As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

Age-adjusted suicide rate rose from 10.5 per 100,000 to 14.2 from 1999 to 2018, according to trends reported by the Centers for Disease Control and Prevention in a data brief.

Holly Hedegaard, MD, and colleagues from the National Center for Health Statistics within the CDC analyzed final mortality data from the National Vital Statistics System. As the second most common cause of death among Americans aged 10-34 years and the fourth most common among those aged 35-54 years, suicide is a major contributer to premature mortality.

The rate was 3.7 times higher in men than in women in 2018, at 22.8 and 6.2 per 100,000, respectively. Young people aged 10-14 years among both genders had the lowest rates of completing suicide, but it was men aged 75 years and older and women aged 45-64 years who had the highest rates. All of these trends were consistent throughout the study period.

Drawing from the 2013 National Center for Health Statistics Urban-Rural Classification Scheme for Counties, the researchers found that rural counties had significantly higher rates of suicide than did urban counties in 2018, and this was true for men and women. That said, suicide rates were still 3.5-3.9 times higher among men than among women regardless of urbanicity or rurality that year.

The full data brief can be found on the CDC website.

[email protected]

Age-adjusted suicide rate rose from 10.5 per 100,000 to 14.2 from 1999 to 2018, according to trends reported by the Centers for Disease Control and Prevention in a data brief.

Holly Hedegaard, MD, and colleagues from the National Center for Health Statistics within the CDC analyzed final mortality data from the National Vital Statistics System. As the second most common cause of death among Americans aged 10-34 years and the fourth most common among those aged 35-54 years, suicide is a major contributer to premature mortality.

The rate was 3.7 times higher in men than in women in 2018, at 22.8 and 6.2 per 100,000, respectively. Young people aged 10-14 years among both genders had the lowest rates of completing suicide, but it was men aged 75 years and older and women aged 45-64 years who had the highest rates. All of these trends were consistent throughout the study period.

Drawing from the 2013 National Center for Health Statistics Urban-Rural Classification Scheme for Counties, the researchers found that rural counties had significantly higher rates of suicide than did urban counties in 2018, and this was true for men and women. That said, suicide rates were still 3.5-3.9 times higher among men than among women regardless of urbanicity or rurality that year.

The full data brief can be found on the CDC website.

[email protected]

Age-adjusted suicide rate rose from 10.5 per 100,000 to 14.2 from 1999 to 2018, according to trends reported by the Centers for Disease Control and Prevention in a data brief.

Holly Hedegaard, MD, and colleagues from the National Center for Health Statistics within the CDC analyzed final mortality data from the National Vital Statistics System. As the second most common cause of death among Americans aged 10-34 years and the fourth most common among those aged 35-54 years, suicide is a major contributer to premature mortality.

The rate was 3.7 times higher in men than in women in 2018, at 22.8 and 6.2 per 100,000, respectively. Young people aged 10-14 years among both genders had the lowest rates of completing suicide, but it was men aged 75 years and older and women aged 45-64 years who had the highest rates. All of these trends were consistent throughout the study period.

Drawing from the 2013 National Center for Health Statistics Urban-Rural Classification Scheme for Counties, the researchers found that rural counties had significantly higher rates of suicide than did urban counties in 2018, and this was true for men and women. That said, suicide rates were still 3.5-3.9 times higher among men than among women regardless of urbanicity or rurality that year.

The full data brief can be found on the CDC website.

[email protected]

As the coronavirus pandemic has swept across America, so have advisories for social distancing. As of April 2, stay-at-home orders had been given in 38 states and parts of 7 more, affecting about 300 million people. Most of these people have been asked to maintain 6 feet of separation to anyone outside their immediate family and to avoid all avoidable contacts.

Typical hospital medicine patients at an academic hospital, however, traditionally receive visits from their hospitalist, an intern, a resident, and sometimes several medical students, pharmacists, and case managers. At University of California, San Diego, Health, many of these visits would occur during Focused Interdisciplinary Team rounds, with providers moving together in close proximity.

Asymptomatic and presymptomatic spread of coronavirus have been documented, which means distancing is a good idea for everyone. The risks of traditional patient visits during the coronavirus pandemic include spread to both patients (at high risk of complications) and staff (taken out of the workforce during surge times). Even if coronavirus were not a risk, visits to isolation rooms consume PPE, which is in short supply.

In response to the pandemic, UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts. Our slide presentations and written guidelines were then distributed to physicians, nurses, pharmacists, and other staff by our pandemic response command center. Key points include the following:

• Target one in-person MD visit per day for stable patients. This means that attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, and so on would not be done for billing or teaching purposes, only when clinically necessary.
• Use phone or video conferencing for follow-up discussions unless direct patient contact is needed.
• Consider skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Interview them remotely or from the door instead.
• Conduct team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoid shared work rooms. Substitute video conferences for in-person meetings. Use EMR embedded messaging to reduce face-to-face discussions.
• Check if a patient is ready for a visit before donning PPE to avoid waste.
• Explain to patients that distancing is being conducted to protect them. In our experience, when patients are asked about distancing, they welcome the changes.

We have also considered that most patient visits are generated by nurses and assistants. To increase distancing and reduce PPE waste, we have encouraged nurses and pharmacists to maximize their use of remote communication with patients and to suggest changes to care plans and come up with creative solutions to reduce traffic. We specifically suggested the following changes to routine care:

• Reduce frequency of taking vital signs, such as just daily or as needed, in stable patients (for example, those awaiting placement).
• Reduce checks for alcohol withdrawal and neurologic status as soon as possible, and stop fingersticks in patients with well-controlled diabetes not receiving insulin.
• Substitute less frequently administered medications where appropriate if doing so would reduce room traffic (such as enoxaparin for heparin, ceftriaxone for cefazolin, naproxen for ibuprofen, or patient-controlled analgesia for as needed morphine).
• Place intravenous pumps in halls if needed – luckily, our situation has not required these measures in San Diego.
• Explore the possibility of increased patient self-management (self-dosed insulin or inhalers) where medically appropriate.
• Eliminate food service and janitorial trips to isolation rooms unless requested by registered nurse.

There are clear downsides to medical distancing for hospital medicine patients. Patients might have delayed diagnosis of new conditions or inadequate management of conditions requiring frequent assessment, such as alcohol withdrawal. Opportunities for miscommunication (either patient-provider or provider-provider) may be increased with distancing. Isolation also comes with emotional costs such as stress and feelings of isolation or abandonment. Given the dynamic nature of the pandemic response, we are continually reevaluating our distancing guidelines to administer the safest and most effective hospital care possible as we approach California’s expected peak coronavirus infection period.

Dr. Jenkins is professor and chair of the Patient Safety Committee in the Division of Hospital Medicine at UCSD. Dr. Seymann is clinical professor and vice chief for academic affairs, UCSD division of hospital medicine. Dr. Horman and Dr. Bell are hospitalists and associate professors of medicine at UC San Diego Health.

As the coronavirus pandemic has swept across America, so have advisories for social distancing. As of April 2, stay-at-home orders had been given in 38 states and parts of 7 more, affecting about 300 million people. Most of these people have been asked to maintain 6 feet of separation to anyone outside their immediate family and to avoid all avoidable contacts.

Typical hospital medicine patients at an academic hospital, however, traditionally receive visits from their hospitalist, an intern, a resident, and sometimes several medical students, pharmacists, and case managers. At University of California, San Diego, Health, many of these visits would occur during Focused Interdisciplinary Team rounds, with providers moving together in close proximity.

Asymptomatic and presymptomatic spread of coronavirus have been documented, which means distancing is a good idea for everyone. The risks of traditional patient visits during the coronavirus pandemic include spread to both patients (at high risk of complications) and staff (taken out of the workforce during surge times). Even if coronavirus were not a risk, visits to isolation rooms consume PPE, which is in short supply.

In response to the pandemic, UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts. Our slide presentations and written guidelines were then distributed to physicians, nurses, pharmacists, and other staff by our pandemic response command center. Key points include the following:

• Target one in-person MD visit per day for stable patients. This means that attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, and so on would not be done for billing or teaching purposes, only when clinically necessary.
• Use phone or video conferencing for follow-up discussions unless direct patient contact is needed.
• Consider skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Interview them remotely or from the door instead.
• Conduct team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoid shared work rooms. Substitute video conferences for in-person meetings. Use EMR embedded messaging to reduce face-to-face discussions.
• Check if a patient is ready for a visit before donning PPE to avoid waste.
• Explain to patients that distancing is being conducted to protect them. In our experience, when patients are asked about distancing, they welcome the changes.

We have also considered that most patient visits are generated by nurses and assistants. To increase distancing and reduce PPE waste, we have encouraged nurses and pharmacists to maximize their use of remote communication with patients and to suggest changes to care plans and come up with creative solutions to reduce traffic. We specifically suggested the following changes to routine care:

• Reduce frequency of taking vital signs, such as just daily or as needed, in stable patients (for example, those awaiting placement).
• Reduce checks for alcohol withdrawal and neurologic status as soon as possible, and stop fingersticks in patients with well-controlled diabetes not receiving insulin.
• Substitute less frequently administered medications where appropriate if doing so would reduce room traffic (such as enoxaparin for heparin, ceftriaxone for cefazolin, naproxen for ibuprofen, or patient-controlled analgesia for as needed morphine).
• Place intravenous pumps in halls if needed – luckily, our situation has not required these measures in San Diego.
• Explore the possibility of increased patient self-management (self-dosed insulin or inhalers) where medically appropriate.
• Eliminate food service and janitorial trips to isolation rooms unless requested by registered nurse.

There are clear downsides to medical distancing for hospital medicine patients. Patients might have delayed diagnosis of new conditions or inadequate management of conditions requiring frequent assessment, such as alcohol withdrawal. Opportunities for miscommunication (either patient-provider or provider-provider) may be increased with distancing. Isolation also comes with emotional costs such as stress and feelings of isolation or abandonment. Given the dynamic nature of the pandemic response, we are continually reevaluating our distancing guidelines to administer the safest and most effective hospital care possible as we approach California’s expected peak coronavirus infection period.

Dr. Jenkins is professor and chair of the Patient Safety Committee in the Division of Hospital Medicine at UCSD. Dr. Seymann is clinical professor and vice chief for academic affairs, UCSD division of hospital medicine. Dr. Horman and Dr. Bell are hospitalists and associate professors of medicine at UC San Diego Health.

As the coronavirus pandemic has swept across America, so have advisories for social distancing. As of April 2, stay-at-home orders had been given in 38 states and parts of 7 more, affecting about 300 million people. Most of these people have been asked to maintain 6 feet of separation to anyone outside their immediate family and to avoid all avoidable contacts.

Typical hospital medicine patients at an academic hospital, however, traditionally receive visits from their hospitalist, an intern, a resident, and sometimes several medical students, pharmacists, and case managers. At University of California, San Diego, Health, many of these visits would occur during Focused Interdisciplinary Team rounds, with providers moving together in close proximity.

Asymptomatic and presymptomatic spread of coronavirus have been documented, which means distancing is a good idea for everyone. The risks of traditional patient visits during the coronavirus pandemic include spread to both patients (at high risk of complications) and staff (taken out of the workforce during surge times). Even if coronavirus were not a risk, visits to isolation rooms consume PPE, which is in short supply.

In response to the pandemic, UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts. Our slide presentations and written guidelines were then distributed to physicians, nurses, pharmacists, and other staff by our pandemic response command center. Key points include the following:

• Target one in-person MD visit per day for stable patients. This means that attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, and so on would not be done for billing or teaching purposes, only when clinically necessary.
• Use phone or video conferencing for follow-up discussions unless direct patient contact is needed.
• Consider skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Interview them remotely or from the door instead.
• Conduct team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoid shared work rooms. Substitute video conferences for in-person meetings. Use EMR embedded messaging to reduce face-to-face discussions.
• Check if a patient is ready for a visit before donning PPE to avoid waste.
• Explain to patients that distancing is being conducted to protect them. In our experience, when patients are asked about distancing, they welcome the changes.

We have also considered that most patient visits are generated by nurses and assistants. To increase distancing and reduce PPE waste, we have encouraged nurses and pharmacists to maximize their use of remote communication with patients and to suggest changes to care plans and come up with creative solutions to reduce traffic. We specifically suggested the following changes to routine care:

• Reduce frequency of taking vital signs, such as just daily or as needed, in stable patients (for example, those awaiting placement).
• Reduce checks for alcohol withdrawal and neurologic status as soon as possible, and stop fingersticks in patients with well-controlled diabetes not receiving insulin.
• Substitute less frequently administered medications where appropriate if doing so would reduce room traffic (such as enoxaparin for heparin, ceftriaxone for cefazolin, naproxen for ibuprofen, or patient-controlled analgesia for as needed morphine).
• Place intravenous pumps in halls if needed – luckily, our situation has not required these measures in San Diego.
• Explore the possibility of increased patient self-management (self-dosed insulin or inhalers) where medically appropriate.
• Eliminate food service and janitorial trips to isolation rooms unless requested by registered nurse.

