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Medical power couple launch robot that helps in the labor room
Medical Power Couples is a new series highlighting spouses or domestic partners prominent in health care. Both have achieved high-level professional success and have made significant contributions to their respective fields.
Julie Shah, PhD, and Neel Shah, MD
Ob.gyn. Neel Shah was telling his wife how challenging it was for labor and delivery nurses to make room assignments: to delegate available beds, predict the timing of patient progression from one room to another, and pair patients with staff nurses, equipment, and resources.
Julie Shah, a roboticist with Massachusetts Institute of Technology, Cambridge, compared the head nurses to air traffic controllers, but without near the decision support. Julie had previously worked for aerospace giant Boeing, where she helped design a set of algorithmic techniques to give decision support to manufacturing personnel and embed robots to aid their work.
Suddenly the Shahs had an idea.
The robot, tested in 2018 at a Boston tertiary care center, produced high-quality recommendations accepted by nurses and physicians 90% of the time. The android was taught to observe actual performances of human tasks – what was done and not done in certain situations – and develop a scheduling policy. The Shahs and their team were the first to field a robotic system on a labor and delivery unit to aid in the coordination of resources required for patient care.
“For the first time, we were able to develop a novel machine-learning technique that could learn from demonstration or observation, heuristics, or strategies for solving resource allocation and scheduling problems, which was really exciting,” Julie said. “We were able to show also how that system could be embedded to offer decision support to reduce the cognitive burden of nurses.”
Neel and Julie joke that their first collaboration dates back to middle school when they sang together in chorus. The Shahs grew up in the same small New Jersey town and met as 14-year-olds.
Though the Shahs have known each other more than half their lives, they haven’t always lived side by side. After they married, Julie accepted an opportunity in Seattle, while Neel remained 3,000 miles away in Boston.
“He does all the cooking, so I did not eat well,” Julie recalled with a laugh. “It was not great.”
“I don’t self-regulate well,” Neel adds. “I just worked 24/7. I started a nonprofit that year, so externally, it looked like I was crushing it, but …”
“He was lonely,” Julie says.
Now back in the same city, the Shahs are doting parents to two toddlers aged 2 and 4, and also serve as heads of house at an MIT graduate dorm.
Julie, 39, is an associate professor in the department of aeronautics and astronautics at MIT and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. She is renowned for her innovative methods for enabling fluid human-robot teamwork in time- and safety-critical environments such as surgery, manufacturing, and space exploration. In 2014, she was recognized by the MIT Technology Review as one of the world’s top innovators under 35, and her work on industrial human-robot collaboration was recognized as one of the 10 breakthrough technologies of 2013.
Neel, 39, is an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School in Boston and chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. A scientist and entrepreneur, Neel is globally recognized for designing solutions to improve health care. He is founder of Costs of Care, an NGO that curates insights from clinicians and patients to help delivery systems provide better care.
He also cofounded the March for Moms Association, a coalition of organizations that works to raise public and private investment in mothers’ well-being. Most recently, Neel and his team designed TeamBirth, an intrapartum care process that aims to improve the safety and dignity of childbirth care and promote communication and teamwork.
The Shahs say their personalities are sometimes opposite, but that they balance each other well.
“Julie thinks in lists, which sometimes drives me crazy, and I think in exploding clouds, which I think drives her crazy, but the combination usually works out,” Neel said. “We seem to be good complements for each other.”
In their own words
What is one food that your spouse eats that you can’t stand?
Neel: She eats raisins, and I hate raisins. Raisins are a crime against humanity. They’re wrong. The chocolate-covered raisins are even grosser.
What is one parenting difference you have?
Julie: Safety. I hover around the kids around safety hazards, and Neel is very relaxed.
What’s one quirky thing about your partner?
Neel: She has a parrot that predates our marriage. He started out as an illegal dorm bird. He just screeches and poops. If you’re developing a character in a book or a movie and you want to make them seem slightly off, you make them a bird owner. Think about it.
Julie: He’s 19 and his name is Bolivar, after the South American revolutionary. He’s very sweet.
Neel: I live in a Hitchcock movie.
If you weren’t a physician/scientist, what is a dream job you might have?
Julie: I would be a dolphin trainer. That was my childhood dream.
Neel: I’d want to do something creative. I’ve always wanted to be a better musician. I play the guitar and piano.
A version of this article first appeared on Medscape.com.
Medical Power Couples is a new series highlighting spouses or domestic partners prominent in health care. Both have achieved high-level professional success and have made significant contributions to their respective fields.
Julie Shah, PhD, and Neel Shah, MD
Ob.gyn. Neel Shah was telling his wife how challenging it was for labor and delivery nurses to make room assignments: to delegate available beds, predict the timing of patient progression from one room to another, and pair patients with staff nurses, equipment, and resources.
Julie Shah, a roboticist with Massachusetts Institute of Technology, Cambridge, compared the head nurses to air traffic controllers, but without near the decision support. Julie had previously worked for aerospace giant Boeing, where she helped design a set of algorithmic techniques to give decision support to manufacturing personnel and embed robots to aid their work.
Suddenly the Shahs had an idea.
The robot, tested in 2018 at a Boston tertiary care center, produced high-quality recommendations accepted by nurses and physicians 90% of the time. The android was taught to observe actual performances of human tasks – what was done and not done in certain situations – and develop a scheduling policy. The Shahs and their team were the first to field a robotic system on a labor and delivery unit to aid in the coordination of resources required for patient care.
“For the first time, we were able to develop a novel machine-learning technique that could learn from demonstration or observation, heuristics, or strategies for solving resource allocation and scheduling problems, which was really exciting,” Julie said. “We were able to show also how that system could be embedded to offer decision support to reduce the cognitive burden of nurses.”
Neel and Julie joke that their first collaboration dates back to middle school when they sang together in chorus. The Shahs grew up in the same small New Jersey town and met as 14-year-olds.
Though the Shahs have known each other more than half their lives, they haven’t always lived side by side. After they married, Julie accepted an opportunity in Seattle, while Neel remained 3,000 miles away in Boston.
“He does all the cooking, so I did not eat well,” Julie recalled with a laugh. “It was not great.”
“I don’t self-regulate well,” Neel adds. “I just worked 24/7. I started a nonprofit that year, so externally, it looked like I was crushing it, but …”
“He was lonely,” Julie says.
Now back in the same city, the Shahs are doting parents to two toddlers aged 2 and 4, and also serve as heads of house at an MIT graduate dorm.
Julie, 39, is an associate professor in the department of aeronautics and astronautics at MIT and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. She is renowned for her innovative methods for enabling fluid human-robot teamwork in time- and safety-critical environments such as surgery, manufacturing, and space exploration. In 2014, she was recognized by the MIT Technology Review as one of the world’s top innovators under 35, and her work on industrial human-robot collaboration was recognized as one of the 10 breakthrough technologies of 2013.
Neel, 39, is an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School in Boston and chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. A scientist and entrepreneur, Neel is globally recognized for designing solutions to improve health care. He is founder of Costs of Care, an NGO that curates insights from clinicians and patients to help delivery systems provide better care.
He also cofounded the March for Moms Association, a coalition of organizations that works to raise public and private investment in mothers’ well-being. Most recently, Neel and his team designed TeamBirth, an intrapartum care process that aims to improve the safety and dignity of childbirth care and promote communication and teamwork.
The Shahs say their personalities are sometimes opposite, but that they balance each other well.
“Julie thinks in lists, which sometimes drives me crazy, and I think in exploding clouds, which I think drives her crazy, but the combination usually works out,” Neel said. “We seem to be good complements for each other.”
In their own words
What is one food that your spouse eats that you can’t stand?
Neel: She eats raisins, and I hate raisins. Raisins are a crime against humanity. They’re wrong. The chocolate-covered raisins are even grosser.
What is one parenting difference you have?
Julie: Safety. I hover around the kids around safety hazards, and Neel is very relaxed.
What’s one quirky thing about your partner?
Neel: She has a parrot that predates our marriage. He started out as an illegal dorm bird. He just screeches and poops. If you’re developing a character in a book or a movie and you want to make them seem slightly off, you make them a bird owner. Think about it.
Julie: He’s 19 and his name is Bolivar, after the South American revolutionary. He’s very sweet.
Neel: I live in a Hitchcock movie.
If you weren’t a physician/scientist, what is a dream job you might have?
Julie: I would be a dolphin trainer. That was my childhood dream.
Neel: I’d want to do something creative. I’ve always wanted to be a better musician. I play the guitar and piano.
A version of this article first appeared on Medscape.com.
Medical Power Couples is a new series highlighting spouses or domestic partners prominent in health care. Both have achieved high-level professional success and have made significant contributions to their respective fields.
Julie Shah, PhD, and Neel Shah, MD
Ob.gyn. Neel Shah was telling his wife how challenging it was for labor and delivery nurses to make room assignments: to delegate available beds, predict the timing of patient progression from one room to another, and pair patients with staff nurses, equipment, and resources.
Julie Shah, a roboticist with Massachusetts Institute of Technology, Cambridge, compared the head nurses to air traffic controllers, but without near the decision support. Julie had previously worked for aerospace giant Boeing, where she helped design a set of algorithmic techniques to give decision support to manufacturing personnel and embed robots to aid their work.
Suddenly the Shahs had an idea.
The robot, tested in 2018 at a Boston tertiary care center, produced high-quality recommendations accepted by nurses and physicians 90% of the time. The android was taught to observe actual performances of human tasks – what was done and not done in certain situations – and develop a scheduling policy. The Shahs and their team were the first to field a robotic system on a labor and delivery unit to aid in the coordination of resources required for patient care.
“For the first time, we were able to develop a novel machine-learning technique that could learn from demonstration or observation, heuristics, or strategies for solving resource allocation and scheduling problems, which was really exciting,” Julie said. “We were able to show also how that system could be embedded to offer decision support to reduce the cognitive burden of nurses.”
Neel and Julie joke that their first collaboration dates back to middle school when they sang together in chorus. The Shahs grew up in the same small New Jersey town and met as 14-year-olds.
Though the Shahs have known each other more than half their lives, they haven’t always lived side by side. After they married, Julie accepted an opportunity in Seattle, while Neel remained 3,000 miles away in Boston.
“He does all the cooking, so I did not eat well,” Julie recalled with a laugh. “It was not great.”
“I don’t self-regulate well,” Neel adds. “I just worked 24/7. I started a nonprofit that year, so externally, it looked like I was crushing it, but …”
“He was lonely,” Julie says.
Now back in the same city, the Shahs are doting parents to two toddlers aged 2 and 4, and also serve as heads of house at an MIT graduate dorm.
Julie, 39, is an associate professor in the department of aeronautics and astronautics at MIT and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. She is renowned for her innovative methods for enabling fluid human-robot teamwork in time- and safety-critical environments such as surgery, manufacturing, and space exploration. In 2014, she was recognized by the MIT Technology Review as one of the world’s top innovators under 35, and her work on industrial human-robot collaboration was recognized as one of the 10 breakthrough technologies of 2013.
Neel, 39, is an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School in Boston and chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. A scientist and entrepreneur, Neel is globally recognized for designing solutions to improve health care. He is founder of Costs of Care, an NGO that curates insights from clinicians and patients to help delivery systems provide better care.
He also cofounded the March for Moms Association, a coalition of organizations that works to raise public and private investment in mothers’ well-being. Most recently, Neel and his team designed TeamBirth, an intrapartum care process that aims to improve the safety and dignity of childbirth care and promote communication and teamwork.
The Shahs say their personalities are sometimes opposite, but that they balance each other well.
“Julie thinks in lists, which sometimes drives me crazy, and I think in exploding clouds, which I think drives her crazy, but the combination usually works out,” Neel said. “We seem to be good complements for each other.”
In their own words
What is one food that your spouse eats that you can’t stand?
Neel: She eats raisins, and I hate raisins. Raisins are a crime against humanity. They’re wrong. The chocolate-covered raisins are even grosser.
What is one parenting difference you have?
Julie: Safety. I hover around the kids around safety hazards, and Neel is very relaxed.
What’s one quirky thing about your partner?
Neel: She has a parrot that predates our marriage. He started out as an illegal dorm bird. He just screeches and poops. If you’re developing a character in a book or a movie and you want to make them seem slightly off, you make them a bird owner. Think about it.
Julie: He’s 19 and his name is Bolivar, after the South American revolutionary. He’s very sweet.
Neel: I live in a Hitchcock movie.
If you weren’t a physician/scientist, what is a dream job you might have?
Julie: I would be a dolphin trainer. That was my childhood dream.
Neel: I’d want to do something creative. I’ve always wanted to be a better musician. I play the guitar and piano.
A version of this article first appeared on Medscape.com.
Unequal resource distribution underlies lung cancer disparities
Lung cancer disparities are reversible, but it will take changes at the social policy and organizational levels to do it, according to Ray Osarogiagbon, MBBS, a medical oncologist in the thoracic oncology program at Baptist Cancer Center, Memphis.
Much of the issue comes down to unequal distribution of services across the country, with less high-end care available in areas hardest hit by lung cancer, which are often areas with higher percentages of Black people, Dr. Osarogiagbon said. He addressed the issues – which he conceptualizes as “avoidable differences” – in a plenary presentation at the virtual 2021 World Conference on Lung Cancer.
He said that much of disparity research has focused on patient-level issues, but it has the least potential to effect change and also has “the unpleasant side effect of stigmatizing the victims of disparate health care delivery.”
Better to look at the big picture. “We have to focus on the areas where we are most likely to be successful, the social policy level, next the organizational level, and then providers,” he said.
Kentucky, followed by Mississippi, Arkansas, Tennessee, West Virginia, and Alabama, has the highest lung cancer burden in the United States. While lung cancer has been on the decline for decades nationwide, some counties in those states in particular continue to struggle with rising lung cancer mortality.
Dr. Osarogiagbon’s own health care system, which serves western Tennessee as well as eastern Arkansas and northern Mississippi, sees about 1,300 lung cancer cases annually, more than many states in the United States.
Regional disparities in lung cancer care span the entirety of available services, from unequal access to tobacco cessation and other preventive measures straight through to access to leading-edge systemic therapies. Disparities are particularly acute with more recent advances such as immunotherapy and low-dose CT screening.
One recent study, for instance, found that several southern states with high lung cancer burdens had screening rates below 4%, while several New England states had rates ranging to over 15%.
“There is a mismatch between the places were lung cancer kills and the places where we have invested in low-dose CT scan facilities,” Dr. Osarogiagbon said. As a side effect, White patients have better access,
It’s not, he said, that Black people are more likely to refuse such services, as least as far as clinical trials go.
Black patients are significantly underrepresented in pharmaceutical industry trials. Part of the issues is that areas hardest hit by lung cancer are often also ones less likely to have the infrastructure to support trials.
But on an equal playing field, Black patients are at least as eager as White patients to sign up for a trial. Dr. Osarogiagbon and colleagues found that, if offered the chance, almost 60% of Black patients said they would participate in a trial versus 53.4% of White patients. If access were equal, there would be “no race-based disparities” in trial participation, he said.
It’s also emerging that Black patients might benefit more from innovations such as immune checkpoint inhibitors treatment and low-dose CT screening, which means that, if they were included in more trials, companies would likely have stronger study results.
It’s something they should pay attention to, if for no other reason than it would help their bottom line, Dr. Osarogiagbon said.
Curative surgery for early-stage lung tumors is another issue. At the county level in the United States, he and his team found that it’s offered to anywhere from 13% to 92% of patients who qualify.
“Counties in the lowest quartile for receipt of surgery were those with a high proportion of non-Hispanic Black subjects, high poverty and uninsured rates, low surgeon-to-population ratio, and nonmetropolitan status,” they found.
Dr. Osarogiagbon is a consultant for and/or has stock in a number of companies, including AstraZeneca, Eli Lilly, and Genentech.
Lung cancer disparities are reversible, but it will take changes at the social policy and organizational levels to do it, according to Ray Osarogiagbon, MBBS, a medical oncologist in the thoracic oncology program at Baptist Cancer Center, Memphis.
Much of the issue comes down to unequal distribution of services across the country, with less high-end care available in areas hardest hit by lung cancer, which are often areas with higher percentages of Black people, Dr. Osarogiagbon said. He addressed the issues – which he conceptualizes as “avoidable differences” – in a plenary presentation at the virtual 2021 World Conference on Lung Cancer.
He said that much of disparity research has focused on patient-level issues, but it has the least potential to effect change and also has “the unpleasant side effect of stigmatizing the victims of disparate health care delivery.”
Better to look at the big picture. “We have to focus on the areas where we are most likely to be successful, the social policy level, next the organizational level, and then providers,” he said.
Kentucky, followed by Mississippi, Arkansas, Tennessee, West Virginia, and Alabama, has the highest lung cancer burden in the United States. While lung cancer has been on the decline for decades nationwide, some counties in those states in particular continue to struggle with rising lung cancer mortality.
