Hematology News

Amid a substantial expansion of therapies in several drug classes for the treatment of osteoporosis, there has been a notable increase in the prescription of denosumab for patients with a cancer-related indication.

ogichobanov/iStock/Getty Images Plus

In an analysis of claims data from January 2009 to March 2020, the bisphosphonate alendronate represented more than 50% of all prescriptions for bone-directed therapies, but growth in the use of the monoclonal antibody denosumab overall and in cancer-related indications particularly was steady throughout the study period.

“In the malignancy cohort, alendronate and zoledronic acid were each used in approximately 30% of individuals at the onset of the study, but use of both then declined,” Sara Cromer, MD, reported at the annual meeting of the Endocrine Society.

For malignancy-based prescriptions, denosumab surpassed either bisphosphonate by 2013 and then continued to rise.

Denosumab use “reached approximately 50% of all bone-directed medication use in the malignancy cohort” by the end of the study period, said Dr. Cromer, a clinical research fellow in endocrinology at Massachusetts General Hospital, Boston.

The claims data for this analysis was drawn from the Clinformatics Data Mart. The analysis was restricted to individuals aged older than 50 years who received a prescription for a bone-directed therapy. The 15.48 million prescriptions evaluated were drawn from 1.46 million unique individuals. The mean age was 69 years, and 89% of those prescribed a drug were women.
 

Oncologic indications one of two tracked cohorts

In the context of a large expansion of treatment options in several drug classes for osteoporosis, the objective of this claims analysis was to document trends in treatment choice, according to Dr. Cromer. She and her coinvestigators looked at prescriptions overall as well as in two cohorts defined by ICD codes. One included patients prescribed a prescription by an oncologist. The other included everyone else.

When all prescriptions for bone-directed therapy were evaluated over the study period, alendronate was the most commonly prescribed therapy, and its use increased over time. Prescriptions of zoledronic acid also rose, doubling over the study period, but use was very low in the beginning and it never climbed above 5%.

The proportion of prescriptions written for bisphosphonates other than alendronate and zoledronic acid “declined steadily” over the study period, Dr. Cromer reported.

Denosumab, a monoclonal antibody that targets a step in the process important to maturation of osteoclasts, was approved in 2010. It accounted for 10% of all prescriptions for osteoporosis by 2015 and 15% by 2018. It was still rising through the end of the study period.

In contrast, prescriptions of raloxifene, a selective estrogen receptor modulator, began to decline after 2013. In general, the rates of prescriptions for other agents, including some of the more recently approved drugs, such as teriparatide, abaloparatide, and romosozumab, changed very little over the study period. None of these therapies ever represented more than 2% of prescriptions.

When looking at the cohort of patients who received a bone-directed reason for a noncancer indication, the trends “paralleled those in the all-user analysis,” Dr. Cromer reported.
 

Denosumab use greater in privately insured

In the malignancy cohort, the decline in the use of bisphosphonates and the rise in the use of denosumab were most pronounced in patients who were privately insured. The increased use of denosumab over the study period “outpaced gains in use of other agents despite guidelines,” said Dr. Cromer, referring to the those issued by the Endocrine Society in 2019 .

In those guidelines, written for management of postmenopausal women at high risk of fractures, bisphosphonates are recommended for initial treatment while denosumab is recommended as an alternative. However, those guidelines do not provide specific recommendations for therapies directed at osteoporosis associated with cancer.

Guidelines for this population exist, including one published by the American Society of Clinical Oncology in 2019.

In the ASCO guidelines, oral bisphosphonates, intravenous bisphosphonates, and subcutaneous denosumab were all identified as “efficacious options,” according to Charles L. Shapiro, MD, director of breast cancer translational research, Mount Sinai Health System, New York.

Specifically, “all three of them work to reduce fractures and improve bone density in women with breast cancer in whom you are trying to prevent or treat osteoporosis,” Dr. Shapiro said in an interview.

There might be relative advantages for one therapy over another in specific subgroups defined by type of cancer or stage of cancer, but trials are not definitive for such outcomes as overall survival. Citing one comparative study associating denosumab with an 18% delay to first skeletal event in women with metastatic breast cancer, Dr. Shapiro observed, “I personally don’t consider an 18% delay [for this outcome] to be that clinically meaningful.”

Although major guidelines from ASCO have not so far favored denosumab over any bisphosphonate in routine care, Dr. Shapiro did not rule out the possibility that future studies will show differences.

Dr. Comer and Dr. Shapiro reported no relevant conflicts of interest.

Amid a substantial expansion of therapies in several drug classes for the treatment of osteoporosis, there has been a notable increase in the prescription of denosumab for patients with a cancer-related indication.

ogichobanov/iStock/Getty Images Plus

In an analysis of claims data from January 2009 to March 2020, the bisphosphonate alendronate represented more than 50% of all prescriptions for bone-directed therapies, but growth in the use of the monoclonal antibody denosumab overall and in cancer-related indications particularly was steady throughout the study period.

“In the malignancy cohort, alendronate and zoledronic acid were each used in approximately 30% of individuals at the onset of the study, but use of both then declined,” Sara Cromer, MD, reported at the annual meeting of the Endocrine Society.

For malignancy-based prescriptions, denosumab surpassed either bisphosphonate by 2013 and then continued to rise.

Denosumab use “reached approximately 50% of all bone-directed medication use in the malignancy cohort” by the end of the study period, said Dr. Cromer, a clinical research fellow in endocrinology at Massachusetts General Hospital, Boston.

The claims data for this analysis was drawn from the Clinformatics Data Mart. The analysis was restricted to individuals aged older than 50 years who received a prescription for a bone-directed therapy. The 15.48 million prescriptions evaluated were drawn from 1.46 million unique individuals. The mean age was 69 years, and 89% of those prescribed a drug were women.
 

Oncologic indications one of two tracked cohorts

In the context of a large expansion of treatment options in several drug classes for osteoporosis, the objective of this claims analysis was to document trends in treatment choice, according to Dr. Cromer. She and her coinvestigators looked at prescriptions overall as well as in two cohorts defined by ICD codes. One included patients prescribed a prescription by an oncologist. The other included everyone else.

When all prescriptions for bone-directed therapy were evaluated over the study period, alendronate was the most commonly prescribed therapy, and its use increased over time. Prescriptions of zoledronic acid also rose, doubling over the study period, but use was very low in the beginning and it never climbed above 5%.

The proportion of prescriptions written for bisphosphonates other than alendronate and zoledronic acid “declined steadily” over the study period, Dr. Cromer reported.

Denosumab, a monoclonal antibody that targets a step in the process important to maturation of osteoclasts, was approved in 2010. It accounted for 10% of all prescriptions for osteoporosis by 2015 and 15% by 2018. It was still rising through the end of the study period.

In contrast, prescriptions of raloxifene, a selective estrogen receptor modulator, began to decline after 2013. In general, the rates of prescriptions for other agents, including some of the more recently approved drugs, such as teriparatide, abaloparatide, and romosozumab, changed very little over the study period. None of these therapies ever represented more than 2% of prescriptions.

When looking at the cohort of patients who received a bone-directed reason for a noncancer indication, the trends “paralleled those in the all-user analysis,” Dr. Cromer reported.
 

Denosumab use greater in privately insured

In the malignancy cohort, the decline in the use of bisphosphonates and the rise in the use of denosumab were most pronounced in patients who were privately insured. The increased use of denosumab over the study period “outpaced gains in use of other agents despite guidelines,” said Dr. Cromer, referring to the those issued by the Endocrine Society in 2019 .

In those guidelines, written for management of postmenopausal women at high risk of fractures, bisphosphonates are recommended for initial treatment while denosumab is recommended as an alternative. However, those guidelines do not provide specific recommendations for therapies directed at osteoporosis associated with cancer.

Guidelines for this population exist, including one published by the American Society of Clinical Oncology in 2019.

In the ASCO guidelines, oral bisphosphonates, intravenous bisphosphonates, and subcutaneous denosumab were all identified as “efficacious options,” according to Charles L. Shapiro, MD, director of breast cancer translational research, Mount Sinai Health System, New York.

Specifically, “all three of them work to reduce fractures and improve bone density in women with breast cancer in whom you are trying to prevent or treat osteoporosis,” Dr. Shapiro said in an interview.

There might be relative advantages for one therapy over another in specific subgroups defined by type of cancer or stage of cancer, but trials are not definitive for such outcomes as overall survival. Citing one comparative study associating denosumab with an 18% delay to first skeletal event in women with metastatic breast cancer, Dr. Shapiro observed, “I personally don’t consider an 18% delay [for this outcome] to be that clinically meaningful.”

Although major guidelines from ASCO have not so far favored denosumab over any bisphosphonate in routine care, Dr. Shapiro did not rule out the possibility that future studies will show differences.

Dr. Comer and Dr. Shapiro reported no relevant conflicts of interest.

Amid a substantial expansion of therapies in several drug classes for the treatment of osteoporosis, there has been a notable increase in the prescription of denosumab for patients with a cancer-related indication.

ogichobanov/iStock/Getty Images Plus

In an analysis of claims data from January 2009 to March 2020, the bisphosphonate alendronate represented more than 50% of all prescriptions for bone-directed therapies, but growth in the use of the monoclonal antibody denosumab overall and in cancer-related indications particularly was steady throughout the study period.

“In the malignancy cohort, alendronate and zoledronic acid were each used in approximately 30% of individuals at the onset of the study, but use of both then declined,” Sara Cromer, MD, reported at the annual meeting of the Endocrine Society.

For malignancy-based prescriptions, denosumab surpassed either bisphosphonate by 2013 and then continued to rise.

Denosumab use “reached approximately 50% of all bone-directed medication use in the malignancy cohort” by the end of the study period, said Dr. Cromer, a clinical research fellow in endocrinology at Massachusetts General Hospital, Boston.

The claims data for this analysis was drawn from the Clinformatics Data Mart. The analysis was restricted to individuals aged older than 50 years who received a prescription for a bone-directed therapy. The 15.48 million prescriptions evaluated were drawn from 1.46 million unique individuals. The mean age was 69 years, and 89% of those prescribed a drug were women.
 

Oncologic indications one of two tracked cohorts

In the context of a large expansion of treatment options in several drug classes for osteoporosis, the objective of this claims analysis was to document trends in treatment choice, according to Dr. Cromer. She and her coinvestigators looked at prescriptions overall as well as in two cohorts defined by ICD codes. One included patients prescribed a prescription by an oncologist. The other included everyone else.

When all prescriptions for bone-directed therapy were evaluated over the study period, alendronate was the most commonly prescribed therapy, and its use increased over time. Prescriptions of zoledronic acid also rose, doubling over the study period, but use was very low in the beginning and it never climbed above 5%.

The proportion of prescriptions written for bisphosphonates other than alendronate and zoledronic acid “declined steadily” over the study period, Dr. Cromer reported.

Denosumab, a monoclonal antibody that targets a step in the process important to maturation of osteoclasts, was approved in 2010. It accounted for 10% of all prescriptions for osteoporosis by 2015 and 15% by 2018. It was still rising through the end of the study period.

In contrast, prescriptions of raloxifene, a selective estrogen receptor modulator, began to decline after 2013. In general, the rates of prescriptions for other agents, including some of the more recently approved drugs, such as teriparatide, abaloparatide, and romosozumab, changed very little over the study period. None of these therapies ever represented more than 2% of prescriptions.

When looking at the cohort of patients who received a bone-directed reason for a noncancer indication, the trends “paralleled those in the all-user analysis,” Dr. Cromer reported.
 

Denosumab use greater in privately insured

In the malignancy cohort, the decline in the use of bisphosphonates and the rise in the use of denosumab were most pronounced in patients who were privately insured. The increased use of denosumab over the study period “outpaced gains in use of other agents despite guidelines,” said Dr. Cromer, referring to the those issued by the Endocrine Society in 2019 .

In those guidelines, written for management of postmenopausal women at high risk of fractures, bisphosphonates are recommended for initial treatment while denosumab is recommended as an alternative. However, those guidelines do not provide specific recommendations for therapies directed at osteoporosis associated with cancer.

Guidelines for this population exist, including one published by the American Society of Clinical Oncology in 2019.

In the ASCO guidelines, oral bisphosphonates, intravenous bisphosphonates, and subcutaneous denosumab were all identified as “efficacious options,” according to Charles L. Shapiro, MD, director of breast cancer translational research, Mount Sinai Health System, New York.

Specifically, “all three of them work to reduce fractures and improve bone density in women with breast cancer in whom you are trying to prevent or treat osteoporosis,” Dr. Shapiro said in an interview.

There might be relative advantages for one therapy over another in specific subgroups defined by type of cancer or stage of cancer, but trials are not definitive for such outcomes as overall survival. Citing one comparative study associating denosumab with an 18% delay to first skeletal event in women with metastatic breast cancer, Dr. Shapiro observed, “I personally don’t consider an 18% delay [for this outcome] to be that clinically meaningful.”

Although major guidelines from ASCO have not so far favored denosumab over any bisphosphonate in routine care, Dr. Shapiro did not rule out the possibility that future studies will show differences.

Dr. Comer and Dr. Shapiro reported no relevant conflicts of interest.

Recently, we had the opportunity to take part in a major EHR conversion project. During this “go-live,” 5 hospitals and approximately 300 ambulatory service and physician practice locations made the transition, consolidating over 100 disparate electronic systems and dozens of interfaces into one world-class medical record.

If you’ve ever been part of such an event, you know it is anything but simple. On the contrary, it requires an enormous financial investment along with years of planning, hours of meetings, and months of training. No matter how much preparation goes into it, there are sure to be bumps along the way. It is a traumatic and stressful time for all involved, but the end result is well worth the effort. Still, there are lessons to be learned and wisdom to be gleaned, and this month we’d like to share a few that we found most important. We believe that many of these are useful lessons even to those who will never live through a go-live.
 

Safety always comes first

Patient safety is a term so often used that it has a tendency to be taken for granted. Health systems build processes and procedures to ensure safety – some even win awards and recognition for their efforts. But the best (and safest) health care institutions build patient safety into their cultures. More than just being taught to use checklists or buzzwords, the staff at these institutions are encouraged to put the welfare of patients first, making all other activities secondary to this pursuit. We had the opportunity to witness the benefits of such a culture during this go-live and were incredibly impressed with the results.

