User login
Politics or protection? What’s behind the push for boosters?
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
Breakthrough infections twice as likely to be asymptomatic
Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.
“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”
For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.
They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.
Likelihood of severe symptoms dropped after one dose
After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.
Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.
When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.
The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.
Findings may have implications for health policies
“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”
The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.
The authors of the paper and Dr. Hijano disclosed no conflicts.
Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.
“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”
For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.
They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.
Likelihood of severe symptoms dropped after one dose
After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.
Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.
When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.
The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.
Findings may have implications for health policies
“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”
The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.
The authors of the paper and Dr. Hijano disclosed no conflicts.
Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.
“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”
For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.
They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.
Likelihood of severe symptoms dropped after one dose
After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.
Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.
When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.
The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.
Findings may have implications for health policies
“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”
The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.
The authors of the paper and Dr. Hijano disclosed no conflicts.
FROM THE LANCET INFECTIOUS DISEASES
Limited evidence for interventions to reduce post-op pulmonary complications
Background: Despite advances in perioperative care, postoperative pulmonary complications represent a leading cause of morbidity and mortality that are associated with increased risk of admission to critical care and prolonged length of hospital stay. There are multiple interventions that are used, despite there being no consensus guidelines aimed at reducing the risk of PPCs.
Study design: Systemic review and meta-analysis of randomized controlled trials.
Setting: Literature search from Medline, Embase, CINHAL, and the Cochrane Central Register of Controlled Trials from January 1990 to December 2017, including trials investigating short-term, protocolized medical interventions around noncardiac surgeries with clinical diagnostic criteria for PPC outcomes.
Synopsis: The authors reviewed 117 trials that included 21,940 participants. The meta-analysis comprised 95 randomized controlled trials with 18,062 patients. The authors identified 11 categories of perioperative care interventions that were tested to reduce PPCs. None of the interventions evaluated was supported by high-quality evidence. There were seven interventions that showed a probable reduction in PPCs. Goal-directed fluid therapy was the only one that was supported by both moderate quality evidence and trial sequential analysis. Lung protective intraoperative ventilation was supported by moderate quality evidence, but not trial sequential analysis. Five interventions had low-quality evidence of benefit: enhanced recovery pathways, prophylactic mucolytics, postoperative continuous positive airway pressure ventilation, prophylactic respiratory physiotherapy, and epidural analgesia.
Unfortunately, only a minority of the trials reviewed were large, multi-center studies with a low risk of bias. The studies were also heterogeneous, posing a challenge for meta-analysis.
Bottom line: There is limited evidence supporting the efficacy of any intervention preventing postoperative pulmonary complications, with moderate-quality evidence supporting intraoperative lung protective ventilation and goal-directed hemodynamic strategies reducing PPCs.
Citation: Odor PM et al. Perioperative interventions for prevention of postoperative pulmonary complication: Systemic review and meta-analysis. BMJ. 2020 Mar 11. doi: 10.1136/bmj.m540.
Dr. Weaver is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.
Background: Despite advances in perioperative care, postoperative pulmonary complications represent a leading cause of morbidity and mortality that are associated with increased risk of admission to critical care and prolonged length of hospital stay. There are multiple interventions that are used, despite there being no consensus guidelines aimed at reducing the risk of PPCs.
Study design: Systemic review and meta-analysis of randomized controlled trials.
Setting: Literature search from Medline, Embase, CINHAL, and the Cochrane Central Register of Controlled Trials from January 1990 to December 2017, including trials investigating short-term, protocolized medical interventions around noncardiac surgeries with clinical diagnostic criteria for PPC outcomes.
Synopsis: The authors reviewed 117 trials that included 21,940 participants. The meta-analysis comprised 95 randomized controlled trials with 18,062 patients. The authors identified 11 categories of perioperative care interventions that were tested to reduce PPCs. None of the interventions evaluated was supported by high-quality evidence. There were seven interventions that showed a probable reduction in PPCs. Goal-directed fluid therapy was the only one that was supported by both moderate quality evidence and trial sequential analysis. Lung protective intraoperative ventilation was supported by moderate quality evidence, but not trial sequential analysis. Five interventions had low-quality evidence of benefit: enhanced recovery pathways, prophylactic mucolytics, postoperative continuous positive airway pressure ventilation, prophylactic respiratory physiotherapy, and epidural analgesia.
Unfortunately, only a minority of the trials reviewed were large, multi-center studies with a low risk of bias. The studies were also heterogeneous, posing a challenge for meta-analysis.
Bottom line: There is limited evidence supporting the efficacy of any intervention preventing postoperative pulmonary complications, with moderate-quality evidence supporting intraoperative lung protective ventilation and goal-directed hemodynamic strategies reducing PPCs.
Citation: Odor PM et al. Perioperative interventions for prevention of postoperative pulmonary complication: Systemic review and meta-analysis. BMJ. 2020 Mar 11. doi: 10.1136/bmj.m540.
Dr. Weaver is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.
Background: Despite advances in perioperative care, postoperative pulmonary complications represent a leading cause of morbidity and mortality that are associated with increased risk of admission to critical care and prolonged length of hospital stay. There are multiple interventions that are used, despite there being no consensus guidelines aimed at reducing the risk of PPCs.
Study design: Systemic review and meta-analysis of randomized controlled trials.
Setting: Literature search from Medline, Embase, CINHAL, and the Cochrane Central Register of Controlled Trials from January 1990 to December 2017, including trials investigating short-term, protocolized medical interventions around noncardiac surgeries with clinical diagnostic criteria for PPC outcomes.
Synopsis: The authors reviewed 117 trials that included 21,940 participants. The meta-analysis comprised 95 randomized controlled trials with 18,062 patients. The authors identified 11 categories of perioperative care interventions that were tested to reduce PPCs. None of the interventions evaluated was supported by high-quality evidence. There were seven interventions that showed a probable reduction in PPCs. Goal-directed fluid therapy was the only one that was supported by both moderate quality evidence and trial sequential analysis. Lung protective intraoperative ventilation was supported by moderate quality evidence, but not trial sequential analysis. Five interventions had low-quality evidence of benefit: enhanced recovery pathways, prophylactic mucolytics, postoperative continuous positive airway pressure ventilation, prophylactic respiratory physiotherapy, and epidural analgesia.
Unfortunately, only a minority of the trials reviewed were large, multi-center studies with a low risk of bias. The studies were also heterogeneous, posing a challenge for meta-analysis.
Bottom line: There is limited evidence supporting the efficacy of any intervention preventing postoperative pulmonary complications, with moderate-quality evidence supporting intraoperative lung protective ventilation and goal-directed hemodynamic strategies reducing PPCs.
Citation: Odor PM et al. Perioperative interventions for prevention of postoperative pulmonary complication: Systemic review and meta-analysis. BMJ. 2020 Mar 11. doi: 10.1136/bmj.m540.
Dr. Weaver is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.
Two swings, two misses with colchicine, Vascepa in COVID-19
The anti-inflammatory agents colchicine and icosapent ethyl (Vascepa; Amarin) failed to provide substantial benefits in separate randomized COVID-19 trials.
Both were reported at the European Society of Cardiology (ESC) Congress 2021.
The open-label ECLA PHRI COLCOVID trial randomized 1,277 hospitalized adults (mean age 62 years) to usual care alone or with colchicine at a loading dose of 1.5 mg for 2 hours followed by 0.5 mg on day 1 and then 0.5 mg twice daily for 14 days or until discharge.
The investigators hypothesized that colchicine, which is widely used to treat gout and other inflammatory conditions, might modulate the hyperinflammatory syndrome, or cytokine storm, associated with COVID-19.
Results showed that the need for mechanical ventilation or death occurred in 25.0% of patients receiving colchicine and 28.8% with usual care (P = .08).
The coprimary endpoint of death at 28 days was also not significantly different between groups (20.5% vs. 22.2%), principal investigator Rafael Diaz, MD, said in a late-breaking COVID-19 trials session at the congress.
Among the secondary outcomes at 28 days, colchicine significantly reduced the incidence of new intubation or death from respiratory failure from 27.0% to 22.3% (hazard ratio, 0.79; 95% confidence interval, 0.63-0.99) but not mortality from respiratory failure (19.5% vs. 16.8%).
The only important adverse effect was severe diarrhea, which was reported in 11.3% of the colchicine group vs. 4.5% in the control group, said Dr. Diaz, director of Estudios Clínicos Latinoamérica (ECLA), Rosario, Argentina.
The results are consistent with those from the massive RECOVERY trial, which earlier this year stopped enrollment in the colchicine arm for lack of efficacy in patients hospitalized with COVID-19, and COLCORONA, which missed its primary endpoint using colchicine among nonhospitalized adults with COVID-19.
Session chair and COLCORONA principal investigator Jean-Claude Tardif, MD, pointed out that, as clinicians, it’s fairly uncommon to combine systemic steroids with colchicine, which was the case in 92% of patients in ECLA PHRI COLCOVID.
“I think it is an inherent limitation of testing colchicine on top of steroids,” said Dr. Tardif, of the Montreal Heart Institute.
Icosapent ethyl in PREPARE-IT
Dr. Diaz returned in the ESC session to present the results of the PREPARE-IT trial, which tested whether icosapent ethyl – at a loading dose of 8 grams (4 capsules) for the first 3 days and 4 g/d on days 4-60 – could reduce the risk for SARS-CoV-2 infection in 2,041 health care and other public workers in Argentina at high risk for infection (mean age 40.5 years).
Vascepa was approved by the Food and Drug Administration in 2012 for the reduction of elevated triglyceride levels, with an added indication in 2019 to reduce cardiovascular (CV) events in people with elevated triglycerides and established CV disease or diabetes with other CV risk factors.
The rationale for using the high-dose prescription eicosapentaenoic acid (EPA) preparation includes its anti-inflammatory and antithrombotic effects, and that unsaturated fatty acids, especially EPA, might inactivate the enveloped virus, he explained.
Among 1,712 participants followed for up to 60 days, however, the SARS-CoV-2 infection rate was 7.9% with icosapent ethyl vs. 7.1% with a mineral oil placebo (P = .58).
There were also no significant changes from baseline in the icosapent ethyl and placebo groups for the secondary outcomes of high-sensitivity C-reactive protein (0 vs. 0), triglycerides (median –2 mg/dL vs. 7 mg/dL), or Influenza Patient-Reported Outcome (FLU-PRO) questionnaire scores (median 0.01 vs. 0.03).
