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Hospitals refused to give patients ivermectin. Lockdowns and political pressure followed.
Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.
And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.
These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.
“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”
Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.
Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.
Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.
In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.
“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.
Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.
The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.
“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”
An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.
That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.
“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.
“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.
A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.
Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.
Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.
The report did not offer any conclusions or allegations of wrongdoing.
Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.
“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.
“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.
The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.
Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.
“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”
He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.
Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.
“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.
Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.
“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.
And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.
These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.
“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”
Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.
Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.
Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.
In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.
“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.
Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.
The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.
“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”
An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.
That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.
“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.
“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.
A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.
Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.
Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.
The report did not offer any conclusions or allegations of wrongdoing.
Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.
“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.
“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.
The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.
Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.
“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”
He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.
Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.
“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.
Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.
“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.
And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.
These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.
“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”
Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.
Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.
Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.
In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.
“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.
Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.
The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.
“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”
An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.
That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.
“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.
“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.
A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.
Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.
Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.
The report did not offer any conclusions or allegations of wrongdoing.
Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.
“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.
“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.
The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.
Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.
“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”
He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.
Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.
“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.
Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.
“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
No serious CV risks for elderly after Pfizer COVID-19 vaccine
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
It feels like COVID is closing in
Like so many of you, I have weathered COVID-19 for the last almost 2 years. We’ve dealt with anxiety in our patients and ourselves, ever conflicting directives over masks, and uncertainty and hope over vaccinations.
In the beginning, it seemed elsewhere. Wuhan, China, the state of Washington, New York City.
In the beginning, I awoke with rising anxiety every morning at 4 a.m.
Now, it is part of life. We know how to do this.
I work in a D.C. hospital that takes care of COVID-19 patients. I don’t intubate or come into direct contact with patients’ secretions.
I felt lucky.
Last summer, I felt relief, after being fully vaccinated. We thought we were almost over it. But the numbers abroad and in the United States keep rising.
We have developed protocols. We test every patient for COVID-19 before admitting them to psychiatry, which is now routine. COVID-19–positive patients with suicidal ideation go to our medicine-psychiatric unit. We are single-room occupancy. No visitors.
Now, it feels like COVID is closing in. Lots of my patients on consultation-liaison psychiatry had COVID-19 or do now. The number of patients with long COVID is increasing. My elderly mother-in-law picked it up from a hospital. My young, healthy adult son got it but is now doing relatively OK. We will see if his ADHD worsens.
I received contact tracing recently for going into a patient room with contact precautions. I had put on the gown and gloves, but did I wear my goggles? I keep them on my forehead but could not remember if I had slipped them over my eyes.
I get tested weekly. My nose runs inside my mask. I sneeze. Is this COVID?
Of course, I am vaccinated with a booster shot. But breakthrough infections occur.
I am lucky, I keep reminding myself. I have a job and income and good PPE.
So, we are learning how to manage this disease. But it still closes in. My brain screams: “I do not want to catch this disease. I do not want to get sick. I do not want to get long COVID.”
“Calm down, Cam,” I tell myself. “You can do this!” I have learned how to do all the PPE, including tying the plastic ties along the backs of the plastic gowns.
All psychiatry meetings are virtual now. I cannot do virtual with enthusiasm. I say I will, but then do not log on. I miss the camaraderie.
All appointments are mainly telehealth. That has its pros and cons.
So bottom line – I will keep keeping on.
But I really want others to get vaccinated and wear masks. More than that, how can we as a psychiatric community get us through this pandemic?
Here are a few suggestions, some of which I have made before:
- Focus on what we can control, especially exercise and sleep. Walk during times when the sun is shining. Rake the gorgeous autumn yellow and orange leaves.
- Give small (or large) gifts of kindness to others. Give to food banks, provide large tips to those who bring you takeout, help out at an animal shelter.
- Talk through established media about self-care and therapy for anxiety and depression.
- Clean out your closets. Give clothes to Afghan refugees.
- Read good books about trying times – such as World War II and the long wars in Afghanistan and Iraq.
- Take care of veterans and the elderly and homeless.
- Take care of yourself and your family.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center. She has no conflicts of interest.
Like so many of you, I have weathered COVID-19 for the last almost 2 years. We’ve dealt with anxiety in our patients and ourselves, ever conflicting directives over masks, and uncertainty and hope over vaccinations.
In the beginning, it seemed elsewhere. Wuhan, China, the state of Washington, New York City.
In the beginning, I awoke with rising anxiety every morning at 4 a.m.
Now, it is part of life. We know how to do this.
I work in a D.C. hospital that takes care of COVID-19 patients. I don’t intubate or come into direct contact with patients’ secretions.
I felt lucky.
Last summer, I felt relief, after being fully vaccinated. We thought we were almost over it. But the numbers abroad and in the United States keep rising.
We have developed protocols. We test every patient for COVID-19 before admitting them to psychiatry, which is now routine. COVID-19–positive patients with suicidal ideation go to our medicine-psychiatric unit. We are single-room occupancy. No visitors.
Now, it feels like COVID is closing in. Lots of my patients on consultation-liaison psychiatry had COVID-19 or do now. The number of patients with long COVID is increasing. My elderly mother-in-law picked it up from a hospital. My young, healthy adult son got it but is now doing relatively OK. We will see if his ADHD worsens.
I received contact tracing recently for going into a patient room with contact precautions. I had put on the gown and gloves, but did I wear my goggles? I keep them on my forehead but could not remember if I had slipped them over my eyes.
I get tested weekly. My nose runs inside my mask. I sneeze. Is this COVID?
Of course, I am vaccinated with a booster shot. But breakthrough infections occur.