There are clear downsides to medical distancing for hospital medicine patients. Patients might have delayed diagnosis of new conditions or inadequate management of conditions requiring frequent assessment, such as alcohol withdrawal. Opportunities for miscommunication (either patient-provider or provider-provider) may be increased with distancing. Isolation also comes with emotional costs such as stress and feelings of isolation or abandonment. Given the dynamic nature of the pandemic response, we are continually reevaluating our distancing guidelines to administer the safest and most effective hospital care possible as we approach California’s expected peak coronavirus infection period.

Dr. Jenkins is professor and chair of the Patient Safety Committee in the Division of Hospital Medicine at UCSD. Dr. Seymann is clinical professor and vice chief for academic affairs, UCSD division of hospital medicine. Dr. Horman and Dr. Bell are hospitalists and associate professors of medicine at UC San Diego Health.

E-consults were highly useful, with more than 80% of them resulting in an avoided visit to a specialist, in a study of e-consult use at a large health system.

Studies have shown that e-consults increase access to specialist care and primary care physician (PCP) education, according to research published in the Annals of Internal Medicine (2020. Apr 14. doi: 10.7326/M19-3852) by Salman Ahmed, MD, and colleagues.

These resources are already being frequently used by physicians, but more often by general internists and hospitalists than by subspecialists, according to a recent survey by the American College of Physicians. That survey found that 42% of its respondents are using e-consults and that subspecialists’ use is less common primarily because of the lack of access to e-consult technology.

What hasn’t been widely researched are the effects of large-scale e-consult programs, said Dr. Ahmed, who is associate physician in the renal division at Brigham and Women’s Hospital, Boston, in an interview.

For frontline providers such as PCPs, e-consults are a way to quickly seek out answers to clinical questions from specialists. In turn, the specialist can help a wider pool of participants, he noted.

The findings of Dr. Ahmed’s study, which included several academic centers and hospitals affiliated with Partners HealthCare System, a nonprofit network in eastern Massachusetts that includes Brigham and Women’s Hospital, used several metrics to analyze the appropriateness and utility of e-consults across a range of specialties. An e-consult was considered useful if it resulted in the avoidance of a visit to a specialist, which was defined as the absence of an in-person visit to the type of specialist consulted electronically for 120 days. An e-consult was considered appropriate if it met the following four criteria.

• It could not be answered by referring to society guidelines or widely available, evidence-based summary sources.
• It did not seek logistic information, such as where to have a specific laboratory test done.
• It did not include a question of high urgency.
• The medical complexity of the clinical situation was not substantial enough to warrant an in-person consultation.

The investigators examined e-consult inquiries to mostly physician health care providers in five specialties – hematology, infectious disease, dermatology, rheumatology, and psychiatry – over a year.
 

High rates of appropriateness

The search spanned 6,512 eligible e-consults from 1,096 referring providers to 121 specialist consultants. Narrowing their search to 741 records with complete data, the investigators found that 70.2% of these consults met the criteria for appropriateness. In an analysis of four reviewers blinded to each other’s results, raters agreed on the appropriateness of 94% of e-consults.

Across specialties, more than 81% of e-consults were associated with avoided in-person visits.

The reasons for most e-consults were to seek answers to questions about diagnosis, therapeutics, or patient inquiries, or to request further education by PCPs.

“Across all specialties, the most common reasons an e-consult was not considered appropriate were failing the point-of-care resource test and asking a question of inappropriately high complexity,” the authors summarized.

Physicians and PCPs from tertiary care practices made up the majority of referring providers, with turnaround time for consults averaging 24 hours across specialties.

Rates of appropriateness, content, patient demographics, and timeliness of e-consult responses varied among the four specialties. Those with high avoidance of visits rates tended to have high appropriateness rates, indicating that some specialties may be more conducive to e-consults than others, the authors noted. Psychiatry and hematology had the highest proportion of appropriate e-consults (77.9% and 73.3% respectively). Rheumatology had the lowest proportion of appropriate e-consults and one of the lowest rates of avoided in-person visits, and dermatology had the lowest rate of avoided in-person visits, at 61.9%.

The majority (93%) of e-consults sought in psychiatry were therapy related, whereas 88.4% of the e-consult questions in rheumatology related to diagnosis.

“Questions about diagnosis were less likely to be answerable via e-consult, which suggests that to provide diagnoses, consultants may wish to engage with the patient directly,” Dr. Ahmed said in an interview.

Infectious disease specialists seemed to be the fastest responders, with nearly 90% of their consultations having been answered within a day. Dermatology specialists had the distinction of having the youngest e-consult patients (mean age, 38.6 years).
 

PCPs weigh in on results

Physicians said in interviews that the study data reflects their own positive experiences with e-consults.

“Although I don’t always think [an e-consult] is able to fully prevent the specialist visit, it does allow the specialist to provide recommendations for work-up that can be done prior to the specialist visit,” said Santina Wheat MD, a family physician at Erie Family Health Center in Chicago. This reduces the time in which the consult is placed to when effective treatment can take place.

Patients who may have to wait months or even years to see a specialty doctor, benefit from e-consults, said Dr. Wheat, who is also a member of the editorial advisory board of Family Practice News. “As part of an organization that does e-consults to another hospital with a different electronic medical record, the e-consult increases the likelihood that all of the clinical information reaches the specialists and prevents tests from being repeated.”

Starting an e-consult may also increase the likelihood that the patient quickly sees a specialist at the contracted hospital, she added.

Sarah G. Candler, MD, said in an interview that she also sees e-consults as an essential tool. “When patients present with rare, complex, or atypical pictures, I find it helpful to have specialists weigh in. The e-consult helps me ensure that I work to the top of my abilities as an internist,” said Dr. Candler, who is practice medical director and physician director of academic relations at Iora Primary Care, Northside Clinic, Houston. However, she did not agree with the study’s avoided in-person visits metric for assessing utility.

“In some cases, the end result of an e-consult is a referral for an in-person evaluation, and the role of the e-consult is to ensure that I have done my due diligence as a primary care doctor asking the correct questions, getting the appropriate work-up completed, and referring to the appropriate specialty for next steps, when necessary,” noted Dr. Candler, who also serves on the editorial advisory board of Internal Medicine News.
 

Financial considerations

The study’s authors suggested taking a closer look at standardizing payment for the use of e-consults and developing appropriateness criteria for them.

Health systems could use such criteria to study what makes an e-consult useful and how to best utilize this tool, Dr. Ahmed said in an interview.

“Compensation models that promote high-quality, effective, and efficient e-consults are needed to reinforce the ability of health systems to optimize the mix of e-consults and in-person visits,” Dr. Ahmed and colleagues suggested.

Because not all patient care requires e-consults, the model makes the most sense in practices that already participate in value-based payment programs. In these types of programs, the cost can be shared according to the variable risk and patient need for the service, Dr. Candler explained.

“I have been fortunate to work in two different systems that function in this way, which means that e-consults have been readily available and encouraged-both to improve patient care and decrease overall cost by decreasing unnecessary testing or specialist referral,” she said.

Dr. Wheat said that the managed care organization affiliated with her practice seems to be saving money with e-consults, as it decreases the need to pay for specialist visits in some instances and for repeated work-ups.
 

Future studies

The study’s cohort represented just one large health care system with a shared electronic health record. “Single-system descriptive studies, such as that of Ahmed and colleagues, are particularly useful for local evaluation and quality improvement efforts,” Varsha G. Vimalananda, MD, and B. Graeme Fincke, MD, both of the Center for Healthcare Organization and Implementation Research at Bedford (Mass.) Veterans Affairs Hospital, wrote in a related editorial.

“However, we need innovative approaches to evaluation that estimate the effect of e-consults on quality and cost of care across health care systems and over time. Implementation studies can help to identify key contributors to success,” the editorialists wrote.

One of the study authors, reported receiving personal fees from Bayer outside the submitted work. The other authors of the paper and the authors of the editorial reported no conflicts of interest. Dr. Candler said her employer contracts with an e-consult service, but that she is not compensated for use of the service. She is also a coeditor of Annals of Internal Medicine’s blog, “Fresh Look.”

SOURCE: Ahmed S et al. Ann Intern Med. 2020 Apr 14. doi: 10.7326/M19-3852.

E-consults were highly useful, with more than 80% of them resulting in an avoided visit to a specialist, in a study of e-consult use at a large health system.

Studies have shown that e-consults increase access to specialist care and primary care physician (PCP) education, according to research published in the Annals of Internal Medicine (2020. Apr 14. doi: 10.7326/M19-3852) by Salman Ahmed, MD, and colleagues.

These resources are already being frequently used by physicians, but more often by general internists and hospitalists than by subspecialists, according to a recent survey by the American College of Physicians. That survey found that 42% of its respondents are using e-consults and that subspecialists’ use is less common primarily because of the lack of access to e-consult technology.

What hasn’t been widely researched are the effects of large-scale e-consult programs, said Dr. Ahmed, who is associate physician in the renal division at Brigham and Women’s Hospital, Boston, in an interview.

For frontline providers such as PCPs, e-consults are a way to quickly seek out answers to clinical questions from specialists. In turn, the specialist can help a wider pool of participants, he noted.

The findings of Dr. Ahmed’s study, which included several academic centers and hospitals affiliated with Partners HealthCare System, a nonprofit network in eastern Massachusetts that includes Brigham and Women’s Hospital, used several metrics to analyze the appropriateness and utility of e-consults across a range of specialties. An e-consult was considered useful if it resulted in the avoidance of a visit to a specialist, which was defined as the absence of an in-person visit to the type of specialist consulted electronically for 120 days. An e-consult was considered appropriate if it met the following four criteria.

• It could not be answered by referring to society guidelines or widely available, evidence-based summary sources.
• It did not seek logistic information, such as where to have a specific laboratory test done.
• It did not include a question of high urgency.
• The medical complexity of the clinical situation was not substantial enough to warrant an in-person consultation.

The investigators examined e-consult inquiries to mostly physician health care providers in five specialties – hematology, infectious disease, dermatology, rheumatology, and psychiatry – over a year.
 

High rates of appropriateness

The search spanned 6,512 eligible e-consults from 1,096 referring providers to 121 specialist consultants. Narrowing their search to 741 records with complete data, the investigators found that 70.2% of these consults met the criteria for appropriateness. In an analysis of four reviewers blinded to each other’s results, raters agreed on the appropriateness of 94% of e-consults.

Across specialties, more than 81% of e-consults were associated with avoided in-person visits.

The reasons for most e-consults were to seek answers to questions about diagnosis, therapeutics, or patient inquiries, or to request further education by PCPs.

“Across all specialties, the most common reasons an e-consult was not considered appropriate were failing the point-of-care resource test and asking a question of inappropriately high complexity,” the authors summarized.

Physicians and PCPs from tertiary care practices made up the majority of referring providers, with turnaround time for consults averaging 24 hours across specialties.

Rates of appropriateness, content, patient demographics, and timeliness of e-consult responses varied among the four specialties. Those with high avoidance of visits rates tended to have high appropriateness rates, indicating that some specialties may be more conducive to e-consults than others, the authors noted. Psychiatry and hematology had the highest proportion of appropriate e-consults (77.9% and 73.3% respectively). Rheumatology had the lowest proportion of appropriate e-consults and one of the lowest rates of avoided in-person visits, and dermatology had the lowest rate of avoided in-person visits, at 61.9%.

The majority (93%) of e-consults sought in psychiatry were therapy related, whereas 88.4% of the e-consult questions in rheumatology related to diagnosis.

“Questions about diagnosis were less likely to be answerable via e-consult, which suggests that to provide diagnoses, consultants may wish to engage with the patient directly,” Dr. Ahmed said in an interview.

Infectious disease specialists seemed to be the fastest responders, with nearly 90% of their consultations having been answered within a day. Dermatology specialists had the distinction of having the youngest e-consult patients (mean age, 38.6 years).
 

PCPs weigh in on results

Physicians said in interviews that the study data reflects their own positive experiences with e-consults.

“Although I don’t always think [an e-consult] is able to fully prevent the specialist visit, it does allow the specialist to provide recommendations for work-up that can be done prior to the specialist visit,” said Santina Wheat MD, a family physician at Erie Family Health Center in Chicago. This reduces the time in which the consult is placed to when effective treatment can take place.

Patients who may have to wait months or even years to see a specialty doctor, benefit from e-consults, said Dr. Wheat, who is also a member of the editorial advisory board of Family Practice News. “As part of an organization that does e-consults to another hospital with a different electronic medical record, the e-consult increases the likelihood that all of the clinical information reaches the specialists and prevents tests from being repeated.”

Starting an e-consult may also increase the likelihood that the patient quickly sees a specialist at the contracted hospital, she added.

Sarah G. Candler, MD, said in an interview that she also sees e-consults as an essential tool. “When patients present with rare, complex, or atypical pictures, I find it helpful to have specialists weigh in. The e-consult helps me ensure that I work to the top of my abilities as an internist,” said Dr. Candler, who is practice medical director and physician director of academic relations at Iora Primary Care, Northside Clinic, Houston. However, she did not agree with the study’s avoided in-person visits metric for assessing utility.

