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COVID-19 may discourage pediatric flu vaccination
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
FROM PEDIATRICS
Inside the flawed White House testing scheme that did not protect Trump
The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.
The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests.
An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.
Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.
The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials.
The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.
The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.
Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.
Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.
“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”
The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.
However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.
“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.
Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.
At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.
“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.
Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.
He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.
While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.
“I wonder how much virus was floating in that room that night,” Osterholm said.
Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.
Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.
It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”
In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.
“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.
Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.
Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.
“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.
The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests.
An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.
Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.
The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials.
The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.
The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.
Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.
Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.
“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”
The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.
However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.
“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.
Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.
At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.
“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.
Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.
He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.
While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.
“I wonder how much virus was floating in that room that night,” Osterholm said.
Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.
Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.
It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”
In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.
“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.
Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.
Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.
“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.
The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests.
An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.
Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.
The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials.
The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.
The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.
Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.
Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.
“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”
The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.
However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.
“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.
Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.
At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.
“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.
Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.
He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.
While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.
“I wonder how much virus was floating in that room that night,” Osterholm said.
Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.
Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.
It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”
In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.
“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.
Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.
Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.
“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Time to screen for liver disease in type 2 diabetes?
With high rates of fatty liver disease known to occur among people with type 2 diabetes, is it time to introduce routine liver screening into daily diabetes practice? The answer depends on whom you ask, and then there are still some important caveats.
From the hepatologist’s perspective, there is no excuse not to consider liver surveillance now that noninvasive screening methods are available, suggested Michael Trauner, MD, of the Medical University of Vienna.
“From a practical standpoint, I think every type 2 diabetic over 50 years of age is at high risk,” and consequently should be screened at diagnosis, Dr. Trauner said during a debate at the virtual annual meeting of the European Association for the Study of Diabetes. “I would screen at diagnosis and then decide on recall depending on noninvasive fibrosis markers.”
“It’s a rising problem that we are facing these days,” observed Michael Roden, MD, chair and professor of internal medicine, endocrinology and metabolic diseases at Heinrich-Heine University in Düsseldorf, Germany, and who cochaired the session. Not only do people with type 2 diabetes have an increased risk for developing liver diseases, but also there’s a higher risk for those with fatty liver diseases developing type 2 diabetes.
A meta-analysis published in Gut in just last week illustrates just how big a problem this is – nonalcoholic fatty liver disease (NAFLD) “doubled the risk of type 2 diabetes,” said Dr Rosen, who is also the director of the division of endocrinology and diabetology at University Clinics Düsseldorf. That analysis was based on more than 500,000 people, almost 28,000 of whom had incident diabetes over a 5-year period.
Screening tools scarce
This makes liver screening in type 2 diabetes patients “a formidable challenge,” cautioned Gianluca Perseghin, MD, professor of endocrinology at the Monza (Italy) Polyclinic and the University of Milano-Bicocca in Milan.
“Hepatologists generally see only the most severe cases,” Dr. Perseghin said. Diabetologists and endocrinologists would be likely to see huge numbers of patients that could potentially be at risk for liver disease and following the recommendations set out in the joint European Association for the Study of the Liver/EASD/European Association for the Study of Obesity guidelines would result in a huge number of patients being identified and potentially needing referral, he argued.
“At this stage, we need to build friendly, reliable and cost-effective screening process to be applied in the health systems,” Dr. Perseghin suggested. He proposed that liver surveillance would need to be not only personalized on a patient level, but also at the infrastructure level. Measuring liver enzymes, for example, was going to be less accurate in picking up liver disease but blood tests were widely available, whereas imaging methods were not going to be something all diabetes clinics would have immediate access to.
“There are clearly a lot of provocative decisions still to be made,” acknowledged Philip Newsome, PhD, FRCPE, an honorary consultant hepatologist at the University of Birmingham (England) and who cochaired the debate.
“We need to demonstrate that looking for the presence of liver disease in this cohort changes their outcomes in a way that is cost effective,” Dr. Newsome, who is also the secretary general of EASL.
“Tests are evolving, but more importantly, treatments are evolving. So, the decision around cost effectiveness will clearly change,” he added.
NAFLD therapies unclar
“There are still a lot of questions,” Dr. Newsome said during a Novo-Nordisk–sponsored “Meet the Expert” session discussing EASL-EASD-EASO guidelines. “We don’t have any licensed therapies at the moment. But there’s been a huge amount of investment, looking at all sorts of different approaches.”
Dr. Newsome added: “We also don’t know how to monitor these patients. Most of the noninvasive are very useful for staging patients, but we don’t really understand how useful they are for monitoring changes in fibrosis.”
Diabetologist Hannele Yki-Järvinen, MD, PhD, of the University of Helsinki, gave her thoughts on the topic during the same session.
“We should add FIB-4 [Fibrosis-4 index] to the annual exam and ask the lab to calculate FIB-4 automatically,” Dr. Yki-Järvinen said. FIB-4is calculated using the patients age and the results of readily available blood tests that measure the AST/ALT ratio and the platelet count.
Dr. Trauner has received advisory fees and grant support from various companies with an interest in developing liver-directed therapies, and is also a coinventor of 24-norursodeoxycholic acid under development for cholestatic liver disease and potentially NAFLD. Dr. Perseghin has received honoraria and grant support from various pharmaceutical companies with an interest in diabetes care. Dr. Roden did not provide any disclosures. Dr. Newsome has received research grants from Boehringer Ingelheim and Novo Nordisk and acted as a consultant to many pharmaceutical companies. Dr. Yki-Järvinen disclosed receiving consultancy fees from Eli Lilly, MSD, and Novo Nordisk.
SOURCE: Trauner M; Persghin G. EASD 2020, Session S27.
With high rates of fatty liver disease known to occur among people with type 2 diabetes, is it time to introduce routine liver screening into daily diabetes practice? The answer depends on whom you ask, and then there are still some important caveats.
From the hepatologist’s perspective, there is no excuse not to consider liver surveillance now that noninvasive screening methods are available, suggested Michael Trauner, MD, of the Medical University of Vienna.
“From a practical standpoint, I think every type 2 diabetic over 50 years of age is at high risk,” and consequently should be screened at diagnosis, Dr. Trauner said during a debate at the virtual annual meeting of the European Association for the Study of Diabetes. “I would screen at diagnosis and then decide on recall depending on noninvasive fibrosis markers.”
“It’s a rising problem that we are facing these days,” observed Michael Roden, MD, chair and professor of internal medicine, endocrinology and metabolic diseases at Heinrich-Heine University in Düsseldorf, Germany, and who cochaired the session. Not only do people with type 2 diabetes have an increased risk for developing liver diseases, but also there’s a higher risk for those with fatty liver diseases developing type 2 diabetes.
A meta-analysis published in Gut in just last week illustrates just how big a problem this is – nonalcoholic fatty liver disease (NAFLD) “doubled the risk of type 2 diabetes,” said Dr Rosen, who is also the director of the division of endocrinology and diabetology at University Clinics Düsseldorf. That analysis was based on more than 500,000 people, almost 28,000 of whom had incident diabetes over a 5-year period.
Screening tools scarce
This makes liver screening in type 2 diabetes patients “a formidable challenge,” cautioned Gianluca Perseghin, MD, professor of endocrinology at the Monza (Italy) Polyclinic and the University of Milano-Bicocca in Milan.
“Hepatologists generally see only the most severe cases,” Dr. Perseghin said. Diabetologists and endocrinologists would be likely to see huge numbers of patients that could potentially be at risk for liver disease and following the recommendations set out in the joint European Association for the Study of the Liver/EASD/European Association for the Study of Obesity guidelines would result in a huge number of patients being identified and potentially needing referral, he argued.
“At this stage, we need to build friendly, reliable and cost-effective screening process to be applied in the health systems,” Dr. Perseghin suggested. He proposed that liver surveillance would need to be not only personalized on a patient level, but also at the infrastructure level. Measuring liver enzymes, for example, was going to be less accurate in picking up liver disease but blood tests were widely available, whereas imaging methods were not going to be something all diabetes clinics would have immediate access to.
“There are clearly a lot of provocative decisions still to be made,” acknowledged Philip Newsome, PhD, FRCPE, an honorary consultant hepatologist at the University of Birmingham (England) and who cochaired the debate.
“We need to demonstrate that looking for the presence of liver disease in this cohort changes their outcomes in a way that is cost effective,” Dr. Newsome, who is also the secretary general of EASL.
“Tests are evolving, but more importantly, treatments are evolving. So, the decision around cost effectiveness will clearly change,” he added.
NAFLD therapies unclar
“There are still a lot of questions,” Dr. Newsome said during a Novo-Nordisk–sponsored “Meet the Expert” session discussing EASL-EASD-EASO guidelines. “We don’t have any licensed therapies at the moment. But there’s been a huge amount of investment, looking at all sorts of different approaches.”
Dr. Newsome added: “We also don’t know how to monitor these patients. Most of the noninvasive are very useful for staging patients, but we don’t really understand how useful they are for monitoring changes in fibrosis.”
Diabetologist Hannele Yki-Järvinen, MD, PhD, of the University of Helsinki, gave her thoughts on the topic during the same session.
“We should add FIB-4 [Fibrosis-4 index] to the annual exam and ask the lab to calculate FIB-4 automatically,” Dr. Yki-Järvinen said. FIB-4is calculated using the patients age and the results of readily available blood tests that measure the AST/ALT ratio and the platelet count.
Dr. Trauner has received advisory fees and grant support from various companies with an interest in developing liver-directed therapies, and is also a coinventor of 24-norursodeoxycholic acid under development for cholestatic liver disease and potentially NAFLD. Dr. Perseghin has received honoraria and grant support from various pharmaceutical companies with an interest in diabetes care. Dr. Roden did not provide any disclosures. Dr. Newsome has received research grants from Boehringer Ingelheim and Novo Nordisk and acted as a consultant to many pharmaceutical companies. Dr. Yki-Järvinen disclosed receiving consultancy fees from Eli Lilly, MSD, and Novo Nordisk.