Dr. Osarogiagbon’s own health care system, which serves western Tennessee as well as eastern Arkansas and northern Mississippi, sees about 1,300 lung cancer cases annually, more than many states in the United States.
Regional disparities in lung cancer care span the entirety of available services, from unequal access to tobacco cessation and other preventive measures straight through to access to leading-edge systemic therapies. Disparities are particularly acute with more recent advances such as immunotherapy and low-dose CT screening.
One recent study, for instance, found that several southern states with high lung cancer burdens had screening rates below 4%, while several New England states had rates ranging to over 15%.
“There is a mismatch between the places were lung cancer kills and the places where we have invested in low-dose CT scan facilities,” Dr. Osarogiagbon said. As a side effect, White patients have better access,
It’s not, he said, that Black people are more likely to refuse such services, as least as far as clinical trials go.
Black patients are significantly underrepresented in pharmaceutical industry trials. Part of the issues is that areas hardest hit by lung cancer are often also ones less likely to have the infrastructure to support trials.
But on an equal playing field, Black patients are at least as eager as White patients to sign up for a trial. Dr. Osarogiagbon and colleagues found that, if offered the chance, almost 60% of Black patients said they would participate in a trial versus 53.4% of White patients. If access were equal, there would be “no race-based disparities” in trial participation, he said.
It’s also emerging that Black patients might benefit more from innovations such as immune checkpoint inhibitors treatment and low-dose CT screening, which means that, if they were included in more trials, companies would likely have stronger study results.
It’s something they should pay attention to, if for no other reason than it would help their bottom line, Dr. Osarogiagbon said.
Curative surgery for early-stage lung tumors is another issue. At the county level in the United States, he and his team found that it’s offered to anywhere from 13% to 92% of patients who qualify.
“Counties in the lowest quartile for receipt of surgery were those with a high proportion of non-Hispanic Black subjects, high poverty and uninsured rates, low surgeon-to-population ratio, and nonmetropolitan status,” they found.
Dr. Osarogiagbon is a consultant for and/or has stock in a number of companies, including AstraZeneca, Eli Lilly, and Genentech.
Lung cancer disparities are reversible, but it will take changes at the social policy and organizational levels to do it, according to Ray Osarogiagbon, MBBS, a medical oncologist in the thoracic oncology program at Baptist Cancer Center, Memphis.
Much of the issue comes down to unequal distribution of services across the country, with less high-end care available in areas hardest hit by lung cancer, which are often areas with higher percentages of Black people, Dr. Osarogiagbon said. He addressed the issues – which he conceptualizes as “avoidable differences” – in a plenary presentation at the virtual 2021 World Conference on Lung Cancer.
He said that much of disparity research has focused on patient-level issues, but it has the least potential to effect change and also has “the unpleasant side effect of stigmatizing the victims of disparate health care delivery.”
Better to look at the big picture. “We have to focus on the areas where we are most likely to be successful, the social policy level, next the organizational level, and then providers,” he said.
Kentucky, followed by Mississippi, Arkansas, Tennessee, West Virginia, and Alabama, has the highest lung cancer burden in the United States. While lung cancer has been on the decline for decades nationwide, some counties in those states in particular continue to struggle with rising lung cancer mortality.
Dr. Osarogiagbon’s own health care system, which serves western Tennessee as well as eastern Arkansas and northern Mississippi, sees about 1,300 lung cancer cases annually, more than many states in the United States.
Regional disparities in lung cancer care span the entirety of available services, from unequal access to tobacco cessation and other preventive measures straight through to access to leading-edge systemic therapies. Disparities are particularly acute with more recent advances such as immunotherapy and low-dose CT screening.
One recent study, for instance, found that several southern states with high lung cancer burdens had screening rates below 4%, while several New England states had rates ranging to over 15%.
“There is a mismatch between the places were lung cancer kills and the places where we have invested in low-dose CT scan facilities,” Dr. Osarogiagbon said. As a side effect, White patients have better access,
It’s not, he said, that Black people are more likely to refuse such services, as least as far as clinical trials go.
Black patients are significantly underrepresented in pharmaceutical industry trials. Part of the issues is that areas hardest hit by lung cancer are often also ones less likely to have the infrastructure to support trials.
But on an equal playing field, Black patients are at least as eager as White patients to sign up for a trial. Dr. Osarogiagbon and colleagues found that, if offered the chance, almost 60% of Black patients said they would participate in a trial versus 53.4% of White patients. If access were equal, there would be “no race-based disparities” in trial participation, he said.
It’s also emerging that Black patients might benefit more from innovations such as immune checkpoint inhibitors treatment and low-dose CT screening, which means that, if they were included in more trials, companies would likely have stronger study results.
It’s something they should pay attention to, if for no other reason than it would help their bottom line, Dr. Osarogiagbon said.
Curative surgery for early-stage lung tumors is another issue. At the county level in the United States, he and his team found that it’s offered to anywhere from 13% to 92% of patients who qualify.
“Counties in the lowest quartile for receipt of surgery were those with a high proportion of non-Hispanic Black subjects, high poverty and uninsured rates, low surgeon-to-population ratio, and nonmetropolitan status,” they found.
Dr. Osarogiagbon is a consultant for and/or has stock in a number of companies, including AstraZeneca, Eli Lilly, and Genentech.
FROM WCLC 2021
Finding the most bang for the buck with adjuvant atezolizumab for NSCLC
Investigators are zeroing in on the stage II-IIIa non–small cell lung cancer patients most likely to benefit from adjuvant atezolizumab (Tecentriq) following resection and chemotherapy.
It seems that PD-L1 positive patients, those who undergo lobectomy, those who have nodal involvement, and those treated with all common platinum doublets, with the possible exception of cisplatin-gemcitabine, are most likely to benefit from adjuvant treatment, according to a report at the virtual 2021 World Congress on Lung Cancer.
Results come for an analysis of IMpower010, which randomized 1,005 patients equally to either best supportive care or atezolizumab every 21 days for 16 cycles following resection and chemotherapy.
The topline results, reported recently, found a 34% improvement in disease-free survival (DFS) in stage II-IIIa patients expressing PD-L1 and a 21% improvement across all patients regardless of PD-L1 expression.
It was the first positive phase 3 trial for adjuvant immunotherapy in NSCLC. Maker Hoffman-La Roche subsequently applied to the U.S. Food and Drug Administration for an indication for adjuvant treatment following surgery and platinum-based chemotherapy for NSCLC with PD-L1 expression of at least 1%.
At the WCLC meeting, investigators took a closer look at IMpower010 to gauge the impact of different surgery and chemotherapy types on outcomes.
“Improved DFS was observed with adjuvant atezolizumab” for II-IIIa disease across most stages in patients “with nodal involvement, and across most surgery resection types and chemotherapy regimens,” said lead investigator Nasser Altorki, MD, director of the division of thoracic surgery at New York Presbyterian-Weill Cornell Medical Center in New York.
Study discussant Ichiro Yoshino, MD, PhD, a thoracic surgeon at Chiba University, in Japan, expanded on the “most” part of the assertion.
“Patients who underwent lobectomy [78%] had more evident benefit. … Patients who had a pneumonectomy [16%] did not benefit from atezolizumab,” he said (DFS hazard ratio, 0.91, 95% confidence interval, 0.56-1.47).
The reasons are unclear. It could be because patients who have pneumonectomies are less tolerant of adjuvant chemotherapy, so might have not gotten complete courses, but whatever the cause, Dr. Yoshino said it’s an important finding that needs further investigation.
Also, there was no DFS benefit in the 16% of patients who received cisplatin-gemcitabine for chemotherapy instead of other platinum doublets (HR, 0.94, 95% CI, 0.56-1.57).
It might have to do with the fact that under 80% of cisplatin-gemcitabine patients completed all four cycles of chemotherapy versus completion rates of up to more than 90% with other platinum doublets. It might also, however, have something to do with the way gemcitabine works or its interaction with atezolizumab.
The issue is another one that needs “to be examined,” Dr. Yoshino said.
The trial was funded by Hoffman-La Roche. Dr. Altorki is an advisor and/or researcher for AstraZeneca, Merck, and Johnson & Johnson. Among various company ties, Dr. Yoshino is an advisor and speaker for AstraZeneca and Johnson & Johnson and a researcher for Pfizer.
Investigators are zeroing in on the stage II-IIIa non–small cell lung cancer patients most likely to benefit from adjuvant atezolizumab (Tecentriq) following resection and chemotherapy.
It seems that PD-L1 positive patients, those who undergo lobectomy, those who have nodal involvement, and those treated with all common platinum doublets, with the possible exception of cisplatin-gemcitabine, are most likely to benefit from adjuvant treatment, according to a report at the virtual 2021 World Congress on Lung Cancer.
Results come for an analysis of IMpower010, which randomized 1,005 patients equally to either best supportive care or atezolizumab every 21 days for 16 cycles following resection and chemotherapy.
The topline results, reported recently, found a 34% improvement in disease-free survival (DFS) in stage II-IIIa patients expressing PD-L1 and a 21% improvement across all patients regardless of PD-L1 expression.
It was the first positive phase 3 trial for adjuvant immunotherapy in NSCLC. Maker Hoffman-La Roche subsequently applied to the U.S. Food and Drug Administration for an indication for adjuvant treatment following surgery and platinum-based chemotherapy for NSCLC with PD-L1 expression of at least 1%.
At the WCLC meeting, investigators took a closer look at IMpower010 to gauge the impact of different surgery and chemotherapy types on outcomes.
“Improved DFS was observed with adjuvant atezolizumab” for II-IIIa disease across most stages in patients “with nodal involvement, and across most surgery resection types and chemotherapy regimens,” said lead investigator Nasser Altorki, MD, director of the division of thoracic surgery at New York Presbyterian-Weill Cornell Medical Center in New York.
Study discussant Ichiro Yoshino, MD, PhD, a thoracic surgeon at Chiba University, in Japan, expanded on the “most” part of the assertion.
“Patients who underwent lobectomy [78%] had more evident benefit. … Patients who had a pneumonectomy [16%] did not benefit from atezolizumab,” he said (DFS hazard ratio, 0.91, 95% confidence interval, 0.56-1.47).
The reasons are unclear. It could be because patients who have pneumonectomies are less tolerant of adjuvant chemotherapy, so might have not gotten complete courses, but whatever the cause, Dr. Yoshino said it’s an important finding that needs further investigation.
Also, there was no DFS benefit in the 16% of patients who received cisplatin-gemcitabine for chemotherapy instead of other platinum doublets (HR, 0.94, 95% CI, 0.56-1.57).
It might have to do with the fact that under 80% of cisplatin-gemcitabine patients completed all four cycles of chemotherapy versus completion rates of up to more than 90% with other platinum doublets. It might also, however, have something to do with the way gemcitabine works or its interaction with atezolizumab.
The issue is another one that needs “to be examined,” Dr. Yoshino said.
The trial was funded by Hoffman-La Roche. Dr. Altorki is an advisor and/or researcher for AstraZeneca, Merck, and Johnson & Johnson. Among various company ties, Dr. Yoshino is an advisor and speaker for AstraZeneca and Johnson & Johnson and a researcher for Pfizer.
Investigators are zeroing in on the stage II-IIIa non–small cell lung cancer patients most likely to benefit from adjuvant atezolizumab (Tecentriq) following resection and chemotherapy.
It seems that PD-L1 positive patients, those who undergo lobectomy, those who have nodal involvement, and those treated with all common platinum doublets, with the possible exception of cisplatin-gemcitabine, are most likely to benefit from adjuvant treatment, according to a report at the virtual 2021 World Congress on Lung Cancer.
Results come for an analysis of IMpower010, which randomized 1,005 patients equally to either best supportive care or atezolizumab every 21 days for 16 cycles following resection and chemotherapy.
The topline results, reported recently, found a 34% improvement in disease-free survival (DFS) in stage II-IIIa patients expressing PD-L1 and a 21% improvement across all patients regardless of PD-L1 expression.
It was the first positive phase 3 trial for adjuvant immunotherapy in NSCLC. Maker Hoffman-La Roche subsequently applied to the U.S. Food and Drug Administration for an indication for adjuvant treatment following surgery and platinum-based chemotherapy for NSCLC with PD-L1 expression of at least 1%.
At the WCLC meeting, investigators took a closer look at IMpower010 to gauge the impact of different surgery and chemotherapy types on outcomes.
“Improved DFS was observed with adjuvant atezolizumab” for II-IIIa disease across most stages in patients “with nodal involvement, and across most surgery resection types and chemotherapy regimens,” said lead investigator Nasser Altorki, MD, director of the division of thoracic surgery at New York Presbyterian-Weill Cornell Medical Center in New York.
Study discussant Ichiro Yoshino, MD, PhD, a thoracic surgeon at Chiba University, in Japan, expanded on the “most” part of the assertion.
“Patients who underwent lobectomy [78%] had more evident benefit. … Patients who had a pneumonectomy [16%] did not benefit from atezolizumab,” he said (DFS hazard ratio, 0.91, 95% confidence interval, 0.56-1.47).
The reasons are unclear. It could be because patients who have pneumonectomies are less tolerant of adjuvant chemotherapy, so might have not gotten complete courses, but whatever the cause, Dr. Yoshino said it’s an important finding that needs further investigation.
Also, there was no DFS benefit in the 16% of patients who received cisplatin-gemcitabine for chemotherapy instead of other platinum doublets (HR, 0.94, 95% CI, 0.56-1.57).
It might have to do with the fact that under 80% of cisplatin-gemcitabine patients completed all four cycles of chemotherapy versus completion rates of up to more than 90% with other platinum doublets. It might also, however, have something to do with the way gemcitabine works or its interaction with atezolizumab.
The issue is another one that needs “to be examined,” Dr. Yoshino said.
The trial was funded by Hoffman-La Roche. Dr. Altorki is an advisor and/or researcher for AstraZeneca, Merck, and Johnson & Johnson. Among various company ties, Dr. Yoshino is an advisor and speaker for AstraZeneca and Johnson & Johnson and a researcher for Pfizer.
FROM WCLC 2021
Gluten-free diet may reduce cancer risk in celiac disease
Overall cancer risk is slightly increased in patients older than 40 years within their first year of a celiac disease diagnosis, but the risk drops within a year of diagnosis, shows a Swedish study of 47,000 people with celiac disease.
“Celiac disease is associated with an increased risk of types of cancer, and we believe that this is due to the longstanding inflammation that is induced by gluten,” said first author Benjamin Lebwohl, MD, director of clinical research at the Columbia University Celiac Disease Center in New York.
Writing in Clinical Gastroenterology and Hepatology, the authors explained that most studies investigating cancer risk in patients with celiac disease were done before both the widespread use of serologic testing for celiac disease and access to gluten-free food was widely available. Earlier studies linked celiac disease to gastrointestinal malignancies, such as small intestinal adenocarcinoma, and lymphomas.
A prior analysis of this Swedish cohort found that the risk of small intestinal adenocarcinoma, while low, continued for up to 10 years after diagnosis with celiac disease. In the study, which was published in Gastroenterology, the authors found the risks of small-bowel adenocarcinoma and adenomas were significantly increased in people with celiac disease, compared with those without this disease.
“We have known from prior studies that people with celiac disease are at increased risk of developing certain cancers, but there has been limited study of this risk in celiac disease in the 21st century, where there is increased recognition (leading to more prompt diagnosis) and increased access to gluten-free food options (which may allow for more effective treatment),” said Dr. Lebwohl, who is also the director of quality improvement in the division of digestive and liver diseases at Columbia University. “We aimed to determine whether there is still an increased risk of cancer in this modern era, and we found that there still is an increased risk, but this increase is small and that it diminishes beyond the first year after the diagnosis of celiac disease.”
This nationwide cohort study in Sweden included 47,241 patients with celiac disease (62% female; mean age, 24 years), of which 64% were diagnosed since 2000. Each patient was age and sex matched to up to five controls. After a median follow-up of 11.5 years, a 1.11-fold increased risk of cancer overall was found in patients with celiac disease, compared with controls. The respective incidences of cancer were 6.5 and 5.7 per 1,000 person-years, and most of the excess risk was caused by gastrointestinal and hematologic cancer.
The overall risk of cancer was increased in the first year after celiac disease diagnosis (HR, 2.47; 95% CI, 2.22-2.74) but not afterwards (HR, 1.01; 95% CI, 0.97-1.05).
“It appears that the increased risk of cancer in people with celiac disease decreased over time, and this may be related to the beneficial effect of the gluten-free diet in the long term,” Dr. Lebwohl said.
The authors suggest that cancer risk, followed by a decline to no risk, may alternatively be due to the increased monitoring and medical examinations among patients with celiac disease. Also, symptoms of cancer, such as weight loss, may lead to broad testing that identifies celiac disease, the authors wrote.