To be successful in an EHR transition of any magnitude, an organization needs to hold patient safety as a core value and provide its employees with the tools to execute on that value. This enables staff to prepare adequately and to identify risks and opportunities before the conversion takes place. Once go-live occurs, staff also must feel empowered to speak up when they identify problem areas that might jeopardize patients’ care. They also must be given a clear escalation path to ensure their voices can be heard. Most importantly, everyone must understand that the electronic health record itself is just one piece of a major operational change.

As workflows are modified to adapt to the new technology, unsafe processes should be called out and fixed quickly. While the EHR may offer the latest in decision support and system integration, no advancement in technology can make up for bad outcomes, nor justify processes that lead to patient harm.
 

Training is no substitute for good support

It takes a long time to train thousands of employees, especially when that training must occur during the era of social distancing in the midst of a pandemic. Still, even in the best of times, education should be married to hands-on experience in order to have a real impact. Unfortunately, this is extremely challenging.

Trainees forget much of what they’ve learned in the weeks or months between education and go-live, so they must be given immediately accessible support to bridge the gap. This is known as “at-the-elbow” (ATE) support, and as the name implies, it consists of individuals who are familiar with the new system and are always available to end users, answering their questions and helping them navigate. Since health care never sleeps, this support needs to be offered 24/7, and it should also be flexible and plentiful.

There are many areas that will require more support than anticipated to accommodate the number of clinical and other staff who will use the system, so support staff must be nimble and available for redeployment. In addition, ensuring high-quality support is essential. As many ATE experts are hired contractors, their knowledge base and communications skills can vary widely. Accountability is key, and end users should feel empowered to identify gaps in coverage and deficits in knowledge base in the ATE.

As employees become more familiar with the new system, the need for ATE will wane, but there will still be questions that arise for many weeks to months, and new EHR users will also be added all the time. A good after–go-live support system should remain available so clinical and clerical employees can get just-in-time assistance whenever they need it.
 

Users should be given clear expectations

Clinicians going through an EHR conversion may be frustrated to discover that the data transferred from their old system into the new one is not quite what they expected. While structured elements such as allergies and immunizations may transfer, unstructured patient histories may not come over at all.

There may be gaps in data, or the opposite may even be true: an overabundance of useless information may transfer over, leaving doctors with dozens of meaningless data points to sift through and eliminate to clean up the chart. This can be extremely time-consuming and discouraging and may jeopardize the success of the go-live.

Providers deserve clear expectations prior to conversion. They should be told what will and will not transfer and be informed that there will be extra work required for documentation at the outset. They may also want the option to preemptively reduce patient volumes to accommodate the additional effort involved in preparing charts. No matter what, this will be a heavy lift, and physicians should understand the implications long before go-live to prepare accordingly.
 

Old habits die hard

One of the most common complaints we’ve heard following EHR conversions is that “things just worked better in the old system.” We always respond with a question: “Were things better, or just different?” The truth may lie somewhere in the middle, but there is no question that muscle memory develops over many years, and change is difficult no matter how much better the new system is. Still, appropriate expectations, access to just-in-time support, and a continual focus on safety will ensure that the long-term benefits of a patient-centered and integrated electronic record will far outweigh the initial challenges of go-live.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Recently, we had the opportunity to take part in a major EHR conversion project. During this “go-live,” 5 hospitals and approximately 300 ambulatory service and physician practice locations made the transition, consolidating over 100 disparate electronic systems and dozens of interfaces into one world-class medical record.

If you’ve ever been part of such an event, you know it is anything but simple. On the contrary, it requires an enormous financial investment along with years of planning, hours of meetings, and months of training. No matter how much preparation goes into it, there are sure to be bumps along the way. It is a traumatic and stressful time for all involved, but the end result is well worth the effort. Still, there are lessons to be learned and wisdom to be gleaned, and this month we’d like to share a few that we found most important. We believe that many of these are useful lessons even to those who will never live through a go-live.
 

Safety always comes first

Patient safety is a term so often used that it has a tendency to be taken for granted. Health systems build processes and procedures to ensure safety – some even win awards and recognition for their efforts. But the best (and safest) health care institutions build patient safety into their cultures. More than just being taught to use checklists or buzzwords, the staff at these institutions are encouraged to put the welfare of patients first, making all other activities secondary to this pursuit. We had the opportunity to witness the benefits of such a culture during this go-live and were incredibly impressed with the results.

To be successful in an EHR transition of any magnitude, an organization needs to hold patient safety as a core value and provide its employees with the tools to execute on that value. This enables staff to prepare adequately and to identify risks and opportunities before the conversion takes place. Once go-live occurs, staff also must feel empowered to speak up when they identify problem areas that might jeopardize patients’ care. They also must be given a clear escalation path to ensure their voices can be heard. Most importantly, everyone must understand that the electronic health record itself is just one piece of a major operational change.

As workflows are modified to adapt to the new technology, unsafe processes should be called out and fixed quickly. While the EHR may offer the latest in decision support and system integration, no advancement in technology can make up for bad outcomes, nor justify processes that lead to patient harm.
 

Training is no substitute for good support

It takes a long time to train thousands of employees, especially when that training must occur during the era of social distancing in the midst of a pandemic. Still, even in the best of times, education should be married to hands-on experience in order to have a real impact. Unfortunately, this is extremely challenging.

Trainees forget much of what they’ve learned in the weeks or months between education and go-live, so they must be given immediately accessible support to bridge the gap. This is known as “at-the-elbow” (ATE) support, and as the name implies, it consists of individuals who are familiar with the new system and are always available to end users, answering their questions and helping them navigate. Since health care never sleeps, this support needs to be offered 24/7, and it should also be flexible and plentiful.

There are many areas that will require more support than anticipated to accommodate the number of clinical and other staff who will use the system, so support staff must be nimble and available for redeployment. In addition, ensuring high-quality support is essential. As many ATE experts are hired contractors, their knowledge base and communications skills can vary widely. Accountability is key, and end users should feel empowered to identify gaps in coverage and deficits in knowledge base in the ATE.

As employees become more familiar with the new system, the need for ATE will wane, but there will still be questions that arise for many weeks to months, and new EHR users will also be added all the time. A good after–go-live support system should remain available so clinical and clerical employees can get just-in-time assistance whenever they need it.
 

Users should be given clear expectations

Clinicians going through an EHR conversion may be frustrated to discover that the data transferred from their old system into the new one is not quite what they expected. While structured elements such as allergies and immunizations may transfer, unstructured patient histories may not come over at all.

There may be gaps in data, or the opposite may even be true: an overabundance of useless information may transfer over, leaving doctors with dozens of meaningless data points to sift through and eliminate to clean up the chart. This can be extremely time-consuming and discouraging and may jeopardize the success of the go-live.

Providers deserve clear expectations prior to conversion. They should be told what will and will not transfer and be informed that there will be extra work required for documentation at the outset. They may also want the option to preemptively reduce patient volumes to accommodate the additional effort involved in preparing charts. No matter what, this will be a heavy lift, and physicians should understand the implications long before go-live to prepare accordingly.
 

Old habits die hard

One of the most common complaints we’ve heard following EHR conversions is that “things just worked better in the old system.” We always respond with a question: “Were things better, or just different?” The truth may lie somewhere in the middle, but there is no question that muscle memory develops over many years, and change is difficult no matter how much better the new system is. Still, appropriate expectations, access to just-in-time support, and a continual focus on safety will ensure that the long-term benefits of a patient-centered and integrated electronic record will far outweigh the initial challenges of go-live.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Recently, we had the opportunity to take part in a major EHR conversion project. During this “go-live,” 5 hospitals and approximately 300 ambulatory service and physician practice locations made the transition, consolidating over 100 disparate electronic systems and dozens of interfaces into one world-class medical record.

If you’ve ever been part of such an event, you know it is anything but simple. On the contrary, it requires an enormous financial investment along with years of planning, hours of meetings, and months of training. No matter how much preparation goes into it, there are sure to be bumps along the way. It is a traumatic and stressful time for all involved, but the end result is well worth the effort. Still, there are lessons to be learned and wisdom to be gleaned, and this month we’d like to share a few that we found most important. We believe that many of these are useful lessons even to those who will never live through a go-live.
 

Safety always comes first

Patient safety is a term so often used that it has a tendency to be taken for granted. Health systems build processes and procedures to ensure safety – some even win awards and recognition for their efforts. But the best (and safest) health care institutions build patient safety into their cultures. More than just being taught to use checklists or buzzwords, the staff at these institutions are encouraged to put the welfare of patients first, making all other activities secondary to this pursuit. We had the opportunity to witness the benefits of such a culture during this go-live and were incredibly impressed with the results.

To be successful in an EHR transition of any magnitude, an organization needs to hold patient safety as a core value and provide its employees with the tools to execute on that value. This enables staff to prepare adequately and to identify risks and opportunities before the conversion takes place. Once go-live occurs, staff also must feel empowered to speak up when they identify problem areas that might jeopardize patients’ care. They also must be given a clear escalation path to ensure their voices can be heard. Most importantly, everyone must understand that the electronic health record itself is just one piece of a major operational change.

As workflows are modified to adapt to the new technology, unsafe processes should be called out and fixed quickly. While the EHR may offer the latest in decision support and system integration, no advancement in technology can make up for bad outcomes, nor justify processes that lead to patient harm.
 

Training is no substitute for good support

It takes a long time to train thousands of employees, especially when that training must occur during the era of social distancing in the midst of a pandemic. Still, even in the best of times, education should be married to hands-on experience in order to have a real impact. Unfortunately, this is extremely challenging.

Trainees forget much of what they’ve learned in the weeks or months between education and go-live, so they must be given immediately accessible support to bridge the gap. This is known as “at-the-elbow” (ATE) support, and as the name implies, it consists of individuals who are familiar with the new system and are always available to end users, answering their questions and helping them navigate. Since health care never sleeps, this support needs to be offered 24/7, and it should also be flexible and plentiful.

There are many areas that will require more support than anticipated to accommodate the number of clinical and other staff who will use the system, so support staff must be nimble and available for redeployment. In addition, ensuring high-quality support is essential. As many ATE experts are hired contractors, their knowledge base and communications skills can vary widely. Accountability is key, and end users should feel empowered to identify gaps in coverage and deficits in knowledge base in the ATE.

As employees become more familiar with the new system, the need for ATE will wane, but there will still be questions that arise for many weeks to months, and new EHR users will also be added all the time. A good after–go-live support system should remain available so clinical and clerical employees can get just-in-time assistance whenever they need it.
 

Users should be given clear expectations

Clinicians going through an EHR conversion may be frustrated to discover that the data transferred from their old system into the new one is not quite what they expected. While structured elements such as allergies and immunizations may transfer, unstructured patient histories may not come over at all.

There may be gaps in data, or the opposite may even be true: an overabundance of useless information may transfer over, leaving doctors with dozens of meaningless data points to sift through and eliminate to clean up the chart. This can be extremely time-consuming and discouraging and may jeopardize the success of the go-live.

Providers deserve clear expectations prior to conversion. They should be told what will and will not transfer and be informed that there will be extra work required for documentation at the outset. They may also want the option to preemptively reduce patient volumes to accommodate the additional effort involved in preparing charts. No matter what, this will be a heavy lift, and physicians should understand the implications long before go-live to prepare accordingly.
 

Old habits die hard

One of the most common complaints we’ve heard following EHR conversions is that “things just worked better in the old system.” We always respond with a question: “Were things better, or just different?” The truth may lie somewhere in the middle, but there is no question that muscle memory develops over many years, and change is difficult no matter how much better the new system is. Still, appropriate expectations, access to just-in-time support, and a continual focus on safety will ensure that the long-term benefits of a patient-centered and integrated electronic record will far outweigh the initial challenges of go-live.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

One of the top research journals in the United States has placed its editor-in-chief on administrative leave pending the outcome of an investigation into a controversial podcast episode that critics labeled as racist.

The American Medical Association’s Joint Oversight Committee announced that Howard Bauchner, MD, is on leave beginning at the end of the day on March 25. Dr. Bauchner is the top editor at JAMA, the journal of the AMA.

“The decision to place the editor-in-chief on administrative leave neither implicates nor exonerates individuals and is standard operating procedure for such investigations,” the committee said in a statement.

More than 2,000 people signed a petition on Change.org calling for an investigation at JAMA over the February podcast episode, called “Structural Racism for Doctors: What Is It?”

Already, Edward H. Livingston, MD, the host of the podcast, has resigned as deputy editor of the journal.

During the podcast, Dr. Livingston, who is White, said, “Structural racism is an unfortunate term. Personally, I think taking racism out of the conversation will help. Many of us are offended by the concept that we are racist.”

The audio of the podcast has been deleted from JAMA’s website. In its place is audio of a statement from Dr. Bauchner. In his statement, which he released in the week prior to his being on leave, he said the comments in the podcast, which also featured Mitch Katz, MD, were “inaccurate, offensive, hurtful, and inconsistent with the standards of JAMA.”

Also deleted was a JAMA tweet promoting the podcast episode. The tweet said: “No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast.”

This story will be updated.

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

One of the top research journals in the United States has placed its editor-in-chief on administrative leave pending the outcome of an investigation into a controversial podcast episode that critics labeled as racist.

The American Medical Association’s Joint Oversight Committee announced that Howard Bauchner, MD, is on leave beginning at the end of the day on March 25. Dr. Bauchner is the top editor at JAMA, the journal of the AMA.

“The decision to place the editor-in-chief on administrative leave neither implicates nor exonerates individuals and is standard operating procedure for such investigations,” the committee said in a statement.

More than 2,000 people signed a petition on Change.org calling for an investigation at JAMA over the February podcast episode, called “Structural Racism for Doctors: What Is It?”

Already, Edward H. Livingston, MD, the host of the podcast, has resigned as deputy editor of the journal.

During the podcast, Dr. Livingston, who is White, said, “Structural racism is an unfortunate term. Personally, I think taking racism out of the conversation will help. Many of us are offended by the concept that we are racist.”

The audio of the podcast has been deleted from JAMA’s website. In its place is audio of a statement from Dr. Bauchner. In his statement, which he released in the week prior to his being on leave, he said the comments in the podcast, which also featured Mitch Katz, MD, were “inaccurate, offensive, hurtful, and inconsistent with the standards of JAMA.”

Also deleted was a JAMA tweet promoting the podcast episode. The tweet said: “No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast.”

This story will be updated.

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

One of the top research journals in the United States has placed its editor-in-chief on administrative leave pending the outcome of an investigation into a controversial podcast episode that critics labeled as racist.