I am lucky, I keep reminding myself. I have a job and income and good PPE.
So, we are learning how to manage this disease. But it still closes in. My brain screams: “I do not want to catch this disease. I do not want to get sick. I do not want to get long COVID.”
“Calm down, Cam,” I tell myself. “You can do this!” I have learned how to do all the PPE, including tying the plastic ties along the backs of the plastic gowns.
All psychiatry meetings are virtual now. I cannot do virtual with enthusiasm. I say I will, but then do not log on. I miss the camaraderie.
All appointments are mainly telehealth. That has its pros and cons.
So bottom line – I will keep keeping on.
But I really want others to get vaccinated and wear masks. More than that, how can we as a psychiatric community get us through this pandemic?
Here are a few suggestions, some of which I have made before:
- Focus on what we can control, especially exercise and sleep. Walk during times when the sun is shining. Rake the gorgeous autumn yellow and orange leaves.
- Give small (or large) gifts of kindness to others. Give to food banks, provide large tips to those who bring you takeout, help out at an animal shelter.
- Talk through established media about self-care and therapy for anxiety and depression.
- Clean out your closets. Give clothes to Afghan refugees.
- Read good books about trying times – such as World War II and the long wars in Afghanistan and Iraq.
- Take care of veterans and the elderly and homeless.
- Take care of yourself and your family.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center. She has no conflicts of interest.
Like so many of you, I have weathered COVID-19 for the last almost 2 years. We’ve dealt with anxiety in our patients and ourselves, ever conflicting directives over masks, and uncertainty and hope over vaccinations.
In the beginning, it seemed elsewhere. Wuhan, China, the state of Washington, New York City.
In the beginning, I awoke with rising anxiety every morning at 4 a.m.
Now, it is part of life. We know how to do this.
I work in a D.C. hospital that takes care of COVID-19 patients. I don’t intubate or come into direct contact with patients’ secretions.
I felt lucky.
Last summer, I felt relief, after being fully vaccinated. We thought we were almost over it. But the numbers abroad and in the United States keep rising.
We have developed protocols. We test every patient for COVID-19 before admitting them to psychiatry, which is now routine. COVID-19–positive patients with suicidal ideation go to our medicine-psychiatric unit. We are single-room occupancy. No visitors.
Now, it feels like COVID is closing in. Lots of my patients on consultation-liaison psychiatry had COVID-19 or do now. The number of patients with long COVID is increasing. My elderly mother-in-law picked it up from a hospital. My young, healthy adult son got it but is now doing relatively OK. We will see if his ADHD worsens.
I received contact tracing recently for going into a patient room with contact precautions. I had put on the gown and gloves, but did I wear my goggles? I keep them on my forehead but could not remember if I had slipped them over my eyes.
I get tested weekly. My nose runs inside my mask. I sneeze. Is this COVID?
Of course, I am vaccinated with a booster shot. But breakthrough infections occur.
I am lucky, I keep reminding myself. I have a job and income and good PPE.
So, we are learning how to manage this disease. But it still closes in. My brain screams: “I do not want to catch this disease. I do not want to get sick. I do not want to get long COVID.”
“Calm down, Cam,” I tell myself. “You can do this!” I have learned how to do all the PPE, including tying the plastic ties along the backs of the plastic gowns.
All psychiatry meetings are virtual now. I cannot do virtual with enthusiasm. I say I will, but then do not log on. I miss the camaraderie.
All appointments are mainly telehealth. That has its pros and cons.
So bottom line – I will keep keeping on.
But I really want others to get vaccinated and wear masks. More than that, how can we as a psychiatric community get us through this pandemic?
Here are a few suggestions, some of which I have made before:
- Focus on what we can control, especially exercise and sleep. Walk during times when the sun is shining. Rake the gorgeous autumn yellow and orange leaves.
- Give small (or large) gifts of kindness to others. Give to food banks, provide large tips to those who bring you takeout, help out at an animal shelter.
- Talk through established media about self-care and therapy for anxiety and depression.
- Clean out your closets. Give clothes to Afghan refugees.
- Read good books about trying times – such as World War II and the long wars in Afghanistan and Iraq.
- Take care of veterans and the elderly and homeless.
- Take care of yourself and your family.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center. She has no conflicts of interest.
COVID-19 and the immunocompromised physician
Working feverishly to complete the myriad patient notes accumulated throughout a hectic day, my phone vibrated – alerting me to a number that, over the past several years, has wrought uncertainty, grief, and overwhelming relief. Answering hesitantly, I listened to my physician’s pharmacist inform me of unexpected and alarming news.
Since COVID-19 was first identified more than 1 year ago, more than 770,000 people have died in the United States. In the wake of those losses, countless grieve while attempting to navigate a future without their loved ones. Meanwhile, scientists worked feverishly to combat a pandemic relentless in contagion. As health care professionals, we work tirelessly against the sharpened scythe of death, toiling day after day without an identifiable end. All the while, advocacy has prevailed as the need for personal protective equipment, improved ventilation systems, sanitization measures, and other mitigation measures, such as mask wearing and social distancing, echoed swiftly across the nation and around the world.
But, as the months have progressed, and life has seemingly transitioned toward a parallel version of reality, subsections of communities have grown restless. Several nontherapeutic, ineffective, and falsely touted regimens have been promoted. Amid the chaos of misinformation, most medical professionals have sought support from respected journals and infectious disease experts to filter out jargon and piece together scientifically sound protocols. Although many lives have prevailed by way of those advancements, mixed messages about interventions have emerged – and in many quarters across the country, anger, resistance, and outright refusal have prevailed.
