Feature

In a webinar designed to guide physicians in the care of hematology patients during the COVID-19 pandemic, three world experts on thalassemia and sickle cell disease (SCD) provided on-the-ground information from physicians who were dealing with the height of the crisis in their countries.

The webinar was organized by the European Hematology Association (EHA) and the Thalassemia International Federation (TIF).

Moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, led the discussion with three guest speakers: Maria-Domenica Cappellini, MD, PhD, professor of hematology at the University of Milan; Androulla Eleftheriou, MD, executive director of TIF in Cyprus; and Raffaella Colombatti , MD, of the University of Padova in Italy, coordinator of the Red Cell Reserve Working Group of the Italian Association of Pediatric Hematology and Oncology.
 

Italian experience with thalassemia and COVID-19

Dr. Cappellini discussed the Italian experience with 11 thalassemia patients followed by a network survey who developed COVID-19 in the northern part of Italy, where the pandemic has been most widespread.

There are no published data focusing specifically on SARS-CoV-2 infection in patients with thalassemic syndromes, but patients with preexisting comorbidities are likely to be more severely affected by SARS-CoV-2, according to Dr. Cappellini.

Of particular concern is the fact that patients with thalassemia, especially older ones, are frequently splenectomized, which renders them more vulnerable to bacterial infections and can trigger life-threatening sepsis. However, splenectomy is not known to increase the risk of viral infection or severe viral illness. Of additional concern is the fact that many thalassemia patients need routine and frequent transfusions.

Overall, the 11 thalassemia patients who developed COVID-19 experienced only mild to moderate symptoms. This is despite the fact that 72% of the patients were splenectomized, which did not appear to affect the clinical course, and all of the patients had thalassemia-related comorbidities.

Around half of the patients were hospitalized, but none of them required transfer to the ICU. One patient who was treated with chemotherapy for diffuse large B-cell lymphoma in 2019 but is now in remission required more intense ventilation support with the use of continuous positive airway pressure.

Only three patients received specific treatment for COVID-19: one with hydroxychloroquine (HCQ) alone, one with HCQ plus anakinra, and one with HCQ plus ritonavir/darunavir.

Overall, “the number of infected thalassemia patients was lower than expected, likely due to earlier and more vigilant self-isolation compared to the general population,” Dr. Cappellini said. She pointed out that the first early response in February by thalassemia physicians was to warn their patients via email and phone calls about the need for self-isolation and precautions against the pandemic.

Physicians “rapidly reorganized activities, postponing nonessential ones” and managed to provide patients “a safe track at the hospital to receive their life-saving treatment in COVID-19–free areas with health care personnel wearing protective equipment” and assessment of all entering patients for COVID-19 infection, Dr. Cappellini said.
 

Results in additional thalassemia patients and SCD patients

Dr. Eleftheriou described 51 cases of thalassemia patients with SARS-CoV-2 infection reported to TIF as of April 16. Patients were from Cyprus, Italy, the United Kingdom, France, Turkey, Iran, Pakistan, and Indonesia.

Of the 51 patients, 46 presented with mild to moderate symptoms. Five patients had severe respiratory symptoms and required hospitalization, two were hospitalized and discharged, and three died between day 5 and day 15 post hospitalization.

Dr. Colombatti followed with a brief presentation of the intersection of COVID-19 with SCD patients. She presented anecdotal data involving 32 SCD patients who exhibited COVID-19 symptoms. Dr. Colombatti obtained the data via personal communication with Pablo Bartolucci, of Hôpitaux Universitaires Henri Mondor in Créteil, France.

All 32 SCD patients were screened and treated for COVID-19, and 17 of them continued treatment for 10 days. In all, 22 patients were hospitalized, 11 were transferred to the ICU, and 1 died.
 

Ensuring adequate blood supply

Dr. Eleftheriou also discussed the TIF response to the COVID-19 pandemic, which focused on the adequacy of blood supplies for these patients who so often need transfusions.

Dr. Eleftheriou stated that a shortage of blood was reported in 75% of the 62 member countries of the TIF, with 58% reporting severe shortages and 35% reporting moderate to severe shortages.

The shortages resulted in many countries returning to older family/friends donation practices, rare use of whole blood transfusions, and the use of older blood transfusions (older than 28 days).

In addition, physicians have modified their transfusion strategy. They have reduced the amount of blood given to thalassemia patients from two units to one unit during any transfusion, while making arrangements for more frequent transfusions; for example, one transfusion per week but with precautions made to “limit the time spent in the clinic and to control blood supplies while safeguarding that all [thalassemia] patients will be able to get their transfusion,” Dr. Eleftheriou said.

The information in the webinar was provided with the caveat that “no general evidence-based guidance can be derived from this discussion.” There were no other disclosures given.

mlesney@mdedge.com

In a webinar designed to guide physicians in the care of hematology patients during the COVID-19 pandemic, three world experts on thalassemia and sickle cell disease (SCD) provided on-the-ground information from physicians who were dealing with the height of the crisis in their countries.

The webinar was organized by the European Hematology Association (EHA) and the Thalassemia International Federation (TIF).

Moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, led the discussion with three guest speakers: Maria-Domenica Cappellini, MD, PhD, professor of hematology at the University of Milan; Androulla Eleftheriou, MD, executive director of TIF in Cyprus; and Raffaella Colombatti , MD, of the University of Padova in Italy, coordinator of the Red Cell Reserve Working Group of the Italian Association of Pediatric Hematology and Oncology.
 

Italian experience with thalassemia and COVID-19

Dr. Cappellini discussed the Italian experience with 11 thalassemia patients followed by a network survey who developed COVID-19 in the northern part of Italy, where the pandemic has been most widespread.

There are no published data focusing specifically on SARS-CoV-2 infection in patients with thalassemic syndromes, but patients with preexisting comorbidities are likely to be more severely affected by SARS-CoV-2, according to Dr. Cappellini.

Of particular concern is the fact that patients with thalassemia, especially older ones, are frequently splenectomized, which renders them more vulnerable to bacterial infections and can trigger life-threatening sepsis. However, splenectomy is not known to increase the risk of viral infection or severe viral illness. Of additional concern is the fact that many thalassemia patients need routine and frequent transfusions.

Overall, the 11 thalassemia patients who developed COVID-19 experienced only mild to moderate symptoms. This is despite the fact that 72% of the patients were splenectomized, which did not appear to affect the clinical course, and all of the patients had thalassemia-related comorbidities.

Around half of the patients were hospitalized, but none of them required transfer to the ICU. One patient who was treated with chemotherapy for diffuse large B-cell lymphoma in 2019 but is now in remission required more intense ventilation support with the use of continuous positive airway pressure.

Only three patients received specific treatment for COVID-19: one with hydroxychloroquine (HCQ) alone, one with HCQ plus anakinra, and one with HCQ plus ritonavir/darunavir.

Overall, “the number of infected thalassemia patients was lower than expected, likely due to earlier and more vigilant self-isolation compared to the general population,” Dr. Cappellini said. She pointed out that the first early response in February by thalassemia physicians was to warn their patients via email and phone calls about the need for self-isolation and precautions against the pandemic.

Physicians “rapidly reorganized activities, postponing nonessential ones” and managed to provide patients “a safe track at the hospital to receive their life-saving treatment in COVID-19–free areas with health care personnel wearing protective equipment” and assessment of all entering patients for COVID-19 infection, Dr. Cappellini said.
 

Results in additional thalassemia patients and SCD patients

Dr. Eleftheriou described 51 cases of thalassemia patients with SARS-CoV-2 infection reported to TIF as of April 16. Patients were from Cyprus, Italy, the United Kingdom, France, Turkey, Iran, Pakistan, and Indonesia.