For cancer subtypes, the strongest association between celiac disease and cancer was found for hematologic, lymphoproliferative and gastrointestinal cancers. Among gastrointestinal cancer subtypes, elevated risks were found for hepatobiliary and pancreatic cancer, but not for gastric or colorectal cancer. The cancer risk in celiac disease decreased in breast and lung cancer, which the authors suggested may be attributed to lower body mass index and smoking rates, respectively, observed in individuals with celiac disease.
Certain cancer types persist after 1 year
Although there was no overall cancer risk for more than 1 year after celiac disease diagnosis, the risks of hematologic and lymphoproliferative cancers persisted. While the increased risk of gastrointestinal cancers collectively was no longer significant beyond 1 year after celiac disease diagnosis, the risk persisted for hepatobiliary and pancreatic cancer.
“We found that the risk of gastrointestinal cancers is increased in people with celiac disease, compared to the general population, but these risks vary according to the cancer type,” Dr. Lebwohl said. “For instance, the risk of pancreatic cancer is increased in people with celiac disease, compared to the general population, while the risk of colon cancer in people with celiac disease is not increased, compared to the general population.
“But pancreatic cancer is far less common than colon cancer. We found that pancreatic cancer occurs in 1 in 5,000 people with celiac disease per year, whereas colorectal cancer occurred in 1 in 1,400 people per year. Taken all together, the risk of any gastrointestinal cancer was around 1 in 700 per year among people with celiac disease,” Dr. Lebwohl said.
The overall cancer risk was highest in patients diagnosed with celiac disease after age 60 and was not increased in those diagnosed with celiac disease before age 40. The authors noted that, in recent years, there has been a pronounced increase in the diagnosis of celiac disease in people aged over 60, an age group with a higher risk of developing severe outcomes related to refractory celiac disease. The cancer risk was similar among patients diagnosed with celiac disease before or after 2000.
Since this is an observational study, causality cannot be proven, and the authors suggested that the findings may not be applicable to settings outside of the relatively homogeneous ethnic population of Sweden.
Carol E. Semrad, MD, professor of medicine and director of clinical research in the Celiac Center at the University of Chicago Medicine, said: “This is an observational study and therefore cannot answer whether celiac disease is the cause of cancer or merely an association.” She added that “it is unknown why the risk for some cancers is higher in celiac disease.
“This paper argues against delayed diagnosis and low detection rate to explain the increase in cancer risk as those diagnosed with celiac disease prior to 2000 had the same cancer risk as those diagnosed after 2000 when diagnostic testing, earlier diagnosis, and access to a gluten-free diet were better,” Dr. Semrad said.
Link to mortality data
The authors said increased cancer risk being restricted to the first year of diagnosis is consistent with prior celiac disease studies of morbidity and mortality.
A study published in 2019 in United European Gastroenterology looked at mortality risk in 602 patients with celiac disease from Lothian, Scotland, identified between 1979 and 1983 and followed up from 1970 to 2016. All-cause mortality was 43% higher than in the general population, mainly from hematologic malignancies, and this risk was greatest during the first few years of diagnosis.
An analysis of cause-specific mortality in the Swedish cohort, published in 2020 in JAMA, found that celiac disease was associated with a small but statistically significant increased mortality risk. After a median follow-up of 12.5 years of 49,829 patients with celiac disease, the mortality rate was 9.7 and 8.6 deaths per 1000 person-years, compared with the general population, respectively. Individuals with celiac disease were at increased risk of death from cancer, cardiovascular disease and respiratory disease. The overall mortality risk was greatest in the first year after diagnosis with celiac disease, after which the risk diminished with the establishment of the gluten-free diet but remained modestly elevated in the long term.
However, a Finnish population-based study, published in the American Journal of Gastroenterology, found no increase in overall mortality in patients with celiac disease. The study included 12,803 adults diagnosed with celiac disease between 2005 and 2014. Participants were followed for an average of 7.7 years and mortality from all malignancies, gastrointestinal tract malignancies or cardiovascular diseases were not increased among patients with celiac disease, compared with the general population. Mortality from lymphoproliferative diseases was increased in patients with celiac disease but was lower than previously reported.
Dr. Lebwohl and colleagues noted that the incidences of cancer types vary by the age and geographical region of the study population, as does the diagnosis of celiac disease, which may explain why increased risk for cancer or cancer related-mortality in patients with celiac disease has not always been reported.
Dr Ludvigsson coordinates a study on behalf of the Swedish IBD quality register. This study has received funding from Janssen. The remaining authors disclosed no conflicts.
Overall cancer risk is slightly increased in patients older than 40 years within their first year of a celiac disease diagnosis, but the risk drops within a year of diagnosis, shows a Swedish study of 47,000 people with celiac disease.
“Celiac disease is associated with an increased risk of types of cancer, and we believe that this is due to the longstanding inflammation that is induced by gluten,” said first author Benjamin Lebwohl, MD, director of clinical research at the Columbia University Celiac Disease Center in New York.
Writing in Clinical Gastroenterology and Hepatology, the authors explained that most studies investigating cancer risk in patients with celiac disease were done before both the widespread use of serologic testing for celiac disease and access to gluten-free food was widely available. Earlier studies linked celiac disease to gastrointestinal malignancies, such as small intestinal adenocarcinoma, and lymphomas.
A prior analysis of this Swedish cohort found that the risk of small intestinal adenocarcinoma, while low, continued for up to 10 years after diagnosis with celiac disease. In the study, which was published in Gastroenterology, the authors found the risks of small-bowel adenocarcinoma and adenomas were significantly increased in people with celiac disease, compared with those without this disease.
“We have known from prior studies that people with celiac disease are at increased risk of developing certain cancers, but there has been limited study of this risk in celiac disease in the 21st century, where there is increased recognition (leading to more prompt diagnosis) and increased access to gluten-free food options (which may allow for more effective treatment),” said Dr. Lebwohl, who is also the director of quality improvement in the division of digestive and liver diseases at Columbia University. “We aimed to determine whether there is still an increased risk of cancer in this modern era, and we found that there still is an increased risk, but this increase is small and that it diminishes beyond the first year after the diagnosis of celiac disease.”
This nationwide cohort study in Sweden included 47,241 patients with celiac disease (62% female; mean age, 24 years), of which 64% were diagnosed since 2000. Each patient was age and sex matched to up to five controls. After a median follow-up of 11.5 years, a 1.11-fold increased risk of cancer overall was found in patients with celiac disease, compared with controls. The respective incidences of cancer were 6.5 and 5.7 per 1,000 person-years, and most of the excess risk was caused by gastrointestinal and hematologic cancer.
The overall risk of cancer was increased in the first year after celiac disease diagnosis (HR, 2.47; 95% CI, 2.22-2.74) but not afterwards (HR, 1.01; 95% CI, 0.97-1.05).
“It appears that the increased risk of cancer in people with celiac disease decreased over time, and this may be related to the beneficial effect of the gluten-free diet in the long term,” Dr. Lebwohl said.
The authors suggest that cancer risk, followed by a decline to no risk, may alternatively be due to the increased monitoring and medical examinations among patients with celiac disease. Also, symptoms of cancer, such as weight loss, may lead to broad testing that identifies celiac disease, the authors wrote.
For cancer subtypes, the strongest association between celiac disease and cancer was found for hematologic, lymphoproliferative and gastrointestinal cancers. Among gastrointestinal cancer subtypes, elevated risks were found for hepatobiliary and pancreatic cancer, but not for gastric or colorectal cancer. The cancer risk in celiac disease decreased in breast and lung cancer, which the authors suggested may be attributed to lower body mass index and smoking rates, respectively, observed in individuals with celiac disease.
Certain cancer types persist after 1 year
Although there was no overall cancer risk for more than 1 year after celiac disease diagnosis, the risks of hematologic and lymphoproliferative cancers persisted. While the increased risk of gastrointestinal cancers collectively was no longer significant beyond 1 year after celiac disease diagnosis, the risk persisted for hepatobiliary and pancreatic cancer.
“We found that the risk of gastrointestinal cancers is increased in people with celiac disease, compared to the general population, but these risks vary according to the cancer type,” Dr. Lebwohl said. “For instance, the risk of pancreatic cancer is increased in people with celiac disease, compared to the general population, while the risk of colon cancer in people with celiac disease is not increased, compared to the general population.
“But pancreatic cancer is far less common than colon cancer. We found that pancreatic cancer occurs in 1 in 5,000 people with celiac disease per year, whereas colorectal cancer occurred in 1 in 1,400 people per year. Taken all together, the risk of any gastrointestinal cancer was around 1 in 700 per year among people with celiac disease,” Dr. Lebwohl said.
The overall cancer risk was highest in patients diagnosed with celiac disease after age 60 and was not increased in those diagnosed with celiac disease before age 40. The authors noted that, in recent years, there has been a pronounced increase in the diagnosis of celiac disease in people aged over 60, an age group with a higher risk of developing severe outcomes related to refractory celiac disease. The cancer risk was similar among patients diagnosed with celiac disease before or after 2000.
Since this is an observational study, causality cannot be proven, and the authors suggested that the findings may not be applicable to settings outside of the relatively homogeneous ethnic population of Sweden.
Carol E. Semrad, MD, professor of medicine and director of clinical research in the Celiac Center at the University of Chicago Medicine, said: “This is an observational study and therefore cannot answer whether celiac disease is the cause of cancer or merely an association.” She added that “it is unknown why the risk for some cancers is higher in celiac disease.
“This paper argues against delayed diagnosis and low detection rate to explain the increase in cancer risk as those diagnosed with celiac disease prior to 2000 had the same cancer risk as those diagnosed after 2000 when diagnostic testing, earlier diagnosis, and access to a gluten-free diet were better,” Dr. Semrad said.
Link to mortality data
The authors said increased cancer risk being restricted to the first year of diagnosis is consistent with prior celiac disease studies of morbidity and mortality.
A study published in 2019 in United European Gastroenterology looked at mortality risk in 602 patients with celiac disease from Lothian, Scotland, identified between 1979 and 1983 and followed up from 1970 to 2016. All-cause mortality was 43% higher than in the general population, mainly from hematologic malignancies, and this risk was greatest during the first few years of diagnosis.
An analysis of cause-specific mortality in the Swedish cohort, published in 2020 in JAMA, found that celiac disease was associated with a small but statistically significant increased mortality risk. After a median follow-up of 12.5 years of 49,829 patients with celiac disease, the mortality rate was 9.7 and 8.6 deaths per 1000 person-years, compared with the general population, respectively. Individuals with celiac disease were at increased risk of death from cancer, cardiovascular disease and respiratory disease. The overall mortality risk was greatest in the first year after diagnosis with celiac disease, after which the risk diminished with the establishment of the gluten-free diet but remained modestly elevated in the long term.
However, a Finnish population-based study, published in the American Journal of Gastroenterology, found no increase in overall mortality in patients with celiac disease. The study included 12,803 adults diagnosed with celiac disease between 2005 and 2014. Participants were followed for an average of 7.7 years and mortality from all malignancies, gastrointestinal tract malignancies or cardiovascular diseases were not increased among patients with celiac disease, compared with the general population. Mortality from lymphoproliferative diseases was increased in patients with celiac disease but was lower than previously reported.
Dr. Lebwohl and colleagues noted that the incidences of cancer types vary by the age and geographical region of the study population, as does the diagnosis of celiac disease, which may explain why increased risk for cancer or cancer related-mortality in patients with celiac disease has not always been reported.
Dr Ludvigsson coordinates a study on behalf of the Swedish IBD quality register. This study has received funding from Janssen. The remaining authors disclosed no conflicts.
Overall cancer risk is slightly increased in patients older than 40 years within their first year of a celiac disease diagnosis, but the risk drops within a year of diagnosis, shows a Swedish study of 47,000 people with celiac disease.
“Celiac disease is associated with an increased risk of types of cancer, and we believe that this is due to the longstanding inflammation that is induced by gluten,” said first author Benjamin Lebwohl, MD, director of clinical research at the Columbia University Celiac Disease Center in New York.
Writing in Clinical Gastroenterology and Hepatology, the authors explained that most studies investigating cancer risk in patients with celiac disease were done before both the widespread use of serologic testing for celiac disease and access to gluten-free food was widely available. Earlier studies linked celiac disease to gastrointestinal malignancies, such as small intestinal adenocarcinoma, and lymphomas.
A prior analysis of this Swedish cohort found that the risk of small intestinal adenocarcinoma, while low, continued for up to 10 years after diagnosis with celiac disease. In the study, which was published in Gastroenterology, the authors found the risks of small-bowel adenocarcinoma and adenomas were significantly increased in people with celiac disease, compared with those without this disease.
“We have known from prior studies that people with celiac disease are at increased risk of developing certain cancers, but there has been limited study of this risk in celiac disease in the 21st century, where there is increased recognition (leading to more prompt diagnosis) and increased access to gluten-free food options (which may allow for more effective treatment),” said Dr. Lebwohl, who is also the director of quality improvement in the division of digestive and liver diseases at Columbia University. “We aimed to determine whether there is still an increased risk of cancer in this modern era, and we found that there still is an increased risk, but this increase is small and that it diminishes beyond the first year after the diagnosis of celiac disease.”
This nationwide cohort study in Sweden included 47,241 patients with celiac disease (62% female; mean age, 24 years), of which 64% were diagnosed since 2000. Each patient was age and sex matched to up to five controls. After a median follow-up of 11.5 years, a 1.11-fold increased risk of cancer overall was found in patients with celiac disease, compared with controls. The respective incidences of cancer were 6.5 and 5.7 per 1,000 person-years, and most of the excess risk was caused by gastrointestinal and hematologic cancer.
The overall risk of cancer was increased in the first year after celiac disease diagnosis (HR, 2.47; 95% CI, 2.22-2.74) but not afterwards (HR, 1.01; 95% CI, 0.97-1.05).
“It appears that the increased risk of cancer in people with celiac disease decreased over time, and this may be related to the beneficial effect of the gluten-free diet in the long term,” Dr. Lebwohl said.
The authors suggest that cancer risk, followed by a decline to no risk, may alternatively be due to the increased monitoring and medical examinations among patients with celiac disease. Also, symptoms of cancer, such as weight loss, may lead to broad testing that identifies celiac disease, the authors wrote.
For cancer subtypes, the strongest association between celiac disease and cancer was found for hematologic, lymphoproliferative and gastrointestinal cancers. Among gastrointestinal cancer subtypes, elevated risks were found for hepatobiliary and pancreatic cancer, but not for gastric or colorectal cancer. The cancer risk in celiac disease decreased in breast and lung cancer, which the authors suggested may be attributed to lower body mass index and smoking rates, respectively, observed in individuals with celiac disease.
Certain cancer types persist after 1 year
Although there was no overall cancer risk for more than 1 year after celiac disease diagnosis, the risks of hematologic and lymphoproliferative cancers persisted. While the increased risk of gastrointestinal cancers collectively was no longer significant beyond 1 year after celiac disease diagnosis, the risk persisted for hepatobiliary and pancreatic cancer.
“We found that the risk of gastrointestinal cancers is increased in people with celiac disease, compared to the general population, but these risks vary according to the cancer type,” Dr. Lebwohl said. “For instance, the risk of pancreatic cancer is increased in people with celiac disease, compared to the general population, while the risk of colon cancer in people with celiac disease is not increased, compared to the general population.
“But pancreatic cancer is far less common than colon cancer. We found that pancreatic cancer occurs in 1 in 5,000 people with celiac disease per year, whereas colorectal cancer occurred in 1 in 1,400 people per year. Taken all together, the risk of any gastrointestinal cancer was around 1 in 700 per year among people with celiac disease,” Dr. Lebwohl said.
The overall cancer risk was highest in patients diagnosed with celiac disease after age 60 and was not increased in those diagnosed with celiac disease before age 40. The authors noted that, in recent years, there has been a pronounced increase in the diagnosis of celiac disease in people aged over 60, an age group with a higher risk of developing severe outcomes related to refractory celiac disease. The cancer risk was similar among patients diagnosed with celiac disease before or after 2000.
Since this is an observational study, causality cannot be proven, and the authors suggested that the findings may not be applicable to settings outside of the relatively homogeneous ethnic population of Sweden.
Carol E. Semrad, MD, professor of medicine and director of clinical research in the Celiac Center at the University of Chicago Medicine, said: “This is an observational study and therefore cannot answer whether celiac disease is the cause of cancer or merely an association.” She added that “it is unknown why the risk for some cancers is higher in celiac disease.
“This paper argues against delayed diagnosis and low detection rate to explain the increase in cancer risk as those diagnosed with celiac disease prior to 2000 had the same cancer risk as those diagnosed after 2000 when diagnostic testing, earlier diagnosis, and access to a gluten-free diet were better,” Dr. Semrad said.
Link to mortality data
The authors said increased cancer risk being restricted to the first year of diagnosis is consistent with prior celiac disease studies of morbidity and mortality.