Yet, we – the medical community – have forged ever onward as the cases continued and the death toll steadily climbed. In many cases, physicians who are years removed from critical care training have been thrust into COVID units, while residents have shifted toward working outside of their chosen specialty. Outpatient offices have closed, salaries have been cut, and furloughs have loomed as days fade into months. Beset with exhaustion and uncertainty, sacrifice has become a common thread that intrinsically united us against an unrelenting foe.
Most people continued navigating the many changes and made concerted efforts to mimic our prepandemic lives. Working from home in makeshift offices, dusting off math skills to assist children through the doldrums of distance learning, and mastering various audiovisual platforms, we reinforced social bonds and forged new connections echoing the hallmark resilience reminiscent of our shared distant ancestry.
As of this writing, thanks to our work – and that of scientists and policy makers – about 69% of Americans have received at least one dose of vaccine, and vaccines are widely available to children 5 and older. But it has been disheartening to watch misinformation about vaccine research and development propagated by political figures, social media, and lay people.
Processing the phone call
While listening to my physician’s pharmacist, I slowed my breaths in an effort to find calm. Years of navigating the American health care industry had left me both equipped and ill-prepared for the unexpected. I listened intently to the pharmacist’s words while staring blankly at a computer screen – uncertain of what had felt so assured not 10 minutes earlier.
That’s when I got the news. The intravenous medication that aided in my stabilization had suffered a critical shortage because of its successful use in the treatment of patients with COVID-19 pneumonia – patients who, in a majority of cases, had likely refused the vaccines. As result, the medication that had enabled my return to work, active engagement in nonwork pursuits, and most importantly, equipped my body to thrive despite the damage it had suffered, suddenly vanished.
Gently placing my phone on the desk, my heart beat rapidly as tears steadily streamed down my face. Staring blankly ahead, my hands gradually balled into fists as I let out a sound of fear, agony, and uncertainty. Screaming at everything and nothing, nausea swelled as panic flooded my body. In that moment, I ruminated on the conversation with the pharmacist. There had been no discussion, no option for me to maintain accessibility to this valuable medicine. Consequently, I felt helpless. Although the same medication, albeit a different mechanism of delivery, was promptly chosen as an adequate substitute, there was no guarantee of it bestowing the same degree of efficacy. So I was terrified, envisioning the progress made over several years as plummeting into an abyss of pain and despair. What are those of us who have chosen medicine as our profession but are immunocompromised expected to make of this?
Over the next several weeks, I diligently adhered to the new regimen and focused on positive mentation. Nevertheless, day by day, the symptoms worsened; eventually, I became bed ridden. I tried to gather what little composure remained to reschedule patients and justify the resounding guilt of perceived failure. I remember the sweet and gentle look of my child as I once again could not summon the strength to play pretend. This felt overwhelming. Would I ever go back to work? Would I see my child grow? No amount of pleading or screaming would change the fact that a medical system chose to roll the dice on my health. In a haze of discomfort and betrayal, I wondered how a physician or medical facility could justify removing medication from someone reliant upon it. How do we choose the appropriate allocation of resources when the consequences are potentially catastrophic?
Searching for context
When a country is founded on the mission of rising as a leading world power built upon the concepts of freedom, basic human rights, and individuality while supporting an infrastructure of capitalism, power, and control, crises – particularly those related to public health – can fan deep divisions. Here in the United States, we have seen misinterpretation, misunderstanding, and bitter indignation fuel the flames of provocation as protests of mask mandates, distance learning, and social distancing were touted as violating the very core upon which the country was established. Frustration, palpable among health care professionals, grew ever greater as the importance of vaccination in quelling virus mutations and decreasing morbidity and mortality were openly disparaged and ignored.
Not only have we watched people refuse the vaccines, but some are ignoring other mitigation measures. So the question becomes: How are we, as health care professionals trying to maintain a therapeutic alliance with those who reject lifesaving practices, expected to process this? Sitting in appointments and attempting interventions without judgment feels impractical and nearly impossible – particularly when the behaviors of these patients have the potential of violating our own health and well-being. How do we remain altruistic in our endeavors when those who seek our care seem callously indifferent to our lives – and to those of our families?
Measuring the value of life
Within the fevered haze of this past year, many stories highlighting grim realities have captured the media spotlight. From individuals unable to have emergency evaluations because of facilities being inundated by COVID-19 patients to individuals prematurely discharged, hospital bed shortages, and financial pressures from insurance companies. In reciting the phrase “Primum non noncere,” we physicians are committing to providing fair and competent medical treatment. At times, urgent decisions are necessary but are always made in the best interest of the patient(s). Ultimately, I am left debating how these agonizing weeks served any meaningful purpose. Moreover, when choosing the many over the few, what are the determinant factors? I am left asking: What is the value of a life?
Philosophically, this ethical dilemma is captured succinctly via the “trolley problem,” formulated in 1967 by Philippa Foot, MD. This is how Dr. Foot’s formulation unfolds: Close your eyes, and imagine you are inside a trolley careening unhindered down the rumbling tracks. Straight ahead you see five people bound to the tracks in imminent danger of being struck, and on the other side, one person is tied to the tracks. Do you continue the same course – thereby condemning five innocent people to death – or do you make the active decision to switch tracks, therefore consigning the one to their fate? Envision the people what do they look like? How old are they? If the one were a small child or a close friend, would that alter your decision? How does one make such a harrowing choice knowing the irreversible consequences? Depending on your action, this quandary falls within two primary schools of thought: Utilitarianism, which posits that the best action is the greatest good for the greatest number of people, and deontologicalism, which suggests that action is inherently right or wrong regardless of the consequences. Therefore, the decision to save the five is not favored.