The American Medical Association’s Joint Oversight Committee announced that Howard Bauchner, MD, is on leave beginning at the end of the day on March 25. Dr. Bauchner is the top editor at JAMA, the journal of the AMA.

“The decision to place the editor-in-chief on administrative leave neither implicates nor exonerates individuals and is standard operating procedure for such investigations,” the committee said in a statement.

More than 2,000 people signed a petition on Change.org calling for an investigation at JAMA over the February podcast episode, called “Structural Racism for Doctors: What Is It?”

Already, Edward H. Livingston, MD, the host of the podcast, has resigned as deputy editor of the journal.

During the podcast, Dr. Livingston, who is White, said, “Structural racism is an unfortunate term. Personally, I think taking racism out of the conversation will help. Many of us are offended by the concept that we are racist.”

The audio of the podcast has been deleted from JAMA’s website. In its place is audio of a statement from Dr. Bauchner. In his statement, which he released in the week prior to his being on leave, he said the comments in the podcast, which also featured Mitch Katz, MD, were “inaccurate, offensive, hurtful, and inconsistent with the standards of JAMA.”

Also deleted was a JAMA tweet promoting the podcast episode. The tweet said: “No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast.”

This story will be updated.

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

“I’m the first person in my circle of family and friends to participate in a clinical trial.”

Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.

At the time, Mrs. Long, who is Black, said her doctor in Dayton, Ohio, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, Durham, N.C., where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital in Boston, where she was accepted into a clinical trial.

“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”

Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000-$1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.

It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.

The Lazarex Cancer Foundation of Danville, Calif., helped Mrs. Long do just that.

Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, said that a patient travels an average of 500 miles to participate in a trial.

The financial hurdles often prevent patients from taking part in clinical trials, Dr. Shegog said. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order.”

Many patients have to make a decision.

“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re okay or at least better than if I wouldn’t have spent all the money traveling back and forth.”

Dr. Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.

Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported more than 6,000 people since opening its doors.

“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Dr. Shegog said. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”

But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Mrs. Long’s trial eventually went virtual.

“It was absolutely fantastic,” she said. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”

The move to virtual studies may have lasting effects on research and treatment.

“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”

This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of Whites.

But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.

Compared with White people, Black people are largely at higher risk for heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.

And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.

Dr. Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are two times more likely to die from advanced prostate cancer, compared with white men. Yet Black men make up just 3% of advanced therapeutic trials.

“A lack of diversity and inclusion in clinical trials is unacceptable,” she said. “If we continue to underrecruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”

Dr. Borno said that telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.

In 2020, the Food and Drug Administration approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were White, 8% were Black, 6% were Asian, and 11% were Hispanic.

Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than White people. In the United States, one in five people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as White people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.

The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.

According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.

“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he said. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”

Dr. Freedman believes that, while access is a big hurdle, it doesn’t end there.

“Many patients have a lack of trust in the health care system,” he said. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”

Genentech started its diversity and inclusion effort several years ago. Dr. Freeman said that, until more trials become diverse, Black Americans will continue to pay the price. “I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”

Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.

She said that Abbott is actively working on solutions.

“We have designed our trials to reduce the barriers to participation and expand access,” she said. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”

They also provide interpretation services to address any language barriers.

“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”

Spokesperson Keanna Ghazvini said that Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.

“We know that if historically underserved populations are left out of clinical trials, they risk not benefiting from medical breakthroughs down the line,” she said.

The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.

There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the NIH, but not all of these studies have been evaluated by the U.S. government.

Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.

“It’s really important that our publicly funded trials represent the people of the country,” she said. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”

Ms. Denicoff believed opening trials in places where people live is key, but having a diverse clinical trials team is as important.

“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”

Ms. Denicoff said that, during the pandemic, the NCI quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.

‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.

But the FDA’s power to require diversity in trials is limited.

“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Dr. Fashoyin-Aje said.

Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?

Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.

She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.

“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”

And with more trials adopting virtual elements, she said it’s time for minorities to get on board.

Dr. Freedman believed the groundwork is being laid for that to happen. “I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”

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

“I’m the first person in my circle of family and friends to participate in a clinical trial.”

Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.

At the time, Mrs. Long, who is Black, said her doctor in Dayton, Ohio, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, Durham, N.C., where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital in Boston, where she was accepted into a clinical trial.

“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”

Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000-$1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.

It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.

The Lazarex Cancer Foundation of Danville, Calif., helped Mrs. Long do just that.

Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, said that a patient travels an average of 500 miles to participate in a trial.

The financial hurdles often prevent patients from taking part in clinical trials, Dr. Shegog said. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order.”

Many patients have to make a decision.

“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re okay or at least better than if I wouldn’t have spent all the money traveling back and forth.”

Dr. Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.

Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported more than 6,000 people since opening its doors.

“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Dr. Shegog said. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”

But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Mrs. Long’s trial eventually went virtual.

“It was absolutely fantastic,” she said. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”

The move to virtual studies may have lasting effects on research and treatment.

“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”

This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of Whites.

But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.

Compared with White people, Black people are largely at higher risk for heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.

And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.

Dr. Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are two times more likely to die from advanced prostate cancer, compared with white men. Yet Black men make up just 3% of advanced therapeutic trials.

“A lack of diversity and inclusion in clinical trials is unacceptable,” she said. “If we continue to underrecruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”

Dr. Borno said that telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.

In 2020, the Food and Drug Administration approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were White, 8% were Black, 6% were Asian, and 11% were Hispanic.

Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than White people. In the United States, one in five people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as White people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.

The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.

According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.

“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he said. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”

Dr. Freedman believes that, while access is a big hurdle, it doesn’t end there.

“Many patients have a lack of trust in the health care system,” he said. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”

Genentech started its diversity and inclusion effort several years ago. Dr. Freeman said that, until more trials become diverse, Black Americans will continue to pay the price. “I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”

Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.

She said that Abbott is actively working on solutions.

“We have designed our trials to reduce the barriers to participation and expand access,” she said. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”

They also provide interpretation services to address any language barriers.

“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”

Spokesperson Keanna Ghazvini said that Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.

“We know that if historically underserved populations are left out of clinical trials, they risk not benefiting from medical breakthroughs down the line,” she said.

The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.

There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the NIH, but not all of these studies have been evaluated by the U.S. government.

Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.

“It’s really important that our publicly funded trials represent the people of the country,” she said. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”

Ms. Denicoff believed opening trials in places where people live is key, but having a diverse clinical trials team is as important.

“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”

Ms. Denicoff said that, during the pandemic, the NCI quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.

‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.

But the FDA’s power to require diversity in trials is limited.

“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Dr. Fashoyin-Aje said.

Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?

Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.

She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.

“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”

And with more trials adopting virtual elements, she said it’s time for minorities to get on board.

Dr. Freedman believed the groundwork is being laid for that to happen. “I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”

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

“I’m the first person in my circle of family and friends to participate in a clinical trial.”

Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.

At the time, Mrs. Long, who is Black, said her doctor in Dayton, Ohio, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, Durham, N.C., where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital in Boston, where she was accepted into a clinical trial.

“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”

Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000-$1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.

It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.

The Lazarex Cancer Foundation of Danville, Calif., helped Mrs. Long do just that.

Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, said that a patient travels an average of 500 miles to participate in a trial.

The financial hurdles often prevent patients from taking part in clinical trials, Dr. Shegog said. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order.”

Many patients have to make a decision.

“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re okay or at least better than if I wouldn’t have spent all the money traveling back and forth.”

Dr. Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.

Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported more than 6,000 people since opening its doors.

“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Dr. Shegog said. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”

But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Mrs. Long’s trial eventually went virtual.

“It was absolutely fantastic,” she said. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”

The move to virtual studies may have lasting effects on research and treatment.

“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”

This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of Whites.

But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.

Compared with White people, Black people are largely at higher risk for heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.

And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.

Dr. Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are two times more likely to die from advanced prostate cancer, compared with white men. Yet Black men make up just 3% of advanced therapeutic trials.

“A lack of diversity and inclusion in clinical trials is unacceptable,” she said. “If we continue to underrecruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”

Dr. Borno said that telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.

In 2020, the Food and Drug Administration approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were White, 8% were Black, 6% were Asian, and 11% were Hispanic.

Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than White people. In the United States, one in five people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as White people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.

The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.

According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.

“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he said. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”

Dr. Freedman believes that, while access is a big hurdle, it doesn’t end there.

“Many patients have a lack of trust in the health care system,” he said. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”

Genentech started its diversity and inclusion effort several years ago. Dr. Freeman said that, until more trials become diverse, Black Americans will continue to pay the price. “I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”

Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.

She said that Abbott is actively working on solutions.

“We have designed our trials to reduce the barriers to participation and expand access,” she said. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”

They also provide interpretation services to address any language barriers.

“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”

Spokesperson Keanna Ghazvini said that Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.

“We know that if historically underserved populations are left out of clinical trials, they risk not benefiting from medical breakthroughs down the line,” she said.

The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.

There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the NIH, but not all of these studies have been evaluated by the U.S. government.

Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.

“It’s really important that our publicly funded trials represent the people of the country,” she said. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”

Ms. Denicoff believed opening trials in places where people live is key, but having a diverse clinical trials team is as important.

“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”

Ms. Denicoff said that, during the pandemic, the NCI quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.

‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.

But the FDA’s power to require diversity in trials is limited.

“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Dr. Fashoyin-Aje said.

Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?

Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.

She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.

“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”

And with more trials adopting virtual elements, she said it’s time for minorities to get on board.

Dr. Freedman believed the groundwork is being laid for that to happen. “I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”

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

The new SARS-CoV-2 variants are not just problems for humans. 

New research shows they can also infect animals, and for the first time, variants have been able to infect mice, a development that may complicate efforts to rein in the global spread of the virus.

In addition, two new studies have implications for pets. Veterinarians in Texas and the United Kingdom have documented infections of B.1.1.7 – the fast-spreading variant first found in the United Kingdom – in dogs and cats. The animals in the U.K. study also had heart damage, but it’s unclear if the damage was caused by the virus or was already there and was found as a result of their infections.

Animal studies of SARS-CoV-2 and its emerging variants are urgent, said Sarah Hamer, DVM, PhD, a veterinarian and epidemiologist at Texas A&M University, College Station. 

She’s part of a network of scientists who are swabbing the pets of people who are diagnosed with COVID-19 to find out how often the virus passes from people to animals.

The collaboration is part of the One Health initiative through the Centers for Disease Control and Prevention. One Health aims to tackle infectious diseases by recognizing that people can’t be fully protected from pathogens unless animals and the environment are also safeguarded. “Over 70% of emerging diseases of humans have their origins in animal populations,” Dr. Hamer said. “So if we are only focusing on studying disease as it emerges in humans and ignoring where those pathogens have been transmitted or circulating for years, then we might miss the ability to detect early emergence. We might miss the ability to control these diseases before they become problems for human health.”
 

Variants move to mice

In new work, researchers at the Institut Pasteur in Paris have shown that the B.1.351 and P.1 variants of concern, which were first identified in South Africa and Brazil, respectively, can infect mice, giving the virus a potential new host. Older versions of the virus couldn’t infect mice because they weren’t able bind to receptors on their cells. These two variants can.

On one hand, that’s a good thing, because it will help scientists more easily conduct experiments in mice. Before, if they wanted to do an experiment with SARS-CoV-2 in mice, they had to use a special strain of mouse that was bred to carry human ACE2 receptors on their lung cells. Now that mice can become naturally infected, any breed will do, making it less costly and time-consuming to study the virus in animals.

On the other hand, the idea that the virus could have more and different ways to spread isn’t good news.

“From the beginning of the epidemic and since human coronaviruses emerged from animals, it has been very important to establish in which species the virus can replicate, in particular the species that live close to humans,” said Xavier Montagutelli, DVM, PhD, head of the Mouse Genetics Laboratory at the Institut Pasteur. His study was published as a preprint ahead of peer review on BioRXIV.

Once a virus establishes itself within a population of animals, it will continue to spread and change and may eventually be passed back to humans. It’s the reason that birds and pigs are closely monitored for influenza viruses.

So far, with SARS-CoV-2, only one animal has been found to catch and spread the virus and pass it back to people – farmed mink. Researchers have also documented SARS-CoV-2 antibodies in escaped mink living near mink farms in Utah, suggesting the virus has the potential to be transmitted to wild populations.

And the move of the virus into mice suggests that SARS-CoV-2 could establish itself in a population of wild animals that live close to humans.

“At this point, we have no evidence that wild mice are infected, or can become infected from humans,” Dr. Montagutelli said. He added that his findings emphasize the need to regularly test animals for signs of the infection. He said these surveys will need to be updated as more variants emerge.

“So far, we’ve been lucky that our livestock species aren’t really susceptible to this,” said Scott Weese, DVM, a professor at Ontario Veterinary College at the University of Guelph, who studies emerging infectious diseases that pass between animals and people.

While the outbreaks on mink farms have been bad, imagine what would happen, Dr. Weese said, if the virus moved to pigs.

“If this infects a barn with a few thousand pigs – which is like the mink scenario – but we have a lot more pig farms than mink farms,” he said.

“With these variants, we have to reset,” he said. “We’ve figured all this about animals and how it spreads or how it doesn’t, but now we need to repeat all those studies to make sure it’s the same thing.”
 

Pets catch variants, too

Pets living with people who are infected with SARS-CoV-2 can catch it from their owners, and cats are particularly susceptible, Dr. Weese said. 

Contact tracing studies, which also tested animals for signs of the virus, have found that about half of cats living with infected people have signs of infection, while 20%-30% of dogs were sick.

“It’s quite common,” for pets to get COVID, Dr. Weese said.

Now, two new studies have shown that pets can also be infected by the newer B.1.1.7 variant.

The first study, from researchers at Texas A&M, documented the variant in a dog and a cat from Brazos County, Texas. Neither the older black Lab mix or the older domestic shorthair cat had symptoms of COVID-19. They were tested as part of a project funded by the CDC.

Dr. Weese said pets are at risk by people who are infected, but they don’t seem to play a big role in spreading the disease to humans. So if you have pets, there’s no reason to worry that they could bring the virus home to you. You’re more likely to be a risk to them.

The second study, from a specialty animal hospital in southeast England, documented infection by the B.1.1.7 virus variant in 11 dogs and cats. Most of the pets had unusual symptoms, including inflamed hearts and heart damage.

Dr. Weese called this study interesting and said its findings deserve more investigation, but pointed out that the study can’t determine whether the infection caused the heart damage, or whether it was already there.