“In some cases, the end result of an e-consult is a referral for an in-person evaluation, and the role of the e-consult is to ensure that I have done my due diligence as a primary care doctor asking the correct questions, getting the appropriate work-up completed, and referring to the appropriate specialty for next steps, when necessary,” noted Dr. Candler, who also serves on the editorial advisory board of Internal Medicine News.
 

Financial considerations

The study’s authors suggested taking a closer look at standardizing payment for the use of e-consults and developing appropriateness criteria for them.

Health systems could use such criteria to study what makes an e-consult useful and how to best utilize this tool, Dr. Ahmed said in an interview.

“Compensation models that promote high-quality, effective, and efficient e-consults are needed to reinforce the ability of health systems to optimize the mix of e-consults and in-person visits,” Dr. Ahmed and colleagues suggested.

Because not all patient care requires e-consults, the model makes the most sense in practices that already participate in value-based payment programs. In these types of programs, the cost can be shared according to the variable risk and patient need for the service, Dr. Candler explained.

“I have been fortunate to work in two different systems that function in this way, which means that e-consults have been readily available and encouraged-both to improve patient care and decrease overall cost by decreasing unnecessary testing or specialist referral,” she said.

Dr. Wheat said that the managed care organization affiliated with her practice seems to be saving money with e-consults, as it decreases the need to pay for specialist visits in some instances and for repeated work-ups.
 

Future studies

The study’s cohort represented just one large health care system with a shared electronic health record. “Single-system descriptive studies, such as that of Ahmed and colleagues, are particularly useful for local evaluation and quality improvement efforts,” Varsha G. Vimalananda, MD, and B. Graeme Fincke, MD, both of the Center for Healthcare Organization and Implementation Research at Bedford (Mass.) Veterans Affairs Hospital, wrote in a related editorial.

“However, we need innovative approaches to evaluation that estimate the effect of e-consults on quality and cost of care across health care systems and over time. Implementation studies can help to identify key contributors to success,” the editorialists wrote.

One of the study authors, reported receiving personal fees from Bayer outside the submitted work. The other authors of the paper and the authors of the editorial reported no conflicts of interest. Dr. Candler said her employer contracts with an e-consult service, but that she is not compensated for use of the service. She is also a coeditor of Annals of Internal Medicine’s blog, “Fresh Look.”

SOURCE: Ahmed S et al. Ann Intern Med. 2020 Apr 14. doi: 10.7326/M19-3852.

E-consults were highly useful, with more than 80% of them resulting in an avoided visit to a specialist, in a study of e-consult use at a large health system.

Studies have shown that e-consults increase access to specialist care and primary care physician (PCP) education, according to research published in the Annals of Internal Medicine (2020. Apr 14. doi: 10.7326/M19-3852) by Salman Ahmed, MD, and colleagues.

These resources are already being frequently used by physicians, but more often by general internists and hospitalists than by subspecialists, according to a recent survey by the American College of Physicians. That survey found that 42% of its respondents are using e-consults and that subspecialists’ use is less common primarily because of the lack of access to e-consult technology.

What hasn’t been widely researched are the effects of large-scale e-consult programs, said Dr. Ahmed, who is associate physician in the renal division at Brigham and Women’s Hospital, Boston, in an interview.

For frontline providers such as PCPs, e-consults are a way to quickly seek out answers to clinical questions from specialists. In turn, the specialist can help a wider pool of participants, he noted.

The findings of Dr. Ahmed’s study, which included several academic centers and hospitals affiliated with Partners HealthCare System, a nonprofit network in eastern Massachusetts that includes Brigham and Women’s Hospital, used several metrics to analyze the appropriateness and utility of e-consults across a range of specialties. An e-consult was considered useful if it resulted in the avoidance of a visit to a specialist, which was defined as the absence of an in-person visit to the type of specialist consulted electronically for 120 days. An e-consult was considered appropriate if it met the following four criteria.

• It could not be answered by referring to society guidelines or widely available, evidence-based summary sources.
• It did not seek logistic information, such as where to have a specific laboratory test done.
• It did not include a question of high urgency.
• The medical complexity of the clinical situation was not substantial enough to warrant an in-person consultation.

The investigators examined e-consult inquiries to mostly physician health care providers in five specialties – hematology, infectious disease, dermatology, rheumatology, and psychiatry – over a year.
 

High rates of appropriateness

The search spanned 6,512 eligible e-consults from 1,096 referring providers to 121 specialist consultants. Narrowing their search to 741 records with complete data, the investigators found that 70.2% of these consults met the criteria for appropriateness. In an analysis of four reviewers blinded to each other’s results, raters agreed on the appropriateness of 94% of e-consults.

Across specialties, more than 81% of e-consults were associated with avoided in-person visits.

The reasons for most e-consults were to seek answers to questions about diagnosis, therapeutics, or patient inquiries, or to request further education by PCPs.

“Across all specialties, the most common reasons an e-consult was not considered appropriate were failing the point-of-care resource test and asking a question of inappropriately high complexity,” the authors summarized.

Physicians and PCPs from tertiary care practices made up the majority of referring providers, with turnaround time for consults averaging 24 hours across specialties.

Rates of appropriateness, content, patient demographics, and timeliness of e-consult responses varied among the four specialties. Those with high avoidance of visits rates tended to have high appropriateness rates, indicating that some specialties may be more conducive to e-consults than others, the authors noted. Psychiatry and hematology had the highest proportion of appropriate e-consults (77.9% and 73.3% respectively). Rheumatology had the lowest proportion of appropriate e-consults and one of the lowest rates of avoided in-person visits, and dermatology had the lowest rate of avoided in-person visits, at 61.9%.

The majority (93%) of e-consults sought in psychiatry were therapy related, whereas 88.4% of the e-consult questions in rheumatology related to diagnosis.

“Questions about diagnosis were less likely to be answerable via e-consult, which suggests that to provide diagnoses, consultants may wish to engage with the patient directly,” Dr. Ahmed said in an interview.

Infectious disease specialists seemed to be the fastest responders, with nearly 90% of their consultations having been answered within a day. Dermatology specialists had the distinction of having the youngest e-consult patients (mean age, 38.6 years).
 

PCPs weigh in on results

Physicians said in interviews that the study data reflects their own positive experiences with e-consults.

“Although I don’t always think [an e-consult] is able to fully prevent the specialist visit, it does allow the specialist to provide recommendations for work-up that can be done prior to the specialist visit,” said Santina Wheat MD, a family physician at Erie Family Health Center in Chicago. This reduces the time in which the consult is placed to when effective treatment can take place.

Patients who may have to wait months or even years to see a specialty doctor, benefit from e-consults, said Dr. Wheat, who is also a member of the editorial advisory board of Family Practice News. “As part of an organization that does e-consults to another hospital with a different electronic medical record, the e-consult increases the likelihood that all of the clinical information reaches the specialists and prevents tests from being repeated.”

Starting an e-consult may also increase the likelihood that the patient quickly sees a specialist at the contracted hospital, she added.

Sarah G. Candler, MD, said in an interview that she also sees e-consults as an essential tool. “When patients present with rare, complex, or atypical pictures, I find it helpful to have specialists weigh in. The e-consult helps me ensure that I work to the top of my abilities as an internist,” said Dr. Candler, who is practice medical director and physician director of academic relations at Iora Primary Care, Northside Clinic, Houston. However, she did not agree with the study’s avoided in-person visits metric for assessing utility.

“In some cases, the end result of an e-consult is a referral for an in-person evaluation, and the role of the e-consult is to ensure that I have done my due diligence as a primary care doctor asking the correct questions, getting the appropriate work-up completed, and referring to the appropriate specialty for next steps, when necessary,” noted Dr. Candler, who also serves on the editorial advisory board of Internal Medicine News.
 

Financial considerations

The study’s authors suggested taking a closer look at standardizing payment for the use of e-consults and developing appropriateness criteria for them.

Health systems could use such criteria to study what makes an e-consult useful and how to best utilize this tool, Dr. Ahmed said in an interview.

“Compensation models that promote high-quality, effective, and efficient e-consults are needed to reinforce the ability of health systems to optimize the mix of e-consults and in-person visits,” Dr. Ahmed and colleagues suggested.

Because not all patient care requires e-consults, the model makes the most sense in practices that already participate in value-based payment programs. In these types of programs, the cost can be shared according to the variable risk and patient need for the service, Dr. Candler explained.

“I have been fortunate to work in two different systems that function in this way, which means that e-consults have been readily available and encouraged-both to improve patient care and decrease overall cost by decreasing unnecessary testing or specialist referral,” she said.

Dr. Wheat said that the managed care organization affiliated with her practice seems to be saving money with e-consults, as it decreases the need to pay for specialist visits in some instances and for repeated work-ups.
 

Future studies

The study’s cohort represented just one large health care system with a shared electronic health record. “Single-system descriptive studies, such as that of Ahmed and colleagues, are particularly useful for local evaluation and quality improvement efforts,” Varsha G. Vimalananda, MD, and B. Graeme Fincke, MD, both of the Center for Healthcare Organization and Implementation Research at Bedford (Mass.) Veterans Affairs Hospital, wrote in a related editorial.

“However, we need innovative approaches to evaluation that estimate the effect of e-consults on quality and cost of care across health care systems and over time. Implementation studies can help to identify key contributors to success,” the editorialists wrote.

One of the study authors, reported receiving personal fees from Bayer outside the submitted work. The other authors of the paper and the authors of the editorial reported no conflicts of interest. Dr. Candler said her employer contracts with an e-consult service, but that she is not compensated for use of the service. She is also a coeditor of Annals of Internal Medicine’s blog, “Fresh Look.”

SOURCE: Ahmed S et al. Ann Intern Med. 2020 Apr 14. doi: 10.7326/M19-3852.

Children with overweight or obese body mass index measures at preschool age were significantly more likely than were normal weight children to suffer upper- and lower-limb fractures before age 15 years, according to data from almost 470,000 children.

Previous studies of adults have shown associations between obesity and fractures, but the impact of higher BMI at preschool age on fracture incidence later in childhood has not been explored, according to Jennifer C.E. Lane, MD, of the University of Oxford (England), and colleagues. “A focused study of the association between preschool obesity and fracture risk offers the opportunity to better understand the impact of obesity in early life,” they wrote in the Journal of Bone and Mineral Research.

The researchers reviewed data from 466,997 children at 296 primary care centers using the Information System for Research in Primary Care, a Spanish national database, for the years 2003-2013. The children were assessed starting at age 4 years and followed until age 15 years or until they left the region or died, or until the study period ended, on Dec. 31, 2016. The average follow-up time was 4.9 years, and 49% of the children were girls. BMI categories were determined via the World Health Organization growth standards for calculating age- and sex-specific BMI z scores, and the categories were defined as underweight (< −2 BMI z score), normal weight (−2 to +2 BMI z score), overweight (> +2 BMI z score), and obese (> +3 BMI z score).

Overall, children with a BMI in the overweight or obese ranges at first assessment were significantly more likely than were their normal weight counterparts to suffer lower-limb fractures (adjusted hazard ratios, 1.42 and 1.74, respectively) and upper-limb fractures (aHRs, 1.10 and 1.19, respectively) during the follow-up period.

The total incidence of fractures during childhood for those in the study who were underweight, normal weight, overweight, or obese, was 9.20%, 10.06%, 11.28%, and 13.05% respectively.

In a secondary analysis, fracture risk varied by anatomic location and reflected previous findings showing an increased risk of distal limb fractures associated with high BMI, the researchers said.

The findings were limited by several factors, including the smaller-than-average proportion of children with overweight or obese BMI measures, the imprecise nature of the BMI z score as a predictor of obesity in children, and the lack of data on sports, medical issues, and general activity levels, the researchers noted.

However, the results were strengthened by the population-based sample and long-term follow-up, and the work “suggests that interventions to treat obesity in early childhood could have benefits for the primary or secondary prevention of fractures later in childhood, especially in the prevention of fractures within the forearm and hand or foot and ankle,” the authors concluded.

The study was supported in part by the NIHR Biomedical Research Centre, Oxford, and La Marató de TV3 Foundation. Dr. Lane disclosed funding from a Versus Arthritis Clinical Research Fellowship but had no financial conflicts to disclose. Some authors reported relationships with numerous pharmaceutical firms.

SOURCE: Lane JCE et al. J Bone Miner Res. 2020 Apr 7. doi: 10.1002/jbmr.3984

Children with overweight or obese body mass index measures at preschool age were significantly more likely than were normal weight children to suffer upper- and lower-limb fractures before age 15 years, according to data from almost 470,000 children.

Previous studies of adults have shown associations between obesity and fractures, but the impact of higher BMI at preschool age on fracture incidence later in childhood has not been explored, according to Jennifer C.E. Lane, MD, of the University of Oxford (England), and colleagues. “A focused study of the association between preschool obesity and fracture risk offers the opportunity to better understand the impact of obesity in early life,” they wrote in the Journal of Bone and Mineral Research.

