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COVID-19 pandemic amplifies uncertainty for immigrant hospitalists
H1-B visa program needs improvement
Statistics tell the tale of immigrants in the American health care workforce in broad strokes. In an interview, though, one hospitalist shared the particulars of his professional and personal journey since arriving in the United States from India 15 years ago.
Mihir Patel, MD, MPH, FHM, came to the United States in 2005 to complete a Master’s in Public Health. Fifteen years later, he is still waiting for the green card that signifies U.S. permanent residency status. The paperwork for the application, he said, was completed in 2012. Since then, he’s been renewing his H-1B visa every three years, and he has no expectation that anything will change soon.
“If you are from India, which has a significant backlog of green cards – up to 50 years…you just wait forever,” he said. “Many people even die waiting for their green card to arrive.”
Arriving on a student visa, Dr. Patel completed his MPH in 2008 and began an internal medicine residency that same year, holding a J-1 visa for the 3 years of his US residency program.
“Post-residency, I started working in a rural hospital in an underserved area of northeast Tennessee as a hospitalist,” thus completing the 3 years of service in a rural underserved area that’s a requirement for J-1 visa holders, said Dr. Patel. “I loved this rural community hospital so much that I ended up staying there for 6 years. During my work at this rural hospital, I was able to enjoy the autonomy of managing a small ICU, doing both critical care procedures and management of intubated critical patients while working as a hospitalist,” he said. Dr. Patel served as chief of staff at the hospital for two years, and also served on the board of directors for his 400-physician medical group.
“I was a proud member of this rural community – Rogersville,” said Dr. Patel. Although he and his wife, who was completing her hospitalist residency, lived in Johnson City, Tenn., “I did not mind driving 120 miles round trip every day to go to my small-town hospital for 6 years,” he said.
Spending this time in rural Tennessee allowed Dr. Patel to finish the requirements necessary for the Physician National Interest Waiver and submit his application for permanent residency. The waiver, though, doesn’t give him priority status in the waiting list for permanent residency status.
After a stint in northern California to be closer to extended family, the pull of “beautiful northeast Tennesse and the rural community” was too strong, so Dr. Patel and his family moved back to Johnson City in 2018.
Now, Dr. Patel is a hospitalist at Ballad Health System in Johnson City. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the COVID-19 Strike Team. He co-founded and is president of the Blue Ridge Chapter of the Society of Hospital Medicine. Under another H-1B visa, Dr. Patel works part-time from home as a telehospitalist, covering six hospitals in 4 different states.
Even in ordinary circumstances, the H-1B visa comes with constraints. Although Dr. Patel’s 6-year old daughter was born in the U.S. and is a citizen, Dr. Patel and his wife have to reapply for their visas every 3 years. “If we travel outside the U.S., we have to get our visas stamped. We cannot change jobs easily due to fear of visa denial, especially with the recent political environment,” said Dr. Patel. “It feels like we are essential health care workers but non-essential immigrants.”
Having recently completed a physician executive MBA program, Dr. Patel said he’d like to start a business of his own using Lean health care principles and telemedicine to improve rural health care. “But while on an H-1B I cannot do anything outside my sponsored employment,” he said.
Ideally, health care organizations would have high flexibility in how and where staff are deployed when a surge of COVID-19 patients hits. Dr. Patel made the point that visa restrictions can make this much harder: “During this COVID crisis, this restriction can cause significant negative impact for small rural hospitals, where local physicians are quarantined and available physicians are on a visa who cannot legally work outside their primary facilities – even though they are willing to work,” he said. “One cannot even work using telemedicine in the same health system, if that is not specifically mentioned during H-1B petition filling. More than 15,000 physicians who are struck by the green card backlog are in the same situation all over U.S.,” he added.
These constraints, though, pale before the consequences of a worst-case pandemic scenario for an immigrant family, where the physician – the primary visa-holder – becomes disabled or dies. In this case, dependent family members must self-deport. “In addition, there would not be any disability or Social Security benefits for the physician or dependents, as they are not citizens or green card holders and they cannot legally stay in the US,” noted Dr. Patel. “Any hospitalist working during the COVID-19 pandemic can have this fate due to our high exposure risk.”
Reauthorizing the H1-B visa program
SHM has been advocating to improve the H1-B visa system for years, Dr. Patel said, The Fairness for High Skilled Immigrants Act passed the U.S. House of Representatives with bipartisan support, and the Society is advocating for its passage in the Senate.
The Fairness for High-Skilled Immigrants Act (S. 386) simplifies the employment-based immigration system by removing per-country caps, converting the employment-based immigration system into a “first-come, first serve” system that does not discriminate on country of origin. The act will also help alleviate the decades-long green card and permanent residency application backlogs.
Dr. Patel emphasized the importance of action by Congress to reauthorize the physician visa waiver program and expediting physician permanent residency. “This is a crisis and we are all physicians who are ready to serve, regardless of our country of origin. Please let us help this great nation by giving us freedom from visa restrictions and providing security for our families.
“During wartime, all frontline soldiers are naturalized and given citizenship by presidential mandate; this is more than war and we are not asking for citizenship – but at least give us a green card which we have already satisfied all requirements for. If not now, then when?” he asked.
H1-B visa program needs improvement
H1-B visa program needs improvement
Statistics tell the tale of immigrants in the American health care workforce in broad strokes. In an interview, though, one hospitalist shared the particulars of his professional and personal journey since arriving in the United States from India 15 years ago.
Mihir Patel, MD, MPH, FHM, came to the United States in 2005 to complete a Master’s in Public Health. Fifteen years later, he is still waiting for the green card that signifies U.S. permanent residency status. The paperwork for the application, he said, was completed in 2012. Since then, he’s been renewing his H-1B visa every three years, and he has no expectation that anything will change soon.
“If you are from India, which has a significant backlog of green cards – up to 50 years…you just wait forever,” he said. “Many people even die waiting for their green card to arrive.”
Arriving on a student visa, Dr. Patel completed his MPH in 2008 and began an internal medicine residency that same year, holding a J-1 visa for the 3 years of his US residency program.
“Post-residency, I started working in a rural hospital in an underserved area of northeast Tennessee as a hospitalist,” thus completing the 3 years of service in a rural underserved area that’s a requirement for J-1 visa holders, said Dr. Patel. “I loved this rural community hospital so much that I ended up staying there for 6 years. During my work at this rural hospital, I was able to enjoy the autonomy of managing a small ICU, doing both critical care procedures and management of intubated critical patients while working as a hospitalist,” he said. Dr. Patel served as chief of staff at the hospital for two years, and also served on the board of directors for his 400-physician medical group.
“I was a proud member of this rural community – Rogersville,” said Dr. Patel. Although he and his wife, who was completing her hospitalist residency, lived in Johnson City, Tenn., “I did not mind driving 120 miles round trip every day to go to my small-town hospital for 6 years,” he said.
Spending this time in rural Tennessee allowed Dr. Patel to finish the requirements necessary for the Physician National Interest Waiver and submit his application for permanent residency. The waiver, though, doesn’t give him priority status in the waiting list for permanent residency status.
After a stint in northern California to be closer to extended family, the pull of “beautiful northeast Tennesse and the rural community” was too strong, so Dr. Patel and his family moved back to Johnson City in 2018.
Now, Dr. Patel is a hospitalist at Ballad Health System in Johnson City. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the COVID-19 Strike Team. He co-founded and is president of the Blue Ridge Chapter of the Society of Hospital Medicine. Under another H-1B visa, Dr. Patel works part-time from home as a telehospitalist, covering six hospitals in 4 different states.
Even in ordinary circumstances, the H-1B visa comes with constraints. Although Dr. Patel’s 6-year old daughter was born in the U.S. and is a citizen, Dr. Patel and his wife have to reapply for their visas every 3 years. “If we travel outside the U.S., we have to get our visas stamped. We cannot change jobs easily due to fear of visa denial, especially with the recent political environment,” said Dr. Patel. “It feels like we are essential health care workers but non-essential immigrants.”
Having recently completed a physician executive MBA program, Dr. Patel said he’d like to start a business of his own using Lean health care principles and telemedicine to improve rural health care. “But while on an H-1B I cannot do anything outside my sponsored employment,” he said.
Ideally, health care organizations would have high flexibility in how and where staff are deployed when a surge of COVID-19 patients hits. Dr. Patel made the point that visa restrictions can make this much harder: “During this COVID crisis, this restriction can cause significant negative impact for small rural hospitals, where local physicians are quarantined and available physicians are on a visa who cannot legally work outside their primary facilities – even though they are willing to work,” he said. “One cannot even work using telemedicine in the same health system, if that is not specifically mentioned during H-1B petition filling. More than 15,000 physicians who are struck by the green card backlog are in the same situation all over U.S.,” he added.
These constraints, though, pale before the consequences of a worst-case pandemic scenario for an immigrant family, where the physician – the primary visa-holder – becomes disabled or dies. In this case, dependent family members must self-deport. “In addition, there would not be any disability or Social Security benefits for the physician or dependents, as they are not citizens or green card holders and they cannot legally stay in the US,” noted Dr. Patel. “Any hospitalist working during the COVID-19 pandemic can have this fate due to our high exposure risk.”
Reauthorizing the H1-B visa program
SHM has been advocating to improve the H1-B visa system for years, Dr. Patel said, The Fairness for High Skilled Immigrants Act passed the U.S. House of Representatives with bipartisan support, and the Society is advocating for its passage in the Senate.
The Fairness for High-Skilled Immigrants Act (S. 386) simplifies the employment-based immigration system by removing per-country caps, converting the employment-based immigration system into a “first-come, first serve” system that does not discriminate on country of origin. The act will also help alleviate the decades-long green card and permanent residency application backlogs.
Dr. Patel emphasized the importance of action by Congress to reauthorize the physician visa waiver program and expediting physician permanent residency. “This is a crisis and we are all physicians who are ready to serve, regardless of our country of origin. Please let us help this great nation by giving us freedom from visa restrictions and providing security for our families.
“During wartime, all frontline soldiers are naturalized and given citizenship by presidential mandate; this is more than war and we are not asking for citizenship – but at least give us a green card which we have already satisfied all requirements for. If not now, then when?” he asked.
Statistics tell the tale of immigrants in the American health care workforce in broad strokes. In an interview, though, one hospitalist shared the particulars of his professional and personal journey since arriving in the United States from India 15 years ago.
Mihir Patel, MD, MPH, FHM, came to the United States in 2005 to complete a Master’s in Public Health. Fifteen years later, he is still waiting for the green card that signifies U.S. permanent residency status. The paperwork for the application, he said, was completed in 2012. Since then, he’s been renewing his H-1B visa every three years, and he has no expectation that anything will change soon.
“If you are from India, which has a significant backlog of green cards – up to 50 years…you just wait forever,” he said. “Many people even die waiting for their green card to arrive.”
Arriving on a student visa, Dr. Patel completed his MPH in 2008 and began an internal medicine residency that same year, holding a J-1 visa for the 3 years of his US residency program.
“Post-residency, I started working in a rural hospital in an underserved area of northeast Tennessee as a hospitalist,” thus completing the 3 years of service in a rural underserved area that’s a requirement for J-1 visa holders, said Dr. Patel. “I loved this rural community hospital so much that I ended up staying there for 6 years. During my work at this rural hospital, I was able to enjoy the autonomy of managing a small ICU, doing both critical care procedures and management of intubated critical patients while working as a hospitalist,” he said. Dr. Patel served as chief of staff at the hospital for two years, and also served on the board of directors for his 400-physician medical group.
“I was a proud member of this rural community – Rogersville,” said Dr. Patel. Although he and his wife, who was completing her hospitalist residency, lived in Johnson City, Tenn., “I did not mind driving 120 miles round trip every day to go to my small-town hospital for 6 years,” he said.
Spending this time in rural Tennessee allowed Dr. Patel to finish the requirements necessary for the Physician National Interest Waiver and submit his application for permanent residency. The waiver, though, doesn’t give him priority status in the waiting list for permanent residency status.
After a stint in northern California to be closer to extended family, the pull of “beautiful northeast Tennesse and the rural community” was too strong, so Dr. Patel and his family moved back to Johnson City in 2018.
Now, Dr. Patel is a hospitalist at Ballad Health System in Johnson City. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the COVID-19 Strike Team. He co-founded and is president of the Blue Ridge Chapter of the Society of Hospital Medicine. Under another H-1B visa, Dr. Patel works part-time from home as a telehospitalist, covering six hospitals in 4 different states.