SOURCE: Trauner M; Persghin G. EASD 2020, Session S27.
With high rates of fatty liver disease known to occur among people with type 2 diabetes, is it time to introduce routine liver screening into daily diabetes practice? The answer depends on whom you ask, and then there are still some important caveats.
From the hepatologist’s perspective, there is no excuse not to consider liver surveillance now that noninvasive screening methods are available, suggested Michael Trauner, MD, of the Medical University of Vienna.
“From a practical standpoint, I think every type 2 diabetic over 50 years of age is at high risk,” and consequently should be screened at diagnosis, Dr. Trauner said during a debate at the virtual annual meeting of the European Association for the Study of Diabetes. “I would screen at diagnosis and then decide on recall depending on noninvasive fibrosis markers.”
“It’s a rising problem that we are facing these days,” observed Michael Roden, MD, chair and professor of internal medicine, endocrinology and metabolic diseases at Heinrich-Heine University in Düsseldorf, Germany, and who cochaired the session. Not only do people with type 2 diabetes have an increased risk for developing liver diseases, but also there’s a higher risk for those with fatty liver diseases developing type 2 diabetes.
A meta-analysis published in Gut in just last week illustrates just how big a problem this is – nonalcoholic fatty liver disease (NAFLD) “doubled the risk of type 2 diabetes,” said Dr Rosen, who is also the director of the division of endocrinology and diabetology at University Clinics Düsseldorf. That analysis was based on more than 500,000 people, almost 28,000 of whom had incident diabetes over a 5-year period.
Screening tools scarce
This makes liver screening in type 2 diabetes patients “a formidable challenge,” cautioned Gianluca Perseghin, MD, professor of endocrinology at the Monza (Italy) Polyclinic and the University of Milano-Bicocca in Milan.
“Hepatologists generally see only the most severe cases,” Dr. Perseghin said. Diabetologists and endocrinologists would be likely to see huge numbers of patients that could potentially be at risk for liver disease and following the recommendations set out in the joint European Association for the Study of the Liver/EASD/European Association for the Study of Obesity guidelines would result in a huge number of patients being identified and potentially needing referral, he argued.
“At this stage, we need to build friendly, reliable and cost-effective screening process to be applied in the health systems,” Dr. Perseghin suggested. He proposed that liver surveillance would need to be not only personalized on a patient level, but also at the infrastructure level. Measuring liver enzymes, for example, was going to be less accurate in picking up liver disease but blood tests were widely available, whereas imaging methods were not going to be something all diabetes clinics would have immediate access to.
“There are clearly a lot of provocative decisions still to be made,” acknowledged Philip Newsome, PhD, FRCPE, an honorary consultant hepatologist at the University of Birmingham (England) and who cochaired the debate.
“We need to demonstrate that looking for the presence of liver disease in this cohort changes their outcomes in a way that is cost effective,” Dr. Newsome, who is also the secretary general of EASL.
“Tests are evolving, but more importantly, treatments are evolving. So, the decision around cost effectiveness will clearly change,” he added.
NAFLD therapies unclar
“There are still a lot of questions,” Dr. Newsome said during a Novo-Nordisk–sponsored “Meet the Expert” session discussing EASL-EASD-EASO guidelines. “We don’t have any licensed therapies at the moment. But there’s been a huge amount of investment, looking at all sorts of different approaches.”
Dr. Newsome added: “We also don’t know how to monitor these patients. Most of the noninvasive are very useful for staging patients, but we don’t really understand how useful they are for monitoring changes in fibrosis.”
Diabetologist Hannele Yki-Järvinen, MD, PhD, of the University of Helsinki, gave her thoughts on the topic during the same session.
“We should add FIB-4 [Fibrosis-4 index] to the annual exam and ask the lab to calculate FIB-4 automatically,” Dr. Yki-Järvinen said. FIB-4is calculated using the patients age and the results of readily available blood tests that measure the AST/ALT ratio and the platelet count.
Dr. Trauner has received advisory fees and grant support from various companies with an interest in developing liver-directed therapies, and is also a coinventor of 24-norursodeoxycholic acid under development for cholestatic liver disease and potentially NAFLD. Dr. Perseghin has received honoraria and grant support from various pharmaceutical companies with an interest in diabetes care. Dr. Roden did not provide any disclosures. Dr. Newsome has received research grants from Boehringer Ingelheim and Novo Nordisk and acted as a consultant to many pharmaceutical companies. Dr. Yki-Järvinen disclosed receiving consultancy fees from Eli Lilly, MSD, and Novo Nordisk.
SOURCE: Trauner M; Persghin G. EASD 2020, Session S27.
REPORTING FROM EASD 2020
Dapagliflozin’s CKD performance sends heart failure messages
The DAPA-CKD trial results, which proved dapagliflozin’s efficacy for slowing chronic kidney disease progression in patients selected for signs of worsening renal function, also have important messages for cardiologists, especially heart failure physicians.
Those messages include findings that were “consistent” with the results of the earlier DAPA-HF trial, which tested the same sodium-glucose transporter 2 (SGLT2) inhibitor in patients selected for having heart failure with reduced ejection fraction (HFrEF). In addition, a specific action of dapagliflozin (Farxiga) on the patients in DAPA-CKD, which enrolled patients based on markers of chronic kidney disease (CKD), was prevention of first and recurrent heart failure hospitalizations, John J.V. McMurray, MD, said at the virtual annual scientific meeting of the Heart Failure Society of America, further highlighting the role that dapagliflozin has in reducing both heart failure and renal events.
What DAPA-CKD means for heart failure
The main findings from the DAPA-CKD trial, published in September in the New England Journal of Medicine, included as a secondary outcome the combined rate of death from cardiovascular causes or hospitalization for heart failure (HHF). Treatment with dapagliflozin linked with a significant 29% relative reduction in this endpoint, compared with placebo-treated patients. At the HFSA meeting, Dr. McMurray reported for the first time the specific HHF numbers, a prespecified secondary endpoint for the study.
Patients on dapagliflozin had 37 total HHF events (1.7%), including both first-time and subsequent hospitalizations, while patients in the placebo arm had a total of 71 HHF events (3.3%) during the study’s median 2.4 years of follow-up, an absolute reduction of 1.6% that translated into a relative risk reduction of 49%.
The HHF findings from DAPA-CKD importantly showed that SGLT2 inhibition in patients with signs of renal dysfunction “will not only slow progression of kidney disease but will also reduce the risk of developing heart failure, crucially in patients with or without type 2 diabetes,” explained Dr. McMurray in an interview. “Cardiologists often consult in the kidney wards and advise on management of patients with chronic kidney disease, even those without heart failure.”
The DAPA-CKD findings carry another important message for heart failure management regarding the minimum level of renal function a patient can have and still safely receive dapagliflozin or possibly another agent from the same SGLT2 inhibitor class. In DAPA-CKD, patients safely received dapagliflozin with an estimated glomerular filtration rate (eGFR) as low as 25 mL/min per 1.73 m2; 14% of enrolled patients had an eGFR of 25-29 mL/min per 1.73 m2.
“Typically, about 40%-50% of patients with heart failure have chronic kidney disease,” which makes this safety finding important to clinicians who care for heart failure patients, but it’s also important for any patient who might be a candidate for dapagliflozin or another drug from its class. “We had no strong evidence before this trial that SGLT2 inhibition could reduce hard renal endpoints,” specifically need for chronic dialysis, renal transplant, or renal death, “in patients with or without diabetes,” Dr. McMurray said.
DAPA-CKD grows the pool of eligible heart failure patients
A further consequence of the DAPA-CKD findings is that when, as expected, regulatory bodies give dapagliflozin an indication for treating the types of CKD patients enrolled in the trial, it will functionally expand this treatment to an even larger swath of heart failure patients who currently don’t qualify for this treatment, specifically patients with CKD who also have heart failure with preserved ejection fraction (HFpEF). On Oct. 2, 2020, the Food and Drug Administration fast-tracked dapagliflozin for the CKD indication by granting it Breakthrough Therapy Designation based on the DAPA-CKD results.
Results first reported in 2019 from the DAPA-HF trial led to dapagliflozin receiving a labeled indication for treating HFrEF, the types of heart failure patients enrolled in the trial. Direct evidence on the efficacy of SGLT2 inhibitors for patients with HFpEF will not be available until results from a few trials now in progress become available during the next 12 months.
In the meantime, nearly half of patients with HFpEF also have CKD, noted Dr. McMurray, and another large portion of HFpEF patients have type 2 diabetes and hence qualify for SGLT2 inhibitor treatment that way. “Obviously, we would like to know specifically about heart failure outcomes in patients with HFpEF” on SGLT2 inhibitor treatment, he acknowledged. But the recent approval of dapagliflozin for patients with HFrEF and the likely indication coming soon for treating CKD means that the number of patients with heart failure who are not eligible for SGLT2 inhibitor treatment is dwindling down to some extent.
New DAPA-HF results show no drug, device interactions
In a separate session at the HFSA virtual meeting, Dr. McMurray and several collaborators on the DAPA-HF trial presented results from some new analyses. Dr. McMurray looked at the impact of dapagliflozin treatment on the primary endpoint when patients were stratified by the diuretic dosage they received at study entry. The results showed that “the benefits from dapagliflozin were irrespective of the use of background diuretic therapy or the diuretic dose,” he reported. Study findings also showed that roughly three-quarters of patients in the study had no change in their diuretic dosage during the course of the trial, that the fraction of patients who had an increase in their dosage was about the same as those whose diuretic dosage decreased, and that this pattern was similar in both the patients on dapagliflozin and in those randomized to placebo.