The researchers reviewed data from 466,997 children at 296 primary care centers using the Information System for Research in Primary Care, a Spanish national database, for the years 2003-2013. The children were assessed starting at age 4 years and followed until age 15 years or until they left the region or died, or until the study period ended, on Dec. 31, 2016. The average follow-up time was 4.9 years, and 49% of the children were girls. BMI categories were determined via the World Health Organization growth standards for calculating age- and sex-specific BMI z scores, and the categories were defined as underweight (< −2 BMI z score), normal weight (−2 to +2 BMI z score), overweight (> +2 BMI z score), and obese (> +3 BMI z score).

Overall, children with a BMI in the overweight or obese ranges at first assessment were significantly more likely than were their normal weight counterparts to suffer lower-limb fractures (adjusted hazard ratios, 1.42 and 1.74, respectively) and upper-limb fractures (aHRs, 1.10 and 1.19, respectively) during the follow-up period.

The total incidence of fractures during childhood for those in the study who were underweight, normal weight, overweight, or obese, was 9.20%, 10.06%, 11.28%, and 13.05% respectively.

In a secondary analysis, fracture risk varied by anatomic location and reflected previous findings showing an increased risk of distal limb fractures associated with high BMI, the researchers said.

The findings were limited by several factors, including the smaller-than-average proportion of children with overweight or obese BMI measures, the imprecise nature of the BMI z score as a predictor of obesity in children, and the lack of data on sports, medical issues, and general activity levels, the researchers noted.

However, the results were strengthened by the population-based sample and long-term follow-up, and the work “suggests that interventions to treat obesity in early childhood could have benefits for the primary or secondary prevention of fractures later in childhood, especially in the prevention of fractures within the forearm and hand or foot and ankle,” the authors concluded.

The study was supported in part by the NIHR Biomedical Research Centre, Oxford, and La Marató de TV3 Foundation. Dr. Lane disclosed funding from a Versus Arthritis Clinical Research Fellowship but had no financial conflicts to disclose. Some authors reported relationships with numerous pharmaceutical firms.

SOURCE: Lane JCE et al. J Bone Miner Res. 2020 Apr 7. doi: 10.1002/jbmr.3984

Children with overweight or obese body mass index measures at preschool age were significantly more likely than were normal weight children to suffer upper- and lower-limb fractures before age 15 years, according to data from almost 470,000 children.

Previous studies of adults have shown associations between obesity and fractures, but the impact of higher BMI at preschool age on fracture incidence later in childhood has not been explored, according to Jennifer C.E. Lane, MD, of the University of Oxford (England), and colleagues. “A focused study of the association between preschool obesity and fracture risk offers the opportunity to better understand the impact of obesity in early life,” they wrote in the Journal of Bone and Mineral Research.

The researchers reviewed data from 466,997 children at 296 primary care centers using the Information System for Research in Primary Care, a Spanish national database, for the years 2003-2013. The children were assessed starting at age 4 years and followed until age 15 years or until they left the region or died, or until the study period ended, on Dec. 31, 2016. The average follow-up time was 4.9 years, and 49% of the children were girls. BMI categories were determined via the World Health Organization growth standards for calculating age- and sex-specific BMI z scores, and the categories were defined as underweight (< −2 BMI z score), normal weight (−2 to +2 BMI z score), overweight (> +2 BMI z score), and obese (> +3 BMI z score).

Overall, children with a BMI in the overweight or obese ranges at first assessment were significantly more likely than were their normal weight counterparts to suffer lower-limb fractures (adjusted hazard ratios, 1.42 and 1.74, respectively) and upper-limb fractures (aHRs, 1.10 and 1.19, respectively) during the follow-up period.

The total incidence of fractures during childhood for those in the study who were underweight, normal weight, overweight, or obese, was 9.20%, 10.06%, 11.28%, and 13.05% respectively.

In a secondary analysis, fracture risk varied by anatomic location and reflected previous findings showing an increased risk of distal limb fractures associated with high BMI, the researchers said.

The findings were limited by several factors, including the smaller-than-average proportion of children with overweight or obese BMI measures, the imprecise nature of the BMI z score as a predictor of obesity in children, and the lack of data on sports, medical issues, and general activity levels, the researchers noted.

However, the results were strengthened by the population-based sample and long-term follow-up, and the work “suggests that interventions to treat obesity in early childhood could have benefits for the primary or secondary prevention of fractures later in childhood, especially in the prevention of fractures within the forearm and hand or foot and ankle,” the authors concluded.

The study was supported in part by the NIHR Biomedical Research Centre, Oxford, and La Marató de TV3 Foundation. Dr. Lane disclosed funding from a Versus Arthritis Clinical Research Fellowship but had no financial conflicts to disclose. Some authors reported relationships with numerous pharmaceutical firms.

SOURCE: Lane JCE et al. J Bone Miner Res. 2020 Apr 7. doi: 10.1002/jbmr.3984

COVID-19 infection in patients with type 2 diabetes is associated with a greater increase in inflammatory and coagulation markers, compared with COVID-19 patients without diabetes, according to preliminary findings from a retrospective analysis of COVID-19 patients in Wuhan, China.

The results, though preliminary, could help explain why patients with diabetes and COVID-19 are at greater risk for more severe disease and death.

The results also suggest that more severe disease in patients with diabetes may be the result of a cytokine storm, in which the patient’s immune system overreacts to the virus and inflicts collateral damage on its own organs, according to Herbert I. Rettinger, MD, a clinical endocrinologist in Orange County, Calif., and member of the editorial advisory board for Clinical Endocrinology News. “Understanding the mechanism might help us understand the best way to treat,” COVID-19 in patients with diabetes, he said in an interview.

Dr. Rettinger, who was not involved in the research, noted that the study included only 24 patients with diabetes. Nevertheless, the finding of heightened inflammatory and coagulation markers was “fascinating.”

“This is the first paper I’ve seen [suggesting] that. I don’t know if we can extrapolate [the findings] to other populations, but if biomarkers are elevated in patients with COVID-19 and diabetes, then it’s something worth looking into, and to be aware of and cautious of. We need to pay attention to this,” he commented.

The study was led by Weina Guo and Desheng Hu at Huazhong University of Science and Technology in Wuhan, China, and published in Diabetes/Metabolism Research and Reviews.

The sample included 174 patients with COVID-19, who were treated consecutively during Feb. 10-29, 2020, at a single center. The researchers first assigned the patients to one of two groups – those with comorbid diabetes and those without. They further excluded all other comorbidities, focusing only on 26 patients with no comorbidities and 24 with only diabetes as a comorbidity, to remove all other comorbidities as possible confounding factors. Patients in the diabetes group were significantly older than those without diabetes (61 vs. 41 years, P < .01). The mortality rate was 16.5% in patients with diabetes and 0% in those without (P = .03).

COVID-19 patients with diabetes alone as a comorbidity had a greater risk for severe pneumonia, as evidenced by a higher mean CT score, compared with those without diabetes and no other comorbidities (P = .04). Patients with diabetes also had higher measures of release of tissue injury–related enzymes and were at higher risk of uncontrolled inflammation and hypercoagulable state. In particular, they had higher levels of interleukin-6 (13.7 vs. 4.1 pg/mL, respectively; P < .01), C-reactive protein (76.4 vs. 7.43 mg/L; P < .01), serum ferritin (764.8 vs. 128.9 ng/mL; P < .01), and D-dimer (1.16 vs. 0.25 mcg/mL; P < .01).

“It’s noteworthy that, for diseases that can induce a cytokine storm, IL-6 is a very good predictor of disease severity and prognosis, and its expression time is longer than other cytokines ([tumor necrosis factor] and IL-1). In addition, a significant rise in serum ferritin indicates the activation of the monocyte-macrophage system, which is a crucial part of inflammatory storm. These results indicate that patients with diabetes are susceptible to form an inflammatory storm, which eventually lead to rapid deterioration of COVID-19,” the authors wrote.

They also cited previous findings suggesting that coronavirus might exacerbate, or even cause, diabetes by seriously damaging islets (Acta Diabetol. 2010;47[3]:193-9). “Since viral infection may cause sharp fluctuation of the blood glucose levels of diabetes patients, which adversely affect the recovery of patients, there is reason to suspect that diabetes combined with SARS-CoV-2 pneumonia may form a vicious circle,” they wrote.

That’s one more reason to carefully monitor diabetes patients, said Dr. Rettinger. “Those patients who are able to make insulin might not be able to do so with the infection, and that may last a while, and they may require insulin. You want to keep a watch on things, and if oral agents are not working well, you want to go to insulin as quickly as you can. Probably diabetics should be way more careful and maybe visit the emergency department at earlier than a nondiabetic would.”

Raghavendra Mirmira, MD, PhD, who conducts translational research on diabetes and insulin production, said that the finding was not a complete surprise to him. “With a lot of diseases, having diabetes as a comorbidity can mean worse outcomes, and that’s certainly true of influenza. It was true for the other COVID-like illnesses, such as SARS and MERS,” Dr. Mirmira, who was not involved in the research, said in an interview.

If the findings hold up in larger numbers of patients and across multiple centers, they have the potential to inform patient management, said Dr. Mirmira, director of the Translational Research Center in the department of medicine at the University of Chicago. That will be especially true as data from long-term follow-up of become available. Elevated values in some biomarkers might dictate a patient be sent straight to the ICU or dictate admission to the hospital rather than being sent home, or it could assist patient selection for some of the new therapies that physicians hope will become available.

“The more information we get [about] total outcome, the more informed we’d be about who would benefit from some of the therapies that are in clinical trials now,” he said. Still, it will be a challenge to prove causation, because patients with diabetes have unique clinical characteristics that could also be the source of the difference.

Dr. Mirmira noted that patients with diabetes only were 20 years older on average than those with no comorbidities. “It’s really hard to know if what you’re looking at for the worse outcomes for people with diabetes is because they were older, and we know that older people tend to do much worse with COVID than younger people.” Ideally, patients would also be matched by age, but there are not enough data to do that yet.

The study was funded by the China National Natural Science Foundation. The authors reported no conflicts of interest. Dr. Rettinger has no relevant financial disclosures. Dr. Mirmira is on scientific advisory boards for Veralox Therapeutics, Sigilon Therapeutics, the Indiana Biosciences Research Institute, and the Juvenile Diabetes Research Foundation.
 

SOURCE: Guo W et al. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319.

COVID-19 infection in patients with type 2 diabetes is associated with a greater increase in inflammatory and coagulation markers, compared with COVID-19 patients without diabetes, according to preliminary findings from a retrospective analysis of COVID-19 patients in Wuhan, China.

The results, though preliminary, could help explain why patients with diabetes and COVID-19 are at greater risk for more severe disease and death.

The results also suggest that more severe disease in patients with diabetes may be the result of a cytokine storm, in which the patient’s immune system overreacts to the virus and inflicts collateral damage on its own organs, according to Herbert I. Rettinger, MD, a clinical endocrinologist in Orange County, Calif., and member of the editorial advisory board for Clinical Endocrinology News. “Understanding the mechanism might help us understand the best way to treat,” COVID-19 in patients with diabetes, he said in an interview.

Dr. Rettinger, who was not involved in the research, noted that the study included only 24 patients with diabetes. Nevertheless, the finding of heightened inflammatory and coagulation markers was “fascinating.”

“This is the first paper I’ve seen [suggesting] that. I don’t know if we can extrapolate [the findings] to other populations, but if biomarkers are elevated in patients with COVID-19 and diabetes, then it’s something worth looking into, and to be aware of and cautious of. We need to pay attention to this,” he commented.

The study was led by Weina Guo and Desheng Hu at Huazhong University of Science and Technology in Wuhan, China, and published in Diabetes/Metabolism Research and Reviews.

The sample included 174 patients with COVID-19, who were treated consecutively during Feb. 10-29, 2020, at a single center. The researchers first assigned the patients to one of two groups – those with comorbid diabetes and those without. They further excluded all other comorbidities, focusing only on 26 patients with no comorbidities and 24 with only diabetes as a comorbidity, to remove all other comorbidities as possible confounding factors. Patients in the diabetes group were significantly older than those without diabetes (61 vs. 41 years, P < .01). The mortality rate was 16.5% in patients with diabetes and 0% in those without (P = .03).

COVID-19 patients with diabetes alone as a comorbidity had a greater risk for severe pneumonia, as evidenced by a higher mean CT score, compared with those without diabetes and no other comorbidities (P = .04). Patients with diabetes also had higher measures of release of tissue injury–related enzymes and were at higher risk of uncontrolled inflammation and hypercoagulable state. In particular, they had higher levels of interleukin-6 (13.7 vs. 4.1 pg/mL, respectively; P < .01), C-reactive protein (76.4 vs. 7.43 mg/L; P < .01), serum ferritin (764.8 vs. 128.9 ng/mL; P < .01), and D-dimer (1.16 vs. 0.25 mcg/mL; P < .01).

“It’s noteworthy that, for diseases that can induce a cytokine storm, IL-6 is a very good predictor of disease severity and prognosis, and its expression time is longer than other cytokines ([tumor necrosis factor] and IL-1). In addition, a significant rise in serum ferritin indicates the activation of the monocyte-macrophage system, which is a crucial part of inflammatory storm. These results indicate that patients with diabetes are susceptible to form an inflammatory storm, which eventually lead to rapid deterioration of COVID-19,” the authors wrote.