Of the 51 patients, 46 presented with mild to moderate symptoms. Five patients had severe respiratory symptoms and required hospitalization, two were hospitalized and discharged, and three died between day 5 and day 15 post hospitalization.

Dr. Colombatti followed with a brief presentation of the intersection of COVID-19 with SCD patients. She presented anecdotal data involving 32 SCD patients who exhibited COVID-19 symptoms. Dr. Colombatti obtained the data via personal communication with Pablo Bartolucci, of Hôpitaux Universitaires Henri Mondor in Créteil, France.

All 32 SCD patients were screened and treated for COVID-19, and 17 of them continued treatment for 10 days. In all, 22 patients were hospitalized, 11 were transferred to the ICU, and 1 died.
 

Ensuring adequate blood supply

Dr. Eleftheriou also discussed the TIF response to the COVID-19 pandemic, which focused on the adequacy of blood supplies for these patients who so often need transfusions.

Dr. Eleftheriou stated that a shortage of blood was reported in 75% of the 62 member countries of the TIF, with 58% reporting severe shortages and 35% reporting moderate to severe shortages.

The shortages resulted in many countries returning to older family/friends donation practices, rare use of whole blood transfusions, and the use of older blood transfusions (older than 28 days).

In addition, physicians have modified their transfusion strategy. They have reduced the amount of blood given to thalassemia patients from two units to one unit during any transfusion, while making arrangements for more frequent transfusions; for example, one transfusion per week but with precautions made to “limit the time spent in the clinic and to control blood supplies while safeguarding that all [thalassemia] patients will be able to get their transfusion,” Dr. Eleftheriou said.

The information in the webinar was provided with the caveat that “no general evidence-based guidance can be derived from this discussion.” There were no other disclosures given.

mlesney@mdedge.com

In a webinar designed to guide physicians in the care of hematology patients during the COVID-19 pandemic, three world experts on thalassemia and sickle cell disease (SCD) provided on-the-ground information from physicians who were dealing with the height of the crisis in their countries.

The webinar was organized by the European Hematology Association (EHA) and the Thalassemia International Federation (TIF).

Moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, led the discussion with three guest speakers: Maria-Domenica Cappellini, MD, PhD, professor of hematology at the University of Milan; Androulla Eleftheriou, MD, executive director of TIF in Cyprus; and Raffaella Colombatti , MD, of the University of Padova in Italy, coordinator of the Red Cell Reserve Working Group of the Italian Association of Pediatric Hematology and Oncology.
 

Italian experience with thalassemia and COVID-19

Dr. Cappellini discussed the Italian experience with 11 thalassemia patients followed by a network survey who developed COVID-19 in the northern part of Italy, where the pandemic has been most widespread.

There are no published data focusing specifically on SARS-CoV-2 infection in patients with thalassemic syndromes, but patients with preexisting comorbidities are likely to be more severely affected by SARS-CoV-2, according to Dr. Cappellini.

Of particular concern is the fact that patients with thalassemia, especially older ones, are frequently splenectomized, which renders them more vulnerable to bacterial infections and can trigger life-threatening sepsis. However, splenectomy is not known to increase the risk of viral infection or severe viral illness. Of additional concern is the fact that many thalassemia patients need routine and frequent transfusions.

Overall, the 11 thalassemia patients who developed COVID-19 experienced only mild to moderate symptoms. This is despite the fact that 72% of the patients were splenectomized, which did not appear to affect the clinical course, and all of the patients had thalassemia-related comorbidities.

Around half of the patients were hospitalized, but none of them required transfer to the ICU. One patient who was treated with chemotherapy for diffuse large B-cell lymphoma in 2019 but is now in remission required more intense ventilation support with the use of continuous positive airway pressure.

Only three patients received specific treatment for COVID-19: one with hydroxychloroquine (HCQ) alone, one with HCQ plus anakinra, and one with HCQ plus ritonavir/darunavir.

Overall, “the number of infected thalassemia patients was lower than expected, likely due to earlier and more vigilant self-isolation compared to the general population,” Dr. Cappellini said. She pointed out that the first early response in February by thalassemia physicians was to warn their patients via email and phone calls about the need for self-isolation and precautions against the pandemic.

Physicians “rapidly reorganized activities, postponing nonessential ones” and managed to provide patients “a safe track at the hospital to receive their life-saving treatment in COVID-19–free areas with health care personnel wearing protective equipment” and assessment of all entering patients for COVID-19 infection, Dr. Cappellini said.
 

Results in additional thalassemia patients and SCD patients

Dr. Eleftheriou described 51 cases of thalassemia patients with SARS-CoV-2 infection reported to TIF as of April 16. Patients were from Cyprus, Italy, the United Kingdom, France, Turkey, Iran, Pakistan, and Indonesia.

Of the 51 patients, 46 presented with mild to moderate symptoms. Five patients had severe respiratory symptoms and required hospitalization, two were hospitalized and discharged, and three died between day 5 and day 15 post hospitalization.

Dr. Colombatti followed with a brief presentation of the intersection of COVID-19 with SCD patients. She presented anecdotal data involving 32 SCD patients who exhibited COVID-19 symptoms. Dr. Colombatti obtained the data via personal communication with Pablo Bartolucci, of Hôpitaux Universitaires Henri Mondor in Créteil, France.

All 32 SCD patients were screened and treated for COVID-19, and 17 of them continued treatment for 10 days. In all, 22 patients were hospitalized, 11 were transferred to the ICU, and 1 died.
 

Ensuring adequate blood supply

Dr. Eleftheriou also discussed the TIF response to the COVID-19 pandemic, which focused on the adequacy of blood supplies for these patients who so often need transfusions.

Dr. Eleftheriou stated that a shortage of blood was reported in 75% of the 62 member countries of the TIF, with 58% reporting severe shortages and 35% reporting moderate to severe shortages.

The shortages resulted in many countries returning to older family/friends donation practices, rare use of whole blood transfusions, and the use of older blood transfusions (older than 28 days).

In addition, physicians have modified their transfusion strategy. They have reduced the amount of blood given to thalassemia patients from two units to one unit during any transfusion, while making arrangements for more frequent transfusions; for example, one transfusion per week but with precautions made to “limit the time spent in the clinic and to control blood supplies while safeguarding that all [thalassemia] patients will be able to get their transfusion,” Dr. Eleftheriou said.

The information in the webinar was provided with the caveat that “no general evidence-based guidance can be derived from this discussion.” There were no other disclosures given.

mlesney@mdedge.com

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

koakes@mdedge.com

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

koakes@mdedge.com

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

koakes@mdedge.com

Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.

Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.

The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.

“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”

It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
 

The data and the depth of the crisis

The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.

In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”

“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.

These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.

The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).

With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.

“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”

Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.

The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.

In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.

The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.

“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.

Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.

“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”

Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.

“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.

The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.

“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.

 

Ongoing efforts

Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.

In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.

Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.

In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.

Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.

“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”

This referral should occur early – preferably in the antenatal period, she added.

The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.

Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.

“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.

CVD-related risks in the post partum

Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.

That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.

Sharon Worcester/MDedge News

James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.

Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.

“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”

sworcester@mdedge.com

Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.

Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.

The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.

“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”

It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
 

The data and the depth of the crisis

The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.

In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”

“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.

These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.

The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).

With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.

“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”

Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.

The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.

In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.

The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.

“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.

Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.

“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”

Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.

“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.

The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.

“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.

 

Ongoing efforts

Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.

In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.

Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.

In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.

Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.

“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”

This referral should occur early – preferably in the antenatal period, she added.