However simplistic those scenarios may read, such principles when viewed through different lenses, they form the basis of medical ethics. In effect, every acute decision, every aspect of treatment is predicated upon the principles of nonmaleficence, beneficence, utility, distributive justice, and autonomy. Yet, the manner in which they are applied is highly contingent upon myriad variables. For example, sociopolitical factors, including population size (rural versus urban), economics (impoverished versus wealthy), as well as demographic factors (age, ethnicity, gender, sexuality) can highly influence and sometimes unknowingly influence interpretation and allocation of health care resources. This dilemma does not yield easily applicable and universal solutions. Nevertheless, it is paramount to evaluate policies effectively and tediously, particularly those with detrimental ramifications. Likewise, remaining flexible in our willingness to explore alternative solutions and encourage open discord among those with opposing viewpoints is key to instituting individual or institutional change that values the one as it values the many.
After several weeks of acute illness and a variety of short-acting interventions, I received approval to resume intravenous therapy. While the saga has ultimately reached a satisfactory conclusion, I am left with stupefied disbelief toward the people who took a gamble on my health. I am facing a battle between understanding the obligation of medicine to provide ethical and reasonable care without hesitation or judgment versus embittered resentment when faced with those who openly campaign against lifesaving interventions, such as the COVID-19 vaccine. For me, each day and the one that follows is riddled with complicated emotion. Every time I prematurely cease activity out of discomfort and weariness, I worry about my increasingly foreboding workload. In those moments, in that place of questions without answers, I remember that someone somewhere ultimately decided to switch the trolley’s track.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
Working feverishly to complete the myriad patient notes accumulated throughout a hectic day, my phone vibrated – alerting me to a number that, over the past several years, has wrought uncertainty, grief, and overwhelming relief. Answering hesitantly, I listened to my physician’s pharmacist inform me of unexpected and alarming news.
Since COVID-19 was first identified more than 1 year ago, more than 770,000 people have died in the United States. In the wake of those losses, countless grieve while attempting to navigate a future without their loved ones. Meanwhile, scientists worked feverishly to combat a pandemic relentless in contagion. As health care professionals, we work tirelessly against the sharpened scythe of death, toiling day after day without an identifiable end. All the while, advocacy has prevailed as the need for personal protective equipment, improved ventilation systems, sanitization measures, and other mitigation measures, such as mask wearing and social distancing, echoed swiftly across the nation and around the world.
But, as the months have progressed, and life has seemingly transitioned toward a parallel version of reality, subsections of communities have grown restless. Several nontherapeutic, ineffective, and falsely touted regimens have been promoted. Amid the chaos of misinformation, most medical professionals have sought support from respected journals and infectious disease experts to filter out jargon and piece together scientifically sound protocols. Although many lives have prevailed by way of those advancements, mixed messages about interventions have emerged – and in many quarters across the country, anger, resistance, and outright refusal have prevailed.
Yet, we – the medical community – have forged ever onward as the cases continued and the death toll steadily climbed. In many cases, physicians who are years removed from critical care training have been thrust into COVID units, while residents have shifted toward working outside of their chosen specialty. Outpatient offices have closed, salaries have been cut, and furloughs have loomed as days fade into months. Beset with exhaustion and uncertainty, sacrifice has become a common thread that intrinsically united us against an unrelenting foe.
Most people continued navigating the many changes and made concerted efforts to mimic our prepandemic lives. Working from home in makeshift offices, dusting off math skills to assist children through the doldrums of distance learning, and mastering various audiovisual platforms, we reinforced social bonds and forged new connections echoing the hallmark resilience reminiscent of our shared distant ancestry.
As of this writing, thanks to our work – and that of scientists and policy makers – about 69% of Americans have received at least one dose of vaccine, and vaccines are widely available to children 5 and older. But it has been disheartening to watch misinformation about vaccine research and development propagated by political figures, social media, and lay people.
Processing the phone call
While listening to my physician’s pharmacist, I slowed my breaths in an effort to find calm. Years of navigating the American health care industry had left me both equipped and ill-prepared for the unexpected. I listened intently to the pharmacist’s words while staring blankly at a computer screen – uncertain of what had felt so assured not 10 minutes earlier.
That’s when I got the news. The intravenous medication that aided in my stabilization had suffered a critical shortage because of its successful use in the treatment of patients with COVID-19 pneumonia – patients who, in a majority of cases, had likely refused the vaccines. As result, the medication that had enabled my return to work, active engagement in nonwork pursuits, and most importantly, equipped my body to thrive despite the damage it had suffered, suddenly vanished.
Gently placing my phone on the desk, my heart beat rapidly as tears steadily streamed down my face. Staring blankly ahead, my hands gradually balled into fists as I let out a sound of fear, agony, and uncertainty. Screaming at everything and nothing, nausea swelled as panic flooded my body. In that moment, I ruminated on the conversation with the pharmacist. There had been no discussion, no option for me to maintain accessibility to this valuable medicine. Consequently, I felt helpless. Although the same medication, albeit a different mechanism of delivery, was promptly chosen as an adequate substitute, there was no guarantee of it bestowing the same degree of efficacy. So I was terrified, envisioning the progress made over several years as plummeting into an abyss of pain and despair. What are those of us who have chosen medicine as our profession but are immunocompromised expected to make of this?