They also cited previous findings suggesting that coronavirus might exacerbate, or even cause, diabetes by seriously damaging islets (Acta Diabetol. 2010;47[3]:193-9). “Since viral infection may cause sharp fluctuation of the blood glucose levels of diabetes patients, which adversely affect the recovery of patients, there is reason to suspect that diabetes combined with SARS-CoV-2 pneumonia may form a vicious circle,” they wrote.

That’s one more reason to carefully monitor diabetes patients, said Dr. Rettinger. “Those patients who are able to make insulin might not be able to do so with the infection, and that may last a while, and they may require insulin. You want to keep a watch on things, and if oral agents are not working well, you want to go to insulin as quickly as you can. Probably diabetics should be way more careful and maybe visit the emergency department at earlier than a nondiabetic would.”

Raghavendra Mirmira, MD, PhD, who conducts translational research on diabetes and insulin production, said that the finding was not a complete surprise to him. “With a lot of diseases, having diabetes as a comorbidity can mean worse outcomes, and that’s certainly true of influenza. It was true for the other COVID-like illnesses, such as SARS and MERS,” Dr. Mirmira, who was not involved in the research, said in an interview.

If the findings hold up in larger numbers of patients and across multiple centers, they have the potential to inform patient management, said Dr. Mirmira, director of the Translational Research Center in the department of medicine at the University of Chicago. That will be especially true as data from long-term follow-up of become available. Elevated values in some biomarkers might dictate a patient be sent straight to the ICU or dictate admission to the hospital rather than being sent home, or it could assist patient selection for some of the new therapies that physicians hope will become available.

“The more information we get [about] total outcome, the more informed we’d be about who would benefit from some of the therapies that are in clinical trials now,” he said. Still, it will be a challenge to prove causation, because patients with diabetes have unique clinical characteristics that could also be the source of the difference.

Dr. Mirmira noted that patients with diabetes only were 20 years older on average than those with no comorbidities. “It’s really hard to know if what you’re looking at for the worse outcomes for people with diabetes is because they were older, and we know that older people tend to do much worse with COVID than younger people.” Ideally, patients would also be matched by age, but there are not enough data to do that yet.

The study was funded by the China National Natural Science Foundation. The authors reported no conflicts of interest. Dr. Rettinger has no relevant financial disclosures. Dr. Mirmira is on scientific advisory boards for Veralox Therapeutics, Sigilon Therapeutics, the Indiana Biosciences Research Institute, and the Juvenile Diabetes Research Foundation.
 

SOURCE: Guo W et al. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319.

COVID-19 infection in patients with type 2 diabetes is associated with a greater increase in inflammatory and coagulation markers, compared with COVID-19 patients without diabetes, according to preliminary findings from a retrospective analysis of COVID-19 patients in Wuhan, China.

The results, though preliminary, could help explain why patients with diabetes and COVID-19 are at greater risk for more severe disease and death.

The results also suggest that more severe disease in patients with diabetes may be the result of a cytokine storm, in which the patient’s immune system overreacts to the virus and inflicts collateral damage on its own organs, according to Herbert I. Rettinger, MD, a clinical endocrinologist in Orange County, Calif., and member of the editorial advisory board for Clinical Endocrinology News. “Understanding the mechanism might help us understand the best way to treat,” COVID-19 in patients with diabetes, he said in an interview.

Dr. Rettinger, who was not involved in the research, noted that the study included only 24 patients with diabetes. Nevertheless, the finding of heightened inflammatory and coagulation markers was “fascinating.”

“This is the first paper I’ve seen [suggesting] that. I don’t know if we can extrapolate [the findings] to other populations, but if biomarkers are elevated in patients with COVID-19 and diabetes, then it’s something worth looking into, and to be aware of and cautious of. We need to pay attention to this,” he commented.

The study was led by Weina Guo and Desheng Hu at Huazhong University of Science and Technology in Wuhan, China, and published in Diabetes/Metabolism Research and Reviews.

The sample included 174 patients with COVID-19, who were treated consecutively during Feb. 10-29, 2020, at a single center. The researchers first assigned the patients to one of two groups – those with comorbid diabetes and those without. They further excluded all other comorbidities, focusing only on 26 patients with no comorbidities and 24 with only diabetes as a comorbidity, to remove all other comorbidities as possible confounding factors. Patients in the diabetes group were significantly older than those without diabetes (61 vs. 41 years, P < .01). The mortality rate was 16.5% in patients with diabetes and 0% in those without (P = .03).

COVID-19 patients with diabetes alone as a comorbidity had a greater risk for severe pneumonia, as evidenced by a higher mean CT score, compared with those without diabetes and no other comorbidities (P = .04). Patients with diabetes also had higher measures of release of tissue injury–related enzymes and were at higher risk of uncontrolled inflammation and hypercoagulable state. In particular, they had higher levels of interleukin-6 (13.7 vs. 4.1 pg/mL, respectively; P < .01), C-reactive protein (76.4 vs. 7.43 mg/L; P < .01), serum ferritin (764.8 vs. 128.9 ng/mL; P < .01), and D-dimer (1.16 vs. 0.25 mcg/mL; P < .01).

“It’s noteworthy that, for diseases that can induce a cytokine storm, IL-6 is a very good predictor of disease severity and prognosis, and its expression time is longer than other cytokines ([tumor necrosis factor] and IL-1). In addition, a significant rise in serum ferritin indicates the activation of the monocyte-macrophage system, which is a crucial part of inflammatory storm. These results indicate that patients with diabetes are susceptible to form an inflammatory storm, which eventually lead to rapid deterioration of COVID-19,” the authors wrote.

They also cited previous findings suggesting that coronavirus might exacerbate, or even cause, diabetes by seriously damaging islets (Acta Diabetol. 2010;47[3]:193-9). “Since viral infection may cause sharp fluctuation of the blood glucose levels of diabetes patients, which adversely affect the recovery of patients, there is reason to suspect that diabetes combined with SARS-CoV-2 pneumonia may form a vicious circle,” they wrote.

That’s one more reason to carefully monitor diabetes patients, said Dr. Rettinger. “Those patients who are able to make insulin might not be able to do so with the infection, and that may last a while, and they may require insulin. You want to keep a watch on things, and if oral agents are not working well, you want to go to insulin as quickly as you can. Probably diabetics should be way more careful and maybe visit the emergency department at earlier than a nondiabetic would.”

Raghavendra Mirmira, MD, PhD, who conducts translational research on diabetes and insulin production, said that the finding was not a complete surprise to him. “With a lot of diseases, having diabetes as a comorbidity can mean worse outcomes, and that’s certainly true of influenza. It was true for the other COVID-like illnesses, such as SARS and MERS,” Dr. Mirmira, who was not involved in the research, said in an interview.

If the findings hold up in larger numbers of patients and across multiple centers, they have the potential to inform patient management, said Dr. Mirmira, director of the Translational Research Center in the department of medicine at the University of Chicago. That will be especially true as data from long-term follow-up of become available. Elevated values in some biomarkers might dictate a patient be sent straight to the ICU or dictate admission to the hospital rather than being sent home, or it could assist patient selection for some of the new therapies that physicians hope will become available.

“The more information we get [about] total outcome, the more informed we’d be about who would benefit from some of the therapies that are in clinical trials now,” he said. Still, it will be a challenge to prove causation, because patients with diabetes have unique clinical characteristics that could also be the source of the difference.

Dr. Mirmira noted that patients with diabetes only were 20 years older on average than those with no comorbidities. “It’s really hard to know if what you’re looking at for the worse outcomes for people with diabetes is because they were older, and we know that older people tend to do much worse with COVID than younger people.” Ideally, patients would also be matched by age, but there are not enough data to do that yet.

The study was funded by the China National Natural Science Foundation. The authors reported no conflicts of interest. Dr. Rettinger has no relevant financial disclosures. Dr. Mirmira is on scientific advisory boards for Veralox Therapeutics, Sigilon Therapeutics, the Indiana Biosciences Research Institute, and the Juvenile Diabetes Research Foundation.
 

SOURCE: Guo W et al. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319.

Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.

On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.

Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”

Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.

Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy. 

Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.

Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.

In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.

WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.

The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.

In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19.  The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs. 

Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks.  “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”

Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.

On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.

Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”

Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.

Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy. 

Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.

Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.

In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.

WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.

The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.

In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19.  The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs. 

Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks.  “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”

Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.

On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.

Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”

Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.

Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy. 

Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.

Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.

In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.

WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.

The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.

In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19.  The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs. 

Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks.  “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”

MAUI, HAWAII – Filgotinib, the oral Janus kinase (JAK) inhibitor now under Food and Drug Administration review for the treatment of RA, has a better safety profile than some of the approved oral JAK inhibitors, but that’s unlikely to save it from being saddled with a black-box safety warning label, experts agreed at the 2020 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

“There’s probably a class label out there,” according to Mark C. Genovese, MD, professor of medicine and clinical chief of the division of immunology and rheumatology at Stanford (Calif.) University.

He cited the example of upadacitinib (Rinvoq), approved last year as the third oral JAK inhibitor for RA. Even though venous thromboembolic (VTE) events weren’t seen with any significantly increased frequency, compared with placebo, in the upadacitinib development program – unlike for the earlier-approved tofacitinib (Xeljanz) and baricitinib (Olumiant) –the FDA nevertheless required that upadacitinib’s product labeling include this black-box warning: “Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions.”

“I would fully expect that there’ll be a similar label in the filgotinib package insert saying that VTEs have been seen in other members of the class,” he predicted.

His copanelist Roy Fleischmann, MD, noted that filgotinib displayed a clean long-term safety profile in a pooled analysis of the 24-week results in the 2,088 filgotinib-treated participants in all phase 3 clinical trials for RA. For example, the incidence of herpes zoster in that large treated population was a mere 0.1%.

“Herpes zoster is almost nonexistent across the program,” observed Dr. Fleischmann, a rheumatologist at the University of Texas and medical director of the Metroplex Clinical Research Center, both in Dallas.

That’s consistent with what he’s heard from Japanese investigators about their experience. They tell him that in their studies the incidence of herpes zoster with filgotinib is five times less than with other JAK inhibitors.

The long-term pooled phase 3 filgotinib safety data also show less than a 0.1% incidence of adjudicated VTE/pulmonary embolism through 24 weeks. That’s a substantially lower rate than with tofacitinib or baricitinib, he noted.

The two rheumatologists, long-time observers of the FDA regulatory scene, stressed that they have no inside information regarding what the agency will do about filgotinib. It seems beyond doubt that the JAK inhibitor will be approved. But an open question of practical importance to clinicians is whether the agency will approve only the 100-mg dose or the 200-mg dose as well. The panelists agreed that having access to both would be advantageous since the clinical trials data indicate the higher dose is more effective and this greater efficacy doesn’t come at a cost of additional safety issues.

“If the 100 mg is sufficient, that’s great, but the reality is if you want to push to low disease activity or remission, the 200 mg seems to work better, particularly in patients who’ve already failed TNF [tumor necrosis factor] inhibitors or other biologics,” Dr. Genovese said. “If you’re not having additional safety concerns and you can get additional efficacy, I love the idea of having flexibility.”

Dr. Fleischmann is skeptical that the regulators will see things that way.

“There is a real risk that the FDA will do what it’s done before and say: ‘Well, the 200 works and the 100 works, so we’re going to approve the lower dose.’ But there doesn’t appear to be a big safety difference between 100 and 200. So I can see why they would approve the two doses, but I think that’d be unusual,” according to the rheumatologist.
 

The RA pipeline

The two speakers also highlighted several agents with novel mechanisms of action moving through the RA developmental pipeline, including olokizumab, otilimab, fenebrutinib, and a promising oral selective interleukin-1 receptor–associated kinase 4 inhibitor (IRAK4).

Olokizumab: This humanized monoclonal antibody targets IL-6. It has a different mechanism of action than the two commercially available IL-6 inhibitors approved for RA, tocilizumab (Actemra) and sarilumab (Kevzara), in that olokizumab uniquely targets the IL-6 ligand.

At the 2019 annual meeting of the American College of Rheumatology, Dr. Genovese presented the positive findings of a double-blind, placebo-controlled, randomized, phase 3 clinical trial of olokizumab in 428 RA patients with an inadequate response to methotrexate. The primary outcome, an ACR 20 response at 12 weeks, occurred in 25.9% of patients on placebo, 63.6% with 64 mg of olokizumab given subcutaneously every 2 weeks, and 70.4% with 64 mg every 4 weeks, with all participants on background methotrexate. An ACR 50 response at week 24 occurred in 7.7%, 42.7%, and 48.6%, respectively, with an acceptable side effect profile.

This was the first phase 3 trial to be presented from a large, ongoing phase 3 olokizumab developmental program for a variety of diseases.

“The results certainly support the idea that a 4-week regimen would probably be quite useful with this medication, although we’ll have to see what happens with the remaining phase 3 trials,” Dr. Genovese said.

Dr. Fleischmann posed a question: Do we really need a third IL-6 inhibitor?

That would make for a crowded field, Dr. Genovese agreed, adding that grabbing a reasonable market share for olokizumab may come down to cost, formulary access, and the convenience factor of once-monthly dosing. Whether the biologic’s unique mechanism of action in blocking the IL-6 ligand makes any practical difference in outcomes is unknown.