Another set of new analyses from DAPA-HF looked at the impact on dapagliflozin efficacy of background medical and device therapies for heart failure, as well as background diabetes therapies. The findings showed no signal of an interaction with background therapies. “The effects of dapagliflozin are incremental and complimentary to conventional therapies for HFrEF,” concluded Lars Kober, MD, a professor and heart failure physician at Copenhagen University Hospital.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. McMurray’s employer, Glasgow University, has received payments from AstraZeneca and several other companies to compensate for his time overseeing various clinical trials. Dr. Kober has received honoraria for speaking on behalf of several companies including AstraZeneca.
The DAPA-CKD trial results, which proved dapagliflozin’s efficacy for slowing chronic kidney disease progression in patients selected for signs of worsening renal function, also have important messages for cardiologists, especially heart failure physicians.
Those messages include findings that were “consistent” with the results of the earlier DAPA-HF trial, which tested the same sodium-glucose transporter 2 (SGLT2) inhibitor in patients selected for having heart failure with reduced ejection fraction (HFrEF). In addition, a specific action of dapagliflozin (Farxiga) on the patients in DAPA-CKD, which enrolled patients based on markers of chronic kidney disease (CKD), was prevention of first and recurrent heart failure hospitalizations, John J.V. McMurray, MD, said at the virtual annual scientific meeting of the Heart Failure Society of America, further highlighting the role that dapagliflozin has in reducing both heart failure and renal events.
What DAPA-CKD means for heart failure
The main findings from the DAPA-CKD trial, published in September in the New England Journal of Medicine, included as a secondary outcome the combined rate of death from cardiovascular causes or hospitalization for heart failure (HHF). Treatment with dapagliflozin linked with a significant 29% relative reduction in this endpoint, compared with placebo-treated patients. At the HFSA meeting, Dr. McMurray reported for the first time the specific HHF numbers, a prespecified secondary endpoint for the study.
Patients on dapagliflozin had 37 total HHF events (1.7%), including both first-time and subsequent hospitalizations, while patients in the placebo arm had a total of 71 HHF events (3.3%) during the study’s median 2.4 years of follow-up, an absolute reduction of 1.6% that translated into a relative risk reduction of 49%.
The HHF findings from DAPA-CKD importantly showed that SGLT2 inhibition in patients with signs of renal dysfunction “will not only slow progression of kidney disease but will also reduce the risk of developing heart failure, crucially in patients with or without type 2 diabetes,” explained Dr. McMurray in an interview. “Cardiologists often consult in the kidney wards and advise on management of patients with chronic kidney disease, even those without heart failure.”
The DAPA-CKD findings carry another important message for heart failure management regarding the minimum level of renal function a patient can have and still safely receive dapagliflozin or possibly another agent from the same SGLT2 inhibitor class. In DAPA-CKD, patients safely received dapagliflozin with an estimated glomerular filtration rate (eGFR) as low as 25 mL/min per 1.73 m2; 14% of enrolled patients had an eGFR of 25-29 mL/min per 1.73 m2.
“Typically, about 40%-50% of patients with heart failure have chronic kidney disease,” which makes this safety finding important to clinicians who care for heart failure patients, but it’s also important for any patient who might be a candidate for dapagliflozin or another drug from its class. “We had no strong evidence before this trial that SGLT2 inhibition could reduce hard renal endpoints,” specifically need for chronic dialysis, renal transplant, or renal death, “in patients with or without diabetes,” Dr. McMurray said.
DAPA-CKD grows the pool of eligible heart failure patients
A further consequence of the DAPA-CKD findings is that when, as expected, regulatory bodies give dapagliflozin an indication for treating the types of CKD patients enrolled in the trial, it will functionally expand this treatment to an even larger swath of heart failure patients who currently don’t qualify for this treatment, specifically patients with CKD who also have heart failure with preserved ejection fraction (HFpEF). On Oct. 2, 2020, the Food and Drug Administration fast-tracked dapagliflozin for the CKD indication by granting it Breakthrough Therapy Designation based on the DAPA-CKD results.
Results first reported in 2019 from the DAPA-HF trial led to dapagliflozin receiving a labeled indication for treating HFrEF, the types of heart failure patients enrolled in the trial. Direct evidence on the efficacy of SGLT2 inhibitors for patients with HFpEF will not be available until results from a few trials now in progress become available during the next 12 months.
In the meantime, nearly half of patients with HFpEF also have CKD, noted Dr. McMurray, and another large portion of HFpEF patients have type 2 diabetes and hence qualify for SGLT2 inhibitor treatment that way. “Obviously, we would like to know specifically about heart failure outcomes in patients with HFpEF” on SGLT2 inhibitor treatment, he acknowledged. But the recent approval of dapagliflozin for patients with HFrEF and the likely indication coming soon for treating CKD means that the number of patients with heart failure who are not eligible for SGLT2 inhibitor treatment is dwindling down to some extent.
New DAPA-HF results show no drug, device interactions
In a separate session at the HFSA virtual meeting, Dr. McMurray and several collaborators on the DAPA-HF trial presented results from some new analyses. Dr. McMurray looked at the impact of dapagliflozin treatment on the primary endpoint when patients were stratified by the diuretic dosage they received at study entry. The results showed that “the benefits from dapagliflozin were irrespective of the use of background diuretic therapy or the diuretic dose,” he reported. Study findings also showed that roughly three-quarters of patients in the study had no change in their diuretic dosage during the course of the trial, that the fraction of patients who had an increase in their dosage was about the same as those whose diuretic dosage decreased, and that this pattern was similar in both the patients on dapagliflozin and in those randomized to placebo.
Another set of new analyses from DAPA-HF looked at the impact on dapagliflozin efficacy of background medical and device therapies for heart failure, as well as background diabetes therapies. The findings showed no signal of an interaction with background therapies. “The effects of dapagliflozin are incremental and complimentary to conventional therapies for HFrEF,” concluded Lars Kober, MD, a professor and heart failure physician at Copenhagen University Hospital.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. McMurray’s employer, Glasgow University, has received payments from AstraZeneca and several other companies to compensate for his time overseeing various clinical trials. Dr. Kober has received honoraria for speaking on behalf of several companies including AstraZeneca.
The DAPA-CKD trial results, which proved dapagliflozin’s efficacy for slowing chronic kidney disease progression in patients selected for signs of worsening renal function, also have important messages for cardiologists, especially heart failure physicians.
Those messages include findings that were “consistent” with the results of the earlier DAPA-HF trial, which tested the same sodium-glucose transporter 2 (SGLT2) inhibitor in patients selected for having heart failure with reduced ejection fraction (HFrEF). In addition, a specific action of dapagliflozin (Farxiga) on the patients in DAPA-CKD, which enrolled patients based on markers of chronic kidney disease (CKD), was prevention of first and recurrent heart failure hospitalizations, John J.V. McMurray, MD, said at the virtual annual scientific meeting of the Heart Failure Society of America, further highlighting the role that dapagliflozin has in reducing both heart failure and renal events.
What DAPA-CKD means for heart failure
The main findings from the DAPA-CKD trial, published in September in the New England Journal of Medicine, included as a secondary outcome the combined rate of death from cardiovascular causes or hospitalization for heart failure (HHF). Treatment with dapagliflozin linked with a significant 29% relative reduction in this endpoint, compared with placebo-treated patients. At the HFSA meeting, Dr. McMurray reported for the first time the specific HHF numbers, a prespecified secondary endpoint for the study.
Patients on dapagliflozin had 37 total HHF events (1.7%), including both first-time and subsequent hospitalizations, while patients in the placebo arm had a total of 71 HHF events (3.3%) during the study’s median 2.4 years of follow-up, an absolute reduction of 1.6% that translated into a relative risk reduction of 49%.
The HHF findings from DAPA-CKD importantly showed that SGLT2 inhibition in patients with signs of renal dysfunction “will not only slow progression of kidney disease but will also reduce the risk of developing heart failure, crucially in patients with or without type 2 diabetes,” explained Dr. McMurray in an interview. “Cardiologists often consult in the kidney wards and advise on management of patients with chronic kidney disease, even those without heart failure.”
The DAPA-CKD findings carry another important message for heart failure management regarding the minimum level of renal function a patient can have and still safely receive dapagliflozin or possibly another agent from the same SGLT2 inhibitor class. In DAPA-CKD, patients safely received dapagliflozin with an estimated glomerular filtration rate (eGFR) as low as 25 mL/min per 1.73 m2; 14% of enrolled patients had an eGFR of 25-29 mL/min per 1.73 m2.
“Typically, about 40%-50% of patients with heart failure have chronic kidney disease,” which makes this safety finding important to clinicians who care for heart failure patients, but it’s also important for any patient who might be a candidate for dapagliflozin or another drug from its class. “We had no strong evidence before this trial that SGLT2 inhibition could reduce hard renal endpoints,” specifically need for chronic dialysis, renal transplant, or renal death, “in patients with or without diabetes,” Dr. McMurray said.
DAPA-CKD grows the pool of eligible heart failure patients
A further consequence of the DAPA-CKD findings is that when, as expected, regulatory bodies give dapagliflozin an indication for treating the types of CKD patients enrolled in the trial, it will functionally expand this treatment to an even larger swath of heart failure patients who currently don’t qualify for this treatment, specifically patients with CKD who also have heart failure with preserved ejection fraction (HFpEF). On Oct. 2, 2020, the Food and Drug Administration fast-tracked dapagliflozin for the CKD indication by granting it Breakthrough Therapy Designation based on the DAPA-CKD results.
Results first reported in 2019 from the DAPA-HF trial led to dapagliflozin receiving a labeled indication for treating HFrEF, the types of heart failure patients enrolled in the trial. Direct evidence on the efficacy of SGLT2 inhibitors for patients with HFpEF will not be available until results from a few trials now in progress become available during the next 12 months.