“This is a human virus. There’s no doubt about it. It can affect other species, but it likes people a lot better,” he said. “If you think about the big picture and what is the potential role of animals, pets are pretty low risk.”
 

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

The new SARS-CoV-2 variants are not just problems for humans. 

New research shows they can also infect animals, and for the first time, variants have been able to infect mice, a development that may complicate efforts to rein in the global spread of the virus.

In addition, two new studies have implications for pets. Veterinarians in Texas and the United Kingdom have documented infections of B.1.1.7 – the fast-spreading variant first found in the United Kingdom – in dogs and cats. The animals in the U.K. study also had heart damage, but it’s unclear if the damage was caused by the virus or was already there and was found as a result of their infections.

Animal studies of SARS-CoV-2 and its emerging variants are urgent, said Sarah Hamer, DVM, PhD, a veterinarian and epidemiologist at Texas A&M University, College Station. 

She’s part of a network of scientists who are swabbing the pets of people who are diagnosed with COVID-19 to find out how often the virus passes from people to animals.

The collaboration is part of the One Health initiative through the Centers for Disease Control and Prevention. One Health aims to tackle infectious diseases by recognizing that people can’t be fully protected from pathogens unless animals and the environment are also safeguarded. “Over 70% of emerging diseases of humans have their origins in animal populations,” Dr. Hamer said. “So if we are only focusing on studying disease as it emerges in humans and ignoring where those pathogens have been transmitted or circulating for years, then we might miss the ability to detect early emergence. We might miss the ability to control these diseases before they become problems for human health.”
 

Variants move to mice

In new work, researchers at the Institut Pasteur in Paris have shown that the B.1.351 and P.1 variants of concern, which were first identified in South Africa and Brazil, respectively, can infect mice, giving the virus a potential new host. Older versions of the virus couldn’t infect mice because they weren’t able bind to receptors on their cells. These two variants can.

On one hand, that’s a good thing, because it will help scientists more easily conduct experiments in mice. Before, if they wanted to do an experiment with SARS-CoV-2 in mice, they had to use a special strain of mouse that was bred to carry human ACE2 receptors on their lung cells. Now that mice can become naturally infected, any breed will do, making it less costly and time-consuming to study the virus in animals.

On the other hand, the idea that the virus could have more and different ways to spread isn’t good news.

“From the beginning of the epidemic and since human coronaviruses emerged from animals, it has been very important to establish in which species the virus can replicate, in particular the species that live close to humans,” said Xavier Montagutelli, DVM, PhD, head of the Mouse Genetics Laboratory at the Institut Pasteur. His study was published as a preprint ahead of peer review on BioRXIV.

Once a virus establishes itself within a population of animals, it will continue to spread and change and may eventually be passed back to humans. It’s the reason that birds and pigs are closely monitored for influenza viruses.

So far, with SARS-CoV-2, only one animal has been found to catch and spread the virus and pass it back to people – farmed mink. Researchers have also documented SARS-CoV-2 antibodies in escaped mink living near mink farms in Utah, suggesting the virus has the potential to be transmitted to wild populations.

And the move of the virus into mice suggests that SARS-CoV-2 could establish itself in a population of wild animals that live close to humans.

“At this point, we have no evidence that wild mice are infected, or can become infected from humans,” Dr. Montagutelli said. He added that his findings emphasize the need to regularly test animals for signs of the infection. He said these surveys will need to be updated as more variants emerge.

“So far, we’ve been lucky that our livestock species aren’t really susceptible to this,” said Scott Weese, DVM, a professor at Ontario Veterinary College at the University of Guelph, who studies emerging infectious diseases that pass between animals and people.

While the outbreaks on mink farms have been bad, imagine what would happen, Dr. Weese said, if the virus moved to pigs.

“If this infects a barn with a few thousand pigs – which is like the mink scenario – but we have a lot more pig farms than mink farms,” he said.

“With these variants, we have to reset,” he said. “We’ve figured all this about animals and how it spreads or how it doesn’t, but now we need to repeat all those studies to make sure it’s the same thing.”
 

Pets catch variants, too

Pets living with people who are infected with SARS-CoV-2 can catch it from their owners, and cats are particularly susceptible, Dr. Weese said. 

Contact tracing studies, which also tested animals for signs of the virus, have found that about half of cats living with infected people have signs of infection, while 20%-30% of dogs were sick.

“It’s quite common,” for pets to get COVID, Dr. Weese said.

Now, two new studies have shown that pets can also be infected by the newer B.1.1.7 variant.

The first study, from researchers at Texas A&M, documented the variant in a dog and a cat from Brazos County, Texas. Neither the older black Lab mix or the older domestic shorthair cat had symptoms of COVID-19. They were tested as part of a project funded by the CDC.

Dr. Weese said pets are at risk by people who are infected, but they don’t seem to play a big role in spreading the disease to humans. So if you have pets, there’s no reason to worry that they could bring the virus home to you. You’re more likely to be a risk to them.

The second study, from a specialty animal hospital in southeast England, documented infection by the B.1.1.7 virus variant in 11 dogs and cats. Most of the pets had unusual symptoms, including inflamed hearts and heart damage.

Dr. Weese called this study interesting and said its findings deserve more investigation, but pointed out that the study can’t determine whether the infection caused the heart damage, or whether it was already there.

“This is a human virus. There’s no doubt about it. It can affect other species, but it likes people a lot better,” he said. “If you think about the big picture and what is the potential role of animals, pets are pretty low risk.”
 

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

The new SARS-CoV-2 variants are not just problems for humans. 

New research shows they can also infect animals, and for the first time, variants have been able to infect mice, a development that may complicate efforts to rein in the global spread of the virus.

In addition, two new studies have implications for pets. Veterinarians in Texas and the United Kingdom have documented infections of B.1.1.7 – the fast-spreading variant first found in the United Kingdom – in dogs and cats. The animals in the U.K. study also had heart damage, but it’s unclear if the damage was caused by the virus or was already there and was found as a result of their infections.

Animal studies of SARS-CoV-2 and its emerging variants are urgent, said Sarah Hamer, DVM, PhD, a veterinarian and epidemiologist at Texas A&M University, College Station. 

She’s part of a network of scientists who are swabbing the pets of people who are diagnosed with COVID-19 to find out how often the virus passes from people to animals.

The collaboration is part of the One Health initiative through the Centers for Disease Control and Prevention. One Health aims to tackle infectious diseases by recognizing that people can’t be fully protected from pathogens unless animals and the environment are also safeguarded. “Over 70% of emerging diseases of humans have their origins in animal populations,” Dr. Hamer said. “So if we are only focusing on studying disease as it emerges in humans and ignoring where those pathogens have been transmitted or circulating for years, then we might miss the ability to detect early emergence. We might miss the ability to control these diseases before they become problems for human health.”
 

Variants move to mice

In new work, researchers at the Institut Pasteur in Paris have shown that the B.1.351 and P.1 variants of concern, which were first identified in South Africa and Brazil, respectively, can infect mice, giving the virus a potential new host. Older versions of the virus couldn’t infect mice because they weren’t able bind to receptors on their cells. These two variants can.

On one hand, that’s a good thing, because it will help scientists more easily conduct experiments in mice. Before, if they wanted to do an experiment with SARS-CoV-2 in mice, they had to use a special strain of mouse that was bred to carry human ACE2 receptors on their lung cells. Now that mice can become naturally infected, any breed will do, making it less costly and time-consuming to study the virus in animals.

On the other hand, the idea that the virus could have more and different ways to spread isn’t good news.

“From the beginning of the epidemic and since human coronaviruses emerged from animals, it has been very important to establish in which species the virus can replicate, in particular the species that live close to humans,” said Xavier Montagutelli, DVM, PhD, head of the Mouse Genetics Laboratory at the Institut Pasteur. His study was published as a preprint ahead of peer review on BioRXIV.

Once a virus establishes itself within a population of animals, it will continue to spread and change and may eventually be passed back to humans. It’s the reason that birds and pigs are closely monitored for influenza viruses.

So far, with SARS-CoV-2, only one animal has been found to catch and spread the virus and pass it back to people – farmed mink. Researchers have also documented SARS-CoV-2 antibodies in escaped mink living near mink farms in Utah, suggesting the virus has the potential to be transmitted to wild populations.

And the move of the virus into mice suggests that SARS-CoV-2 could establish itself in a population of wild animals that live close to humans.

“At this point, we have no evidence that wild mice are infected, or can become infected from humans,” Dr. Montagutelli said. He added that his findings emphasize the need to regularly test animals for signs of the infection. He said these surveys will need to be updated as more variants emerge.

“So far, we’ve been lucky that our livestock species aren’t really susceptible to this,” said Scott Weese, DVM, a professor at Ontario Veterinary College at the University of Guelph, who studies emerging infectious diseases that pass between animals and people.

While the outbreaks on mink farms have been bad, imagine what would happen, Dr. Weese said, if the virus moved to pigs.

“If this infects a barn with a few thousand pigs – which is like the mink scenario – but we have a lot more pig farms than mink farms,” he said.

“With these variants, we have to reset,” he said. “We’ve figured all this about animals and how it spreads or how it doesn’t, but now we need to repeat all those studies to make sure it’s the same thing.”
 

Pets catch variants, too

Pets living with people who are infected with SARS-CoV-2 can catch it from their owners, and cats are particularly susceptible, Dr. Weese said. 

Contact tracing studies, which also tested animals for signs of the virus, have found that about half of cats living with infected people have signs of infection, while 20%-30% of dogs were sick.

“It’s quite common,” for pets to get COVID, Dr. Weese said.

Now, two new studies have shown that pets can also be infected by the newer B.1.1.7 variant.

The first study, from researchers at Texas A&M, documented the variant in a dog and a cat from Brazos County, Texas. Neither the older black Lab mix or the older domestic shorthair cat had symptoms of COVID-19. They were tested as part of a project funded by the CDC.

Dr. Weese said pets are at risk by people who are infected, but they don’t seem to play a big role in spreading the disease to humans. So if you have pets, there’s no reason to worry that they could bring the virus home to you. You’re more likely to be a risk to them.

The second study, from a specialty animal hospital in southeast England, documented infection by the B.1.1.7 virus variant in 11 dogs and cats. Most of the pets had unusual symptoms, including inflamed hearts and heart damage.

Dr. Weese called this study interesting and said its findings deserve more investigation, but pointed out that the study can’t determine whether the infection caused the heart damage, or whether it was already there.

“This is a human virus. There’s no doubt about it. It can affect other species, but it likes people a lot better,” he said. “If you think about the big picture and what is the potential role of animals, pets are pretty low risk.”
 

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

Researchers developed a predictive score for the risk of graft failure in patients with acute leukemia who underwent allogeneic hematopoietic stem cell transplantation (aHSCT) with ex vivo T-cell depletion. T-cell depletion is performed in an effort to prevent subsequent graft-versus-host disease (GVHD) after transplant.

The risk score was based on patient age and the T-lymphocyte population pre-aHSCT with 1 point of risk possible in each category. Patients with 1 point had a graft failure risk of 5% and 13% if they had 2 points, according to the results of the study presented at the virtual meeting of the European Society for Blood and Marrow Transplantation.

Graft failure is a potentially severe complication in patients treated with aHSCT, but there are few studies analyzing risk factors when ex vivo T-cell depletion is used, Ivan López Torija of the Hospital Infantil Universitario Niño Jesús, Madrid, and colleagues noted in their presentation, which won the Best Young Poster Abstract Award at the meeting.

The researchers assessed 148 pediatric patients (64% boys) with acute leukemia who underwent allogeneic HSCT from haploidentical donors using ex vivo T-cell depletion between 2005 and 2020. About 53% of the patients were diagnosed with acute lymphoblastic leukemia, the rest with acute myeloid leukemia. The donor mean age was 40 years, and all transplant patients received toxicity reduction conditioning based on fludarabine busulfan and thiotepa.
 

Predictive results

Multivariate analysis showed that T-cell count (CD3+/CD8+ ≥ 350/mL: hazard ratio, 2,6; P = .01) and patient age (less than 9 years: HR; 5.0; P = .04) were associated with graft failure. A risk score was established using these results and based on patient age and T lymphocyte pre-aHSCT with 1 point each for each increased risk category. Patients with 1 point had a graft failure risk of 5% and a risk of 13% if they had 2 points.

However, in this particular population, with a mean follow up of 4 years, the overall survival rate was 60%, with no significant differences seen between patients that presented graft failure and those without graft failure.

“Patient age and pretransplant number of CD3+/CD8+ are associated with [graft failure] in pediatric patients with acute leukemia undergoing ex vivo T-cell–depleted haploidentical transplantation. These findings highlight the importance of preexisting cellular immunity in the transplant recipient and support T-cell population analysis as part of a pretransplant working program,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Researchers developed a predictive score for the risk of graft failure in patients with acute leukemia who underwent allogeneic hematopoietic stem cell transplantation (aHSCT) with ex vivo T-cell depletion. T-cell depletion is performed in an effort to prevent subsequent graft-versus-host disease (GVHD) after transplant.

The risk score was based on patient age and the T-lymphocyte population pre-aHSCT with 1 point of risk possible in each category. Patients with 1 point had a graft failure risk of 5% and 13% if they had 2 points, according to the results of the study presented at the virtual meeting of the European Society for Blood and Marrow Transplantation.

Graft failure is a potentially severe complication in patients treated with aHSCT, but there are few studies analyzing risk factors when ex vivo T-cell depletion is used, Ivan López Torija of the Hospital Infantil Universitario Niño Jesús, Madrid, and colleagues noted in their presentation, which won the Best Young Poster Abstract Award at the meeting.

The researchers assessed 148 pediatric patients (64% boys) with acute leukemia who underwent allogeneic HSCT from haploidentical donors using ex vivo T-cell depletion between 2005 and 2020. About 53% of the patients were diagnosed with acute lymphoblastic leukemia, the rest with acute myeloid leukemia. The donor mean age was 40 years, and all transplant patients received toxicity reduction conditioning based on fludarabine busulfan and thiotepa.
 

Predictive results

Multivariate analysis showed that T-cell count (CD3+/CD8+ ≥ 350/mL: hazard ratio, 2,6; P = .01) and patient age (less than 9 years: HR; 5.0; P = .04) were associated with graft failure. A risk score was established using these results and based on patient age and T lymphocyte pre-aHSCT with 1 point each for each increased risk category. Patients with 1 point had a graft failure risk of 5% and a risk of 13% if they had 2 points.

However, in this particular population, with a mean follow up of 4 years, the overall survival rate was 60%, with no significant differences seen between patients that presented graft failure and those without graft failure.