Even in ordinary circumstances, the H-1B visa comes with constraints. Although Dr. Patel’s 6-year old daughter was born in the U.S. and is a citizen, Dr. Patel and his wife have to reapply for their visas every 3 years. “If we travel outside the U.S., we have to get our visas stamped. We cannot change jobs easily due to fear of visa denial, especially with the recent political environment,” said Dr. Patel. “It feels like we are essential health care workers but non-essential immigrants.”
Having recently completed a physician executive MBA program, Dr. Patel said he’d like to start a business of his own using Lean health care principles and telemedicine to improve rural health care. “But while on an H-1B I cannot do anything outside my sponsored employment,” he said.
Ideally, health care organizations would have high flexibility in how and where staff are deployed when a surge of COVID-19 patients hits. Dr. Patel made the point that visa restrictions can make this much harder: “During this COVID crisis, this restriction can cause significant negative impact for small rural hospitals, where local physicians are quarantined and available physicians are on a visa who cannot legally work outside their primary facilities – even though they are willing to work,” he said. “One cannot even work using telemedicine in the same health system, if that is not specifically mentioned during H-1B petition filling. More than 15,000 physicians who are struck by the green card backlog are in the same situation all over U.S.,” he added.
These constraints, though, pale before the consequences of a worst-case pandemic scenario for an immigrant family, where the physician – the primary visa-holder – becomes disabled or dies. In this case, dependent family members must self-deport. “In addition, there would not be any disability or Social Security benefits for the physician or dependents, as they are not citizens or green card holders and they cannot legally stay in the US,” noted Dr. Patel. “Any hospitalist working during the COVID-19 pandemic can have this fate due to our high exposure risk.”
Reauthorizing the H1-B visa program
SHM has been advocating to improve the H1-B visa system for years, Dr. Patel said, The Fairness for High Skilled Immigrants Act passed the U.S. House of Representatives with bipartisan support, and the Society is advocating for its passage in the Senate.
The Fairness for High-Skilled Immigrants Act (S. 386) simplifies the employment-based immigration system by removing per-country caps, converting the employment-based immigration system into a “first-come, first serve” system that does not discriminate on country of origin. The act will also help alleviate the decades-long green card and permanent residency application backlogs.
Dr. Patel emphasized the importance of action by Congress to reauthorize the physician visa waiver program and expediting physician permanent residency. “This is a crisis and we are all physicians who are ready to serve, regardless of our country of origin. Please let us help this great nation by giving us freedom from visa restrictions and providing security for our families.
“During wartime, all frontline soldiers are naturalized and given citizenship by presidential mandate; this is more than war and we are not asking for citizenship – but at least give us a green card which we have already satisfied all requirements for. If not now, then when?” he asked.
Visa worries besiege immigrant physicians fighting COVID-19
Physicians and their sponsoring health care facilities shouldn’t have to worry about visa technicalities as they work on the front lines during the COVID-19 pandemic, said health care leaders and immigration reform advocates.
In a press call hosted by the National Immigration Forum, speakers highlighted the need for fast and flexible solutions to enable health care workers, including physicians, to contribute to efforts to combat the pandemic.
Nationwide, over one in five physicians are immigrants, according to data from the Forum. That figure is over one in three in New York, New Jersey, and California, three states hard-hit by COVID-19 cases.
Many physicians stand willing and able to serve where they’re needed, but visa restrictions often block the ability of immigrant physicians to meet COVID-19 surges across the country, said Amit Vashist, MD, senior vice president and chief clinical officer for Ballad Health, Johnson City, Tenn., and a member of the public policy committee of the Society of Hospital Medicine. Ballad Health is an integrated health care system that serves 29 counties in the rural Southeast.
“This pandemic is a war with an invisible enemy, and immigrant physicians have been absolutely critical to providing quality care, especially on the front lines – but current visa restrictions have limited the ability to deploy these physicians in communities with the greatest need,” said Dr. Vashist during the press conference.
Visa requirements currently tie a non-US citizen resident physician to a particular institution and facility, limiting the ability to meet demand flexibly. “Federal agencies and Congress should provide additional flexibility in visa processing to allow for automatic renewals and expediting processing so immigrant medical workers can focus on treating the sick and not on their visa requirements,” said Dr. Vashist.
Dr. Vashist noted that, when he speaks with the many Ballad Health hospitalists who are waiting on permanent residency or citizenship, many of them also cite worries about the fate of their families should they themselves fall ill. Depending on the physician’s visa status, the family may face deportation without recourse if the physician should die.
“Tens of thousands of our physicians continue to endure years, even decades of waiting to obtain a permanent residency in the United States and at the same time, relentlessly and fearlessly serve their communities including in this COVID-19 pandemic,” said Dr. Vashist. “It’s time we take care of them and their long-term immigration needs, and give them the peace of mind that they so desperately deserve,” he added.
Frank Trinity, chief legal officer for the Association of American Medical Colleges, also participated in the call. “For decades,” he said, the United States “has relied on physicians from other countries, especially in rural and underserved areas.”
One of these physicians, Mihir Patel, MD, FHM, a hospitalist at Ballad Health, came to the United States in 2005, but 15 years later is still waiting for the green card that signifies U.S. permanent residency status. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the health system’s COVID-10 Strike Team.
“During the COVID crisis, these restrictions can cause significant negative impact for small rural hospitals,” Dr. Patel said. “There are physicians on a visa who cannot legally work outside their primary facilities – even though they are willing to do so.”
Regarding the pandemic, Mr. Trinity expressed concerns about whether the surge of patients would “outstrip our workforce.” He noted that, with an unprecedented number of desperately ill patients needing emergency care all across the country, “now is the time for our government to take every possible action to ensure that these highly qualified and courageous health professionals are available in the fight against the coronavirus.”
Mr. Trinity outlined five governmental actions AAMC is proposing to allow immigrant physicians to participate fully in the battle against COVID-19. The first would be to approve a blanket extension of visa deadlines. The second would be to expedite processing of visa extension applications, including reinstating expedited processing of physicians currently holding H-1B visa status.
The third action proposed by AAMC is to provide flexibility to visa sponsors during the emergency so that an individual whose visa is currently limited to a particular program can provide care at another location or by means of telehealth.
Fourth, AAMC proposes streamlined entry for the 4,200 physicians who are matched into residency programs so that they may begin their residencies on time or early.
Finally, Mr. Trinity said that AAMC is proposing that work authorizations be maintained for the 29,000 physicians who are currently not U.S. citizens and actively participating in the health care workforce.
Jacinta Ma, the Forum’s vice president of policy and advocacy, said immigrants are a critical component of the U.S. health care workforce as a whole.
“With immigrants accounting for 17% of health care workers amid the COVID-19 pandemic, it’s clear that they are vital to our communities,” she said. “Congress and the Trump administration both have an opportunity to advance solutions that protect immigrants, and remove immigration-related barriers for immigrant medical professionals by ensuring that immigrant doctors, nurses, home health care workers, researchers, and others can continue their vital work during this pandemic while being afforded adequate protection from COVID-19.”
Physicians and their sponsoring health care facilities shouldn’t have to worry about visa technicalities as they work on the front lines during the COVID-19 pandemic, said health care leaders and immigration reform advocates.
In a press call hosted by the National Immigration Forum, speakers highlighted the need for fast and flexible solutions to enable health care workers, including physicians, to contribute to efforts to combat the pandemic.
Nationwide, over one in five physicians are immigrants, according to data from the Forum. That figure is over one in three in New York, New Jersey, and California, three states hard-hit by COVID-19 cases.
Many physicians stand willing and able to serve where they’re needed, but visa restrictions often block the ability of immigrant physicians to meet COVID-19 surges across the country, said Amit Vashist, MD, senior vice president and chief clinical officer for Ballad Health, Johnson City, Tenn., and a member of the public policy committee of the Society of Hospital Medicine. Ballad Health is an integrated health care system that serves 29 counties in the rural Southeast.
“This pandemic is a war with an invisible enemy, and immigrant physicians have been absolutely critical to providing quality care, especially on the front lines – but current visa restrictions have limited the ability to deploy these physicians in communities with the greatest need,” said Dr. Vashist during the press conference.
Visa requirements currently tie a non-US citizen resident physician to a particular institution and facility, limiting the ability to meet demand flexibly. “Federal agencies and Congress should provide additional flexibility in visa processing to allow for automatic renewals and expediting processing so immigrant medical workers can focus on treating the sick and not on their visa requirements,” said Dr. Vashist.
Dr. Vashist noted that, when he speaks with the many Ballad Health hospitalists who are waiting on permanent residency or citizenship, many of them also cite worries about the fate of their families should they themselves fall ill. Depending on the physician’s visa status, the family may face deportation without recourse if the physician should die.
“Tens of thousands of our physicians continue to endure years, even decades of waiting to obtain a permanent residency in the United States and at the same time, relentlessly and fearlessly serve their communities including in this COVID-19 pandemic,” said Dr. Vashist. “It’s time we take care of them and their long-term immigration needs, and give them the peace of mind that they so desperately deserve,” he added.
Frank Trinity, chief legal officer for the Association of American Medical Colleges, also participated in the call. “For decades,” he said, the United States “has relied on physicians from other countries, especially in rural and underserved areas.”
One of these physicians, Mihir Patel, MD, FHM, a hospitalist at Ballad Health, came to the United States in 2005, but 15 years later is still waiting for the green card that signifies U.S. permanent residency status. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the health system’s COVID-10 Strike Team.
“During the COVID crisis, these restrictions can cause significant negative impact for small rural hospitals,” Dr. Patel said. “There are physicians on a visa who cannot legally work outside their primary facilities – even though they are willing to do so.”
Regarding the pandemic, Mr. Trinity expressed concerns about whether the surge of patients would “outstrip our workforce.” He noted that, with an unprecedented number of desperately ill patients needing emergency care all across the country, “now is the time for our government to take every possible action to ensure that these highly qualified and courageous health professionals are available in the fight against the coronavirus.”
Mr. Trinity outlined five governmental actions AAMC is proposing to allow immigrant physicians to participate fully in the battle against COVID-19. The first would be to approve a blanket extension of visa deadlines. The second would be to expedite processing of visa extension applications, including reinstating expedited processing of physicians currently holding H-1B visa status.
The third action proposed by AAMC is to provide flexibility to visa sponsors during the emergency so that an individual whose visa is currently limited to a particular program can provide care at another location or by means of telehealth.
Fourth, AAMC proposes streamlined entry for the 4,200 physicians who are matched into residency programs so that they may begin their residencies on time or early.
Finally, Mr. Trinity said that AAMC is proposing that work authorizations be maintained for the 29,000 physicians who are currently not U.S. citizens and actively participating in the health care workforce.
Jacinta Ma, the Forum’s vice president of policy and advocacy, said immigrants are a critical component of the U.S. health care workforce as a whole.
“With immigrants accounting for 17% of health care workers amid the COVID-19 pandemic, it’s clear that they are vital to our communities,” she said. “Congress and the Trump administration both have an opportunity to advance solutions that protect immigrants, and remove immigration-related barriers for immigrant medical professionals by ensuring that immigrant doctors, nurses, home health care workers, researchers, and others can continue their vital work during this pandemic while being afforded adequate protection from COVID-19.”
Physicians and their sponsoring health care facilities shouldn’t have to worry about visa technicalities as they work on the front lines during the COVID-19 pandemic, said health care leaders and immigration reform advocates.
In a press call hosted by the National Immigration Forum, speakers highlighted the need for fast and flexible solutions to enable health care workers, including physicians, to contribute to efforts to combat the pandemic.
Nationwide, over one in five physicians are immigrants, according to data from the Forum. That figure is over one in three in New York, New Jersey, and California, three states hard-hit by COVID-19 cases.
Many physicians stand willing and able to serve where they’re needed, but visa restrictions often block the ability of immigrant physicians to meet COVID-19 surges across the country, said Amit Vashist, MD, senior vice president and chief clinical officer for Ballad Health, Johnson City, Tenn., and a member of the public policy committee of the Society of Hospital Medicine. Ballad Health is an integrated health care system that serves 29 counties in the rural Southeast.
“This pandemic is a war with an invisible enemy, and immigrant physicians have been absolutely critical to providing quality care, especially on the front lines – but current visa restrictions have limited the ability to deploy these physicians in communities with the greatest need,” said Dr. Vashist during the press conference.
Visa requirements currently tie a non-US citizen resident physician to a particular institution and facility, limiting the ability to meet demand flexibly. “Federal agencies and Congress should provide additional flexibility in visa processing to allow for automatic renewals and expediting processing so immigrant medical workers can focus on treating the sick and not on their visa requirements,” said Dr. Vashist.
Dr. Vashist noted that, when he speaks with the many Ballad Health hospitalists who are waiting on permanent residency or citizenship, many of them also cite worries about the fate of their families should they themselves fall ill. Depending on the physician’s visa status, the family may face deportation without recourse if the physician should die.