In the meantime, nearly half of patients with HFpEF also have CKD, noted Dr. McMurray, and another large portion of HFpEF patients have type 2 diabetes and hence qualify for SGLT2 inhibitor treatment that way. “Obviously, we would like to know specifically about heart failure outcomes in patients with HFpEF” on SGLT2 inhibitor treatment, he acknowledged. But the recent approval of dapagliflozin for patients with HFrEF and the likely indication coming soon for treating CKD means that the number of patients with heart failure who are not eligible for SGLT2 inhibitor treatment is dwindling down to some extent.
New DAPA-HF results show no drug, device interactions
In a separate session at the HFSA virtual meeting, Dr. McMurray and several collaborators on the DAPA-HF trial presented results from some new analyses. Dr. McMurray looked at the impact of dapagliflozin treatment on the primary endpoint when patients were stratified by the diuretic dosage they received at study entry. The results showed that “the benefits from dapagliflozin were irrespective of the use of background diuretic therapy or the diuretic dose,” he reported. Study findings also showed that roughly three-quarters of patients in the study had no change in their diuretic dosage during the course of the trial, that the fraction of patients who had an increase in their dosage was about the same as those whose diuretic dosage decreased, and that this pattern was similar in both the patients on dapagliflozin and in those randomized to placebo.
Another set of new analyses from DAPA-HF looked at the impact on dapagliflozin efficacy of background medical and device therapies for heart failure, as well as background diabetes therapies. The findings showed no signal of an interaction with background therapies. “The effects of dapagliflozin are incremental and complimentary to conventional therapies for HFrEF,” concluded Lars Kober, MD, a professor and heart failure physician at Copenhagen University Hospital.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. McMurray’s employer, Glasgow University, has received payments from AstraZeneca and several other companies to compensate for his time overseeing various clinical trials. Dr. Kober has received honoraria for speaking on behalf of several companies including AstraZeneca.
FROM HFSA 2020
‘Celebration’ will be ‘short-lived’ if COVID vaccine rushed: Experts
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
Screening algorithm safely selects patients for OSA treatment before bariatric surgery
A novel algorithm for selecting patients who require treatment for obstructive sleep apnea (OSA) before undergoing bariatric surgery proved safe in a prospective cohort study of 1,103 patients.
Screening for OSA is recommended before bariatric surgery. OSA has been associated in several meta-analyses with increased risk for postoperative complications – not limited to bariatric surgery – and some studies have suggested that this increased risk may be limited to severe OSA, said Frédéric Series, MD, of Université Laval, Quebec City, at the virtual annual meeting of the Associated Sleep Societies.
The preoperative screening algorithm, which utilizes the results of nocturnal home oximetry and morning capillary gas measurements, effectively stratified patients for the risk of postoperative adverse events and “safely selected patients who don’t need [continuous positive airway pressure] before bariatric surgery,” he said. “The risk of postoperative adverse events following bariatric surgery was not increased in untreated OSA patients with low or moderate risk of severe OSA and hypoventilation.”
The study also demonstrated, he said, that patients with severe OSA with or without hypoventilation, even when correctly treated, remain at higher risk for complications.
The algorithm utilizes an oxygen desaturation index (ODI) corresponding to 3% drops in SaO2 and the percent of the total recording time with an SaO2 below 90%, as well as capillary gas measurements (PCO2). Treatment was initiated for those with severe OSA (ODI ≥ 25/hr, < 10% of recording time with a SaO2 below 90%) or OSA with hypoventilation (PCO2 ≥ 45).
“When the ODI was less than 25 per hour, and when the total recording time spent below 90% SaO2 was less than 10%, with PCO2 < 45 mmHg, we expected no need for CPAP treatment,” Dr. Series said. For analysis, the investigators considered part of the untreated group – those with an ODI < 10/hr (no or mild OSA) – as a control group.
Treated patients underwent CPAP/BiPAP for a mean duration of 1.5 months. Good treatment compliance was mandatory for surgery, and treatment was continued immediately after extubation, in the recovery room, in nearly all patients, Dr. Series reported.
The analysis covered 1,103 patients: 447 controls (40.8%), 358 untreated (32.7%), 289 treated for OSA (26.4%) and 9 (0.8%) treated for OSA + hypoventilation. Patients with OSA, particularly those with severe OSA and those with hypoventilation, were older and heavier and significantly more likely to have hypertension and diabetes than controls.
There were no differences between the four groups in 10-day reoperation or 30-day readmission occurrence, and postoperative complications were “particularly infrequent in the control and OSA-untreated groups, with no differences between these two groups,” Dr. Series said.
Cardiac arrhythmia (mainly atrial fibrillation) occurred more frequently in the OSA-treated group (2.4%) and the OSA/hypoventilation patients (11%) than in the other groups (0.5%-0.6%).
Respiratory failure occurred in about one-third of patients with hypoventilation, and admission to the ICU was “dramatically higher” in patients with hypoventilation (67%), because of respiratory failure, arrhythmia, or other unstable medical conditions, Dr. Series said.
There were no differences between the groups in the duration of surgery or the amount of anesthetic used, but the length of stay in the recovery room was significantly longer in the OSA-treated and hypoventilation groups. The length of hospital stay was also longer in these groups. Sleeve gastrectomy was the most frequent bariatric surgical procedure across all groups, including 100% of patients with hypoventilation, he noted.
Asked to comment on the study, Octavian C. Ioachimescu, MD, PhD, of Emory University in Atlanta and the Atlanta Veterans Affairs Medical Center in Decatur, said the algorithm “clearly deserves further validation in other clinical-based cohorts and longer-term outcome assessment.”
Dr. Series reported that he has no relevant disclosures. Dr. Ioachimescu also said he has no relevant disclosures.
A novel algorithm for selecting patients who require treatment for obstructive sleep apnea (OSA) before undergoing bariatric surgery proved safe in a prospective cohort study of 1,103 patients.
Screening for OSA is recommended before bariatric surgery. OSA has been associated in several meta-analyses with increased risk for postoperative complications – not limited to bariatric surgery – and some studies have suggested that this increased risk may be limited to severe OSA, said Frédéric Series, MD, of Université Laval, Quebec City, at the virtual annual meeting of the Associated Sleep Societies.
The preoperative screening algorithm, which utilizes the results of nocturnal home oximetry and morning capillary gas measurements, effectively stratified patients for the risk of postoperative adverse events and “safely selected patients who don’t need [continuous positive airway pressure] before bariatric surgery,” he said. “The risk of postoperative adverse events following bariatric surgery was not increased in untreated OSA patients with low or moderate risk of severe OSA and hypoventilation.”
The study also demonstrated, he said, that patients with severe OSA with or without hypoventilation, even when correctly treated, remain at higher risk for complications.
The algorithm utilizes an oxygen desaturation index (ODI) corresponding to 3% drops in SaO2 and the percent of the total recording time with an SaO2 below 90%, as well as capillary gas measurements (PCO2). Treatment was initiated for those with severe OSA (ODI ≥ 25/hr, < 10% of recording time with a SaO2 below 90%) or OSA with hypoventilation (PCO2 ≥ 45).
“When the ODI was less than 25 per hour, and when the total recording time spent below 90% SaO2 was less than 10%, with PCO2 < 45 mmHg, we expected no need for CPAP treatment,” Dr. Series said. For analysis, the investigators considered part of the untreated group – those with an ODI < 10/hr (no or mild OSA) – as a control group.
Treated patients underwent CPAP/BiPAP for a mean duration of 1.5 months. Good treatment compliance was mandatory for surgery, and treatment was continued immediately after extubation, in the recovery room, in nearly all patients, Dr. Series reported.
The analysis covered 1,103 patients: 447 controls (40.8%), 358 untreated (32.7%), 289 treated for OSA (26.4%) and 9 (0.8%) treated for OSA + hypoventilation. Patients with OSA, particularly those with severe OSA and those with hypoventilation, were older and heavier and significantly more likely to have hypertension and diabetes than controls.
There were no differences between the four groups in 10-day reoperation or 30-day readmission occurrence, and postoperative complications were “particularly infrequent in the control and OSA-untreated groups, with no differences between these two groups,” Dr. Series said.
Cardiac arrhythmia (mainly atrial fibrillation) occurred more frequently in the OSA-treated group (2.4%) and the OSA/hypoventilation patients (11%) than in the other groups (0.5%-0.6%).
Respiratory failure occurred in about one-third of patients with hypoventilation, and admission to the ICU was “dramatically higher” in patients with hypoventilation (67%), because of respiratory failure, arrhythmia, or other unstable medical conditions, Dr. Series said.
There were no differences between the groups in the duration of surgery or the amount of anesthetic used, but the length of stay in the recovery room was significantly longer in the OSA-treated and hypoventilation groups. The length of hospital stay was also longer in these groups. Sleeve gastrectomy was the most frequent bariatric surgical procedure across all groups, including 100% of patients with hypoventilation, he noted.
Asked to comment on the study, Octavian C. Ioachimescu, MD, PhD, of Emory University in Atlanta and the Atlanta Veterans Affairs Medical Center in Decatur, said the algorithm “clearly deserves further validation in other clinical-based cohorts and longer-term outcome assessment.”
Dr. Series reported that he has no relevant disclosures. Dr. Ioachimescu also said he has no relevant disclosures.
A novel algorithm for selecting patients who require treatment for obstructive sleep apnea (OSA) before undergoing bariatric surgery proved safe in a prospective cohort study of 1,103 patients.
Screening for OSA is recommended before bariatric surgery. OSA has been associated in several meta-analyses with increased risk for postoperative complications – not limited to bariatric surgery – and some studies have suggested that this increased risk may be limited to severe OSA, said Frédéric Series, MD, of Université Laval, Quebec City, at the virtual annual meeting of the Associated Sleep Societies.
