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FDA tightens requirements for COVID-19 antibody tests
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
Hydroxychloroquine-triggered QTc-interval prolongations mount in COVID-19 patients
The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.
A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.
The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.
These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.
The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.
In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.
None of the authors of the two reports and editorial had relevant commercial disclosures.
The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.
A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.
The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.
These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.
The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.
In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.
None of the authors of the two reports and editorial had relevant commercial disclosures.
The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.
A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.
The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.
These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.
The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.
In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.
None of the authors of the two reports and editorial had relevant commercial disclosures.
FROM JAMA CARDIOLOGY
COVID-19: Social distancing with young children
Emma just celebrated her second birthday, and she has been working on the usual things that children start to master at this age: potty training, making friends, exerting her will through both actions and words, and generally enjoying life as the center of attention for both her parents and grandparents. Like everyone else in Maryland, Emma’s life changed suddenly with the coronavirus stay-at-home order that was issued on March 30. There is no more day care and her parents work from home while caring for her. Her grandparents visit, but only outside and only from a distance – there are no more hugs and there is no more sitting in her grandfather’s lap while he reads stories.
One afternoon a few weeks ago, Emma was looking out the window when she saw her friend, Max, walk by with his parents. Before her parents could stop her, Emma bolted out the door, and she and little Max wrapped each other in a tight embrace. Their parents snapped a photo of the smiling toddlers hugging before they separated the children. The photo is adorable, but as all struggle with social distancing, the poignance of two innocent toddlers in a forbidden embrace is a bit heartbreaking.
Everyone who has ever observed children knows that social distancing is not in their nature. Children play, they hug, they wrestle and tackle and poke, and sometimes even bite. And every student of social psychology has been taught about Harry Harlow’s experiments with rhesus macaques who were separated from their mothers and given access to an inanimate object to serve as a surrogate mother. The Harlow studies, while controversial, were revolutionary in demonstrating that early interactions with both a mother and with playmates were essential in the development of normal social relationships.
Regine Galanti, PhD, is a clinical psychologist at Long Island Behavioral Psychology, Cedarhurst, N.Y., who specializes in the treatment of anxiety and behavior problems. With young children she uses parent-child interaction therapy (PCIT) to help build relationships and discipline. Dr. Galanti said: “I don’t think we’re well prepared as a field to answer questions about the long-term effects of social distancing. If you need young children to socially distance, the responsibility has to fall on the adults. It’s important to explain to children what’s going on and to be honest in a developmentally appropriate way.”
Dr. Galanti has noticed that the issues that people had before COVID-19 are exacerbated by the stress of the current situation. What we do know is that young children thrive on structure.”
Tovah P. Klein, PhD, is the author of “How Toddlers Thrive” (Touchstone, 2015) and is the director of the Barnard College Center for Toddler Development in Manhattan. “When this started, we thought we would be closed for a few weeks,” Dr. Klein said. “We wanted to maintain a connection to the children, so we made videos for the parents to show to the kids, just to say ‘We’re still here.’ But as time went on and we realized it was going to be a while, we felt it was important to provide connection, so we launched a virtual program.”
Dr. Klein said that the teachers meet with their classes of 13 2-year-olds over Zoom, and when they first started, she asked the teachers to try to meet for 10 minutes. They are now meeting for 40 minutes twice a week. The children like seeing their teachers in their homes and they like seeing each other. In addition, the teachers make videos to send home and they are currently working on one to demystify masks. “We’re working on normalizing masks and showing children that when you put the mask on, you’re still there underneath.”
The center has existed for 48 years. There have been struggles for some of the children who attend; some of the parents have been hospitalized with the virus, and some work on the front line and so parents may be living away from a child.
“We’ve seen more challenging behaviors during this time, more tantrums, toileting issues, night awakenings, and more fragility. But as the new normal takes hold, things are settling in. Parents have been good about getting new routines and it helps if parents can handle their own stress,” Dr. Klein said. She also pointed out that for parents working at home while caring for their children, this can be particularly difficult on a young child. “The child knows the parent is home, but isn’t spending time with him, and he sees it as a rejection.”
Margaret Adams, MD, is a child psychiatrist in Maryland who works with very young children and their parents. She says that some of the children are thriving with the extra attention from their parents. “I often have seen difficulties with readjustment to the routine of separations to day care after a family vacation of a week, or sometimes even a weekend, even for those young ones who seem to love the social aspects of day care. I think it is likely a big impact will come upon return, depending on the developmental stage of the child,” Dr. Adams noted.
Despite the hardships of the moment, all three experts expressed hopefulness about the future for these children.
“Young children are super-resilient and that’s the blessing of this,” Dr. Galanti said. “I think they will be okay.”
Emma is home for now with her parents, who are expecting another child soon. Her mother notes: “The days are long and balancing work is an impossible challenge, but being with Emma has been a total blessing, and when would I ever have this much time to spend with my kid? She’s at such a fun age – so curious and adventurous – it’s amazing to watch her language and skills progress. I wish we weren’t in the midst of a pandemic, but Emma is definitely the bright spot.”
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.
Emma just celebrated her second birthday, and she has been working on the usual things that children start to master at this age: potty training, making friends, exerting her will through both actions and words, and generally enjoying life as the center of attention for both her parents and grandparents. Like everyone else in Maryland, Emma’s life changed suddenly with the coronavirus stay-at-home order that was issued on March 30. There is no more day care and her parents work from home while caring for her. Her grandparents visit, but only outside and only from a distance – there are no more hugs and there is no more sitting in her grandfather’s lap while he reads stories.
One afternoon a few weeks ago, Emma was looking out the window when she saw her friend, Max, walk by with his parents. Before her parents could stop her, Emma bolted out the door, and she and little Max wrapped each other in a tight embrace. Their parents snapped a photo of the smiling toddlers hugging before they separated the children. The photo is adorable, but as all struggle with social distancing, the poignance of two innocent toddlers in a forbidden embrace is a bit heartbreaking.
Everyone who has ever observed children knows that social distancing is not in their nature. Children play, they hug, they wrestle and tackle and poke, and sometimes even bite. And every student of social psychology has been taught about Harry Harlow’s experiments with rhesus macaques who were separated from their mothers and given access to an inanimate object to serve as a surrogate mother. The Harlow studies, while controversial, were revolutionary in demonstrating that early interactions with both a mother and with playmates were essential in the development of normal social relationships.
Regine Galanti, PhD, is a clinical psychologist at Long Island Behavioral Psychology, Cedarhurst, N.Y., who specializes in the treatment of anxiety and behavior problems. With young children she uses parent-child interaction therapy (PCIT) to help build relationships and discipline. Dr. Galanti said: “I don’t think we’re well prepared as a field to answer questions about the long-term effects of social distancing. If you need young children to socially distance, the responsibility has to fall on the adults. It’s important to explain to children what’s going on and to be honest in a developmentally appropriate way.”
Dr. Galanti has noticed that the issues that people had before COVID-19 are exacerbated by the stress of the current situation. What we do know is that young children thrive on structure.”
Tovah P. Klein, PhD, is the author of “How Toddlers Thrive” (Touchstone, 2015) and is the director of the Barnard College Center for Toddler Development in Manhattan. “When this started, we thought we would be closed for a few weeks,” Dr. Klein said. “We wanted to maintain a connection to the children, so we made videos for the parents to show to the kids, just to say ‘We’re still here.’ But as time went on and we realized it was going to be a while, we felt it was important to provide connection, so we launched a virtual program.”
Dr. Klein said that the teachers meet with their classes of 13 2-year-olds over Zoom, and when they first started, she asked the teachers to try to meet for 10 minutes. They are now meeting for 40 minutes twice a week. The children like seeing their teachers in their homes and they like seeing each other. In addition, the teachers make videos to send home and they are currently working on one to demystify masks. “We’re working on normalizing masks and showing children that when you put the mask on, you’re still there underneath.”
The center has existed for 48 years. There have been struggles for some of the children who attend; some of the parents have been hospitalized with the virus, and some work on the front line and so parents may be living away from a child.
“We’ve seen more challenging behaviors during this time, more tantrums, toileting issues, night awakenings, and more fragility. But as the new normal takes hold, things are settling in. Parents have been good about getting new routines and it helps if parents can handle their own stress,” Dr. Klein said. She also pointed out that for parents working at home while caring for their children, this can be particularly difficult on a young child. “The child knows the parent is home, but isn’t spending time with him, and he sees it as a rejection.”
Margaret Adams, MD, is a child psychiatrist in Maryland who works with very young children and their parents. She says that some of the children are thriving with the extra attention from their parents. “I often have seen difficulties with readjustment to the routine of separations to day care after a family vacation of a week, or sometimes even a weekend, even for those young ones who seem to love the social aspects of day care. I think it is likely a big impact will come upon return, depending on the developmental stage of the child,” Dr. Adams noted.
Despite the hardships of the moment, all three experts expressed hopefulness about the future for these children.
“Young children are super-resilient and that’s the blessing of this,” Dr. Galanti said. “I think they will be okay.”
Emma is home for now with her parents, who are expecting another child soon. Her mother notes: “The days are long and balancing work is an impossible challenge, but being with Emma has been a total blessing, and when would I ever have this much time to spend with my kid? She’s at such a fun age – so curious and adventurous – it’s amazing to watch her language and skills progress. I wish we weren’t in the midst of a pandemic, but Emma is definitely the bright spot.”
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.
Emma just celebrated her second birthday, and she has been working on the usual things that children start to master at this age: potty training, making friends, exerting her will through both actions and words, and generally enjoying life as the center of attention for both her parents and grandparents. Like everyone else in Maryland, Emma’s life changed suddenly with the coronavirus stay-at-home order that was issued on March 30. There is no more day care and her parents work from home while caring for her. Her grandparents visit, but only outside and only from a distance – there are no more hugs and there is no more sitting in her grandfather’s lap while he reads stories.
One afternoon a few weeks ago, Emma was looking out the window when she saw her friend, Max, walk by with his parents. Before her parents could stop her, Emma bolted out the door, and she and little Max wrapped each other in a tight embrace. Their parents snapped a photo of the smiling toddlers hugging before they separated the children. The photo is adorable, but as all struggle with social distancing, the poignance of two innocent toddlers in a forbidden embrace is a bit heartbreaking.
Everyone who has ever observed children knows that social distancing is not in their nature. Children play, they hug, they wrestle and tackle and poke, and sometimes even bite. And every student of social psychology has been taught about Harry Harlow’s experiments with rhesus macaques who were separated from their mothers and given access to an inanimate object to serve as a surrogate mother. The Harlow studies, while controversial, were revolutionary in demonstrating that early interactions with both a mother and with playmates were essential in the development of normal social relationships.
Regine Galanti, PhD, is a clinical psychologist at Long Island Behavioral Psychology, Cedarhurst, N.Y., who specializes in the treatment of anxiety and behavior problems. With young children she uses parent-child interaction therapy (PCIT) to help build relationships and discipline. Dr. Galanti said: “I don’t think we’re well prepared as a field to answer questions about the long-term effects of social distancing. If you need young children to socially distance, the responsibility has to fall on the adults. It’s important to explain to children what’s going on and to be honest in a developmentally appropriate way.”
Dr. Galanti has noticed that the issues that people had before COVID-19 are exacerbated by the stress of the current situation. What we do know is that young children thrive on structure.”