IRAK4 inhibitor: PF-06650833 is an oral selective reversible inhibitor of IRAK4, a key signaling kinase for IL-1 and toll-like receptors.

“This should be a really good drug for IL-1-mediated diseases,” according to Dr. Fleischmann.

In a phase 2b, double-blind, randomized, placebo-controlled, 12-week study featuring tofacitinib at 5 mg twice daily as an active comparator, the IRAK4 inhibitor exhibited dose-dependent efficacy for the primary endpoint of improvement from baseline in Simple Disease Activity Index score, compared with placebo. The same was true for the secondary endpoint, change over time in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). The trial results were also presented at the 2019 ACR annual meeting.

“This is a drug they should probably take forward and see how far it goes in RA,” he said.

Dr. Genovese concurred.

“We’re still trying to figure out how we can put together rational combinations in RA, and this might be something that could be considered as a combination play. In fact, Pfizer has already teed up a study looking at a JAK inhibitor/IRAK4 combination. The question will be whether this is a standalone or has an opportunity to be part of a combination approach,” the rheumatologist said.

Otilimab: This monoclonal antibody is a granulocyte-macrophage colony-stimulating factor inhibitor. In a secondary analysis of the BAROQUE trial, a phase 2b, 50-week study in RA inadequately responsive to methotrexate, otilimab demonstrated an impressive effect in terms of pain reduction. This new analysis, which was first presented at the 2019 ACR annual meeting, showed that, at week 12, a minimum clinically important difference in pain was achieved in 29% of placebo-treated controls, compared with 65%-75% of patients on low to higher doses of otilimab.

“The question is: Is this pain effect unique to this molecule, this pathway, or is it a simple reflection of the treated patient population?” Dr. Genovese commented. “It’s an interesting molecule. It’s being developed in RA, and it might have unique benefits on the pain side.”

A tale of two BTK inhibitors: Bruton tyrosine kinase (BTK) is an intracellular kinase viewed as a promising target in autoimmune disease. Fenebrutinib is an oral, noncovalent, reversible, and highly selective BTK inhibitor that performed well in a phase 2, randomized, double-blind, placebo-controlled clinical trial with adalimumab as an active comparator in 480 patients with an inadequate response to methotrexate in one branch, and in 98 patients with an inadequate response to TNF inhibitor therapy in the other. All subjects were on background methotrexate. (The study results were published April 9 in Arthritis & Rheumatology.)

In the group with a prior inadequate response to TNF inhibitors, the ACR 50 response rate at 12 weeks was 25% in the group on fenebrutinib at 200 mg twice daily, significantly better than the 12% rate in placebo. And there were favorable effects on biomarkers: The reduction in erythrocyte sedimentation rate from baseline was nearly twice as great with fenebrutinib, the drop in CRP was nearly three times greater than with placebo, and there was also a significantly greater decrease over time in DAS28-CRP.

In the methotrexate-inadequate responders, the ACR50 rates were 28% and 35% with the BTK inhibitor at 150 and 200 mg once daily, respectively, compared with 15% in controls.

The safety picture was encouraging, with similarly low adverse event rates across all treatment arms.

In contrast to the fenebrutinib experience, Dr. Genovese was lead investigator in a 250-patient, phase 2 study of another oral BTK inhibitor, poseltinib, which differs from fenebrutinib in that it is an irreversible covalent inhibitor. It was a failed study, with no significant difference between poseltinib and placebo in ACR 20 response at 12 weeks. It’s unclear whether the problem was insufficient dosing or that poseltinib is a failed molecule, perhaps because of its irreversible covalent binding to BTK, he said.
 

Other notable failures

The spleen tyrosine kinase (Syk) inhibitor known as GS-9876 showed no clinical efficacy in a phase 2, double-blind, randomized trial in 83 RA patients with an inadequate response to methotrexate or a biologic DMARD.

“This is like the fourth Syk inhibitor that’s failed. Syk inhibition is not sick, Syk is dead,” Dr. Fleischmann declared.

Cadherin-11 is an inflammatory cytokine expressed on fibroblasts in RA joints. In a phase 2, double-blind, randomized trial in 109 patients with RA inadequately responsive to TNF inhibitors, RG6125, a humanized monoclonal antibody directed against cadherin-11, failed to outperform placebo.

“It should have worked. It didn’t. So the question is whether this pathway is not an appropriate pathway, or the molecule was not quite the right molecule. I have a feeling it was possibly not the right molecule and the pathway may be viable,” according to Dr. Fleischmann.

He reported receiving clinical trial research grants from and serving as a consultant to more than a dozen pharmaceutical companies. Dr. Genovese also reported financial relationships with more than a dozen pharmaceutical companies.
 

[email protected]

MAUI, HAWAII – Filgotinib, the oral Janus kinase (JAK) inhibitor now under Food and Drug Administration review for the treatment of RA, has a better safety profile than some of the approved oral JAK inhibitors, but that’s unlikely to save it from being saddled with a black-box safety warning label, experts agreed at the 2020 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

“There’s probably a class label out there,” according to Mark C. Genovese, MD, professor of medicine and clinical chief of the division of immunology and rheumatology at Stanford (Calif.) University.

He cited the example of upadacitinib (Rinvoq), approved last year as the third oral JAK inhibitor for RA. Even though venous thromboembolic (VTE) events weren’t seen with any significantly increased frequency, compared with placebo, in the upadacitinib development program – unlike for the earlier-approved tofacitinib (Xeljanz) and baricitinib (Olumiant) –the FDA nevertheless required that upadacitinib’s product labeling include this black-box warning: “Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions.”

“I would fully expect that there’ll be a similar label in the filgotinib package insert saying that VTEs have been seen in other members of the class,” he predicted.

His copanelist Roy Fleischmann, MD, noted that filgotinib displayed a clean long-term safety profile in a pooled analysis of the 24-week results in the 2,088 filgotinib-treated participants in all phase 3 clinical trials for RA. For example, the incidence of herpes zoster in that large treated population was a mere 0.1%.

“Herpes zoster is almost nonexistent across the program,” observed Dr. Fleischmann, a rheumatologist at the University of Texas and medical director of the Metroplex Clinical Research Center, both in Dallas.

That’s consistent with what he’s heard from Japanese investigators about their experience. They tell him that in their studies the incidence of herpes zoster with filgotinib is five times less than with other JAK inhibitors.

The long-term pooled phase 3 filgotinib safety data also show less than a 0.1% incidence of adjudicated VTE/pulmonary embolism through 24 weeks. That’s a substantially lower rate than with tofacitinib or baricitinib, he noted.

The two rheumatologists, long-time observers of the FDA regulatory scene, stressed that they have no inside information regarding what the agency will do about filgotinib. It seems beyond doubt that the JAK inhibitor will be approved. But an open question of practical importance to clinicians is whether the agency will approve only the 100-mg dose or the 200-mg dose as well. The panelists agreed that having access to both would be advantageous since the clinical trials data indicate the higher dose is more effective and this greater efficacy doesn’t come at a cost of additional safety issues.

“If the 100 mg is sufficient, that’s great, but the reality is if you want to push to low disease activity or remission, the 200 mg seems to work better, particularly in patients who’ve already failed TNF [tumor necrosis factor] inhibitors or other biologics,” Dr. Genovese said. “If you’re not having additional safety concerns and you can get additional efficacy, I love the idea of having flexibility.”

Dr. Fleischmann is skeptical that the regulators will see things that way.

“There is a real risk that the FDA will do what it’s done before and say: ‘Well, the 200 works and the 100 works, so we’re going to approve the lower dose.’ But there doesn’t appear to be a big safety difference between 100 and 200. So I can see why they would approve the two doses, but I think that’d be unusual,” according to the rheumatologist.
 

The RA pipeline

The two speakers also highlighted several agents with novel mechanisms of action moving through the RA developmental pipeline, including olokizumab, otilimab, fenebrutinib, and a promising oral selective interleukin-1 receptor–associated kinase 4 inhibitor (IRAK4).

Olokizumab: This humanized monoclonal antibody targets IL-6. It has a different mechanism of action than the two commercially available IL-6 inhibitors approved for RA, tocilizumab (Actemra) and sarilumab (Kevzara), in that olokizumab uniquely targets the IL-6 ligand.

At the 2019 annual meeting of the American College of Rheumatology, Dr. Genovese presented the positive findings of a double-blind, placebo-controlled, randomized, phase 3 clinical trial of olokizumab in 428 RA patients with an inadequate response to methotrexate. The primary outcome, an ACR 20 response at 12 weeks, occurred in 25.9% of patients on placebo, 63.6% with 64 mg of olokizumab given subcutaneously every 2 weeks, and 70.4% with 64 mg every 4 weeks, with all participants on background methotrexate. An ACR 50 response at week 24 occurred in 7.7%, 42.7%, and 48.6%, respectively, with an acceptable side effect profile.

This was the first phase 3 trial to be presented from a large, ongoing phase 3 olokizumab developmental program for a variety of diseases.

“The results certainly support the idea that a 4-week regimen would probably be quite useful with this medication, although we’ll have to see what happens with the remaining phase 3 trials,” Dr. Genovese said.

Dr. Fleischmann posed a question: Do we really need a third IL-6 inhibitor?

That would make for a crowded field, Dr. Genovese agreed, adding that grabbing a reasonable market share for olokizumab may come down to cost, formulary access, and the convenience factor of once-monthly dosing. Whether the biologic’s unique mechanism of action in blocking the IL-6 ligand makes any practical difference in outcomes is unknown.

IRAK4 inhibitor: PF-06650833 is an oral selective reversible inhibitor of IRAK4, a key signaling kinase for IL-1 and toll-like receptors.

“This should be a really good drug for IL-1-mediated diseases,” according to Dr. Fleischmann.

In a phase 2b, double-blind, randomized, placebo-controlled, 12-week study featuring tofacitinib at 5 mg twice daily as an active comparator, the IRAK4 inhibitor exhibited dose-dependent efficacy for the primary endpoint of improvement from baseline in Simple Disease Activity Index score, compared with placebo. The same was true for the secondary endpoint, change over time in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). The trial results were also presented at the 2019 ACR annual meeting.

“This is a drug they should probably take forward and see how far it goes in RA,” he said.

Dr. Genovese concurred.

“We’re still trying to figure out how we can put together rational combinations in RA, and this might be something that could be considered as a combination play. In fact, Pfizer has already teed up a study looking at a JAK inhibitor/IRAK4 combination. The question will be whether this is a standalone or has an opportunity to be part of a combination approach,” the rheumatologist said.

Otilimab: This monoclonal antibody is a granulocyte-macrophage colony-stimulating factor inhibitor. In a secondary analysis of the BAROQUE trial, a phase 2b, 50-week study in RA inadequately responsive to methotrexate, otilimab demonstrated an impressive effect in terms of pain reduction. This new analysis, which was first presented at the 2019 ACR annual meeting, showed that, at week 12, a minimum clinically important difference in pain was achieved in 29% of placebo-treated controls, compared with 65%-75% of patients on low to higher doses of otilimab.

“The question is: Is this pain effect unique to this molecule, this pathway, or is it a simple reflection of the treated patient population?” Dr. Genovese commented. “It’s an interesting molecule. It’s being developed in RA, and it might have unique benefits on the pain side.”

A tale of two BTK inhibitors: Bruton tyrosine kinase (BTK) is an intracellular kinase viewed as a promising target in autoimmune disease. Fenebrutinib is an oral, noncovalent, reversible, and highly selective BTK inhibitor that performed well in a phase 2, randomized, double-blind, placebo-controlled clinical trial with adalimumab as an active comparator in 480 patients with an inadequate response to methotrexate in one branch, and in 98 patients with an inadequate response to TNF inhibitor therapy in the other. All subjects were on background methotrexate. (The study results were published April 9 in Arthritis & Rheumatology.)

In the group with a prior inadequate response to TNF inhibitors, the ACR 50 response rate at 12 weeks was 25% in the group on fenebrutinib at 200 mg twice daily, significantly better than the 12% rate in placebo. And there were favorable effects on biomarkers: The reduction in erythrocyte sedimentation rate from baseline was nearly twice as great with fenebrutinib, the drop in CRP was nearly three times greater than with placebo, and there was also a significantly greater decrease over time in DAS28-CRP.

In the methotrexate-inadequate responders, the ACR50 rates were 28% and 35% with the BTK inhibitor at 150 and 200 mg once daily, respectively, compared with 15% in controls.

The safety picture was encouraging, with similarly low adverse event rates across all treatment arms.

In contrast to the fenebrutinib experience, Dr. Genovese was lead investigator in a 250-patient, phase 2 study of another oral BTK inhibitor, poseltinib, which differs from fenebrutinib in that it is an irreversible covalent inhibitor. It was a failed study, with no significant difference between poseltinib and placebo in ACR 20 response at 12 weeks. It’s unclear whether the problem was insufficient dosing or that poseltinib is a failed molecule, perhaps because of its irreversible covalent binding to BTK, he said.
 