Over the next several weeks, I diligently adhered to the new regimen and focused on positive mentation. Nevertheless, day by day, the symptoms worsened; eventually, I became bed ridden. I tried to gather what little composure remained to reschedule patients and justify the resounding guilt of perceived failure. I remember the sweet and gentle look of my child as I once again could not summon the strength to play pretend. This felt overwhelming. Would I ever go back to work? Would I see my child grow? No amount of pleading or screaming would change the fact that a medical system chose to roll the dice on my health. In a haze of discomfort and betrayal, I wondered how a physician or medical facility could justify removing medication from someone reliant upon it. How do we choose the appropriate allocation of resources when the consequences are potentially catastrophic?
Searching for context
When a country is founded on the mission of rising as a leading world power built upon the concepts of freedom, basic human rights, and individuality while supporting an infrastructure of capitalism, power, and control, crises – particularly those related to public health – can fan deep divisions. Here in the United States, we have seen misinterpretation, misunderstanding, and bitter indignation fuel the flames of provocation as protests of mask mandates, distance learning, and social distancing were touted as violating the very core upon which the country was established. Frustration, palpable among health care professionals, grew ever greater as the importance of vaccination in quelling virus mutations and decreasing morbidity and mortality were openly disparaged and ignored.
Not only have we watched people refuse the vaccines, but some are ignoring other mitigation measures. So the question becomes: How are we, as health care professionals trying to maintain a therapeutic alliance with those who reject lifesaving practices, expected to process this? Sitting in appointments and attempting interventions without judgment feels impractical and nearly impossible – particularly when the behaviors of these patients have the potential of violating our own health and well-being. How do we remain altruistic in our endeavors when those who seek our care seem callously indifferent to our lives – and to those of our families?
Measuring the value of life
Within the fevered haze of this past year, many stories highlighting grim realities have captured the media spotlight. From individuals unable to have emergency evaluations because of facilities being inundated by COVID-19 patients to individuals prematurely discharged, hospital bed shortages, and financial pressures from insurance companies. In reciting the phrase “Primum non noncere,” we physicians are committing to providing fair and competent medical treatment. At times, urgent decisions are necessary but are always made in the best interest of the patient(s). Ultimately, I am left debating how these agonizing weeks served any meaningful purpose. Moreover, when choosing the many over the few, what are the determinant factors? I am left asking: What is the value of a life?
Philosophically, this ethical dilemma is captured succinctly via the “trolley problem,” formulated in 1967 by Philippa Foot, MD. This is how Dr. Foot’s formulation unfolds: Close your eyes, and imagine you are inside a trolley careening unhindered down the rumbling tracks. Straight ahead you see five people bound to the tracks in imminent danger of being struck, and on the other side, one person is tied to the tracks. Do you continue the same course – thereby condemning five innocent people to death – or do you make the active decision to switch tracks, therefore consigning the one to their fate? Envision the people what do they look like? How old are they? If the one were a small child or a close friend, would that alter your decision? How does one make such a harrowing choice knowing the irreversible consequences? Depending on your action, this quandary falls within two primary schools of thought: Utilitarianism, which posits that the best action is the greatest good for the greatest number of people, and deontologicalism, which suggests that action is inherently right or wrong regardless of the consequences. Therefore, the decision to save the five is not favored.
However simplistic those scenarios may read, such principles when viewed through different lenses, they form the basis of medical ethics. In effect, every acute decision, every aspect of treatment is predicated upon the principles of nonmaleficence, beneficence, utility, distributive justice, and autonomy. Yet, the manner in which they are applied is highly contingent upon myriad variables. For example, sociopolitical factors, including population size (rural versus urban), economics (impoverished versus wealthy), as well as demographic factors (age, ethnicity, gender, sexuality) can highly influence and sometimes unknowingly influence interpretation and allocation of health care resources. This dilemma does not yield easily applicable and universal solutions. Nevertheless, it is paramount to evaluate policies effectively and tediously, particularly those with detrimental ramifications. Likewise, remaining flexible in our willingness to explore alternative solutions and encourage open discord among those with opposing viewpoints is key to instituting individual or institutional change that values the one as it values the many.
After several weeks of acute illness and a variety of short-acting interventions, I received approval to resume intravenous therapy. While the saga has ultimately reached a satisfactory conclusion, I am left with stupefied disbelief toward the people who took a gamble on my health. I am facing a battle between understanding the obligation of medicine to provide ethical and reasonable care without hesitation or judgment versus embittered resentment when faced with those who openly campaign against lifesaving interventions, such as the COVID-19 vaccine. For me, each day and the one that follows is riddled with complicated emotion. Every time I prematurely cease activity out of discomfort and weariness, I worry about my increasingly foreboding workload. In those moments, in that place of questions without answers, I remember that someone somewhere ultimately decided to switch the trolley’s track.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
Working feverishly to complete the myriad patient notes accumulated throughout a hectic day, my phone vibrated – alerting me to a number that, over the past several years, has wrought uncertainty, grief, and overwhelming relief. Answering hesitantly, I listened to my physician’s pharmacist inform me of unexpected and alarming news.
Since COVID-19 was first identified more than 1 year ago, more than 770,000 people have died in the United States. In the wake of those losses, countless grieve while attempting to navigate a future without their loved ones. Meanwhile, scientists worked feverishly to combat a pandemic relentless in contagion. As health care professionals, we work tirelessly against the sharpened scythe of death, toiling day after day without an identifiable end. All the while, advocacy has prevailed as the need for personal protective equipment, improved ventilation systems, sanitization measures, and other mitigation measures, such as mask wearing and social distancing, echoed swiftly across the nation and around the world.