Tovah P. Klein, PhD, is the author of “How Toddlers Thrive” (Touchstone, 2015) and is the director of the Barnard College Center for Toddler Development in Manhattan. “When this started, we thought we would be closed for a few weeks,” Dr. Klein said. “We wanted to maintain a connection to the children, so we made videos for the parents to show to the kids, just to say ‘We’re still here.’ But as time went on and we realized it was going to be a while, we felt it was important to provide connection, so we launched a virtual program.”
Dr. Klein said that the teachers meet with their classes of 13 2-year-olds over Zoom, and when they first started, she asked the teachers to try to meet for 10 minutes. They are now meeting for 40 minutes twice a week. The children like seeing their teachers in their homes and they like seeing each other. In addition, the teachers make videos to send home and they are currently working on one to demystify masks. “We’re working on normalizing masks and showing children that when you put the mask on, you’re still there underneath.”
The center has existed for 48 years. There have been struggles for some of the children who attend; some of the parents have been hospitalized with the virus, and some work on the front line and so parents may be living away from a child.
“We’ve seen more challenging behaviors during this time, more tantrums, toileting issues, night awakenings, and more fragility. But as the new normal takes hold, things are settling in. Parents have been good about getting new routines and it helps if parents can handle their own stress,” Dr. Klein said. She also pointed out that for parents working at home while caring for their children, this can be particularly difficult on a young child. “The child knows the parent is home, but isn’t spending time with him, and he sees it as a rejection.”
Margaret Adams, MD, is a child psychiatrist in Maryland who works with very young children and their parents. She says that some of the children are thriving with the extra attention from their parents. “I often have seen difficulties with readjustment to the routine of separations to day care after a family vacation of a week, or sometimes even a weekend, even for those young ones who seem to love the social aspects of day care. I think it is likely a big impact will come upon return, depending on the developmental stage of the child,” Dr. Adams noted.
Despite the hardships of the moment, all three experts expressed hopefulness about the future for these children.
“Young children are super-resilient and that’s the blessing of this,” Dr. Galanti said. “I think they will be okay.”
Emma is home for now with her parents, who are expecting another child soon. Her mother notes: “The days are long and balancing work is an impossible challenge, but being with Emma has been a total blessing, and when would I ever have this much time to spend with my kid? She’s at such a fun age – so curious and adventurous – it’s amazing to watch her language and skills progress. I wish we weren’t in the midst of a pandemic, but Emma is definitely the bright spot.”
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.
COVID-19: To have and to hold ... in quarantine
Tips for marriage survival during a pandemic
Most married couples vowed to stay with their partners during sickness and health, but none of us vowed to remain trapped with our loved ones behind the same four walls, all day, every day, for an unknown period of time. We didn’t sign up for this! Some romantics may be titillated by the prospect, while more independent partners may panic at the mere thought of spending all day and night with their loved ones.
Because of the swift implementation of the lifestyle-altering restrictions, couples did not have ample time to mentally and physically prepare. A lack of preparation and loss of control heightens our emotions. It can make couples more susceptible to engage in unhealthy styles of communication and destructive behaviors that are harmful to their relationships.
There are psychological reasons that “absence makes the heart grow fonder.” Distance from your partner is not just a clever way to make your partner appreciate and desire you more. It is human nature to habituate to what is part of your daily life. For instance, when your partner is away from you while on a work trip, you may find the first night or two alone relaxing; but by day 3, you begin to miss your partner’s hugs and kisses, smell, and touch. And after many days apart, you may even miss the incessant nagging that secretly motivates you. Physical distance from our partners essentially gives us the ability to long for and appreciate each other. Our brains are wired to pay more attention to things that are novel and exciting and less interested in what is in our everyday lives.
Separation gives us the ability to miss our partners, while quarantine does the complete opposite.
To avoid contemplating how to murder one’s spouse before quarantine ends, partners can strengthen their relationships by using the strategies I’ve outlined below, which are loosely based on dialectical behavior therapy (DBT). These strategies can be useful for anyone – providers and patients alike – going through these struggles.
Dialectical behavior therapy was developed by psychologist Marsha Linehan PhD, to help regulate emotions for people diagnosed with borderline personality disorder. These skills help to identify thoughts and feelings, to accept one’s inner emotional world and outward behaviors. The idea is that, once you can recognize and accept, then change is possible. The “dialectic” in dialectical behavior therapy implies that one is attempting to find a balance between acceptance and change. All of us can benefit from these skills, especially emotionally volatile couples who are trapped together in quarantine.
Radically accept what is uncertain in your lives
Radical acceptance is a practice used in DBT in situations that are out of our control, such as the COVID-19 pandemic. Radically accept that you and your partner are trapped in quarantine without attempting to place blame on our government, your spouse, your boss, and even yourself. Radical acceptance is exactly what the name implies. Accept your current situation for what it is and not what you hoped it to be.
Accept the unknown and unanswered questions such as when will this quarantine end? Will there be a summer camp? Will I get back to my office this summer? Will my children even return to school in the fall? The acceptance of what is out of your control will ultimately decrease your mental time spent worrying and obsessing about the uncertainties of your post-quarantine life and instead provide you more time to be present with your spouse.
Remain mindful during all communication with your spouse. To stay in the moment, you need to be aware of your bodily reactions to distress and notice when your heart rate increases, breathing becomes more shallow, stomach muscles tighten, and when your thoughts become more negative. Mindfulness skills enable us to use physiological changes in our body to become aware of our emotions. You can use your partner’s nonverbal body language and tone of voice to gauge that person’s emotional reactivity.
The practice of mindfulness leads to an increased emotional intelligence. The goal is to have enough self-awareness and emotional understanding of your partner and enough empathy to know when a conversation is becoming too emotionally charged and to let it go and back off. Mindfulness is not nagging your partner to remember to change the heating unit filters with a reminder of what happened years ago when this wasn’t done promptly – without first checking in to make sure your partner is emotionally ready for this type of conversation.
When we have strong emotions, we are using the more primitive parts of our brain that induce a fight or flight reaction. These emotional reactions overshadow the more advanced prefrontal region of our brain that stores our rational thoughts and reasoning skills, a concept identified by psychologist Daniel Goleman as “emotional hijacking.”
Use distress tolerance skills to deal with negative emotions
Distress tolerance is an individual’s ability to manage feelings in response to stress. Distress tolerance skills are aimed at helping one manage intense emotions without worsening a situation by engaging in behaviors that are destructive and may exacerbate the problem. The goal is to tolerate the stress while with your partner and not respond negatively or in a way that is harmful to the integrity of your relationship.
To prioritize your relationship, this may mean that you choose not to react negatively when your partner makes a passive-aggressive comment on how you spent your day during quarantine since you still have a pile of laundry on your bedroom floor and overflowing dishes in the kitchen sink. A high level of distress tolerance will enable you to not overreact or withdraw from your spouse when flooded with emotions of anger or sadness.
Distraction techniques are a type of distress tolerance skill. You can engage in activities that keep you distracted and require your full attention. When things get heated between you and your spouse during quarantine, try to obtain some distance from each other to cool down and engage in an activity that involves your full concentration.
Many of us have been surprised by our hidden talents that were discovered during the quarantine. Use the time away from your partner to distract yourself with your new passion for writing, baking, organizing, and even your newfound love of balloon artistry. Do an activity that engages your mind and provides you the necessary physical and mental time away from your partner to deescalate. You can always revisit the initial cause of the conflict when both you and your partner are not emotionally charged. You can also distract yourself with self-soothing tactics such as taking a warm bath or a reading good book. Perhaps distract yourself by giving back to others and spending time planning a drive-by surprise party for your sister’s birthday next month. It can be helpful to distract yourself by comparing yourself to others less fortunate than you or a time in your life when you and your partner were struggling much worse than now, to provide perspective. The goal is not to add to your distress but instead, provide yourself a sense of perspective.
Use interpersonal effectiveness skills to establish a healthy relationship
Be gentle in all your communications with your partner, think about your spouse’s perspective, show empathy and interest in what your partner has to say by your verbal communication or body language, such as maintaining eye contact, and offer recognitional cues, such as “uh-huh” and “oh, really.” Avoid communication that is at all invalidating. Never start a sentence with “YOU” while having heated conversations with your spouse; instead, use “I feel” statements. This type of communication avoids the blame game that gets many couples into trouble.
Instead, communicate how you feel while not necessarily blaming your spouse but rather expressing your emotions. This will ultimately lead to less defensive communication from your partner. Remember that not all communication is for the sole purpose of communicating. Much of the time, communication is used as an attempt for one partner to connect with the other partner. Couples may say that they have difficulty with communication when it is not the communication that is the issue but instead the underlying disconnect of the couple.
This disconnect usually manifests while couples are communicating, and therefore, can be misconstrued as solely a communication issue by the couple. When your partner asks you to stop staring at your phone during dinner, it is not necessarily that your spouse is attempting to control you or wants to engage in some deep conversation, but more likely a bid to try to connect with you. Your partner is attempting to tell you that he or she feels disconnected, misses you, and wants to reconnect.
Provide validation and acceptance to your partner
Focus on your partner’s strengths and accept the weaknesses. Accept that your partner is scattered, disorganized, and takes at least 20 minutes to find the phone and keys every morning. Remember that during your courtship days, you found your partner’s flighty attributes to be endearing. Do the same for your strengths and weaknesses.
Accept that the pandemic is unpredictable and that you may need to strengthen your ability to be flexible and more adaptable. This will ultimately lead to feeling less disappointment by your partner and more accepting of shortcomings. Acceptance of your imperfections will improve your sense of worth and confidence and lessen negative emotions, such as guilt, regret, and shame.
Accept the fact that, as similar as we all are, we use different methods to recharge ourselves. In contrast, your spouse needs alone time without distractions to reboot mentally and prepare for the following day. In the pre-pandemic world, if there were a mismatch in what a couple needed to feel rejuvenated, they could independently compensate and search for fulfillment outside of the home. Before stay-at-home orders were rolled out throughout the country, spouses had ample opportunities to spend time away from their partners at work, dinner with friends, or while squeezing in a 7 p.m. yoga sculpt class – barely getting home in time to kiss our children goodnight – with a few minutes to spare to engage in mundane conversation with our partners before our nighttime routine of TV commenced. Unfortunately, COVID-19 has made it very hard for couples to carve out that time for compensatory activities outside of the home.
Remember that you are a team
Remind yourself of the reason why you initially fell in love with your partner. Teammates do not keep score or compete with one another. They support each other when one player is not feeling well, and they make sacrifices for the betterment of the team.
Your marriage vows included “through sickness and health” and now should include “through quarantine.”
Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.
Tips for marriage survival during a pandemic
Tips for marriage survival during a pandemic
Most married couples vowed to stay with their partners during sickness and health, but none of us vowed to remain trapped with our loved ones behind the same four walls, all day, every day, for an unknown period of time. We didn’t sign up for this! Some romantics may be titillated by the prospect, while more independent partners may panic at the mere thought of spending all day and night with their loved ones.
Because of the swift implementation of the lifestyle-altering restrictions, couples did not have ample time to mentally and physically prepare. A lack of preparation and loss of control heightens our emotions. It can make couples more susceptible to engage in unhealthy styles of communication and destructive behaviors that are harmful to their relationships.
There are psychological reasons that “absence makes the heart grow fonder.” Distance from your partner is not just a clever way to make your partner appreciate and desire you more. It is human nature to habituate to what is part of your daily life. For instance, when your partner is away from you while on a work trip, you may find the first night or two alone relaxing; but by day 3, you begin to miss your partner’s hugs and kisses, smell, and touch. And after many days apart, you may even miss the incessant nagging that secretly motivates you. Physical distance from our partners essentially gives us the ability to long for and appreciate each other. Our brains are wired to pay more attention to things that are novel and exciting and less interested in what is in our everyday lives.