“Patient age and pretransplant number of CD3+/CD8+ are associated with [graft failure] in pediatric patients with acute leukemia undergoing ex vivo T-cell–depleted haploidentical transplantation. These findings highlight the importance of preexisting cellular immunity in the transplant recipient and support T-cell population analysis as part of a pretransplant working program,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Researchers developed a predictive score for the risk of graft failure in patients with acute leukemia who underwent allogeneic hematopoietic stem cell transplantation (aHSCT) with ex vivo T-cell depletion. T-cell depletion is performed in an effort to prevent subsequent graft-versus-host disease (GVHD) after transplant.

The risk score was based on patient age and the T-lymphocyte population pre-aHSCT with 1 point of risk possible in each category. Patients with 1 point had a graft failure risk of 5% and 13% if they had 2 points, according to the results of the study presented at the virtual meeting of the European Society for Blood and Marrow Transplantation.

Graft failure is a potentially severe complication in patients treated with aHSCT, but there are few studies analyzing risk factors when ex vivo T-cell depletion is used, Ivan López Torija of the Hospital Infantil Universitario Niño Jesús, Madrid, and colleagues noted in their presentation, which won the Best Young Poster Abstract Award at the meeting.

The researchers assessed 148 pediatric patients (64% boys) with acute leukemia who underwent allogeneic HSCT from haploidentical donors using ex vivo T-cell depletion between 2005 and 2020. About 53% of the patients were diagnosed with acute lymphoblastic leukemia, the rest with acute myeloid leukemia. The donor mean age was 40 years, and all transplant patients received toxicity reduction conditioning based on fludarabine busulfan and thiotepa.
 

Predictive results

Multivariate analysis showed that T-cell count (CD3+/CD8+ ≥ 350/mL: hazard ratio, 2,6; P = .01) and patient age (less than 9 years: HR; 5.0; P = .04) were associated with graft failure. A risk score was established using these results and based on patient age and T lymphocyte pre-aHSCT with 1 point each for each increased risk category. Patients with 1 point had a graft failure risk of 5% and a risk of 13% if they had 2 points.

However, in this particular population, with a mean follow up of 4 years, the overall survival rate was 60%, with no significant differences seen between patients that presented graft failure and those without graft failure.

“Patient age and pretransplant number of CD3+/CD8+ are associated with [graft failure] in pediatric patients with acute leukemia undergoing ex vivo T-cell–depleted haploidentical transplantation. These findings highlight the importance of preexisting cellular immunity in the transplant recipient and support T-cell population analysis as part of a pretransplant working program,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

The use of allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival in minimal residual disease (MRD)–negative remission patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) after the start of monoclonal antibody treatment, according to the results of a landmark analysis presented at the virtual meeting of the European Society for Blood and Marrow Transplantation.

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

Previous studies have indicated that allo-HSCT improves the results of treatment in r/r B-ALL patients, compared with chemotherapy alone. In addition, it has been found that the monoclonal antibodies (Mab), anti-CD19-blinatumomab and anti-CD22-inotuzumab ozogamicin, induced remission in a significant proportion of such patients.

To determine if the use of allo-HSCT improves the outcome of patients in MRD-negative remission with or without Mab treatment, researchers performed a landmark analysis of 110 patients who achieved MRD-negative status after Mab treatment. The analysis examined results at 2, 4, and 6 months subsequent to the initiation of Mab treatment, according to poster presentation by Inna V. Markova, MD, and colleagues at Pavlov University, Saint Petersburg, Russian Federation.
 

Study details

The researchers included 110 patients who achieved MRD-negative status outside of clinical trials at a single institution in the analysis. Forty of the patients (36%) were children and 70 (64%) were adults. The median age for all patients was 23 years and the median follow up was 24 months. Fifty-seven (52%) and 53 (48%) patients received Mab for hematological relapse and persistent measurable residual disease or for molecular relapse, respectively. Therapy with Mab alone without subsequent allo-HSCT was used in 36 (31%) patients (30 received blinatumomab and 6 received inotuzumab ozogamicin). A total of 74 (69%) patients received allo-HSCT from a matched related or unrelated donor (MD-HSCT, n = 38) or haploidentical donor (Haplo-HSCT, n = 36). All patients received posttransplantation cyclophosphamide (PTCY)–based graft-versus host disease (GVHD) prophylaxis. Landmark analysis was performed at 2, 4, and 6 months after Mab therapy initiation to determine the effect of allo-HSCT on the outcome and the optimal timing of HSCT. Overall survival and disease-free survival (DFS) were used as outcomes.
 

Promising results

No significant differences between the MD-HSCT, Mab alone, and Haplo-HSCT groups were observed in 2-month landmark analysis (P = .4 for OS and P =.65 for DFS). However, the 4-month landmark analysis demonstrated superior overall survival and DFS in patients after MD-HSCT, but not Haplo-HSCT, compared with Mab alone: 2-year OS was 75%, 50%, and 27,7% (P = .032) and DFS was 53.5%, 51.3%, and 16.6% (P = .02) for MD-HSCT, Mab alone and Haplo-HSCT groups, respectively. In addition, 6-month analysis showed that there was no benefit from subsequent transplantation, according to the authors, with regard to overall survival (P = .11).

“Our study demonstrated that at least MD-HSCT with PTCY platform improves survival in MRD-negative remission if performed during the first 4 months after Mab initiation. Haplo-HSCT or MD-HSCT beyond 4 months are not associated with improved outcomes in this groups of patients,” the researchers concluded.

The researchers reported they had no conflicts of interest to declare.

[email protected]

The use of allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival in minimal residual disease (MRD)–negative remission patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) after the start of monoclonal antibody treatment, according to the results of a landmark analysis presented at the virtual meeting of the European Society for Blood and Marrow Transplantation.

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

Previous studies have indicated that allo-HSCT improves the results of treatment in r/r B-ALL patients, compared with chemotherapy alone. In addition, it has been found that the monoclonal antibodies (Mab), anti-CD19-blinatumomab and anti-CD22-inotuzumab ozogamicin, induced remission in a significant proportion of such patients.

To determine if the use of allo-HSCT improves the outcome of patients in MRD-negative remission with or without Mab treatment, researchers performed a landmark analysis of 110 patients who achieved MRD-negative status after Mab treatment. The analysis examined results at 2, 4, and 6 months subsequent to the initiation of Mab treatment, according to poster presentation by Inna V. Markova, MD, and colleagues at Pavlov University, Saint Petersburg, Russian Federation.
 

Study details

The researchers included 110 patients who achieved MRD-negative status outside of clinical trials at a single institution in the analysis. Forty of the patients (36%) were children and 70 (64%) were adults. The median age for all patients was 23 years and the median follow up was 24 months. Fifty-seven (52%) and 53 (48%) patients received Mab for hematological relapse and persistent measurable residual disease or for molecular relapse, respectively. Therapy with Mab alone without subsequent allo-HSCT was used in 36 (31%) patients (30 received blinatumomab and 6 received inotuzumab ozogamicin). A total of 74 (69%) patients received allo-HSCT from a matched related or unrelated donor (MD-HSCT, n = 38) or haploidentical donor (Haplo-HSCT, n = 36). All patients received posttransplantation cyclophosphamide (PTCY)–based graft-versus host disease (GVHD) prophylaxis. Landmark analysis was performed at 2, 4, and 6 months after Mab therapy initiation to determine the effect of allo-HSCT on the outcome and the optimal timing of HSCT. Overall survival and disease-free survival (DFS) were used as outcomes.
 

Promising results

No significant differences between the MD-HSCT, Mab alone, and Haplo-HSCT groups were observed in 2-month landmark analysis (P = .4 for OS and P =.65 for DFS). However, the 4-month landmark analysis demonstrated superior overall survival and DFS in patients after MD-HSCT, but not Haplo-HSCT, compared with Mab alone: 2-year OS was 75%, 50%, and 27,7% (P = .032) and DFS was 53.5%, 51.3%, and 16.6% (P = .02) for MD-HSCT, Mab alone and Haplo-HSCT groups, respectively. In addition, 6-month analysis showed that there was no benefit from subsequent transplantation, according to the authors, with regard to overall survival (P = .11).

“Our study demonstrated that at least MD-HSCT with PTCY platform improves survival in MRD-negative remission if performed during the first 4 months after Mab initiation. Haplo-HSCT or MD-HSCT beyond 4 months are not associated with improved outcomes in this groups of patients,” the researchers concluded.

The researchers reported they had no conflicts of interest to declare.

[email protected]

The use of allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival in minimal residual disease (MRD)–negative remission patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) after the start of monoclonal antibody treatment, according to the results of a landmark analysis presented at the virtual meeting of the European Society for Blood and Marrow Transplantation.

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

Previous studies have indicated that allo-HSCT improves the results of treatment in r/r B-ALL patients, compared with chemotherapy alone. In addition, it has been found that the monoclonal antibodies (Mab), anti-CD19-blinatumomab and anti-CD22-inotuzumab ozogamicin, induced remission in a significant proportion of such patients.

To determine if the use of allo-HSCT improves the outcome of patients in MRD-negative remission with or without Mab treatment, researchers performed a landmark analysis of 110 patients who achieved MRD-negative status after Mab treatment. The analysis examined results at 2, 4, and 6 months subsequent to the initiation of Mab treatment, according to poster presentation by Inna V. Markova, MD, and colleagues at Pavlov University, Saint Petersburg, Russian Federation.
 

Study details

The researchers included 110 patients who achieved MRD-negative status outside of clinical trials at a single institution in the analysis. Forty of the patients (36%) were children and 70 (64%) were adults. The median age for all patients was 23 years and the median follow up was 24 months. Fifty-seven (52%) and 53 (48%) patients received Mab for hematological relapse and persistent measurable residual disease or for molecular relapse, respectively. Therapy with Mab alone without subsequent allo-HSCT was used in 36 (31%) patients (30 received blinatumomab and 6 received inotuzumab ozogamicin). A total of 74 (69%) patients received allo-HSCT from a matched related or unrelated donor (MD-HSCT, n = 38) or haploidentical donor (Haplo-HSCT, n = 36). All patients received posttransplantation cyclophosphamide (PTCY)–based graft-versus host disease (GVHD) prophylaxis. Landmark analysis was performed at 2, 4, and 6 months after Mab therapy initiation to determine the effect of allo-HSCT on the outcome and the optimal timing of HSCT. Overall survival and disease-free survival (DFS) were used as outcomes.
 

Promising results

No significant differences between the MD-HSCT, Mab alone, and Haplo-HSCT groups were observed in 2-month landmark analysis (P = .4 for OS and P =.65 for DFS). However, the 4-month landmark analysis demonstrated superior overall survival and DFS in patients after MD-HSCT, but not Haplo-HSCT, compared with Mab alone: 2-year OS was 75%, 50%, and 27,7% (P = .032) and DFS was 53.5%, 51.3%, and 16.6% (P = .02) for MD-HSCT, Mab alone and Haplo-HSCT groups, respectively. In addition, 6-month analysis showed that there was no benefit from subsequent transplantation, according to the authors, with regard to overall survival (P = .11).

“Our study demonstrated that at least MD-HSCT with PTCY platform improves survival in MRD-negative remission if performed during the first 4 months after Mab initiation. Haplo-HSCT or MD-HSCT beyond 4 months are not associated with improved outcomes in this groups of patients,” the researchers concluded.

The researchers reported they had no conflicts of interest to declare.

[email protected]

Individuals who experience inflammation of the thyroid gland during acute COVID-19 illness may still have subacute thyroiditis months later, even if thyroid function has normalized, new research suggests.

Furthermore, the thyroiditis seems to be different from thyroid inflammation caused by other viruses, said Ilaria Muller, MD, PhD, when presenting her findings March 21 at the virtual ENDO 2021 meeting.

“SARS-CoV-2 seems to have multifactorial action on thyroid function,” said Dr. Muller, of the University of Milan, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Italy.

In July 2020, Dr. Muller and colleagues described patients hospitalized at their institution with severe COVID-19, 15% of whom had thyrotoxicosis due to atypical subacute thyroiditis, compared with just 1% of a comparison group hospitalized in the same subintensive care units during the spring of 2019, as reported by this news organization.

The “atypical” thyroiditis that occurred in the patients with COVID-19 was not associated with neck pain and affected more men than women. Moreover, it was associated with low TSH and free-triiodothyronine (T3) levels, and normal or elevated levels of free-thyroxine (T4), which is a very different presentation to classic nonthyroidal illness syndrome (NTIS) usually seen in critically ill patients, she explained.

Although transient T4 elevations can occur in acute illness, that phenomenon is not associated with low TSH. This newly described scenario appears to be a combination of thyrotoxicosis and NTIS, Dr. Muller and colleagues had speculated last summer.
 

Follow patients with COVID-19 and thyroid dysfunction for a year

Now, in an assessment of 51 patients 3 months after hospitalization for moderate-to-severe COVID-19 reported by Dr. Muller at ENDO 2021, both inflammatory markers and thyroid function had normalized, yet on imaging, a third of patients still exhibited focal hypoechoic areas suggestive of thyroiditis.

Of those, two-thirds had reduced uptake on thyroid scintigraphy, but few had antithyroid autoantibodies.

“The thyroid dysfunction induced by COVID-19 seems not mediated by autoimmunity. It is important to continue to follow these patients since they might develop thyroid dysfunction during the following months,” Dr. Muller emphasized.

Asked to comment, session moderator Robert W. Lash, MD, the Endocrine Society’s chief professional & clinical affairs officer, told this news organization: “When you’re ICU-level sick, it’s not unusual to have weird thyroid tests. Some viruses cause thyroid problems as well ... What makes this different is that while a lot of thyroid inflammation is caused by antibodies, this was not.”

“It looks like this was [SARS-CoV-2] causing damage to the thyroid gland, which is interesting,” he noted, adding that the thyroid gland expresses high levels of angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine 2 (TMPRSS2), which allow SARS-CoV-2 to infect human cells.

“This is probably part of that same story,” Dr. Lash said.  

For patients who had thyroid abnormalities during acute COVID-19 illness or develop symptoms that might be thyroid-related afterward, he advises: “You should keep an eye on thyroid tests. It just raises your awareness ... You might check their thyroid tests every 6 months for a year.”
 

Signs of focal thyroiditis despite normalized thyroid function

The 51 patients (33 men and 18 women) hospitalized with moderate-to-severe COVID-19 had no history of thyroid disease and had not been taking thyroid medications, amiodarone, or steroids before baseline TSH was measured.