But, as the months have progressed, and life has seemingly transitioned toward a parallel version of reality, subsections of communities have grown restless. Several nontherapeutic, ineffective, and falsely touted regimens have been promoted. Amid the chaos of misinformation, most medical professionals have sought support from respected journals and infectious disease experts to filter out jargon and piece together scientifically sound protocols. Although many lives have prevailed by way of those advancements, mixed messages about interventions have emerged – and in many quarters across the country, anger, resistance, and outright refusal have prevailed.
Yet, we – the medical community – have forged ever onward as the cases continued and the death toll steadily climbed. In many cases, physicians who are years removed from critical care training have been thrust into COVID units, while residents have shifted toward working outside of their chosen specialty. Outpatient offices have closed, salaries have been cut, and furloughs have loomed as days fade into months. Beset with exhaustion and uncertainty, sacrifice has become a common thread that intrinsically united us against an unrelenting foe.
Most people continued navigating the many changes and made concerted efforts to mimic our prepandemic lives. Working from home in makeshift offices, dusting off math skills to assist children through the doldrums of distance learning, and mastering various audiovisual platforms, we reinforced social bonds and forged new connections echoing the hallmark resilience reminiscent of our shared distant ancestry.
As of this writing, thanks to our work – and that of scientists and policy makers – about 69% of Americans have received at least one dose of vaccine, and vaccines are widely available to children 5 and older. But it has been disheartening to watch misinformation about vaccine research and development propagated by political figures, social media, and lay people.
Processing the phone call
While listening to my physician’s pharmacist, I slowed my breaths in an effort to find calm. Years of navigating the American health care industry had left me both equipped and ill-prepared for the unexpected. I listened intently to the pharmacist’s words while staring blankly at a computer screen – uncertain of what had felt so assured not 10 minutes earlier.
That’s when I got the news. The intravenous medication that aided in my stabilization had suffered a critical shortage because of its successful use in the treatment of patients with COVID-19 pneumonia – patients who, in a majority of cases, had likely refused the vaccines. As result, the medication that had enabled my return to work, active engagement in nonwork pursuits, and most importantly, equipped my body to thrive despite the damage it had suffered, suddenly vanished.
Gently placing my phone on the desk, my heart beat rapidly as tears steadily streamed down my face. Staring blankly ahead, my hands gradually balled into fists as I let out a sound of fear, agony, and uncertainty. Screaming at everything and nothing, nausea swelled as panic flooded my body. In that moment, I ruminated on the conversation with the pharmacist. There had been no discussion, no option for me to maintain accessibility to this valuable medicine. Consequently, I felt helpless. Although the same medication, albeit a different mechanism of delivery, was promptly chosen as an adequate substitute, there was no guarantee of it bestowing the same degree of efficacy. So I was terrified, envisioning the progress made over several years as plummeting into an abyss of pain and despair. What are those of us who have chosen medicine as our profession but are immunocompromised expected to make of this?
Over the next several weeks, I diligently adhered to the new regimen and focused on positive mentation. Nevertheless, day by day, the symptoms worsened; eventually, I became bed ridden. I tried to gather what little composure remained to reschedule patients and justify the resounding guilt of perceived failure. I remember the sweet and gentle look of my child as I once again could not summon the strength to play pretend. This felt overwhelming. Would I ever go back to work? Would I see my child grow? No amount of pleading or screaming would change the fact that a medical system chose to roll the dice on my health. In a haze of discomfort and betrayal, I wondered how a physician or medical facility could justify removing medication from someone reliant upon it. How do we choose the appropriate allocation of resources when the consequences are potentially catastrophic?
Searching for context
When a country is founded on the mission of rising as a leading world power built upon the concepts of freedom, basic human rights, and individuality while supporting an infrastructure of capitalism, power, and control, crises – particularly those related to public health – can fan deep divisions. Here in the United States, we have seen misinterpretation, misunderstanding, and bitter indignation fuel the flames of provocation as protests of mask mandates, distance learning, and social distancing were touted as violating the very core upon which the country was established. Frustration, palpable among health care professionals, grew ever greater as the importance of vaccination in quelling virus mutations and decreasing morbidity and mortality were openly disparaged and ignored.
Not only have we watched people refuse the vaccines, but some are ignoring other mitigation measures. So the question becomes: How are we, as health care professionals trying to maintain a therapeutic alliance with those who reject lifesaving practices, expected to process this? Sitting in appointments and attempting interventions without judgment feels impractical and nearly impossible – particularly when the behaviors of these patients have the potential of violating our own health and well-being. How do we remain altruistic in our endeavors when those who seek our care seem callously indifferent to our lives – and to those of our families?
Measuring the value of life
Within the fevered haze of this past year, many stories highlighting grim realities have captured the media spotlight. From individuals unable to have emergency evaluations because of facilities being inundated by COVID-19 patients to individuals prematurely discharged, hospital bed shortages, and financial pressures from insurance companies. In reciting the phrase “Primum non noncere,” we physicians are committing to providing fair and competent medical treatment. At times, urgent decisions are necessary but are always made in the best interest of the patient(s). Ultimately, I am left debating how these agonizing weeks served any meaningful purpose. Moreover, when choosing the many over the few, what are the determinant factors? I am left asking: What is the value of a life?