Separation gives us the ability to miss our partners, while quarantine does the complete opposite.
To avoid contemplating how to murder one’s spouse before quarantine ends, partners can strengthen their relationships by using the strategies I’ve outlined below, which are loosely based on dialectical behavior therapy (DBT). These strategies can be useful for anyone – providers and patients alike – going through these struggles.
Dialectical behavior therapy was developed by psychologist Marsha Linehan PhD, to help regulate emotions for people diagnosed with borderline personality disorder. These skills help to identify thoughts and feelings, to accept one’s inner emotional world and outward behaviors. The idea is that, once you can recognize and accept, then change is possible. The “dialectic” in dialectical behavior therapy implies that one is attempting to find a balance between acceptance and change. All of us can benefit from these skills, especially emotionally volatile couples who are trapped together in quarantine.
Radically accept what is uncertain in your lives
Radical acceptance is a practice used in DBT in situations that are out of our control, such as the COVID-19 pandemic. Radically accept that you and your partner are trapped in quarantine without attempting to place blame on our government, your spouse, your boss, and even yourself. Radical acceptance is exactly what the name implies. Accept your current situation for what it is and not what you hoped it to be.
Accept the unknown and unanswered questions such as when will this quarantine end? Will there be a summer camp? Will I get back to my office this summer? Will my children even return to school in the fall? The acceptance of what is out of your control will ultimately decrease your mental time spent worrying and obsessing about the uncertainties of your post-quarantine life and instead provide you more time to be present with your spouse.
Remain mindful during all communication with your spouse. To stay in the moment, you need to be aware of your bodily reactions to distress and notice when your heart rate increases, breathing becomes more shallow, stomach muscles tighten, and when your thoughts become more negative. Mindfulness skills enable us to use physiological changes in our body to become aware of our emotions. You can use your partner’s nonverbal body language and tone of voice to gauge that person’s emotional reactivity.
The practice of mindfulness leads to an increased emotional intelligence. The goal is to have enough self-awareness and emotional understanding of your partner and enough empathy to know when a conversation is becoming too emotionally charged and to let it go and back off. Mindfulness is not nagging your partner to remember to change the heating unit filters with a reminder of what happened years ago when this wasn’t done promptly – without first checking in to make sure your partner is emotionally ready for this type of conversation.
When we have strong emotions, we are using the more primitive parts of our brain that induce a fight or flight reaction. These emotional reactions overshadow the more advanced prefrontal region of our brain that stores our rational thoughts and reasoning skills, a concept identified by psychologist Daniel Goleman as “emotional hijacking.”
Use distress tolerance skills to deal with negative emotions
Distress tolerance is an individual’s ability to manage feelings in response to stress. Distress tolerance skills are aimed at helping one manage intense emotions without worsening a situation by engaging in behaviors that are destructive and may exacerbate the problem. The goal is to tolerate the stress while with your partner and not respond negatively or in a way that is harmful to the integrity of your relationship.
To prioritize your relationship, this may mean that you choose not to react negatively when your partner makes a passive-aggressive comment on how you spent your day during quarantine since you still have a pile of laundry on your bedroom floor and overflowing dishes in the kitchen sink. A high level of distress tolerance will enable you to not overreact or withdraw from your spouse when flooded with emotions of anger or sadness.
Distraction techniques are a type of distress tolerance skill. You can engage in activities that keep you distracted and require your full attention. When things get heated between you and your spouse during quarantine, try to obtain some distance from each other to cool down and engage in an activity that involves your full concentration.
Many of us have been surprised by our hidden talents that were discovered during the quarantine. Use the time away from your partner to distract yourself with your new passion for writing, baking, organizing, and even your newfound love of balloon artistry. Do an activity that engages your mind and provides you the necessary physical and mental time away from your partner to deescalate. You can always revisit the initial cause of the conflict when both you and your partner are not emotionally charged. You can also distract yourself with self-soothing tactics such as taking a warm bath or a reading good book. Perhaps distract yourself by giving back to others and spending time planning a drive-by surprise party for your sister’s birthday next month. It can be helpful to distract yourself by comparing yourself to others less fortunate than you or a time in your life when you and your partner were struggling much worse than now, to provide perspective. The goal is not to add to your distress but instead, provide yourself a sense of perspective.
Use interpersonal effectiveness skills to establish a healthy relationship
Be gentle in all your communications with your partner, think about your spouse’s perspective, show empathy and interest in what your partner has to say by your verbal communication or body language, such as maintaining eye contact, and offer recognitional cues, such as “uh-huh” and “oh, really.” Avoid communication that is at all invalidating. Never start a sentence with “YOU” while having heated conversations with your spouse; instead, use “I feel” statements. This type of communication avoids the blame game that gets many couples into trouble.
Instead, communicate how you feel while not necessarily blaming your spouse but rather expressing your emotions. This will ultimately lead to less defensive communication from your partner. Remember that not all communication is for the sole purpose of communicating. Much of the time, communication is used as an attempt for one partner to connect with the other partner. Couples may say that they have difficulty with communication when it is not the communication that is the issue but instead the underlying disconnect of the couple.
This disconnect usually manifests while couples are communicating, and therefore, can be misconstrued as solely a communication issue by the couple. When your partner asks you to stop staring at your phone during dinner, it is not necessarily that your spouse is attempting to control you or wants to engage in some deep conversation, but more likely a bid to try to connect with you. Your partner is attempting to tell you that he or she feels disconnected, misses you, and wants to reconnect.
Provide validation and acceptance to your partner
Focus on your partner’s strengths and accept the weaknesses. Accept that your partner is scattered, disorganized, and takes at least 20 minutes to find the phone and keys every morning. Remember that during your courtship days, you found your partner’s flighty attributes to be endearing. Do the same for your strengths and weaknesses.
Accept that the pandemic is unpredictable and that you may need to strengthen your ability to be flexible and more adaptable. This will ultimately lead to feeling less disappointment by your partner and more accepting of shortcomings. Acceptance of your imperfections will improve your sense of worth and confidence and lessen negative emotions, such as guilt, regret, and shame.
Accept the fact that, as similar as we all are, we use different methods to recharge ourselves. In contrast, your spouse needs alone time without distractions to reboot mentally and prepare for the following day. In the pre-pandemic world, if there were a mismatch in what a couple needed to feel rejuvenated, they could independently compensate and search for fulfillment outside of the home. Before stay-at-home orders were rolled out throughout the country, spouses had ample opportunities to spend time away from their partners at work, dinner with friends, or while squeezing in a 7 p.m. yoga sculpt class – barely getting home in time to kiss our children goodnight – with a few minutes to spare to engage in mundane conversation with our partners before our nighttime routine of TV commenced. Unfortunately, COVID-19 has made it very hard for couples to carve out that time for compensatory activities outside of the home.
Remember that you are a team
Remind yourself of the reason why you initially fell in love with your partner. Teammates do not keep score or compete with one another. They support each other when one player is not feeling well, and they make sacrifices for the betterment of the team.
Your marriage vows included “through sickness and health” and now should include “through quarantine.”
Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.
Most married couples vowed to stay with their partners during sickness and health, but none of us vowed to remain trapped with our loved ones behind the same four walls, all day, every day, for an unknown period of time. We didn’t sign up for this! Some romantics may be titillated by the prospect, while more independent partners may panic at the mere thought of spending all day and night with their loved ones.
Because of the swift implementation of the lifestyle-altering restrictions, couples did not have ample time to mentally and physically prepare. A lack of preparation and loss of control heightens our emotions. It can make couples more susceptible to engage in unhealthy styles of communication and destructive behaviors that are harmful to their relationships.
There are psychological reasons that “absence makes the heart grow fonder.” Distance from your partner is not just a clever way to make your partner appreciate and desire you more. It is human nature to habituate to what is part of your daily life. For instance, when your partner is away from you while on a work trip, you may find the first night or two alone relaxing; but by day 3, you begin to miss your partner’s hugs and kisses, smell, and touch. And after many days apart, you may even miss the incessant nagging that secretly motivates you. Physical distance from our partners essentially gives us the ability to long for and appreciate each other. Our brains are wired to pay more attention to things that are novel and exciting and less interested in what is in our everyday lives.
Separation gives us the ability to miss our partners, while quarantine does the complete opposite.
To avoid contemplating how to murder one’s spouse before quarantine ends, partners can strengthen their relationships by using the strategies I’ve outlined below, which are loosely based on dialectical behavior therapy (DBT). These strategies can be useful for anyone – providers and patients alike – going through these struggles.
Dialectical behavior therapy was developed by psychologist Marsha Linehan PhD, to help regulate emotions for people diagnosed with borderline personality disorder. These skills help to identify thoughts and feelings, to accept one’s inner emotional world and outward behaviors. The idea is that, once you can recognize and accept, then change is possible. The “dialectic” in dialectical behavior therapy implies that one is attempting to find a balance between acceptance and change. All of us can benefit from these skills, especially emotionally volatile couples who are trapped together in quarantine.
Radically accept what is uncertain in your lives
Radical acceptance is a practice used in DBT in situations that are out of our control, such as the COVID-19 pandemic. Radically accept that you and your partner are trapped in quarantine without attempting to place blame on our government, your spouse, your boss, and even yourself. Radical acceptance is exactly what the name implies. Accept your current situation for what it is and not what you hoped it to be.
Accept the unknown and unanswered questions such as when will this quarantine end? Will there be a summer camp? Will I get back to my office this summer? Will my children even return to school in the fall? The acceptance of what is out of your control will ultimately decrease your mental time spent worrying and obsessing about the uncertainties of your post-quarantine life and instead provide you more time to be present with your spouse.
Remain mindful during all communication with your spouse. To stay in the moment, you need to be aware of your bodily reactions to distress and notice when your heart rate increases, breathing becomes more shallow, stomach muscles tighten, and when your thoughts become more negative. Mindfulness skills enable us to use physiological changes in our body to become aware of our emotions. You can use your partner’s nonverbal body language and tone of voice to gauge that person’s emotional reactivity.
The practice of mindfulness leads to an increased emotional intelligence. The goal is to have enough self-awareness and emotional understanding of your partner and enough empathy to know when a conversation is becoming too emotionally charged and to let it go and back off. Mindfulness is not nagging your partner to remember to change the heating unit filters with a reminder of what happened years ago when this wasn’t done promptly – without first checking in to make sure your partner is emotionally ready for this type of conversation.
When we have strong emotions, we are using the more primitive parts of our brain that induce a fight or flight reaction. These emotional reactions overshadow the more advanced prefrontal region of our brain that stores our rational thoughts and reasoning skills, a concept identified by psychologist Daniel Goleman as “emotional hijacking.”
Use distress tolerance skills to deal with negative emotions
Distress tolerance is an individual’s ability to manage feelings in response to stress. Distress tolerance skills are aimed at helping one manage intense emotions without worsening a situation by engaging in behaviors that are destructive and may exacerbate the problem. The goal is to tolerate the stress while with your partner and not respond negatively or in a way that is harmful to the integrity of your relationship.
To prioritize your relationship, this may mean that you choose not to react negatively when your partner makes a passive-aggressive comment on how you spent your day during quarantine since you still have a pile of laundry on your bedroom floor and overflowing dishes in the kitchen sink. A high level of distress tolerance will enable you to not overreact or withdraw from your spouse when flooded with emotions of anger or sadness.