The use of a mineral oil placebo has been the subject of controversy in previous fish oil trials, but, Dr. Diaz noted, it did not have a significant proinflammatory effect or cause any excess adverse events.
Overall, adverse events were similar between the active and placebo groups, including atrial fibrillation (none), major bleeding (none), minor bleeding (7 events vs. 10 events), gastrointestinal symptoms (6.8% vs. 7.0%), and diarrhea (8.6% vs. 7.7%).
Although it missed the primary endpoint, Dr. Diaz said, “this is the first large, randomized blinded trial to demonstrate excellent safety and tolerability of an 8-gram-per-day loading dose of icosapent ethyl, opening up the potential for acute use in randomized trials of myocardial infarction, acute coronary syndromes, strokes, and revascularization.”
During a discussion of the results, Dr. Diaz said the Delta variant was not present at the time of the analysis and that the second half of the trial will report on whether icosapent ethyl can reduce the risk for hospitalization or death in participants diagnosed with COVID-19.
ECLA PHRI COLCOVID was supported by the Estudios Clínicos Latinoamérica Population Health Research Institute. PREPARE-IT was supported by Estudios Clínicos Latinoamérica with collaboration from Amarin. Dr. Diaz reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The anti-inflammatory agents colchicine and icosapent ethyl (Vascepa; Amarin) failed to provide substantial benefits in separate randomized COVID-19 trials.
Both were reported at the European Society of Cardiology (ESC) Congress 2021.
The open-label ECLA PHRI COLCOVID trial randomized 1,277 hospitalized adults (mean age 62 years) to usual care alone or with colchicine at a loading dose of 1.5 mg for 2 hours followed by 0.5 mg on day 1 and then 0.5 mg twice daily for 14 days or until discharge.
The investigators hypothesized that colchicine, which is widely used to treat gout and other inflammatory conditions, might modulate the hyperinflammatory syndrome, or cytokine storm, associated with COVID-19.
Results showed that the need for mechanical ventilation or death occurred in 25.0% of patients receiving colchicine and 28.8% with usual care (P = .08).
The coprimary endpoint of death at 28 days was also not significantly different between groups (20.5% vs. 22.2%), principal investigator Rafael Diaz, MD, said in a late-breaking COVID-19 trials session at the congress.
Among the secondary outcomes at 28 days, colchicine significantly reduced the incidence of new intubation or death from respiratory failure from 27.0% to 22.3% (hazard ratio, 0.79; 95% confidence interval, 0.63-0.99) but not mortality from respiratory failure (19.5% vs. 16.8%).
The only important adverse effect was severe diarrhea, which was reported in 11.3% of the colchicine group vs. 4.5% in the control group, said Dr. Diaz, director of Estudios Clínicos Latinoamérica (ECLA), Rosario, Argentina.
The results are consistent with those from the massive RECOVERY trial, which earlier this year stopped enrollment in the colchicine arm for lack of efficacy in patients hospitalized with COVID-19, and COLCORONA, which missed its primary endpoint using colchicine among nonhospitalized adults with COVID-19.
Session chair and COLCORONA principal investigator Jean-Claude Tardif, MD, pointed out that, as clinicians, it’s fairly uncommon to combine systemic steroids with colchicine, which was the case in 92% of patients in ECLA PHRI COLCOVID.
“I think it is an inherent limitation of testing colchicine on top of steroids,” said Dr. Tardif, of the Montreal Heart Institute.
Icosapent ethyl in PREPARE-IT
Dr. Diaz returned in the ESC session to present the results of the PREPARE-IT trial, which tested whether icosapent ethyl – at a loading dose of 8 grams (4 capsules) for the first 3 days and 4 g/d on days 4-60 – could reduce the risk for SARS-CoV-2 infection in 2,041 health care and other public workers in Argentina at high risk for infection (mean age 40.5 years).
Vascepa was approved by the Food and Drug Administration in 2012 for the reduction of elevated triglyceride levels, with an added indication in 2019 to reduce cardiovascular (CV) events in people with elevated triglycerides and established CV disease or diabetes with other CV risk factors.
The rationale for using the high-dose prescription eicosapentaenoic acid (EPA) preparation includes its anti-inflammatory and antithrombotic effects, and that unsaturated fatty acids, especially EPA, might inactivate the enveloped virus, he explained.
Among 1,712 participants followed for up to 60 days, however, the SARS-CoV-2 infection rate was 7.9% with icosapent ethyl vs. 7.1% with a mineral oil placebo (P = .58).
There were also no significant changes from baseline in the icosapent ethyl and placebo groups for the secondary outcomes of high-sensitivity C-reactive protein (0 vs. 0), triglycerides (median –2 mg/dL vs. 7 mg/dL), or Influenza Patient-Reported Outcome (FLU-PRO) questionnaire scores (median 0.01 vs. 0.03).
The use of a mineral oil placebo has been the subject of controversy in previous fish oil trials, but, Dr. Diaz noted, it did not have a significant proinflammatory effect or cause any excess adverse events.
Overall, adverse events were similar between the active and placebo groups, including atrial fibrillation (none), major bleeding (none), minor bleeding (7 events vs. 10 events), gastrointestinal symptoms (6.8% vs. 7.0%), and diarrhea (8.6% vs. 7.7%).
Although it missed the primary endpoint, Dr. Diaz said, “this is the first large, randomized blinded trial to demonstrate excellent safety and tolerability of an 8-gram-per-day loading dose of icosapent ethyl, opening up the potential for acute use in randomized trials of myocardial infarction, acute coronary syndromes, strokes, and revascularization.”
During a discussion of the results, Dr. Diaz said the Delta variant was not present at the time of the analysis and that the second half of the trial will report on whether icosapent ethyl can reduce the risk for hospitalization or death in participants diagnosed with COVID-19.
ECLA PHRI COLCOVID was supported by the Estudios Clínicos Latinoamérica Population Health Research Institute. PREPARE-IT was supported by Estudios Clínicos Latinoamérica with collaboration from Amarin. Dr. Diaz reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The anti-inflammatory agents colchicine and icosapent ethyl (Vascepa; Amarin) failed to provide substantial benefits in separate randomized COVID-19 trials.
Both were reported at the European Society of Cardiology (ESC) Congress 2021.
The open-label ECLA PHRI COLCOVID trial randomized 1,277 hospitalized adults (mean age 62 years) to usual care alone or with colchicine at a loading dose of 1.5 mg for 2 hours followed by 0.5 mg on day 1 and then 0.5 mg twice daily for 14 days or until discharge.
The investigators hypothesized that colchicine, which is widely used to treat gout and other inflammatory conditions, might modulate the hyperinflammatory syndrome, or cytokine storm, associated with COVID-19.
Results showed that the need for mechanical ventilation or death occurred in 25.0% of patients receiving colchicine and 28.8% with usual care (P = .08).
The coprimary endpoint of death at 28 days was also not significantly different between groups (20.5% vs. 22.2%), principal investigator Rafael Diaz, MD, said in a late-breaking COVID-19 trials session at the congress.
Among the secondary outcomes at 28 days, colchicine significantly reduced the incidence of new intubation or death from respiratory failure from 27.0% to 22.3% (hazard ratio, 0.79; 95% confidence interval, 0.63-0.99) but not mortality from respiratory failure (19.5% vs. 16.8%).
The only important adverse effect was severe diarrhea, which was reported in 11.3% of the colchicine group vs. 4.5% in the control group, said Dr. Diaz, director of Estudios Clínicos Latinoamérica (ECLA), Rosario, Argentina.
The results are consistent with those from the massive RECOVERY trial, which earlier this year stopped enrollment in the colchicine arm for lack of efficacy in patients hospitalized with COVID-19, and COLCORONA, which missed its primary endpoint using colchicine among nonhospitalized adults with COVID-19.
Session chair and COLCORONA principal investigator Jean-Claude Tardif, MD, pointed out that, as clinicians, it’s fairly uncommon to combine systemic steroids with colchicine, which was the case in 92% of patients in ECLA PHRI COLCOVID.
“I think it is an inherent limitation of testing colchicine on top of steroids,” said Dr. Tardif, of the Montreal Heart Institute.
Icosapent ethyl in PREPARE-IT
Dr. Diaz returned in the ESC session to present the results of the PREPARE-IT trial, which tested whether icosapent ethyl – at a loading dose of 8 grams (4 capsules) for the first 3 days and 4 g/d on days 4-60 – could reduce the risk for SARS-CoV-2 infection in 2,041 health care and other public workers in Argentina at high risk for infection (mean age 40.5 years).
Vascepa was approved by the Food and Drug Administration in 2012 for the reduction of elevated triglyceride levels, with an added indication in 2019 to reduce cardiovascular (CV) events in people with elevated triglycerides and established CV disease or diabetes with other CV risk factors.
The rationale for using the high-dose prescription eicosapentaenoic acid (EPA) preparation includes its anti-inflammatory and antithrombotic effects, and that unsaturated fatty acids, especially EPA, might inactivate the enveloped virus, he explained.
Among 1,712 participants followed for up to 60 days, however, the SARS-CoV-2 infection rate was 7.9% with icosapent ethyl vs. 7.1% with a mineral oil placebo (P = .58).
There were also no significant changes from baseline in the icosapent ethyl and placebo groups for the secondary outcomes of high-sensitivity C-reactive protein (0 vs. 0), triglycerides (median –2 mg/dL vs. 7 mg/dL), or Influenza Patient-Reported Outcome (FLU-PRO) questionnaire scores (median 0.01 vs. 0.03).
The use of a mineral oil placebo has been the subject of controversy in previous fish oil trials, but, Dr. Diaz noted, it did not have a significant proinflammatory effect or cause any excess adverse events.
Overall, adverse events were similar between the active and placebo groups, including atrial fibrillation (none), major bleeding (none), minor bleeding (7 events vs. 10 events), gastrointestinal symptoms (6.8% vs. 7.0%), and diarrhea (8.6% vs. 7.7%).
Although it missed the primary endpoint, Dr. Diaz said, “this is the first large, randomized blinded trial to demonstrate excellent safety and tolerability of an 8-gram-per-day loading dose of icosapent ethyl, opening up the potential for acute use in randomized trials of myocardial infarction, acute coronary syndromes, strokes, and revascularization.”