“Tens of thousands of our physicians continue to endure years, even decades of waiting to obtain a permanent residency in the United States and at the same time, relentlessly and fearlessly serve their communities including in this COVID-19 pandemic,” said Dr. Vashist. “It’s time we take care of them and their long-term immigration needs, and give them the peace of mind that they so desperately deserve,” he added.
Frank Trinity, chief legal officer for the Association of American Medical Colleges, also participated in the call. “For decades,” he said, the United States “has relied on physicians from other countries, especially in rural and underserved areas.”
One of these physicians, Mihir Patel, MD, FHM, a hospitalist at Ballad Health, came to the United States in 2005, but 15 years later is still waiting for the green card that signifies U.S. permanent residency status. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the health system’s COVID-10 Strike Team.
“During the COVID crisis, these restrictions can cause significant negative impact for small rural hospitals,” Dr. Patel said. “There are physicians on a visa who cannot legally work outside their primary facilities – even though they are willing to do so.”
Regarding the pandemic, Mr. Trinity expressed concerns about whether the surge of patients would “outstrip our workforce.” He noted that, with an unprecedented number of desperately ill patients needing emergency care all across the country, “now is the time for our government to take every possible action to ensure that these highly qualified and courageous health professionals are available in the fight against the coronavirus.”
Mr. Trinity outlined five governmental actions AAMC is proposing to allow immigrant physicians to participate fully in the battle against COVID-19. The first would be to approve a blanket extension of visa deadlines. The second would be to expedite processing of visa extension applications, including reinstating expedited processing of physicians currently holding H-1B visa status.
The third action proposed by AAMC is to provide flexibility to visa sponsors during the emergency so that an individual whose visa is currently limited to a particular program can provide care at another location or by means of telehealth.
Fourth, AAMC proposes streamlined entry for the 4,200 physicians who are matched into residency programs so that they may begin their residencies on time or early.
Finally, Mr. Trinity said that AAMC is proposing that work authorizations be maintained for the 29,000 physicians who are currently not U.S. citizens and actively participating in the health care workforce.
Jacinta Ma, the Forum’s vice president of policy and advocacy, said immigrants are a critical component of the U.S. health care workforce as a whole.
“With immigrants accounting for 17% of health care workers amid the COVID-19 pandemic, it’s clear that they are vital to our communities,” she said. “Congress and the Trump administration both have an opportunity to advance solutions that protect immigrants, and remove immigration-related barriers for immigrant medical professionals by ensuring that immigrant doctors, nurses, home health care workers, researchers, and others can continue their vital work during this pandemic while being afforded adequate protection from COVID-19.”
Inactivated Bifidobacterium improves IBS symptoms
pointing the way to a therapeutic path that could avoid some risks of live probiotic use.
Of 443 patients taking part in a randomized, double-blind, placebo-controlled trial of a heat-inactivated nonviable Bifidobacterium probiotic, 221 received the probiotic while 222 received placebo capsules. The study’s primary endpoint was a composite of at least 30% improvement in abdominal pain and “adequate relief” of overall irritable bowel syndrome (IBS) symptoms in at least 4 of the 8 weeks of the study.
Within the B. bifidum group, 74 patients (34%) reached this endpoint, compared with 43 (19%) of those in the placebo group, for a risk ratio of 1.7 (P = .0007). Patients had no serious adverse events from the oral therapy, which they took in the form of two capsules daily for 8 weeks, and participants found both the inactivated Bifidobacterium treatment and placebo tolerable overall.
Bowel movements became more frequent in those who received B. bifidum capsules who had constipation-predominant IBS and less frequent in those with diarrhea-predominant IBS; the changes were statistically significant in both subgroups.
“Some probiotic strains can adhere well to epithelial cells and strengthen intestinal barrier function, providing an explanation for the efficacy of at least some probiotics in the treatment of IBS,” wrote Viola Andresen, MD, MSc, the study‘s lead author.
“Accordingly, enhancing the gut barrier is a useful treatment approach for patients with IBS,” added Dr. Andresen, of the department of internal medicine at the University of Hamburg (Germany) Teaching Hospital, and collaborators. The adherent properties of some strains of Bifidobacteria are mainly dependent on properties of the cell surface that are not changed by heat inactivation, which makes the bacteria nonviable – and removes the risk of infection.
Additional benefits of using nonviable bacteria for IBS therapy might include more stability and enhanced standardization, although previous studies have shown a reduction in efficacy when bacteria are made nonviable. Inactivated B. bifidum MIMBb75 was used in this study because it had previously been shown effective against IBS symptoms, noted Dr. Andresen and coauthors.
Adult patients were included if they met criteria for IBS according to Rome III and had abdominal pain rated at least 4 on an 11-point scale for at least 2 days of a 2-week run-in phase. Among the many criteria for exclusion from the study were history of inflammatory gastrointestinal disease, cancer, other serious stomach diseases, diabetes, many abdominal surgeries, and recent antipsychotic or steroid use.
During the study, participants recorded their abdominal pain over the last 24 hours daily; weekly averages were tallied for each patient. Patients were also asked to rate their relief of IBS symptoms, including abdominal pain, bowel habits, and other symptoms over the past week at weekly time points on a 7-point Likert scale, where scores of 3 or less indicated some measure of relief; IBS symptoms were considered to be adequately relieved with a score of 3 or less.
Secondary outcome measures for the study included changes in the Subjects’ Global Assessment of symptoms, and changes in individual symptoms. Number of bowel movements, stool form, sensation of incomplete evacuation, and medication use were also recorded daily.
Participants were aged a mean of 41 years, and about 70% were female. The mean body mass index was just under 25 kg/m2. About half of each study arm had diarrhea-predominant IBS. About a quarter had constipation-predominant IBS, and most of the rest were not subtyped.
Looking at the primary endpoint, the number needed to treat for benefit was 7.1 in favor of the inactivated bacterium, using an intention-to-treat analysis. Results were similar when a per-protocol analysis was applied. The investigators saw response to treatment climb through the duration of the study for both the probiotic and the placebo arms, with the gap in improvement between the groups widening over the 8-week study period.
“It might be assumed that the use of nonviable bacteria for the treatment of IBS could be a safe alternative, even in patients who are potentially susceptible to infection,” concluded Dr. Andresen and colleagues. A further advantage, noted the researchers, is greater product stability in fluctuating temperatures compared with viable bacteria, ensuring better standardization even in regions with warm or changing climates.
Perspective was offered in an accompanying commentary whose lead author was Nicholas Talley, MD, PhD, a gastroenterologist, adjunct professor, and pro vice-chancellor for global research at the University of Newcastle (Australia).
“By heat inactivating the bacteria the researchers did not administer a probiotic but a bacterial therapy,” wrote Dr. Talley and coauthors. In any event, they added, the exact mechanism by which probiotics benefit individuals with IBS is unknown.
“The concept that a probiotic might be efficacious in IBS even if nonviable organisms are administered is an important observation,” they wrote. Fewer benefits have been seen with oral probiotic therapy than with fecal microbial transfer, and oral therapy does not produce durable results unless administered on a chronic basis, Dr. Talley and coauthors added.
“The absence of fundamental knowledge in terms of how bacterial therapy alters mechanisms in IBS continues to hamper improvements in treatment, limiting any success to short-term symptom control rather than the true goal, reversal of disease,” they concluded.
The study was funded by Synformulas. Dr. Andresen reported financial relationships with several pharmaceutical companies. Dr. Talley reported financial relationships with several pharmaceutical and nutritional companies.
SOURCE: Andresen V et al. Lancet Gastroenterol Hepatol. 2020 Apr 8. doi: 10.1016/S2468-1253(20)30079-0
pointing the way to a therapeutic path that could avoid some risks of live probiotic use.
Of 443 patients taking part in a randomized, double-blind, placebo-controlled trial of a heat-inactivated nonviable Bifidobacterium probiotic, 221 received the probiotic while 222 received placebo capsules. The study’s primary endpoint was a composite of at least 30% improvement in abdominal pain and “adequate relief” of overall irritable bowel syndrome (IBS) symptoms in at least 4 of the 8 weeks of the study.
Within the B. bifidum group, 74 patients (34%) reached this endpoint, compared with 43 (19%) of those in the placebo group, for a risk ratio of 1.7 (P = .0007). Patients had no serious adverse events from the oral therapy, which they took in the form of two capsules daily for 8 weeks, and participants found both the inactivated Bifidobacterium treatment and placebo tolerable overall.
Bowel movements became more frequent in those who received B. bifidum capsules who had constipation-predominant IBS and less frequent in those with diarrhea-predominant IBS; the changes were statistically significant in both subgroups.
“Some probiotic strains can adhere well to epithelial cells and strengthen intestinal barrier function, providing an explanation for the efficacy of at least some probiotics in the treatment of IBS,” wrote Viola Andresen, MD, MSc, the study‘s lead author.
“Accordingly, enhancing the gut barrier is a useful treatment approach for patients with IBS,” added Dr. Andresen, of the department of internal medicine at the University of Hamburg (Germany) Teaching Hospital, and collaborators. The adherent properties of some strains of Bifidobacteria are mainly dependent on properties of the cell surface that are not changed by heat inactivation, which makes the bacteria nonviable – and removes the risk of infection.
Additional benefits of using nonviable bacteria for IBS therapy might include more stability and enhanced standardization, although previous studies have shown a reduction in efficacy when bacteria are made nonviable. Inactivated B. bifidum MIMBb75 was used in this study because it had previously been shown effective against IBS symptoms, noted Dr. Andresen and coauthors.
Adult patients were included if they met criteria for IBS according to Rome III and had abdominal pain rated at least 4 on an 11-point scale for at least 2 days of a 2-week run-in phase. Among the many criteria for exclusion from the study were history of inflammatory gastrointestinal disease, cancer, other serious stomach diseases, diabetes, many abdominal surgeries, and recent antipsychotic or steroid use.
During the study, participants recorded their abdominal pain over the last 24 hours daily; weekly averages were tallied for each patient. Patients were also asked to rate their relief of IBS symptoms, including abdominal pain, bowel habits, and other symptoms over the past week at weekly time points on a 7-point Likert scale, where scores of 3 or less indicated some measure of relief; IBS symptoms were considered to be adequately relieved with a score of 3 or less.
Secondary outcome measures for the study included changes in the Subjects’ Global Assessment of symptoms, and changes in individual symptoms. Number of bowel movements, stool form, sensation of incomplete evacuation, and medication use were also recorded daily.
Participants were aged a mean of 41 years, and about 70% were female. The mean body mass index was just under 25 kg/m2. About half of each study arm had diarrhea-predominant IBS. About a quarter had constipation-predominant IBS, and most of the rest were not subtyped.
Looking at the primary endpoint, the number needed to treat for benefit was 7.1 in favor of the inactivated bacterium, using an intention-to-treat analysis. Results were similar when a per-protocol analysis was applied. The investigators saw response to treatment climb through the duration of the study for both the probiotic and the placebo arms, with the gap in improvement between the groups widening over the 8-week study period.
“It might be assumed that the use of nonviable bacteria for the treatment of IBS could be a safe alternative, even in patients who are potentially susceptible to infection,” concluded Dr. Andresen and colleagues. A further advantage, noted the researchers, is greater product stability in fluctuating temperatures compared with viable bacteria, ensuring better standardization even in regions with warm or changing climates.
Perspective was offered in an accompanying commentary whose lead author was Nicholas Talley, MD, PhD, a gastroenterologist, adjunct professor, and pro vice-chancellor for global research at the University of Newcastle (Australia).
“By heat inactivating the bacteria the researchers did not administer a probiotic but a bacterial therapy,” wrote Dr. Talley and coauthors. In any event, they added, the exact mechanism by which probiotics benefit individuals with IBS is unknown.
“The concept that a probiotic might be efficacious in IBS even if nonviable organisms are administered is an important observation,” they wrote. Fewer benefits have been seen with oral probiotic therapy than with fecal microbial transfer, and oral therapy does not produce durable results unless administered on a chronic basis, Dr. Talley and coauthors added.
“The absence of fundamental knowledge in terms of how bacterial therapy alters mechanisms in IBS continues to hamper improvements in treatment, limiting any success to short-term symptom control rather than the true goal, reversal of disease,” they concluded.
The study was funded by Synformulas. Dr. Andresen reported financial relationships with several pharmaceutical companies. Dr. Talley reported financial relationships with several pharmaceutical and nutritional companies.