Distraction techniques are a type of distress tolerance skill. You can engage in activities that keep you distracted and require your full attention. When things get heated between you and your spouse during quarantine, try to obtain some distance from each other to cool down and engage in an activity that involves your full concentration.
Many of us have been surprised by our hidden talents that were discovered during the quarantine. Use the time away from your partner to distract yourself with your new passion for writing, baking, organizing, and even your newfound love of balloon artistry. Do an activity that engages your mind and provides you the necessary physical and mental time away from your partner to deescalate. You can always revisit the initial cause of the conflict when both you and your partner are not emotionally charged. You can also distract yourself with self-soothing tactics such as taking a warm bath or a reading good book. Perhaps distract yourself by giving back to others and spending time planning a drive-by surprise party for your sister’s birthday next month. It can be helpful to distract yourself by comparing yourself to others less fortunate than you or a time in your life when you and your partner were struggling much worse than now, to provide perspective. The goal is not to add to your distress but instead, provide yourself a sense of perspective.
Use interpersonal effectiveness skills to establish a healthy relationship
Be gentle in all your communications with your partner, think about your spouse’s perspective, show empathy and interest in what your partner has to say by your verbal communication or body language, such as maintaining eye contact, and offer recognitional cues, such as “uh-huh” and “oh, really.” Avoid communication that is at all invalidating. Never start a sentence with “YOU” while having heated conversations with your spouse; instead, use “I feel” statements. This type of communication avoids the blame game that gets many couples into trouble.
Instead, communicate how you feel while not necessarily blaming your spouse but rather expressing your emotions. This will ultimately lead to less defensive communication from your partner. Remember that not all communication is for the sole purpose of communicating. Much of the time, communication is used as an attempt for one partner to connect with the other partner. Couples may say that they have difficulty with communication when it is not the communication that is the issue but instead the underlying disconnect of the couple.
This disconnect usually manifests while couples are communicating, and therefore, can be misconstrued as solely a communication issue by the couple. When your partner asks you to stop staring at your phone during dinner, it is not necessarily that your spouse is attempting to control you or wants to engage in some deep conversation, but more likely a bid to try to connect with you. Your partner is attempting to tell you that he or she feels disconnected, misses you, and wants to reconnect.
Provide validation and acceptance to your partner
Focus on your partner’s strengths and accept the weaknesses. Accept that your partner is scattered, disorganized, and takes at least 20 minutes to find the phone and keys every morning. Remember that during your courtship days, you found your partner’s flighty attributes to be endearing. Do the same for your strengths and weaknesses.
Accept that the pandemic is unpredictable and that you may need to strengthen your ability to be flexible and more adaptable. This will ultimately lead to feeling less disappointment by your partner and more accepting of shortcomings. Acceptance of your imperfections will improve your sense of worth and confidence and lessen negative emotions, such as guilt, regret, and shame.
Accept the fact that, as similar as we all are, we use different methods to recharge ourselves. In contrast, your spouse needs alone time without distractions to reboot mentally and prepare for the following day. In the pre-pandemic world, if there were a mismatch in what a couple needed to feel rejuvenated, they could independently compensate and search for fulfillment outside of the home. Before stay-at-home orders were rolled out throughout the country, spouses had ample opportunities to spend time away from their partners at work, dinner with friends, or while squeezing in a 7 p.m. yoga sculpt class – barely getting home in time to kiss our children goodnight – with a few minutes to spare to engage in mundane conversation with our partners before our nighttime routine of TV commenced. Unfortunately, COVID-19 has made it very hard for couples to carve out that time for compensatory activities outside of the home.
Remember that you are a team
Remind yourself of the reason why you initially fell in love with your partner. Teammates do not keep score or compete with one another. They support each other when one player is not feeling well, and they make sacrifices for the betterment of the team.
Your marriage vows included “through sickness and health” and now should include “through quarantine.”
Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.
FDA authorizes emergency use of remdesivir for COVID-19
The investigational antiviral drug, manufactured by Gilead Sciences Inc., was shown in a preliminary analysis of a National Institutes of Health (NIH) clinical trial to shorten recovery time in some patients, according to information presented during a White House press conference earlier this week. However, the results of the trial have not been published and little is known about how safe and effective it is in treating people in the hospital with COVID-19.
The emergency use authorization (EUA) designation means remdesivir can be distributed in the United States and administered intravenously by healthcare providers, as appropriate to treat severe disease. Those with severe disease, the FDA said in a press release, are patients with low blood oxygen levels or those who need oxygen therapy or more intensive support such as a mechanical ventilator.
“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
The FDA writes, “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”
The drug must be administered intravenously and the optimal dosing and duration are not yet known, the company said in a press release issued May 1.
In addition, Gilead advises that infusion-related reactions and liver transaminase elevations have been seen in patients treated with the drug.
“If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy,” the company said.
Before granting the emergency use authorization, the FDA had allowed for study of the drug in clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead.
“The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance,” the FDA said.
This article first appeared on Medscape.com.
The investigational antiviral drug, manufactured by Gilead Sciences Inc., was shown in a preliminary analysis of a National Institutes of Health (NIH) clinical trial to shorten recovery time in some patients, according to information presented during a White House press conference earlier this week. However, the results of the trial have not been published and little is known about how safe and effective it is in treating people in the hospital with COVID-19.
The emergency use authorization (EUA) designation means remdesivir can be distributed in the United States and administered intravenously by healthcare providers, as appropriate to treat severe disease. Those with severe disease, the FDA said in a press release, are patients with low blood oxygen levels or those who need oxygen therapy or more intensive support such as a mechanical ventilator.
“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
The FDA writes, “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”
The drug must be administered intravenously and the optimal dosing and duration are not yet known, the company said in a press release issued May 1.
In addition, Gilead advises that infusion-related reactions and liver transaminase elevations have been seen in patients treated with the drug.
“If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy,” the company said.
Before granting the emergency use authorization, the FDA had allowed for study of the drug in clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead.
“The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance,” the FDA said.
This article first appeared on Medscape.com.
The investigational antiviral drug, manufactured by Gilead Sciences Inc., was shown in a preliminary analysis of a National Institutes of Health (NIH) clinical trial to shorten recovery time in some patients, according to information presented during a White House press conference earlier this week. However, the results of the trial have not been published and little is known about how safe and effective it is in treating people in the hospital with COVID-19.
The emergency use authorization (EUA) designation means remdesivir can be distributed in the United States and administered intravenously by healthcare providers, as appropriate to treat severe disease. Those with severe disease, the FDA said in a press release, are patients with low blood oxygen levels or those who need oxygen therapy or more intensive support such as a mechanical ventilator.
“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
The FDA writes, “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”
The drug must be administered intravenously and the optimal dosing and duration are not yet known, the company said in a press release issued May 1.
In addition, Gilead advises that infusion-related reactions and liver transaminase elevations have been seen in patients treated with the drug.
“If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy,” the company said.
Before granting the emergency use authorization, the FDA had allowed for study of the drug in clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead.
“The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance,” the FDA said.
This article first appeared on Medscape.com.
CMS hikes telephone visit payments during pandemic
Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.
On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.
Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.
The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.
“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”
CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.
“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”
Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”
Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*
“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”
Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.
“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”
The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.
*Correction, 5/5/2020: An earlier version of this story misstated Dr. Samuel Jones' affiliation. He is the chair of the Health Affairs Committee at the American College of Cardiology.
Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.
On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.
Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.
The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.
“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”
CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.
“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”
Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”
Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*
“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”
Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.
“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”
The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.
*Correction, 5/5/2020: An earlier version of this story misstated Dr. Samuel Jones' affiliation. He is the chair of the Health Affairs Committee at the American College of Cardiology.
Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.
On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.
Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.
The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.
“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”
CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.
“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”
Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”
Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*
“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”
Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.
“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”
The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.
*Correction, 5/5/2020: An earlier version of this story misstated Dr. Samuel Jones' affiliation. He is the chair of the Health Affairs Committee at the American College of Cardiology.
Out-of-hospital cardiac arrests soar during COVID-19 in Italy
Out-of-hospital cardiac arrests increased 58% during the peak of the COVID-19 outbreak in the hard-hit region of Lombardy, Italy, compared with the same period last year, a new analysis shows.
During the first 40 days of the outbreak beginning Feb. 21, four provinces in northern Italy reported 362 cases of out-of-hospital cardiac arrest compared with 229 during the same period in 2019.
The increases in these provinces varied in magnitude from 18% in Mantua, where there were 1,688 confirmed COVID-19 cases, to 187% in Lodi, which had 2,116 COVID-19 cases. The Cremona province, which had the highest number of COVID-19 cases at 3,869, saw a 143% increase in out-of-hospital cardiac arrests.
The mortality rate in the field was 14.9 percentage points higher in 2020 than in 2019 among patients in whom resuscitation was attempted by emergency medical services (EMS), Enrico Baldi, MD, University of Pavia, Italy, and colleagues reported in a letter April 29 in the New England Journal of Medicine.
“The sex and age of the patients were similar in the 2020 and 2019 periods, but in 2020, the incidence of out-of-hospital cardiac arrest due to a medical cause was 6.5 percentage points higher, the incidence of out-of-hospital cardiac arrest at home was 7.3 percentage points higher, and the incidence of unwitnessed cardiac arrest was 11.3 percentage points higher,” the authors wrote.
Patients were also less likely to receive cardiopulmonary resuscitation from bystanders in 2020 vs 2019 (–15.6 percentage points) and were more likely to die before reaching the hospital when resuscitation was attempted by EMS (+14.9 percentage points).
Among all patients, the death rate in the field increased 11.4 percentage points during the outbreak, from 77.3% in 2019 to 88.7% in 2020.
The cumulative incidence of out-of-hospital cardiac arrest in 2020 was “strongly associated” with the cumulative incidence of COVID-19 (Spearman rank correlation coefficient, 0.87; 95% confidence interval, 0.83-0.91) and the spike in cases “followed the time course of the COVID-19 outbreak,” the researchers noted.
A total of 103 patients, who arrested out of hospital and were diagnosed with or suspected of having COVID-19, “account for 77.4% of the increase in cases of out-of-hospital cardiac arrest observed in these provinces in 2020,” the investigators noted.
As the pandemic has taken hold, hospitals and physicians across the United States are also voicing concerns about the drop in the number of patients presenting with myocardial infarction (MI) or stroke.
Nearly one-third of Americans (29%) report having delayed or avoided medical care because of concerns of catching COVID-19, according to a new poll released April 28 from the American College of Emergency Physicians (ACEP) and Morning Consult, a global data research firm.
Despite many emergency departments reporting a decline in patient volume, 74% of respondents said they were worried about hospital wait times and overcrowding. Another 59% expressed concerns about being turned away from the hospital or doctor’s office.
At the same time, the survey found strong support for emergency physicians and 73% of respondents said they were concerned about overstressing the health care system.
The drop-off in Americans seeking care for MI and strokes nationally prompted eight professional societies – including ACEP, the American Heart Association, and the Association of Black Cardiologists – to issue a joint statement urging those experiencing symptoms to call 911 and seek care for these life-threatening events.
The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Out-of-hospital cardiac arrests increased 58% during the peak of the COVID-19 outbreak in the hard-hit region of Lombardy, Italy, compared with the same period last year, a new analysis shows.
During the first 40 days of the outbreak beginning Feb. 21, four provinces in northern Italy reported 362 cases of out-of-hospital cardiac arrest compared with 229 during the same period in 2019.