A study published in 2019 in United European Gastroenterology looked at mortality risk in 602 patients with celiac disease from Lothian, Scotland, identified between 1979 and 1983 and followed up from 1970 to 2016. All-cause mortality was 43% higher than in the general population, mainly from hematologic malignancies, and this risk was greatest during the first few years of diagnosis.
An analysis of cause-specific mortality in the Swedish cohort, published in 2020 in JAMA, found that celiac disease was associated with a small but statistically significant increased mortality risk. After a median follow-up of 12.5 years of 49,829 patients with celiac disease, the mortality rate was 9.7 and 8.6 deaths per 1000 person-years, compared with the general population, respectively. Individuals with celiac disease were at increased risk of death from cancer, cardiovascular disease and respiratory disease. The overall mortality risk was greatest in the first year after diagnosis with celiac disease, after which the risk diminished with the establishment of the gluten-free diet but remained modestly elevated in the long term.
However, a Finnish population-based study, published in the American Journal of Gastroenterology, found no increase in overall mortality in patients with celiac disease. The study included 12,803 adults diagnosed with celiac disease between 2005 and 2014. Participants were followed for an average of 7.7 years and mortality from all malignancies, gastrointestinal tract malignancies or cardiovascular diseases were not increased among patients with celiac disease, compared with the general population. Mortality from lymphoproliferative diseases was increased in patients with celiac disease but was lower than previously reported.
Dr. Lebwohl and colleagues noted that the incidences of cancer types vary by the age and geographical region of the study population, as does the diagnosis of celiac disease, which may explain why increased risk for cancer or cancer related-mortality in patients with celiac disease has not always been reported.
Dr Ludvigsson coordinates a study on behalf of the Swedish IBD quality register. This study has received funding from Janssen. The remaining authors disclosed no conflicts.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Medical boards: Docs who spread COVID misinformation put license at risk
Leaders of the American Board of Family Medicine, the American Board of Internal Medicine, and the American Board of Pediatrics said Sept. 9 that they support FSMB’s position.
“We also want all physicians certified by our boards to know that such unethical or unprofessional conduct may prompt their respective Board to take action that could put their certification at risk,” a statement read.
“Expertise matters, and board-certified physicians have demonstrated that they have stayed current in their field. Spreading misinformation or falsehoods to the public during a time of a public health emergency goes against everything our boards and our community of board-certified physicians stand for,” the leaders wrote.
“The evidence that we have safe, effective, and widely available vaccines against COVID-19 is overwhelming. We are particularly concerned about physicians who use their authority to denigrate vaccination at a time when vaccines continue to demonstrate excellent effectiveness against severe illness, hospitalization, and death.”
Small number spread false information
However, a small number of doctors continue to spread misinformation against the vaccines and communicate other false information surrounding COVID-19.
Some of the misinformation spreaders have had ultra-viral reach.
Among them is Daniel Stock, MD, a family physician in Indiana who has come out against COVID-19 vaccines. At a recent meeting of the Mt. Vernon Community School board in Indiana, he gave a speech urging the board to ignore the prevailing recommendations around COVID-19, such as test-and-trace measures.
Forbes reported in August that versions of the video of Stock›s speech on Facebook “have collected a total of 90 million engagements – a metric encompassing things such as comments, likes and shares – according to data collected by Media Matters for America, a liberal tech-watchdog group.”
This news organization published a story in August asking whether physicians who spread such information should lose their license and the question drew rapid-fire comments.
Commenters who argued with potential disciplinary actions raised questions about where the line will be drawn between misinformation and deeply held beliefs in terms of care.
Several comments centered on ivermectin, which is not approved by the Food and Drug Administration to treat COVID-19 but is enthusiastically supported as a COVID-19 treatment by a group of physicians called the Front Line COVID-19 Critical Care Alliance, whose website includes requests for donations.
Some cited free speech protections.
‘Not consistent with standards’
As for ivermectin, David G. Nichols, MD, president and CEO of the American Board of Pediatrics, gave this news organization an example: “Spreading the notion that one would not need to get vaccinated because if you get sick you could take ivermectin is a very dangerous statement. That is not consistent with the standards of professionalism required for certification or licensure.”
Ivermectin, he noted, is not an approved treatment for COVID-19.
“To say that it is or has any benefit is a false statement. We’re not willing to allow individuals who make false statements to devalue the terrific work of tens of thousands of physicians across the United States doing work under very difficult circumstances,” Dr. Nichols said.
He continued: “To suggest treatments that are known not to be effective in exchange for treatment that is known to be effective is dangerous – and ivermectin falls under that category.”
Asked whether such suggestions could result in suspension or revocation of a physician’s license, Dr. Nichols said, “It’s the kind of thing that would certainly trigger a review.”
He said the standard for separating misinformation from personal beliefs is based on whether there is scientific evidence to support the belief.
The boards are not, with this statement, attempting to referee legitimate scientific debate, he said.
The misinformation the boards are referring to, Dr. Nichols said, is “where the evidence is 100% on one side and zero on another. And the zero is not only that the opinions or beliefs are unsupported or unsubstantiated, they are indeed harmful if followed. That’s the distinction we’re trying to make here.”
As for free-speech arguments, he said, “Free speech is a constitutional right. You can say whatever you want. The issue here is you do not have the right to expect continued professional sanction of a board certificate if you are lying to the public.”
The board statement also said: “We all look to board-certified physicians to provide outstanding care and guidance; providing misinformation about a lethal disease is unethical, unprofessional, and dangerous. In times of medical emergency, the community of expert physicians committed to science and evidence collectively shares a responsibility for giving the public the most accurate and timely health information available, so they can make decisions that work best for themselves and their families.”
In addition to Dr. Nichols, the statement was signed by Warren Newton, MD, MPH, president and CEO of the American Board of Family Medicine, and Richard J. Baron, MD, president and CEO of the American Board of Internal Medicine.
A version of this article first appeared on Medscape.com.
Leaders of the American Board of Family Medicine, the American Board of Internal Medicine, and the American Board of Pediatrics said Sept. 9 that they support FSMB’s position.
“We also want all physicians certified by our boards to know that such unethical or unprofessional conduct may prompt their respective Board to take action that could put their certification at risk,” a statement read.
“Expertise matters, and board-certified physicians have demonstrated that they have stayed current in their field. Spreading misinformation or falsehoods to the public during a time of a public health emergency goes against everything our boards and our community of board-certified physicians stand for,” the leaders wrote.
“The evidence that we have safe, effective, and widely available vaccines against COVID-19 is overwhelming. We are particularly concerned about physicians who use their authority to denigrate vaccination at a time when vaccines continue to demonstrate excellent effectiveness against severe illness, hospitalization, and death.”
Small number spread false information
However, a small number of doctors continue to spread misinformation against the vaccines and communicate other false information surrounding COVID-19.
Some of the misinformation spreaders have had ultra-viral reach.
Among them is Daniel Stock, MD, a family physician in Indiana who has come out against COVID-19 vaccines. At a recent meeting of the Mt. Vernon Community School board in Indiana, he gave a speech urging the board to ignore the prevailing recommendations around COVID-19, such as test-and-trace measures.
Forbes reported in August that versions of the video of Stock›s speech on Facebook “have collected a total of 90 million engagements – a metric encompassing things such as comments, likes and shares – according to data collected by Media Matters for America, a liberal tech-watchdog group.”
This news organization published a story in August asking whether physicians who spread such information should lose their license and the question drew rapid-fire comments.
Commenters who argued with potential disciplinary actions raised questions about where the line will be drawn between misinformation and deeply held beliefs in terms of care.
Several comments centered on ivermectin, which is not approved by the Food and Drug Administration to treat COVID-19 but is enthusiastically supported as a COVID-19 treatment by a group of physicians called the Front Line COVID-19 Critical Care Alliance, whose website includes requests for donations.
Some cited free speech protections.
‘Not consistent with standards’
As for ivermectin, David G. Nichols, MD, president and CEO of the American Board of Pediatrics, gave this news organization an example: “Spreading the notion that one would not need to get vaccinated because if you get sick you could take ivermectin is a very dangerous statement. That is not consistent with the standards of professionalism required for certification or licensure.”
Ivermectin, he noted, is not an approved treatment for COVID-19.
“To say that it is or has any benefit is a false statement. We’re not willing to allow individuals who make false statements to devalue the terrific work of tens of thousands of physicians across the United States doing work under very difficult circumstances,” Dr. Nichols said.
He continued: “To suggest treatments that are known not to be effective in exchange for treatment that is known to be effective is dangerous – and ivermectin falls under that category.”
Asked whether such suggestions could result in suspension or revocation of a physician’s license, Dr. Nichols said, “It’s the kind of thing that would certainly trigger a review.”
He said the standard for separating misinformation from personal beliefs is based on whether there is scientific evidence to support the belief.
The boards are not, with this statement, attempting to referee legitimate scientific debate, he said.
The misinformation the boards are referring to, Dr. Nichols said, is “where the evidence is 100% on one side and zero on another. And the zero is not only that the opinions or beliefs are unsupported or unsubstantiated, they are indeed harmful if followed. That’s the distinction we’re trying to make here.”
As for free-speech arguments, he said, “Free speech is a constitutional right. You can say whatever you want. The issue here is you do not have the right to expect continued professional sanction of a board certificate if you are lying to the public.”
The board statement also said: “We all look to board-certified physicians to provide outstanding care and guidance; providing misinformation about a lethal disease is unethical, unprofessional, and dangerous. In times of medical emergency, the community of expert physicians committed to science and evidence collectively shares a responsibility for giving the public the most accurate and timely health information available, so they can make decisions that work best for themselves and their families.”
In addition to Dr. Nichols, the statement was signed by Warren Newton, MD, MPH, president and CEO of the American Board of Family Medicine, and Richard J. Baron, MD, president and CEO of the American Board of Internal Medicine.
A version of this article first appeared on Medscape.com.
Leaders of the American Board of Family Medicine, the American Board of Internal Medicine, and the American Board of Pediatrics said Sept. 9 that they support FSMB’s position.
“We also want all physicians certified by our boards to know that such unethical or unprofessional conduct may prompt their respective Board to take action that could put their certification at risk,” a statement read.
“Expertise matters, and board-certified physicians have demonstrated that they have stayed current in their field. Spreading misinformation or falsehoods to the public during a time of a public health emergency goes against everything our boards and our community of board-certified physicians stand for,” the leaders wrote.
“The evidence that we have safe, effective, and widely available vaccines against COVID-19 is overwhelming. We are particularly concerned about physicians who use their authority to denigrate vaccination at a time when vaccines continue to demonstrate excellent effectiveness against severe illness, hospitalization, and death.”
Small number spread false information
However, a small number of doctors continue to spread misinformation against the vaccines and communicate other false information surrounding COVID-19.
Some of the misinformation spreaders have had ultra-viral reach.
Among them is Daniel Stock, MD, a family physician in Indiana who has come out against COVID-19 vaccines. At a recent meeting of the Mt. Vernon Community School board in Indiana, he gave a speech urging the board to ignore the prevailing recommendations around COVID-19, such as test-and-trace measures.
Forbes reported in August that versions of the video of Stock›s speech on Facebook “have collected a total of 90 million engagements – a metric encompassing things such as comments, likes and shares – according to data collected by Media Matters for America, a liberal tech-watchdog group.”
This news organization published a story in August asking whether physicians who spread such information should lose their license and the question drew rapid-fire comments.
Commenters who argued with potential disciplinary actions raised questions about where the line will be drawn between misinformation and deeply held beliefs in terms of care.
Several comments centered on ivermectin, which is not approved by the Food and Drug Administration to treat COVID-19 but is enthusiastically supported as a COVID-19 treatment by a group of physicians called the Front Line COVID-19 Critical Care Alliance, whose website includes requests for donations.
Some cited free speech protections.
‘Not consistent with standards’
As for ivermectin, David G. Nichols, MD, president and CEO of the American Board of Pediatrics, gave this news organization an example: “Spreading the notion that one would not need to get vaccinated because if you get sick you could take ivermectin is a very dangerous statement. That is not consistent with the standards of professionalism required for certification or licensure.”
Ivermectin, he noted, is not an approved treatment for COVID-19.
“To say that it is or has any benefit is a false statement. We’re not willing to allow individuals who make false statements to devalue the terrific work of tens of thousands of physicians across the United States doing work under very difficult circumstances,” Dr. Nichols said.
He continued: “To suggest treatments that are known not to be effective in exchange for treatment that is known to be effective is dangerous – and ivermectin falls under that category.”
Asked whether such suggestions could result in suspension or revocation of a physician’s license, Dr. Nichols said, “It’s the kind of thing that would certainly trigger a review.”
He said the standard for separating misinformation from personal beliefs is based on whether there is scientific evidence to support the belief.
The boards are not, with this statement, attempting to referee legitimate scientific debate, he said.
The misinformation the boards are referring to, Dr. Nichols said, is “where the evidence is 100% on one side and zero on another. And the zero is not only that the opinions or beliefs are unsupported or unsubstantiated, they are indeed harmful if followed. That’s the distinction we’re trying to make here.”
As for free-speech arguments, he said, “Free speech is a constitutional right. You can say whatever you want. The issue here is you do not have the right to expect continued professional sanction of a board certificate if you are lying to the public.”
The board statement also said: “We all look to board-certified physicians to provide outstanding care and guidance; providing misinformation about a lethal disease is unethical, unprofessional, and dangerous. In times of medical emergency, the community of expert physicians committed to science and evidence collectively shares a responsibility for giving the public the most accurate and timely health information available, so they can make decisions that work best for themselves and their families.”
In addition to Dr. Nichols, the statement was signed by Warren Newton, MD, MPH, president and CEO of the American Board of Family Medicine, and Richard J. Baron, MD, president and CEO of the American Board of Internal Medicine.
A version of this article first appeared on Medscape.com.
Data supporting cannabis for childhood epilepsy remain scarce
, according to two leading experts.
In a recent invited review article, Martin Kirkpatrick, MD, of the University of Dundee (Scotland), and Finbar O’Callaghan, MD, PhD, of University College London suggested that childhood epilepsy may be easy terrain for commercial interests to break ground, and from there, build their presence.
“Children with epilepsy are at risk of being used as the ‘Trojan horse’ for the cannabis industry,” Dr. Kirkpatrick and Dr. O’Callaghan wrote in Developmental Medicine & Child Neurology.
They noted that some of the first publicized success stories involving cannabis oil for epilepsy coincided with the rise of the medicinal and recreational cannabis markets, which will constitute an estimated 55-billion-dollar industry by 2027.
“Pediatric neurologists, imbued with the need to practice evidence-based medicine and wary of prescribing unlicensed medicines that had inadequate safety data, suddenly found themselves at odds with an array of vested interests and, most unfortunately, with the families of patients who were keen to try anything that would alleviate the effects of their child’s seizures,” the investigators wrote.
According to the review, fundamental questions about cannabis remain unanswered, including concerns about safety with long-term use, and the medicinal value of various plant components, such as myrcene, a terpene that gives cannabis its characteristic smell.
“A widely discussed issue is whether the terpenes add any therapeutic benefit, contributing to the so-called entourage effect of ‘whole-plant’ medicines,” the investigators wrote. “The concept is that all the constituents of the plant together create ‘the sum of all the parts that leads to the magic or power of cannabis.’ Although commonly referred to, there is little or no robust evidence to support the entourage effect as a credible clinical concept.”
Clinical evidence for treatment of pediatric epilepsy is also lacking, according to Dr. Kirkpatrick and Dr. O’Callaghan.
“Unfortunately, apart from the studies of pure cannabidiol (CBD) in Lennox–Gastaut and Dravet syndromes and tuberous sclerosis complex, level I evidence in the field of CBMPs and refractory epilepsy is lacking,” they wrote.
While other experts have pointed out that lower-level evidence – such as patient-reported outcomes and observational data – have previously been sufficient for drug licensing, Dr. Kirkpatrick and Dr. O’Callaghan noted that such exceptions “almost always” involve conditions without any effective treatments, or drugs that are undeniably effective.
“This is not the scenario with CBMPs,” they wrote, referring to current clinical data as “low-level” evidence “suggesting … possible efficacy.”
They highlighted concerns about placebo effect with open-label epilepsy studies, citing a randomized controlled trial for Dravet syndrome, in which 27% of patients given placebo had a 50% reduction in seizure frequency.
“We need carefully designed, good-quality CBMP studies that produce results on which we can rely,” Dr. Kirkpatrick and Dr. O’Callaghan concluded. “We can then work with families to choose the best treatments for children and young people with epilepsy. We owe this to them.”
A therapy of last resort
Jerzy P. Szaflarski, MD, PhD, of the University of Alabama at Birmingham, agreed that data are lacking for the use of CBMPs with patients who have epilepsy and other neurologic conditions; however, he also suggested that Dr. Kirkpatrick and Dr. O’Callaghan did not provide adequate real-world clinical context.