The preoperative screening algorithm, which utilizes the results of nocturnal home oximetry and morning capillary gas measurements, effectively stratified patients for the risk of postoperative adverse events and “safely selected patients who don’t need [continuous positive airway pressure] before bariatric surgery,” he said. “The risk of postoperative adverse events following bariatric surgery was not increased in untreated OSA patients with low or moderate risk of severe OSA and hypoventilation.”
The study also demonstrated, he said, that patients with severe OSA with or without hypoventilation, even when correctly treated, remain at higher risk for complications.
The algorithm utilizes an oxygen desaturation index (ODI) corresponding to 3% drops in SaO2 and the percent of the total recording time with an SaO2 below 90%, as well as capillary gas measurements (PCO2). Treatment was initiated for those with severe OSA (ODI ≥ 25/hr, < 10% of recording time with a SaO2 below 90%) or OSA with hypoventilation (PCO2 ≥ 45).
“When the ODI was less than 25 per hour, and when the total recording time spent below 90% SaO2 was less than 10%, with PCO2 < 45 mmHg, we expected no need for CPAP treatment,” Dr. Series said. For analysis, the investigators considered part of the untreated group – those with an ODI < 10/hr (no or mild OSA) – as a control group.
Treated patients underwent CPAP/BiPAP for a mean duration of 1.5 months. Good treatment compliance was mandatory for surgery, and treatment was continued immediately after extubation, in the recovery room, in nearly all patients, Dr. Series reported.
The analysis covered 1,103 patients: 447 controls (40.8%), 358 untreated (32.7%), 289 treated for OSA (26.4%) and 9 (0.8%) treated for OSA + hypoventilation. Patients with OSA, particularly those with severe OSA and those with hypoventilation, were older and heavier and significantly more likely to have hypertension and diabetes than controls.
There were no differences between the four groups in 10-day reoperation or 30-day readmission occurrence, and postoperative complications were “particularly infrequent in the control and OSA-untreated groups, with no differences between these two groups,” Dr. Series said.
Cardiac arrhythmia (mainly atrial fibrillation) occurred more frequently in the OSA-treated group (2.4%) and the OSA/hypoventilation patients (11%) than in the other groups (0.5%-0.6%).
Respiratory failure occurred in about one-third of patients with hypoventilation, and admission to the ICU was “dramatically higher” in patients with hypoventilation (67%), because of respiratory failure, arrhythmia, or other unstable medical conditions, Dr. Series said.
There were no differences between the groups in the duration of surgery or the amount of anesthetic used, but the length of stay in the recovery room was significantly longer in the OSA-treated and hypoventilation groups. The length of hospital stay was also longer in these groups. Sleeve gastrectomy was the most frequent bariatric surgical procedure across all groups, including 100% of patients with hypoventilation, he noted.
Asked to comment on the study, Octavian C. Ioachimescu, MD, PhD, of Emory University in Atlanta and the Atlanta Veterans Affairs Medical Center in Decatur, said the algorithm “clearly deserves further validation in other clinical-based cohorts and longer-term outcome assessment.”
Dr. Series reported that he has no relevant disclosures. Dr. Ioachimescu also said he has no relevant disclosures.
REPORTING FROM SLEEP 2020
Nerve damage linked to prone positioning in COVID-19
A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.
“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.
The article was published online Sept. 4 in the British Journal of Anaesthesiology.
Unique type of nerve injury
Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.
“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.
With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.
Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”
Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.
The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.
The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
A major contributor
Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”
“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.
“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.
The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.
“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.
Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.
Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.
Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.
“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.
The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
Irreversible damage?
Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”
Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”
The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.
“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.
The article was published online Sept. 4 in the British Journal of Anaesthesiology.
Unique type of nerve injury
Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.
“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.
With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.
Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”
Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.
The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.
The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
A major contributor
Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”
“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.
“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.
The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.
“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.
Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.
Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.
Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.
“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.
The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
Irreversible damage?
Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”
Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”
The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.
“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.
The article was published online Sept. 4 in the British Journal of Anaesthesiology.
Unique type of nerve injury
Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.
“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.
With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.
Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”
Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.
The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.
The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
A major contributor
Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”
“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.
“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.
The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.
“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.
Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.
Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.
Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.
“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.
The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
Irreversible damage?
Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”
Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”
The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM THE BRITISH JOURNAL OF ANAESTHESIOLOGY
British protocol allows insulin-treated pilots to fly safely
A protocol developed in the United Kingdom that allows commercial pilots with insulin-treated diabetes to fly airplanes has resulted in precise glycemic control during flight and no safety issues, new research finds.
The results are believed to be the largest-ever dataset for people with insulin-treated diabetes in “safety-critical” occupations, said Gillian L. Garden, MD, who presented the findings this week at the virtual annual meeting of the European Association for the Study of Diabetes.
The protocol, which involves multiple glucose measurements before and throughout flights and corrective action for out-of-range values, resulted in 98% of glucose values in target range with no pilot incapacitation. The results were also published in Diabetes Care earlier this year, noted Dr. Garden, a clinical fellow in diabetes and endocrinology at the Royal Surrey NHS Foundation Trust, Guildford, England.
“There were no safety concerns at all and certainly no episodes of pilot incapacitation throughout the [7.5] years of the study. Our study proves that the protocol is feasible, is practical to implement, and is easily understood by both pilots and copilots,” she observed.
Dr. Garden foresees wider use of this approach: “We believe the study is of international importance and this protocol could be adopted by other aviation authorities to allow more insulin-treated pilots worldwide to be able to fly commercial aircraft.”
“With proper oversight and a defined protocol such as the one that we’ve been working to produce it is possible for anybody with insulin-treated diabetes to, in fact, adequately perform other safety-critical occupations as well, and it would be good to see fewer people being discriminated against on the basis of their diabetes,” she emphasized.
‘Impressive’ study of highly motivated individuals
Historically, insulin-treated patients – with both types of diabetes – had been barred from many “safety-critical” occupations, including commercial airline piloting. This was out of concern both for the potential immediate effects of hypoglycemia, including cognitive impairment and slowing of reaction times, as well as the long-term effects of diabetes, including vision loss and nerve damage, Dr. Garden explained.
However, “with advances in diabetes management, including different insulin types, methods of delivery, and glucose-monitoring systems, it’s now possible for individuals to have excellent glycemic control. This, along with the implementation of legislation against discrimination, has allowed insulin-treated people to no longer be debarred from certain employments,” she explained during an EASD press briefing on Sept. 24.
An expert panel convened in 2010 by the U.K. Civil Aviation Authority developed the protocol, and in 2012, the CAA began issuing class 1 medical certificates to insulin-treated pilots. The protocol was subsequently adopted by Ireland in 2015 and by Austria in 2016.
Initial results from nearly 9,000 glucose readings of 26 U.K. pilots who received a certificate between 2012 and 2015 were reported at the EASD 2016 Annual Meeting and published in 2017.
The current study is far larger, with 38,621 glucose readings from 49 pilots from the United Kingdom, Ireland, and Austria who have been using the protocol since 2012.
Mark Evans, MD, of Addenbrookes Hospital, Cambridge, England, said in an interview that “I thought this was a fascinating paper. ... I was deeply impressed by the data.”
Dr. Evans, who chairs the U.K. Department of Transport advisory panel on driving and diabetes, also noted: “The group of people with insulin-treated diabetes flying planes are a phenomenally motivated group who are prepared to do things that probably most drivers of motor vehicles would find oppressive or very difficult to do.”
“I thought the outcomes were really impressive in terms of the amount of time they were able to maintain themselves within glucose target ranges.”
Indeed, Dr. Garden said, “pilots are typically very organized and used to dealing with strict protocols with regard to all of the processes they have to follow before they fly and the safety checks they have to do. They adapted to this additional safety measure really well.”
Traffic light protocol keeps pilots in range
The protocol requires pilots to perform fingerstick glucose checks 30 minutes prior to flight, every hour during flight, and 30 minutes before landing. They must also attend clinical reviews every 6 months.
A traffic light system is used to denote acceptable pre- and in-flight glucose levels, with green meaning acceptable (5.0-15.0 mmol/L [90-270 mg/dL]), amber indicating caution for low (4.0-4.9 mmol/L [72-88 mg/dL]) or high (15.1-20.0 mmol/L [272-360 mg/dL]) blood glucose. Red requires immediate action (low blood glucose <4 mmol/L [72 mg/dL] and high >20 mmol/L [>360 mg/dL]).
Low amber values require the pilot to ingest 10-15 fast-acting carbohydrates and retest after 30 minutes. Low red values indicate the pilot must hand over the controls to the copilot. High readings of >15.0 mmol/L (>270 mg/dL) require an insulin dosing review. A high red value also requires the pilot to hand over the controls.
Of the 49 pilots, 84% had type 1 diabetes and 16% had insulin-treated type 2 diabetes. Most (61%) had class 1 medical certificates (required to validate a commercial pilot license) and 39% had class 2 medical certificates (required to validate a private pilot’s license). Median diabetes duration was 10.9 years.
Of note, all had become pilots prior to diabetes onset. As of now, the EU Aviation Safety Agency doesn’t allow people with preexisting insulin-treated diabetes to become pilots.
“We are fighting to change that, but with the U.K. leaving the EU, the Civil Aviation Authority might pursue it [separately]. We don’t know how that will pan out,” Dr. Garden noted during the briefing.
Over the 7.5 years, 97.7% of readings were within the green range, while just 1.42% were in the low amber range and 0.75% in the high amber range. Just 48 readings (0.12%) were in the low red range and 6 (0.02%) in the high red range. Of the 48 low reds, just 14 were recorded during flight. Of the six high reds, only two occurred during flight.
There were no instances of pilot incapacitation or changes in average hemoglobin A1c.
The results should alleviate concerns expressed after a prior report that pilots’ overall glycemic control could worsen if they pushed too hard to avoid lows, Dr. Garden noted.