The increases in these provinces varied in magnitude from 18% in Mantua, where there were 1,688 confirmed COVID-19 cases, to 187% in Lodi, which had 2,116 COVID-19 cases. The Cremona province, which had the highest number of COVID-19 cases at 3,869, saw a 143% increase in out-of-hospital cardiac arrests.
The mortality rate in the field was 14.9 percentage points higher in 2020 than in 2019 among patients in whom resuscitation was attempted by emergency medical services (EMS), Enrico Baldi, MD, University of Pavia, Italy, and colleagues reported in a letter April 29 in the New England Journal of Medicine.
“The sex and age of the patients were similar in the 2020 and 2019 periods, but in 2020, the incidence of out-of-hospital cardiac arrest due to a medical cause was 6.5 percentage points higher, the incidence of out-of-hospital cardiac arrest at home was 7.3 percentage points higher, and the incidence of unwitnessed cardiac arrest was 11.3 percentage points higher,” the authors wrote.
Patients were also less likely to receive cardiopulmonary resuscitation from bystanders in 2020 vs 2019 (–15.6 percentage points) and were more likely to die before reaching the hospital when resuscitation was attempted by EMS (+14.9 percentage points).
Among all patients, the death rate in the field increased 11.4 percentage points during the outbreak, from 77.3% in 2019 to 88.7% in 2020.
The cumulative incidence of out-of-hospital cardiac arrest in 2020 was “strongly associated” with the cumulative incidence of COVID-19 (Spearman rank correlation coefficient, 0.87; 95% confidence interval, 0.83-0.91) and the spike in cases “followed the time course of the COVID-19 outbreak,” the researchers noted.
A total of 103 patients, who arrested out of hospital and were diagnosed with or suspected of having COVID-19, “account for 77.4% of the increase in cases of out-of-hospital cardiac arrest observed in these provinces in 2020,” the investigators noted.
As the pandemic has taken hold, hospitals and physicians across the United States are also voicing concerns about the drop in the number of patients presenting with myocardial infarction (MI) or stroke.
Nearly one-third of Americans (29%) report having delayed or avoided medical care because of concerns of catching COVID-19, according to a new poll released April 28 from the American College of Emergency Physicians (ACEP) and Morning Consult, a global data research firm.
Despite many emergency departments reporting a decline in patient volume, 74% of respondents said they were worried about hospital wait times and overcrowding. Another 59% expressed concerns about being turned away from the hospital or doctor’s office.
At the same time, the survey found strong support for emergency physicians and 73% of respondents said they were concerned about overstressing the health care system.
The drop-off in Americans seeking care for MI and strokes nationally prompted eight professional societies – including ACEP, the American Heart Association, and the Association of Black Cardiologists – to issue a joint statement urging those experiencing symptoms to call 911 and seek care for these life-threatening events.
The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Out-of-hospital cardiac arrests increased 58% during the peak of the COVID-19 outbreak in the hard-hit region of Lombardy, Italy, compared with the same period last year, a new analysis shows.
During the first 40 days of the outbreak beginning Feb. 21, four provinces in northern Italy reported 362 cases of out-of-hospital cardiac arrest compared with 229 during the same period in 2019.
The increases in these provinces varied in magnitude from 18% in Mantua, where there were 1,688 confirmed COVID-19 cases, to 187% in Lodi, which had 2,116 COVID-19 cases. The Cremona province, which had the highest number of COVID-19 cases at 3,869, saw a 143% increase in out-of-hospital cardiac arrests.
The mortality rate in the field was 14.9 percentage points higher in 2020 than in 2019 among patients in whom resuscitation was attempted by emergency medical services (EMS), Enrico Baldi, MD, University of Pavia, Italy, and colleagues reported in a letter April 29 in the New England Journal of Medicine.
“The sex and age of the patients were similar in the 2020 and 2019 periods, but in 2020, the incidence of out-of-hospital cardiac arrest due to a medical cause was 6.5 percentage points higher, the incidence of out-of-hospital cardiac arrest at home was 7.3 percentage points higher, and the incidence of unwitnessed cardiac arrest was 11.3 percentage points higher,” the authors wrote.
Patients were also less likely to receive cardiopulmonary resuscitation from bystanders in 2020 vs 2019 (–15.6 percentage points) and were more likely to die before reaching the hospital when resuscitation was attempted by EMS (+14.9 percentage points).
Among all patients, the death rate in the field increased 11.4 percentage points during the outbreak, from 77.3% in 2019 to 88.7% in 2020.
The cumulative incidence of out-of-hospital cardiac arrest in 2020 was “strongly associated” with the cumulative incidence of COVID-19 (Spearman rank correlation coefficient, 0.87; 95% confidence interval, 0.83-0.91) and the spike in cases “followed the time course of the COVID-19 outbreak,” the researchers noted.
A total of 103 patients, who arrested out of hospital and were diagnosed with or suspected of having COVID-19, “account for 77.4% of the increase in cases of out-of-hospital cardiac arrest observed in these provinces in 2020,” the investigators noted.
As the pandemic has taken hold, hospitals and physicians across the United States are also voicing concerns about the drop in the number of patients presenting with myocardial infarction (MI) or stroke.
Nearly one-third of Americans (29%) report having delayed or avoided medical care because of concerns of catching COVID-19, according to a new poll released April 28 from the American College of Emergency Physicians (ACEP) and Morning Consult, a global data research firm.
Despite many emergency departments reporting a decline in patient volume, 74% of respondents said they were worried about hospital wait times and overcrowding. Another 59% expressed concerns about being turned away from the hospital or doctor’s office.
At the same time, the survey found strong support for emergency physicians and 73% of respondents said they were concerned about overstressing the health care system.
The drop-off in Americans seeking care for MI and strokes nationally prompted eight professional societies – including ACEP, the American Heart Association, and the Association of Black Cardiologists – to issue a joint statement urging those experiencing symptoms to call 911 and seek care for these life-threatening events.
The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Cautionary findings on acquired immunodeficiency from anti-CD20 MS therapy
, Brandi L. Vollmer, MPH, reported online as part of the 2020 American Academy of Neurology Science Highlights.
The hypogammaglobulinemia was preceded by an IgM of 40 mg/dL or less in 35% of cases and was accompanied by concurrent development of low IgM in another 39%, added Ms. Vollmer, a professional research assistant at the Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado, Denver.
She presented a retrospective study of 527 randomly selected MS patients and another 17 with neuromyelitis optica spectrum disorder who averaged 44 years of age and a 9.2-year disease duration upon commencing rituximab (Rituxan) with close laboratory monitoring. Their mean cumulative rituximab dose during a mean 30.2 months of therapy was 3,312 mg. Ninety-six MS patients eventually switched to ocrelizumab (Ocrevus), accumulating a total dose of 1,175 mg of that anti-CD20 humanized monoclonal antibody.
Absolute lymphocyte count dropped to 500 cells/mm3 or lower in 10.4% of patients at a mean of 11.3 months into anti-CD20 therapy. Low immunoglobulins came later: The mean time to onset of low IgM in affected patients was 19.7 months, and hypogammaglobulinemia, as defined by an IgG of 500 mg/dL or less, occurred at a mean of 36.1 months. Higher cumulative doses of anti-CD20 agents were associated with increased likelihood of hypogammaglobulinemia.
Asked to comment on the research findings, neurologist Nida Laurin, MD, said the Colorado study provides helpful insights into the timing of onset of acquired immunodeficiency in patients on B-cell-targeted therapy.
“This paper informs us that we should monitor our patients much closer for signs of hypogammaglobulinemia and lymphopenia starting with year 2 on therapy, and switch treatment when the threshold is reached. I do expect production of gamma globulins and lymphocytes to recover with discontinuation of anti-CD20 therapy, maybe over a period of 6-10 months. It might also recover with lower-dose therapy because the effect on B cells is dose-dependent,” observed Dr. Laurin, an MS specialist at the Banner Health–University Medicine Neuroscience Institute in Phoenix and the University of Arizona in Tucson.
Her colleague Barry Hendin, MD, noted that there is no consensus regarding the best response to all these changes.
“Some clinicians add IVIG, some change therapies, and some observe only,” said Dr. Hendin, a neurologist at Banner Health–University Medical Center, Phoenix, and clinical professor of neurology at the University of Arizona in Tucson.
However, Dr. Laurin asserted that it would be a mistake for physicians and patients to shrug off anti-CD20 therapy–induced lymphopenia in light of studies demonstrating that lymphopenia and older age are two main risk factors for progressive multifocal leukoencephalopathy in patients on disease-modifying therapies.
“More cases of PML can be expected with continuous use of anti-CD20 therapies if lymphopenia is ignored,” she cautioned.
Depressed levels of IgM and IgG have been associated with increased risk of serious infections. In light of the COVID-19 pandemic and the eventual prospect of a vaccine, it is especially important to avoid putting patients with MS in harm’s way via treatment-induced acquired immunodeficiency, Dr. Laurin said.
Ms. Vollmer reported having no financial conflicts regarding her study. Dr. Laurin reported serving as a speaker or consultant for Alexion, Allergan, Biogen, Bristol-Myers Squibb, EMD Serono, Genentech, Lundbeck, and Sanofi Genzyme. Dr. Hendin serves as a consultant to Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Bristol-Myers Squibb.
SOURCE: Vollmer BL et al. AAN 2020. Abstract S29.002.
, Brandi L. Vollmer, MPH, reported online as part of the 2020 American Academy of Neurology Science Highlights.
The hypogammaglobulinemia was preceded by an IgM of 40 mg/dL or less in 35% of cases and was accompanied by concurrent development of low IgM in another 39%, added Ms. Vollmer, a professional research assistant at the Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado, Denver.
She presented a retrospective study of 527 randomly selected MS patients and another 17 with neuromyelitis optica spectrum disorder who averaged 44 years of age and a 9.2-year disease duration upon commencing rituximab (Rituxan) with close laboratory monitoring. Their mean cumulative rituximab dose during a mean 30.2 months of therapy was 3,312 mg. Ninety-six MS patients eventually switched to ocrelizumab (Ocrevus), accumulating a total dose of 1,175 mg of that anti-CD20 humanized monoclonal antibody.
Absolute lymphocyte count dropped to 500 cells/mm3 or lower in 10.4% of patients at a mean of 11.3 months into anti-CD20 therapy. Low immunoglobulins came later: The mean time to onset of low IgM in affected patients was 19.7 months, and hypogammaglobulinemia, as defined by an IgG of 500 mg/dL or less, occurred at a mean of 36.1 months. Higher cumulative doses of anti-CD20 agents were associated with increased likelihood of hypogammaglobulinemia.
Asked to comment on the research findings, neurologist Nida Laurin, MD, said the Colorado study provides helpful insights into the timing of onset of acquired immunodeficiency in patients on B-cell-targeted therapy.
“This paper informs us that we should monitor our patients much closer for signs of hypogammaglobulinemia and lymphopenia starting with year 2 on therapy, and switch treatment when the threshold is reached. I do expect production of gamma globulins and lymphocytes to recover with discontinuation of anti-CD20 therapy, maybe over a period of 6-10 months. It might also recover with lower-dose therapy because the effect on B cells is dose-dependent,” observed Dr. Laurin, an MS specialist at the Banner Health–University Medicine Neuroscience Institute in Phoenix and the University of Arizona in Tucson.
Her colleague Barry Hendin, MD, noted that there is no consensus regarding the best response to all these changes.
“Some clinicians add IVIG, some change therapies, and some observe only,” said Dr. Hendin, a neurologist at Banner Health–University Medical Center, Phoenix, and clinical professor of neurology at the University of Arizona in Tucson.