“Medical cannabis is not used as a first-, second-, or third-line therapy,” Dr. Szaflarski said. “It’s mostly used as a last resort in the sense that patients have already failed multiple other therapies.” In that respect, patients and parents are desperate to try anything that might work. “We have medical cannabis, and our patients want to try it, and at the point when multiple therapies have failed, it’s a reasonable option.”
While Dr. Szaflarski agreed that more high-quality clinical trials are needed, he also noted the practical challenges involved in such trials, largely because of variations in cannabis plants.
“The content of the cannabis plant changes depending on the day that it’s collected and the exposure to sun and how much water it has and what’s in the soil and many other things,” Dr. Szaflarski said. “It’s hard to get a very good, standardized product, and that’s why there needs to be a good-quality product delivered by the industry, which I have not seen thus far.”
For this reason, Dr. Szaflarski steers parents and patients away from over-the-counter CBMPs and toward Epidiolex, the only FDA-approved form of CBD.
“There is evidence that Epidiolex works,” he said. “I don’t know whether the products that are sold in a local cannabis store have the same high purity as Epidiolex. I tell [parents] that we should try Epidiolex first because it’s the one that is approved. But if it doesn’t work, we can go in that [other] direction.”
For those going the commercial route, Dr. Szaflarski advised close attention to product ingredients, to ensure that CBMPs are “devoid of any impurities, pesticides, fungicides, and other products that could be potentially dangerous.”
Parents considering CBMPs for their children also need to weigh concerns about long-term neurological safety, he added, noting that, on one hand, commercial products lack data, while on the other, epilepsy itself may cause harm.
“They need to consider the potential effects [of CBMPs] on their child’s brain and development versus … the effects of seizures on the brain,” Dr. Szaflarski said.
Dr. Kirkpatrick and Dr. O’Callaghan disclosed an application for a National Institute for Health Research–funded randomized controlled trial on CBMPs and joint authorship of British Paediatric Neurology Association Guidance on the use of CBMPs in children and young people with epilepsy. Dr. Szaflarski disclosed a relationship with Greenwich Biosciences and several other cannabis companies.
, according to two leading experts.
In a recent invited review article, Martin Kirkpatrick, MD, of the University of Dundee (Scotland), and Finbar O’Callaghan, MD, PhD, of University College London suggested that childhood epilepsy may be easy terrain for commercial interests to break ground, and from there, build their presence.
“Children with epilepsy are at risk of being used as the ‘Trojan horse’ for the cannabis industry,” Dr. Kirkpatrick and Dr. O’Callaghan wrote in Developmental Medicine & Child Neurology.
They noted that some of the first publicized success stories involving cannabis oil for epilepsy coincided with the rise of the medicinal and recreational cannabis markets, which will constitute an estimated 55-billion-dollar industry by 2027.
“Pediatric neurologists, imbued with the need to practice evidence-based medicine and wary of prescribing unlicensed medicines that had inadequate safety data, suddenly found themselves at odds with an array of vested interests and, most unfortunately, with the families of patients who were keen to try anything that would alleviate the effects of their child’s seizures,” the investigators wrote.
According to the review, fundamental questions about cannabis remain unanswered, including concerns about safety with long-term use, and the medicinal value of various plant components, such as myrcene, a terpene that gives cannabis its characteristic smell.
“A widely discussed issue is whether the terpenes add any therapeutic benefit, contributing to the so-called entourage effect of ‘whole-plant’ medicines,” the investigators wrote. “The concept is that all the constituents of the plant together create ‘the sum of all the parts that leads to the magic or power of cannabis.’ Although commonly referred to, there is little or no robust evidence to support the entourage effect as a credible clinical concept.”
Clinical evidence for treatment of pediatric epilepsy is also lacking, according to Dr. Kirkpatrick and Dr. O’Callaghan.
“Unfortunately, apart from the studies of pure cannabidiol (CBD) in Lennox–Gastaut and Dravet syndromes and tuberous sclerosis complex, level I evidence in the field of CBMPs and refractory epilepsy is lacking,” they wrote.
While other experts have pointed out that lower-level evidence – such as patient-reported outcomes and observational data – have previously been sufficient for drug licensing, Dr. Kirkpatrick and Dr. O’Callaghan noted that such exceptions “almost always” involve conditions without any effective treatments, or drugs that are undeniably effective.
“This is not the scenario with CBMPs,” they wrote, referring to current clinical data as “low-level” evidence “suggesting … possible efficacy.”
They highlighted concerns about placebo effect with open-label epilepsy studies, citing a randomized controlled trial for Dravet syndrome, in which 27% of patients given placebo had a 50% reduction in seizure frequency.
“We need carefully designed, good-quality CBMP studies that produce results on which we can rely,” Dr. Kirkpatrick and Dr. O’Callaghan concluded. “We can then work with families to choose the best treatments for children and young people with epilepsy. We owe this to them.”
A therapy of last resort
Jerzy P. Szaflarski, MD, PhD, of the University of Alabama at Birmingham, agreed that data are lacking for the use of CBMPs with patients who have epilepsy and other neurologic conditions; however, he also suggested that Dr. Kirkpatrick and Dr. O’Callaghan did not provide adequate real-world clinical context.
“Medical cannabis is not used as a first-, second-, or third-line therapy,” Dr. Szaflarski said. “It’s mostly used as a last resort in the sense that patients have already failed multiple other therapies.” In that respect, patients and parents are desperate to try anything that might work. “We have medical cannabis, and our patients want to try it, and at the point when multiple therapies have failed, it’s a reasonable option.”
While Dr. Szaflarski agreed that more high-quality clinical trials are needed, he also noted the practical challenges involved in such trials, largely because of variations in cannabis plants.
“The content of the cannabis plant changes depending on the day that it’s collected and the exposure to sun and how much water it has and what’s in the soil and many other things,” Dr. Szaflarski said. “It’s hard to get a very good, standardized product, and that’s why there needs to be a good-quality product delivered by the industry, which I have not seen thus far.”
For this reason, Dr. Szaflarski steers parents and patients away from over-the-counter CBMPs and toward Epidiolex, the only FDA-approved form of CBD.
“There is evidence that Epidiolex works,” he said. “I don’t know whether the products that are sold in a local cannabis store have the same high purity as Epidiolex. I tell [parents] that we should try Epidiolex first because it’s the one that is approved. But if it doesn’t work, we can go in that [other] direction.”
For those going the commercial route, Dr. Szaflarski advised close attention to product ingredients, to ensure that CBMPs are “devoid of any impurities, pesticides, fungicides, and other products that could be potentially dangerous.”
Parents considering CBMPs for their children also need to weigh concerns about long-term neurological safety, he added, noting that, on one hand, commercial products lack data, while on the other, epilepsy itself may cause harm.
“They need to consider the potential effects [of CBMPs] on their child’s brain and development versus … the effects of seizures on the brain,” Dr. Szaflarski said.
Dr. Kirkpatrick and Dr. O’Callaghan disclosed an application for a National Institute for Health Research–funded randomized controlled trial on CBMPs and joint authorship of British Paediatric Neurology Association Guidance on the use of CBMPs in children and young people with epilepsy. Dr. Szaflarski disclosed a relationship with Greenwich Biosciences and several other cannabis companies.
, according to two leading experts.
In a recent invited review article, Martin Kirkpatrick, MD, of the University of Dundee (Scotland), and Finbar O’Callaghan, MD, PhD, of University College London suggested that childhood epilepsy may be easy terrain for commercial interests to break ground, and from there, build their presence.
“Children with epilepsy are at risk of being used as the ‘Trojan horse’ for the cannabis industry,” Dr. Kirkpatrick and Dr. O’Callaghan wrote in Developmental Medicine & Child Neurology.
They noted that some of the first publicized success stories involving cannabis oil for epilepsy coincided with the rise of the medicinal and recreational cannabis markets, which will constitute an estimated 55-billion-dollar industry by 2027.
“Pediatric neurologists, imbued with the need to practice evidence-based medicine and wary of prescribing unlicensed medicines that had inadequate safety data, suddenly found themselves at odds with an array of vested interests and, most unfortunately, with the families of patients who were keen to try anything that would alleviate the effects of their child’s seizures,” the investigators wrote.
According to the review, fundamental questions about cannabis remain unanswered, including concerns about safety with long-term use, and the medicinal value of various plant components, such as myrcene, a terpene that gives cannabis its characteristic smell.
“A widely discussed issue is whether the terpenes add any therapeutic benefit, contributing to the so-called entourage effect of ‘whole-plant’ medicines,” the investigators wrote. “The concept is that all the constituents of the plant together create ‘the sum of all the parts that leads to the magic or power of cannabis.’ Although commonly referred to, there is little or no robust evidence to support the entourage effect as a credible clinical concept.”
Clinical evidence for treatment of pediatric epilepsy is also lacking, according to Dr. Kirkpatrick and Dr. O’Callaghan.
“Unfortunately, apart from the studies of pure cannabidiol (CBD) in Lennox–Gastaut and Dravet syndromes and tuberous sclerosis complex, level I evidence in the field of CBMPs and refractory epilepsy is lacking,” they wrote.
While other experts have pointed out that lower-level evidence – such as patient-reported outcomes and observational data – have previously been sufficient for drug licensing, Dr. Kirkpatrick and Dr. O’Callaghan noted that such exceptions “almost always” involve conditions without any effective treatments, or drugs that are undeniably effective.
“This is not the scenario with CBMPs,” they wrote, referring to current clinical data as “low-level” evidence “suggesting … possible efficacy.”
They highlighted concerns about placebo effect with open-label epilepsy studies, citing a randomized controlled trial for Dravet syndrome, in which 27% of patients given placebo had a 50% reduction in seizure frequency.
“We need carefully designed, good-quality CBMP studies that produce results on which we can rely,” Dr. Kirkpatrick and Dr. O’Callaghan concluded. “We can then work with families to choose the best treatments for children and young people with epilepsy. We owe this to them.”
A therapy of last resort
Jerzy P. Szaflarski, MD, PhD, of the University of Alabama at Birmingham, agreed that data are lacking for the use of CBMPs with patients who have epilepsy and other neurologic conditions; however, he also suggested that Dr. Kirkpatrick and Dr. O’Callaghan did not provide adequate real-world clinical context.
“Medical cannabis is not used as a first-, second-, or third-line therapy,” Dr. Szaflarski said. “It’s mostly used as a last resort in the sense that patients have already failed multiple other therapies.” In that respect, patients and parents are desperate to try anything that might work. “We have medical cannabis, and our patients want to try it, and at the point when multiple therapies have failed, it’s a reasonable option.”
While Dr. Szaflarski agreed that more high-quality clinical trials are needed, he also noted the practical challenges involved in such trials, largely because of variations in cannabis plants.
“The content of the cannabis plant changes depending on the day that it’s collected and the exposure to sun and how much water it has and what’s in the soil and many other things,” Dr. Szaflarski said. “It’s hard to get a very good, standardized product, and that’s why there needs to be a good-quality product delivered by the industry, which I have not seen thus far.”
For this reason, Dr. Szaflarski steers parents and patients away from over-the-counter CBMPs and toward Epidiolex, the only FDA-approved form of CBD.
“There is evidence that Epidiolex works,” he said. “I don’t know whether the products that are sold in a local cannabis store have the same high purity as Epidiolex. I tell [parents] that we should try Epidiolex first because it’s the one that is approved. But if it doesn’t work, we can go in that [other] direction.”
For those going the commercial route, Dr. Szaflarski advised close attention to product ingredients, to ensure that CBMPs are “devoid of any impurities, pesticides, fungicides, and other products that could be potentially dangerous.”
Parents considering CBMPs for their children also need to weigh concerns about long-term neurological safety, he added, noting that, on one hand, commercial products lack data, while on the other, epilepsy itself may cause harm.
“They need to consider the potential effects [of CBMPs] on their child’s brain and development versus … the effects of seizures on the brain,” Dr. Szaflarski said.
Dr. Kirkpatrick and Dr. O’Callaghan disclosed an application for a National Institute for Health Research–funded randomized controlled trial on CBMPs and joint authorship of British Paediatric Neurology Association Guidance on the use of CBMPs in children and young people with epilepsy. Dr. Szaflarski disclosed a relationship with Greenwich Biosciences and several other cannabis companies.
FROM DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY
Hair regrowth stimulated by microneedle patch in preclinical study
Those who are unhappy about losing their hair might be interested to hear about a new approach where scientists use mechanical stimulation to promote hair regrowth.
Currently, Food and Drug Administration–approved drugs for hair loss include minoxidil (Rogaine) and finasteride (Propecia). But there are side effects, and the treatments only work when continuously used for an extended time.
Some people may opt instead to have hair follicle transplants, but study coauthor Fangyuan Li, PhD, from the College of Pharmaceutical Sciences at Zhejiang University in Hangzhou, China, explains, the surgery is painful and not always successful because it depends a lot on the quality of donor hair follicles, which can vary.
Seeking to develop a new nonsurgical option, the scientists, led by Jianqing Gao, vice dean of the College of Pharmaceutical Sciences at Zhejiang University, designed a dissolvable microneedle patch to deliver treatment near hair roots beneath the skin.
Male- or female-pattern baldness can be permanent when there aren’t enough blood vessels surrounding hair follicles to deliver nutrients and other essential molecules. A buildup of reactive oxygen in the scalp can prompt the death of cells that would otherwise grow new hair.
In a previous investigation, the researchers found that nanoparticles containing cerium, a silvery-white metal, can mimic the enzymes inside the body that can help ease oxidative stress.
The scientists coated cerium nanoparticles with a biodegradable compound. Then they made the microneedle patch by pouring a mixture of hyaluronic acid with cerium-containing nanoparticles into a mold.
The small needles don’t hurt when applied, Dr. Li said, as they deliver treatment to a region under the skin with no pain receptors.
The researchers tested control patches and the cerium-containing ones on male mice with bald spots created by a hair-removal cream. Both applications stimulated new blood vessels to form around the mice hair follicles. But those treated with the nanoparticle patch showed faster signs of hair recuperation at the root.
The mice also had fewer oxidative stress compounds in their skin. Microneedle patch use resulted in faster hair regrowth, compared with a cream-based treatment, and could be applied less frequently.
And though the idea is not yet ready to be tried on people, it represents an inventive step forward in addressing a common problem.
A version of this article first appeared on WebMD.com.
Those who are unhappy about losing their hair might be interested to hear about a new approach where scientists use mechanical stimulation to promote hair regrowth.
Currently, Food and Drug Administration–approved drugs for hair loss include minoxidil (Rogaine) and finasteride (Propecia). But there are side effects, and the treatments only work when continuously used for an extended time.
Some people may opt instead to have hair follicle transplants, but study coauthor Fangyuan Li, PhD, from the College of Pharmaceutical Sciences at Zhejiang University in Hangzhou, China, explains, the surgery is painful and not always successful because it depends a lot on the quality of donor hair follicles, which can vary.
Seeking to develop a new nonsurgical option, the scientists, led by Jianqing Gao, vice dean of the College of Pharmaceutical Sciences at Zhejiang University, designed a dissolvable microneedle patch to deliver treatment near hair roots beneath the skin.
Male- or female-pattern baldness can be permanent when there aren’t enough blood vessels surrounding hair follicles to deliver nutrients and other essential molecules. A buildup of reactive oxygen in the scalp can prompt the death of cells that would otherwise grow new hair.
In a previous investigation, the researchers found that nanoparticles containing cerium, a silvery-white metal, can mimic the enzymes inside the body that can help ease oxidative stress.
The scientists coated cerium nanoparticles with a biodegradable compound. Then they made the microneedle patch by pouring a mixture of hyaluronic acid with cerium-containing nanoparticles into a mold.
The small needles don’t hurt when applied, Dr. Li said, as they deliver treatment to a region under the skin with no pain receptors.
The researchers tested control patches and the cerium-containing ones on male mice with bald spots created by a hair-removal cream. Both applications stimulated new blood vessels to form around the mice hair follicles. But those treated with the nanoparticle patch showed faster signs of hair recuperation at the root.
The mice also had fewer oxidative stress compounds in their skin. Microneedle patch use resulted in faster hair regrowth, compared with a cream-based treatment, and could be applied less frequently.
And though the idea is not yet ready to be tried on people, it represents an inventive step forward in addressing a common problem.
A version of this article first appeared on WebMD.com.
Those who are unhappy about losing their hair might be interested to hear about a new approach where scientists use mechanical stimulation to promote hair regrowth.
Currently, Food and Drug Administration–approved drugs for hair loss include minoxidil (Rogaine) and finasteride (Propecia). But there are side effects, and the treatments only work when continuously used for an extended time.
Some people may opt instead to have hair follicle transplants, but study coauthor Fangyuan Li, PhD, from the College of Pharmaceutical Sciences at Zhejiang University in Hangzhou, China, explains, the surgery is painful and not always successful because it depends a lot on the quality of donor hair follicles, which can vary.