The proportion of out-of-range values declined from 5.7% in 2013 to 1.2% in 2019. Low red values didn’t change (0.2% in 2013 and 0.1% in 2019) but high red values had completely disappeared by 2017.
What about CGM?
In response to a question during the briefing about use of continuous glucose monitoring, Dr. Garden said that some of the pilots were using CGM in addition to following the fingerstick protocol.
At the time the protocol was developed a decade ago, CGM wasn’t considered accurate enough and there wasn’t evidence for its use at high altitude.
But there has been a great deal more data since then, she said, noting “we believe it would be safer to use now because of how good that equipment is. ... Certainly, there’s a good number [of pilots] using CGM, and hopefully that will increase and the protocol will change to allow them all to use CGM if they want to.
“I think we’ll probably see CGM in the protocol within the next year to 2 years. Hopefully, that will make things a lot easier, so pilots won’t have to prick their fingers while they’re flying.”
Her group is currently conducting a study (DEXFLY) on use of the Dexcom G6 in addition to fingersticks in commercial pilots with insulin-treated diabetes. Results are expected by the end of the year.
Dr. Evans commented: “I think it’s a no-brainer that CGM will become the gold standard. I understand why they’re going to want to be cautious about this, but if they can generate data to show it will be a low-risk change, I think it will come.”
He also noted that it was only a couple of years ago that U.K. law was changed to allow car drivers with insulin-treated diabetes to use CGM as part of their glucose-testing requirements (before driving and every 2 hours). CGM still isn’t approved for use by drivers of trucks or other large vehicles, but “I think at some point in the future it will become more accepted,” Dr. Evans commented.
Dr. Garden reported no relevant financial relationships. Dr. Evans has reported being an advisory board member of, speaker for, and/or grant recipient from Novo Nordisk, Dexcom, Medtronic, Abbott, Eli Lilly, and Roche.
A version of this article originally appeared on Medscape.com.
A protocol developed in the United Kingdom that allows commercial pilots with insulin-treated diabetes to fly airplanes has resulted in precise glycemic control during flight and no safety issues, new research finds.
The results are believed to be the largest-ever dataset for people with insulin-treated diabetes in “safety-critical” occupations, said Gillian L. Garden, MD, who presented the findings this week at the virtual annual meeting of the European Association for the Study of Diabetes.
The protocol, which involves multiple glucose measurements before and throughout flights and corrective action for out-of-range values, resulted in 98% of glucose values in target range with no pilot incapacitation. The results were also published in Diabetes Care earlier this year, noted Dr. Garden, a clinical fellow in diabetes and endocrinology at the Royal Surrey NHS Foundation Trust, Guildford, England.
“There were no safety concerns at all and certainly no episodes of pilot incapacitation throughout the [7.5] years of the study. Our study proves that the protocol is feasible, is practical to implement, and is easily understood by both pilots and copilots,” she observed.
Dr. Garden foresees wider use of this approach: “We believe the study is of international importance and this protocol could be adopted by other aviation authorities to allow more insulin-treated pilots worldwide to be able to fly commercial aircraft.”
“With proper oversight and a defined protocol such as the one that we’ve been working to produce it is possible for anybody with insulin-treated diabetes to, in fact, adequately perform other safety-critical occupations as well, and it would be good to see fewer people being discriminated against on the basis of their diabetes,” she emphasized.
‘Impressive’ study of highly motivated individuals
Historically, insulin-treated patients – with both types of diabetes – had been barred from many “safety-critical” occupations, including commercial airline piloting. This was out of concern both for the potential immediate effects of hypoglycemia, including cognitive impairment and slowing of reaction times, as well as the long-term effects of diabetes, including vision loss and nerve damage, Dr. Garden explained.
However, “with advances in diabetes management, including different insulin types, methods of delivery, and glucose-monitoring systems, it’s now possible for individuals to have excellent glycemic control. This, along with the implementation of legislation against discrimination, has allowed insulin-treated people to no longer be debarred from certain employments,” she explained during an EASD press briefing on Sept. 24.
An expert panel convened in 2010 by the U.K. Civil Aviation Authority developed the protocol, and in 2012, the CAA began issuing class 1 medical certificates to insulin-treated pilots. The protocol was subsequently adopted by Ireland in 2015 and by Austria in 2016.
Initial results from nearly 9,000 glucose readings of 26 U.K. pilots who received a certificate between 2012 and 2015 were reported at the EASD 2016 Annual Meeting and published in 2017.
The current study is far larger, with 38,621 glucose readings from 49 pilots from the United Kingdom, Ireland, and Austria who have been using the protocol since 2012.
Mark Evans, MD, of Addenbrookes Hospital, Cambridge, England, said in an interview that “I thought this was a fascinating paper. ... I was deeply impressed by the data.”
Dr. Evans, who chairs the U.K. Department of Transport advisory panel on driving and diabetes, also noted: “The group of people with insulin-treated diabetes flying planes are a phenomenally motivated group who are prepared to do things that probably most drivers of motor vehicles would find oppressive or very difficult to do.”
“I thought the outcomes were really impressive in terms of the amount of time they were able to maintain themselves within glucose target ranges.”
Indeed, Dr. Garden said, “pilots are typically very organized and used to dealing with strict protocols with regard to all of the processes they have to follow before they fly and the safety checks they have to do. They adapted to this additional safety measure really well.”
Traffic light protocol keeps pilots in range
The protocol requires pilots to perform fingerstick glucose checks 30 minutes prior to flight, every hour during flight, and 30 minutes before landing. They must also attend clinical reviews every 6 months.
A traffic light system is used to denote acceptable pre- and in-flight glucose levels, with green meaning acceptable (5.0-15.0 mmol/L [90-270 mg/dL]), amber indicating caution for low (4.0-4.9 mmol/L [72-88 mg/dL]) or high (15.1-20.0 mmol/L [272-360 mg/dL]) blood glucose. Red requires immediate action (low blood glucose <4 mmol/L [72 mg/dL] and high >20 mmol/L [>360 mg/dL]).
Low amber values require the pilot to ingest 10-15 fast-acting carbohydrates and retest after 30 minutes. Low red values indicate the pilot must hand over the controls to the copilot. High readings of >15.0 mmol/L (>270 mg/dL) require an insulin dosing review. A high red value also requires the pilot to hand over the controls.
Of the 49 pilots, 84% had type 1 diabetes and 16% had insulin-treated type 2 diabetes. Most (61%) had class 1 medical certificates (required to validate a commercial pilot license) and 39% had class 2 medical certificates (required to validate a private pilot’s license). Median diabetes duration was 10.9 years.
Of note, all had become pilots prior to diabetes onset. As of now, the EU Aviation Safety Agency doesn’t allow people with preexisting insulin-treated diabetes to become pilots.
“We are fighting to change that, but with the U.K. leaving the EU, the Civil Aviation Authority might pursue it [separately]. We don’t know how that will pan out,” Dr. Garden noted during the briefing.
Over the 7.5 years, 97.7% of readings were within the green range, while just 1.42% were in the low amber range and 0.75% in the high amber range. Just 48 readings (0.12%) were in the low red range and 6 (0.02%) in the high red range. Of the 48 low reds, just 14 were recorded during flight. Of the six high reds, only two occurred during flight.
There were no instances of pilot incapacitation or changes in average hemoglobin A1c.
The results should alleviate concerns expressed after a prior report that pilots’ overall glycemic control could worsen if they pushed too hard to avoid lows, Dr. Garden noted.
The proportion of out-of-range values declined from 5.7% in 2013 to 1.2% in 2019. Low red values didn’t change (0.2% in 2013 and 0.1% in 2019) but high red values had completely disappeared by 2017.
What about CGM?
In response to a question during the briefing about use of continuous glucose monitoring, Dr. Garden said that some of the pilots were using CGM in addition to following the fingerstick protocol.
At the time the protocol was developed a decade ago, CGM wasn’t considered accurate enough and there wasn’t evidence for its use at high altitude.
But there has been a great deal more data since then, she said, noting “we believe it would be safer to use now because of how good that equipment is. ... Certainly, there’s a good number [of pilots] using CGM, and hopefully that will increase and the protocol will change to allow them all to use CGM if they want to.
“I think we’ll probably see CGM in the protocol within the next year to 2 years. Hopefully, that will make things a lot easier, so pilots won’t have to prick their fingers while they’re flying.”
Her group is currently conducting a study (DEXFLY) on use of the Dexcom G6 in addition to fingersticks in commercial pilots with insulin-treated diabetes. Results are expected by the end of the year.
Dr. Evans commented: “I think it’s a no-brainer that CGM will become the gold standard. I understand why they’re going to want to be cautious about this, but if they can generate data to show it will be a low-risk change, I think it will come.”
He also noted that it was only a couple of years ago that U.K. law was changed to allow car drivers with insulin-treated diabetes to use CGM as part of their glucose-testing requirements (before driving and every 2 hours). CGM still isn’t approved for use by drivers of trucks or other large vehicles, but “I think at some point in the future it will become more accepted,” Dr. Evans commented.
Dr. Garden reported no relevant financial relationships. Dr. Evans has reported being an advisory board member of, speaker for, and/or grant recipient from Novo Nordisk, Dexcom, Medtronic, Abbott, Eli Lilly, and Roche.
A version of this article originally appeared on Medscape.com.
A protocol developed in the United Kingdom that allows commercial pilots with insulin-treated diabetes to fly airplanes has resulted in precise glycemic control during flight and no safety issues, new research finds.
The results are believed to be the largest-ever dataset for people with insulin-treated diabetes in “safety-critical” occupations, said Gillian L. Garden, MD, who presented the findings this week at the virtual annual meeting of the European Association for the Study of Diabetes.
The protocol, which involves multiple glucose measurements before and throughout flights and corrective action for out-of-range values, resulted in 98% of glucose values in target range with no pilot incapacitation. The results were also published in Diabetes Care earlier this year, noted Dr. Garden, a clinical fellow in diabetes and endocrinology at the Royal Surrey NHS Foundation Trust, Guildford, England.