The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.

Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.

“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.

CVD-related risks in the post partum

Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.

That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.

Sharon Worcester/MDedge News

James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.

Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.

“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”

sworcester@mdedge.com

Nearly 700 women died from pregnancy-related complications in the United States in 2018, and almost a third of those deaths were associated with cardiovascular disease, according to the latest data from the Centers for Disease Control and Prevention.

Strikingly, studies suggest that up to half of cardiovascular disease–related maternal deaths are preventable, yet CVD remains the leading cause of maternal morbidity and mortality – and the incidence has been rising steadily for 2 decades.

The American College of Obstetricians and Gynecologists says that acquired heart disease is the likely culprit in the rise in incidence of maternal mortality as women enter pregnancy with an increasingly heavy burden of CVD risk factors, including older age, obesity, diabetes, and hypertension.

“They are entering pregnancy while already at risk, and that has led to an increase in morbidity and mortality during pregnancy,” Renee Patrice Bullock-Palmer, MD, a cardiologist and director of the Women’s Heart Center at Deborah Heart and Lung Center in Browns Mills, N.J., explained in an interview. “Unfortunately, among developed countries, the U.S. has the highest rates of maternal morbidity and mortality, and that’s shocking.”

It’s a problem that requires collaboration between obstetricians, cardiologists, and others involved in the care of pregnant women, she said.
 

The data and the depth of the crisis

The maternal mortality rate in 1987 – the year the CDC’s Pregnancy Mortality Surveillance System was implemented – was 7.2 per 100,000 live births. The rate in 2016 was more than double that at 16.9, and the rate in 2018, the most recent year for which data are available, was 17.4 – and significant racial and ethnic disparities in those rates have persisted over time.

In an August 2019 article published on the American Heart Association website, Dr. Bullock-Palmer addressed the cardiovascular state of health for pregnant women and the role of the cardiologists in their care, noting that there is a “role for increased collaboration between the cardiologist and the obstetrician with regards to a pregnancy heart team.”

“It is vital that mothers who are at increased risk for CVD or have established CVD be referred to a cardiologist for cardiovascular assessment and management,” she wrote, adding it is important to raise awareness among ob.gyns. and to improve cardiologists’ recognition of women at risk when they present for care for the first time.

These referrals should be made in the antepartum and early postpartum period, she said in an interview. More attention also must be paid to racial and ethnic disparities, and the role of cardiologists in addressing these disparities.

The CDC has emphasized racial and ethnic disparities in maternal mortality, noting in a 2019 Morbidity and Mortality Weekly report that, compared with white women, black and American Indian/Alaskan Native women aged over 30 years have a 300%-400% higher rate of pregnancy-related deaths (Morb Mortal Wkly Rep. 2019 Sep 6;68[35]:762-5).

With regard to disparities, Dr. Bullock-Palmer said the causes are multifold and may be related to a higher prevalence of CVD risk factors like obesity and hypertension in non-Hispanic black women.

“There may also be limited access to adequate postpartum care in this patient population,” she wrote, adding that some attention has been paid to addressing disparities, but that “there is a lot of work left to be done in resolving these inequities in maternal health care.”

Partnerships across specialties will help in addressing most of the factors associated with CVD and maternal death, she said.

The urgent need for these partnerships is underscored by the latest findings on CVD-related complications in pregnancy. A study published in March 2020 in the Journal of the American College of Cardiology, for example, looked specifically at the incidence of serious cardiac events (SCEs) in pregnant women with heart disease, and whether the events were preventable.

In a prospective cohort of 1,315 pregnancies among women with heart disease, Birgit Pfaller, MD, of the University of Toronto Pregnancy and Heart Disease Research Program, and colleagues found that SCEs occurred in 3.6% of cases (47 women) – most often during the antepartum period – that 49% were preventable, and that 74% were related to provider management factors.

The most common SCEs were cardiac death or arrest, heart failure, arrhythmias, and urgent intervention, and they were more likely to occur in women with acquired heart disease, severe aortic or mitral stenosis, mechanical valves, and systemic ventricular dysfunction. Adverse fetal and neonatal outcomes more than doubled in cases involving SCEs, compared with those without (62% vs. 29%), and adverse obstetric events occurred most often in women with severe preeclampsia.

“The majority of the preventable events occurred due to provider management factors, including: failure to identify the patient condition prior to pregnancy, failure to identify the patient as high risk, late recognition in cardiac deterioration, delay in treatment/intervention, inappropriate treatment, and lack of preconception counseling,” Melinda Davis, MD, of the University of Michigan, Ann Arbor, wrote in a summary and editorial published in the Journal of the American College of Cardiology.

Some preventable events were attributable to patient failure to seek care, noncompliance with care recommendations, and lack of access to care, Dr. Davis noted.

“These findings suggest that provider training, patient education, and health care advocacy are all important interventions to improve outcomes among pregnant women,” she wrote, adding that “the development of multidisciplinary cardio-obstetric clinics at tertiary care centers may also be helpful.”

Dr. Bullock-Palmer added the need for greater risk-prediction tools to the list, explaining that these are needed to assess CVD risk in the prenatal, antenatal, and postnatal period.

“The recently concluded Cardiac Disease in Pregnancy [CARPREG II] study indicated that there were 10 predictors that could be utilized to asses maternal CVD risk,” she noted.

The CARPREG II authors identified five general predictors (prior cardiac events or arrhythmias, poor functional class or cyanosis, high-risk valve disease/left ventricular outflow tract obstruction, systemic ventricular dysfunction, no prior cardiac interventions), four lesion-specific predictors (mechanical valves, high-risk aortopathies, pulmonary hypertension, coronary artery disease), and one delivery-of-care predictor (late pregnancy assessment), and incorporated them into a risk index.

“It is hopeful that these new initiatives will assist providers in improving their ability to appropriately risk stratify women,” Dr. Bullock-Palmer said.

 

Ongoing efforts

Efforts also are ongoing to develop the types of cardio-obstetric clinics mentioned by Dr. Davis and to establish collaborations and “pregnancy heart teams” as attention is increasingly focused on the U.S. maternal mortality crisis.

In fact, such teams are a cornerstone of ACOG’s guidance on pregnancy and heart disease. In May 2019 the college released a Practice Bulletin with 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period.

Pregnant women and postpartum women with known or suspected CVD should undergo evaluation by a “pregnancy heart team that includes a cardiologist and maternal-fetal medicine subspecialist, or both, and other subspecialists as necessary,” according to the bulletin.

In a recent interview, Lisa Hollier, MD, immediate past president of ACOG and an instrumental figure in the push to better address maternal mortality – and in particular the cardiovascular contributors to the crisis – said she is “seeing a strengthening of that” with numerous organizations establishing pregnancy health teams.

Dr. Bullock-Palmer said she also is seeing progress, and added that collaboration should be prioritized even in the absence of dedicated pregnancy heart teams and clinics.

“Heart disease in pregnancy requires a multidisciplinary approach. You can’t just see the patient from the cardiac perspective – you also have to interact and team up with the obstetrician who is handling the pregnancy,” she said, adding that, without a dedicated team, coordination takes more effort, but is imperative for improving outcomes. “You have to collaborate at times when it is beyond the expertise of the institution or the physician; you have to know when to refer these higher-risk patients, particularly women with adult congenital heart disease.”

This referral should occur early – preferably in the antenatal period, she added.

The most important thing, however, is “recognizing these women ... even before the pregnancy,” Dr. Bullock-Palmer said, explaining that this can facilitate the necessary management – and in some cases, postponement – of pregnancy for women whose cardiac issues need to be addressed first.