Philosophically, this ethical dilemma is captured succinctly via the “trolley problem,” formulated in 1967 by Philippa Foot, MD. This is how Dr. Foot’s formulation unfolds: Close your eyes, and imagine you are inside a trolley careening unhindered down the rumbling tracks. Straight ahead you see five people bound to the tracks in imminent danger of being struck, and on the other side, one person is tied to the tracks. Do you continue the same course – thereby condemning five innocent people to death – or do you make the active decision to switch tracks, therefore consigning the one to their fate? Envision the people what do they look like? How old are they? If the one were a small child or a close friend, would that alter your decision? How does one make such a harrowing choice knowing the irreversible consequences? Depending on your action, this quandary falls within two primary schools of thought: Utilitarianism, which posits that the best action is the greatest good for the greatest number of people, and deontologicalism, which suggests that action is inherently right or wrong regardless of the consequences. Therefore, the decision to save the five is not favored.
However simplistic those scenarios may read, such principles when viewed through different lenses, they form the basis of medical ethics. In effect, every acute decision, every aspect of treatment is predicated upon the principles of nonmaleficence, beneficence, utility, distributive justice, and autonomy. Yet, the manner in which they are applied is highly contingent upon myriad variables. For example, sociopolitical factors, including population size (rural versus urban), economics (impoverished versus wealthy), as well as demographic factors (age, ethnicity, gender, sexuality) can highly influence and sometimes unknowingly influence interpretation and allocation of health care resources. This dilemma does not yield easily applicable and universal solutions. Nevertheless, it is paramount to evaluate policies effectively and tediously, particularly those with detrimental ramifications. Likewise, remaining flexible in our willingness to explore alternative solutions and encourage open discord among those with opposing viewpoints is key to instituting individual or institutional change that values the one as it values the many.
After several weeks of acute illness and a variety of short-acting interventions, I received approval to resume intravenous therapy. While the saga has ultimately reached a satisfactory conclusion, I am left with stupefied disbelief toward the people who took a gamble on my health. I am facing a battle between understanding the obligation of medicine to provide ethical and reasonable care without hesitation or judgment versus embittered resentment when faced with those who openly campaign against lifesaving interventions, such as the COVID-19 vaccine. For me, each day and the one that follows is riddled with complicated emotion. Every time I prematurely cease activity out of discomfort and weariness, I worry about my increasingly foreboding workload. In those moments, in that place of questions without answers, I remember that someone somewhere ultimately decided to switch the trolley’s track.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
COVID-19 antibody drug likely works against Omicron, companies say
The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.
GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.
Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.
GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.
Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.
Other companies have also been testing their antibody treatments against the Omicron variant.
Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.
Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.
Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.
Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.
In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.
The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.
A version of this article first appeared on WebMD.com.
The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.
GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.
Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.
GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.
Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.
Other companies have also been testing their antibody treatments against the Omicron variant.
Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.
Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.
Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.
Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.
In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.
The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.
A version of this article first appeared on WebMD.com.
The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.
GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.
Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.
GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.
Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.
Other companies have also been testing their antibody treatments against the Omicron variant.
Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.
Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.
Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.
Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.
In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.
The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.
A version of this article first appeared on WebMD.com.
Tranexamic acid does not reduce risk of death in GI bleed
Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.
Study design: Randomized, double-blind, placebo-controlled trial.
Setting: 164 hospitals in 15 countries.
Synopsis: A total of 12,009 patients presenting with suspected significant upper or lower GI bleeding were randomized to receive either high-dose TXA or placebo. Death resulting from bleeding within 5 days (primary outcome) was similar in the two groups (3.7% with TXA and 3.8% with placebo; relative risk, 0.99; 95% confidence interval, 0.82-1.18). All-cause mortality at 28 days was also similar (9.5% with TXA and 9.2% with placebo; RR, 1.03; 95% CI, 0.92-1.16).
There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).
Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.
Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.
Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.
Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.
Study design: Randomized, double-blind, placebo-controlled trial.
Setting: 164 hospitals in 15 countries.
Synopsis: A total of 12,009 patients presenting with suspected significant upper or lower GI bleeding were randomized to receive either high-dose TXA or placebo. Death resulting from bleeding within 5 days (primary outcome) was similar in the two groups (3.7% with TXA and 3.8% with placebo; relative risk, 0.99; 95% confidence interval, 0.82-1.18). All-cause mortality at 28 days was also similar (9.5% with TXA and 9.2% with placebo; RR, 1.03; 95% CI, 0.92-1.16).
There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).
Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.
Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.
Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.
Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.
Study design: Randomized, double-blind, placebo-controlled trial.
Setting: 164 hospitals in 15 countries.
Synopsis: A total of 12,009 patients presenting with suspected significant upper or lower GI bleeding were randomized to receive either high-dose TXA or placebo. Death resulting from bleeding within 5 days (primary outcome) was similar in the two groups (3.7% with TXA and 3.8% with placebo; relative risk, 0.99; 95% confidence interval, 0.82-1.18). All-cause mortality at 28 days was also similar (9.5% with TXA and 9.2% with placebo; RR, 1.03; 95% CI, 0.92-1.16).
There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).
Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.
Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.
Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.
Second U.S. COVID-19 case caused by Omicron found
A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.
The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before. He sought testing on Nov. 24. His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health. The man was fully vaccinated, the department said.
He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.
“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”
The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.
This breaking news story will be updated.
A version of this article first appeared on WebMD.com.
A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.
The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before. He sought testing on Nov. 24. His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health. The man was fully vaccinated, the department said.
He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.
“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”
The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.
This breaking news story will be updated.
A version of this article first appeared on WebMD.com.
A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.
The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before. He sought testing on Nov. 24. His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health. The man was fully vaccinated, the department said.
He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.
“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”
The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.
This breaking news story will be updated.
A version of this article first appeared on WebMD.com.
SGLT2 inhibitor use tied to fewer atrial arrhythmias
Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years.