SOURCE: Andresen V et al. Lancet Gastroenterol Hepatol. 2020 Apr 8. doi: 10.1016/S2468-1253(20)30079-0
pointing the way to a therapeutic path that could avoid some risks of live probiotic use.
Of 443 patients taking part in a randomized, double-blind, placebo-controlled trial of a heat-inactivated nonviable Bifidobacterium probiotic, 221 received the probiotic while 222 received placebo capsules. The study’s primary endpoint was a composite of at least 30% improvement in abdominal pain and “adequate relief” of overall irritable bowel syndrome (IBS) symptoms in at least 4 of the 8 weeks of the study.
Within the B. bifidum group, 74 patients (34%) reached this endpoint, compared with 43 (19%) of those in the placebo group, for a risk ratio of 1.7 (P = .0007). Patients had no serious adverse events from the oral therapy, which they took in the form of two capsules daily for 8 weeks, and participants found both the inactivated Bifidobacterium treatment and placebo tolerable overall.
Bowel movements became more frequent in those who received B. bifidum capsules who had constipation-predominant IBS and less frequent in those with diarrhea-predominant IBS; the changes were statistically significant in both subgroups.
“Some probiotic strains can adhere well to epithelial cells and strengthen intestinal barrier function, providing an explanation for the efficacy of at least some probiotics in the treatment of IBS,” wrote Viola Andresen, MD, MSc, the study‘s lead author.
“Accordingly, enhancing the gut barrier is a useful treatment approach for patients with IBS,” added Dr. Andresen, of the department of internal medicine at the University of Hamburg (Germany) Teaching Hospital, and collaborators. The adherent properties of some strains of Bifidobacteria are mainly dependent on properties of the cell surface that are not changed by heat inactivation, which makes the bacteria nonviable – and removes the risk of infection.
Additional benefits of using nonviable bacteria for IBS therapy might include more stability and enhanced standardization, although previous studies have shown a reduction in efficacy when bacteria are made nonviable. Inactivated B. bifidum MIMBb75 was used in this study because it had previously been shown effective against IBS symptoms, noted Dr. Andresen and coauthors.
Adult patients were included if they met criteria for IBS according to Rome III and had abdominal pain rated at least 4 on an 11-point scale for at least 2 days of a 2-week run-in phase. Among the many criteria for exclusion from the study were history of inflammatory gastrointestinal disease, cancer, other serious stomach diseases, diabetes, many abdominal surgeries, and recent antipsychotic or steroid use.
During the study, participants recorded their abdominal pain over the last 24 hours daily; weekly averages were tallied for each patient. Patients were also asked to rate their relief of IBS symptoms, including abdominal pain, bowel habits, and other symptoms over the past week at weekly time points on a 7-point Likert scale, where scores of 3 or less indicated some measure of relief; IBS symptoms were considered to be adequately relieved with a score of 3 or less.
Secondary outcome measures for the study included changes in the Subjects’ Global Assessment of symptoms, and changes in individual symptoms. Number of bowel movements, stool form, sensation of incomplete evacuation, and medication use were also recorded daily.
Participants were aged a mean of 41 years, and about 70% were female. The mean body mass index was just under 25 kg/m2. About half of each study arm had diarrhea-predominant IBS. About a quarter had constipation-predominant IBS, and most of the rest were not subtyped.
Looking at the primary endpoint, the number needed to treat for benefit was 7.1 in favor of the inactivated bacterium, using an intention-to-treat analysis. Results were similar when a per-protocol analysis was applied. The investigators saw response to treatment climb through the duration of the study for both the probiotic and the placebo arms, with the gap in improvement between the groups widening over the 8-week study period.
“It might be assumed that the use of nonviable bacteria for the treatment of IBS could be a safe alternative, even in patients who are potentially susceptible to infection,” concluded Dr. Andresen and colleagues. A further advantage, noted the researchers, is greater product stability in fluctuating temperatures compared with viable bacteria, ensuring better standardization even in regions with warm or changing climates.
Perspective was offered in an accompanying commentary whose lead author was Nicholas Talley, MD, PhD, a gastroenterologist, adjunct professor, and pro vice-chancellor for global research at the University of Newcastle (Australia).
“By heat inactivating the bacteria the researchers did not administer a probiotic but a bacterial therapy,” wrote Dr. Talley and coauthors. In any event, they added, the exact mechanism by which probiotics benefit individuals with IBS is unknown.
“The concept that a probiotic might be efficacious in IBS even if nonviable organisms are administered is an important observation,” they wrote. Fewer benefits have been seen with oral probiotic therapy than with fecal microbial transfer, and oral therapy does not produce durable results unless administered on a chronic basis, Dr. Talley and coauthors added.
“The absence of fundamental knowledge in terms of how bacterial therapy alters mechanisms in IBS continues to hamper improvements in treatment, limiting any success to short-term symptom control rather than the true goal, reversal of disease,” they concluded.
The study was funded by Synformulas. Dr. Andresen reported financial relationships with several pharmaceutical companies. Dr. Talley reported financial relationships with several pharmaceutical and nutritional companies.
SOURCE: Andresen V et al. Lancet Gastroenterol Hepatol. 2020 Apr 8. doi: 10.1016/S2468-1253(20)30079-0
FROM THE LANCET GASTROENTEROLOGY AND HEPATOLOGY
During a pandemic, infusion center nursing team pitches in to keep patients on track
How do you run a chemotherapy infusion center during a pandemic?
Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.
When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.
North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”
Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.
These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.
Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.
The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.
Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.
In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.
Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.
Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”
Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.
Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.
A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”
Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”
On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”
Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”
Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”
Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”
The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.
Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.
The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”
koakes@mdedge.com
How do you run a chemotherapy infusion center during a pandemic?
Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.
When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.
North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”
Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.
These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.
Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.
The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.
Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.
In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.
Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.
Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”
Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.
Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.
A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”
Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”
On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”
Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”
Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”
Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”
The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.
Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.
The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”
koakes@mdedge.com
How do you run a chemotherapy infusion center during a pandemic?
Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.
When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.
North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”
Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.
These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.
Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.
The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.
Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.
In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.
Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.
Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”
Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.
Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.
A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”
Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”
On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”
Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”
Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”
Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”
The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.
Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.
The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”
koakes@mdedge.com
Flexibility and speed mark the race to a COVID-19 vaccine
Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.
The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.
Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.
Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”
In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.
“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”
Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.
Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.
Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.
From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.
As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.
However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.
Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”
“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”
He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.
The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.
“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.
Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.
“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.
Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”
Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.
“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.
Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.
Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.
Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.
The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.
Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.
Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”
In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.
“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”
Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.
Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.
Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.
From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.
As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.
However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.
Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”
“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”
He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.
The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.
“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.
Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.
“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.
Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”
Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.
“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.
Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.
Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.
Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.
The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.
Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.
Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”
In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.
“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”
Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.
Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.
Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.
From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.
As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.
However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.
Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”
“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”
He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.
The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.
“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.
Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.
“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.
Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”
Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.
“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.
Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.
Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.
Bone density slow to rebound after lactation in women with HIV
Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).
“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”
Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).
Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.
In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.
In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.
For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.
“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.
Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”
The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.
SOURCE: Nabwire F et al. CROI 2020, Abstract 768.
Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).
“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”
Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).
Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.
In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.
In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.
For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.
“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.
Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”
The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.
SOURCE: Nabwire F et al. CROI 2020, Abstract 768.
Women with HIV had more bone mobilization during lactation, and attenuated skeletal recovery after lactation, compared with HIV-negative women, according to research presented during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
The study “demonstrated that there were reductions as expected in BMD during breastfeeding, and there was recovery at the end of breastfeeding, which was higher among women who were not HIV-infected compared to HIV-infected women,” said Mary Glenn Fowler, MD, speaking in a video presentation during the virtual conference. The differences between women who had HIV and the HIV-negative reference group were statistically significant (P = .003 for lumbar spine and P less than .001 for whole-body aBMD).
“We also saw that for whole-body BMD, there was recovery at the end of breastfeeding for women who were not HIV infected, but a dampened response of recovery for BMD for HIV-infected women,” she went on, adding: “These findings held after adjustment for parity, age, body mass, breastfeeding practices, duration of breastfeeding, use of [injectable medroxyprogesterone acetate], and resumption of menses.”
Dr. Fowler presented the study’s results on behalf of lead author Florence Nabwire, PhD, an investigator scientist in the nutrition and bone health group of the United Kingdom’s Medical Research Council (Cambridge).
Although it’s known that antiretroviral therapy (ART) is associated with bone loss, Dr. Fowler explained that there are only limited data in HIV-positive women who are lactating. It’s important to see what happens during lactation for this group of women because of the potential sequelae later in life of insufficient recovery from the physiological bone mobilization that occurs during lactation. The study looked at changes in areal bone mineral density (aBMD) both during and after lactation for women with HIV living in Uganda who were taking Option B+ ART, a regimen that includes tenofovir, 3TC, and efavirenz. These women were compared with a reference group of HIV-negative women.
In all, 95 women with HIV and 96 HIV negative women were recruited into the study during pregnancy. Participants were followed postpartum at weeks 2, 14, and 26, and at a final visit that occurred 14 weeks after lactation stopped.
In addition to lumbar spine, total hip, and femoral neck aBMD measurements, the investigators also obtained whole body-less-head reading.
For total hip and femoral neck aBMD, the nadir of density was seen at 26 postpartum, when a drop of about 6% was seen from baseline readings. By the final post-lactation visit, women without HIV had recovered to their baseline; for women with HIV, some recovery also occurred, but the effect was dampened, with a persistent bone density deficit of about 3% from baseline. The differences between HIV-positive and HIV-negative women in these measurements were also statistically significant, at P less than .001 for total hip aBMD differences and P = .0008 for femoral neck differences. Again, correction for multiple confounders didn’t attenuate the results, said Dr. Fowler.
“In conclusion, these data showed accentuated mobilization of hip and whole body aBMD during lactation,” said Dr. Fowler, who also noted “slower skeletal recovery post lactation for HIV-infected women.” Clinical implications of these findings aren’t currently known, she said. Further ongoing studies are aiming to tease out both mechanisms and longer-term consequences for the bone health of HIV-infected women and their children, who may also see differences in bone mineral accretion and growth.
Session moderator Risa Hoffman, MD, in introductory remarks, set the findings in some context. “As we know, HIV-positive adults have low bone mineral density, and this appears to be a result of interactions of HIV, traditional risk factors for loss of bone density, and antiretroviral therapy,” said Dr. Hoffman, director of the global health program at the University of California, Los Angeles. She added that previous work had shown that “middle-aged HIV-positive women have higher 10-year fracture incidence compared to their HIV-negative counterparts.” The current study, she said, “has both short- and long-term implications for women as they go through multiple pregnancies and multiple periods of breastfeeding.”
The study was funded by the United Kingdom’s Medical Research Council and Department for International Development as well as the Alborada Trust and the Gates Cambridge Scholarship. The authors reported no conflicts of interest.
SOURCE: Nabwire F et al. CROI 2020, Abstract 768.
FROM CROI 2020
Drone flight launches first-ever insulin drop
After a year of planning, researchers sent a drone flight off the coast of western Ireland to the Aran Islands, delivering insulin and glucagon and retrieving a blood sample from the first patient to receive insulin successfully by autonomous drone delivery.
The nuts and bolts of arranging the drop and retrieval, which occurred in September 2019, were detailed by Spyridoula Maraka, MD, during a virtual news conference held by the Endocrine Society. The study had been slated for presentaion during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.
“There are multiple medical drone delivery opportunities that could be lifesaving during sentinel events such as hurricanes, earthquakes, and, of course, pandemics like the one we are currently experiencing,” said Dr. Maraka.
Drones, or unmanned aerial vehicles, are popular for recreational use and in some commercial applications – notably photography – but they are largely untapped as a medical resource, said Dr. Maraka, a collaborator on the project and an endocrinologist at the University of Arkansas for Medical Sciences, Little Rock.
Most of the exploration of drones for medical purposes has been in countries with emerging economies, such as Ghana and Rwanda in Africa, where the unmanned vehicles have been used by the U.S. medical product delivery company Zipline since 2016 to deliver blood.
The autonomous drone delivery of insulin originated in Galway, where the project’s lead investigator, Derek O’Keefe, MD, PhD, is an endocrinologist and professor of medical device technology at the National University of Ireland.
In 2017, Ireland was pummeled by Ophelia, a category 3 hurricane, and a year later by Storm Emma, a winter blizzard, said Dr. Maraka. Those extreme weather events trapped patients in their homes, made streets impassable for days on end, and interrupted the delivery of essential medical supplies, including insulin.
Until then, Ireland’s medical management plan had been passive and rested on the assumption that any weather-related interruptions would be relatively brief and not result in large-scale disruption of care and supply delivery for geographically isolated patients, said Dr. Maraka. But the two extreme and disruptive weather events in relatively quick succession prompted a reassessment of emergency medical management plans.