From baseline to 3 months, TSH rose from 1.2 to 1.6 mIU/L, while serum concentrations of T4, T3, C-reactive protein, and full blood counts had all normalized (all P < 0.01 vs. baseline).

Thyroid ultrasound at 3 months in 49 patients showed signs of focal thyroiditis in 16 (33%).

Among 14 patients of those who further underwent thyroid 99mTc or I123 uptake scans, four (29%) were normal, eight (57%) had focally reduced uptake, and two (14%) had diffusely reduced uptake.

Of the 16 patients with focal thyroiditis, only three were positive for autoantibodies to thyroglobulin (TgAb) or thyroid peroxidase (TPOAb). All were negative for autoantibodies to the TSH receptor.

“Importantly, of the two with diffusely reduced uptake, only one was positive for TPOAb or TgAb,” Dr. Muller noted, adding, “SARS-CoV-2 disease seems to trigger some dysfunction which very likely has complex and multifactorial mechanisms.”

In response to a question about a possible role for biopsies and thyroid cytology, Dr. Muller replied: “That’s definitely the key ... So far we’re just making guesses, so the key will be cytological or histological studies to see what is really going on in the thyroid.”

“What we know is that [unlike] classical thyroiditis that has been described after viral diseases including SARS-CoV-2, these patients have a different scenario ... Probably something is going on within the thyroid with a different mechanism, so surely cytology and histology studies are what we need,” she concluded.

The study was funded by Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, and by a COVID-19 research grant from the European Society of Endocrinology. Dr. Muller and Dr. Lash have reported no relevant financial relationships.

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

Individuals who experience inflammation of the thyroid gland during acute COVID-19 illness may still have subacute thyroiditis months later, even if thyroid function has normalized, new research suggests.

Furthermore, the thyroiditis seems to be different from thyroid inflammation caused by other viruses, said Ilaria Muller, MD, PhD, when presenting her findings March 21 at the virtual ENDO 2021 meeting.

“SARS-CoV-2 seems to have multifactorial action on thyroid function,” said Dr. Muller, of the University of Milan, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Italy.

In July 2020, Dr. Muller and colleagues described patients hospitalized at their institution with severe COVID-19, 15% of whom had thyrotoxicosis due to atypical subacute thyroiditis, compared with just 1% of a comparison group hospitalized in the same subintensive care units during the spring of 2019, as reported by this news organization.

The “atypical” thyroiditis that occurred in the patients with COVID-19 was not associated with neck pain and affected more men than women. Moreover, it was associated with low TSH and free-triiodothyronine (T3) levels, and normal or elevated levels of free-thyroxine (T4), which is a very different presentation to classic nonthyroidal illness syndrome (NTIS) usually seen in critically ill patients, she explained.

Although transient T4 elevations can occur in acute illness, that phenomenon is not associated with low TSH. This newly described scenario appears to be a combination of thyrotoxicosis and NTIS, Dr. Muller and colleagues had speculated last summer.
 

Follow patients with COVID-19 and thyroid dysfunction for a year

Now, in an assessment of 51 patients 3 months after hospitalization for moderate-to-severe COVID-19 reported by Dr. Muller at ENDO 2021, both inflammatory markers and thyroid function had normalized, yet on imaging, a third of patients still exhibited focal hypoechoic areas suggestive of thyroiditis.

Of those, two-thirds had reduced uptake on thyroid scintigraphy, but few had antithyroid autoantibodies.

“The thyroid dysfunction induced by COVID-19 seems not mediated by autoimmunity. It is important to continue to follow these patients since they might develop thyroid dysfunction during the following months,” Dr. Muller emphasized.

Asked to comment, session moderator Robert W. Lash, MD, the Endocrine Society’s chief professional & clinical affairs officer, told this news organization: “When you’re ICU-level sick, it’s not unusual to have weird thyroid tests. Some viruses cause thyroid problems as well ... What makes this different is that while a lot of thyroid inflammation is caused by antibodies, this was not.”

“It looks like this was [SARS-CoV-2] causing damage to the thyroid gland, which is interesting,” he noted, adding that the thyroid gland expresses high levels of angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine 2 (TMPRSS2), which allow SARS-CoV-2 to infect human cells.

“This is probably part of that same story,” Dr. Lash said.  

For patients who had thyroid abnormalities during acute COVID-19 illness or develop symptoms that might be thyroid-related afterward, he advises: “You should keep an eye on thyroid tests. It just raises your awareness ... You might check their thyroid tests every 6 months for a year.”
 

Signs of focal thyroiditis despite normalized thyroid function

The 51 patients (33 men and 18 women) hospitalized with moderate-to-severe COVID-19 had no history of thyroid disease and had not been taking thyroid medications, amiodarone, or steroids before baseline TSH was measured.

From baseline to 3 months, TSH rose from 1.2 to 1.6 mIU/L, while serum concentrations of T4, T3, C-reactive protein, and full blood counts had all normalized (all P < 0.01 vs. baseline).

Thyroid ultrasound at 3 months in 49 patients showed signs of focal thyroiditis in 16 (33%).

Among 14 patients of those who further underwent thyroid 99mTc or I123 uptake scans, four (29%) were normal, eight (57%) had focally reduced uptake, and two (14%) had diffusely reduced uptake.

Of the 16 patients with focal thyroiditis, only three were positive for autoantibodies to thyroglobulin (TgAb) or thyroid peroxidase (TPOAb). All were negative for autoantibodies to the TSH receptor.

“Importantly, of the two with diffusely reduced uptake, only one was positive for TPOAb or TgAb,” Dr. Muller noted, adding, “SARS-CoV-2 disease seems to trigger some dysfunction which very likely has complex and multifactorial mechanisms.”

In response to a question about a possible role for biopsies and thyroid cytology, Dr. Muller replied: “That’s definitely the key ... So far we’re just making guesses, so the key will be cytological or histological studies to see what is really going on in the thyroid.”

“What we know is that [unlike] classical thyroiditis that has been described after viral diseases including SARS-CoV-2, these patients have a different scenario ... Probably something is going on within the thyroid with a different mechanism, so surely cytology and histology studies are what we need,” she concluded.

The study was funded by Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, and by a COVID-19 research grant from the European Society of Endocrinology. Dr. Muller and Dr. Lash have reported no relevant financial relationships.

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

Individuals who experience inflammation of the thyroid gland during acute COVID-19 illness may still have subacute thyroiditis months later, even if thyroid function has normalized, new research suggests.

Furthermore, the thyroiditis seems to be different from thyroid inflammation caused by other viruses, said Ilaria Muller, MD, PhD, when presenting her findings March 21 at the virtual ENDO 2021 meeting.

“SARS-CoV-2 seems to have multifactorial action on thyroid function,” said Dr. Muller, of the University of Milan, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Italy.

In July 2020, Dr. Muller and colleagues described patients hospitalized at their institution with severe COVID-19, 15% of whom had thyrotoxicosis due to atypical subacute thyroiditis, compared with just 1% of a comparison group hospitalized in the same subintensive care units during the spring of 2019, as reported by this news organization.

The “atypical” thyroiditis that occurred in the patients with COVID-19 was not associated with neck pain and affected more men than women. Moreover, it was associated with low TSH and free-triiodothyronine (T3) levels, and normal or elevated levels of free-thyroxine (T4), which is a very different presentation to classic nonthyroidal illness syndrome (NTIS) usually seen in critically ill patients, she explained.

Although transient T4 elevations can occur in acute illness, that phenomenon is not associated with low TSH. This newly described scenario appears to be a combination of thyrotoxicosis and NTIS, Dr. Muller and colleagues had speculated last summer.
 

Follow patients with COVID-19 and thyroid dysfunction for a year

Now, in an assessment of 51 patients 3 months after hospitalization for moderate-to-severe COVID-19 reported by Dr. Muller at ENDO 2021, both inflammatory markers and thyroid function had normalized, yet on imaging, a third of patients still exhibited focal hypoechoic areas suggestive of thyroiditis.

Of those, two-thirds had reduced uptake on thyroid scintigraphy, but few had antithyroid autoantibodies.

“The thyroid dysfunction induced by COVID-19 seems not mediated by autoimmunity. It is important to continue to follow these patients since they might develop thyroid dysfunction during the following months,” Dr. Muller emphasized.

Asked to comment, session moderator Robert W. Lash, MD, the Endocrine Society’s chief professional & clinical affairs officer, told this news organization: “When you’re ICU-level sick, it’s not unusual to have weird thyroid tests. Some viruses cause thyroid problems as well ... What makes this different is that while a lot of thyroid inflammation is caused by antibodies, this was not.”

“It looks like this was [SARS-CoV-2] causing damage to the thyroid gland, which is interesting,” he noted, adding that the thyroid gland expresses high levels of angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine 2 (TMPRSS2), which allow SARS-CoV-2 to infect human cells.

“This is probably part of that same story,” Dr. Lash said.  

For patients who had thyroid abnormalities during acute COVID-19 illness or develop symptoms that might be thyroid-related afterward, he advises: “You should keep an eye on thyroid tests. It just raises your awareness ... You might check their thyroid tests every 6 months for a year.”
 

Signs of focal thyroiditis despite normalized thyroid function

The 51 patients (33 men and 18 women) hospitalized with moderate-to-severe COVID-19 had no history of thyroid disease and had not been taking thyroid medications, amiodarone, or steroids before baseline TSH was measured.

From baseline to 3 months, TSH rose from 1.2 to 1.6 mIU/L, while serum concentrations of T4, T3, C-reactive protein, and full blood counts had all normalized (all P < 0.01 vs. baseline).

Thyroid ultrasound at 3 months in 49 patients showed signs of focal thyroiditis in 16 (33%).

Among 14 patients of those who further underwent thyroid 99mTc or I123 uptake scans, four (29%) were normal, eight (57%) had focally reduced uptake, and two (14%) had diffusely reduced uptake.

Of the 16 patients with focal thyroiditis, only three were positive for autoantibodies to thyroglobulin (TgAb) or thyroid peroxidase (TPOAb). All were negative for autoantibodies to the TSH receptor.

“Importantly, of the two with diffusely reduced uptake, only one was positive for TPOAb or TgAb,” Dr. Muller noted, adding, “SARS-CoV-2 disease seems to trigger some dysfunction which very likely has complex and multifactorial mechanisms.”

In response to a question about a possible role for biopsies and thyroid cytology, Dr. Muller replied: “That’s definitely the key ... So far we’re just making guesses, so the key will be cytological or histological studies to see what is really going on in the thyroid.”

“What we know is that [unlike] classical thyroiditis that has been described after viral diseases including SARS-CoV-2, these patients have a different scenario ... Probably something is going on within the thyroid with a different mechanism, so surely cytology and histology studies are what we need,” she concluded.

The study was funded by Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, and by a COVID-19 research grant from the European Society of Endocrinology. Dr. Muller and Dr. Lash have reported no relevant financial relationships.

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

More sleep at night, fewer or no sleep problems, and low levels of professional burnout were associated with a lower risk of developing COVID-19 among health care workers considered to be at high risk for exposure to patients with COVID-19, new evidence reveals.

PRImageFactory/iStock/Getty Images

For each additional hour of sleep at night, for example, risk for COVID-19 dropped by 12% in a study of 2844 frontline health care workers.

Furthermore, those who reported experiencing work-related burnout every day were 2.6 times more likely to report having COVID-19, to report having COVID-19 for a longer time, and to experience COVID-19 of more severity.

“This study underscores the importance of non–hygiene-related risk factors for COVID-19 and supports a holistic approach to health – including optimal sleep and job stress reduction to protect our health care workers from this and future pandemics,” senior author Sara B. Seidelmann, MD, said in an interview.

“Our findings add to the literature that sleep duration at night, sleep problems, and burnout may be risk factors for viral illnesses like COVID-19,” wrote Dr. Seidelmann and colleagues.

This is the first study to link COVID-19 risk to sleep habits – including number of hours of sleep at night, daytime napping hours, and severe sleep problems – among health care workers across multiple countries.

The study was published online March 22 in BMJ Nutrition, Prevention, and Health.

The researchers surveyed health care professionals in specialties considered to place personnel at high risk for exposure to SARS-CoV-2: critical care, emergency care, and internal medicine.

The association between sleep and burnout risk factors and COVID-19 did not vary significantly by specialty. “We didn’t detect any significant interactions between age, sex, specialty, or country,” said Dr. Seidelmann, assistant professor of clinical medicine at Columbia University College of Physicians and Surgeons, New York, and an internist at Stamford (Conn.) Hospital.

In addition to the 12% lower risk associated with each additional hour of sleep at night, each 1 additional hour of daytime napping was linked with a 6% increased risk for COVID-19 in an adjusted analysis (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.01-1.12).

Daytime napping slightly increased risk for COVID-19 in five of the six countries included in the study: France, Germany, Italy, the United Kingdom, and the United States. In contrast, in Spain, napping had a nonsignificant protective effect.

The survey asked health care workers to recall nighttime sleep duration, sleep disorders, and burnout in the year prior to onset of the COVID-19 pandemic.
 

‘Significant, close contact’ with COVID-19?

Lead author Hyunju Kim, NP, Dr. Seidelmann, and colleagues conducted the population-based, case-control study from July 17 to Sept. 25, 2020. They identified health care workers from the SurveyHealthcareGlobus (SHG) network.

Of the respondents, 72% were men. The mean age of the participants was 48 years, and the study population was 77% White, 12% Asian, 6% mixed background, 2% Black, and 1% other. (The remainder preferred not to say).

The 568 health care workers considered to have COVID-19 were classified on the basis of self-reported symptoms. Control participants had no symptoms associated with COVID-19.

All 2,844 participants answered yes to a question about having “significant close contact” with COVID-19 patients in their workplace.

Compared to reporting no sleep problems, having three such problems – difficulty sleeping at night, poor sleep continuity, and frequent use of sleeping pills – was associated with 88% greater odds of COVID-19 (OR, 1.88; 95% CI, 1.17–3.01).

Having one sleep problem was not associated with COVID-19.
 

More burnout, greater risk

The health care workers reported the severity of any work-related burnout. “There was a significant dose-response relationship between frequency of burnout and COVID-19,” the researchers noted.

Those who reported having burnout rarely or weekly had a 1.3-1.4 greater chance of reporting COVID-19 compared to those who reported having no burnout, for example.

In addition, reporting a high level of burnout was linked to about three times the risk for having COVID-19 of longer duration and of greater severity.