“There were no safety concerns at all and certainly no episodes of pilot incapacitation throughout the [7.5] years of the study. Our study proves that the protocol is feasible, is practical to implement, and is easily understood by both pilots and copilots,” she observed.
Dr. Garden foresees wider use of this approach: “We believe the study is of international importance and this protocol could be adopted by other aviation authorities to allow more insulin-treated pilots worldwide to be able to fly commercial aircraft.”
“With proper oversight and a defined protocol such as the one that we’ve been working to produce it is possible for anybody with insulin-treated diabetes to, in fact, adequately perform other safety-critical occupations as well, and it would be good to see fewer people being discriminated against on the basis of their diabetes,” she emphasized.
‘Impressive’ study of highly motivated individuals
Historically, insulin-treated patients – with both types of diabetes – had been barred from many “safety-critical” occupations, including commercial airline piloting. This was out of concern both for the potential immediate effects of hypoglycemia, including cognitive impairment and slowing of reaction times, as well as the long-term effects of diabetes, including vision loss and nerve damage, Dr. Garden explained.
However, “with advances in diabetes management, including different insulin types, methods of delivery, and glucose-monitoring systems, it’s now possible for individuals to have excellent glycemic control. This, along with the implementation of legislation against discrimination, has allowed insulin-treated people to no longer be debarred from certain employments,” she explained during an EASD press briefing on Sept. 24.
An expert panel convened in 2010 by the U.K. Civil Aviation Authority developed the protocol, and in 2012, the CAA began issuing class 1 medical certificates to insulin-treated pilots. The protocol was subsequently adopted by Ireland in 2015 and by Austria in 2016.
Initial results from nearly 9,000 glucose readings of 26 U.K. pilots who received a certificate between 2012 and 2015 were reported at the EASD 2016 Annual Meeting and published in 2017.
The current study is far larger, with 38,621 glucose readings from 49 pilots from the United Kingdom, Ireland, and Austria who have been using the protocol since 2012.
Mark Evans, MD, of Addenbrookes Hospital, Cambridge, England, said in an interview that “I thought this was a fascinating paper. ... I was deeply impressed by the data.”
Dr. Evans, who chairs the U.K. Department of Transport advisory panel on driving and diabetes, also noted: “The group of people with insulin-treated diabetes flying planes are a phenomenally motivated group who are prepared to do things that probably most drivers of motor vehicles would find oppressive or very difficult to do.”
“I thought the outcomes were really impressive in terms of the amount of time they were able to maintain themselves within glucose target ranges.”
Indeed, Dr. Garden said, “pilots are typically very organized and used to dealing with strict protocols with regard to all of the processes they have to follow before they fly and the safety checks they have to do. They adapted to this additional safety measure really well.”
Traffic light protocol keeps pilots in range
The protocol requires pilots to perform fingerstick glucose checks 30 minutes prior to flight, every hour during flight, and 30 minutes before landing. They must also attend clinical reviews every 6 months.
A traffic light system is used to denote acceptable pre- and in-flight glucose levels, with green meaning acceptable (5.0-15.0 mmol/L [90-270 mg/dL]), amber indicating caution for low (4.0-4.9 mmol/L [72-88 mg/dL]) or high (15.1-20.0 mmol/L [272-360 mg/dL]) blood glucose. Red requires immediate action (low blood glucose <4 mmol/L [72 mg/dL] and high >20 mmol/L [>360 mg/dL]).
Low amber values require the pilot to ingest 10-15 fast-acting carbohydrates and retest after 30 minutes. Low red values indicate the pilot must hand over the controls to the copilot. High readings of >15.0 mmol/L (>270 mg/dL) require an insulin dosing review. A high red value also requires the pilot to hand over the controls.
Of the 49 pilots, 84% had type 1 diabetes and 16% had insulin-treated type 2 diabetes. Most (61%) had class 1 medical certificates (required to validate a commercial pilot license) and 39% had class 2 medical certificates (required to validate a private pilot’s license). Median diabetes duration was 10.9 years.
Of note, all had become pilots prior to diabetes onset. As of now, the EU Aviation Safety Agency doesn’t allow people with preexisting insulin-treated diabetes to become pilots.
“We are fighting to change that, but with the U.K. leaving the EU, the Civil Aviation Authority might pursue it [separately]. We don’t know how that will pan out,” Dr. Garden noted during the briefing.
Over the 7.5 years, 97.7% of readings were within the green range, while just 1.42% were in the low amber range and 0.75% in the high amber range. Just 48 readings (0.12%) were in the low red range and 6 (0.02%) in the high red range. Of the 48 low reds, just 14 were recorded during flight. Of the six high reds, only two occurred during flight.
There were no instances of pilot incapacitation or changes in average hemoglobin A1c.
The results should alleviate concerns expressed after a prior report that pilots’ overall glycemic control could worsen if they pushed too hard to avoid lows, Dr. Garden noted.
The proportion of out-of-range values declined from 5.7% in 2013 to 1.2% in 2019. Low red values didn’t change (0.2% in 2013 and 0.1% in 2019) but high red values had completely disappeared by 2017.
What about CGM?
In response to a question during the briefing about use of continuous glucose monitoring, Dr. Garden said that some of the pilots were using CGM in addition to following the fingerstick protocol.
At the time the protocol was developed a decade ago, CGM wasn’t considered accurate enough and there wasn’t evidence for its use at high altitude.
But there has been a great deal more data since then, she said, noting “we believe it would be safer to use now because of how good that equipment is. ... Certainly, there’s a good number [of pilots] using CGM, and hopefully that will increase and the protocol will change to allow them all to use CGM if they want to.
“I think we’ll probably see CGM in the protocol within the next year to 2 years. Hopefully, that will make things a lot easier, so pilots won’t have to prick their fingers while they’re flying.”
Her group is currently conducting a study (DEXFLY) on use of the Dexcom G6 in addition to fingersticks in commercial pilots with insulin-treated diabetes. Results are expected by the end of the year.
Dr. Evans commented: “I think it’s a no-brainer that CGM will become the gold standard. I understand why they’re going to want to be cautious about this, but if they can generate data to show it will be a low-risk change, I think it will come.”
He also noted that it was only a couple of years ago that U.K. law was changed to allow car drivers with insulin-treated diabetes to use CGM as part of their glucose-testing requirements (before driving and every 2 hours). CGM still isn’t approved for use by drivers of trucks or other large vehicles, but “I think at some point in the future it will become more accepted,” Dr. Evans commented.
Dr. Garden reported no relevant financial relationships. Dr. Evans has reported being an advisory board member of, speaker for, and/or grant recipient from Novo Nordisk, Dexcom, Medtronic, Abbott, Eli Lilly, and Roche.
A version of this article originally appeared on Medscape.com.
FROM EASD 2020
Trump signs Medicare loan relief bill delaying repayments
President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.
In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.
Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.
Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.
For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
New terms
The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.
More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.
In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
This article first appeared on Medscape.com.
President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.
In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.
Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.
Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.
For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
New terms
The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.
More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.
In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
This article first appeared on Medscape.com.
President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.
In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.
Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.
Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.
For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
New terms
The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.
More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.
In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
This article first appeared on Medscape.com.
AHA scientific statement highlights cardiorenal benefit of new diabetes drugs
To protect the heart and kidneys, sodium-glucose transporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) receptor agonists should be considered for people with type 2 diabetes and chronic kidney disease (CKD), the American Heart Association advised in a new scientific statement.
Taken together, the results of relevant clinical trials indicate that SGLT2 inhibitors and GLP-1 receptor agonists safely and significantly reduce the risk for cardiovascular (CV) events, death, and the slow progression of CKD to end-stage kidney disease, including the risks for dialysis, transplantation, and death, the writing group says.
The scientific statement was published online Sept. 28 in Circulation.
“There has been rapid reporting of high-quality data in the cardio-renal-metabolic space with significant heart and kidney benefits, particularly with these two newer classes of antihyperglycemic agents,” Janani Rangaswami, MD, who chaired the writing group, said in an interview.
“More recent data show benefits in chronic kidney disease and heart failure even in patients without diabetes,” said Dr. Rangaswami, Einstein Medical Center and Sidney Kimmel Medical College, both in Philadelphia.
“These data are practice-changing in both cardiology and nephrology, and usher in a new era of disease-modifying therapies in heart and kidney disease,” Dr. Rangaswami added.
Recommendations at a glance
- Provide early and ongoing assessment of risks for CVD and CKD to patients who may benefit from SGLT2 inhibitors of GLP-1 receptor agonists.
- Tailor medication choices that meet the needs of individual patients. Realize that, given “consistent class-wide effects,” the choice of a specific SGLT2 inhibitor or GLP-1 receptor agonist may be dictated by affordability, coverage, and formulary considerations.
- Adjust all medications in tandem with these medicines and consider the burden of polypharmacy, which is common among people with type 2 diabetes. Adjust concomitant therapies and deprescribe where possible.
- Identify risks for hypoglycemia and educate patients on the signs so they can seek treatment quickly.
- Monitor and control high blood pressure.
- Counsel patients about the risks for and symptoms of euglycemic diabetic ketoacidosis when taking SGLT2 inhibitors, as well as classic DKA, which can be fatal.
- Regularly screen and counsel patients about foot care to prevent foot ulcers or blisters that can quickly become infected and lead to amputation.
The writing group identified two additional patient subgroups that may benefit from SGLT2 inhibitors and GLP-1 receptor agonists: those with heart failure with reduced ejection fraction with or without diabetes; and those with CKD who do not have diabetes. They say more data are anticipated to validate the use of SGLT2 inhibitors and GLP-1 receptor agonists in these “at-risk” patients.