“We realized that [the prevailing plans were] not good enough,” said Dr. Maraka. “Medicine has a track record of practicing for emergencies before they actually happen,” to make sure that necessary resources are available and protocols in place in case of an emergency. The researchers extrapolated this preparedness mindset to medication delivery and realized that drones could be used both for a medication drop and to bring blood or other samples back from patients for testing.
Ireland’s Aran Islands came to mind as a location that was at risk of being cut off from services, but that was reachable by drone from Galway. “We quickly realized that this project would be very challenging, as no one in the developed world had done drone deliveries beyond the visual line of sight,” said Dr. Maraka, adding that flight operations had significant regulatory constraints.
The cross-disciplinary team that was pulled together to run the Diabetes Drone Mission, as the project was dubbed, included physicians and experts from pharmacies and pharmaceutical companies. To address drone operation specifically, a drone manufacturer, a flight operations firm, and a telecommunications company were also engaged. Drone pilots had to be licensed for beyond-the-visual-line-of-sight (BVLOS) operation, and Irish and European aviation regulators were consulted.
It took a full year to pull the pieces together for the inaugural flight. “One of the first challenges we faced was that we wanted to perform a civilian drone flight covering more than 40 kilometers,” said Dr. Maraka, whereas most drones flights are in the range of 1-10 km (0.6-6.2 miles). This long-range BVLOS flight required the drone to send live camera feed for the flight duration, which necessitated uninterrupted 4G wireless connectivity with satellite telecommunications as backup.
The Wingcopter 178 drone that was eventually chosen has a wingspan of 178 cm (about 70 inches) and can reach a top speed of 130 km/hr (about 81 mph) in fixed-wing mode.
“We had to comply with medication-dispensing legislation ... and we had to comply with medication transportation cold-chain legislation,” said Dr. Maraka. In other words, the insulin could not be loaded and delivered without the usual prescribing, dispensing, and chain-of-custody procedures being met.
In the end, the successful proof-of-concept flight saw the drone covering 43.3 km (26.9 miles) in a 32-minute flight to deliver insulin and glucagon and return a blood sample for hemoglobin A1c testing.
Dr. Maraka said she and her collaborators have an active collaboration with United Parcel Service and drone suppliers to expand into regular medical supply deliveries.
Dr. Maraka reported no conflicts of interest.
The report will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
SOURCE: Maraka S et al. ENDO 2020, Abstract OR30-04.
This article was updated on 4/17/2020.
After a year of planning, researchers sent a drone flight off the coast of western Ireland to the Aran Islands, delivering insulin and glucagon and retrieving a blood sample from the first patient to receive insulin successfully by autonomous drone delivery.
The nuts and bolts of arranging the drop and retrieval, which occurred in September 2019, were detailed by Spyridoula Maraka, MD, during a virtual news conference held by the Endocrine Society. The study had been slated for presentaion during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.
“There are multiple medical drone delivery opportunities that could be lifesaving during sentinel events such as hurricanes, earthquakes, and, of course, pandemics like the one we are currently experiencing,” said Dr. Maraka.
Drones, or unmanned aerial vehicles, are popular for recreational use and in some commercial applications – notably photography – but they are largely untapped as a medical resource, said Dr. Maraka, a collaborator on the project and an endocrinologist at the University of Arkansas for Medical Sciences, Little Rock.
Most of the exploration of drones for medical purposes has been in countries with emerging economies, such as Ghana and Rwanda in Africa, where the unmanned vehicles have been used by the U.S. medical product delivery company Zipline since 2016 to deliver blood.
The autonomous drone delivery of insulin originated in Galway, where the project’s lead investigator, Derek O’Keefe, MD, PhD, is an endocrinologist and professor of medical device technology at the National University of Ireland.
In 2017, Ireland was pummeled by Ophelia, a category 3 hurricane, and a year later by Storm Emma, a winter blizzard, said Dr. Maraka. Those extreme weather events trapped patients in their homes, made streets impassable for days on end, and interrupted the delivery of essential medical supplies, including insulin.
Until then, Ireland’s medical management plan had been passive and rested on the assumption that any weather-related interruptions would be relatively brief and not result in large-scale disruption of care and supply delivery for geographically isolated patients, said Dr. Maraka. But the two extreme and disruptive weather events in relatively quick succession prompted a reassessment of emergency medical management plans.
“We realized that [the prevailing plans were] not good enough,” said Dr. Maraka. “Medicine has a track record of practicing for emergencies before they actually happen,” to make sure that necessary resources are available and protocols in place in case of an emergency. The researchers extrapolated this preparedness mindset to medication delivery and realized that drones could be used both for a medication drop and to bring blood or other samples back from patients for testing.
Ireland’s Aran Islands came to mind as a location that was at risk of being cut off from services, but that was reachable by drone from Galway. “We quickly realized that this project would be very challenging, as no one in the developed world had done drone deliveries beyond the visual line of sight,” said Dr. Maraka, adding that flight operations had significant regulatory constraints.
The cross-disciplinary team that was pulled together to run the Diabetes Drone Mission, as the project was dubbed, included physicians and experts from pharmacies and pharmaceutical companies. To address drone operation specifically, a drone manufacturer, a flight operations firm, and a telecommunications company were also engaged. Drone pilots had to be licensed for beyond-the-visual-line-of-sight (BVLOS) operation, and Irish and European aviation regulators were consulted.
It took a full year to pull the pieces together for the inaugural flight. “One of the first challenges we faced was that we wanted to perform a civilian drone flight covering more than 40 kilometers,” said Dr. Maraka, whereas most drones flights are in the range of 1-10 km (0.6-6.2 miles). This long-range BVLOS flight required the drone to send live camera feed for the flight duration, which necessitated uninterrupted 4G wireless connectivity with satellite telecommunications as backup.
The Wingcopter 178 drone that was eventually chosen has a wingspan of 178 cm (about 70 inches) and can reach a top speed of 130 km/hr (about 81 mph) in fixed-wing mode.
“We had to comply with medication-dispensing legislation ... and we had to comply with medication transportation cold-chain legislation,” said Dr. Maraka. In other words, the insulin could not be loaded and delivered without the usual prescribing, dispensing, and chain-of-custody procedures being met.
In the end, the successful proof-of-concept flight saw the drone covering 43.3 km (26.9 miles) in a 32-minute flight to deliver insulin and glucagon and return a blood sample for hemoglobin A1c testing.
Dr. Maraka said she and her collaborators have an active collaboration with United Parcel Service and drone suppliers to expand into regular medical supply deliveries.
Dr. Maraka reported no conflicts of interest.
The report will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
SOURCE: Maraka S et al. ENDO 2020, Abstract OR30-04.
This article was updated on 4/17/2020.
After a year of planning, researchers sent a drone flight off the coast of western Ireland to the Aran Islands, delivering insulin and glucagon and retrieving a blood sample from the first patient to receive insulin successfully by autonomous drone delivery.
The nuts and bolts of arranging the drop and retrieval, which occurred in September 2019, were detailed by Spyridoula Maraka, MD, during a virtual news conference held by the Endocrine Society. The study had been slated for presentaion during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.
“There are multiple medical drone delivery opportunities that could be lifesaving during sentinel events such as hurricanes, earthquakes, and, of course, pandemics like the one we are currently experiencing,” said Dr. Maraka.
Drones, or unmanned aerial vehicles, are popular for recreational use and in some commercial applications – notably photography – but they are largely untapped as a medical resource, said Dr. Maraka, a collaborator on the project and an endocrinologist at the University of Arkansas for Medical Sciences, Little Rock.
Most of the exploration of drones for medical purposes has been in countries with emerging economies, such as Ghana and Rwanda in Africa, where the unmanned vehicles have been used by the U.S. medical product delivery company Zipline since 2016 to deliver blood.
The autonomous drone delivery of insulin originated in Galway, where the project’s lead investigator, Derek O’Keefe, MD, PhD, is an endocrinologist and professor of medical device technology at the National University of Ireland.
In 2017, Ireland was pummeled by Ophelia, a category 3 hurricane, and a year later by Storm Emma, a winter blizzard, said Dr. Maraka. Those extreme weather events trapped patients in their homes, made streets impassable for days on end, and interrupted the delivery of essential medical supplies, including insulin.
Until then, Ireland’s medical management plan had been passive and rested on the assumption that any weather-related interruptions would be relatively brief and not result in large-scale disruption of care and supply delivery for geographically isolated patients, said Dr. Maraka. But the two extreme and disruptive weather events in relatively quick succession prompted a reassessment of emergency medical management plans.
“We realized that [the prevailing plans were] not good enough,” said Dr. Maraka. “Medicine has a track record of practicing for emergencies before they actually happen,” to make sure that necessary resources are available and protocols in place in case of an emergency. The researchers extrapolated this preparedness mindset to medication delivery and realized that drones could be used both for a medication drop and to bring blood or other samples back from patients for testing.
Ireland’s Aran Islands came to mind as a location that was at risk of being cut off from services, but that was reachable by drone from Galway. “We quickly realized that this project would be very challenging, as no one in the developed world had done drone deliveries beyond the visual line of sight,” said Dr. Maraka, adding that flight operations had significant regulatory constraints.
The cross-disciplinary team that was pulled together to run the Diabetes Drone Mission, as the project was dubbed, included physicians and experts from pharmacies and pharmaceutical companies. To address drone operation specifically, a drone manufacturer, a flight operations firm, and a telecommunications company were also engaged. Drone pilots had to be licensed for beyond-the-visual-line-of-sight (BVLOS) operation, and Irish and European aviation regulators were consulted.
It took a full year to pull the pieces together for the inaugural flight. “One of the first challenges we faced was that we wanted to perform a civilian drone flight covering more than 40 kilometers,” said Dr. Maraka, whereas most drones flights are in the range of 1-10 km (0.6-6.2 miles). This long-range BVLOS flight required the drone to send live camera feed for the flight duration, which necessitated uninterrupted 4G wireless connectivity with satellite telecommunications as backup.
The Wingcopter 178 drone that was eventually chosen has a wingspan of 178 cm (about 70 inches) and can reach a top speed of 130 km/hr (about 81 mph) in fixed-wing mode.
“We had to comply with medication-dispensing legislation ... and we had to comply with medication transportation cold-chain legislation,” said Dr. Maraka. In other words, the insulin could not be loaded and delivered without the usual prescribing, dispensing, and chain-of-custody procedures being met.
In the end, the successful proof-of-concept flight saw the drone covering 43.3 km (26.9 miles) in a 32-minute flight to deliver insulin and glucagon and return a blood sample for hemoglobin A1c testing.
Dr. Maraka said she and her collaborators have an active collaboration with United Parcel Service and drone suppliers to expand into regular medical supply deliveries.
Dr. Maraka reported no conflicts of interest.
The report will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
SOURCE: Maraka S et al. ENDO 2020, Abstract OR30-04.
This article was updated on 4/17/2020.
FROM ENDO 2020
Higher baseline fitness may help maintain weight loss
Participants who had higher levels of fitness when beginning a behavioral weight-loss intervention kept off more weight over the course of an 18-month study, compared with those with lower levels of fitness at baseline.
Those with higher baseline fitness also were able to achieve higher levels of moderate to vigorous physical activity at the 18-month mark, Adnin Zaman, MD, said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.
“Our study really comes from an observation that we often see significant variability in how much weight participants lose during a behavioral weight-loss intervention study, said Dr. Zaman, an endocrinology research fellow at the University of Colorado at Denver, Aurora.
She and her colleagues wanted to look at baseline cardiovascular fitness as an individual-specific factor that could affect how much weight people lost when participating in a behavioral intervention.
“Very little is known about how cardiovascular fitness affects [people’s] ability to lose weight [or] to adhere to high levels of physical activity, which is a very common recommendation during a program for both weight loss and weight-loss maintenance,” she added.
Dr. Zaman and colleagues conducted a secondary analysis of data from an 18-month trial of behavioral interventions for weight loss. The trial randomized 170 participants 1:1 to receive either concurrent exercise and a dietary behavior modification intervention or sequential dietary and exercise interventions.
The 85 participants in the concurrent intervention arm received 18 months of combined dietary modifications (calorie-restricted diet and group-based behavioral support) and exercise (supervised for the first 6 months of the study, unsupervised for the final 12). Those participating in the sequential intervention arm received a diet-only intervention during the first 6 months of the study, after which supervised exercise was added to the dietary intervention for 6 months, followed by a final 6 months of unsupervised exercise.
Participants in both study arms worked up to 300 minutes a week of moderate to vigorous physical activity in the supervised exercise phase.