What drives the association between sleep problems, burnout, and higher risk for COVID-19 and severe COVID-19 remains unknown.

“The mechanism underlying these associations isn’t clear, but suboptimal sleep, sleep disorders, and stress may result in immune system dysregulation, increased inflammation, and alterations in hormones such as cortisol and melatonin that may increase vulnerability to viral infections,” Dr. Seidelmann said.
 

Strengths and limitations

Using a large network of health care workers in the early phase of the pandemic is a strength of the study. How generalizable the findings are outside the SHG database of 1.5 million health care workers remains unknown.

Another limitation was reliance on self-reporting of COVID-19 patient exposure, outcomes, and covariates, which could have introduced bias.

“However,” the researchers noted, “health care workers are likely a reliable source of information.”
 

Insomnia a common challenge

A 2020 meta-analysis examined the effect of insomnia and psychological factors on COVID-19 risk among health care workers. Lead author Kavita Batra, PhD, of the University of Nevada, Las Vegas (UNLV), and colleagues found that the pooled prevalence of insomnia was almost 28%.

“The recent six-country study by Kim and colleagues also underscores this relationship between lack of sleep and having higher odds of COVID-19 infection,” Manoj Sharma, MBBS, PhD, professor of social and behavioral health in the UNLV department of environmental and occupational health, and one of the study authors, said in an interview.

More research is warranted to learn the direction of the association, he said. Does reduced sleep lower immunity and make a health care worker more susceptible to SARS-CoV-2 infection, or does the anxiety associated with COVID-19 contribute to insomnia?

“Practicing sleep hygiene is a must not only for health workers but also for everyone,” Dr. Sharma added. Recommendations include having fixed hours of going to bed, fixed hours of waking up, not overdoing naps, having at least 30 minutes of winding down before sleeping, having a dark bedroom devoid of all electronics and other disturbances, avoiding smoking, alcohol, and stimulants (such as caffeine) before sleeping, and practicing relaxation right before sleeping, he said.

“It is hard for some health care workers, especially those who work night shifts, but it must be a priority to follow as many sleep hygiene measures as possible,” Dr. Sharma said. “After all, if you do not take care of yourself how can you take care of others?”

Dr. Seidelmann, Dr. Batra, and Dr. Sharma have disclosed no relevant financial relationships.

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

More sleep at night, fewer or no sleep problems, and low levels of professional burnout were associated with a lower risk of developing COVID-19 among health care workers considered to be at high risk for exposure to patients with COVID-19, new evidence reveals.

PRImageFactory/iStock/Getty Images

For each additional hour of sleep at night, for example, risk for COVID-19 dropped by 12% in a study of 2844 frontline health care workers.

Furthermore, those who reported experiencing work-related burnout every day were 2.6 times more likely to report having COVID-19, to report having COVID-19 for a longer time, and to experience COVID-19 of more severity.

“This study underscores the importance of non–hygiene-related risk factors for COVID-19 and supports a holistic approach to health – including optimal sleep and job stress reduction to protect our health care workers from this and future pandemics,” senior author Sara B. Seidelmann, MD, said in an interview.

“Our findings add to the literature that sleep duration at night, sleep problems, and burnout may be risk factors for viral illnesses like COVID-19,” wrote Dr. Seidelmann and colleagues.

This is the first study to link COVID-19 risk to sleep habits – including number of hours of sleep at night, daytime napping hours, and severe sleep problems – among health care workers across multiple countries.

The study was published online March 22 in BMJ Nutrition, Prevention, and Health.

The researchers surveyed health care professionals in specialties considered to place personnel at high risk for exposure to SARS-CoV-2: critical care, emergency care, and internal medicine.

The association between sleep and burnout risk factors and COVID-19 did not vary significantly by specialty. “We didn’t detect any significant interactions between age, sex, specialty, or country,” said Dr. Seidelmann, assistant professor of clinical medicine at Columbia University College of Physicians and Surgeons, New York, and an internist at Stamford (Conn.) Hospital.

In addition to the 12% lower risk associated with each additional hour of sleep at night, each 1 additional hour of daytime napping was linked with a 6% increased risk for COVID-19 in an adjusted analysis (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.01-1.12).

Daytime napping slightly increased risk for COVID-19 in five of the six countries included in the study: France, Germany, Italy, the United Kingdom, and the United States. In contrast, in Spain, napping had a nonsignificant protective effect.

The survey asked health care workers to recall nighttime sleep duration, sleep disorders, and burnout in the year prior to onset of the COVID-19 pandemic.
 

‘Significant, close contact’ with COVID-19?

Lead author Hyunju Kim, NP, Dr. Seidelmann, and colleagues conducted the population-based, case-control study from July 17 to Sept. 25, 2020. They identified health care workers from the SurveyHealthcareGlobus (SHG) network.

Of the respondents, 72% were men. The mean age of the participants was 48 years, and the study population was 77% White, 12% Asian, 6% mixed background, 2% Black, and 1% other. (The remainder preferred not to say).

The 568 health care workers considered to have COVID-19 were classified on the basis of self-reported symptoms. Control participants had no symptoms associated with COVID-19.

All 2,844 participants answered yes to a question about having “significant close contact” with COVID-19 patients in their workplace.

Compared to reporting no sleep problems, having three such problems – difficulty sleeping at night, poor sleep continuity, and frequent use of sleeping pills – was associated with 88% greater odds of COVID-19 (OR, 1.88; 95% CI, 1.17–3.01).

Having one sleep problem was not associated with COVID-19.
 

More burnout, greater risk

The health care workers reported the severity of any work-related burnout. “There was a significant dose-response relationship between frequency of burnout and COVID-19,” the researchers noted.

Those who reported having burnout rarely or weekly had a 1.3-1.4 greater chance of reporting COVID-19 compared to those who reported having no burnout, for example.

In addition, reporting a high level of burnout was linked to about three times the risk for having COVID-19 of longer duration and of greater severity.

What drives the association between sleep problems, burnout, and higher risk for COVID-19 and severe COVID-19 remains unknown.

“The mechanism underlying these associations isn’t clear, but suboptimal sleep, sleep disorders, and stress may result in immune system dysregulation, increased inflammation, and alterations in hormones such as cortisol and melatonin that may increase vulnerability to viral infections,” Dr. Seidelmann said.
 

Strengths and limitations

Using a large network of health care workers in the early phase of the pandemic is a strength of the study. How generalizable the findings are outside the SHG database of 1.5 million health care workers remains unknown.

Another limitation was reliance on self-reporting of COVID-19 patient exposure, outcomes, and covariates, which could have introduced bias.

“However,” the researchers noted, “health care workers are likely a reliable source of information.”
 

Insomnia a common challenge

A 2020 meta-analysis examined the effect of insomnia and psychological factors on COVID-19 risk among health care workers. Lead author Kavita Batra, PhD, of the University of Nevada, Las Vegas (UNLV), and colleagues found that the pooled prevalence of insomnia was almost 28%.

“The recent six-country study by Kim and colleagues also underscores this relationship between lack of sleep and having higher odds of COVID-19 infection,” Manoj Sharma, MBBS, PhD, professor of social and behavioral health in the UNLV department of environmental and occupational health, and one of the study authors, said in an interview.

More research is warranted to learn the direction of the association, he said. Does reduced sleep lower immunity and make a health care worker more susceptible to SARS-CoV-2 infection, or does the anxiety associated with COVID-19 contribute to insomnia?

“Practicing sleep hygiene is a must not only for health workers but also for everyone,” Dr. Sharma added. Recommendations include having fixed hours of going to bed, fixed hours of waking up, not overdoing naps, having at least 30 minutes of winding down before sleeping, having a dark bedroom devoid of all electronics and other disturbances, avoiding smoking, alcohol, and stimulants (such as caffeine) before sleeping, and practicing relaxation right before sleeping, he said.

“It is hard for some health care workers, especially those who work night shifts, but it must be a priority to follow as many sleep hygiene measures as possible,” Dr. Sharma said. “After all, if you do not take care of yourself how can you take care of others?”

Dr. Seidelmann, Dr. Batra, and Dr. Sharma have disclosed no relevant financial relationships.

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

More sleep at night, fewer or no sleep problems, and low levels of professional burnout were associated with a lower risk of developing COVID-19 among health care workers considered to be at high risk for exposure to patients with COVID-19, new evidence reveals.

PRImageFactory/iStock/Getty Images

For each additional hour of sleep at night, for example, risk for COVID-19 dropped by 12% in a study of 2844 frontline health care workers.

Furthermore, those who reported experiencing work-related burnout every day were 2.6 times more likely to report having COVID-19, to report having COVID-19 for a longer time, and to experience COVID-19 of more severity.

“This study underscores the importance of non–hygiene-related risk factors for COVID-19 and supports a holistic approach to health – including optimal sleep and job stress reduction to protect our health care workers from this and future pandemics,” senior author Sara B. Seidelmann, MD, said in an interview.

“Our findings add to the literature that sleep duration at night, sleep problems, and burnout may be risk factors for viral illnesses like COVID-19,” wrote Dr. Seidelmann and colleagues.

This is the first study to link COVID-19 risk to sleep habits – including number of hours of sleep at night, daytime napping hours, and severe sleep problems – among health care workers across multiple countries.

The study was published online March 22 in BMJ Nutrition, Prevention, and Health.

The researchers surveyed health care professionals in specialties considered to place personnel at high risk for exposure to SARS-CoV-2: critical care, emergency care, and internal medicine.

The association between sleep and burnout risk factors and COVID-19 did not vary significantly by specialty. “We didn’t detect any significant interactions between age, sex, specialty, or country,” said Dr. Seidelmann, assistant professor of clinical medicine at Columbia University College of Physicians and Surgeons, New York, and an internist at Stamford (Conn.) Hospital.

In addition to the 12% lower risk associated with each additional hour of sleep at night, each 1 additional hour of daytime napping was linked with a 6% increased risk for COVID-19 in an adjusted analysis (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.01-1.12).

Daytime napping slightly increased risk for COVID-19 in five of the six countries included in the study: France, Germany, Italy, the United Kingdom, and the United States. In contrast, in Spain, napping had a nonsignificant protective effect.

The survey asked health care workers to recall nighttime sleep duration, sleep disorders, and burnout in the year prior to onset of the COVID-19 pandemic.
 

‘Significant, close contact’ with COVID-19?

Lead author Hyunju Kim, NP, Dr. Seidelmann, and colleagues conducted the population-based, case-control study from July 17 to Sept. 25, 2020. They identified health care workers from the SurveyHealthcareGlobus (SHG) network.

Of the respondents, 72% were men. The mean age of the participants was 48 years, and the study population was 77% White, 12% Asian, 6% mixed background, 2% Black, and 1% other. (The remainder preferred not to say).

The 568 health care workers considered to have COVID-19 were classified on the basis of self-reported symptoms. Control participants had no symptoms associated with COVID-19.

All 2,844 participants answered yes to a question about having “significant close contact” with COVID-19 patients in their workplace.

Compared to reporting no sleep problems, having three such problems – difficulty sleeping at night, poor sleep continuity, and frequent use of sleeping pills – was associated with 88% greater odds of COVID-19 (OR, 1.88; 95% CI, 1.17–3.01).

Having one sleep problem was not associated with COVID-19.
 

More burnout, greater risk

The health care workers reported the severity of any work-related burnout. “There was a significant dose-response relationship between frequency of burnout and COVID-19,” the researchers noted.

Those who reported having burnout rarely or weekly had a 1.3-1.4 greater chance of reporting COVID-19 compared to those who reported having no burnout, for example.

In addition, reporting a high level of burnout was linked to about three times the risk for having COVID-19 of longer duration and of greater severity.

What drives the association between sleep problems, burnout, and higher risk for COVID-19 and severe COVID-19 remains unknown.

“The mechanism underlying these associations isn’t clear, but suboptimal sleep, sleep disorders, and stress may result in immune system dysregulation, increased inflammation, and alterations in hormones such as cortisol and melatonin that may increase vulnerability to viral infections,” Dr. Seidelmann said.
 

Strengths and limitations

Using a large network of health care workers in the early phase of the pandemic is a strength of the study. How generalizable the findings are outside the SHG database of 1.5 million health care workers remains unknown.

Another limitation was reliance on self-reporting of COVID-19 patient exposure, outcomes, and covariates, which could have introduced bias.

“However,” the researchers noted, “health care workers are likely a reliable source of information.”
 

Insomnia a common challenge

A 2020 meta-analysis examined the effect of insomnia and psychological factors on COVID-19 risk among health care workers. Lead author Kavita Batra, PhD, of the University of Nevada, Las Vegas (UNLV), and colleagues found that the pooled prevalence of insomnia was almost 28%.

“The recent six-country study by Kim and colleagues also underscores this relationship between lack of sleep and having higher odds of COVID-19 infection,” Manoj Sharma, MBBS, PhD, professor of social and behavioral health in the UNLV department of environmental and occupational health, and one of the study authors, said in an interview.

More research is warranted to learn the direction of the association, he said. Does reduced sleep lower immunity and make a health care worker more susceptible to SARS-CoV-2 infection, or does the anxiety associated with COVID-19 contribute to insomnia?

“Practicing sleep hygiene is a must not only for health workers but also for everyone,” Dr. Sharma added. Recommendations include having fixed hours of going to bed, fixed hours of waking up, not overdoing naps, having at least 30 minutes of winding down before sleeping, having a dark bedroom devoid of all electronics and other disturbances, avoiding smoking, alcohol, and stimulants (such as caffeine) before sleeping, and practicing relaxation right before sleeping, he said.

“It is hard for some health care workers, especially those who work night shifts, but it must be a priority to follow as many sleep hygiene measures as possible,” Dr. Sharma said. “After all, if you do not take care of yourself how can you take care of others?”

Dr. Seidelmann, Dr. Batra, and Dr. Sharma have disclosed no relevant financial relationships.

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

Federal regulators on March 23 said they were “concerned” that drug maker AstraZeneca included “outdated information” in its announcement the previous day that the company’s COVID-19 vaccine was effective.

The federal Data and Safety Monitoring Board shared those concerns with the company as well as with the National Institute of Allergy and Infectious Diseases, and the U.S. Biomedical Advanced Research and Development Authority, according to a statement from NIAID issued early March 23.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the agency said.

The NIAID statement does not say what data may have been outdated or how it may have changed the results. The company said March 22 it plans to see U.S. authorization for the vaccine in April.