Other notable failures

The spleen tyrosine kinase (Syk) inhibitor known as GS-9876 showed no clinical efficacy in a phase 2, double-blind, randomized trial in 83 RA patients with an inadequate response to methotrexate or a biologic DMARD.

“This is like the fourth Syk inhibitor that’s failed. Syk inhibition is not sick, Syk is dead,” Dr. Fleischmann declared.

Cadherin-11 is an inflammatory cytokine expressed on fibroblasts in RA joints. In a phase 2, double-blind, randomized trial in 109 patients with RA inadequately responsive to TNF inhibitors, RG6125, a humanized monoclonal antibody directed against cadherin-11, failed to outperform placebo.

“It should have worked. It didn’t. So the question is whether this pathway is not an appropriate pathway, or the molecule was not quite the right molecule. I have a feeling it was possibly not the right molecule and the pathway may be viable,” according to Dr. Fleischmann.

He reported receiving clinical trial research grants from and serving as a consultant to more than a dozen pharmaceutical companies. Dr. Genovese also reported financial relationships with more than a dozen pharmaceutical companies.
 

[email protected]

MAUI, HAWAII – Filgotinib, the oral Janus kinase (JAK) inhibitor now under Food and Drug Administration review for the treatment of RA, has a better safety profile than some of the approved oral JAK inhibitors, but that’s unlikely to save it from being saddled with a black-box safety warning label, experts agreed at the 2020 Rheumatology Winter Clinical Symposium.

Bruce Jancin/MDedge News

“There’s probably a class label out there,” according to Mark C. Genovese, MD, professor of medicine and clinical chief of the division of immunology and rheumatology at Stanford (Calif.) University.

He cited the example of upadacitinib (Rinvoq), approved last year as the third oral JAK inhibitor for RA. Even though venous thromboembolic (VTE) events weren’t seen with any significantly increased frequency, compared with placebo, in the upadacitinib development program – unlike for the earlier-approved tofacitinib (Xeljanz) and baricitinib (Olumiant) –the FDA nevertheless required that upadacitinib’s product labeling include this black-box warning: “Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions.”

“I would fully expect that there’ll be a similar label in the filgotinib package insert saying that VTEs have been seen in other members of the class,” he predicted.

His copanelist Roy Fleischmann, MD, noted that filgotinib displayed a clean long-term safety profile in a pooled analysis of the 24-week results in the 2,088 filgotinib-treated participants in all phase 3 clinical trials for RA. For example, the incidence of herpes zoster in that large treated population was a mere 0.1%.

“Herpes zoster is almost nonexistent across the program,” observed Dr. Fleischmann, a rheumatologist at the University of Texas and medical director of the Metroplex Clinical Research Center, both in Dallas.

That’s consistent with what he’s heard from Japanese investigators about their experience. They tell him that in their studies the incidence of herpes zoster with filgotinib is five times less than with other JAK inhibitors.

The long-term pooled phase 3 filgotinib safety data also show less than a 0.1% incidence of adjudicated VTE/pulmonary embolism through 24 weeks. That’s a substantially lower rate than with tofacitinib or baricitinib, he noted.

The two rheumatologists, long-time observers of the FDA regulatory scene, stressed that they have no inside information regarding what the agency will do about filgotinib. It seems beyond doubt that the JAK inhibitor will be approved. But an open question of practical importance to clinicians is whether the agency will approve only the 100-mg dose or the 200-mg dose as well. The panelists agreed that having access to both would be advantageous since the clinical trials data indicate the higher dose is more effective and this greater efficacy doesn’t come at a cost of additional safety issues.

“If the 100 mg is sufficient, that’s great, but the reality is if you want to push to low disease activity or remission, the 200 mg seems to work better, particularly in patients who’ve already failed TNF [tumor necrosis factor] inhibitors or other biologics,” Dr. Genovese said. “If you’re not having additional safety concerns and you can get additional efficacy, I love the idea of having flexibility.”

Dr. Fleischmann is skeptical that the regulators will see things that way.

“There is a real risk that the FDA will do what it’s done before and say: ‘Well, the 200 works and the 100 works, so we’re going to approve the lower dose.’ But there doesn’t appear to be a big safety difference between 100 and 200. So I can see why they would approve the two doses, but I think that’d be unusual,” according to the rheumatologist.
 

The RA pipeline

The two speakers also highlighted several agents with novel mechanisms of action moving through the RA developmental pipeline, including olokizumab, otilimab, fenebrutinib, and a promising oral selective interleukin-1 receptor–associated kinase 4 inhibitor (IRAK4).

Olokizumab: This humanized monoclonal antibody targets IL-6. It has a different mechanism of action than the two commercially available IL-6 inhibitors approved for RA, tocilizumab (Actemra) and sarilumab (Kevzara), in that olokizumab uniquely targets the IL-6 ligand.

At the 2019 annual meeting of the American College of Rheumatology, Dr. Genovese presented the positive findings of a double-blind, placebo-controlled, randomized, phase 3 clinical trial of olokizumab in 428 RA patients with an inadequate response to methotrexate. The primary outcome, an ACR 20 response at 12 weeks, occurred in 25.9% of patients on placebo, 63.6% with 64 mg of olokizumab given subcutaneously every 2 weeks, and 70.4% with 64 mg every 4 weeks, with all participants on background methotrexate. An ACR 50 response at week 24 occurred in 7.7%, 42.7%, and 48.6%, respectively, with an acceptable side effect profile.

This was the first phase 3 trial to be presented from a large, ongoing phase 3 olokizumab developmental program for a variety of diseases.

“The results certainly support the idea that a 4-week regimen would probably be quite useful with this medication, although we’ll have to see what happens with the remaining phase 3 trials,” Dr. Genovese said.

Dr. Fleischmann posed a question: Do we really need a third IL-6 inhibitor?

That would make for a crowded field, Dr. Genovese agreed, adding that grabbing a reasonable market share for olokizumab may come down to cost, formulary access, and the convenience factor of once-monthly dosing. Whether the biologic’s unique mechanism of action in blocking the IL-6 ligand makes any practical difference in outcomes is unknown.

IRAK4 inhibitor: PF-06650833 is an oral selective reversible inhibitor of IRAK4, a key signaling kinase for IL-1 and toll-like receptors.

“This should be a really good drug for IL-1-mediated diseases,” according to Dr. Fleischmann.

In a phase 2b, double-blind, randomized, placebo-controlled, 12-week study featuring tofacitinib at 5 mg twice daily as an active comparator, the IRAK4 inhibitor exhibited dose-dependent efficacy for the primary endpoint of improvement from baseline in Simple Disease Activity Index score, compared with placebo. The same was true for the secondary endpoint, change over time in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). The trial results were also presented at the 2019 ACR annual meeting.

“This is a drug they should probably take forward and see how far it goes in RA,” he said.

Dr. Genovese concurred.

“We’re still trying to figure out how we can put together rational combinations in RA, and this might be something that could be considered as a combination play. In fact, Pfizer has already teed up a study looking at a JAK inhibitor/IRAK4 combination. The question will be whether this is a standalone or has an opportunity to be part of a combination approach,” the rheumatologist said.

Otilimab: This monoclonal antibody is a granulocyte-macrophage colony-stimulating factor inhibitor. In a secondary analysis of the BAROQUE trial, a phase 2b, 50-week study in RA inadequately responsive to methotrexate, otilimab demonstrated an impressive effect in terms of pain reduction. This new analysis, which was first presented at the 2019 ACR annual meeting, showed that, at week 12, a minimum clinically important difference in pain was achieved in 29% of placebo-treated controls, compared with 65%-75% of patients on low to higher doses of otilimab.

“The question is: Is this pain effect unique to this molecule, this pathway, or is it a simple reflection of the treated patient population?” Dr. Genovese commented. “It’s an interesting molecule. It’s being developed in RA, and it might have unique benefits on the pain side.”

A tale of two BTK inhibitors: Bruton tyrosine kinase (BTK) is an intracellular kinase viewed as a promising target in autoimmune disease. Fenebrutinib is an oral, noncovalent, reversible, and highly selective BTK inhibitor that performed well in a phase 2, randomized, double-blind, placebo-controlled clinical trial with adalimumab as an active comparator in 480 patients with an inadequate response to methotrexate in one branch, and in 98 patients with an inadequate response to TNF inhibitor therapy in the other. All subjects were on background methotrexate. (The study results were published April 9 in Arthritis & Rheumatology.)

In the group with a prior inadequate response to TNF inhibitors, the ACR 50 response rate at 12 weeks was 25% in the group on fenebrutinib at 200 mg twice daily, significantly better than the 12% rate in placebo. And there were favorable effects on biomarkers: The reduction in erythrocyte sedimentation rate from baseline was nearly twice as great with fenebrutinib, the drop in CRP was nearly three times greater than with placebo, and there was also a significantly greater decrease over time in DAS28-CRP.

In the methotrexate-inadequate responders, the ACR50 rates were 28% and 35% with the BTK inhibitor at 150 and 200 mg once daily, respectively, compared with 15% in controls.

The safety picture was encouraging, with similarly low adverse event rates across all treatment arms.

In contrast to the fenebrutinib experience, Dr. Genovese was lead investigator in a 250-patient, phase 2 study of another oral BTK inhibitor, poseltinib, which differs from fenebrutinib in that it is an irreversible covalent inhibitor. It was a failed study, with no significant difference between poseltinib and placebo in ACR 20 response at 12 weeks. It’s unclear whether the problem was insufficient dosing or that poseltinib is a failed molecule, perhaps because of its irreversible covalent binding to BTK, he said.
 

Other notable failures

The spleen tyrosine kinase (Syk) inhibitor known as GS-9876 showed no clinical efficacy in a phase 2, double-blind, randomized trial in 83 RA patients with an inadequate response to methotrexate or a biologic DMARD.

“This is like the fourth Syk inhibitor that’s failed. Syk inhibition is not sick, Syk is dead,” Dr. Fleischmann declared.

Cadherin-11 is an inflammatory cytokine expressed on fibroblasts in RA joints. In a phase 2, double-blind, randomized trial in 109 patients with RA inadequately responsive to TNF inhibitors, RG6125, a humanized monoclonal antibody directed against cadherin-11, failed to outperform placebo.

“It should have worked. It didn’t. So the question is whether this pathway is not an appropriate pathway, or the molecule was not quite the right molecule. I have a feeling it was possibly not the right molecule and the pathway may be viable,” according to Dr. Fleischmann.

He reported receiving clinical trial research grants from and serving as a consultant to more than a dozen pharmaceutical companies. Dr. Genovese also reported financial relationships with more than a dozen pharmaceutical companies.
 

[email protected]

The American Medical Association (AMA) along with scores of specialty and state medical societies are asking the Trump administration to help the nation’s clinicians out with an immediate cash infusion that they say they need to sustain their practices, many of which have been crippled by the COVID-19 crisis.

In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial assistance” from the government for all US physicians and nurse practitioners and physician assistants enrolled in Medicare or Medicaid. These payments would be equal to roughly 1 month’s worth of prepandemic revenue from all payers.

Under the methodology laid out in the letter, HHS would use an individual clinician’s average monthly Medicare payment from October to December 2019 to determine their precrisis monthly revenue.

Because Medicare business generates an average of 35% of practice revenue in most specialties, the letter suggests that HHS triple the monthly Medicare payment to calculate the amount of emergency funding it should provide to each clinician.

The letter acknowledges that this approach wouldn’t work for certain specialties, such as psychiatry, allergy/immunology, obstetrics/gynecology, and pediatrics, which derive far less revenue from Medicare than other specialties do. These physicians’ payouts “should be adjusted upward accordingly,” the letter states.

“Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the AMA writes. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

Other Emergency Funding Programs

These disbursements would be separate from the $30 billion in direct provider payments announced on April 7 by Seema Verma, the administrator of the Centers for Medicare and Medicaid Services (CMS). Because these payments are based on Medicare volume, the vast majority of this money is expected to go to hospitals.

The government is also providing financial support to hospitals, physicians, and other clinicians affected by the pandemic through CMS’s accelerated/advance payment program, as reported by Medscape Medical News. Physician practices can apply to receive upfront payments equal to 3 months’ worth of their historical Medicare payments, but they must pay back these loans, starting at 120 days after receiving them.

In addition, providers with less than 500 employees can apply for Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven.

Medical leaders defended their request for direct physician relief in excess of what these three government programs are offering.

“From the very beginning, the AMA has been advocating for [financial] support for physician practices,” AMA President Patrice Harris, MD, told Medscape Medical News. “It’s not an either/or, it’s not a choice between hospitals or physician practices, it’s both.”

She made it clear that this applied not only to the direct payments that the CURES Act allocated to healthcare providers, but also to the SBA loans.

“We’ve been pleased to see support through the Small Business Administration, and we know that many practices have applied for loans,” Harris said. “We’ll review this, because physician practices have to be included.”

Thus far, she added, “I haven’t heard of anyone [in a medical practice] who has actually received a loan. We’ll be monitoring that, because that will be key.”

Likewise, Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians (ACP), said he hadn’t heard of any practices receiving SBA loans, although many have applied.