During a discussion of the results, Dr. Diaz said the Delta variant was not present at the time of the analysis and that the second half of the trial will report on whether icosapent ethyl can reduce the risk for hospitalization or death in participants diagnosed with COVID-19.
ECLA PHRI COLCOVID was supported by the Estudios Clínicos Latinoamérica Population Health Research Institute. PREPARE-IT was supported by Estudios Clínicos Latinoamérica with collaboration from Amarin. Dr. Diaz reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Deeper dive’ into opioid overdose deaths during COVID pandemic
Opioid overdose deaths were significantly higher during 2020, but occurrences were not homogeneous across nine states. Male deaths were higher than in the 2 previous years in two states, according to a new, granular examination of data collected by researchers at the Massachusetts General Hospital (Mass General), Boston.
The analysis also showed that synthetic opioids such as fentanyl played an outsized role in most of the states that were reviewed. Additional drugs of abuse found in decedents, such as cocaine and psychostimulants, were more prevalent in some states than in others.
The Centers for Disease Control and Prevention used provisional death data in its recent report. It found that opioid-related deaths substantially rose in 2020 and that synthetic opioids were a primary driver.
The current Mass General analysis provides a more timely and detailed dive, senior author Mohammad Jalali, PhD, who is a senior scientist at Mass General’s Institute for Technology Assessment, told this news organization.
The findings, which have not yet been peer reviewed, were published in MedRxiv.
Shifting sands of opioid use disorder
to analyze and project trends and also to be better prepared to address the shifting sands of opioid use disorder in the United States.
They attempted to collect data on confirmed opioid overdose deaths from all 50 states and Washington, D.C. to assess what might have changed during the COVID-19 pandemic. Only nine states provided enough data for the analysis, which has been submitted to a peer reviewed publication.
These states were Alaska, Connecticut, Indiana, Massachusetts, North Carolina, Rhode Island, Colorado, Utah, and Wyoming.
“Drug overdose data are collected and reported more slowly than COVID-19 data,” Dr. Jalali said in a press release. The data reflected a lag time of about 4 to 8 months in Massachusetts and North Carolina to more than a year in Maryland and Ohio, he noted.
The reporting lag “has clouded the understanding of the effects of the COVID-19 pandemic on opioid-related overdose deaths,” said Dr. Jalali.
Commenting on the findings, Brandon Marshall, PhD, associate professor of epidemiology at Brown University, Providence, R.I, said that “the overall pattern of what’s being reported here is not surprising,” given the national trends seen in the CDC data.
“This paper adds a deeper dive into some of the sociodemographic trends that we’re starting to observe in specific states,” Dr. Marshall said.
Also commenting for this news organization, Brian Fuehrlein, MD, PhD, director of the psychiatric emergency department at the VA Connecticut Healthcare System in West Haven, Connecticut, noted that the current study “highlights things that we are currently seeing at VA Connecticut.”
Decrease in heroin, rise in fentanyl
The investigators found a significant reduction in overdose deaths that involved heroin in Alaska, Connecticut, Indiana, Massachusetts, North Carolina, and Rhode Island. That was a new trend for Alaska, Indiana, and Rhode Island, although with only 3 years of data, it’s hard to say whether it will continue, Dr. Jalali noted.
The decrease in heroin involvement seemed to continue a trend previously observed in Colorado, Connecticut, Massachusetts, and North Carolina.
In Connecticut, heroin was involved in 36% of deaths in 2018, 30% in 2019, and 16% in 2020, according to the study.
“We have begun seeing more and more heroin-negative, fentanyl-positive drug screens,” said Dr. Fuehrlein, who is also associate professor of psychiatry at Yale University, New Haven, Conn.
“There is a shift from fentanyl being an adulterant to fentanyl being what is sold and used exclusively,” he added.
In 2020, 92% (n = 887) of deaths in Connecticut involved synthetic opioids, continuing a trend. In Alaska, however, synthetic opioids were involved in 60% (44) of deaths, which is a big jump from 23% (9) in 2018.
Synthetic opioids were involved in the largest percentage of overdoses in all of the states studied. The fewest deaths, 17 (49%), occurred in Wyoming.
Cocaine is also increasingly found in addition to other substances in decedents. In Alaska, about 14% of individuals who overdosed in 2020 also had cocaine in their system, which was a jump from 2% in the prior year.
In Colorado, 19% (94) of those who died also had taken cocaine, up from 13% in 2019. Cocaine was also frequently found in those who died in the northeast: 39% (467) of those who died in Massachusetts, 29% (280) in Connecticut, and 47% (109) in Rhode Island.
There was also an increase in psychostimulants found in those who had died in Massachusetts in 2020.
More male overdoses in 2020
Results also showed that, compared to 2019, significantly more men died from overdoses in 2020 in Colorado (61% vs. 70%, P = .017) and Indiana (62% vs. 70%, P = .026).
This finding was unexpected, said Dr. Marshall, who has observed the same phenomenon in Rhode Island. He is the scientific director of PreventOverdoseRI, Rhode Island’s drug overdose surveillance and information dashboard.
Dr. Marshall and his colleagues conducted a study that also found disproportionate increases in overdoses among men. The findings of that study will be published in September.
“We’re still trying to wrap our head around why that is,” he said. He added that a deeper dive into the Rhode Island data showed that the deaths were increased especially among middle-aged men who had been diagnosed with depression and anxiety.
The same patterns were not seen among women in either Dr. Jalali’s study or his own analysis of the Rhode Island data, said Dr. Marshall.
“That suggests the COVID-19 pandemic impacted men who are at risk for overdose in some particularly severe way,” he noted.
Dr. Fuehrlein said he believes a variety of factors have led to an increase in overdose deaths during the pandemic, including the fact that many patients who would normally seek help avoided care or dropped out of treatment because of COVID fears. In addition, other support systems, such as group therapy and Narcotics Anonymous, were unavailable.
The pandemic increased stress, which can lead to worsening substance use, said Dr. Fuehrlein. He also noted that regular opioid suppliers were often not available, which led some to buy from different dealers, “which can lead to overdose if the fentanyl content is different.”
Identifying at-risk individuals
Dr. Jalali and colleagues note that clinicians and policymakers could use the new study to help identify and treat at-risk individuals.
“Practitioners and policy makers can use our findings to help them anticipate which groups of people might be most affected by opioid overdose and which types of policy interventions might be most effective given each state’s unique situation,” said lead study author Gian-Gabriel P. Garcia, PhD, in a press release. At the time of the study, Dr. Garcia was a postdoctoral fellow at Mass General and Harvard Medical School. He is currently an assistant professor at Georgia Tech, Atlanta.
Dr. Marshall pointed out that Dr. Jalali’s study is also relevant for emergency departments.
ED clinicians “are and will be seeing patients coming in who have no idea they were exposed to an opioid, nevermind fentanyl,” he said. ED clinicians can discuss with patients various harm reduction techniques, including the use of naloxone as well as test strips that can detect fentanyl in the drug supply, he added.
“Given the increasing use of fentanyl, which is very dangerous in overdose, clinicians need to be well versed in a harm reduction/overdose prevention approach to patient care,” Dr. Fuehrlein agreed.
A version of this article first appeared on Medscape.com.
Opioid overdose deaths were significantly higher during 2020, but occurrences were not homogeneous across nine states. Male deaths were higher than in the 2 previous years in two states, according to a new, granular examination of data collected by researchers at the Massachusetts General Hospital (Mass General), Boston.
The analysis also showed that synthetic opioids such as fentanyl played an outsized role in most of the states that were reviewed. Additional drugs of abuse found in decedents, such as cocaine and psychostimulants, were more prevalent in some states than in others.
The Centers for Disease Control and Prevention used provisional death data in its recent report. It found that opioid-related deaths substantially rose in 2020 and that synthetic opioids were a primary driver.
The current Mass General analysis provides a more timely and detailed dive, senior author Mohammad Jalali, PhD, who is a senior scientist at Mass General’s Institute for Technology Assessment, told this news organization.
The findings, which have not yet been peer reviewed, were published in MedRxiv.
Shifting sands of opioid use disorder
to analyze and project trends and also to be better prepared to address the shifting sands of opioid use disorder in the United States.
They attempted to collect data on confirmed opioid overdose deaths from all 50 states and Washington, D.C. to assess what might have changed during the COVID-19 pandemic. Only nine states provided enough data for the analysis, which has been submitted to a peer reviewed publication.
These states were Alaska, Connecticut, Indiana, Massachusetts, North Carolina, Rhode Island, Colorado, Utah, and Wyoming.
“Drug overdose data are collected and reported more slowly than COVID-19 data,” Dr. Jalali said in a press release. The data reflected a lag time of about 4 to 8 months in Massachusetts and North Carolina to more than a year in Maryland and Ohio, he noted.
The reporting lag “has clouded the understanding of the effects of the COVID-19 pandemic on opioid-related overdose deaths,” said Dr. Jalali.
Commenting on the findings, Brandon Marshall, PhD, associate professor of epidemiology at Brown University, Providence, R.I, said that “the overall pattern of what’s being reported here is not surprising,” given the national trends seen in the CDC data.
“This paper adds a deeper dive into some of the sociodemographic trends that we’re starting to observe in specific states,” Dr. Marshall said.
Also commenting for this news organization, Brian Fuehrlein, MD, PhD, director of the psychiatric emergency department at the VA Connecticut Healthcare System in West Haven, Connecticut, noted that the current study “highlights things that we are currently seeing at VA Connecticut.”
Decrease in heroin, rise in fentanyl
The investigators found a significant reduction in overdose deaths that involved heroin in Alaska, Connecticut, Indiana, Massachusetts, North Carolina, and Rhode Island. That was a new trend for Alaska, Indiana, and Rhode Island, although with only 3 years of data, it’s hard to say whether it will continue, Dr. Jalali noted.
The decrease in heroin involvement seemed to continue a trend previously observed in Colorado, Connecticut, Massachusetts, and North Carolina.
In Connecticut, heroin was involved in 36% of deaths in 2018, 30% in 2019, and 16% in 2020, according to the study.