The statement from NIAID comes a day after AstraZeneca said the interim results of their phase III U.S. study found it was 79% effective against symptomatic COVID-19, 80% effective in people 65 years and older, and 100% effective against severe or critical disease and hospitalization.

Company officials and clinical trial investigators on March 22 also addressed the recent concerns about blood clots, how well the vaccine will perform against variants, and provided a timeline for seeking regulatory approval.

“There are many countries in Europe and throughout the world that have already authorized this. The fact that a United States-run study has confirmed the efficacy and safety of this vaccine, I think is an important contribution to global health in general,” Anthony Fauci, MD, chief medical advisor to President Joe Biden, said during a White House press briefing March 22.

Andy Slavitt, White House senior advisor for the COVID-19 Response Team, had a more tempered reaction.

“It’s important to remind everyone we cannot and will not get ahead of the FDA,” he said. “While we would certainly call today’s news encouraging, it’s the kind of thing we like to see, we have a rigorous process that will come once an EUA is submitted and that will give us more information.”

With 30 million doses at the ready, the company plans to file for FDA emergency use authorization “within weeks,” Menelas Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said during a media briefing March 22.
 

Risk of thrombosis addressed

Regarding highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found the vaccine creates no greater risks, as did the European Medicines Agency

“We’ve had absolute confidence in the efficacy of the vaccine. Seeing this data now I hope gives others increased confidence that this is a very safe and effective vaccine,” Mr. Pangalos said.

“We’re glad this is being investigated really thoroughly,” Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University In New York City, said. “It’s incredibly reassuring that the regulatory agencies have looked at the data thoroughly and there is no enhanced signal above what is seen in the population.”

“There were no concerning signals noted in the U.S. data,” she added.

Regarding the risk of blood clots, “These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.” Andrew Garrett, PhD, executive vice president of scientific operations at ICON Clinical Research, agreed.

The vaccine was well-tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild-to-moderate headaches, fatigue, chills, fever, muscle aches. and malaise were among the reported reactions.

The phase III interim results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the whole breakdown yet . . . these are the high-level results we just got this week,” Mr. Pangalos said. Further information on rates of mild to moderate COVID-19 illness between groups is not yet available, for example.

The company explained that participants were randomly assigned to vaccine or placebo, with twice as many receiving the actual vaccine.

The trial is ongoing, so the FDA will receive information on more than the 141 COVID-19 symptomatic cases when the company submits a full primary analysis to the agency, Mr. Pangalos said.

In the phase III study, patients received two doses 4 weeks apart.

Beyond the U.S. study, the company has additional information, including real-world data from the United Kingdom, that it intends to submit to the FDA. Part of this evidence suggests increased efficacy when a second dose is administered at 3 months
 

‘Robust’ findings

“This is a large study, so these results can be expected to be robust. They could be expected to be even more so if there were more cases to compare between the groups, but 141 is still a substantial number of cases,” said Peter English, MD, of Horsham, United Kingdom, who is immediate past chair of the British Medical Association Public Health Medicine Committee.

Experts welcomed the 80% efficacy in people 65 and older in particular. “Importantly, the trial provides further support for efficacy in the elderly where previous clinical trial data, other than immunologic data, had been lacking,” Dr. Garrett said.

“It is clear this vaccine has very good efficacy. Remember that 60% was, prior to any trials being started, regarded as a good target,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “This efficacy does not show a notable decline at older ages. This was expected and the speculation that it was ineffective or quasi-ineffective at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided,” he added.
 

Efficacy against variants?

Regarding virus variants, Mr. Pangalos noted the study was conducted when several variants of concern were in circulation.

“What I can say is given this study was conducted much later in terms of timing, it’s very encouraging that we’ve got such high efficacy numbers when undoubtedly there are variants of concern in circulation in this study,” Mr. Pangalos said.

“It also highlights why we believe that against severe disease, our vaccine will be effective against all variants of concern,” he added.

Once the company submits its EUA to the FDA, the company is ready to immediately distribute 30 million doses of the vaccine and expects to ship 50 million total within the first month, Ruud Dobber, PhD, AstraZeneca executive vice president and president of the AZ Biopharmaceuticals Business Unit, said during the briefing.

The vaccine can be stored at 2 to 8 degrees Celsius for at least 6 months. Like other COVID-19 vaccines already authorized for emergency use, the duration of protection with the AstraZeneca product remains unknown.

This article was updated March 23, 2021.

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

Federal regulators on March 23 said they were “concerned” that drug maker AstraZeneca included “outdated information” in its announcement the previous day that the company’s COVID-19 vaccine was effective.

The federal Data and Safety Monitoring Board shared those concerns with the company as well as with the National Institute of Allergy and Infectious Diseases, and the U.S. Biomedical Advanced Research and Development Authority, according to a statement from NIAID issued early March 23.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the agency said.

The NIAID statement does not say what data may have been outdated or how it may have changed the results. The company said March 22 it plans to see U.S. authorization for the vaccine in April.

The statement from NIAID comes a day after AstraZeneca said the interim results of their phase III U.S. study found it was 79% effective against symptomatic COVID-19, 80% effective in people 65 years and older, and 100% effective against severe or critical disease and hospitalization.

Company officials and clinical trial investigators on March 22 also addressed the recent concerns about blood clots, how well the vaccine will perform against variants, and provided a timeline for seeking regulatory approval.

“There are many countries in Europe and throughout the world that have already authorized this. The fact that a United States-run study has confirmed the efficacy and safety of this vaccine, I think is an important contribution to global health in general,” Anthony Fauci, MD, chief medical advisor to President Joe Biden, said during a White House press briefing March 22.

Andy Slavitt, White House senior advisor for the COVID-19 Response Team, had a more tempered reaction.

“It’s important to remind everyone we cannot and will not get ahead of the FDA,” he said. “While we would certainly call today’s news encouraging, it’s the kind of thing we like to see, we have a rigorous process that will come once an EUA is submitted and that will give us more information.”

With 30 million doses at the ready, the company plans to file for FDA emergency use authorization “within weeks,” Menelas Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said during a media briefing March 22.
 

Risk of thrombosis addressed

Regarding highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found the vaccine creates no greater risks, as did the European Medicines Agency

“We’ve had absolute confidence in the efficacy of the vaccine. Seeing this data now I hope gives others increased confidence that this is a very safe and effective vaccine,” Mr. Pangalos said.

“We’re glad this is being investigated really thoroughly,” Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University In New York City, said. “It’s incredibly reassuring that the regulatory agencies have looked at the data thoroughly and there is no enhanced signal above what is seen in the population.”

“There were no concerning signals noted in the U.S. data,” she added.

Regarding the risk of blood clots, “These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.” Andrew Garrett, PhD, executive vice president of scientific operations at ICON Clinical Research, agreed.

The vaccine was well-tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild-to-moderate headaches, fatigue, chills, fever, muscle aches. and malaise were among the reported reactions.

The phase III interim results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the whole breakdown yet . . . these are the high-level results we just got this week,” Mr. Pangalos said. Further information on rates of mild to moderate COVID-19 illness between groups is not yet available, for example.

The company explained that participants were randomly assigned to vaccine or placebo, with twice as many receiving the actual vaccine.

The trial is ongoing, so the FDA will receive information on more than the 141 COVID-19 symptomatic cases when the company submits a full primary analysis to the agency, Mr. Pangalos said.

In the phase III study, patients received two doses 4 weeks apart.

Beyond the U.S. study, the company has additional information, including real-world data from the United Kingdom, that it intends to submit to the FDA. Part of this evidence suggests increased efficacy when a second dose is administered at 3 months
 

‘Robust’ findings

“This is a large study, so these results can be expected to be robust. They could be expected to be even more so if there were more cases to compare between the groups, but 141 is still a substantial number of cases,” said Peter English, MD, of Horsham, United Kingdom, who is immediate past chair of the British Medical Association Public Health Medicine Committee.

Experts welcomed the 80% efficacy in people 65 and older in particular. “Importantly, the trial provides further support for efficacy in the elderly where previous clinical trial data, other than immunologic data, had been lacking,” Dr. Garrett said.

“It is clear this vaccine has very good efficacy. Remember that 60% was, prior to any trials being started, regarded as a good target,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “This efficacy does not show a notable decline at older ages. This was expected and the speculation that it was ineffective or quasi-ineffective at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided,” he added.
 

Efficacy against variants?

Regarding virus variants, Mr. Pangalos noted the study was conducted when several variants of concern were in circulation.

“What I can say is given this study was conducted much later in terms of timing, it’s very encouraging that we’ve got such high efficacy numbers when undoubtedly there are variants of concern in circulation in this study,” Mr. Pangalos said.

“It also highlights why we believe that against severe disease, our vaccine will be effective against all variants of concern,” he added.

Once the company submits its EUA to the FDA, the company is ready to immediately distribute 30 million doses of the vaccine and expects to ship 50 million total within the first month, Ruud Dobber, PhD, AstraZeneca executive vice president and president of the AZ Biopharmaceuticals Business Unit, said during the briefing.

The vaccine can be stored at 2 to 8 degrees Celsius for at least 6 months. Like other COVID-19 vaccines already authorized for emergency use, the duration of protection with the AstraZeneca product remains unknown.

This article was updated March 23, 2021.

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

Federal regulators on March 23 said they were “concerned” that drug maker AstraZeneca included “outdated information” in its announcement the previous day that the company’s COVID-19 vaccine was effective.

The federal Data and Safety Monitoring Board shared those concerns with the company as well as with the National Institute of Allergy and Infectious Diseases, and the U.S. Biomedical Advanced Research and Development Authority, according to a statement from NIAID issued early March 23.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the agency said.

The NIAID statement does not say what data may have been outdated or how it may have changed the results. The company said March 22 it plans to see U.S. authorization for the vaccine in April.

The statement from NIAID comes a day after AstraZeneca said the interim results of their phase III U.S. study found it was 79% effective against symptomatic COVID-19, 80% effective in people 65 years and older, and 100% effective against severe or critical disease and hospitalization.

Company officials and clinical trial investigators on March 22 also addressed the recent concerns about blood clots, how well the vaccine will perform against variants, and provided a timeline for seeking regulatory approval.

“There are many countries in Europe and throughout the world that have already authorized this. The fact that a United States-run study has confirmed the efficacy and safety of this vaccine, I think is an important contribution to global health in general,” Anthony Fauci, MD, chief medical advisor to President Joe Biden, said during a White House press briefing March 22.

Andy Slavitt, White House senior advisor for the COVID-19 Response Team, had a more tempered reaction.

“It’s important to remind everyone we cannot and will not get ahead of the FDA,” he said. “While we would certainly call today’s news encouraging, it’s the kind of thing we like to see, we have a rigorous process that will come once an EUA is submitted and that will give us more information.”

With 30 million doses at the ready, the company plans to file for FDA emergency use authorization “within weeks,” Menelas Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said during a media briefing March 22.
 

Risk of thrombosis addressed

Regarding highly publicized reports of problems with blood clots from the AstraZeneca vaccine, the World Health Organization found the vaccine creates no greater risks, as did the European Medicines Agency

“We’ve had absolute confidence in the efficacy of the vaccine. Seeing this data now I hope gives others increased confidence that this is a very safe and effective vaccine,” Mr. Pangalos said.

“We’re glad this is being investigated really thoroughly,” Magda Sobieszczyk, MD, an infectious disease specialist at Columbia University In New York City, said. “It’s incredibly reassuring that the regulatory agencies have looked at the data thoroughly and there is no enhanced signal above what is seen in the population.”

“There were no concerning signals noted in the U.S. data,” she added.

Regarding the risk of blood clots, “These data are therefore timely in further addressing any safety concerns that could undermine vaccine uptake.” Andrew Garrett, PhD, executive vice president of scientific operations at ICON Clinical Research, agreed.

The vaccine was well-tolerated, the company reported, with no serious adverse events. Temporary pain and tenderness at the injection site, mild-to-moderate headaches, fatigue, chills, fever, muscle aches. and malaise were among the reported reactions.

The phase III interim results show 141 cases of symptomatic COVID-19 in the study of 32,449 adults. “We don’t have the whole breakdown yet . . . these are the high-level results we just got this week,” Mr. Pangalos said. Further information on rates of mild to moderate COVID-19 illness between groups is not yet available, for example.

The company explained that participants were randomly assigned to vaccine or placebo, with twice as many receiving the actual vaccine.

The trial is ongoing, so the FDA will receive information on more than the 141 COVID-19 symptomatic cases when the company submits a full primary analysis to the agency, Mr. Pangalos said.

In the phase III study, patients received two doses 4 weeks apart.

Beyond the U.S. study, the company has additional information, including real-world data from the United Kingdom, that it intends to submit to the FDA. Part of this evidence suggests increased efficacy when a second dose is administered at 3 months
 

‘Robust’ findings

“This is a large study, so these results can be expected to be robust. They could be expected to be even more so if there were more cases to compare between the groups, but 141 is still a substantial number of cases,” said Peter English, MD, of Horsham, United Kingdom, who is immediate past chair of the British Medical Association Public Health Medicine Committee.

Experts welcomed the 80% efficacy in people 65 and older in particular. “Importantly, the trial provides further support for efficacy in the elderly where previous clinical trial data, other than immunologic data, had been lacking,” Dr. Garrett said.

“It is clear this vaccine has very good efficacy. Remember that 60% was, prior to any trials being started, regarded as a good target,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. “This efficacy does not show a notable decline at older ages. This was expected and the speculation that it was ineffective or quasi-ineffective at older ages was totally unjustified.

“This is good news for the global community and one hopes that any political statements around this good news are avoided,” he added.
 

Efficacy against variants?

Regarding virus variants, Mr. Pangalos noted the study was conducted when several variants of concern were in circulation.

“What I can say is given this study was conducted much later in terms of timing, it’s very encouraging that we’ve got such high efficacy numbers when undoubtedly there are variants of concern in circulation in this study,” Mr. Pangalos said.

“It also highlights why we believe that against severe disease, our vaccine will be effective against all variants of concern,” he added.

Once the company submits its EUA to the FDA, the company is ready to immediately distribute 30 million doses of the vaccine and expects to ship 50 million total within the first month, Ruud Dobber, PhD, AstraZeneca executive vice president and president of the AZ Biopharmaceuticals Business Unit, said during the briefing.

The vaccine can be stored at 2 to 8 degrees Celsius for at least 6 months. Like other COVID-19 vaccines already authorized for emergency use, the duration of protection with the AstraZeneca product remains unknown.

This article was updated March 23, 2021.

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