Among other efforts to address maternal mortality are several programs developed by ACOG, and the Heart Outcomes in Pregnancy: Expectations for Mom and Baby Registry (HOPE) project of the Saint Luke’s Health System in Kansas.

“Hopefully the [HOPE] research collaborative ... which aims to address key clinical questions surrounding the preconception period, antenatal care, delivery planning and outcomes, and long-term postpartum care and outcomes of women will help to address the knowledge gaps and disparities in the care of women with heart disease in pregnancy,” Dr. Bullock-Palmer wrote in her article.

CVD-related risks in the post partum

Dr. Bullock-Palmer has particular concern for postpartum follow-up, given the increased risk for future heart disease among women with CVD-related pregnancy complications and the heightened risk of certain CVD-related events in the postpartum period.

That’s a component of the crisis that also was addressed during a press briefing at the 2019 ACOG annual meeting when the Pregnancy and Heart Disease Practice Bulletin was released.

Sharon Worcester/MDedge News

James Martin, MD, chair of ACOG’s Pregnancy and Heart Disease Task Force and a past ACOG president, explained during the briefing that CVD-related risks may accelerate and persist in the days and weeks after delivery, underscoring the need for follow-up and postpartum care.

Cardiomyopathy is a particular concern during this time – it’s the major cause of maternal mortality after 42 days, he noted. An emphasis on postpartum care also is especially important given that some data suggest up to 40% of women don’t return for that care.

“That is a very sad statistic and perhaps it reflects on our need to change payment models so that physicians and patients realize the importance of coming back for continuing care, because this really may be the end of pregnancy, but it is the beginning of the rest of their life,” he said. “And if they have cardiovascular disease or the risk factors ... they are going to possibly become worse over the course of their lifetime.”

sworcester@mdedge.com

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

The take-home message from a growing number of recent COVID-19 case reports is that the infection might be far more than a respiratory disease.

Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.

For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).

In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
 

Kidney injuries prominent

“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”

It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.

“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
 

“Look for tricky symptoms”

The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.

Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.

There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.

A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.

Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.

An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
 

‘Make sure that they didn’t die in vain’

There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.

Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.

The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.

The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.

“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”

To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”

aotto@mdedge.com

The take-home message from a growing number of recent COVID-19 case reports is that the infection might be far more than a respiratory disease.

Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.

For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).

In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
 

Kidney injuries prominent

“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”

It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.

“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
 

“Look for tricky symptoms”

The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.

Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.

There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.

A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.

Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.

An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
 

‘Make sure that they didn’t die in vain’

There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.

Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.

The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.

The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.

“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”

To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”

aotto@mdedge.com

The take-home message from a growing number of recent COVID-19 case reports is that the infection might be far more than a respiratory disease.

Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.

For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).

In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
 

Kidney injuries prominent

“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”

It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.

“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
 

“Look for tricky symptoms”

The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.

Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.

There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.

A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.

Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.

An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
 

‘Make sure that they didn’t die in vain’

There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.

Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.

The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.

The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.

“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”

To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”

aotto@mdedge.com

Vidyard Video

This transcript has been edited for clarity.

Gary S. Ferenchick, MD, MS: I'm Gary Ferenchick with Hannah Ferenchick, who has agreed to join us to talk about what's going on in Detroit, and also about PPE and decontamination processes. Why don't you introduce yourself?

Hannah R.B. Ferenchick, MD: I am Hannah Ferenchick. I'm an ER physician and medical intensivist. I split my time between the medical ICU and the emergency department at Detroit Medical Center.

Dr Gary Ferenchick: We were talking earlier about some of the not-well-described clinical scenarios that patients with definitive COVID might present with. One of these was the idea of "silent hypoxemia." Could you describe that?

Dr Hannah Ferenchick: Silent hypoxemia is being described in many of these COVID patients. That means the patient is very hypoxemic—they may have an oxygen saturation of about 85% on room air, but clinically they look very comfortable—they are not dyspneic or tachypneic and may not even verbalize a significant sense of shortness of breath. It's not every patient, but it has been interesting to see patients sitting there looking fairly normal, with a resting oxygen saturation much lower than you would expect for someone who doesn't have underlying pulmonary disease or other symptoms.

Dr Gary Ferenchick: What abnormalities are you seeing on standard or not-so-standard lab tests?

Dr Hannah Ferenchick: Some of the characteristic lab findings we are seeing are lymphopenia and elevated inflammatory markers (eg, CRP). A couple of other atypical findings seem to be specific for COVID—elevated LDH, ferritin, CPK, and procalcitonin levels. Some of the hematologic markers that we look at—the coagulation profile studies—are also abnormal, showing thrombocytopenia and elevated D-dimer levels.

That constellation of symptoms represents more of a clinical picture. A lot of times we have only a very high clinical suspicion, because in many parts of the country it still takes days to get back a confirmatory PCR test.

Much like we do for the flu, the confirmatory test is a nasopharyngeal swab that is run for COVID/coronavirus PCR. Unfortunately the sensitivity of that test is not great. Some studies have quoted 75%-80%, so even a negative PCR does not necessarily rule out the disease, especially if you have a high clinical suspicion. A clinical suspicion is based on the typical symptoms. Many patients, although not all, will have symptoms of lower respiratory tract infection.

Dr Gary Ferenchick: So the right clinical scenario with the right hematologic/biochemical findings dramatically raises the chance that the patient has COVID?

Dr Hannah Ferenchick: Yes, and one thing that we have all been astonished by is how terrible some of these x-rays can look. There are a lot of typical findings on x-ray. Some describe them as looking like pulmonary edema, but the patient has no history of heart failure. Peripheral consolidation and ground-glass opacities are classically described. If you saw one of these x-rays from a patient with bacterial pneumonia, you would expect that patient to be very ill-appearing. Sometimes we get x-rays on patients who are sitting there, maybe mildly symptomatic on room air, and we are astonished by how terrible their x-rays look.

Unfortunately, imaging studies are something we haven't been able to rely on too much for diagnosis. Part of that is to maintain hospital safety, because to take a patient to CT scan, you have to consider the turnaround time for cleaning the CT scanner and the exposure of additional staff to a possibly infected patient. Some of those logistical considerations have limited the availability of radiography.

Gary S. Ferenchick, MD, MS, is a family physician and professor in the Department of Medicine at Michigan State University in East Lansing, Michigan. His daughter, Hannah R.B. Ferenchick, MD, is an assistant professor in the Department of Emergency Medicine, Division of Pulmonary & Critical Care and Sleep Medicine, at Wayne State University, Detroit, Michigan, and a medical intensivist and emergency medicine physician at Detroit Medical Center.

Vidyard Video

This transcript has been edited for clarity.

Gary S. Ferenchick, MD, MS: I'm Gary Ferenchick with Hannah Ferenchick, who has agreed to join us to talk about what's going on in Detroit, and also about PPE and decontamination processes. Why don't you introduce yourself?

Hannah R.B. Ferenchick, MD: I am Hannah Ferenchick. I'm an ER physician and medical intensivist. I split my time between the medical ICU and the emergency department at Detroit Medical Center.

Dr Gary Ferenchick: We were talking earlier about some of the not-well-described clinical scenarios that patients with definitive COVID might present with. One of these was the idea of "silent hypoxemia." Could you describe that?

Dr Hannah Ferenchick: Silent hypoxemia is being described in many of these COVID patients. That means the patient is very hypoxemic—they may have an oxygen saturation of about 85% on room air, but clinically they look very comfortable—they are not dyspneic or tachypneic and may not even verbalize a significant sense of shortness of breath. It's not every patient, but it has been interesting to see patients sitting there looking fairly normal, with a resting oxygen saturation much lower than you would expect for someone who doesn't have underlying pulmonary disease or other symptoms.