“We have begun seeing more and more heroin-negative, fentanyl-positive drug screens,” said Dr. Fuehrlein, who is also associate professor of psychiatry at Yale University, New Haven, Conn.
“There is a shift from fentanyl being an adulterant to fentanyl being what is sold and used exclusively,” he added.
In 2020, 92% (n = 887) of deaths in Connecticut involved synthetic opioids, continuing a trend. In Alaska, however, synthetic opioids were involved in 60% (44) of deaths, which is a big jump from 23% (9) in 2018.
Synthetic opioids were involved in the largest percentage of overdoses in all of the states studied. The fewest deaths, 17 (49%), occurred in Wyoming.
Cocaine is also increasingly found in addition to other substances in decedents. In Alaska, about 14% of individuals who overdosed in 2020 also had cocaine in their system, which was a jump from 2% in the prior year.
In Colorado, 19% (94) of those who died also had taken cocaine, up from 13% in 2019. Cocaine was also frequently found in those who died in the northeast: 39% (467) of those who died in Massachusetts, 29% (280) in Connecticut, and 47% (109) in Rhode Island.
There was also an increase in psychostimulants found in those who had died in Massachusetts in 2020.
More male overdoses in 2020
Results also showed that, compared to 2019, significantly more men died from overdoses in 2020 in Colorado (61% vs. 70%, P = .017) and Indiana (62% vs. 70%, P = .026).
This finding was unexpected, said Dr. Marshall, who has observed the same phenomenon in Rhode Island. He is the scientific director of PreventOverdoseRI, Rhode Island’s drug overdose surveillance and information dashboard.
Dr. Marshall and his colleagues conducted a study that also found disproportionate increases in overdoses among men. The findings of that study will be published in September.
“We’re still trying to wrap our head around why that is,” he said. He added that a deeper dive into the Rhode Island data showed that the deaths were increased especially among middle-aged men who had been diagnosed with depression and anxiety.
The same patterns were not seen among women in either Dr. Jalali’s study or his own analysis of the Rhode Island data, said Dr. Marshall.
“That suggests the COVID-19 pandemic impacted men who are at risk for overdose in some particularly severe way,” he noted.
Dr. Fuehrlein said he believes a variety of factors have led to an increase in overdose deaths during the pandemic, including the fact that many patients who would normally seek help avoided care or dropped out of treatment because of COVID fears. In addition, other support systems, such as group therapy and Narcotics Anonymous, were unavailable.
The pandemic increased stress, which can lead to worsening substance use, said Dr. Fuehrlein. He also noted that regular opioid suppliers were often not available, which led some to buy from different dealers, “which can lead to overdose if the fentanyl content is different.”
Identifying at-risk individuals
Dr. Jalali and colleagues note that clinicians and policymakers could use the new study to help identify and treat at-risk individuals.
“Practitioners and policy makers can use our findings to help them anticipate which groups of people might be most affected by opioid overdose and which types of policy interventions might be most effective given each state’s unique situation,” said lead study author Gian-Gabriel P. Garcia, PhD, in a press release. At the time of the study, Dr. Garcia was a postdoctoral fellow at Mass General and Harvard Medical School. He is currently an assistant professor at Georgia Tech, Atlanta.
Dr. Marshall pointed out that Dr. Jalali’s study is also relevant for emergency departments.
ED clinicians “are and will be seeing patients coming in who have no idea they were exposed to an opioid, nevermind fentanyl,” he said. ED clinicians can discuss with patients various harm reduction techniques, including the use of naloxone as well as test strips that can detect fentanyl in the drug supply, he added.
“Given the increasing use of fentanyl, which is very dangerous in overdose, clinicians need to be well versed in a harm reduction/overdose prevention approach to patient care,” Dr. Fuehrlein agreed.
A version of this article first appeared on Medscape.com.
Opioid overdose deaths were significantly higher during 2020, but occurrences were not homogeneous across nine states. Male deaths were higher than in the 2 previous years in two states, according to a new, granular examination of data collected by researchers at the Massachusetts General Hospital (Mass General), Boston.
The analysis also showed that synthetic opioids such as fentanyl played an outsized role in most of the states that were reviewed. Additional drugs of abuse found in decedents, such as cocaine and psychostimulants, were more prevalent in some states than in others.
The Centers for Disease Control and Prevention used provisional death data in its recent report. It found that opioid-related deaths substantially rose in 2020 and that synthetic opioids were a primary driver.
The current Mass General analysis provides a more timely and detailed dive, senior author Mohammad Jalali, PhD, who is a senior scientist at Mass General’s Institute for Technology Assessment, told this news organization.
The findings, which have not yet been peer reviewed, were published in MedRxiv.
Shifting sands of opioid use disorder
to analyze and project trends and also to be better prepared to address the shifting sands of opioid use disorder in the United States.
They attempted to collect data on confirmed opioid overdose deaths from all 50 states and Washington, D.C. to assess what might have changed during the COVID-19 pandemic. Only nine states provided enough data for the analysis, which has been submitted to a peer reviewed publication.
These states were Alaska, Connecticut, Indiana, Massachusetts, North Carolina, Rhode Island, Colorado, Utah, and Wyoming.
“Drug overdose data are collected and reported more slowly than COVID-19 data,” Dr. Jalali said in a press release. The data reflected a lag time of about 4 to 8 months in Massachusetts and North Carolina to more than a year in Maryland and Ohio, he noted.
The reporting lag “has clouded the understanding of the effects of the COVID-19 pandemic on opioid-related overdose deaths,” said Dr. Jalali.
Commenting on the findings, Brandon Marshall, PhD, associate professor of epidemiology at Brown University, Providence, R.I, said that “the overall pattern of what’s being reported here is not surprising,” given the national trends seen in the CDC data.
“This paper adds a deeper dive into some of the sociodemographic trends that we’re starting to observe in specific states,” Dr. Marshall said.
Also commenting for this news organization, Brian Fuehrlein, MD, PhD, director of the psychiatric emergency department at the VA Connecticut Healthcare System in West Haven, Connecticut, noted that the current study “highlights things that we are currently seeing at VA Connecticut.”
Decrease in heroin, rise in fentanyl
The investigators found a significant reduction in overdose deaths that involved heroin in Alaska, Connecticut, Indiana, Massachusetts, North Carolina, and Rhode Island. That was a new trend for Alaska, Indiana, and Rhode Island, although with only 3 years of data, it’s hard to say whether it will continue, Dr. Jalali noted.
The decrease in heroin involvement seemed to continue a trend previously observed in Colorado, Connecticut, Massachusetts, and North Carolina.
In Connecticut, heroin was involved in 36% of deaths in 2018, 30% in 2019, and 16% in 2020, according to the study.
“We have begun seeing more and more heroin-negative, fentanyl-positive drug screens,” said Dr. Fuehrlein, who is also associate professor of psychiatry at Yale University, New Haven, Conn.
“There is a shift from fentanyl being an adulterant to fentanyl being what is sold and used exclusively,” he added.
In 2020, 92% (n = 887) of deaths in Connecticut involved synthetic opioids, continuing a trend. In Alaska, however, synthetic opioids were involved in 60% (44) of deaths, which is a big jump from 23% (9) in 2018.
Synthetic opioids were involved in the largest percentage of overdoses in all of the states studied. The fewest deaths, 17 (49%), occurred in Wyoming.
Cocaine is also increasingly found in addition to other substances in decedents. In Alaska, about 14% of individuals who overdosed in 2020 also had cocaine in their system, which was a jump from 2% in the prior year.
In Colorado, 19% (94) of those who died also had taken cocaine, up from 13% in 2019. Cocaine was also frequently found in those who died in the northeast: 39% (467) of those who died in Massachusetts, 29% (280) in Connecticut, and 47% (109) in Rhode Island.
There was also an increase in psychostimulants found in those who had died in Massachusetts in 2020.
More male overdoses in 2020
Results also showed that, compared to 2019, significantly more men died from overdoses in 2020 in Colorado (61% vs. 70%, P = .017) and Indiana (62% vs. 70%, P = .026).
This finding was unexpected, said Dr. Marshall, who has observed the same phenomenon in Rhode Island. He is the scientific director of PreventOverdoseRI, Rhode Island’s drug overdose surveillance and information dashboard.
Dr. Marshall and his colleagues conducted a study that also found disproportionate increases in overdoses among men. The findings of that study will be published in September.
“We’re still trying to wrap our head around why that is,” he said. He added that a deeper dive into the Rhode Island data showed that the deaths were increased especially among middle-aged men who had been diagnosed with depression and anxiety.
The same patterns were not seen among women in either Dr. Jalali’s study or his own analysis of the Rhode Island data, said Dr. Marshall.
“That suggests the COVID-19 pandemic impacted men who are at risk for overdose in some particularly severe way,” he noted.
Dr. Fuehrlein said he believes a variety of factors have led to an increase in overdose deaths during the pandemic, including the fact that many patients who would normally seek help avoided care or dropped out of treatment because of COVID fears. In addition, other support systems, such as group therapy and Narcotics Anonymous, were unavailable.
The pandemic increased stress, which can lead to worsening substance use, said Dr. Fuehrlein. He also noted that regular opioid suppliers were often not available, which led some to buy from different dealers, “which can lead to overdose if the fentanyl content is different.”
Identifying at-risk individuals
Dr. Jalali and colleagues note that clinicians and policymakers could use the new study to help identify and treat at-risk individuals.
“Practitioners and policy makers can use our findings to help them anticipate which groups of people might be most affected by opioid overdose and which types of policy interventions might be most effective given each state’s unique situation,” said lead study author Gian-Gabriel P. Garcia, PhD, in a press release. At the time of the study, Dr. Garcia was a postdoctoral fellow at Mass General and Harvard Medical School. He is currently an assistant professor at Georgia Tech, Atlanta.
Dr. Marshall pointed out that Dr. Jalali’s study is also relevant for emergency departments.
ED clinicians “are and will be seeing patients coming in who have no idea they were exposed to an opioid, nevermind fentanyl,” he said. ED clinicians can discuss with patients various harm reduction techniques, including the use of naloxone as well as test strips that can detect fentanyl in the drug supply, he added.
“Given the increasing use of fentanyl, which is very dangerous in overdose, clinicians need to be well versed in a harm reduction/overdose prevention approach to patient care,” Dr. Fuehrlein agreed.