However, Dr. Laurin asserted that it would be a mistake for physicians and patients to shrug off anti-CD20 therapy–induced lymphopenia in light of studies demonstrating that lymphopenia and older age are two main risk factors for progressive multifocal leukoencephalopathy in patients on disease-modifying therapies.
“More cases of PML can be expected with continuous use of anti-CD20 therapies if lymphopenia is ignored,” she cautioned.
Depressed levels of IgM and IgG have been associated with increased risk of serious infections. In light of the COVID-19 pandemic and the eventual prospect of a vaccine, it is especially important to avoid putting patients with MS in harm’s way via treatment-induced acquired immunodeficiency, Dr. Laurin said.
Ms. Vollmer reported having no financial conflicts regarding her study. Dr. Laurin reported serving as a speaker or consultant for Alexion, Allergan, Biogen, Bristol-Myers Squibb, EMD Serono, Genentech, Lundbeck, and Sanofi Genzyme. Dr. Hendin serves as a consultant to Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Bristol-Myers Squibb.
SOURCE: Vollmer BL et al. AAN 2020. Abstract S29.002.
, Brandi L. Vollmer, MPH, reported online as part of the 2020 American Academy of Neurology Science Highlights.
The hypogammaglobulinemia was preceded by an IgM of 40 mg/dL or less in 35% of cases and was accompanied by concurrent development of low IgM in another 39%, added Ms. Vollmer, a professional research assistant at the Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado, Denver.
She presented a retrospective study of 527 randomly selected MS patients and another 17 with neuromyelitis optica spectrum disorder who averaged 44 years of age and a 9.2-year disease duration upon commencing rituximab (Rituxan) with close laboratory monitoring. Their mean cumulative rituximab dose during a mean 30.2 months of therapy was 3,312 mg. Ninety-six MS patients eventually switched to ocrelizumab (Ocrevus), accumulating a total dose of 1,175 mg of that anti-CD20 humanized monoclonal antibody.
Absolute lymphocyte count dropped to 500 cells/mm3 or lower in 10.4% of patients at a mean of 11.3 months into anti-CD20 therapy. Low immunoglobulins came later: The mean time to onset of low IgM in affected patients was 19.7 months, and hypogammaglobulinemia, as defined by an IgG of 500 mg/dL or less, occurred at a mean of 36.1 months. Higher cumulative doses of anti-CD20 agents were associated with increased likelihood of hypogammaglobulinemia.
Asked to comment on the research findings, neurologist Nida Laurin, MD, said the Colorado study provides helpful insights into the timing of onset of acquired immunodeficiency in patients on B-cell-targeted therapy.
“This paper informs us that we should monitor our patients much closer for signs of hypogammaglobulinemia and lymphopenia starting with year 2 on therapy, and switch treatment when the threshold is reached. I do expect production of gamma globulins and lymphocytes to recover with discontinuation of anti-CD20 therapy, maybe over a period of 6-10 months. It might also recover with lower-dose therapy because the effect on B cells is dose-dependent,” observed Dr. Laurin, an MS specialist at the Banner Health–University Medicine Neuroscience Institute in Phoenix and the University of Arizona in Tucson.
Her colleague Barry Hendin, MD, noted that there is no consensus regarding the best response to all these changes.
“Some clinicians add IVIG, some change therapies, and some observe only,” said Dr. Hendin, a neurologist at Banner Health–University Medical Center, Phoenix, and clinical professor of neurology at the University of Arizona in Tucson.
However, Dr. Laurin asserted that it would be a mistake for physicians and patients to shrug off anti-CD20 therapy–induced lymphopenia in light of studies demonstrating that lymphopenia and older age are two main risk factors for progressive multifocal leukoencephalopathy in patients on disease-modifying therapies.
“More cases of PML can be expected with continuous use of anti-CD20 therapies if lymphopenia is ignored,” she cautioned.
Depressed levels of IgM and IgG have been associated with increased risk of serious infections. In light of the COVID-19 pandemic and the eventual prospect of a vaccine, it is especially important to avoid putting patients with MS in harm’s way via treatment-induced acquired immunodeficiency, Dr. Laurin said.
Ms. Vollmer reported having no financial conflicts regarding her study. Dr. Laurin reported serving as a speaker or consultant for Alexion, Allergan, Biogen, Bristol-Myers Squibb, EMD Serono, Genentech, Lundbeck, and Sanofi Genzyme. Dr. Hendin serves as a consultant to Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Bristol-Myers Squibb.
SOURCE: Vollmer BL et al. AAN 2020. Abstract S29.002.
REPORTING FROM AAN 2020
Five-year siponimod data support early MS treatment
Among and had a lower annualized relapse rate up to 5 years later, compared with patients who initially received placebo and switched to siponimod. This research was presented online as part of the 2020 American Academy of Neurology Science Highlights.
Benefits of siponimod gained during the controlled period were “sustained for up to 5 years, suggesting a continuous effect of siponimod and underlining the advantages of early treatment initiation with siponimod,” the researchers said. Incidence rates of adverse events during the extension study were consistent with those during the controlled treatment period.
The results “highlight the critical importance of early treatment intervention ... to ensure the best possible long-term outcomes for patients with MS who are experiencing progression,” study investigator Bruce Cree, MD, PhD, said in a news release.
“It’s never too early to stay ahead of progression in MS, since the early identification of physical and cognitive changes – even subtle ones – can indicate MS disease progression and therefore allow for timely intervention.” said Dr. Cree, who is clinical research director and George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California, San Francisco.
Siponimod, marketed as Mayzent, is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors. The oral drug was approved by the Food and Drug Administration in 2019 for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults.
To assess the long-term efficacy and safety of siponimod in patients with secondary progressive MS, Dr. Cree and colleagues analyzed data from patients in the controlled and extension parts of the EXPAND trial. Patients could have had been in the study for as long as 5 years at the data cutoff in April 2019. Efficacy analyses included time to 3-month confirmed disability progression on the Expanded Disability Status Scale (EDSS), time to 6-month confirmed disability progression, time to 6-month confirmed worsening of 4 or more points on the Symbol Digit Modalities Test (SDMT), and annualized relapse rate. In EXPAND, the researchers defined confirmed disability progression as a 1-point increase in EDSS if the baseline score was 3.0-5.0, or a 0.5-point increase if the baseline score was 5.5-6.5.
“Of the 1,224 (74% of 1,651 randomized) patients entering the extension, 878 (72%) were ongoing,” the researchers reported. Patients who received siponimod continuously were less likely to experience 3-month confirmed disability progression and 6-month confirmed disability progression, relative to patients who switched from placebo. In addition, patients who received continuous siponimod treatment had a prolonged time to 6-month confirmed disability progression, compared with patients who switched from placebo. For the 25th percentile of patients, continuous siponimod treatment corresponded to a delay of 54% (21 months vs. 13.6 months). Risk of worsening on the SDMT was reduced by 23% in the continuous siponimod–treatment group. For the 25th percentile of patients, this reduced risk corresponded to a delay of 62% (29.6 months vs. 18.3 months). ARR was 0.054 in the continuous-siponimod group, compared with 0.097 in the group that switched to siponimod from placebo, a reduction of 52%.
Dr. Cree has received personal compensation from Novartis, which markets siponimod, as well as Akili, Alexion, Atara, Biogen, EMD Serono, and TG Therapeutics. His coauthors reported receiving research support and personal compensation from Novartis and other pharmaceutical companies. Several coauthors were Novartis employees.
SOURCE: Kappos L et al. AAN 2020, Abstract S40.003.
Among and had a lower annualized relapse rate up to 5 years later, compared with patients who initially received placebo and switched to siponimod. This research was presented online as part of the 2020 American Academy of Neurology Science Highlights.
Benefits of siponimod gained during the controlled period were “sustained for up to 5 years, suggesting a continuous effect of siponimod and underlining the advantages of early treatment initiation with siponimod,” the researchers said. Incidence rates of adverse events during the extension study were consistent with those during the controlled treatment period.
The results “highlight the critical importance of early treatment intervention ... to ensure the best possible long-term outcomes for patients with MS who are experiencing progression,” study investigator Bruce Cree, MD, PhD, said in a news release.
“It’s never too early to stay ahead of progression in MS, since the early identification of physical and cognitive changes – even subtle ones – can indicate MS disease progression and therefore allow for timely intervention.” said Dr. Cree, who is clinical research director and George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California, San Francisco.
Siponimod, marketed as Mayzent, is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors. The oral drug was approved by the Food and Drug Administration in 2019 for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults.
To assess the long-term efficacy and safety of siponimod in patients with secondary progressive MS, Dr. Cree and colleagues analyzed data from patients in the controlled and extension parts of the EXPAND trial. Patients could have had been in the study for as long as 5 years at the data cutoff in April 2019. Efficacy analyses included time to 3-month confirmed disability progression on the Expanded Disability Status Scale (EDSS), time to 6-month confirmed disability progression, time to 6-month confirmed worsening of 4 or more points on the Symbol Digit Modalities Test (SDMT), and annualized relapse rate. In EXPAND, the researchers defined confirmed disability progression as a 1-point increase in EDSS if the baseline score was 3.0-5.0, or a 0.5-point increase if the baseline score was 5.5-6.5.
“Of the 1,224 (74% of 1,651 randomized) patients entering the extension, 878 (72%) were ongoing,” the researchers reported. Patients who received siponimod continuously were less likely to experience 3-month confirmed disability progression and 6-month confirmed disability progression, relative to patients who switched from placebo. In addition, patients who received continuous siponimod treatment had a prolonged time to 6-month confirmed disability progression, compared with patients who switched from placebo. For the 25th percentile of patients, continuous siponimod treatment corresponded to a delay of 54% (21 months vs. 13.6 months). Risk of worsening on the SDMT was reduced by 23% in the continuous siponimod–treatment group. For the 25th percentile of patients, this reduced risk corresponded to a delay of 62% (29.6 months vs. 18.3 months). ARR was 0.054 in the continuous-siponimod group, compared with 0.097 in the group that switched to siponimod from placebo, a reduction of 52%.
Dr. Cree has received personal compensation from Novartis, which markets siponimod, as well as Akili, Alexion, Atara, Biogen, EMD Serono, and TG Therapeutics. His coauthors reported receiving research support and personal compensation from Novartis and other pharmaceutical companies. Several coauthors were Novartis employees.
SOURCE: Kappos L et al. AAN 2020, Abstract S40.003.
Among and had a lower annualized relapse rate up to 5 years later, compared with patients who initially received placebo and switched to siponimod. This research was presented online as part of the 2020 American Academy of Neurology Science Highlights.
Benefits of siponimod gained during the controlled period were “sustained for up to 5 years, suggesting a continuous effect of siponimod and underlining the advantages of early treatment initiation with siponimod,” the researchers said. Incidence rates of adverse events during the extension study were consistent with those during the controlled treatment period.
The results “highlight the critical importance of early treatment intervention ... to ensure the best possible long-term outcomes for patients with MS who are experiencing progression,” study investigator Bruce Cree, MD, PhD, said in a news release.
“It’s never too early to stay ahead of progression in MS, since the early identification of physical and cognitive changes – even subtle ones – can indicate MS disease progression and therefore allow for timely intervention.” said Dr. Cree, who is clinical research director and George A. Zimmermann Endowed Professor in Multiple Sclerosis at the University of California, San Francisco.
Siponimod, marketed as Mayzent, is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors. The oral drug was approved by the Food and Drug Administration in 2019 for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults.