Dr Gary Ferenchick: What abnormalities are you seeing on standard or not-so-standard lab tests?

Dr Hannah Ferenchick: Some of the characteristic lab findings we are seeing are lymphopenia and elevated inflammatory markers (eg, CRP). A couple of other atypical findings seem to be specific for COVID—elevated LDH, ferritin, CPK, and procalcitonin levels. Some of the hematologic markers that we look at—the coagulation profile studies—are also abnormal, showing thrombocytopenia and elevated D-dimer levels.

That constellation of symptoms represents more of a clinical picture. A lot of times we have only a very high clinical suspicion, because in many parts of the country it still takes days to get back a confirmatory PCR test.

Much like we do for the flu, the confirmatory test is a nasopharyngeal swab that is run for COVID/coronavirus PCR. Unfortunately the sensitivity of that test is not great. Some studies have quoted 75%-80%, so even a negative PCR does not necessarily rule out the disease, especially if you have a high clinical suspicion. A clinical suspicion is based on the typical symptoms. Many patients, although not all, will have symptoms of lower respiratory tract infection.

Dr Gary Ferenchick: So the right clinical scenario with the right hematologic/biochemical findings dramatically raises the chance that the patient has COVID?

Dr Hannah Ferenchick: Yes, and one thing that we have all been astonished by is how terrible some of these x-rays can look. There are a lot of typical findings on x-ray. Some describe them as looking like pulmonary edema, but the patient has no history of heart failure. Peripheral consolidation and ground-glass opacities are classically described. If you saw one of these x-rays from a patient with bacterial pneumonia, you would expect that patient to be very ill-appearing. Sometimes we get x-rays on patients who are sitting there, maybe mildly symptomatic on room air, and we are astonished by how terrible their x-rays look.

Unfortunately, imaging studies are something we haven't been able to rely on too much for diagnosis. Part of that is to maintain hospital safety, because to take a patient to CT scan, you have to consider the turnaround time for cleaning the CT scanner and the exposure of additional staff to a possibly infected patient. Some of those logistical considerations have limited the availability of radiography.

Gary S. Ferenchick, MD, MS, is a family physician and professor in the Department of Medicine at Michigan State University in East Lansing, Michigan. His daughter, Hannah R.B. Ferenchick, MD, is an assistant professor in the Department of Emergency Medicine, Division of Pulmonary & Critical Care and Sleep Medicine, at Wayne State University, Detroit, Michigan, and a medical intensivist and emergency medicine physician at Detroit Medical Center.

Vidyard Video

This transcript has been edited for clarity.

Gary S. Ferenchick, MD, MS: I'm Gary Ferenchick with Hannah Ferenchick, who has agreed to join us to talk about what's going on in Detroit, and also about PPE and decontamination processes. Why don't you introduce yourself?

Hannah R.B. Ferenchick, MD: I am Hannah Ferenchick. I'm an ER physician and medical intensivist. I split my time between the medical ICU and the emergency department at Detroit Medical Center.

Dr Gary Ferenchick: We were talking earlier about some of the not-well-described clinical scenarios that patients with definitive COVID might present with. One of these was the idea of "silent hypoxemia." Could you describe that?

Dr Hannah Ferenchick: Silent hypoxemia is being described in many of these COVID patients. That means the patient is very hypoxemic—they may have an oxygen saturation of about 85% on room air, but clinically they look very comfortable—they are not dyspneic or tachypneic and may not even verbalize a significant sense of shortness of breath. It's not every patient, but it has been interesting to see patients sitting there looking fairly normal, with a resting oxygen saturation much lower than you would expect for someone who doesn't have underlying pulmonary disease or other symptoms.

Dr Gary Ferenchick: What abnormalities are you seeing on standard or not-so-standard lab tests?

Dr Hannah Ferenchick: Some of the characteristic lab findings we are seeing are lymphopenia and elevated inflammatory markers (eg, CRP). A couple of other atypical findings seem to be specific for COVID—elevated LDH, ferritin, CPK, and procalcitonin levels. Some of the hematologic markers that we look at—the coagulation profile studies—are also abnormal, showing thrombocytopenia and elevated D-dimer levels.

That constellation of symptoms represents more of a clinical picture. A lot of times we have only a very high clinical suspicion, because in many parts of the country it still takes days to get back a confirmatory PCR test.

Much like we do for the flu, the confirmatory test is a nasopharyngeal swab that is run for COVID/coronavirus PCR. Unfortunately the sensitivity of that test is not great. Some studies have quoted 75%-80%, so even a negative PCR does not necessarily rule out the disease, especially if you have a high clinical suspicion. A clinical suspicion is based on the typical symptoms. Many patients, although not all, will have symptoms of lower respiratory tract infection.

Dr Gary Ferenchick: So the right clinical scenario with the right hematologic/biochemical findings dramatically raises the chance that the patient has COVID?

Dr Hannah Ferenchick: Yes, and one thing that we have all been astonished by is how terrible some of these x-rays can look. There are a lot of typical findings on x-ray. Some describe them as looking like pulmonary edema, but the patient has no history of heart failure. Peripheral consolidation and ground-glass opacities are classically described. If you saw one of these x-rays from a patient with bacterial pneumonia, you would expect that patient to be very ill-appearing. Sometimes we get x-rays on patients who are sitting there, maybe mildly symptomatic on room air, and we are astonished by how terrible their x-rays look.

Unfortunately, imaging studies are something we haven't been able to rely on too much for diagnosis. Part of that is to maintain hospital safety, because to take a patient to CT scan, you have to consider the turnaround time for cleaning the CT scanner and the exposure of additional staff to a possibly infected patient. Some of those logistical considerations have limited the availability of radiography.

Gary S. Ferenchick, MD, MS, is a family physician and professor in the Department of Medicine at Michigan State University in East Lansing, Michigan. His daughter, Hannah R.B. Ferenchick, MD, is an assistant professor in the Department of Emergency Medicine, Division of Pulmonary & Critical Care and Sleep Medicine, at Wayne State University, Detroit, Michigan, and a medical intensivist and emergency medicine physician at Detroit Medical Center.

African Americans are overrepresented among patients who have died as a result of the COVID-19 pandemic, but the current crisis puts a spotlight on long-standing racial disparities in health care and health access in the United States, according to David R. Williams, PhD, a professor of public health at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Williams, a social scientist specializing in the link between race and health, is a professor of African and African American Studies and of Sociology at Harvard. He spoke on the topic of racial disparities amid the COVID-19 pandemic in a teleconference sponsored by the Robert Wood Johnson Foundation.

“Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said.

Keys to the increased mortality among African Americans include an increased prevalence of risk factors, increased risk for exposure to the virus because of socioeconomic factors, and less access to health care if they do become ill, he said.

Many minority individuals work outside the home in areas deemed essential during the pandemic, such as transit, delivery, maintenance, cleaning, and in businesses such as grocery stores, although in general “race continues to matter for health at every level of income and education,” Dr. Williams said.

In addition, social distance guidelines are not realistic for many people in high-density, low-income areas, who often live in shared, multigenerational housing, he said.

Data show that individuals with chronic conditions such as diabetes and cardiovascular disease are more likely to die as a result of COVID-19, and minority populations are more likely to develop these conditions at younger ages, Dr. Williams noted. Access to health care also plays a role. Many minority individuals of lower socioeconomic status are less likely to have health insurance, or if they do, may have Medicaid, which is not consistently accepted, he said. Also, some low-income neighborhoods lack convenient access to primary care and thus to screening services, he noted.