A version of this article first appeared on Medscape.com.
Early end for trial of experimental oxygenation strategies in ARDS
Background: Both observational studies and clinical trials have found that a liberal oxygenation strategy in multiple inpatient settings may be harmful. Furthermore, a conservative strategy is what has been recommended in guidelines. Conversely, the relevance of this recent concept has been challenged in a large trial of a critically ill population (ICU-ROX).
Study design: Randomized clinical trial, unblinded.
Setting: Thirteen sites in France.
Synopsis: In a multicenter randomized clinical trial, investigators enrolled patients with ARDS to either a liberal oxygenation group (PaO2 target 90-105 mm Hg or SpO2 of 96% or greater) or a conservative oxygenation group (PaO2 target 55-70 mm Hg or SpO2 88%-92%). The trial was planned for inclusion of 850 patients, but the data and safety monitoring board decided to stop the trial after inclusion of 205 patients. Although the primary outcome (28-day all-cause mortality) was not significantly different between groups (34.3% vs 26.5%; absolute difference, 7.8%; 95% confidence interval, –4.8 to 20.6), the direction was signaling possible harm and there were five episodes of mesenteric ischemia in the conservative oxygenation group (none in the liberal oxygenation group).
Bottom line: A conservative oxygenation strategy cannot be currently recommended to patients with ARDS in the ICU. A minimum SpO2 of 90% was suggested in an accompanying editorial.
Editorial commentary: Interestingly, the supplemental results of the article show that prone positioning was used much less frequently in the conservative oxygenation group (34.3 vs 51.0%). If the impressive results of Guerin (2013) would be repeated in this population, this difference could help explain the higher observed mortality in the conservative oxygenation group. It is possible that, by aiming to be less aggressive in improving the PaO2, clinicians inadvertently withheld effective treatments for ARDS. The results of this trial bring up several interesting questions, but provide the bedside clinician with few answers. The complex interplay of treatment factors needs to be dissected in future trials.
Citation: Barrot L et al. Liberal or conservative oxygen therapy for acute respiratory distress syndrome. N Eng J Med. 2020;382:999-1008.
Dr. Saraiva is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.
Background: Both observational studies and clinical trials have found that a liberal oxygenation strategy in multiple inpatient settings may be harmful. Furthermore, a conservative strategy is what has been recommended in guidelines. Conversely, the relevance of this recent concept has been challenged in a large trial of a critically ill population (ICU-ROX).
Study design: Randomized clinical trial, unblinded.
Setting: Thirteen sites in France.
Synopsis: In a multicenter randomized clinical trial, investigators enrolled patients with ARDS to either a liberal oxygenation group (PaO2 target 90-105 mm Hg or SpO2 of 96% or greater) or a conservative oxygenation group (PaO2 target 55-70 mm Hg or SpO2 88%-92%). The trial was planned for inclusion of 850 patients, but the data and safety monitoring board decided to stop the trial after inclusion of 205 patients. Although the primary outcome (28-day all-cause mortality) was not significantly different between groups (34.3% vs 26.5%; absolute difference, 7.8%; 95% confidence interval, –4.8 to 20.6), the direction was signaling possible harm and there were five episodes of mesenteric ischemia in the conservative oxygenation group (none in the liberal oxygenation group).
Bottom line: A conservative oxygenation strategy cannot be currently recommended to patients with ARDS in the ICU. A minimum SpO2 of 90% was suggested in an accompanying editorial.
Editorial commentary: Interestingly, the supplemental results of the article show that prone positioning was used much less frequently in the conservative oxygenation group (34.3 vs 51.0%). If the impressive results of Guerin (2013) would be repeated in this population, this difference could help explain the higher observed mortality in the conservative oxygenation group. It is possible that, by aiming to be less aggressive in improving the PaO2, clinicians inadvertently withheld effective treatments for ARDS. The results of this trial bring up several interesting questions, but provide the bedside clinician with few answers. The complex interplay of treatment factors needs to be dissected in future trials.
Citation: Barrot L et al. Liberal or conservative oxygen therapy for acute respiratory distress syndrome. N Eng J Med. 2020;382:999-1008.
Dr. Saraiva is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.
Background: Both observational studies and clinical trials have found that a liberal oxygenation strategy in multiple inpatient settings may be harmful. Furthermore, a conservative strategy is what has been recommended in guidelines. Conversely, the relevance of this recent concept has been challenged in a large trial of a critically ill population (ICU-ROX).
Study design: Randomized clinical trial, unblinded.
Setting: Thirteen sites in France.
Synopsis: In a multicenter randomized clinical trial, investigators enrolled patients with ARDS to either a liberal oxygenation group (PaO2 target 90-105 mm Hg or SpO2 of 96% or greater) or a conservative oxygenation group (PaO2 target 55-70 mm Hg or SpO2 88%-92%). The trial was planned for inclusion of 850 patients, but the data and safety monitoring board decided to stop the trial after inclusion of 205 patients. Although the primary outcome (28-day all-cause mortality) was not significantly different between groups (34.3% vs 26.5%; absolute difference, 7.8%; 95% confidence interval, –4.8 to 20.6), the direction was signaling possible harm and there were five episodes of mesenteric ischemia in the conservative oxygenation group (none in the liberal oxygenation group).
Bottom line: A conservative oxygenation strategy cannot be currently recommended to patients with ARDS in the ICU. A minimum SpO2 of 90% was suggested in an accompanying editorial.
Editorial commentary: Interestingly, the supplemental results of the article show that prone positioning was used much less frequently in the conservative oxygenation group (34.3 vs 51.0%). If the impressive results of Guerin (2013) would be repeated in this population, this difference could help explain the higher observed mortality in the conservative oxygenation group. It is possible that, by aiming to be less aggressive in improving the PaO2, clinicians inadvertently withheld effective treatments for ARDS. The results of this trial bring up several interesting questions, but provide the bedside clinician with few answers. The complex interplay of treatment factors needs to be dissected in future trials.
Citation: Barrot L et al. Liberal or conservative oxygen therapy for acute respiratory distress syndrome. N Eng J Med. 2020;382:999-1008.
Dr. Saraiva is a hospitalist and assistant professor of medicine at UK HealthCare, Lexington, Ky.
Advocates seek to reframe masks as a disability accommodation
As governors and legislatures in states such as Texas, Florida, South Carolina, and Arkansas have banned schools and other entities from implementing mask mandates, disability rights advocates have pushed back. In federal civil rights lawsuits, they argue that bans on mask mandates violate antidiscrimination laws protecting people with disabilities.
For unvaccinated and immunosuppressed individuals, masks can provide crucial protection from SARS-CoV-2.
argues Mical Raz, MD, PhD, a professor at the University of Rochester (N.Y.) and a physician at Strong Memorial Hospital, also in Rochester, New York, in an article published in JAMA with coauthor Doron Dorfman, LLB, JSD.
This news organization talked with Dr. Raz about approaching mask requirements as disability accommodation during the COVID-19 pandemic. The following interview was lightly edited for length and clarity.
How did you come to think about mask requirements as a form of disability accommodation?
I saw a tweet from a professor at a university who said they couldn’t ask students about their vaccination status or to wear a mask. All agency was removed from the professor to take care of and protect themselves. I thought, well, that can’t be right. And ostensibly, that would be particularly dangerous for somebody with immunosuppression for whom the vaccine is not adequately protective. So, I called my friend, Doron Dorfman, and asked him to help me think through the legal part of this. We fleshed it out and wrote the article that same night.
How novel is it to view accommodations for people who are immunosuppressed through the lens of disability accommodation?
I think there has not been enough focus during the pandemic on individuals with disabilities or on how disability law can be mobilized during this pandemic to help supplement the public health law. This framework should be used a lot more because it’s good for everybody, not just for individuals with disabilities.
For example, take what’s called the “curb effect.” If you expand sidewalks, yes, it helps individuals who use a wheelchair. But it also helps me as a mom with a stroller. It helps somebody with a shopping cart, or a kid with a bike. If we adopt policies that are inclusive to those who are disadvantaged, it’s good for everybody. We should always strive to be an inclusive society, not just because it’s the right thing to do but because it really makes our society better.
How can mask requirements be used as a form of disability accommodation, as you argue in the JAMA article?
The ADA requires employers to provide reasonable accommodations for disability. In this case, the disability is your immunosuppressive status. We have an abundance of evidence showing individuals who are immunocompromised and vaccinated are still inadequately protected from the SARS-CoV-2 virus. So, there is absolute data to show individuals with immunosuppression have a disability that requires accommodation.
The ADA has a mandate requiring employers to adjust or modify policies in order to accommodate a disability. There are certain situations in which you cannot or do not need to accommodate a disability, when it would fundamentally alter the kind of employment you offer or if it’s an undue burden or hardship. But given that we’ve been wearing masks and working remotely for a year now, arguing that somehow these accommodations are no longer possible seems disingenuous.
In that way, allowing a person who’s immunocompromised to require those around them to mask is a form of modified protective policies. And in this case, those policies line up with a public health good, masking in the face of the highly contagious Delta variant ravaging our country right now.
In your view, can this argument be used in the mask debates happening right now across the country?
This argument can and should be useful for a couple of different lawsuits that are now underway in different states. I hope our article will provide further support for those suits. And I hope in school board hearings, when parents and teachers are talking about their concerns, this could be one way to argue for why we should allow mask mandates in classes. I’ve received emails from parents who said they’re going to bring this article to their school board hearing.
I also hope this could shift the narrative around the pandemic. Instead of focusing on individual responsibility – I got my vaccine shot so I’m fine – let’s focus on how we create an inclusive environment where we protect everybody, including those who cannot be vaccinated because of age or disability, or those who are vaccinated but inadequately protected because of their underlying conditions.
In the JAMA article, you talk about how our pandemic response has focused on individual health and how that individual focus can be ableist. Can you explain that point?
I think this idea that we just make our choices – like whether to get vaccinated or wear a mask, or not – and live with it really perpetuates a highly individualistic and ableist mindset. It doesn’t consider the people I admit to the hospital who are vaccinated but have a heart transplant and didn’t mount the sufficient immune response. Or even the people who chose not to be vaccinated because they were exposed to hours and hours of misinformation on TV.