To assess the long-term efficacy and safety of siponimod in patients with secondary progressive MS, Dr. Cree and colleagues analyzed data from patients in the controlled and extension parts of the EXPAND trial. Patients could have had been in the study for as long as 5 years at the data cutoff in April 2019. Efficacy analyses included time to 3-month confirmed disability progression on the Expanded Disability Status Scale (EDSS), time to 6-month confirmed disability progression, time to 6-month confirmed worsening of 4 or more points on the Symbol Digit Modalities Test (SDMT), and annualized relapse rate. In EXPAND, the researchers defined confirmed disability progression as a 1-point increase in EDSS if the baseline score was 3.0-5.0, or a 0.5-point increase if the baseline score was 5.5-6.5.
“Of the 1,224 (74% of 1,651 randomized) patients entering the extension, 878 (72%) were ongoing,” the researchers reported. Patients who received siponimod continuously were less likely to experience 3-month confirmed disability progression and 6-month confirmed disability progression, relative to patients who switched from placebo. In addition, patients who received continuous siponimod treatment had a prolonged time to 6-month confirmed disability progression, compared with patients who switched from placebo. For the 25th percentile of patients, continuous siponimod treatment corresponded to a delay of 54% (21 months vs. 13.6 months). Risk of worsening on the SDMT was reduced by 23% in the continuous siponimod–treatment group. For the 25th percentile of patients, this reduced risk corresponded to a delay of 62% (29.6 months vs. 18.3 months). ARR was 0.054 in the continuous-siponimod group, compared with 0.097 in the group that switched to siponimod from placebo, a reduction of 52%.
Dr. Cree has received personal compensation from Novartis, which markets siponimod, as well as Akili, Alexion, Atara, Biogen, EMD Serono, and TG Therapeutics. His coauthors reported receiving research support and personal compensation from Novartis and other pharmaceutical companies. Several coauthors were Novartis employees.
SOURCE: Kappos L et al. AAN 2020, Abstract S40.003.
FROM AAN 2020
New study of diabetes drug for COVID-19 raises eyebrows
A just-launched study of the type 2 diabetes agent dapagliflozin (Farxiga, AstraZeneca) in patients with mild to moderate COVID-19 is raising eyebrows, given that several expert groups have advised that drugs in this class – the sodium-glucose cotransporter 2 (SGLT2) inhibitors – be stopped in all patients hospitalized with COVID-19 because of the increased risk for diabetic ketoacidosis (DKA).
The randomized, double-blind, placebo-controlled, phase 3 Dapagliflozin in Respiratory Failure in Patients With COVID-19 (DARE-19) study is sponsored by AstraZeneca and Saint Luke’s Mid America Heart Institute.
The trial will assess whether dapagliflozin reduces the risks of disease progression, clinical complications, and death because of COVID-19 in patients with type 2 diabetes, cardiovascular disease, and/or mild to moderate chronic kidney disease (CKD).
“Dapagliflozin has demonstrated cardio- and renal-protective benefits and improved outcomes in high-risk patients with type 2 diabetes, heart failure with reduced ejection fraction, and CKD,” said the principal investigator of DARE-19, Mikhail N. Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo.
And “patients with COVID-19 and underlying cardiometabolic disease appear to be at the highest risk of morbid complications,” he explained in an AstraZeneca statement.
“Through DARE-19, we hope to decrease the severity of illness, and prevent cardiovascular, respiratory, and kidney decompensation, which are common in patients with COVID-19,” Dr. Kosiborod continued.
However, advice to stop SGLT2 inhibitors in patients hospitalized with COVID-19 because of its associated DKA risk has come from several channels.
These include initial guidance from Diabetes UK; experts who spoke during an American Diabetes Association webinar; and most recently, an international panel of diabetes experts.
Some clinicians went so far as to say that they view the trial as potentially dangerous, while others said they could see some logic to it, as long as it is carefully managed.
“A dangerous proposition – a DARE I would not take”
Partha Kar, MD, of Portsmouth Hospitals NHS Trust and national clinical director of diabetes at NHS England, said in an interview: “It’s interesting to see [AstraZeneca] embark on a study with a particular class of drug whereby ... [in] the UK we have said that if you get sent to hospital with COVID-19 you should stop [SGLT2 inhibitors] immediately.”
It “sounds like a risky proposition to go ahead with, [and it] definitely made me raise an eyebrow,” he added.
Nephrologist Bruce R. Leslie, MD, of Seventh Doctor Consulting in Princeton, N.J., agreed with Dr. Kar.
“Giving SGLT2 inhibitors to patients in the DARE-19 study is a dangerous proposition because these drugs can induce ketoacidosis during the stress of acute illness such as COVID-19. ... Moreover, ketoacidosis is associated with hypercoagulability which could be especially dangerous in COVID-19, given that it has been causing thrombophilia with large-vessel occlusive strokes in young patients,” he said in an interview.
“One wonders how these risks were assessed by the authorities that approved the DARE-19 study,” said Dr. Leslie, who formerly worked for Bristol-Myers Squibb.
“How does the sponsor intend to secure informed consent given the risks? This is a DARE I would not take,” he said.
Asked to address these concerns, Dr. Kosiborod said in an interview that “the DARE-19 trial will assess both the efficacy and the safety of dapagliflozin in this patient population in a closely monitored environment of a rigorously designed randomized clinical trial. The trial protocol excludes patients with type 1 diabetes or at high risk for DKA.
“Furthermore, the protocol includes detailed specific instructions to ensure careful monitoring for DKA, including frequent assessments of acid-base status in the hospital setting. The safety data will be closely monitored by an independent data-monitoring committee,” he continued.
Dr. Kosiborod also pointed out that there is “no systematically collected information on the use of dapagliflozin or any other SGLT2 inhibitor in patients being treated for COVID-19, including the associated potential benefits, possible risks such as DKA, and the balance of these potential benefits and risks.”
DARE-19 design: Several outcomes will be examined
The DARE-19 trial is designed to enroll 900 adults with confirmed SARS-CoV-2 infection and oxygen saturation of 94% or greater.
Inclusion criteria include a medical history of hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and/or stage 3-4 CKD. Exclusion criteria include current SGLT2 inhibitor treatment, type 1 diabetes, severe CKD, and severe COVID-19.
Dapagliflozin is approved in the EU for use in some patients with type 1 diabetes; this is not the case in the United States, although SGLT2 inhibitors in general are sometimes used off label in these patients.
Patients in DARE-19 will be randomized to 10 mg/day dapagliflozin or placebo for 30 days, in addition to standard care, in participating hospital. Primary outcomes are time to first occurrence of either death or new or worsened organ dysfunction, including respiratory decompensation, new or worsening heart failure, requirement for vasopressor therapy, ventricular tachycardia, and renal failure.
Secondary outcomes include a composite of time to death from any cause, time to new/worsened organ dysfunction, clinical status at day 30, and time to hospital discharge.
Rationale for the study
Irl B. Hirsch, MD, professor and diabetes treatment and teaching chair at the University of Washington, Seattle, said in an interview that he does see some logic to the trial.
Admitting that he doesn’t know much about “COVID-19 cardiomyopathy” – which would be one of the targets of dapagliflozin – other than it is quite common, he said that this, along with the potential renal benefits of dapagliflozin in the setting of COVID-19, make the study “intriguing.”
“Perhaps there is some rationale to it,” he said. However, “my concern is these sick COVID-19 patients are often acidemic, and besides the very complex acid-base challenges we see with intubated patients, these patients likely have combination lactic and ketoacidemia, the latter at least some from starvation.
“Still, if enough dextrose and insulin are provided to prevent ketoacid accumulation, my guess is it would do at least as well as hydroxychloroquine,” he said.
And Simon Heller, MD, professor of clinical diabetes at the University of Sheffield (England), said in an interview: “I think it is quite a brave study, mainly because of the increased risk of DKA.
“However, on the basis that these patients will be carefully monitored, the risk of DKA shouldn’t be great. I think it is important that patients with type 2 diabetes can participate whenever possible in such trials,” he said.
The estimated completion date for DARE-19 is December 2020.
Dr. Kosiborod has reported receiving grant support, honoraria, and/or research support from AstraZeneca, Boehringer Ingelheim, Sanofi, Amgen, Novo Nordisk, Merck, Eisai, Janssen, Bayer, GlaxoSmithKline, Glytec, Intarcia Therapeutics, Novartis, Applied Therapeutics, Amarin, and Eli Lilly. Dr. Leslie has reported owning stock in Bristol-Myers Squibb, Pfizer, and Lilly. Dr. Hirsch has reported consulting for Abbott Diabetes Care, Roche, and Bigfoot Biomedical, conducting research for Medtronic, and is a diabetes editor for UpToDate. Dr. Heller has received advisory or consultation fees from Lilly, Novo Nordisk, Takeda, MSD, and Becton Dickinson; has served as a speaker for AstraZeneca, Lilly, Novo Nordisk, Boehringer Ingelheim, and Takeda; and has received research support from Medtronic UK. He is on the advisory board for Medscape. Dr. Kar has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A just-launched study of the type 2 diabetes agent dapagliflozin (Farxiga, AstraZeneca) in patients with mild to moderate COVID-19 is raising eyebrows, given that several expert groups have advised that drugs in this class – the sodium-glucose cotransporter 2 (SGLT2) inhibitors – be stopped in all patients hospitalized with COVID-19 because of the increased risk for diabetic ketoacidosis (DKA).
The randomized, double-blind, placebo-controlled, phase 3 Dapagliflozin in Respiratory Failure in Patients With COVID-19 (DARE-19) study is sponsored by AstraZeneca and Saint Luke’s Mid America Heart Institute.
The trial will assess whether dapagliflozin reduces the risks of disease progression, clinical complications, and death because of COVID-19 in patients with type 2 diabetes, cardiovascular disease, and/or mild to moderate chronic kidney disease (CKD).
“Dapagliflozin has demonstrated cardio- and renal-protective benefits and improved outcomes in high-risk patients with type 2 diabetes, heart failure with reduced ejection fraction, and CKD,” said the principal investigator of DARE-19, Mikhail N. Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo.
And “patients with COVID-19 and underlying cardiometabolic disease appear to be at the highest risk of morbid complications,” he explained in an AstraZeneca statement.
“Through DARE-19, we hope to decrease the severity of illness, and prevent cardiovascular, respiratory, and kidney decompensation, which are common in patients with COVID-19,” Dr. Kosiborod continued.
However, advice to stop SGLT2 inhibitors in patients hospitalized with COVID-19 because of its associated DKA risk has come from several channels.
These include initial guidance from Diabetes UK; experts who spoke during an American Diabetes Association webinar; and most recently, an international panel of diabetes experts.
Some clinicians went so far as to say that they view the trial as potentially dangerous, while others said they could see some logic to it, as long as it is carefully managed.
“A dangerous proposition – a DARE I would not take”
Partha Kar, MD, of Portsmouth Hospitals NHS Trust and national clinical director of diabetes at NHS England, said in an interview: “It’s interesting to see [AstraZeneca] embark on a study with a particular class of drug whereby ... [in] the UK we have said that if you get sent to hospital with COVID-19 you should stop [SGLT2 inhibitors] immediately.”
It “sounds like a risky proposition to go ahead with, [and it] definitely made me raise an eyebrow,” he added.
Nephrologist Bruce R. Leslie, MD, of Seventh Doctor Consulting in Princeton, N.J., agreed with Dr. Kar.