A recent study from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report cited COVID-NET (the COVID-19 Associated Hospitalization Surveillance Network) as showing that, in their catchment population, “approximately 59% of residents are white, 18% are black, and 14% are Hispanic; however, among 580 hospitalized COVID-19 patients with race/ethnicity data, approximately 45% were white, 33% were black, and 8% were Hispanic, suggesting that black populations might be disproportionately affected by COVID-19,” the researchers said.

“These findings, including the potential impact of both sex and race on COVID-19–associated hospitalization rates, need to be confirmed with additional data,” according to the report.

Collecting racial/ethnic information is not always feasible on the front lines, and many areas still face shortages of ventilators and protective equipment, said Dr. Williams.

“I want to salute the providers on the front lines of this pandemic, many putting their own lives at risk, I want to acknowledge the good that they are doing,” Dr. Williams emphasized. He noted that all of us, himself included, may have conscious or unconscious stereotypes, but the key is to acknowledge the potential for these thoughts and feelings and continue to provide the best care.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

“Even though these data are preliminary and further study is warranted, the pattern is irrefutable: Underrepresented minorities are developing COVID-19 infection more frequently and dying disproportionately,” said Dr. Yancy.

Dr. Williams’ and Dr. Yancy’s comments were supported by an analysis of COVID-19 patient data from several areas of the country conducted by the Washington Post. In that analysis, data showed that several counties with a majority black population showed three times the rate of COVID-19 infections and approximately six times as many deaths compared with counties with a majority of white residents.

“The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event,” said Dr. Yancy. “Certainly, within the broad and powerful economic and legislative engines of the US, there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain,” he said.

Dr. Williams had no financial conflicts to disclose. Dr. Yancy had no financial conflicts to disclose.

SOURCES: Yancy CW. JAMA 2020 Apr 15. doi: 10.1001/jama.2020.6548Garg S et al. MMWR Morb Mortal Wkly Rep 2020 Apr 8;69:458-64.

Thebault R et al. The coronavirus is infecting and killing black Americans at an alarmingly high rate. Washington Post. 2020 Apr 7.

African Americans are overrepresented among patients who have died as a result of the COVID-19 pandemic, but the current crisis puts a spotlight on long-standing racial disparities in health care and health access in the United States, according to David R. Williams, PhD, a professor of public health at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Williams, a social scientist specializing in the link between race and health, is a professor of African and African American Studies and of Sociology at Harvard. He spoke on the topic of racial disparities amid the COVID-19 pandemic in a teleconference sponsored by the Robert Wood Johnson Foundation.

“Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said.

Keys to the increased mortality among African Americans include an increased prevalence of risk factors, increased risk for exposure to the virus because of socioeconomic factors, and less access to health care if they do become ill, he said.

Many minority individuals work outside the home in areas deemed essential during the pandemic, such as transit, delivery, maintenance, cleaning, and in businesses such as grocery stores, although in general “race continues to matter for health at every level of income and education,” Dr. Williams said.

In addition, social distance guidelines are not realistic for many people in high-density, low-income areas, who often live in shared, multigenerational housing, he said.

Data show that individuals with chronic conditions such as diabetes and cardiovascular disease are more likely to die as a result of COVID-19, and minority populations are more likely to develop these conditions at younger ages, Dr. Williams noted. Access to health care also plays a role. Many minority individuals of lower socioeconomic status are less likely to have health insurance, or if they do, may have Medicaid, which is not consistently accepted, he said. Also, some low-income neighborhoods lack convenient access to primary care and thus to screening services, he noted.

A recent study from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report cited COVID-NET (the COVID-19 Associated Hospitalization Surveillance Network) as showing that, in their catchment population, “approximately 59% of residents are white, 18% are black, and 14% are Hispanic; however, among 580 hospitalized COVID-19 patients with race/ethnicity data, approximately 45% were white, 33% were black, and 8% were Hispanic, suggesting that black populations might be disproportionately affected by COVID-19,” the researchers said.

“These findings, including the potential impact of both sex and race on COVID-19–associated hospitalization rates, need to be confirmed with additional data,” according to the report.

Collecting racial/ethnic information is not always feasible on the front lines, and many areas still face shortages of ventilators and protective equipment, said Dr. Williams.

“I want to salute the providers on the front lines of this pandemic, many putting their own lives at risk, I want to acknowledge the good that they are doing,” Dr. Williams emphasized. He noted that all of us, himself included, may have conscious or unconscious stereotypes, but the key is to acknowledge the potential for these thoughts and feelings and continue to provide the best care.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

“Even though these data are preliminary and further study is warranted, the pattern is irrefutable: Underrepresented minorities are developing COVID-19 infection more frequently and dying disproportionately,” said Dr. Yancy.

Dr. Williams’ and Dr. Yancy’s comments were supported by an analysis of COVID-19 patient data from several areas of the country conducted by the Washington Post. In that analysis, data showed that several counties with a majority black population showed three times the rate of COVID-19 infections and approximately six times as many deaths compared with counties with a majority of white residents.

“The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event,” said Dr. Yancy. “Certainly, within the broad and powerful economic and legislative engines of the US, there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain,” he said.

Dr. Williams had no financial conflicts to disclose. Dr. Yancy had no financial conflicts to disclose.

SOURCES: Yancy CW. JAMA 2020 Apr 15. doi: 10.1001/jama.2020.6548Garg S et al. MMWR Morb Mortal Wkly Rep 2020 Apr 8;69:458-64.

Thebault R et al. The coronavirus is infecting and killing black Americans at an alarmingly high rate. Washington Post. 2020 Apr 7.

African Americans are overrepresented among patients who have died as a result of the COVID-19 pandemic, but the current crisis puts a spotlight on long-standing racial disparities in health care and health access in the United States, according to David R. Williams, PhD, a professor of public health at the Harvard T.H. Chan School of Public Health in Boston.

Dr. Williams, a social scientist specializing in the link between race and health, is a professor of African and African American Studies and of Sociology at Harvard. He spoke on the topic of racial disparities amid the COVID-19 pandemic in a teleconference sponsored by the Robert Wood Johnson Foundation.

“Many Americans are shocked” by the higher mortality rates among African American COVID-19 patients, said Dr. Williams. However, data from decades of research show that “black people in America live sicker and shorter lives,” he said.

Keys to the increased mortality among African Americans include an increased prevalence of risk factors, increased risk for exposure to the virus because of socioeconomic factors, and less access to health care if they do become ill, he said.

Many minority individuals work outside the home in areas deemed essential during the pandemic, such as transit, delivery, maintenance, cleaning, and in businesses such as grocery stores, although in general “race continues to matter for health at every level of income and education,” Dr. Williams said.

In addition, social distance guidelines are not realistic for many people in high-density, low-income areas, who often live in shared, multigenerational housing, he said.

Data show that individuals with chronic conditions such as diabetes and cardiovascular disease are more likely to die as a result of COVID-19, and minority populations are more likely to develop these conditions at younger ages, Dr. Williams noted. Access to health care also plays a role. Many minority individuals of lower socioeconomic status are less likely to have health insurance, or if they do, may have Medicaid, which is not consistently accepted, he said. Also, some low-income neighborhoods lack convenient access to primary care and thus to screening services, he noted.

A recent study from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report cited COVID-NET (the COVID-19 Associated Hospitalization Surveillance Network) as showing that, in their catchment population, “approximately 59% of residents are white, 18% are black, and 14% are Hispanic; however, among 580 hospitalized COVID-19 patients with race/ethnicity data, approximately 45% were white, 33% were black, and 8% were Hispanic, suggesting that black populations might be disproportionately affected by COVID-19,” the researchers said.