We like to individualize everything, focusing on personal responsibility and choices, but a pandemic is one of those moments where everybody’s choices affect everybody else. Laying responsibility at the doorstep of each person, rather than thinking about what steps we as a society could be taking, is cheap and politically expedient. There is no public health rationale behind the bans on mask requirements in states like Texas, Iowa, and Florida. These choices are about politics. And the price is always borne by the most disadvantaged among us.
A version of this article first appeared on Medscape.com.
As governors and legislatures in states such as Texas, Florida, South Carolina, and Arkansas have banned schools and other entities from implementing mask mandates, disability rights advocates have pushed back. In federal civil rights lawsuits, they argue that bans on mask mandates violate antidiscrimination laws protecting people with disabilities.
For unvaccinated and immunosuppressed individuals, masks can provide crucial protection from SARS-CoV-2.
argues Mical Raz, MD, PhD, a professor at the University of Rochester (N.Y.) and a physician at Strong Memorial Hospital, also in Rochester, New York, in an article published in JAMA with coauthor Doron Dorfman, LLB, JSD.
This news organization talked with Dr. Raz about approaching mask requirements as disability accommodation during the COVID-19 pandemic. The following interview was lightly edited for length and clarity.
How did you come to think about mask requirements as a form of disability accommodation?
I saw a tweet from a professor at a university who said they couldn’t ask students about their vaccination status or to wear a mask. All agency was removed from the professor to take care of and protect themselves. I thought, well, that can’t be right. And ostensibly, that would be particularly dangerous for somebody with immunosuppression for whom the vaccine is not adequately protective. So, I called my friend, Doron Dorfman, and asked him to help me think through the legal part of this. We fleshed it out and wrote the article that same night.
How novel is it to view accommodations for people who are immunosuppressed through the lens of disability accommodation?
I think there has not been enough focus during the pandemic on individuals with disabilities or on how disability law can be mobilized during this pandemic to help supplement the public health law. This framework should be used a lot more because it’s good for everybody, not just for individuals with disabilities.
For example, take what’s called the “curb effect.” If you expand sidewalks, yes, it helps individuals who use a wheelchair. But it also helps me as a mom with a stroller. It helps somebody with a shopping cart, or a kid with a bike. If we adopt policies that are inclusive to those who are disadvantaged, it’s good for everybody. We should always strive to be an inclusive society, not just because it’s the right thing to do but because it really makes our society better.
How can mask requirements be used as a form of disability accommodation, as you argue in the JAMA article?
The ADA requires employers to provide reasonable accommodations for disability. In this case, the disability is your immunosuppressive status. We have an abundance of evidence showing individuals who are immunocompromised and vaccinated are still inadequately protected from the SARS-CoV-2 virus. So, there is absolute data to show individuals with immunosuppression have a disability that requires accommodation.
The ADA has a mandate requiring employers to adjust or modify policies in order to accommodate a disability. There are certain situations in which you cannot or do not need to accommodate a disability, when it would fundamentally alter the kind of employment you offer or if it’s an undue burden or hardship. But given that we’ve been wearing masks and working remotely for a year now, arguing that somehow these accommodations are no longer possible seems disingenuous.
In that way, allowing a person who’s immunocompromised to require those around them to mask is a form of modified protective policies. And in this case, those policies line up with a public health good, masking in the face of the highly contagious Delta variant ravaging our country right now.
In your view, can this argument be used in the mask debates happening right now across the country?
This argument can and should be useful for a couple of different lawsuits that are now underway in different states. I hope our article will provide further support for those suits. And I hope in school board hearings, when parents and teachers are talking about their concerns, this could be one way to argue for why we should allow mask mandates in classes. I’ve received emails from parents who said they’re going to bring this article to their school board hearing.
I also hope this could shift the narrative around the pandemic. Instead of focusing on individual responsibility – I got my vaccine shot so I’m fine – let’s focus on how we create an inclusive environment where we protect everybody, including those who cannot be vaccinated because of age or disability, or those who are vaccinated but inadequately protected because of their underlying conditions.
In the JAMA article, you talk about how our pandemic response has focused on individual health and how that individual focus can be ableist. Can you explain that point?
I think this idea that we just make our choices – like whether to get vaccinated or wear a mask, or not – and live with it really perpetuates a highly individualistic and ableist mindset. It doesn’t consider the people I admit to the hospital who are vaccinated but have a heart transplant and didn’t mount the sufficient immune response. Or even the people who chose not to be vaccinated because they were exposed to hours and hours of misinformation on TV.
We like to individualize everything, focusing on personal responsibility and choices, but a pandemic is one of those moments where everybody’s choices affect everybody else. Laying responsibility at the doorstep of each person, rather than thinking about what steps we as a society could be taking, is cheap and politically expedient. There is no public health rationale behind the bans on mask requirements in states like Texas, Iowa, and Florida. These choices are about politics. And the price is always borne by the most disadvantaged among us.
A version of this article first appeared on Medscape.com.
As governors and legislatures in states such as Texas, Florida, South Carolina, and Arkansas have banned schools and other entities from implementing mask mandates, disability rights advocates have pushed back. In federal civil rights lawsuits, they argue that bans on mask mandates violate antidiscrimination laws protecting people with disabilities.
For unvaccinated and immunosuppressed individuals, masks can provide crucial protection from SARS-CoV-2.
argues Mical Raz, MD, PhD, a professor at the University of Rochester (N.Y.) and a physician at Strong Memorial Hospital, also in Rochester, New York, in an article published in JAMA with coauthor Doron Dorfman, LLB, JSD.
This news organization talked with Dr. Raz about approaching mask requirements as disability accommodation during the COVID-19 pandemic. The following interview was lightly edited for length and clarity.
How did you come to think about mask requirements as a form of disability accommodation?
I saw a tweet from a professor at a university who said they couldn’t ask students about their vaccination status or to wear a mask. All agency was removed from the professor to take care of and protect themselves. I thought, well, that can’t be right. And ostensibly, that would be particularly dangerous for somebody with immunosuppression for whom the vaccine is not adequately protective. So, I called my friend, Doron Dorfman, and asked him to help me think through the legal part of this. We fleshed it out and wrote the article that same night.
How novel is it to view accommodations for people who are immunosuppressed through the lens of disability accommodation?
I think there has not been enough focus during the pandemic on individuals with disabilities or on how disability law can be mobilized during this pandemic to help supplement the public health law. This framework should be used a lot more because it’s good for everybody, not just for individuals with disabilities.
For example, take what’s called the “curb effect.” If you expand sidewalks, yes, it helps individuals who use a wheelchair. But it also helps me as a mom with a stroller. It helps somebody with a shopping cart, or a kid with a bike. If we adopt policies that are inclusive to those who are disadvantaged, it’s good for everybody. We should always strive to be an inclusive society, not just because it’s the right thing to do but because it really makes our society better.
How can mask requirements be used as a form of disability accommodation, as you argue in the JAMA article?
The ADA requires employers to provide reasonable accommodations for disability. In this case, the disability is your immunosuppressive status. We have an abundance of evidence showing individuals who are immunocompromised and vaccinated are still inadequately protected from the SARS-CoV-2 virus. So, there is absolute data to show individuals with immunosuppression have a disability that requires accommodation.
The ADA has a mandate requiring employers to adjust or modify policies in order to accommodate a disability. There are certain situations in which you cannot or do not need to accommodate a disability, when it would fundamentally alter the kind of employment you offer or if it’s an undue burden or hardship. But given that we’ve been wearing masks and working remotely for a year now, arguing that somehow these accommodations are no longer possible seems disingenuous.
In that way, allowing a person who’s immunocompromised to require those around them to mask is a form of modified protective policies. And in this case, those policies line up with a public health good, masking in the face of the highly contagious Delta variant ravaging our country right now.
In your view, can this argument be used in the mask debates happening right now across the country?
This argument can and should be useful for a couple of different lawsuits that are now underway in different states. I hope our article will provide further support for those suits. And I hope in school board hearings, when parents and teachers are talking about their concerns, this could be one way to argue for why we should allow mask mandates in classes. I’ve received emails from parents who said they’re going to bring this article to their school board hearing.
I also hope this could shift the narrative around the pandemic. Instead of focusing on individual responsibility – I got my vaccine shot so I’m fine – let’s focus on how we create an inclusive environment where we protect everybody, including those who cannot be vaccinated because of age or disability, or those who are vaccinated but inadequately protected because of their underlying conditions.
In the JAMA article, you talk about how our pandemic response has focused on individual health and how that individual focus can be ableist. Can you explain that point?
I think this idea that we just make our choices – like whether to get vaccinated or wear a mask, or not – and live with it really perpetuates a highly individualistic and ableist mindset. It doesn’t consider the people I admit to the hospital who are vaccinated but have a heart transplant and didn’t mount the sufficient immune response. Or even the people who chose not to be vaccinated because they were exposed to hours and hours of misinformation on TV.
We like to individualize everything, focusing on personal responsibility and choices, but a pandemic is one of those moments where everybody’s choices affect everybody else. Laying responsibility at the doorstep of each person, rather than thinking about what steps we as a society could be taking, is cheap and politically expedient. There is no public health rationale behind the bans on mask requirements in states like Texas, Iowa, and Florida. These choices are about politics. And the price is always borne by the most disadvantaged among us.
A version of this article first appeared on Medscape.com.
EAACI review urges reduction in antibiotic overuse with allergy
Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.
Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.
The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.
Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.
In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.
“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.
Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.
Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
Recommendations have global relevance
She said although the recommendations are coming from the EAACI group, they apply worldwide.
“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.
She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.
Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.
“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.
“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”
The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.
The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.
Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.
Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.
Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.
“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.
Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.
“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.
The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.
Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.
The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.
Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.
In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.
“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.
Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.
Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
Recommendations have global relevance
She said although the recommendations are coming from the EAACI group, they apply worldwide.
“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.
She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.
Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.
“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.
“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”
The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.
The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.
Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.
Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.
Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.
“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.
Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.
“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.
The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.
Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.
The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.
Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.
In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.
“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.
Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.
Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
Recommendations have global relevance
She said although the recommendations are coming from the EAACI group, they apply worldwide.
“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.
She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.
Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.
“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.
“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”
The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.
The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.
Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.
Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.
Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.
“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.
Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.
“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.
