University of Campania Luigi Vanvitelli.

The study compared 25 patients who were admitted from March 9 to May 18, 2020, with 38 patients who were admitted from a longer period between January and May 2019. The demographics of the groups are similar, with average ages in the early 60s and more men than women (21:4, respectively, in 2020 and 23:15, respectively, in 2019.)

The results reveal high numbers of emergent and serious cases in 2020. Compared with 2019, fewer were outpatients (16% vs. 45%, P = .028) and more were emergency patients (76% vs. 26%, P < .001).

Clinically, gangrene was much more common in the 2020 group, compared with the 2019 group (64% vs. 29%, P = .009), as was amputation (60% vs. 18%, P = .001).

The researchers determined that amputation was more than three times more likely in the 2020 versus the 2019 group (relative risk, 3.26; 95% confidence interval, 1.55-6.84) even though the 2019 period was longer. After adjustment for gender, the heightened risk in 2020 was 2.50 (95% CI, 1.18-5.29).

There was no statistically significant increase in the risk of revascularization.

“The COVID-19 lockdown may have had a detrimental impact on amputation risk because of the sudden interruption of DFU care and lower-limb preservation pathways, resulting in delayed diagnosis and treatment,” the researchers wrote. “DFU is often characterized by progressive clinical course, which can rapidly lead patients to critical worsening of their ulcers.”

They added that “the higher risk of amputation observed during COVID-19 lockdown confirms the need for proper and timely management of DFU patients to prevent dramatic outcomes responsible for a reduction of quality of life and increased morbidity and mortality.”

The study authors didn’t discuss why more patients seemed to have stayed home and not gotten proper care. It’s not clear if they were scared to get treatment or couldn’t obtain it because of the national shutdown.

Both have been factors affecting diabetic foot care in the United States during the pandemic, said Dr. Tettelbach. He called the study “timely and pertinent,” and said it highlights how wound care is “a critical need” that must remain available even when other medical services such as elective surgeries are shut down.

Infection-control protocols such as allowing patients to wait for appointments in their cars instead of waiting rooms will alleviate the fears of certain patients about seeking in-person care during the pandemic, he said. But some patients will be afraid to come in no matter what, he said, and home health may be the best solution for their care.

Several of the study authors reported various disclosures. Dr. Tettelbach reported no relevant disclosures.

SOURCE: Caruso P et al. Diabetes Care. 2020 Jul 23. doi:10.2337/dc20-1347.