“Giving SGLT2 inhibitors to patients in the DARE-19 study is a dangerous proposition because these drugs can induce ketoacidosis during the stress of acute illness such as COVID-19. ... Moreover, ketoacidosis is associated with hypercoagulability which could be especially dangerous in COVID-19, given that it has been causing thrombophilia with large-vessel occlusive strokes in young patients,” he said in an interview.
“One wonders how these risks were assessed by the authorities that approved the DARE-19 study,” said Dr. Leslie, who formerly worked for Bristol-Myers Squibb.
“How does the sponsor intend to secure informed consent given the risks? This is a DARE I would not take,” he said.
Asked to address these concerns, Dr. Kosiborod said in an interview that “the DARE-19 trial will assess both the efficacy and the safety of dapagliflozin in this patient population in a closely monitored environment of a rigorously designed randomized clinical trial. The trial protocol excludes patients with type 1 diabetes or at high risk for DKA.
“Furthermore, the protocol includes detailed specific instructions to ensure careful monitoring for DKA, including frequent assessments of acid-base status in the hospital setting. The safety data will be closely monitored by an independent data-monitoring committee,” he continued.
Dr. Kosiborod also pointed out that there is “no systematically collected information on the use of dapagliflozin or any other SGLT2 inhibitor in patients being treated for COVID-19, including the associated potential benefits, possible risks such as DKA, and the balance of these potential benefits and risks.”
DARE-19 design: Several outcomes will be examined
The DARE-19 trial is designed to enroll 900 adults with confirmed SARS-CoV-2 infection and oxygen saturation of 94% or greater.
Inclusion criteria include a medical history of hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and/or stage 3-4 CKD. Exclusion criteria include current SGLT2 inhibitor treatment, type 1 diabetes, severe CKD, and severe COVID-19.
Dapagliflozin is approved in the EU for use in some patients with type 1 diabetes; this is not the case in the United States, although SGLT2 inhibitors in general are sometimes used off label in these patients.
Patients in DARE-19 will be randomized to 10 mg/day dapagliflozin or placebo for 30 days, in addition to standard care, in participating hospital. Primary outcomes are time to first occurrence of either death or new or worsened organ dysfunction, including respiratory decompensation, new or worsening heart failure, requirement for vasopressor therapy, ventricular tachycardia, and renal failure.
Secondary outcomes include a composite of time to death from any cause, time to new/worsened organ dysfunction, clinical status at day 30, and time to hospital discharge.
Rationale for the study
Irl B. Hirsch, MD, professor and diabetes treatment and teaching chair at the University of Washington, Seattle, said in an interview that he does see some logic to the trial.
Admitting that he doesn’t know much about “COVID-19 cardiomyopathy” – which would be one of the targets of dapagliflozin – other than it is quite common, he said that this, along with the potential renal benefits of dapagliflozin in the setting of COVID-19, make the study “intriguing.”
“Perhaps there is some rationale to it,” he said. However, “my concern is these sick COVID-19 patients are often acidemic, and besides the very complex acid-base challenges we see with intubated patients, these patients likely have combination lactic and ketoacidemia, the latter at least some from starvation.
“Still, if enough dextrose and insulin are provided to prevent ketoacid accumulation, my guess is it would do at least as well as hydroxychloroquine,” he said.
And Simon Heller, MD, professor of clinical diabetes at the University of Sheffield (England), said in an interview: “I think it is quite a brave study, mainly because of the increased risk of DKA.
“However, on the basis that these patients will be carefully monitored, the risk of DKA shouldn’t be great. I think it is important that patients with type 2 diabetes can participate whenever possible in such trials,” he said.
The estimated completion date for DARE-19 is December 2020.
Dr. Kosiborod has reported receiving grant support, honoraria, and/or research support from AstraZeneca, Boehringer Ingelheim, Sanofi, Amgen, Novo Nordisk, Merck, Eisai, Janssen, Bayer, GlaxoSmithKline, Glytec, Intarcia Therapeutics, Novartis, Applied Therapeutics, Amarin, and Eli Lilly. Dr. Leslie has reported owning stock in Bristol-Myers Squibb, Pfizer, and Lilly. Dr. Hirsch has reported consulting for Abbott Diabetes Care, Roche, and Bigfoot Biomedical, conducting research for Medtronic, and is a diabetes editor for UpToDate. Dr. Heller has received advisory or consultation fees from Lilly, Novo Nordisk, Takeda, MSD, and Becton Dickinson; has served as a speaker for AstraZeneca, Lilly, Novo Nordisk, Boehringer Ingelheim, and Takeda; and has received research support from Medtronic UK. He is on the advisory board for Medscape. Dr. Kar has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A just-launched study of the type 2 diabetes agent dapagliflozin (Farxiga, AstraZeneca) in patients with mild to moderate COVID-19 is raising eyebrows, given that several expert groups have advised that drugs in this class – the sodium-glucose cotransporter 2 (SGLT2) inhibitors – be stopped in all patients hospitalized with COVID-19 because of the increased risk for diabetic ketoacidosis (DKA).
The randomized, double-blind, placebo-controlled, phase 3 Dapagliflozin in Respiratory Failure in Patients With COVID-19 (DARE-19) study is sponsored by AstraZeneca and Saint Luke’s Mid America Heart Institute.
The trial will assess whether dapagliflozin reduces the risks of disease progression, clinical complications, and death because of COVID-19 in patients with type 2 diabetes, cardiovascular disease, and/or mild to moderate chronic kidney disease (CKD).
“Dapagliflozin has demonstrated cardio- and renal-protective benefits and improved outcomes in high-risk patients with type 2 diabetes, heart failure with reduced ejection fraction, and CKD,” said the principal investigator of DARE-19, Mikhail N. Kosiborod, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo.
And “patients with COVID-19 and underlying cardiometabolic disease appear to be at the highest risk of morbid complications,” he explained in an AstraZeneca statement.
“Through DARE-19, we hope to decrease the severity of illness, and prevent cardiovascular, respiratory, and kidney decompensation, which are common in patients with COVID-19,” Dr. Kosiborod continued.
However, advice to stop SGLT2 inhibitors in patients hospitalized with COVID-19 because of its associated DKA risk has come from several channels.
These include initial guidance from Diabetes UK; experts who spoke during an American Diabetes Association webinar; and most recently, an international panel of diabetes experts.
Some clinicians went so far as to say that they view the trial as potentially dangerous, while others said they could see some logic to it, as long as it is carefully managed.
“A dangerous proposition – a DARE I would not take”
Partha Kar, MD, of Portsmouth Hospitals NHS Trust and national clinical director of diabetes at NHS England, said in an interview: “It’s interesting to see [AstraZeneca] embark on a study with a particular class of drug whereby ... [in] the UK we have said that if you get sent to hospital with COVID-19 you should stop [SGLT2 inhibitors] immediately.”
It “sounds like a risky proposition to go ahead with, [and it] definitely made me raise an eyebrow,” he added.
Nephrologist Bruce R. Leslie, MD, of Seventh Doctor Consulting in Princeton, N.J., agreed with Dr. Kar.
“Giving SGLT2 inhibitors to patients in the DARE-19 study is a dangerous proposition because these drugs can induce ketoacidosis during the stress of acute illness such as COVID-19. ... Moreover, ketoacidosis is associated with hypercoagulability which could be especially dangerous in COVID-19, given that it has been causing thrombophilia with large-vessel occlusive strokes in young patients,” he said in an interview.
“One wonders how these risks were assessed by the authorities that approved the DARE-19 study,” said Dr. Leslie, who formerly worked for Bristol-Myers Squibb.
“How does the sponsor intend to secure informed consent given the risks? This is a DARE I would not take,” he said.
Asked to address these concerns, Dr. Kosiborod said in an interview that “the DARE-19 trial will assess both the efficacy and the safety of dapagliflozin in this patient population in a closely monitored environment of a rigorously designed randomized clinical trial. The trial protocol excludes patients with type 1 diabetes or at high risk for DKA.
“Furthermore, the protocol includes detailed specific instructions to ensure careful monitoring for DKA, including frequent assessments of acid-base status in the hospital setting. The safety data will be closely monitored by an independent data-monitoring committee,” he continued.
Dr. Kosiborod also pointed out that there is “no systematically collected information on the use of dapagliflozin or any other SGLT2 inhibitor in patients being treated for COVID-19, including the associated potential benefits, possible risks such as DKA, and the balance of these potential benefits and risks.”
DARE-19 design: Several outcomes will be examined
The DARE-19 trial is designed to enroll 900 adults with confirmed SARS-CoV-2 infection and oxygen saturation of 94% or greater.
Inclusion criteria include a medical history of hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and/or stage 3-4 CKD. Exclusion criteria include current SGLT2 inhibitor treatment, type 1 diabetes, severe CKD, and severe COVID-19.
Dapagliflozin is approved in the EU for use in some patients with type 1 diabetes; this is not the case in the United States, although SGLT2 inhibitors in general are sometimes used off label in these patients.
Patients in DARE-19 will be randomized to 10 mg/day dapagliflozin or placebo for 30 days, in addition to standard care, in participating hospital. Primary outcomes are time to first occurrence of either death or new or worsened organ dysfunction, including respiratory decompensation, new or worsening heart failure, requirement for vasopressor therapy, ventricular tachycardia, and renal failure.
Secondary outcomes include a composite of time to death from any cause, time to new/worsened organ dysfunction, clinical status at day 30, and time to hospital discharge.
Rationale for the study
Irl B. Hirsch, MD, professor and diabetes treatment and teaching chair at the University of Washington, Seattle, said in an interview that he does see some logic to the trial.
Admitting that he doesn’t know much about “COVID-19 cardiomyopathy” – which would be one of the targets of dapagliflozin – other than it is quite common, he said that this, along with the potential renal benefits of dapagliflozin in the setting of COVID-19, make the study “intriguing.”
“Perhaps there is some rationale to it,” he said. However, “my concern is these sick COVID-19 patients are often acidemic, and besides the very complex acid-base challenges we see with intubated patients, these patients likely have combination lactic and ketoacidemia, the latter at least some from starvation.
“Still, if enough dextrose and insulin are provided to prevent ketoacid accumulation, my guess is it would do at least as well as hydroxychloroquine,” he said.
And Simon Heller, MD, professor of clinical diabetes at the University of Sheffield (England), said in an interview: “I think it is quite a brave study, mainly because of the increased risk of DKA.
“However, on the basis that these patients will be carefully monitored, the risk of DKA shouldn’t be great. I think it is important that patients with type 2 diabetes can participate whenever possible in such trials,” he said.
The estimated completion date for DARE-19 is December 2020.
Dr. Kosiborod has reported receiving grant support, honoraria, and/or research support from AstraZeneca, Boehringer Ingelheim, Sanofi, Amgen, Novo Nordisk, Merck, Eisai, Janssen, Bayer, GlaxoSmithKline, Glytec, Intarcia Therapeutics, Novartis, Applied Therapeutics, Amarin, and Eli Lilly. Dr. Leslie has reported owning stock in Bristol-Myers Squibb, Pfizer, and Lilly. Dr. Hirsch has reported consulting for Abbott Diabetes Care, Roche, and Bigfoot Biomedical, conducting research for Medtronic, and is a diabetes editor for UpToDate. Dr. Heller has received advisory or consultation fees from Lilly, Novo Nordisk, Takeda, MSD, and Becton Dickinson; has served as a speaker for AstraZeneca, Lilly, Novo Nordisk, Boehringer Ingelheim, and Takeda; and has received research support from Medtronic UK. He is on the advisory board for Medscape. Dr. Kar has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.