“These findings, including the potential impact of both sex and race on COVID-19–associated hospitalization rates, need to be confirmed with additional data,” according to the report.

Collecting racial/ethnic information is not always feasible on the front lines, and many areas still face shortages of ventilators and protective equipment, said Dr. Williams.

“I want to salute the providers on the front lines of this pandemic, many putting their own lives at risk, I want to acknowledge the good that they are doing,” Dr. Williams emphasized. He noted that all of us, himself included, may have conscious or unconscious stereotypes, but the key is to acknowledge the potential for these thoughts and feelings and continue to provide the best care.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

“Even though these data are preliminary and further study is warranted, the pattern is irrefutable: Underrepresented minorities are developing COVID-19 infection more frequently and dying disproportionately,” said Dr. Yancy.

Dr. Williams’ and Dr. Yancy’s comments were supported by an analysis of COVID-19 patient data from several areas of the country conducted by the Washington Post. In that analysis, data showed that several counties with a majority black population showed three times the rate of COVID-19 infections and approximately six times as many deaths compared with counties with a majority of white residents.

“The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event,” said Dr. Yancy. “Certainly, within the broad and powerful economic and legislative engines of the US, there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain,” he said.

Dr. Williams had no financial conflicts to disclose. Dr. Yancy had no financial conflicts to disclose.

SOURCES: Yancy CW. JAMA 2020 Apr 15. doi: 10.1001/jama.2020.6548Garg S et al. MMWR Morb Mortal Wkly Rep 2020 Apr 8;69:458-64.

Thebault R et al. The coronavirus is infecting and killing black Americans at an alarmingly high rate. Washington Post. 2020 Apr 7.

The COVID-19 pandemic is putting a strain on the blood supply and could be putting people – including those who normally get transfusions, such as patients with sickle cell disease and cancer – at risk.

“Around the beginning of March, the hematology community got wind of what was going on because the blood banks were saying think about your patients and begin to restrict blood usage because we are expecting an increase in usage for COVID-positive ICU patients,” Ifeyinwa (Ify) Osunkwo, MD, a specialist in hematology and sickle cell disease at Levine Cancer Institute in Charlotte, N.C., said in an interview.

“I think that was the first call to arms around hematology ... you don’t want to shortchange somebody who is well and who is being sustained by life-giving transfusions and cut out their transfusion therapy because you are hoping to use the blood for people who are coming in with COVID-19,” she continued. “That is an ethical dilemma that no doctor wants to have to go through. But the reality is we have to do something to make it work for everybody.”

And the timing of the social restrictions due to the pandemic has added additional strain on the blood supply.

“Over the winter, traditionally, blood drives slow down because of the flu and different viruses,” she noted. “The spring and the summer are when we see the biggest recruitment and uptake of blood donation. COVID-19 hit [and] a lot of the blood drives that were traditionally scheduled to supply blood for the country have been canceled because of the new guidance for social distancing.”

Another big source of blood are health care professionals themselves and they may not be able to donate because of the extra hours being worked because of the pandemic.

In speaking about the needs for traditional patients such as those who are dealing with cancer or leukemia or sickle cell diseases as well as those who are being treated for COVID-19 in North Carolina, “we are not at the critical point, but I am a little bit nervous that we may get there because they are not going to up the usual blood drives anytime this summer. We project [sometime] in the fall, but maybe not even then. So there needs to be a significant call-out for people to make every effort to donate blood,” said Dr. Osunkwo. She added that in places such as New York City that are hot spots for the COVID-19 outbreak, the need is likely a lot greater.

She recalled a recent incident at a New York hospital that highlighted how those managing blood supplies are being restrictive and how this could be harming patients.

“A sickle cell patient came in with COVID-19 and the treatment recommendation was do a red blood cell exchange but the blood bank was nervous about getting enough blood to supply for that exchange transfusion,” she said, noting that the doctor still went to bat for that patient to get the needed treatment. “We gave her the supporting evidence that when you are on treatment for sickle cell disease, you tend to do better if you get COVID-19 or any other viral infection. The symptoms of COVID-19 in sickle cell disease is acute chest syndrome, for which the treatment is red blood cell exchange. Not doing that for [these patients] is really not giving them the optimal way of managing their disease, and managing their disease in the setting of COVID-19.”

To that end, Dr. Osunkwo stressed that doctors need to be doing all they can to get the word out that blood is needed and that the American Red Cross and other donation organizations are making it safe for people to donate. She has been using social media to highlight when her fellow doctors and others make donations as a way to motivate individuals.

“Everybody can do something during this pandemic,” she said. “Don’t feel like you are not working, that you are not a frontline worker, that you have nothing to contribute. You can donate blood. Your cousin can donate blood. You can tell your friends, your neighbors, your relatives, your enemies to go donate. We will take every kind of blood we can get because people are needing it more now. Even though we canceled elective surgeries, my patients when they get COVID-19, they need more blood ... than they usually do during their regular sickle cell admission. It is going to be the same for people who have other blood disorders like cancer and leukemia. We can’t stop life-saving treatments just because we have the COVID pandemic.”

Dr. Osunkwo also praised recent actions taken by the Food and Drug Administration to lessen some of the deferral periods for when an individual can donate.

The FDA on April 2 issued three sets of revised recommendations aimed at getting more people eligible to donate blood. All of the revised recommendations will remain in effect after the COVID-19 health emergency is declared over.

The first revised recommendation makes changes to December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period has been reduced from 12 months to 3 months. That deferral period change also applies to female donors who had sex with a man who had sex with another man as well as for those with recent tattoos and piercings.

The second recommendation revises guidance from August 2013 and relates to the risk of transfusion-transmitted malaria.

Under the new recommendations, for those who traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the FDA is lowering the recommended deferral period from 12 months to 3 months, and also provides notices of an alternate procedure that permits donations without a deferral period provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalizes draft guidance from January that eliminates the referral period for donors who spent time in certain European countries or were on military bases in Europe and were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

Dr. Osunkwo reports consultancy and being on the speakers bureau and participating in the advisory board for Novartis, and relationships with a variety of other pharmaceutical companies. She is the editor-in-chief for Hematology News.

gtwachtman@mdedge.com

The COVID-19 pandemic is putting a strain on the blood supply and could be putting people – including those who normally get transfusions, such as patients with sickle cell disease and cancer – at risk.

“Around the beginning of March, the hematology community got wind of what was going on because the blood banks were saying think about your patients and begin to restrict blood usage because we are expecting an increase in usage for COVID-positive ICU patients,” Ifeyinwa (Ify) Osunkwo, MD, a specialist in hematology and sickle cell disease at Levine Cancer Institute in Charlotte, N.C., said in an interview.

“I think that was the first call to arms around hematology ... you don’t want to shortchange somebody who is well and who is being sustained by life-giving transfusions and cut out their transfusion therapy because you are hoping to use the blood for people who are coming in with COVID-19,” she continued. “That is an ethical dilemma that no doctor wants to have to go through. But the reality is we have to do something to make it work for everybody.”

And the timing of the social restrictions due to the pandemic has added additional strain on the blood supply.

“Over the winter, traditionally, blood drives slow down because of the flu and different viruses,” she noted. “The spring and the summer are when we see the biggest recruitment and uptake of blood donation. COVID-19 hit [and] a lot of the blood drives that were traditionally scheduled to supply blood for the country have been canceled because of the new guidance for social distancing.”

Another big source of blood are health care professionals themselves and they may not be able to donate because of the extra hours being worked because of the pandemic.