Seeking to develop a new nonsurgical option, the scientists, led by Jianqing Gao, vice dean of the College of Pharmaceutical Sciences at Zhejiang University, designed a dissolvable microneedle patch to deliver treatment near hair roots beneath the skin.
Male- or female-pattern baldness can be permanent when there aren’t enough blood vessels surrounding hair follicles to deliver nutrients and other essential molecules. A buildup of reactive oxygen in the scalp can prompt the death of cells that would otherwise grow new hair.
In a previous investigation, the researchers found that nanoparticles containing cerium, a silvery-white metal, can mimic the enzymes inside the body that can help ease oxidative stress.
The scientists coated cerium nanoparticles with a biodegradable compound. Then they made the microneedle patch by pouring a mixture of hyaluronic acid with cerium-containing nanoparticles into a mold.
The small needles don’t hurt when applied, Dr. Li said, as they deliver treatment to a region under the skin with no pain receptors.
The researchers tested control patches and the cerium-containing ones on male mice with bald spots created by a hair-removal cream. Both applications stimulated new blood vessels to form around the mice hair follicles. But those treated with the nanoparticle patch showed faster signs of hair recuperation at the root.
The mice also had fewer oxidative stress compounds in their skin. Microneedle patch use resulted in faster hair regrowth, compared with a cream-based treatment, and could be applied less frequently.
And though the idea is not yet ready to be tried on people, it represents an inventive step forward in addressing a common problem.
A version of this article first appeared on WebMD.com.
Microwave ablation an alternative therapy in lung malignancy
Lung cancer patients with relatively small nodules who cannot or will not undergo surgery or radiotherapy can be successfully treated with targeted transbronchial microwave ablation, indicate results from a U.K.-led preliminary trial.
The NAVABLATE study included 30 patients from the U.K. and Hong Kong who had malignant lung nodules no more than 30 mm in diameter, who underwent transbronchial microwave ablation and were followed up one month later.
On the day, the technique was performed successfully in all 30 patients, while follow-up imaging at one month suggested that the ablation had been satisfactory in every case, with no repeat procedures necessary.
It was also associated with a “low rate of device-related adverse events and no serious adverse events,” said lead author Kevin Lau, Barts Thorax Centre, St. Bartholomew’s Hospital, Barts Health NHS Trust, London.
Consequently, transbronchial microwave ablation can be considered “an alternative treatment modality for patients with primary and metastatic malignant lung nodules … who decline or are ineligible” for surgery and radiotherapy.
The research was presented at the European Respiratory Society International Congress (ERS) 2021 on September 5.
‘Encouraging’ results
Professor Stefano Elia, head of the European Respiratory Society’s Assembly on Thoracic Surgery and Transplantation, told this news organization that the results “are encouraging.”
However, the patient numbers are “very low, so it is difficult to draw value conclusions,” and he would like to have seen more detailed characterization of the patients’ tumors.
Prof. Elia, from the University of Rome Tor Vergata, added that transbronchial microwave ablation should, in line with the study’s inclusion criteria, “probably be reserved” for lung cancer patients “who are unfit for or refuse surgery or alternative treatment strategies.”
He added that “prospective, randomized trials are warranted to see if the technique is feasible, safe and indicated” in these patients, and the potential cost of performing it needs to be specified.
Study details
Presenting the study, Mr. Lau explained that NAVABLATE was a prospective, multicenter study that enrolled patients with a confirmed malignant lung nodule ≤30 mm that did not abut the pleura, fissure, or critical structures.
In addition, the patients had declined or were not eligible for both surgery and stereotactic body radiotherapy.
They underwent transbronchial microwave ablation with the Emprint ablation catheter (Medtronic) in a hybrid theatre while undergoing cone-beam computed tomography. Only one nodule was ablated if the patients had more than one.
The team recruited 30 patients at two centres in the U.K. and Hong Kong, who had a mean age of 68.4 years and of whom 40% were female. The majority (66.7%) were prior or current tobacco users.
Primary lung cancer was the diagnosis in 20 patients, while 10 had oligometastatic disease, and the median nodule size was 12.5 mm. Thirty percent of patients had previously undergone lobectomy and 16.7% wedge resection.
Thirty-nine ablations were performed in the 30 patients, with 22 having a single ablation. Two ablations were performed in seven patients, while one had three ablations.
The most common ablation times were 10 minutes, in 21 procedures, and 7 minutes, in eight procedures, and the average total bronchoscopy time was 127 minutes.
Technical success
The procedure was deemed a technical success, defined as the nodule being reached and ablated according to the study protocol, in all patients.
The average ablation margin was 9.9 mm, and 1-month follow-up imaging was performed in all patients. This revealed a satisfactory ablation in 100% of cases. No patients required retreatment.
One patient had an adverse event relating to the ablation itself over the one-month follow-up, consisting of grade 1 mild haemoptysis on day 5, which self-resolved.
Adverse events relating to any aspect of the bronchoscopy were seen in 70% of patients, while 13.3% had grade ≥3 events, These included post-procedure pleuritic chest pain in two patients, pleural effusion in two patients, post-ablation syndrome in one patient, and ablation site infection in one patient, all grade 3.
The researchers found that the patients reported only mild pain immediately post-procedure, at an average score of 1.5 on a 10-point scale, falling to 1.4 one week later. At one month, the average pain score was 0.5.
Quality of life, as measured on the EQ-5D-3L was unaffected by the procedure, with scores rising slightly from 74.6 at baseline to 77.4 at the one-month follow-up.
The study was sponsored and funded by Medtronic.
Mr. Lau declares relationships with Medtronic, Philips, and Johnson & Johnson.
A version of this article first appeared on Medscape.com.
Lung cancer patients with relatively small nodules who cannot or will not undergo surgery or radiotherapy can be successfully treated with targeted transbronchial microwave ablation, indicate results from a U.K.-led preliminary trial.
The NAVABLATE study included 30 patients from the U.K. and Hong Kong who had malignant lung nodules no more than 30 mm in diameter, who underwent transbronchial microwave ablation and were followed up one month later.
On the day, the technique was performed successfully in all 30 patients, while follow-up imaging at one month suggested that the ablation had been satisfactory in every case, with no repeat procedures necessary.
It was also associated with a “low rate of device-related adverse events and no serious adverse events,” said lead author Kevin Lau, Barts Thorax Centre, St. Bartholomew’s Hospital, Barts Health NHS Trust, London.
Consequently, transbronchial microwave ablation can be considered “an alternative treatment modality for patients with primary and metastatic malignant lung nodules … who decline or are ineligible” for surgery and radiotherapy.
The research was presented at the European Respiratory Society International Congress (ERS) 2021 on September 5.
‘Encouraging’ results
Professor Stefano Elia, head of the European Respiratory Society’s Assembly on Thoracic Surgery and Transplantation, told this news organization that the results “are encouraging.”
However, the patient numbers are “very low, so it is difficult to draw value conclusions,” and he would like to have seen more detailed characterization of the patients’ tumors.
Prof. Elia, from the University of Rome Tor Vergata, added that transbronchial microwave ablation should, in line with the study’s inclusion criteria, “probably be reserved” for lung cancer patients “who are unfit for or refuse surgery or alternative treatment strategies.”
He added that “prospective, randomized trials are warranted to see if the technique is feasible, safe and indicated” in these patients, and the potential cost of performing it needs to be specified.
Study details
Presenting the study, Mr. Lau explained that NAVABLATE was a prospective, multicenter study that enrolled patients with a confirmed malignant lung nodule ≤30 mm that did not abut the pleura, fissure, or critical structures.
In addition, the patients had declined or were not eligible for both surgery and stereotactic body radiotherapy.
They underwent transbronchial microwave ablation with the Emprint ablation catheter (Medtronic) in a hybrid theatre while undergoing cone-beam computed tomography. Only one nodule was ablated if the patients had more than one.
The team recruited 30 patients at two centres in the U.K. and Hong Kong, who had a mean age of 68.4 years and of whom 40% were female. The majority (66.7%) were prior or current tobacco users.
Primary lung cancer was the diagnosis in 20 patients, while 10 had oligometastatic disease, and the median nodule size was 12.5 mm. Thirty percent of patients had previously undergone lobectomy and 16.7% wedge resection.
Thirty-nine ablations were performed in the 30 patients, with 22 having a single ablation. Two ablations were performed in seven patients, while one had three ablations.
The most common ablation times were 10 minutes, in 21 procedures, and 7 minutes, in eight procedures, and the average total bronchoscopy time was 127 minutes.
Technical success
The procedure was deemed a technical success, defined as the nodule being reached and ablated according to the study protocol, in all patients.
The average ablation margin was 9.9 mm, and 1-month follow-up imaging was performed in all patients. This revealed a satisfactory ablation in 100% of cases. No patients required retreatment.
One patient had an adverse event relating to the ablation itself over the one-month follow-up, consisting of grade 1 mild haemoptysis on day 5, which self-resolved.
Adverse events relating to any aspect of the bronchoscopy were seen in 70% of patients, while 13.3% had grade ≥3 events, These included post-procedure pleuritic chest pain in two patients, pleural effusion in two patients, post-ablation syndrome in one patient, and ablation site infection in one patient, all grade 3.
The researchers found that the patients reported only mild pain immediately post-procedure, at an average score of 1.5 on a 10-point scale, falling to 1.4 one week later. At one month, the average pain score was 0.5.
Quality of life, as measured on the EQ-5D-3L was unaffected by the procedure, with scores rising slightly from 74.6 at baseline to 77.4 at the one-month follow-up.
The study was sponsored and funded by Medtronic.
Mr. Lau declares relationships with Medtronic, Philips, and Johnson & Johnson.
A version of this article first appeared on Medscape.com.
Lung cancer patients with relatively small nodules who cannot or will not undergo surgery or radiotherapy can be successfully treated with targeted transbronchial microwave ablation, indicate results from a U.K.-led preliminary trial.
The NAVABLATE study included 30 patients from the U.K. and Hong Kong who had malignant lung nodules no more than 30 mm in diameter, who underwent transbronchial microwave ablation and were followed up one month later.
On the day, the technique was performed successfully in all 30 patients, while follow-up imaging at one month suggested that the ablation had been satisfactory in every case, with no repeat procedures necessary.
It was also associated with a “low rate of device-related adverse events and no serious adverse events,” said lead author Kevin Lau, Barts Thorax Centre, St. Bartholomew’s Hospital, Barts Health NHS Trust, London.
Consequently, transbronchial microwave ablation can be considered “an alternative treatment modality for patients with primary and metastatic malignant lung nodules … who decline or are ineligible” for surgery and radiotherapy.
The research was presented at the European Respiratory Society International Congress (ERS) 2021 on September 5.
‘Encouraging’ results
Professor Stefano Elia, head of the European Respiratory Society’s Assembly on Thoracic Surgery and Transplantation, told this news organization that the results “are encouraging.”
However, the patient numbers are “very low, so it is difficult to draw value conclusions,” and he would like to have seen more detailed characterization of the patients’ tumors.
Prof. Elia, from the University of Rome Tor Vergata, added that transbronchial microwave ablation should, in line with the study’s inclusion criteria, “probably be reserved” for lung cancer patients “who are unfit for or refuse surgery or alternative treatment strategies.”
He added that “prospective, randomized trials are warranted to see if the technique is feasible, safe and indicated” in these patients, and the potential cost of performing it needs to be specified.
Study details
Presenting the study, Mr. Lau explained that NAVABLATE was a prospective, multicenter study that enrolled patients with a confirmed malignant lung nodule ≤30 mm that did not abut the pleura, fissure, or critical structures.
In addition, the patients had declined or were not eligible for both surgery and stereotactic body radiotherapy.
They underwent transbronchial microwave ablation with the Emprint ablation catheter (Medtronic) in a hybrid theatre while undergoing cone-beam computed tomography. Only one nodule was ablated if the patients had more than one.
The team recruited 30 patients at two centres in the U.K. and Hong Kong, who had a mean age of 68.4 years and of whom 40% were female. The majority (66.7%) were prior or current tobacco users.
Primary lung cancer was the diagnosis in 20 patients, while 10 had oligometastatic disease, and the median nodule size was 12.5 mm. Thirty percent of patients had previously undergone lobectomy and 16.7% wedge resection.
Thirty-nine ablations were performed in the 30 patients, with 22 having a single ablation. Two ablations were performed in seven patients, while one had three ablations.
The most common ablation times were 10 minutes, in 21 procedures, and 7 minutes, in eight procedures, and the average total bronchoscopy time was 127 minutes.
Technical success
The procedure was deemed a technical success, defined as the nodule being reached and ablated according to the study protocol, in all patients.
The average ablation margin was 9.9 mm, and 1-month follow-up imaging was performed in all patients. This revealed a satisfactory ablation in 100% of cases. No patients required retreatment.
One patient had an adverse event relating to the ablation itself over the one-month follow-up, consisting of grade 1 mild haemoptysis on day 5, which self-resolved.
Adverse events relating to any aspect of the bronchoscopy were seen in 70% of patients, while 13.3% had grade ≥3 events, These included post-procedure pleuritic chest pain in two patients, pleural effusion in two patients, post-ablation syndrome in one patient, and ablation site infection in one patient, all grade 3.
The researchers found that the patients reported only mild pain immediately post-procedure, at an average score of 1.5 on a 10-point scale, falling to 1.4 one week later. At one month, the average pain score was 0.5.
Quality of life, as measured on the EQ-5D-3L was unaffected by the procedure, with scores rising slightly from 74.6 at baseline to 77.4 at the one-month follow-up.
The study was sponsored and funded by Medtronic.
Mr. Lau declares relationships with Medtronic, Philips, and Johnson & Johnson.
A version of this article first appeared on Medscape.com.
More reassuring data on COVID-19 vaccines and pregnancy
Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.
The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.
Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.
“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”
Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.
In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.
The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.
“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.
A version of this article first appeared on Medscape.com.
Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.
The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.
Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.
“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”
Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.
In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.
The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.
“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.
A version of this article first appeared on Medscape.com.
Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.
The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.
Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.
“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”
Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.
In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.
The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.
“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.
A version of this article first appeared on Medscape.com.
How an ‘ad hoc’ hospitalist model evolved during India’s COVID surge
Hospital administrators recognize the efficiencies
A year after the start of the COVID-19 pandemic, as the United States was getting a reprieve in new cases from its winter surge, the opposite was happening in the rest of the world. In India, a deadly second wave hit, crippling the health care system in the country for months.
Yugandhar Bhatt, MBBS, MD, a consultant pulmonologist with Yashoda Hospital–Malakpet in Hyderabad, India, told this news organization that someone looking at his hospital before the pandemic – a 400-bed multispecialty care unit – would see patients being treated for respiratory failure secondary to exacerbation of chronic obstructive pulmonary disease, bronchial asthma, community-acquired pneumonia, and heart failure. About 30-40 patients per day were treated on an outpatient basis, and more than 30 people were admitted as inpatients.
“After [the] COVID-19 surge, our hospital totally divided into COVID and non-COVID [wards], in which COVID patients occupied 70% of [the] total,” he said. About half of COVID-19 patients were in the ICU, with half of those patients requiring supplemental oxygen.
During the first wave in India, which lasted from May to December 2020, 50% of patients who were intubated were discharged. The percentage of extubated patients decreased to 20% in the second wave, Dr. Bhatt said.
The death toll during the second wave of COVID-19 cases was unlike anything India has seen previously. Between March 1 and June 29, 2021, an estimated 19.24 million individuals were newly infected with COVID-19 and 241,206 patients died, according to Our World in Data, a project of the Global Change Data Lab. When the second wave peaked on May 22, more than 4,000 people were dying each day.
“All hospitals [in India] were treating COVID-19 more than any other acute or chronic disease,” Ramesh Adhikari, MD, MS, SFHM, a hospitalist with Franciscan Health in Lafayette, Ind., said in an interview.
Challenges arose in treating COVID-19 in India that ran counter to how medicine was usually performed. Physicians were seeing more inpatient cases than usual – and more patients in general. The change, Dr. Adhikari said, forced health care providers to think outside the box.
An ‘on-the-fly’ hospitalist model
Patients in India access health care by visiting a hospital or primary health center and then are referred out to consultants – specialist doctors – if needed. While India has universal health coverage, it is a multi-payer system that includes approximately 37% of the population covered under the government plan, a large number of private health care facilities and no caps on cost-sharing for the patient. Initiatives like Rashtriya Swasthya Bima Yojana in 2008 and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana in 2018 have attempted to close the gap and raise the number of lower-income individuals in India covered under the government plan and reduce out-of-pocket spending. Out-of-pocket payments still consist of about 70% of total health expenditures, according to the Commonwealth Fund.
“There is not much scope for a hospitalist because it’s so cash driven,” Shyam Odeti, MD, SFHM, section chief, hospital medicine, at the Carilion Clinic in Roanoke, Va., said in an interview. “For a hospitalist, there is no urgency in getting them out of the hospital. There was no need for much efficiency before.”