For the secondary analysis, Dr. Zaman and colleagues looked only at the 60 participants who received concurrent diet and exercise interventions and who completed the full 18-month study. The mean age in that group was 40 years, mean baseline body mass index (BMI) was 34.6 kg/m2, and 80% of participants in the group were women.
Cardiovascular fitness as measured by VO2max was assessed at baseline using a graded exercise test. Participants were designated as having either “very poor” or “poor or better” cardiovascular fitness (20 and 40 participants, respectively).
Participants in the original trial were inactive at baseline and had a BMI range of 27-42 kg/m2. Among the subset of participants studied by Dr. Zaman and colleagues, those who were in the poor or better fitness category actually weighed less at baseline and had a lower BMI, compared with those in the very poor group (33.7 vs. 36.2, respectively), she said. Mean VO2max for those with very poor fitness was 22.5 mL/kg per minute, compared with 25.6 mL/kg per minute for those with poor or better fitness.
“Despite those differences, it is interesting to note that, during the supervised exercise portion of the study ... everyone lost pretty much the same amount of weight in the first 6 months,” said Dr. Zaman. At the 6-month mark, those with very poor fitness had lost 9.2 kg (20.3 pounds), and those with poor or better fitness had lost 9.1 kg (20.1 pounds). However, weight regain was less likely in those with poor or better fitness, and those participants had a net loss of weight from baseline of 8.2 kg (18.1 pounds), compared with 4.4 kg (9.7 pounds) for those with very poor fitness.
Those with poor or better fitness were able to sustain a 33-minute bout of moderate to vigorous physical activity at baseline, whereas those with very poor fitness could achieve only about half of that. The difference in achievable physical activity between the two groups persisted throughout the study, with a peak at the 6-month mark, at about 60 minutes for the more fit participants and 38 minutes for those in the poor fitness group. By the end of the study, the less-fit participants achieved about 24 minutes of activity, whereas those who were more fit could sustain about 42 minutes of moderate to vigorous physical activity.
Physical activity levels were measured with a validated, wrist-worn device during a 1-week period at baseline and again at study months 6, 12, and 18.
Dr. Zaman noted that baseline weight may have confounded fitness categorization, because VO2max includes body weight in its calculations. A newer method of calculating cardiorespiratory fitness that scales VO2max to body weight may help minimize this potential confounder.
The investigators reported no outside sources of funding and reported that they had no financial conflicts of interest.
The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
SOURCE: Zaman A et al. ENDO 2020, Abstract 575.
This article was updated on 4/17/2020.
Participants who had higher levels of fitness when beginning a behavioral weight-loss intervention kept off more weight over the course of an 18-month study, compared with those with lower levels of fitness at baseline.
Those with higher baseline fitness also were able to achieve higher levels of moderate to vigorous physical activity at the 18-month mark, Adnin Zaman, MD, said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.
“Our study really comes from an observation that we often see significant variability in how much weight participants lose during a behavioral weight-loss intervention study, said Dr. Zaman, an endocrinology research fellow at the University of Colorado at Denver, Aurora.
She and her colleagues wanted to look at baseline cardiovascular fitness as an individual-specific factor that could affect how much weight people lost when participating in a behavioral intervention.
“Very little is known about how cardiovascular fitness affects [people’s] ability to lose weight [or] to adhere to high levels of physical activity, which is a very common recommendation during a program for both weight loss and weight-loss maintenance,” she added.
Dr. Zaman and colleagues conducted a secondary analysis of data from an 18-month trial of behavioral interventions for weight loss. The trial randomized 170 participants 1:1 to receive either concurrent exercise and a dietary behavior modification intervention or sequential dietary and exercise interventions.
The 85 participants in the concurrent intervention arm received 18 months of combined dietary modifications (calorie-restricted diet and group-based behavioral support) and exercise (supervised for the first 6 months of the study, unsupervised for the final 12). Those participating in the sequential intervention arm received a diet-only intervention during the first 6 months of the study, after which supervised exercise was added to the dietary intervention for 6 months, followed by a final 6 months of unsupervised exercise.
Participants in both study arms worked up to 300 minutes a week of moderate to vigorous physical activity in the supervised exercise phase.
For the secondary analysis, Dr. Zaman and colleagues looked only at the 60 participants who received concurrent diet and exercise interventions and who completed the full 18-month study. The mean age in that group was 40 years, mean baseline body mass index (BMI) was 34.6 kg/m2, and 80% of participants in the group were women.
Cardiovascular fitness as measured by VO2max was assessed at baseline using a graded exercise test. Participants were designated as having either “very poor” or “poor or better” cardiovascular fitness (20 and 40 participants, respectively).
Participants in the original trial were inactive at baseline and had a BMI range of 27-42 kg/m2. Among the subset of participants studied by Dr. Zaman and colleagues, those who were in the poor or better fitness category actually weighed less at baseline and had a lower BMI, compared with those in the very poor group (33.7 vs. 36.2, respectively), she said. Mean VO2max for those with very poor fitness was 22.5 mL/kg per minute, compared with 25.6 mL/kg per minute for those with poor or better fitness.
“Despite those differences, it is interesting to note that, during the supervised exercise portion of the study ... everyone lost pretty much the same amount of weight in the first 6 months,” said Dr. Zaman. At the 6-month mark, those with very poor fitness had lost 9.2 kg (20.3 pounds), and those with poor or better fitness had lost 9.1 kg (20.1 pounds). However, weight regain was less likely in those with poor or better fitness, and those participants had a net loss of weight from baseline of 8.2 kg (18.1 pounds), compared with 4.4 kg (9.7 pounds) for those with very poor fitness.
Those with poor or better fitness were able to sustain a 33-minute bout of moderate to vigorous physical activity at baseline, whereas those with very poor fitness could achieve only about half of that. The difference in achievable physical activity between the two groups persisted throughout the study, with a peak at the 6-month mark, at about 60 minutes for the more fit participants and 38 minutes for those in the poor fitness group. By the end of the study, the less-fit participants achieved about 24 minutes of activity, whereas those who were more fit could sustain about 42 minutes of moderate to vigorous physical activity.
Physical activity levels were measured with a validated, wrist-worn device during a 1-week period at baseline and again at study months 6, 12, and 18.
Dr. Zaman noted that baseline weight may have confounded fitness categorization, because VO2max includes body weight in its calculations. A newer method of calculating cardiorespiratory fitness that scales VO2max to body weight may help minimize this potential confounder.
The investigators reported no outside sources of funding and reported that they had no financial conflicts of interest.
The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
SOURCE: Zaman A et al. ENDO 2020, Abstract 575.
This article was updated on 4/17/2020.
Participants who had higher levels of fitness when beginning a behavioral weight-loss intervention kept off more weight over the course of an 18-month study, compared with those with lower levels of fitness at baseline.
Those with higher baseline fitness also were able to achieve higher levels of moderate to vigorous physical activity at the 18-month mark, Adnin Zaman, MD, said during a virtual news conference held by the Endocrine Society. The study had been slated for presentation during ENDO 2020, the society's annual meeting, which was canceled because of the COVID-19 pandemic.
“Our study really comes from an observation that we often see significant variability in how much weight participants lose during a behavioral weight-loss intervention study, said Dr. Zaman, an endocrinology research fellow at the University of Colorado at Denver, Aurora.
She and her colleagues wanted to look at baseline cardiovascular fitness as an individual-specific factor that could affect how much weight people lost when participating in a behavioral intervention.
“Very little is known about how cardiovascular fitness affects [people’s] ability to lose weight [or] to adhere to high levels of physical activity, which is a very common recommendation during a program for both weight loss and weight-loss maintenance,” she added.
Dr. Zaman and colleagues conducted a secondary analysis of data from an 18-month trial of behavioral interventions for weight loss. The trial randomized 170 participants 1:1 to receive either concurrent exercise and a dietary behavior modification intervention or sequential dietary and exercise interventions.
The 85 participants in the concurrent intervention arm received 18 months of combined dietary modifications (calorie-restricted diet and group-based behavioral support) and exercise (supervised for the first 6 months of the study, unsupervised for the final 12). Those participating in the sequential intervention arm received a diet-only intervention during the first 6 months of the study, after which supervised exercise was added to the dietary intervention for 6 months, followed by a final 6 months of unsupervised exercise.
Participants in both study arms worked up to 300 minutes a week of moderate to vigorous physical activity in the supervised exercise phase.
For the secondary analysis, Dr. Zaman and colleagues looked only at the 60 participants who received concurrent diet and exercise interventions and who completed the full 18-month study. The mean age in that group was 40 years, mean baseline body mass index (BMI) was 34.6 kg/m2, and 80% of participants in the group were women.
Cardiovascular fitness as measured by VO2max was assessed at baseline using a graded exercise test. Participants were designated as having either “very poor” or “poor or better” cardiovascular fitness (20 and 40 participants, respectively).
Participants in the original trial were inactive at baseline and had a BMI range of 27-42 kg/m2. Among the subset of participants studied by Dr. Zaman and colleagues, those who were in the poor or better fitness category actually weighed less at baseline and had a lower BMI, compared with those in the very poor group (33.7 vs. 36.2, respectively), she said. Mean VO2max for those with very poor fitness was 22.5 mL/kg per minute, compared with 25.6 mL/kg per minute for those with poor or better fitness.
“Despite those differences, it is interesting to note that, during the supervised exercise portion of the study ... everyone lost pretty much the same amount of weight in the first 6 months,” said Dr. Zaman. At the 6-month mark, those with very poor fitness had lost 9.2 kg (20.3 pounds), and those with poor or better fitness had lost 9.1 kg (20.1 pounds). However, weight regain was less likely in those with poor or better fitness, and those participants had a net loss of weight from baseline of 8.2 kg (18.1 pounds), compared with 4.4 kg (9.7 pounds) for those with very poor fitness.
Those with poor or better fitness were able to sustain a 33-minute bout of moderate to vigorous physical activity at baseline, whereas those with very poor fitness could achieve only about half of that. The difference in achievable physical activity between the two groups persisted throughout the study, with a peak at the 6-month mark, at about 60 minutes for the more fit participants and 38 minutes for those in the poor fitness group. By the end of the study, the less-fit participants achieved about 24 minutes of activity, whereas those who were more fit could sustain about 42 minutes of moderate to vigorous physical activity.
Physical activity levels were measured with a validated, wrist-worn device during a 1-week period at baseline and again at study months 6, 12, and 18.
Dr. Zaman noted that baseline weight may have confounded fitness categorization, because VO2max includes body weight in its calculations. A newer method of calculating cardiorespiratory fitness that scales VO2max to body weight may help minimize this potential confounder.
The investigators reported no outside sources of funding and reported that they had no financial conflicts of interest.
The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
SOURCE: Zaman A et al. ENDO 2020, Abstract 575.
This article was updated on 4/17/2020.
FROM ENDO 2020
Dupilumab hits the mark for severe AD in younger children
The monoclonal antibody , according to new clinical trial results.
In a cohort of children with severe AD, 33% achieved clear or nearly clear skin after 16 weeks of treatment with every 4-week dosing of the injectable medication, while 30% also achieved that mark when receiving a weight-based dose every 2 weeks. Both groups had results that were significantly better than those receiving placebo, with 11% of these children had clear or nearly clear skin by 16 weeks of dupilumab (Dupixent) therapy (P less than .0001 for both therapy arms versus placebo).
“Dupilumab with a topical corticosteroid showed clinically meaningful and statistically significant improvement in the atopic dermatitis signs and symptoms in children aged 6 to less than 12 years of age with severe atopic dermatitis,” said Amy Paller, MD, the Walter J. Hamlin professor and chair of the department of dermatology at Northwestern University, Chicago, presenting the results at the Revolutionizing Atopic Dermatitis virtual symposium. Portions of the conference, which has been rescheduled to December 2020, in Chicago, were presented virtually because of the COVID-19 pandemic.
The phase 3 trial of subcutaneously injected dupilumab for atopic dermatitis, dubbed LIBERTY AD PEDS, included children aged 6-11 years with severe AD. The study’s primary endpoint was the proportion of patients achieving a score of 0 or 1 (clear or almost clear skin) on the Investigator’s Global Assessment (IGA) scale by study week 16.
For the purposes of reporting results to the European Medicines Agency, the investigators added a coprimary endpoint of patients reaching 75% clearing on the Eczema Area and Severity Index (EASI-75) by week 16.
The randomized, double-blind, placebo-controlled trial enrolled 367 children with IGA scores of 4, denoting severe AD. The EASI score had to be at least 21 and patients had to endorse peak pruritus of at least 4 on a 0-10 numeric rating scale; body surface involvement had to be at least 15%. Patients went through a washout period of any systemic therapies before beginning the trial, which randomized patients 1:1:1 to receive placebo, dupilumab 300 mg every 4 weeks, or dupilumab every 2 weeks with weight-dependent dosing. All participants were also permitted topical corticosteroids.