In speaking about the needs for traditional patients such as those who are dealing with cancer or leukemia or sickle cell diseases as well as those who are being treated for COVID-19 in North Carolina, “we are not at the critical point, but I am a little bit nervous that we may get there because they are not going to up the usual blood drives anytime this summer. We project [sometime] in the fall, but maybe not even then. So there needs to be a significant call-out for people to make every effort to donate blood,” said Dr. Osunkwo. She added that in places such as New York City that are hot spots for the COVID-19 outbreak, the need is likely a lot greater.

She recalled a recent incident at a New York hospital that highlighted how those managing blood supplies are being restrictive and how this could be harming patients.

“A sickle cell patient came in with COVID-19 and the treatment recommendation was do a red blood cell exchange but the blood bank was nervous about getting enough blood to supply for that exchange transfusion,” she said, noting that the doctor still went to bat for that patient to get the needed treatment. “We gave her the supporting evidence that when you are on treatment for sickle cell disease, you tend to do better if you get COVID-19 or any other viral infection. The symptoms of COVID-19 in sickle cell disease is acute chest syndrome, for which the treatment is red blood cell exchange. Not doing that for [these patients] is really not giving them the optimal way of managing their disease, and managing their disease in the setting of COVID-19.”

To that end, Dr. Osunkwo stressed that doctors need to be doing all they can to get the word out that blood is needed and that the American Red Cross and other donation organizations are making it safe for people to donate. She has been using social media to highlight when her fellow doctors and others make donations as a way to motivate individuals.

“Everybody can do something during this pandemic,” she said. “Don’t feel like you are not working, that you are not a frontline worker, that you have nothing to contribute. You can donate blood. Your cousin can donate blood. You can tell your friends, your neighbors, your relatives, your enemies to go donate. We will take every kind of blood we can get because people are needing it more now. Even though we canceled elective surgeries, my patients when they get COVID-19, they need more blood ... than they usually do during their regular sickle cell admission. It is going to be the same for people who have other blood disorders like cancer and leukemia. We can’t stop life-saving treatments just because we have the COVID pandemic.”

Dr. Osunkwo also praised recent actions taken by the Food and Drug Administration to lessen some of the deferral periods for when an individual can donate.

The FDA on April 2 issued three sets of revised recommendations aimed at getting more people eligible to donate blood. All of the revised recommendations will remain in effect after the COVID-19 health emergency is declared over.

The first revised recommendation makes changes to December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period has been reduced from 12 months to 3 months. That deferral period change also applies to female donors who had sex with a man who had sex with another man as well as for those with recent tattoos and piercings.

The second recommendation revises guidance from August 2013 and relates to the risk of transfusion-transmitted malaria.

Under the new recommendations, for those who traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the FDA is lowering the recommended deferral period from 12 months to 3 months, and also provides notices of an alternate procedure that permits donations without a deferral period provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalizes draft guidance from January that eliminates the referral period for donors who spent time in certain European countries or were on military bases in Europe and were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

Dr. Osunkwo reports consultancy and being on the speakers bureau and participating in the advisory board for Novartis, and relationships with a variety of other pharmaceutical companies. She is the editor-in-chief for Hematology News.

gtwachtman@mdedge.com

The COVID-19 pandemic is putting a strain on the blood supply and could be putting people – including those who normally get transfusions, such as patients with sickle cell disease and cancer – at risk.

“Around the beginning of March, the hematology community got wind of what was going on because the blood banks were saying think about your patients and begin to restrict blood usage because we are expecting an increase in usage for COVID-positive ICU patients,” Ifeyinwa (Ify) Osunkwo, MD, a specialist in hematology and sickle cell disease at Levine Cancer Institute in Charlotte, N.C., said in an interview.

“I think that was the first call to arms around hematology ... you don’t want to shortchange somebody who is well and who is being sustained by life-giving transfusions and cut out their transfusion therapy because you are hoping to use the blood for people who are coming in with COVID-19,” she continued. “That is an ethical dilemma that no doctor wants to have to go through. But the reality is we have to do something to make it work for everybody.”

And the timing of the social restrictions due to the pandemic has added additional strain on the blood supply.

“Over the winter, traditionally, blood drives slow down because of the flu and different viruses,” she noted. “The spring and the summer are when we see the biggest recruitment and uptake of blood donation. COVID-19 hit [and] a lot of the blood drives that were traditionally scheduled to supply blood for the country have been canceled because of the new guidance for social distancing.”

Another big source of blood are health care professionals themselves and they may not be able to donate because of the extra hours being worked because of the pandemic.

In speaking about the needs for traditional patients such as those who are dealing with cancer or leukemia or sickle cell diseases as well as those who are being treated for COVID-19 in North Carolina, “we are not at the critical point, but I am a little bit nervous that we may get there because they are not going to up the usual blood drives anytime this summer. We project [sometime] in the fall, but maybe not even then. So there needs to be a significant call-out for people to make every effort to donate blood,” said Dr. Osunkwo. She added that in places such as New York City that are hot spots for the COVID-19 outbreak, the need is likely a lot greater.

She recalled a recent incident at a New York hospital that highlighted how those managing blood supplies are being restrictive and how this could be harming patients.

“A sickle cell patient came in with COVID-19 and the treatment recommendation was do a red blood cell exchange but the blood bank was nervous about getting enough blood to supply for that exchange transfusion,” she said, noting that the doctor still went to bat for that patient to get the needed treatment. “We gave her the supporting evidence that when you are on treatment for sickle cell disease, you tend to do better if you get COVID-19 or any other viral infection. The symptoms of COVID-19 in sickle cell disease is acute chest syndrome, for which the treatment is red blood cell exchange. Not doing that for [these patients] is really not giving them the optimal way of managing their disease, and managing their disease in the setting of COVID-19.”

To that end, Dr. Osunkwo stressed that doctors need to be doing all they can to get the word out that blood is needed and that the American Red Cross and other donation organizations are making it safe for people to donate. She has been using social media to highlight when her fellow doctors and others make donations as a way to motivate individuals.

“Everybody can do something during this pandemic,” she said. “Don’t feel like you are not working, that you are not a frontline worker, that you have nothing to contribute. You can donate blood. Your cousin can donate blood. You can tell your friends, your neighbors, your relatives, your enemies to go donate. We will take every kind of blood we can get because people are needing it more now. Even though we canceled elective surgeries, my patients when they get COVID-19, they need more blood ... than they usually do during their regular sickle cell admission. It is going to be the same for people who have other blood disorders like cancer and leukemia. We can’t stop life-saving treatments just because we have the COVID pandemic.”

Dr. Osunkwo also praised recent actions taken by the Food and Drug Administration to lessen some of the deferral periods for when an individual can donate.

The FDA on April 2 issued three sets of revised recommendations aimed at getting more people eligible to donate blood. All of the revised recommendations will remain in effect after the COVID-19 health emergency is declared over.

The first revised recommendation makes changes to December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period has been reduced from 12 months to 3 months. That deferral period change also applies to female donors who had sex with a man who had sex with another man as well as for those with recent tattoos and piercings.

The second recommendation revises guidance from August 2013 and relates to the risk of transfusion-transmitted malaria.

Under the new recommendations, for those who traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the FDA is lowering the recommended deferral period from 12 months to 3 months, and also provides notices of an alternate procedure that permits donations without a deferral period provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalizes draft guidance from January that eliminates the referral period for donors who spent time in certain European countries or were on military bases in Europe and were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

Dr. Osunkwo reports consultancy and being on the speakers bureau and participating in the advisory board for Novartis, and relationships with a variety of other pharmaceutical companies. She is the editor-in-chief for Hematology News.

gtwachtman@mdedge.com