The first issue during the second wave was figuring out which consultants would care for COVID-19 patients. As there is no dedicated specialty for infectious disease in India, the responsibilities fell to internists and critical care medicine consultants who volunteered. Both are considered small specialties in India. They became “makeshift hospitalists” who learned as they went and became the experts in COVID-19 care, treating their own patients while making themselves available for consultations, Dr. Odeti said.
While no official hospital medicine model in India exists like in the United States, the second COVID-19 surge caused these consultants to begin thinking like hospitalists. Tenets of hospital medicine – like team-based treatment across specialties – arose out of necessity during the crisis. “They were trying to implement a hospitalist model because that’s the only way they could treat COVID-19,” said Dr. Adhikari, an editorial advisory board member for the Hospitalist.
“Even in the U.S. when we started the hospitalist model, it started out of necessity. It’s a combination of creating efficiencies and improving quality,” Dr. Odeti said. “It’s the same thing in India. It’s borne of necessity, but it was [done] at a rapid pace.”
Problems with patient flow
The next issue was triaging patients in the hospital based on COVID-19 severity. When the second wave began, hospitals in India ran out of beds and experienced staff shortages like in many countries. But this situation “was unusual for the health system,” according to Dr. Odeti, who is also an editorial board member for the Hospitalist.
“We never had that issue. There were so many patients wanting to come to the hospital, and so there was this rush.” There was no process to triage patients to determine who needed to stay. “Everybody got put into the hospital,” he said.
Once it was determined who would take care of patients with COVID-19, access to supplies became the primary problem, Dr. Adhikari explained. Lack of oxygen, ventilators, and critical medicines like the antiviral drug remdesivir were and continue to be in short supply. “I had friends who [said] they could not admit patients because they were worried if their oxygen supply [went] low in the middle of the night. They will treat the patients who were already admitted versus taking new patients. That had caused problems for the administrators,” Dr. Adhikari added.
It is also a source of additional stress for the physicians. Where patients flow through a hospital medicine model in the United States, a system that might include case managers, social workers, pharmacists, physician advocates, and other professionals to keep a patient’s care on track, the physician is the go-to person in India for patient care. While physicians provide access to medications and remain available to a patient’s family, those duties become much harder when caring for a greater number of patients during the pandemic. “That has led to some unrealistic expectations among the patients,” Dr. Adhikari said.
Dr. Bhatt said “more than half” of a physician’s time in India is spent counseling patients on concerns about COVID-19. “Awareness about the disease is limited from the patient and patient’s family perspective, as [there is] too much apprehension toward the nature of [the] disease,” he added. “Theoretical discussions collected from social media” obstruct the physician from executing his or her duties.
Physicians in India have had to contend with physical violence from patients and individuals on the street, Dr. Adhikari added. Workplace violence was already a concern – for years, the Indian Medical Association has cited a statistic that 75% of doctors in India have experienced violence at work (Indian J Psychiatry. 2019 Apr;61[Suppl 4]:S782-5). But the threat of violence against physicians has sharply increased during the COVID-19 pandemic. Disruptions to daily life through lockdowns “made people fearful, anxious, and sometimes they have found it difficult to access emergency treatment,” according to a letter published by Karthikeyan Iyengar and colleagues in the Postgraduate Medical Journal. In response to the restlessness, irritation, and despair resulting from hospitals closing their doors, “people have shown their frustration by verbally abusing and threatening to physically assault doctors and other health care workers,” the authors wrote.
A telemedicine boon in India
Back in the United States, hospitalists with family and friends in India were trying to figure out how to help. Some were working through the day, only to answer calls and WhatsApp messages from loved ones at night. “Everyone knows a physician or someone who’s your colleague, who owns a hospital or runs a hospital, or one of the family members is sick,” Dr. Adhikari said.
These U.S.-based hospitalists were burning the candle at both ends, helping with the pandemic in both countries. Physicians in India were posing questions to U.S. colleagues who they saw as having the most recent evidence for COVID-19 treatment. Out of the 180 physicians he trained with in India, Dr. Odeti said 110 of the physicians were in a large WhatsApp group chat that was constantly exchanging messages and serving as “kind of a friendly support group.”
In Dr. Odeti’s group chat, physicians helped one another find hospital beds for patients who reached out to them. “The first couple of weeks, there was no proper way for people to know where [patients] were based. There was no way to find if this hospital had a bed, so they reached out to any doctors they knew,” he said.
While he said it was emotionally draining, “at the same time, we felt a responsibility toward colleagues in India,” Dr. Odeti said, noting that as COVID-19 cases have decreased in India, the requests have been less frequent.
Because of concerns about traveling to India during the pandemic while on a J-1, H-1B, or other visa with the United States, directly helping friends and family in India seemed out of reach. But many hospitalists of Indian origin instead turned to telemedicine to help their colleagues. Telemedicine had already been steadily growing in India, but was accelerated by the pandemic. The current ratio of doctors to patients in India is 0.62 to 1,000 – lower than recommendations from the World Health Organization. That makes telemedicine a unique opportunity for one physician in India to reach many patients regardless of location.
Dr. Adhikari said he helped out his colleagues in India by performing consults for their patients. “They were just worried because they did not ‘know where to go, or what to get,” he said. “I was treating more patients in India than I was actually treating here.”
In March 2020, the Indian Ministry of Health and Family Welfare released telemedicine practice guidelines for the country, which relaxed regulations on privacy requirements and has been credited in part for giving telemedicine an additional boost during the pandemic. “That makes it easy for people to reach out but also has its own problems,” Dr. Adhikari said.
Monitoring of milder COVID-19 cases that don’t require hospitalization can be performed by a nurse who calls every few hours to check on a patient, make recommendations, and text treatment plans. “The telemedicine platforms are being adopted really fast,” Dr. Adhikari said. “The platforms were built in no time.”
According to NewZoo, a games market data analytics company, India has 345.9 million smartphone users as of 2019 – the second highest number of users in the world after China. Dr. Odeti said he believes telemedicine will be widely adopted.
“In India, they are very proactive in accepting these kinds of methods, so I’m sure they will,” he said. “Governments were trying to do it before the pandemic, because access to care is a problem in India. There are villages which are very, very remote.”
Reversion to old systems
After the peak in late May, new COVID-19 cases in India began to decrease, and the second wave waned on a national level. Hospitals began to get the supplies they needed, beds are available, and patients aren’t as sick as before, according to Dr. Adhikari. The federal government has begun issuing supplies to patients in each state, including COVID-19 vaccines. “The peak for the second wave is gone,” he said.
What remains is a group of physicians trained in how to triage patients and create efficiencies in a hospital setting. Could those skills be put to use elsewhere in India after the pandemic?
According to Dr. Bhatt, the patient care model is likely to revert to the system that existed before. “Whatever the changes, interims of bed occupancy, cost of ICU will be temporary [and] will change to normal,” he said. “But awareness about masks [and] sanitizing methods will be permanent.”
Dr. Adhikari believes that not utilizing the skills of newly minted hospitalists in India would be a missed opportunity. “This is a silver lining from COVID-19, that hospital medicine plays a vital role in the sickest patients, whether it is in India or the U.S. or anywhere,” he said. “I think the model of hospital medicine should be adopted. It’s not: ‘Should it really be adopted or not?’ It should be. There is a huge potential in doing inpatient coordinated [care], having people dedicated in the hospital.”
There are tangible benefits to creating efficiencies in India’s health system, Dr. Odeti said. Length of stay for sicker patients “was much longer” at 10-14 days during the second wave, compared with the United States, before lowering to around 5 days. “These hospitals right now are learning the efficient ways of doing it: when to send [patients] out, how to send them out, how to [perform] service-based practices, creating processes which were nonexistent before.”
While he doesn’t personally believe physicians will adopt a full-fledged hospitalist model unless the payer structure in India changes, “these people are at an advantage with this extra set of skills,” he said. “I think all the knowledge that these people have are going to come in handy.”
Opportunities for growth
Dr. Odeti sees the potential for the hospitalist model to grow in India – if not into its own specialty, then in how critical care consultants handle sicker patients and handoffs.
“The critical care clinician cannot keep the patient from the time they are admitted to the ICU until the discharge, so there will be a need for the transition,” Dr. Odeti said. “In the past, there were not many capabilities in Indian health systems to take care of these extremely sick patients, and now it is evolving. I think that is one more thing that will help.”
Dr. Adhikari said hospital systems in India are beginning to realize how having dedicated hospital physicians could benefit them. In India, “if you’re sick, you go to your doctor, you get treated and you disappear,” he said. The next time, you may see the same doctor or a completely different doctor. “There’s no system there, so it’s really hard for hospital medicine as such because patients, when they are very sick, they just come to the ER. They’re not followed by their primary care.”
Anecdotally, Dr. Odeti sees patients already adapting to having access to a physician for asking questions normally answered by primary care physicians. “I think primary care will come into play,” he said. “When I was doing a Zoom call for patients, they were asking me questions about sciatica. I think they are getting comfortable with this technology.”
A hospitalist model could even be applied to specific diseases with a large population of patients. Hospital administrators “have seen this for the first time, how efficient it could be if they had their own hospitalists and actually run it. So that’s the part that has crossed their minds,” Dr. Adhikari said. “How they will apply it going forward, other than during the COVID-19 pandemic, depends on the size of the hospital and the volume of the patients for a particular disease.”
“You can see in certain areas there is large growth for hospital medicine. But to rise to the level of the United States and how we do it, India needs bigger health systems to adopt the model,” Dr. Adhikari said.
Hospital administrators recognize the efficiencies
Hospital administrators recognize the efficiencies
A year after the start of the COVID-19 pandemic, as the United States was getting a reprieve in new cases from its winter surge, the opposite was happening in the rest of the world. In India, a deadly second wave hit, crippling the health care system in the country for months.
Yugandhar Bhatt, MBBS, MD, a consultant pulmonologist with Yashoda Hospital–Malakpet in Hyderabad, India, told this news organization that someone looking at his hospital before the pandemic – a 400-bed multispecialty care unit – would see patients being treated for respiratory failure secondary to exacerbation of chronic obstructive pulmonary disease, bronchial asthma, community-acquired pneumonia, and heart failure. About 30-40 patients per day were treated on an outpatient basis, and more than 30 people were admitted as inpatients.
“After [the] COVID-19 surge, our hospital totally divided into COVID and non-COVID [wards], in which COVID patients occupied 70% of [the] total,” he said. About half of COVID-19 patients were in the ICU, with half of those patients requiring supplemental oxygen.
During the first wave in India, which lasted from May to December 2020, 50% of patients who were intubated were discharged. The percentage of extubated patients decreased to 20% in the second wave, Dr. Bhatt said.
The death toll during the second wave of COVID-19 cases was unlike anything India has seen previously. Between March 1 and June 29, 2021, an estimated 19.24 million individuals were newly infected with COVID-19 and 241,206 patients died, according to Our World in Data, a project of the Global Change Data Lab. When the second wave peaked on May 22, more than 4,000 people were dying each day.
“All hospitals [in India] were treating COVID-19 more than any other acute or chronic disease,” Ramesh Adhikari, MD, MS, SFHM, a hospitalist with Franciscan Health in Lafayette, Ind., said in an interview.
Challenges arose in treating COVID-19 in India that ran counter to how medicine was usually performed. Physicians were seeing more inpatient cases than usual – and more patients in general. The change, Dr. Adhikari said, forced health care providers to think outside the box.
An ‘on-the-fly’ hospitalist model
Patients in India access health care by visiting a hospital or primary health center and then are referred out to consultants – specialist doctors – if needed. While India has universal health coverage, it is a multi-payer system that includes approximately 37% of the population covered under the government plan, a large number of private health care facilities and no caps on cost-sharing for the patient. Initiatives like Rashtriya Swasthya Bima Yojana in 2008 and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana in 2018 have attempted to close the gap and raise the number of lower-income individuals in India covered under the government plan and reduce out-of-pocket spending. Out-of-pocket payments still consist of about 70% of total health expenditures, according to the Commonwealth Fund.
“There is not much scope for a hospitalist because it’s so cash driven,” Shyam Odeti, MD, SFHM, section chief, hospital medicine, at the Carilion Clinic in Roanoke, Va., said in an interview. “For a hospitalist, there is no urgency in getting them out of the hospital. There was no need for much efficiency before.”
The first issue during the second wave was figuring out which consultants would care for COVID-19 patients. As there is no dedicated specialty for infectious disease in India, the responsibilities fell to internists and critical care medicine consultants who volunteered. Both are considered small specialties in India. They became “makeshift hospitalists” who learned as they went and became the experts in COVID-19 care, treating their own patients while making themselves available for consultations, Dr. Odeti said.
While no official hospital medicine model in India exists like in the United States, the second COVID-19 surge caused these consultants to begin thinking like hospitalists. Tenets of hospital medicine – like team-based treatment across specialties – arose out of necessity during the crisis. “They were trying to implement a hospitalist model because that’s the only way they could treat COVID-19,” said Dr. Adhikari, an editorial advisory board member for the Hospitalist.
“Even in the U.S. when we started the hospitalist model, it started out of necessity. It’s a combination of creating efficiencies and improving quality,” Dr. Odeti said. “It’s the same thing in India. It’s borne of necessity, but it was [done] at a rapid pace.”
Problems with patient flow
The next issue was triaging patients in the hospital based on COVID-19 severity. When the second wave began, hospitals in India ran out of beds and experienced staff shortages like in many countries. But this situation “was unusual for the health system,” according to Dr. Odeti, who is also an editorial board member for the Hospitalist.
“We never had that issue. There were so many patients wanting to come to the hospital, and so there was this rush.” There was no process to triage patients to determine who needed to stay. “Everybody got put into the hospital,” he said.
Once it was determined who would take care of patients with COVID-19, access to supplies became the primary problem, Dr. Adhikari explained. Lack of oxygen, ventilators, and critical medicines like the antiviral drug remdesivir were and continue to be in short supply. “I had friends who [said] they could not admit patients because they were worried if their oxygen supply [went] low in the middle of the night. They will treat the patients who were already admitted versus taking new patients. That had caused problems for the administrators,” Dr. Adhikari added.
It is also a source of additional stress for the physicians. Where patients flow through a hospital medicine model in the United States, a system that might include case managers, social workers, pharmacists, physician advocates, and other professionals to keep a patient’s care on track, the physician is the go-to person in India for patient care. While physicians provide access to medications and remain available to a patient’s family, those duties become much harder when caring for a greater number of patients during the pandemic. “That has led to some unrealistic expectations among the patients,” Dr. Adhikari said.
Dr. Bhatt said “more than half” of a physician’s time in India is spent counseling patients on concerns about COVID-19. “Awareness about the disease is limited from the patient and patient’s family perspective, as [there is] too much apprehension toward the nature of [the] disease,” he added. “Theoretical discussions collected from social media” obstruct the physician from executing his or her duties.
Physicians in India have had to contend with physical violence from patients and individuals on the street, Dr. Adhikari added. Workplace violence was already a concern – for years, the Indian Medical Association has cited a statistic that 75% of doctors in India have experienced violence at work (Indian J Psychiatry. 2019 Apr;61[Suppl 4]:S782-5). But the threat of violence against physicians has sharply increased during the COVID-19 pandemic. Disruptions to daily life through lockdowns “made people fearful, anxious, and sometimes they have found it difficult to access emergency treatment,” according to a letter published by Karthikeyan Iyengar and colleagues in the Postgraduate Medical Journal. In response to the restlessness, irritation, and despair resulting from hospitals closing their doors, “people have shown their frustration by verbally abusing and threatening to physically assault doctors and other health care workers,” the authors wrote.
A telemedicine boon in India
Back in the United States, hospitalists with family and friends in India were trying to figure out how to help. Some were working through the day, only to answer calls and WhatsApp messages from loved ones at night. “Everyone knows a physician or someone who’s your colleague, who owns a hospital or runs a hospital, or one of the family members is sick,” Dr. Adhikari said.
These U.S.-based hospitalists were burning the candle at both ends, helping with the pandemic in both countries. Physicians in India were posing questions to U.S. colleagues who they saw as having the most recent evidence for COVID-19 treatment. Out of the 180 physicians he trained with in India, Dr. Odeti said 110 of the physicians were in a large WhatsApp group chat that was constantly exchanging messages and serving as “kind of a friendly support group.”
In Dr. Odeti’s group chat, physicians helped one another find hospital beds for patients who reached out to them. “The first couple of weeks, there was no proper way for people to know where [patients] were based. There was no way to find if this hospital had a bed, so they reached out to any doctors they knew,” he said.
While he said it was emotionally draining, “at the same time, we felt a responsibility toward colleagues in India,” Dr. Odeti said, noting that as COVID-19 cases have decreased in India, the requests have been less frequent.