Patients were an average of aged 8 years, about half were female, and about two-thirds were white. Most participants had developed AD within their first year of life. Patients were about evenly divided between weighing over and under 30 kg, which was the cutoff for 100 mcg versus 200 mcg dupilumab for the every-2-week dosing group.
Over 90% of patients had other atopic comorbidities, and the mean EASI score was about 38 with average weekly peak pruritus averaging 7.8 on the numeric rating scale.
“When we’re talking about how severe this population is, it’s interesting to note that about 30 to 35% were all that had been previously treated with either systemic steroids or some systemic nonsteroidal immunosuppressants,” Dr. Paller pointed out. “I think that reflects the fact that so many of these very severely affected children are not put on a systemic therapy, but are still staying on topical therapies to try to control their disease.”
Looking at the proportion of patients reaching EASI-75, both dosing strategies for dupilumab out-performed placebo, with 70% of the every 4-week group and 67% of the every 2-week group reaching EASI-75 at 16 weeks, compared with 27% of those on placebo (P less than .0001 for both active arms). “These differences were seen very early on; by 2 weeks already, we can see that we’re starting to see a difference in both of these arms,” noted Dr. Paller, adding that the difference was statistically significant by 4 weeks into the study.
The overall group of dupilumab participants saw their EASI scores drop by about 80%, while those taking placebo saw a 49% drop in EASI scores.
For the group of participants weighing less than 30 kg, the every 4-week strategy resulted in better clearing as measured by both IGA and EASI-75. This effect wasn’t seen for heavier patients. Trough dupilumab concentrations at 16 weeks were higher for lighter patients with every 4-week dosing and for heavier patients with the biweekly strategy, noted Dr. Paller.
In terms of itch, 60% to 68% of participants receiving dupilumab had a drop of at least 3 points in peak pruritus on the numeric rating scale, compared with 21% of those receiving placebo (P less than .001), while about half of the dupilumab groups and 12% of the placebo group saw pruritus improvements of 4 points or more (P less than .001). Pruritus improved early in the active arms of the study, becoming statistically significant at the 2 to 4 week range.
Treatment-emergent adverse events were numerically higher in patients in the placebo group, including infections and adjudicated skin infections. Conjunctivitis occurred more frequently in the dupilumab group, as did injection-site reactions.
“Overall, dupilumab was well tolerated, and data were consistent with the known dupilumab safety profile observed in adults and adolescents,” Dr. Paller said.
Dupilumab has been approved by the Food and Drug Administration to treat moderate to severe AD in those aged 12 years and older whose disease can’t be adequately controlled with topical prescription medications, or when those treatments are not advisable.
The fully human monoclonal antibody blocks a shared receptor component for interleukin-4 and interleukin-13, which contribute to inflammation in AD, as well as asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
Dr. Paller reported receiving support from multiple pharmaceutical companies including Sanofi and Regeneron Pharmaceuticals, which sponsored the study.
The monoclonal antibody , according to new clinical trial results.
In a cohort of children with severe AD, 33% achieved clear or nearly clear skin after 16 weeks of treatment with every 4-week dosing of the injectable medication, while 30% also achieved that mark when receiving a weight-based dose every 2 weeks. Both groups had results that were significantly better than those receiving placebo, with 11% of these children had clear or nearly clear skin by 16 weeks of dupilumab (Dupixent) therapy (P less than .0001 for both therapy arms versus placebo).
“Dupilumab with a topical corticosteroid showed clinically meaningful and statistically significant improvement in the atopic dermatitis signs and symptoms in children aged 6 to less than 12 years of age with severe atopic dermatitis,” said Amy Paller, MD, the Walter J. Hamlin professor and chair of the department of dermatology at Northwestern University, Chicago, presenting the results at the Revolutionizing Atopic Dermatitis virtual symposium. Portions of the conference, which has been rescheduled to December 2020, in Chicago, were presented virtually because of the COVID-19 pandemic.
The phase 3 trial of subcutaneously injected dupilumab for atopic dermatitis, dubbed LIBERTY AD PEDS, included children aged 6-11 years with severe AD. The study’s primary endpoint was the proportion of patients achieving a score of 0 or 1 (clear or almost clear skin) on the Investigator’s Global Assessment (IGA) scale by study week 16.
For the purposes of reporting results to the European Medicines Agency, the investigators added a coprimary endpoint of patients reaching 75% clearing on the Eczema Area and Severity Index (EASI-75) by week 16.
The randomized, double-blind, placebo-controlled trial enrolled 367 children with IGA scores of 4, denoting severe AD. The EASI score had to be at least 21 and patients had to endorse peak pruritus of at least 4 on a 0-10 numeric rating scale; body surface involvement had to be at least 15%. Patients went through a washout period of any systemic therapies before beginning the trial, which randomized patients 1:1:1 to receive placebo, dupilumab 300 mg every 4 weeks, or dupilumab every 2 weeks with weight-dependent dosing. All participants were also permitted topical corticosteroids.
Patients were an average of aged 8 years, about half were female, and about two-thirds were white. Most participants had developed AD within their first year of life. Patients were about evenly divided between weighing over and under 30 kg, which was the cutoff for 100 mcg versus 200 mcg dupilumab for the every-2-week dosing group.
Over 90% of patients had other atopic comorbidities, and the mean EASI score was about 38 with average weekly peak pruritus averaging 7.8 on the numeric rating scale.
“When we’re talking about how severe this population is, it’s interesting to note that about 30 to 35% were all that had been previously treated with either systemic steroids or some systemic nonsteroidal immunosuppressants,” Dr. Paller pointed out. “I think that reflects the fact that so many of these very severely affected children are not put on a systemic therapy, but are still staying on topical therapies to try to control their disease.”
Looking at the proportion of patients reaching EASI-75, both dosing strategies for dupilumab out-performed placebo, with 70% of the every 4-week group and 67% of the every 2-week group reaching EASI-75 at 16 weeks, compared with 27% of those on placebo (P less than .0001 for both active arms). “These differences were seen very early on; by 2 weeks already, we can see that we’re starting to see a difference in both of these arms,” noted Dr. Paller, adding that the difference was statistically significant by 4 weeks into the study.
The overall group of dupilumab participants saw their EASI scores drop by about 80%, while those taking placebo saw a 49% drop in EASI scores.
For the group of participants weighing less than 30 kg, the every 4-week strategy resulted in better clearing as measured by both IGA and EASI-75. This effect wasn’t seen for heavier patients. Trough dupilumab concentrations at 16 weeks were higher for lighter patients with every 4-week dosing and for heavier patients with the biweekly strategy, noted Dr. Paller.
In terms of itch, 60% to 68% of participants receiving dupilumab had a drop of at least 3 points in peak pruritus on the numeric rating scale, compared with 21% of those receiving placebo (P less than .001), while about half of the dupilumab groups and 12% of the placebo group saw pruritus improvements of 4 points or more (P less than .001). Pruritus improved early in the active arms of the study, becoming statistically significant at the 2 to 4 week range.
Treatment-emergent adverse events were numerically higher in patients in the placebo group, including infections and adjudicated skin infections. Conjunctivitis occurred more frequently in the dupilumab group, as did injection-site reactions.
“Overall, dupilumab was well tolerated, and data were consistent with the known dupilumab safety profile observed in adults and adolescents,” Dr. Paller said.
Dupilumab has been approved by the Food and Drug Administration to treat moderate to severe AD in those aged 12 years and older whose disease can’t be adequately controlled with topical prescription medications, or when those treatments are not advisable.
The fully human monoclonal antibody blocks a shared receptor component for interleukin-4 and interleukin-13, which contribute to inflammation in AD, as well as asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
Dr. Paller reported receiving support from multiple pharmaceutical companies including Sanofi and Regeneron Pharmaceuticals, which sponsored the study.
The monoclonal antibody , according to new clinical trial results.
In a cohort of children with severe AD, 33% achieved clear or nearly clear skin after 16 weeks of treatment with every 4-week dosing of the injectable medication, while 30% also achieved that mark when receiving a weight-based dose every 2 weeks. Both groups had results that were significantly better than those receiving placebo, with 11% of these children had clear or nearly clear skin by 16 weeks of dupilumab (Dupixent) therapy (P less than .0001 for both therapy arms versus placebo).
“Dupilumab with a topical corticosteroid showed clinically meaningful and statistically significant improvement in the atopic dermatitis signs and symptoms in children aged 6 to less than 12 years of age with severe atopic dermatitis,” said Amy Paller, MD, the Walter J. Hamlin professor and chair of the department of dermatology at Northwestern University, Chicago, presenting the results at the Revolutionizing Atopic Dermatitis virtual symposium. Portions of the conference, which has been rescheduled to December 2020, in Chicago, were presented virtually because of the COVID-19 pandemic.
The phase 3 trial of subcutaneously injected dupilumab for atopic dermatitis, dubbed LIBERTY AD PEDS, included children aged 6-11 years with severe AD. The study’s primary endpoint was the proportion of patients achieving a score of 0 or 1 (clear or almost clear skin) on the Investigator’s Global Assessment (IGA) scale by study week 16.
For the purposes of reporting results to the European Medicines Agency, the investigators added a coprimary endpoint of patients reaching 75% clearing on the Eczema Area and Severity Index (EASI-75) by week 16.
The randomized, double-blind, placebo-controlled trial enrolled 367 children with IGA scores of 4, denoting severe AD. The EASI score had to be at least 21 and patients had to endorse peak pruritus of at least 4 on a 0-10 numeric rating scale; body surface involvement had to be at least 15%. Patients went through a washout period of any systemic therapies before beginning the trial, which randomized patients 1:1:1 to receive placebo, dupilumab 300 mg every 4 weeks, or dupilumab every 2 weeks with weight-dependent dosing. All participants were also permitted topical corticosteroids.
Patients were an average of aged 8 years, about half were female, and about two-thirds were white. Most participants had developed AD within their first year of life. Patients were about evenly divided between weighing over and under 30 kg, which was the cutoff for 100 mcg versus 200 mcg dupilumab for the every-2-week dosing group.
Over 90% of patients had other atopic comorbidities, and the mean EASI score was about 38 with average weekly peak pruritus averaging 7.8 on the numeric rating scale.
“When we’re talking about how severe this population is, it’s interesting to note that about 30 to 35% were all that had been previously treated with either systemic steroids or some systemic nonsteroidal immunosuppressants,” Dr. Paller pointed out. “I think that reflects the fact that so many of these very severely affected children are not put on a systemic therapy, but are still staying on topical therapies to try to control their disease.”
Looking at the proportion of patients reaching EASI-75, both dosing strategies for dupilumab out-performed placebo, with 70% of the every 4-week group and 67% of the every 2-week group reaching EASI-75 at 16 weeks, compared with 27% of those on placebo (P less than .0001 for both active arms). “These differences were seen very early on; by 2 weeks already, we can see that we’re starting to see a difference in both of these arms,” noted Dr. Paller, adding that the difference was statistically significant by 4 weeks into the study.
The overall group of dupilumab participants saw their EASI scores drop by about 80%, while those taking placebo saw a 49% drop in EASI scores.
For the group of participants weighing less than 30 kg, the every 4-week strategy resulted in better clearing as measured by both IGA and EASI-75. This effect wasn’t seen for heavier patients. Trough dupilumab concentrations at 16 weeks were higher for lighter patients with every 4-week dosing and for heavier patients with the biweekly strategy, noted Dr. Paller.
In terms of itch, 60% to 68% of participants receiving dupilumab had a drop of at least 3 points in peak pruritus on the numeric rating scale, compared with 21% of those receiving placebo (P less than .001), while about half of the dupilumab groups and 12% of the placebo group saw pruritus improvements of 4 points or more (P less than .001). Pruritus improved early in the active arms of the study, becoming statistically significant at the 2 to 4 week range.
Treatment-emergent adverse events were numerically higher in patients in the placebo group, including infections and adjudicated skin infections. Conjunctivitis occurred more frequently in the dupilumab group, as did injection-site reactions.
“Overall, dupilumab was well tolerated, and data were consistent with the known dupilumab safety profile observed in adults and adolescents,” Dr. Paller said.
Dupilumab has been approved by the Food and Drug Administration to treat moderate to severe AD in those aged 12 years and older whose disease can’t be adequately controlled with topical prescription medications, or when those treatments are not advisable.
The fully human monoclonal antibody blocks a shared receptor component for interleukin-4 and interleukin-13, which contribute to inflammation in AD, as well as asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
Dr. Paller reported receiving support from multiple pharmaceutical companies including Sanofi and Regeneron Pharmaceuticals, which sponsored the study.