Collaborative care model
The writing group proposed a collaborative care model, bridging cardiologists, nephrologists, endocrinologists, and primary care physicians, to help facilitate the “prompt and appropriate” integration of these new classes of medications in the management of patients with type 2 diabetes and CKD.
There is “an unmet need for a cardio-renal-metabolic care model that incorporates best practices in the real world to help align these therapies, especially with vulnerable high-risk patients with cardiorenal disease, and to overcome barriers toward uptake of these agents. Hopefully this statement provides some guidance to the cardiology and nephrology communities in that area,” Dr. Rangaswami said in an interview.
But old habits die hard, as research continues to show the slow adoption of these newer medications in the real world.
For example, a large observational study published last year showed a “striking” discordance between evidence-based, guideline-recommended use of SGLT2 inhibitors for the treatment of type 2 diabetes and their actual uptake in clinical practice.
Paradoxically, patients with CVD, heart failure, hypertension, CKD, and those at risk for hypoglycemia were less apt to receive an SGLT2 inhibitor than other patients.
“The relatively slow uptake of these agents is multifactorial,” Dr. Rangaswami said. “Cardiologists and nephrologists may suffer from some level of ‘therapeutic inertia’ when using new agents they are unfamiliar with and originally branded as ‘antidiabetic’ agents, with the perception of these agents being outside the scope of their practice.”
Two other factors are also at play. “The current health care system is based on ‘specialty silos,’ where specialists tend to stick to the traditional scope of their specialty and are reluctant to view these agents as part of their therapeutic armamentarium. Finally, insurance coverage barriers and affordability also limit the use on a widespread basis,” Dr. Rangaswami said.
A version of this article originally appeared on Medscape.com .
To protect the heart and kidneys, sodium-glucose transporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) receptor agonists should be considered for people with type 2 diabetes and chronic kidney disease (CKD), the American Heart Association advised in a new scientific statement.
Taken together, the results of relevant clinical trials indicate that SGLT2 inhibitors and GLP-1 receptor agonists safely and significantly reduce the risk for cardiovascular (CV) events, death, and the slow progression of CKD to end-stage kidney disease, including the risks for dialysis, transplantation, and death, the writing group says.
The scientific statement was published online Sept. 28 in Circulation.
“There has been rapid reporting of high-quality data in the cardio-renal-metabolic space with significant heart and kidney benefits, particularly with these two newer classes of antihyperglycemic agents,” Janani Rangaswami, MD, who chaired the writing group, said in an interview.
“More recent data show benefits in chronic kidney disease and heart failure even in patients without diabetes,” said Dr. Rangaswami, Einstein Medical Center and Sidney Kimmel Medical College, both in Philadelphia.
“These data are practice-changing in both cardiology and nephrology, and usher in a new era of disease-modifying therapies in heart and kidney disease,” Dr. Rangaswami added.
Recommendations at a glance
- Provide early and ongoing assessment of risks for CVD and CKD to patients who may benefit from SGLT2 inhibitors of GLP-1 receptor agonists.
- Tailor medication choices that meet the needs of individual patients. Realize that, given “consistent class-wide effects,” the choice of a specific SGLT2 inhibitor or GLP-1 receptor agonist may be dictated by affordability, coverage, and formulary considerations.
- Adjust all medications in tandem with these medicines and consider the burden of polypharmacy, which is common among people with type 2 diabetes. Adjust concomitant therapies and deprescribe where possible.
- Identify risks for hypoglycemia and educate patients on the signs so they can seek treatment quickly.
- Monitor and control high blood pressure.
- Counsel patients about the risks for and symptoms of euglycemic diabetic ketoacidosis when taking SGLT2 inhibitors, as well as classic DKA, which can be fatal.
- Regularly screen and counsel patients about foot care to prevent foot ulcers or blisters that can quickly become infected and lead to amputation.
The writing group identified two additional patient subgroups that may benefit from SGLT2 inhibitors and GLP-1 receptor agonists: those with heart failure with reduced ejection fraction with or without diabetes; and those with CKD who do not have diabetes. They say more data are anticipated to validate the use of SGLT2 inhibitors and GLP-1 receptor agonists in these “at-risk” patients.
Collaborative care model
The writing group proposed a collaborative care model, bridging cardiologists, nephrologists, endocrinologists, and primary care physicians, to help facilitate the “prompt and appropriate” integration of these new classes of medications in the management of patients with type 2 diabetes and CKD.
There is “an unmet need for a cardio-renal-metabolic care model that incorporates best practices in the real world to help align these therapies, especially with vulnerable high-risk patients with cardiorenal disease, and to overcome barriers toward uptake of these agents. Hopefully this statement provides some guidance to the cardiology and nephrology communities in that area,” Dr. Rangaswami said in an interview.
But old habits die hard, as research continues to show the slow adoption of these newer medications in the real world.
For example, a large observational study published last year showed a “striking” discordance between evidence-based, guideline-recommended use of SGLT2 inhibitors for the treatment of type 2 diabetes and their actual uptake in clinical practice.
Paradoxically, patients with CVD, heart failure, hypertension, CKD, and those at risk for hypoglycemia were less apt to receive an SGLT2 inhibitor than other patients.
“The relatively slow uptake of these agents is multifactorial,” Dr. Rangaswami said. “Cardiologists and nephrologists may suffer from some level of ‘therapeutic inertia’ when using new agents they are unfamiliar with and originally branded as ‘antidiabetic’ agents, with the perception of these agents being outside the scope of their practice.”
Two other factors are also at play. “The current health care system is based on ‘specialty silos,’ where specialists tend to stick to the traditional scope of their specialty and are reluctant to view these agents as part of their therapeutic armamentarium. Finally, insurance coverage barriers and affordability also limit the use on a widespread basis,” Dr. Rangaswami said.
A version of this article originally appeared on Medscape.com .
To protect the heart and kidneys, sodium-glucose transporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) receptor agonists should be considered for people with type 2 diabetes and chronic kidney disease (CKD), the American Heart Association advised in a new scientific statement.
Taken together, the results of relevant clinical trials indicate that SGLT2 inhibitors and GLP-1 receptor agonists safely and significantly reduce the risk for cardiovascular (CV) events, death, and the slow progression of CKD to end-stage kidney disease, including the risks for dialysis, transplantation, and death, the writing group says.
The scientific statement was published online Sept. 28 in Circulation.
“There has been rapid reporting of high-quality data in the cardio-renal-metabolic space with significant heart and kidney benefits, particularly with these two newer classes of antihyperglycemic agents,” Janani Rangaswami, MD, who chaired the writing group, said in an interview.
“More recent data show benefits in chronic kidney disease and heart failure even in patients without diabetes,” said Dr. Rangaswami, Einstein Medical Center and Sidney Kimmel Medical College, both in Philadelphia.
“These data are practice-changing in both cardiology and nephrology, and usher in a new era of disease-modifying therapies in heart and kidney disease,” Dr. Rangaswami added.
Recommendations at a glance
- Provide early and ongoing assessment of risks for CVD and CKD to patients who may benefit from SGLT2 inhibitors of GLP-1 receptor agonists.
- Tailor medication choices that meet the needs of individual patients. Realize that, given “consistent class-wide effects,” the choice of a specific SGLT2 inhibitor or GLP-1 receptor agonist may be dictated by affordability, coverage, and formulary considerations.
- Adjust all medications in tandem with these medicines and consider the burden of polypharmacy, which is common among people with type 2 diabetes. Adjust concomitant therapies and deprescribe where possible.
- Identify risks for hypoglycemia and educate patients on the signs so they can seek treatment quickly.
- Monitor and control high blood pressure.
- Counsel patients about the risks for and symptoms of euglycemic diabetic ketoacidosis when taking SGLT2 inhibitors, as well as classic DKA, which can be fatal.
- Regularly screen and counsel patients about foot care to prevent foot ulcers or blisters that can quickly become infected and lead to amputation.
The writing group identified two additional patient subgroups that may benefit from SGLT2 inhibitors and GLP-1 receptor agonists: those with heart failure with reduced ejection fraction with or without diabetes; and those with CKD who do not have diabetes. They say more data are anticipated to validate the use of SGLT2 inhibitors and GLP-1 receptor agonists in these “at-risk” patients.
Collaborative care model
The writing group proposed a collaborative care model, bridging cardiologists, nephrologists, endocrinologists, and primary care physicians, to help facilitate the “prompt and appropriate” integration of these new classes of medications in the management of patients with type 2 diabetes and CKD.
There is “an unmet need for a cardio-renal-metabolic care model that incorporates best practices in the real world to help align these therapies, especially with vulnerable high-risk patients with cardiorenal disease, and to overcome barriers toward uptake of these agents. Hopefully this statement provides some guidance to the cardiology and nephrology communities in that area,” Dr. Rangaswami said in an interview.
But old habits die hard, as research continues to show the slow adoption of these newer medications in the real world.
For example, a large observational study published last year showed a “striking” discordance between evidence-based, guideline-recommended use of SGLT2 inhibitors for the treatment of type 2 diabetes and their actual uptake in clinical practice.
Paradoxically, patients with CVD, heart failure, hypertension, CKD, and those at risk for hypoglycemia were less apt to receive an SGLT2 inhibitor than other patients.
“The relatively slow uptake of these agents is multifactorial,” Dr. Rangaswami said. “Cardiologists and nephrologists may suffer from some level of ‘therapeutic inertia’ when using new agents they are unfamiliar with and originally branded as ‘antidiabetic’ agents, with the perception of these agents being outside the scope of their practice.”
Two other factors are also at play. “The current health care system is based on ‘specialty silos,’ where specialists tend to stick to the traditional scope of their specialty and are reluctant to view these agents as part of their therapeutic armamentarium. Finally, insurance coverage barriers and affordability also limit the use on a widespread basis,” Dr. Rangaswami said.
A version of this article originally appeared on Medscape.com .