The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Genetic link may tie cannabis use disorder to severe COVID-19
The same genetic variations may boost susceptibility to both severe COVID-19 and cannabis use disorder (CUD), a new study suggests. The research does not confirm a genetic link, but the lead author said the signs of an association are still “troubling.”
“Reducing cannabis use among heavy users may potentially provide protection against severe COVID-19 presentations,” Alexander S. Hatoum, PhD, a postdoctoral scholar at Washington University, St. Louis, said in an interview. “Outside of individual risk, these data also have important implications for policy regarding vaccination as well as treatment prioritization in an overly taxed medical system.”
The study was published in the journal Biological Psychiatry Global Open Science.
Dr. Hatoum and colleagues launched the study to gain insight into whether CUD might be a risk factor for severe COVID-19 presentations.
As defined by the DSM-5, people with CUD suffer from impairment or distress because of their cannabis use and meet at least 2 of 11 criteria over a 12-month period, such as cravings, cannabis tolerance, and withdrawal symptoms. According to a 2020 study that examined 2008-2016 data, 2.72% of children aged 12-17 showed signs of CUD, as did 1.23% of those aged over 26.
The primary reasons for hospitalization and death related to COVID-19 are respiratory symptoms. “And we have observed that genetic vulnerability to CUD is shared with respiratory disease, even after tobacco use is considered,” Dr. Hatoum said.
He and his colleagues examined data from genomewide association studies and searched for genetic correlations between CUD (14,080 cases, 343,726 controls) and COVID-19 hospitalization (9,373 cases, 1,197,256 controls). “Genetic vulnerability to COVID-19 was correlated with genetic liability to CUD (P = 1.33e–6),” the researchers wrote. “This association remained when accounting for genetic liability to related risk factors and covariates (P = .012-.049).”
According to Dr. Hatoum, the researchers found inconclusive evidence that CUD might worsen COVID-19 cases. “We applied statistical causal models, which found an effect consistent with causality, but it was nonsignificant,” he said.
Despite the absence of causality, the study findings could prove useful for clinicians and policy makers.
“Those struggling with CUD may be prioritized for vaccination and vaccination boosters to mitigate their higher likelihood of a severe COVID-19 presentation,” Dr. Hatoum said. “When testing positive for COVID-19, they may also be prioritized for earlier treatment.”
The study authors also added that the findings “urge caution” in regard to the wave of U.S. states legalizing cannabis. “Our data suggest that heavy cannabis use, but not lifetime cannabis use, represents a risk factor for severe COVID-19 presentations,” Dr. Hatoum said.
In an interview, Danielle Dick, PhD, who was not involved with the study, said it applies “cutting-edge methods to an important research question” and offers a “hint” of a genetic risk factor that makes some people more likely to be hospitalized for COVID-19. However, “the study does not tell us what those underlying genetically influenced processes might be,” added Dr. Dick, professor of psychology, and human and molecular genetics at Virginia Commonwealth University, Richmond. “And it’s an important caveat to point out that the results from this study are limited in that they are based on data from people from European descent – so they can’t necessarily be applied to address the harm experienced by so many people of color from the COVID pandemic. That’s an unfortunate limitation.”
As for the idea that the study findings should prompt caution about marijuana legalization, Dr. Dick said it’s true that increased acceptability of drug use “increases the likelihood that individuals who are genetically vulnerable will develop problems. There is robust evidence of this.”
However, Dr. Dick said, “the legalization of marijuana is a complex topic because the health consequences aren’t the only consideration when it comes to legalization. The other side of the coin is the huge harm that has been caused to communities of color through marijuana criminalization. Legalization will hopefully lead to decreased harm on that front. So it’s a double-edged sword.”
Dr. Hatoum, his colleagues, and Dr. Dick reported no relevant disclosures.
The same genetic variations may boost susceptibility to both severe COVID-19 and cannabis use disorder (CUD), a new study suggests. The research does not confirm a genetic link, but the lead author said the signs of an association are still “troubling.”
“Reducing cannabis use among heavy users may potentially provide protection against severe COVID-19 presentations,” Alexander S. Hatoum, PhD, a postdoctoral scholar at Washington University, St. Louis, said in an interview. “Outside of individual risk, these data also have important implications for policy regarding vaccination as well as treatment prioritization in an overly taxed medical system.”
The study was published in the journal Biological Psychiatry Global Open Science.
Dr. Hatoum and colleagues launched the study to gain insight into whether CUD might be a risk factor for severe COVID-19 presentations.
As defined by the DSM-5, people with CUD suffer from impairment or distress because of their cannabis use and meet at least 2 of 11 criteria over a 12-month period, such as cravings, cannabis tolerance, and withdrawal symptoms. According to a 2020 study that examined 2008-2016 data, 2.72% of children aged 12-17 showed signs of CUD, as did 1.23% of those aged over 26.
The primary reasons for hospitalization and death related to COVID-19 are respiratory symptoms. “And we have observed that genetic vulnerability to CUD is shared with respiratory disease, even after tobacco use is considered,” Dr. Hatoum said.
He and his colleagues examined data from genomewide association studies and searched for genetic correlations between CUD (14,080 cases, 343,726 controls) and COVID-19 hospitalization (9,373 cases, 1,197,256 controls). “Genetic vulnerability to COVID-19 was correlated with genetic liability to CUD (P = 1.33e–6),” the researchers wrote. “This association remained when accounting for genetic liability to related risk factors and covariates (P = .012-.049).”
According to Dr. Hatoum, the researchers found inconclusive evidence that CUD might worsen COVID-19 cases. “We applied statistical causal models, which found an effect consistent with causality, but it was nonsignificant,” he said.
Despite the absence of causality, the study findings could prove useful for clinicians and policy makers.
“Those struggling with CUD may be prioritized for vaccination and vaccination boosters to mitigate their higher likelihood of a severe COVID-19 presentation,” Dr. Hatoum said. “When testing positive for COVID-19, they may also be prioritized for earlier treatment.”
The study authors also added that the findings “urge caution” in regard to the wave of U.S. states legalizing cannabis. “Our data suggest that heavy cannabis use, but not lifetime cannabis use, represents a risk factor for severe COVID-19 presentations,” Dr. Hatoum said.
In an interview, Danielle Dick, PhD, who was not involved with the study, said it applies “cutting-edge methods to an important research question” and offers a “hint” of a genetic risk factor that makes some people more likely to be hospitalized for COVID-19. However, “the study does not tell us what those underlying genetically influenced processes might be,” added Dr. Dick, professor of psychology, and human and molecular genetics at Virginia Commonwealth University, Richmond. “And it’s an important caveat to point out that the results from this study are limited in that they are based on data from people from European descent – so they can’t necessarily be applied to address the harm experienced by so many people of color from the COVID pandemic. That’s an unfortunate limitation.”
As for the idea that the study findings should prompt caution about marijuana legalization, Dr. Dick said it’s true that increased acceptability of drug use “increases the likelihood that individuals who are genetically vulnerable will develop problems. There is robust evidence of this.”
However, Dr. Dick said, “the legalization of marijuana is a complex topic because the health consequences aren’t the only consideration when it comes to legalization. The other side of the coin is the huge harm that has been caused to communities of color through marijuana criminalization. Legalization will hopefully lead to decreased harm on that front. So it’s a double-edged sword.”
Dr. Hatoum, his colleagues, and Dr. Dick reported no relevant disclosures.
The same genetic variations may boost susceptibility to both severe COVID-19 and cannabis use disorder (CUD), a new study suggests. The research does not confirm a genetic link, but the lead author said the signs of an association are still “troubling.”
“Reducing cannabis use among heavy users may potentially provide protection against severe COVID-19 presentations,” Alexander S. Hatoum, PhD, a postdoctoral scholar at Washington University, St. Louis, said in an interview. “Outside of individual risk, these data also have important implications for policy regarding vaccination as well as treatment prioritization in an overly taxed medical system.”
The study was published in the journal Biological Psychiatry Global Open Science.
Dr. Hatoum and colleagues launched the study to gain insight into whether CUD might be a risk factor for severe COVID-19 presentations.
As defined by the DSM-5, people with CUD suffer from impairment or distress because of their cannabis use and meet at least 2 of 11 criteria over a 12-month period, such as cravings, cannabis tolerance, and withdrawal symptoms. According to a 2020 study that examined 2008-2016 data, 2.72% of children aged 12-17 showed signs of CUD, as did 1.23% of those aged over 26.
The primary reasons for hospitalization and death related to COVID-19 are respiratory symptoms. “And we have observed that genetic vulnerability to CUD is shared with respiratory disease, even after tobacco use is considered,” Dr. Hatoum said.
He and his colleagues examined data from genomewide association studies and searched for genetic correlations between CUD (14,080 cases, 343,726 controls) and COVID-19 hospitalization (9,373 cases, 1,197,256 controls). “Genetic vulnerability to COVID-19 was correlated with genetic liability to CUD (P = 1.33e–6),” the researchers wrote. “This association remained when accounting for genetic liability to related risk factors and covariates (P = .012-.049).”
According to Dr. Hatoum, the researchers found inconclusive evidence that CUD might worsen COVID-19 cases. “We applied statistical causal models, which found an effect consistent with causality, but it was nonsignificant,” he said.
Despite the absence of causality, the study findings could prove useful for clinicians and policy makers.
“Those struggling with CUD may be prioritized for vaccination and vaccination boosters to mitigate their higher likelihood of a severe COVID-19 presentation,” Dr. Hatoum said. “When testing positive for COVID-19, they may also be prioritized for earlier treatment.”
The study authors also added that the findings “urge caution” in regard to the wave of U.S. states legalizing cannabis. “Our data suggest that heavy cannabis use, but not lifetime cannabis use, represents a risk factor for severe COVID-19 presentations,” Dr. Hatoum said.
In an interview, Danielle Dick, PhD, who was not involved with the study, said it applies “cutting-edge methods to an important research question” and offers a “hint” of a genetic risk factor that makes some people more likely to be hospitalized for COVID-19. However, “the study does not tell us what those underlying genetically influenced processes might be,” added Dr. Dick, professor of psychology, and human and molecular genetics at Virginia Commonwealth University, Richmond. “And it’s an important caveat to point out that the results from this study are limited in that they are based on data from people from European descent – so they can’t necessarily be applied to address the harm experienced by so many people of color from the COVID pandemic. That’s an unfortunate limitation.”