FROM REVOLUTIONIZING AD 2020
Patients with preexisting diabetes benefit less from bariatric surgery
according to a retrospective review of patients receiving both sleeve gastrectomy and gastric bypass.
The difference was particularly pronounced and persistent for patients who had gastric bypass, Yingying Luo, MD, said during a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.
“Our findings demonstrated that having bariatric surgery before developing diabetes may result in greater weight loss from the surgery, especially within the first 3 years after surgery and in patients undergoing gastric bypass surgery,” said Dr. Luo.
More than a third of U.S. adults have obesity, and more than half the population is overweight or has obesity, said Dr. Luo, citing data from the Centers for Disease Control and Prevention.
Bariatric surgery not only reduces body weight, but also “can lead to remission of many metabolic disorders, including diabetes, hypertension, and dyslipidemia,” said Dr. Luo, a visiting scholar at the University of Michigan’s division of metabolism, endocrinology, and diabetes. However, until now, it has not been known how diabetes interacts with bariatric surgery to affect weight loss outcomes.
To address that question, Dr. Luo and her colleagues looked at patients in the Michigan Bariatric Surgery Cohort who were at least 18 years old and had a body mass index (BMI) of more than 40 kg/m2, or of more than 35 kg/m2 with comorbidities.
The researchers followed 380 patients who received gastric bypass and 334 who received sleeve gastrectomy for at least 5 years. Over time, sleeve gastrectomy became the predominant type of surgery conducted, noted Dr. Luo.
At baseline, and yearly for 5 years thereafter, the researchers recorded participants’ BMI as well as their lipid levels and other laboratory values. Medication use was also tracked. Patients with a diagnosis of diabetes also had their hemoglobin A1c levels recorded at each visit.
Overall, patients in the sleeve gastrectomy group were more overweight, and those in the gastric bypass group had higher HbA1c and total cholesterol levels. The mean baseline weight for the sleeve gastrectomy recipients was 141.5 kg, compared with 133.5 kg for those receiving gastric bypass (BMI, 49.9 vs. 47.3 kg/m2, respectively; P < .01 for both measures). Mean HbA1c was 6.5% for the gastric bypass group, compared with 6.3% for the sleeve gastrectomy group (P = .03).
At baseline, 149 (39.2%) of the gastric bypass patients had diabetes, compared with 108 (32.3%) of the sleeve gastrectomy patients, but the difference was not statistically significant.
About two-thirds of the full cohort were tracked for at least 5 years, which is still considered “a good follow-up rate in a real-world study,” said Dr. Luo.
Total weight loss was defined as the difference between initial weight and postoperative weight at a given point in time. Excess weight was the difference between initial weight and an individual’s ideal weight, that is, what their weight would have been if they had a BMI of 25 kg/m2.
“The probability of achieving a BMI of less than 30 kg/m2 or excess weight loss of 50% or more was higher in patients who did not have diabetes diagnosis at baseline. We found that the presence of diabetes at baseline substantially impacted the probability of achieving both indicators,” said Dr. Luo. “Individuals without diabetes had a 1.5 times higher chance of achieving a BMI of under 30 kg/m2, and … [they also] had a 1.6 times higher chance of achieving excess body weight loss of 50%, or more.” Both of those differences were statistically significant on univariate analysis (P = .0249 and .0021, respectively).
The researchers conducted further statistical analysis – adjusted for age, gender, surgery type, and baseline weight – to examine whether diabetes still predicted future weight loss after bariatric surgery. After those adjustments, they still found that “the presence of diabetes before surgery is an indicator of future weight loss outcomes,” said Dr. Luo.
The differences in outcomes for those with and without diabetes tended to diminish over time in looking at the cohort as a whole. However, greater BMI reduction for those without diabetes persisted for the full 5 years of follow-up for the gastric bypass recipients. Those trends held when the researchers looked at the proportion of patients whose BMI dropped to below 30 kg/m2, and those who achieved excess weight loss of more than 50%.
Dr. Luo acknowledged that an ideal study would track patients for longer than 5 years and that studies involving more patients would also be useful. Still, she said, “our study opens the door for further research to understand why diabetes diminishes the weight loss effect of bariatric surgery.”
The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
Dr. Luo reported no outside sources of funding and no conflicts of interest.
SOURCE: Luo Y et al. ENDO 2020, Abstract 590.
according to a retrospective review of patients receiving both sleeve gastrectomy and gastric bypass.
The difference was particularly pronounced and persistent for patients who had gastric bypass, Yingying Luo, MD, said during a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.
“Our findings demonstrated that having bariatric surgery before developing diabetes may result in greater weight loss from the surgery, especially within the first 3 years after surgery and in patients undergoing gastric bypass surgery,” said Dr. Luo.
More than a third of U.S. adults have obesity, and more than half the population is overweight or has obesity, said Dr. Luo, citing data from the Centers for Disease Control and Prevention.
Bariatric surgery not only reduces body weight, but also “can lead to remission of many metabolic disorders, including diabetes, hypertension, and dyslipidemia,” said Dr. Luo, a visiting scholar at the University of Michigan’s division of metabolism, endocrinology, and diabetes. However, until now, it has not been known how diabetes interacts with bariatric surgery to affect weight loss outcomes.
To address that question, Dr. Luo and her colleagues looked at patients in the Michigan Bariatric Surgery Cohort who were at least 18 years old and had a body mass index (BMI) of more than 40 kg/m2, or of more than 35 kg/m2 with comorbidities.
The researchers followed 380 patients who received gastric bypass and 334 who received sleeve gastrectomy for at least 5 years. Over time, sleeve gastrectomy became the predominant type of surgery conducted, noted Dr. Luo.
At baseline, and yearly for 5 years thereafter, the researchers recorded participants’ BMI as well as their lipid levels and other laboratory values. Medication use was also tracked. Patients with a diagnosis of diabetes also had their hemoglobin A1c levels recorded at each visit.
Overall, patients in the sleeve gastrectomy group were more overweight, and those in the gastric bypass group had higher HbA1c and total cholesterol levels. The mean baseline weight for the sleeve gastrectomy recipients was 141.5 kg, compared with 133.5 kg for those receiving gastric bypass (BMI, 49.9 vs. 47.3 kg/m2, respectively; P < .01 for both measures). Mean HbA1c was 6.5% for the gastric bypass group, compared with 6.3% for the sleeve gastrectomy group (P = .03).
At baseline, 149 (39.2%) of the gastric bypass patients had diabetes, compared with 108 (32.3%) of the sleeve gastrectomy patients, but the difference was not statistically significant.
About two-thirds of the full cohort were tracked for at least 5 years, which is still considered “a good follow-up rate in a real-world study,” said Dr. Luo.
Total weight loss was defined as the difference between initial weight and postoperative weight at a given point in time. Excess weight was the difference between initial weight and an individual’s ideal weight, that is, what their weight would have been if they had a BMI of 25 kg/m2.
“The probability of achieving a BMI of less than 30 kg/m2 or excess weight loss of 50% or more was higher in patients who did not have diabetes diagnosis at baseline. We found that the presence of diabetes at baseline substantially impacted the probability of achieving both indicators,” said Dr. Luo. “Individuals without diabetes had a 1.5 times higher chance of achieving a BMI of under 30 kg/m2, and … [they also] had a 1.6 times higher chance of achieving excess body weight loss of 50%, or more.” Both of those differences were statistically significant on univariate analysis (P = .0249 and .0021, respectively).
The researchers conducted further statistical analysis – adjusted for age, gender, surgery type, and baseline weight – to examine whether diabetes still predicted future weight loss after bariatric surgery. After those adjustments, they still found that “the presence of diabetes before surgery is an indicator of future weight loss outcomes,” said Dr. Luo.
The differences in outcomes for those with and without diabetes tended to diminish over time in looking at the cohort as a whole. However, greater BMI reduction for those without diabetes persisted for the full 5 years of follow-up for the gastric bypass recipients. Those trends held when the researchers looked at the proportion of patients whose BMI dropped to below 30 kg/m2, and those who achieved excess weight loss of more than 50%.
Dr. Luo acknowledged that an ideal study would track patients for longer than 5 years and that studies involving more patients would also be useful. Still, she said, “our study opens the door for further research to understand why diabetes diminishes the weight loss effect of bariatric surgery.”
The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
Dr. Luo reported no outside sources of funding and no conflicts of interest.
SOURCE: Luo Y et al. ENDO 2020, Abstract 590.
according to a retrospective review of patients receiving both sleeve gastrectomy and gastric bypass.
The difference was particularly pronounced and persistent for patients who had gastric bypass, Yingying Luo, MD, said during a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.
“Our findings demonstrated that having bariatric surgery before developing diabetes may result in greater weight loss from the surgery, especially within the first 3 years after surgery and in patients undergoing gastric bypass surgery,” said Dr. Luo.
More than a third of U.S. adults have obesity, and more than half the population is overweight or has obesity, said Dr. Luo, citing data from the Centers for Disease Control and Prevention.
Bariatric surgery not only reduces body weight, but also “can lead to remission of many metabolic disorders, including diabetes, hypertension, and dyslipidemia,” said Dr. Luo, a visiting scholar at the University of Michigan’s division of metabolism, endocrinology, and diabetes. However, until now, it has not been known how diabetes interacts with bariatric surgery to affect weight loss outcomes.
To address that question, Dr. Luo and her colleagues looked at patients in the Michigan Bariatric Surgery Cohort who were at least 18 years old and had a body mass index (BMI) of more than 40 kg/m2, or of more than 35 kg/m2 with comorbidities.
The researchers followed 380 patients who received gastric bypass and 334 who received sleeve gastrectomy for at least 5 years. Over time, sleeve gastrectomy became the predominant type of surgery conducted, noted Dr. Luo.
At baseline, and yearly for 5 years thereafter, the researchers recorded participants’ BMI as well as their lipid levels and other laboratory values. Medication use was also tracked. Patients with a diagnosis of diabetes also had their hemoglobin A1c levels recorded at each visit.
Overall, patients in the sleeve gastrectomy group were more overweight, and those in the gastric bypass group had higher HbA1c and total cholesterol levels. The mean baseline weight for the sleeve gastrectomy recipients was 141.5 kg, compared with 133.5 kg for those receiving gastric bypass (BMI, 49.9 vs. 47.3 kg/m2, respectively; P < .01 for both measures). Mean HbA1c was 6.5% for the gastric bypass group, compared with 6.3% for the sleeve gastrectomy group (P = .03).
At baseline, 149 (39.2%) of the gastric bypass patients had diabetes, compared with 108 (32.3%) of the sleeve gastrectomy patients, but the difference was not statistically significant.
About two-thirds of the full cohort were tracked for at least 5 years, which is still considered “a good follow-up rate in a real-world study,” said Dr. Luo.
Total weight loss was defined as the difference between initial weight and postoperative weight at a given point in time. Excess weight was the difference between initial weight and an individual’s ideal weight, that is, what their weight would have been if they had a BMI of 25 kg/m2.
“The probability of achieving a BMI of less than 30 kg/m2 or excess weight loss of 50% or more was higher in patients who did not have diabetes diagnosis at baseline. We found that the presence of diabetes at baseline substantially impacted the probability of achieving both indicators,” said Dr. Luo. “Individuals without diabetes had a 1.5 times higher chance of achieving a BMI of under 30 kg/m2, and … [they also] had a 1.6 times higher chance of achieving excess body weight loss of 50%, or more.” Both of those differences were statistically significant on univariate analysis (P = .0249 and .0021, respectively).
The researchers conducted further statistical analysis – adjusted for age, gender, surgery type, and baseline weight – to examine whether diabetes still predicted future weight loss after bariatric surgery. After those adjustments, they still found that “the presence of diabetes before surgery is an indicator of future weight loss outcomes,” said Dr. Luo.
The differences in outcomes for those with and without diabetes tended to diminish over time in looking at the cohort as a whole. However, greater BMI reduction for those without diabetes persisted for the full 5 years of follow-up for the gastric bypass recipients. Those trends held when the researchers looked at the proportion of patients whose BMI dropped to below 30 kg/m2, and those who achieved excess weight loss of more than 50%.
Dr. Luo acknowledged that an ideal study would track patients for longer than 5 years and that studies involving more patients would also be useful. Still, she said, “our study opens the door for further research to understand why diabetes diminishes the weight loss effect of bariatric surgery.”
The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.
Dr. Luo reported no outside sources of funding and no conflicts of interest.
SOURCE: Luo Y et al. ENDO 2020, Abstract 590.
FROM ENDO 2020