What he has heard is that “people couldn’t even get through the SBA process and the website was freezing up. They also have to find a lender, submit documentation and get approved by the lender. And they’re competing with all the other small businesses” for a finite amount of money.

Doherty said it was unclear how many practices have received advance payments from CMS so far. CMS said it disbursed $34 billion in these payments in the first week of the program. These went to over 17,000 of the more than 25,000 applicants, CMS noted.

The ACP – which joined the AMA in its request to HHS – supports the advanced-payment program, Doherty added, but “a loan is a loan. You have to repay it. It brings in cash now, but it means you don’t have cash a few months from now. That’s different from what we’re recommending, which is an infusion of cash to practices that wouldn’t have to be repaid.”

Another advantage of the AMA-led proposal, he said, is its simplicity. It’s based on data that CMS already has, and it doesn’t require physicians to fill out forms or provide documents.

In contrast, he said, “We don’t think HHS would have the ability to process applications from thousands and thousands of physicians [for direct payments]. To create a situation where they’d have to review applications from physicians for funding out of that [CARES Act] emergency fund is probably almost impossible for HHS to administer effectively.”

Most Practices Need Help

While the medical societies’ letter makes a strong pitch for supporting physicians who are combating COVID-19, Harris and Doherty noted that physicians in all kinds of practice situations desperately need this help.

“We’ve heard from many physician practices that they have trouble making payroll,” Doherty said. “Many of them are not seeking any money out of the practices for themselves right now. They’re just trying to keep their staff employed. And some will shut their doors, unless there’s a significant and immediate infusion of money to them. From a healthcare capacity viewpoint, it’s not going to be to anyone’s benefit to see a substantial number of practices laying off staff or closing up entirely because they don’t have the money coming in to keep the doors open,” he said.

Harris agreed. “We’re hearing from practices large and small all over the country, including solo practices. Even the larger practices are losing revenue,” she pointed out. “They appropriately shut down their offices or reduced their hours. They didn’t want to contribute to the further spread of COVID-19.”

Rural practices and those launched by young physicians are facing especially difficult challenges, Harris added, and some may not make it.

It’s also important for policy makers to look ahead to what lies after the pandemic, she said. “We will come out of this, but when we come out of it there will be a lot of pent-up or unmet need where folks delayed necessary visits. Physicians and practices will have to be ready to go. If practices have to furlough some staff, it’s going to take time to ramp that up. So we’re glad to see support of physician practices so the infrastructure is strong when we start again.”

What happens if HHS turns down the medical societies’ request? “We’re hopeful that the [HHS] secretary will agree to what we’re asking,” Doherty said. While it’s always possible to ask Congress to intervene in the next stimulus bill, he said, that wouldn’t happen fast enough to get the money to physicians when they really need it.

This article first appeared on Medscape.com.

The American Medical Association (AMA) along with scores of specialty and state medical societies are asking the Trump administration to help the nation’s clinicians out with an immediate cash infusion that they say they need to sustain their practices, many of which have been crippled by the COVID-19 crisis.

In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial assistance” from the government for all US physicians and nurse practitioners and physician assistants enrolled in Medicare or Medicaid. These payments would be equal to roughly 1 month’s worth of prepandemic revenue from all payers.

Under the methodology laid out in the letter, HHS would use an individual clinician’s average monthly Medicare payment from October to December 2019 to determine their precrisis monthly revenue.

Because Medicare business generates an average of 35% of practice revenue in most specialties, the letter suggests that HHS triple the monthly Medicare payment to calculate the amount of emergency funding it should provide to each clinician.

The letter acknowledges that this approach wouldn’t work for certain specialties, such as psychiatry, allergy/immunology, obstetrics/gynecology, and pediatrics, which derive far less revenue from Medicare than other specialties do. These physicians’ payouts “should be adjusted upward accordingly,” the letter states.

“Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the AMA writes. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

Other Emergency Funding Programs

These disbursements would be separate from the $30 billion in direct provider payments announced on April 7 by Seema Verma, the administrator of the Centers for Medicare and Medicaid Services (CMS). Because these payments are based on Medicare volume, the vast majority of this money is expected to go to hospitals.

The government is also providing financial support to hospitals, physicians, and other clinicians affected by the pandemic through CMS’s accelerated/advance payment program, as reported by Medscape Medical News. Physician practices can apply to receive upfront payments equal to 3 months’ worth of their historical Medicare payments, but they must pay back these loans, starting at 120 days after receiving them.

In addition, providers with less than 500 employees can apply for Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven.

Medical leaders defended their request for direct physician relief in excess of what these three government programs are offering.

“From the very beginning, the AMA has been advocating for [financial] support for physician practices,” AMA President Patrice Harris, MD, told Medscape Medical News. “It’s not an either/or, it’s not a choice between hospitals or physician practices, it’s both.”

She made it clear that this applied not only to the direct payments that the CURES Act allocated to healthcare providers, but also to the SBA loans.

“We’ve been pleased to see support through the Small Business Administration, and we know that many practices have applied for loans,” Harris said. “We’ll review this, because physician practices have to be included.”

Thus far, she added, “I haven’t heard of anyone [in a medical practice] who has actually received a loan. We’ll be monitoring that, because that will be key.”

Likewise, Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians (ACP), said he hadn’t heard of any practices receiving SBA loans, although many have applied.

What he has heard is that “people couldn’t even get through the SBA process and the website was freezing up. They also have to find a lender, submit documentation and get approved by the lender. And they’re competing with all the other small businesses” for a finite amount of money.

Doherty said it was unclear how many practices have received advance payments from CMS so far. CMS said it disbursed $34 billion in these payments in the first week of the program. These went to over 17,000 of the more than 25,000 applicants, CMS noted.

The ACP – which joined the AMA in its request to HHS – supports the advanced-payment program, Doherty added, but “a loan is a loan. You have to repay it. It brings in cash now, but it means you don’t have cash a few months from now. That’s different from what we’re recommending, which is an infusion of cash to practices that wouldn’t have to be repaid.”

Another advantage of the AMA-led proposal, he said, is its simplicity. It’s based on data that CMS already has, and it doesn’t require physicians to fill out forms or provide documents.

In contrast, he said, “We don’t think HHS would have the ability to process applications from thousands and thousands of physicians [for direct payments]. To create a situation where they’d have to review applications from physicians for funding out of that [CARES Act] emergency fund is probably almost impossible for HHS to administer effectively.”

Most Practices Need Help

While the medical societies’ letter makes a strong pitch for supporting physicians who are combating COVID-19, Harris and Doherty noted that physicians in all kinds of practice situations desperately need this help.

“We’ve heard from many physician practices that they have trouble making payroll,” Doherty said. “Many of them are not seeking any money out of the practices for themselves right now. They’re just trying to keep their staff employed. And some will shut their doors, unless there’s a significant and immediate infusion of money to them. From a healthcare capacity viewpoint, it’s not going to be to anyone’s benefit to see a substantial number of practices laying off staff or closing up entirely because they don’t have the money coming in to keep the doors open,” he said.

Harris agreed. “We’re hearing from practices large and small all over the country, including solo practices. Even the larger practices are losing revenue,” she pointed out. “They appropriately shut down their offices or reduced their hours. They didn’t want to contribute to the further spread of COVID-19.”

Rural practices and those launched by young physicians are facing especially difficult challenges, Harris added, and some may not make it.

It’s also important for policy makers to look ahead to what lies after the pandemic, she said. “We will come out of this, but when we come out of it there will be a lot of pent-up or unmet need where folks delayed necessary visits. Physicians and practices will have to be ready to go. If practices have to furlough some staff, it’s going to take time to ramp that up. So we’re glad to see support of physician practices so the infrastructure is strong when we start again.”

What happens if HHS turns down the medical societies’ request? “We’re hopeful that the [HHS] secretary will agree to what we’re asking,” Doherty said. While it’s always possible to ask Congress to intervene in the next stimulus bill, he said, that wouldn’t happen fast enough to get the money to physicians when they really need it.

This article first appeared on Medscape.com.

The American Medical Association (AMA) along with scores of specialty and state medical societies are asking the Trump administration to help the nation’s clinicians out with an immediate cash infusion that they say they need to sustain their practices, many of which have been crippled by the COVID-19 crisis.

In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial assistance” from the government for all US physicians and nurse practitioners and physician assistants enrolled in Medicare or Medicaid. These payments would be equal to roughly 1 month’s worth of prepandemic revenue from all payers.

Under the methodology laid out in the letter, HHS would use an individual clinician’s average monthly Medicare payment from October to December 2019 to determine their precrisis monthly revenue.

Because Medicare business generates an average of 35% of practice revenue in most specialties, the letter suggests that HHS triple the monthly Medicare payment to calculate the amount of emergency funding it should provide to each clinician.

The letter acknowledges that this approach wouldn’t work for certain specialties, such as psychiatry, allergy/immunology, obstetrics/gynecology, and pediatrics, which derive far less revenue from Medicare than other specialties do. These physicians’ payouts “should be adjusted upward accordingly,” the letter states.

“Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the AMA writes. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

Other Emergency Funding Programs

These disbursements would be separate from the $30 billion in direct provider payments announced on April 7 by Seema Verma, the administrator of the Centers for Medicare and Medicaid Services (CMS). Because these payments are based on Medicare volume, the vast majority of this money is expected to go to hospitals.

The government is also providing financial support to hospitals, physicians, and other clinicians affected by the pandemic through CMS’s accelerated/advance payment program, as reported by Medscape Medical News. Physician practices can apply to receive upfront payments equal to 3 months’ worth of their historical Medicare payments, but they must pay back these loans, starting at 120 days after receiving them.

In addition, providers with less than 500 employees can apply for Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven.

Medical leaders defended their request for direct physician relief in excess of what these three government programs are offering.

“From the very beginning, the AMA has been advocating for [financial] support for physician practices,” AMA President Patrice Harris, MD, told Medscape Medical News. “It’s not an either/or, it’s not a choice between hospitals or physician practices, it’s both.”

She made it clear that this applied not only to the direct payments that the CURES Act allocated to healthcare providers, but also to the SBA loans.

“We’ve been pleased to see support through the Small Business Administration, and we know that many practices have applied for loans,” Harris said. “We’ll review this, because physician practices have to be included.”

Thus far, she added, “I haven’t heard of anyone [in a medical practice] who has actually received a loan. We’ll be monitoring that, because that will be key.”

Likewise, Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians (ACP), said he hadn’t heard of any practices receiving SBA loans, although many have applied.

What he has heard is that “people couldn’t even get through the SBA process and the website was freezing up. They also have to find a lender, submit documentation and get approved by the lender. And they’re competing with all the other small businesses” for a finite amount of money.

Doherty said it was unclear how many practices have received advance payments from CMS so far. CMS said it disbursed $34 billion in these payments in the first week of the program. These went to over 17,000 of the more than 25,000 applicants, CMS noted.

The ACP – which joined the AMA in its request to HHS – supports the advanced-payment program, Doherty added, but “a loan is a loan. You have to repay it. It brings in cash now, but it means you don’t have cash a few months from now. That’s different from what we’re recommending, which is an infusion of cash to practices that wouldn’t have to be repaid.”

Another advantage of the AMA-led proposal, he said, is its simplicity. It’s based on data that CMS already has, and it doesn’t require physicians to fill out forms or provide documents.

In contrast, he said, “We don’t think HHS would have the ability to process applications from thousands and thousands of physicians [for direct payments]. To create a situation where they’d have to review applications from physicians for funding out of that [CARES Act] emergency fund is probably almost impossible for HHS to administer effectively.”

Most Practices Need Help

While the medical societies’ letter makes a strong pitch for supporting physicians who are combating COVID-19, Harris and Doherty noted that physicians in all kinds of practice situations desperately need this help.

“We’ve heard from many physician practices that they have trouble making payroll,” Doherty said. “Many of them are not seeking any money out of the practices for themselves right now. They’re just trying to keep their staff employed. And some will shut their doors, unless there’s a significant and immediate infusion of money to them. From a healthcare capacity viewpoint, it’s not going to be to anyone’s benefit to see a substantial number of practices laying off staff or closing up entirely because they don’t have the money coming in to keep the doors open,” he said.

Harris agreed. “We’re hearing from practices large and small all over the country, including solo practices. Even the larger practices are losing revenue,” she pointed out. “They appropriately shut down their offices or reduced their hours. They didn’t want to contribute to the further spread of COVID-19.”

Rural practices and those launched by young physicians are facing especially difficult challenges, Harris added, and some may not make it.

It’s also important for policy makers to look ahead to what lies after the pandemic, she said. “We will come out of this, but when we come out of it there will be a lot of pent-up or unmet need where folks delayed necessary visits. Physicians and practices will have to be ready to go. If practices have to furlough some staff, it’s going to take time to ramp that up. So we’re glad to see support of physician practices so the infrastructure is strong when we start again.”

What happens if HHS turns down the medical societies’ request? “We’re hopeful that the [HHS] secretary will agree to what we’re asking,” Doherty said. While it’s always possible to ask Congress to intervene in the next stimulus bill, he said, that wouldn’t happen fast enough to get the money to physicians when they really need it.

This article first appeared on Medscape.com.