As for the idea that the study findings should prompt caution about marijuana legalization, Dr. Dick said it’s true that increased acceptability of drug use “increases the likelihood that individuals who are genetically vulnerable will develop problems. There is robust evidence of this.”
However, Dr. Dick said, “the legalization of marijuana is a complex topic because the health consequences aren’t the only consideration when it comes to legalization. The other side of the coin is the huge harm that has been caused to communities of color through marijuana criminalization. Legalization will hopefully lead to decreased harm on that front. So it’s a double-edged sword.”
Dr. Hatoum, his colleagues, and Dr. Dick reported no relevant disclosures.
FROM BIOLOGICAL PSYCHIATRY GLOBAL OPEN SCIENCE
AHA targets rising prevalence of obstructive sleep apnea in children
Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association.
The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese.
The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association.
Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented.
“There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.”
Clarity on polysomnography
For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr. Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.”
The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring.
In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.”
Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote.
Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.
Risk factors for OSA in children
The statement also reviewed risk factors for OSA, among them obesity, particularly among children younger than 6 years. Other risk factors include upper and lower airway disease, hypotonia, parental history of hyperplasia of the adenoids and tonsils, craniofacial malformations, and neuromuscular disorders. However, the committee cited “limited data” to support that children with congenital heart disease may be at greater risk for OSA and sleep-disordered breathing (SDB).
Black children are at significantly greater risk, and socioeconomic factors “may be potential confounders,” the committee stated. Other risk factors include allergic rhinitis and sickle cell disease.
But the statement underscores that “obesity is the main risk factor” for OSA in children and adolescents, and that the presence of increased inflammation may explain this relationship. Steroids may alleviate these symptoms, even in nonobese children, and removal of the adenoids or tonsils is an option to reduce inflammation in children with OSA.
“Obesity is a significant risk factor for sleep disturbances and obstructive sleep apnea, and the severity of sleep apnea may be improved by weight-loss interventions, which then improves metabolic syndrome factors such as insulin sensitivity,” Dr. Baker-Smith said. “We need to increase awareness about how the rising prevalence of obesity may be impacting sleep quality in kids and recognize sleep-disordered breathing as something that could contribute to risks for hypertension and later cardiovascular disease.”
Children in whom OSA is suspected should also undergo screening for metabolic syndrome, and central nervous system and behavioral disorders.
Cardiovascular risks
The statement explores the connection between cardiovascular complications and SDB and OSA in depth.
“Inadequate sleep duration of < 5 hours per night in children and adolescents has been linked to an increased risk of hypertension and is also associated with an increased prevalence of obesity,” the committee wrote.
However, the statement left one question hanging: whether OSA alone or obesity cause higher BP in younger patients with OSA. But the committee concluded that BP levels increase with the severity of OSA, although the effects can vary with age. OSA in children peaks between ages 2 and 8, corresponding to the peak prevalence of hypertrophy of the tonsils and adenoids. Children aged 10-11 with more severe OSA may have BP dysregulation, while older adolescents develop higher sustained BP. Obesity may be a confounder for daytime BP elevations, while nighttime hypertension depends less on obesity and more on OSA severity.
“OSA is associated with abnormal BP in youth and, in particular, higher nighttime blood pressures and loss of the normal decline in BP that should occur during sleep,” Dr. Baker-Smith said. “Children with OSA appear to have higher BP than controls during both sleep and wake times, and BP levels increase with increasing severity of OSA.”
Nonetheless, children with OSA are at greater risk for other cardiovascular problems. Left ventricular hypertrophy may be a secondary outcome. “The presence of obstructive sleep apnea in children is associated with an 11-fold increased risk for LVH in children, a relationship not seen in the presence of primary snoring alone,” Dr. Baker-Smith said.
Dr. Baker-Smith had no relevant disclosures. Coauthor Amal Isaiah, MD, is coinventor of an imaging system for sleep apnea and receives royalties from the University of Maryland. The other coauthors have no relevant financial relationships to disclose.
Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association.
The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese.
The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association.
Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented.
“There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.”
Clarity on polysomnography
For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr. Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.”
The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring.
In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.”
Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote.
Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.
Risk factors for OSA in children
The statement also reviewed risk factors for OSA, among them obesity, particularly among children younger than 6 years. Other risk factors include upper and lower airway disease, hypotonia, parental history of hyperplasia of the adenoids and tonsils, craniofacial malformations, and neuromuscular disorders. However, the committee cited “limited data” to support that children with congenital heart disease may be at greater risk for OSA and sleep-disordered breathing (SDB).
Black children are at significantly greater risk, and socioeconomic factors “may be potential confounders,” the committee stated. Other risk factors include allergic rhinitis and sickle cell disease.
But the statement underscores that “obesity is the main risk factor” for OSA in children and adolescents, and that the presence of increased inflammation may explain this relationship. Steroids may alleviate these symptoms, even in nonobese children, and removal of the adenoids or tonsils is an option to reduce inflammation in children with OSA.
“Obesity is a significant risk factor for sleep disturbances and obstructive sleep apnea, and the severity of sleep apnea may be improved by weight-loss interventions, which then improves metabolic syndrome factors such as insulin sensitivity,” Dr. Baker-Smith said. “We need to increase awareness about how the rising prevalence of obesity may be impacting sleep quality in kids and recognize sleep-disordered breathing as something that could contribute to risks for hypertension and later cardiovascular disease.”
Children in whom OSA is suspected should also undergo screening for metabolic syndrome, and central nervous system and behavioral disorders.
Cardiovascular risks
The statement explores the connection between cardiovascular complications and SDB and OSA in depth.
“Inadequate sleep duration of < 5 hours per night in children and adolescents has been linked to an increased risk of hypertension and is also associated with an increased prevalence of obesity,” the committee wrote.
However, the statement left one question hanging: whether OSA alone or obesity cause higher BP in younger patients with OSA. But the committee concluded that BP levels increase with the severity of OSA, although the effects can vary with age. OSA in children peaks between ages 2 and 8, corresponding to the peak prevalence of hypertrophy of the tonsils and adenoids. Children aged 10-11 with more severe OSA may have BP dysregulation, while older adolescents develop higher sustained BP. Obesity may be a confounder for daytime BP elevations, while nighttime hypertension depends less on obesity and more on OSA severity.
“OSA is associated with abnormal BP in youth and, in particular, higher nighttime blood pressures and loss of the normal decline in BP that should occur during sleep,” Dr. Baker-Smith said. “Children with OSA appear to have higher BP than controls during both sleep and wake times, and BP levels increase with increasing severity of OSA.”
Nonetheless, children with OSA are at greater risk for other cardiovascular problems. Left ventricular hypertrophy may be a secondary outcome. “The presence of obstructive sleep apnea in children is associated with an 11-fold increased risk for LVH in children, a relationship not seen in the presence of primary snoring alone,” Dr. Baker-Smith said.
Dr. Baker-Smith had no relevant disclosures. Coauthor Amal Isaiah, MD, is coinventor of an imaging system for sleep apnea and receives royalties from the University of Maryland. The other coauthors have no relevant financial relationships to disclose.
Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association.
The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese.
The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association.
Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented.
“There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.”
Clarity on polysomnography
For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr. Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.”
The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring.
In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.”
Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote.
Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.
Risk factors for OSA in children
The statement also reviewed risk factors for OSA, among them obesity, particularly among children younger than 6 years. Other risk factors include upper and lower airway disease, hypotonia, parental history of hyperplasia of the adenoids and tonsils, craniofacial malformations, and neuromuscular disorders. However, the committee cited “limited data” to support that children with congenital heart disease may be at greater risk for OSA and sleep-disordered breathing (SDB).
Black children are at significantly greater risk, and socioeconomic factors “may be potential confounders,” the committee stated. Other risk factors include allergic rhinitis and sickle cell disease.
But the statement underscores that “obesity is the main risk factor” for OSA in children and adolescents, and that the presence of increased inflammation may explain this relationship. Steroids may alleviate these symptoms, even in nonobese children, and removal of the adenoids or tonsils is an option to reduce inflammation in children with OSA.
“Obesity is a significant risk factor for sleep disturbances and obstructive sleep apnea, and the severity of sleep apnea may be improved by weight-loss interventions, which then improves metabolic syndrome factors such as insulin sensitivity,” Dr. Baker-Smith said. “We need to increase awareness about how the rising prevalence of obesity may be impacting sleep quality in kids and recognize sleep-disordered breathing as something that could contribute to risks for hypertension and later cardiovascular disease.”
Children in whom OSA is suspected should also undergo screening for metabolic syndrome, and central nervous system and behavioral disorders.
Cardiovascular risks
The statement explores the connection between cardiovascular complications and SDB and OSA in depth.
“Inadequate sleep duration of < 5 hours per night in children and adolescents has been linked to an increased risk of hypertension and is also associated with an increased prevalence of obesity,” the committee wrote.
However, the statement left one question hanging: whether OSA alone or obesity cause higher BP in younger patients with OSA. But the committee concluded that BP levels increase with the severity of OSA, although the effects can vary with age. OSA in children peaks between ages 2 and 8, corresponding to the peak prevalence of hypertrophy of the tonsils and adenoids. Children aged 10-11 with more severe OSA may have BP dysregulation, while older adolescents develop higher sustained BP. Obesity may be a confounder for daytime BP elevations, while nighttime hypertension depends less on obesity and more on OSA severity.
“OSA is associated with abnormal BP in youth and, in particular, higher nighttime blood pressures and loss of the normal decline in BP that should occur during sleep,” Dr. Baker-Smith said. “Children with OSA appear to have higher BP than controls during both sleep and wake times, and BP levels increase with increasing severity of OSA.”
Nonetheless, children with OSA are at greater risk for other cardiovascular problems. Left ventricular hypertrophy may be a secondary outcome. “The presence of obstructive sleep apnea in children is associated with an 11-fold increased risk for LVH in children, a relationship not seen in the presence of primary snoring alone,” Dr. Baker-Smith said.
Dr. Baker-Smith had no relevant disclosures. Coauthor Amal Isaiah, MD, is coinventor of an imaging system for sleep apnea and receives royalties from the University of Maryland. The other coauthors have no relevant financial relationships to disclose.
FROM JOURNAL OF THE AMERICAN HEART ASSOCIATION