Because of concerns about traveling to India during the pandemic while on a J-1, H-1B, or other visa with the United States, directly helping friends and family in India seemed out of reach. But many hospitalists of Indian origin instead turned to telemedicine to help their colleagues. Telemedicine had already been steadily growing in India, but was accelerated by the pandemic. The current ratio of doctors to patients in India is 0.62 to 1,000 – lower than recommendations from the World Health Organization. That makes telemedicine a unique opportunity for one physician in India to reach many patients regardless of location.
Dr. Adhikari said he helped out his colleagues in India by performing consults for their patients. “They were just worried because they did not ‘know where to go, or what to get,” he said. “I was treating more patients in India than I was actually treating here.”
In March 2020, the Indian Ministry of Health and Family Welfare released telemedicine practice guidelines for the country, which relaxed regulations on privacy requirements and has been credited in part for giving telemedicine an additional boost during the pandemic. “That makes it easy for people to reach out but also has its own problems,” Dr. Adhikari said.
Monitoring of milder COVID-19 cases that don’t require hospitalization can be performed by a nurse who calls every few hours to check on a patient, make recommendations, and text treatment plans. “The telemedicine platforms are being adopted really fast,” Dr. Adhikari said. “The platforms were built in no time.”
According to NewZoo, a games market data analytics company, India has 345.9 million smartphone users as of 2019 – the second highest number of users in the world after China. Dr. Odeti said he believes telemedicine will be widely adopted.
“In India, they are very proactive in accepting these kinds of methods, so I’m sure they will,” he said. “Governments were trying to do it before the pandemic, because access to care is a problem in India. There are villages which are very, very remote.”
Reversion to old systems
After the peak in late May, new COVID-19 cases in India began to decrease, and the second wave waned on a national level. Hospitals began to get the supplies they needed, beds are available, and patients aren’t as sick as before, according to Dr. Adhikari. The federal government has begun issuing supplies to patients in each state, including COVID-19 vaccines. “The peak for the second wave is gone,” he said.
What remains is a group of physicians trained in how to triage patients and create efficiencies in a hospital setting. Could those skills be put to use elsewhere in India after the pandemic?
According to Dr. Bhatt, the patient care model is likely to revert to the system that existed before. “Whatever the changes, interims of bed occupancy, cost of ICU will be temporary [and] will change to normal,” he said. “But awareness about masks [and] sanitizing methods will be permanent.”
Dr. Adhikari believes that not utilizing the skills of newly minted hospitalists in India would be a missed opportunity. “This is a silver lining from COVID-19, that hospital medicine plays a vital role in the sickest patients, whether it is in India or the U.S. or anywhere,” he said. “I think the model of hospital medicine should be adopted. It’s not: ‘Should it really be adopted or not?’ It should be. There is a huge potential in doing inpatient coordinated [care], having people dedicated in the hospital.”
There are tangible benefits to creating efficiencies in India’s health system, Dr. Odeti said. Length of stay for sicker patients “was much longer” at 10-14 days during the second wave, compared with the United States, before lowering to around 5 days. “These hospitals right now are learning the efficient ways of doing it: when to send [patients] out, how to send them out, how to [perform] service-based practices, creating processes which were nonexistent before.”
While he doesn’t personally believe physicians will adopt a full-fledged hospitalist model unless the payer structure in India changes, “these people are at an advantage with this extra set of skills,” he said. “I think all the knowledge that these people have are going to come in handy.”
Opportunities for growth
Dr. Odeti sees the potential for the hospitalist model to grow in India – if not into its own specialty, then in how critical care consultants handle sicker patients and handoffs.
“The critical care clinician cannot keep the patient from the time they are admitted to the ICU until the discharge, so there will be a need for the transition,” Dr. Odeti said. “In the past, there were not many capabilities in Indian health systems to take care of these extremely sick patients, and now it is evolving. I think that is one more thing that will help.”
Dr. Adhikari said hospital systems in India are beginning to realize how having dedicated hospital physicians could benefit them. In India, “if you’re sick, you go to your doctor, you get treated and you disappear,” he said. The next time, you may see the same doctor or a completely different doctor. “There’s no system there, so it’s really hard for hospital medicine as such because patients, when they are very sick, they just come to the ER. They’re not followed by their primary care.”
Anecdotally, Dr. Odeti sees patients already adapting to having access to a physician for asking questions normally answered by primary care physicians. “I think primary care will come into play,” he said. “When I was doing a Zoom call for patients, they were asking me questions about sciatica. I think they are getting comfortable with this technology.”
A hospitalist model could even be applied to specific diseases with a large population of patients. Hospital administrators “have seen this for the first time, how efficient it could be if they had their own hospitalists and actually run it. So that’s the part that has crossed their minds,” Dr. Adhikari said. “How they will apply it going forward, other than during the COVID-19 pandemic, depends on the size of the hospital and the volume of the patients for a particular disease.”
“You can see in certain areas there is large growth for hospital medicine. But to rise to the level of the United States and how we do it, India needs bigger health systems to adopt the model,” Dr. Adhikari said.
A year after the start of the COVID-19 pandemic, as the United States was getting a reprieve in new cases from its winter surge, the opposite was happening in the rest of the world. In India, a deadly second wave hit, crippling the health care system in the country for months.
Yugandhar Bhatt, MBBS, MD, a consultant pulmonologist with Yashoda Hospital–Malakpet in Hyderabad, India, told this news organization that someone looking at his hospital before the pandemic – a 400-bed multispecialty care unit – would see patients being treated for respiratory failure secondary to exacerbation of chronic obstructive pulmonary disease, bronchial asthma, community-acquired pneumonia, and heart failure. About 30-40 patients per day were treated on an outpatient basis, and more than 30 people were admitted as inpatients.
“After [the] COVID-19 surge, our hospital totally divided into COVID and non-COVID [wards], in which COVID patients occupied 70% of [the] total,” he said. About half of COVID-19 patients were in the ICU, with half of those patients requiring supplemental oxygen.
During the first wave in India, which lasted from May to December 2020, 50% of patients who were intubated were discharged. The percentage of extubated patients decreased to 20% in the second wave, Dr. Bhatt said.
The death toll during the second wave of COVID-19 cases was unlike anything India has seen previously. Between March 1 and June 29, 2021, an estimated 19.24 million individuals were newly infected with COVID-19 and 241,206 patients died, according to Our World in Data, a project of the Global Change Data Lab. When the second wave peaked on May 22, more than 4,000 people were dying each day.
“All hospitals [in India] were treating COVID-19 more than any other acute or chronic disease,” Ramesh Adhikari, MD, MS, SFHM, a hospitalist with Franciscan Health in Lafayette, Ind., said in an interview.
Challenges arose in treating COVID-19 in India that ran counter to how medicine was usually performed. Physicians were seeing more inpatient cases than usual – and more patients in general. The change, Dr. Adhikari said, forced health care providers to think outside the box.
An ‘on-the-fly’ hospitalist model
Patients in India access health care by visiting a hospital or primary health center and then are referred out to consultants – specialist doctors – if needed. While India has universal health coverage, it is a multi-payer system that includes approximately 37% of the population covered under the government plan, a large number of private health care facilities and no caps on cost-sharing for the patient. Initiatives like Rashtriya Swasthya Bima Yojana in 2008 and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana in 2018 have attempted to close the gap and raise the number of lower-income individuals in India covered under the government plan and reduce out-of-pocket spending. Out-of-pocket payments still consist of about 70% of total health expenditures, according to the Commonwealth Fund.
“There is not much scope for a hospitalist because it’s so cash driven,” Shyam Odeti, MD, SFHM, section chief, hospital medicine, at the Carilion Clinic in Roanoke, Va., said in an interview. “For a hospitalist, there is no urgency in getting them out of the hospital. There was no need for much efficiency before.”
The first issue during the second wave was figuring out which consultants would care for COVID-19 patients. As there is no dedicated specialty for infectious disease in India, the responsibilities fell to internists and critical care medicine consultants who volunteered. Both are considered small specialties in India. They became “makeshift hospitalists” who learned as they went and became the experts in COVID-19 care, treating their own patients while making themselves available for consultations, Dr. Odeti said.
While no official hospital medicine model in India exists like in the United States, the second COVID-19 surge caused these consultants to begin thinking like hospitalists. Tenets of hospital medicine – like team-based treatment across specialties – arose out of necessity during the crisis. “They were trying to implement a hospitalist model because that’s the only way they could treat COVID-19,” said Dr. Adhikari, an editorial advisory board member for the Hospitalist.
“Even in the U.S. when we started the hospitalist model, it started out of necessity. It’s a combination of creating efficiencies and improving quality,” Dr. Odeti said. “It’s the same thing in India. It’s borne of necessity, but it was [done] at a rapid pace.”
Problems with patient flow
The next issue was triaging patients in the hospital based on COVID-19 severity. When the second wave began, hospitals in India ran out of beds and experienced staff shortages like in many countries. But this situation “was unusual for the health system,” according to Dr. Odeti, who is also an editorial board member for the Hospitalist.
“We never had that issue. There were so many patients wanting to come to the hospital, and so there was this rush.” There was no process to triage patients to determine who needed to stay. “Everybody got put into the hospital,” he said.
Once it was determined who would take care of patients with COVID-19, access to supplies became the primary problem, Dr. Adhikari explained. Lack of oxygen, ventilators, and critical medicines like the antiviral drug remdesivir were and continue to be in short supply. “I had friends who [said] they could not admit patients because they were worried if their oxygen supply [went] low in the middle of the night. They will treat the patients who were already admitted versus taking new patients. That had caused problems for the administrators,” Dr. Adhikari added.
It is also a source of additional stress for the physicians. Where patients flow through a hospital medicine model in the United States, a system that might include case managers, social workers, pharmacists, physician advocates, and other professionals to keep a patient’s care on track, the physician is the go-to person in India for patient care. While physicians provide access to medications and remain available to a patient’s family, those duties become much harder when caring for a greater number of patients during the pandemic. “That has led to some unrealistic expectations among the patients,” Dr. Adhikari said.
Dr. Bhatt said “more than half” of a physician’s time in India is spent counseling patients on concerns about COVID-19. “Awareness about the disease is limited from the patient and patient’s family perspective, as [there is] too much apprehension toward the nature of [the] disease,” he added. “Theoretical discussions collected from social media” obstruct the physician from executing his or her duties.
Physicians in India have had to contend with physical violence from patients and individuals on the street, Dr. Adhikari added. Workplace violence was already a concern – for years, the Indian Medical Association has cited a statistic that 75% of doctors in India have experienced violence at work (Indian J Psychiatry. 2019 Apr;61[Suppl 4]:S782-5). But the threat of violence against physicians has sharply increased during the COVID-19 pandemic. Disruptions to daily life through lockdowns “made people fearful, anxious, and sometimes they have found it difficult to access emergency treatment,” according to a letter published by Karthikeyan Iyengar and colleagues in the Postgraduate Medical Journal. In response to the restlessness, irritation, and despair resulting from hospitals closing their doors, “people have shown their frustration by verbally abusing and threatening to physically assault doctors and other health care workers,” the authors wrote.
A telemedicine boon in India
Back in the United States, hospitalists with family and friends in India were trying to figure out how to help. Some were working through the day, only to answer calls and WhatsApp messages from loved ones at night. “Everyone knows a physician or someone who’s your colleague, who owns a hospital or runs a hospital, or one of the family members is sick,” Dr. Adhikari said.
These U.S.-based hospitalists were burning the candle at both ends, helping with the pandemic in both countries. Physicians in India were posing questions to U.S. colleagues who they saw as having the most recent evidence for COVID-19 treatment. Out of the 180 physicians he trained with in India, Dr. Odeti said 110 of the physicians were in a large WhatsApp group chat that was constantly exchanging messages and serving as “kind of a friendly support group.”
In Dr. Odeti’s group chat, physicians helped one another find hospital beds for patients who reached out to them. “The first couple of weeks, there was no proper way for people to know where [patients] were based. There was no way to find if this hospital had a bed, so they reached out to any doctors they knew,” he said.
While he said it was emotionally draining, “at the same time, we felt a responsibility toward colleagues in India,” Dr. Odeti said, noting that as COVID-19 cases have decreased in India, the requests have been less frequent.
Because of concerns about traveling to India during the pandemic while on a J-1, H-1B, or other visa with the United States, directly helping friends and family in India seemed out of reach. But many hospitalists of Indian origin instead turned to telemedicine to help their colleagues. Telemedicine had already been steadily growing in India, but was accelerated by the pandemic. The current ratio of doctors to patients in India is 0.62 to 1,000 – lower than recommendations from the World Health Organization. That makes telemedicine a unique opportunity for one physician in India to reach many patients regardless of location.
Dr. Adhikari said he helped out his colleagues in India by performing consults for their patients. “They were just worried because they did not ‘know where to go, or what to get,” he said. “I was treating more patients in India than I was actually treating here.”
In March 2020, the Indian Ministry of Health and Family Welfare released telemedicine practice guidelines for the country, which relaxed regulations on privacy requirements and has been credited in part for giving telemedicine an additional boost during the pandemic. “That makes it easy for people to reach out but also has its own problems,” Dr. Adhikari said.
Monitoring of milder COVID-19 cases that don’t require hospitalization can be performed by a nurse who calls every few hours to check on a patient, make recommendations, and text treatment plans. “The telemedicine platforms are being adopted really fast,” Dr. Adhikari said. “The platforms were built in no time.”
According to NewZoo, a games market data analytics company, India has 345.9 million smartphone users as of 2019 – the second highest number of users in the world after China. Dr. Odeti said he believes telemedicine will be widely adopted.
“In India, they are very proactive in accepting these kinds of methods, so I’m sure they will,” he said. “Governments were trying to do it before the pandemic, because access to care is a problem in India. There are villages which are very, very remote.”
Reversion to old systems
After the peak in late May, new COVID-19 cases in India began to decrease, and the second wave waned on a national level. Hospitals began to get the supplies they needed, beds are available, and patients aren’t as sick as before, according to Dr. Adhikari. The federal government has begun issuing supplies to patients in each state, including COVID-19 vaccines. “The peak for the second wave is gone,” he said.
What remains is a group of physicians trained in how to triage patients and create efficiencies in a hospital setting. Could those skills be put to use elsewhere in India after the pandemic?
According to Dr. Bhatt, the patient care model is likely to revert to the system that existed before. “Whatever the changes, interims of bed occupancy, cost of ICU will be temporary [and] will change to normal,” he said. “But awareness about masks [and] sanitizing methods will be permanent.”
Dr. Adhikari believes that not utilizing the skills of newly minted hospitalists in India would be a missed opportunity. “This is a silver lining from COVID-19, that hospital medicine plays a vital role in the sickest patients, whether it is in India or the U.S. or anywhere,” he said. “I think the model of hospital medicine should be adopted. It’s not: ‘Should it really be adopted or not?’ It should be. There is a huge potential in doing inpatient coordinated [care], having people dedicated in the hospital.”
There are tangible benefits to creating efficiencies in India’s health system, Dr. Odeti said. Length of stay for sicker patients “was much longer” at 10-14 days during the second wave, compared with the United States, before lowering to around 5 days. “These hospitals right now are learning the efficient ways of doing it: when to send [patients] out, how to send them out, how to [perform] service-based practices, creating processes which were nonexistent before.”
While he doesn’t personally believe physicians will adopt a full-fledged hospitalist model unless the payer structure in India changes, “these people are at an advantage with this extra set of skills,” he said. “I think all the knowledge that these people have are going to come in handy.”
Opportunities for growth
Dr. Odeti sees the potential for the hospitalist model to grow in India – if not into its own specialty, then in how critical care consultants handle sicker patients and handoffs.
“The critical care clinician cannot keep the patient from the time they are admitted to the ICU until the discharge, so there will be a need for the transition,” Dr. Odeti said. “In the past, there were not many capabilities in Indian health systems to take care of these extremely sick patients, and now it is evolving. I think that is one more thing that will help.”
Dr. Adhikari said hospital systems in India are beginning to realize how having dedicated hospital physicians could benefit them. In India, “if you’re sick, you go to your doctor, you get treated and you disappear,” he said. The next time, you may see the same doctor or a completely different doctor. “There’s no system there, so it’s really hard for hospital medicine as such because patients, when they are very sick, they just come to the ER. They’re not followed by their primary care.”
Anecdotally, Dr. Odeti sees patients already adapting to having access to a physician for asking questions normally answered by primary care physicians. “I think primary care will come into play,” he said. “When I was doing a Zoom call for patients, they were asking me questions about sciatica. I think they are getting comfortable with this technology.”
A hospitalist model could even be applied to specific diseases with a large population of patients. Hospital administrators “have seen this for the first time, how efficient it could be if they had their own hospitalists and actually run it. So that’s the part that has crossed their minds,” Dr. Adhikari said. “How they will apply it going forward, other than during the COVID-19 pandemic, depends on the size of the hospital and the volume of the patients for a particular disease.”
“You can see in certain areas there is large growth for hospital medicine. But to rise to the level of the United States and how we do it, India needs bigger health systems to adopt the model,” Dr. Adhikari said.