The findings suggest that use of an agent from the class of SGLT2 inhibitors “is associated with a pronounced reduction in atrial arrhythmia burden and all-cause mortality in patients with a CIED in a real-world setting,” said Ilan Goldenberg, MD, at the American Heart Association scientific sessions. “These data indicate possible antiarrhythmic properties of SGLT2 inhibitors that are incremental to the beneficial effects of the drug on heart failure outcomes,” added Dr. Goldenberg, director of the Clinical Cardiovascular Research Center at the University of Rochester (N.Y.).
In a propensity score–matched analysis that included more than 5,000 of the enrolled patients with a CIED, treatment with an SGLT2 inhibitor was tied to a significant 23% relative reduction in atrial arrhythmia events and a 44% relative drop in all-cause death, he reported.
Effect mediated by reduced left atrial pressure?
“Other heart failure drugs have shown some decrease in the rate of sudden cardiac death, but this is the first [heart failure] drug to associate with a reduction in atrial arrhythmias,” Dr. Goldenberg noted. “We think that a reduction in left atrial pressure” produced by treatment with an SGLT2 inhibitor “may be linked to the reduction in atrial arrhythmias.”
The study did not show an association of SGLT2-inhibitor use and a change in ventricular arrhythmias, compared with patients with CIEDs who did not receive an agent from this class.
The findings suggest “expanding the possible indications for SGLT2 inhibitors,” commented Harriette G.C. Van Spall, MD, a cardiologist at McMaster University, Hamilton, Ont., who moderated the session where Dr. Goldenberg gave his report.
The study included 13,890 consecutive, prospectively enrolled patients who received a CIED during January 2015–April 2020 at any of five hospitals operated by either of two tertiary health care systems, one run by the University of Rochester and the second based at Sheba Medical Center in Tel HaShomer, Israel. The devices that made patients eligible for the study included permanent pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and implantable cardiac monitors. A blinded adjudication committee composed of electrophysiologists identified the arrhythmic episodes.
At entry into the study (the time of device implantation), 12,992 patients were not receiving an SGLT2 inhibitor (94%) and 898 (6%) were receiving a drug from this class. Of those, 39% were on dapagliflozin (Farxiga), 35% were on empagliflozin (Jardiance), and 26% were on canagliflozin (Invokana).
Patients receiving an SGLT2 inhibitor at baseline were on average substantially younger than the patients not on this drug class (59 years vs. 69 years); they had a substantially higher prevalence of diabetes (78% vs. 25%), and ischemic cardiomyopathy (63% vs. 39%). Patients on an SGLT2 inhibitor at baseline also had more modestly higher prevalence rates of prior heart failure (38% vs. 31%), and hypertension (69% vs. 63%). Prevalence of a history of atrial fibrillation (AFib) was nearly the same in both groups: 31% in patients on an SGLT2 inhibitor and 35% in those not on these drugs.
The study’s primary endpoint was the total number of arrhythmia events during follow-up of 24,442 patient-years, during which patients exhibited 19,633 atrial arrhythmia events and 3,231 ventricular arrhythmia events.
1% absolute reduction in atrial arrhythmias
A multivariate analysis of the entire population – adjusted for baseline differences in age, diabetes, sex, and history of AFib – showed that treatment with an SGLT2 inhibitor at baseline was linked with a significant 24% relative reduction in incident atrial arrhythmia events, a significant 24% reduction in both atrial and ventricular arrhythmia events, and a 42% relative reduction in all-cause deaths, compared with no SGLT2-inhibitor treatment.
The only analyzed endpoint that showed no significant between-group difference was incidence of ventricular arrhythmias, which was a relative 7% lower in the SGLT2-inhibitor group.
On an absolute basis, treatment with an SGLT2 inhibitor was tied to about a 1% lower rate of atrial arrhythmia events per year, a reduction from a 2.5% rate in those not on an SGLT2 inhibitor to about a 1.5% rate in those taking this drug class.
A second, confirmatory analysis used propensity score matching to identify 5,323 patients not on an SGLT2 inhibitor at baseline who closely matched the 898 patients on an SGLT2 inhibitor. The multivariate modeling for this analysis also adjusted for age, diabetes, sex, and history of AFib.
The results of these analyses closely matched the calculations that used the entire study population. Relative to patients not on an SGLT2 inhibitor those on a drug from this class had 23% fewer atrial arrhythmias, 44% fewer total death, and 22% fewer atrial or ventricular arrhythmias, all significant differences. However, ventricular arrhythmias only reduced by a relative 5%, a nonsignificant difference.
In the propensity score–matched analysis, the absolute reduction in atrial arrhythmias in those on an SGLT2 inhibitor at baseline was roughly 1.3% fewer per year, compared with those not on this drug class.
The study was funded by an unrestricted grant to the University of Rochester from AstraZeneca, the company that markets the SGLT2 inhibitor dapagliflozin (Farxiga). Dr. Goldenberg and Dr. Van Spall had no disclosures.
Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years.
The findings suggest that use of an agent from the class of SGLT2 inhibitors “is associated with a pronounced reduction in atrial arrhythmia burden and all-cause mortality in patients with a CIED in a real-world setting,” said Ilan Goldenberg, MD, at the American Heart Association scientific sessions. “These data indicate possible antiarrhythmic properties of SGLT2 inhibitors that are incremental to the beneficial effects of the drug on heart failure outcomes,” added Dr. Goldenberg, director of the Clinical Cardiovascular Research Center at the University of Rochester (N.Y.).
In a propensity score–matched analysis that included more than 5,000 of the enrolled patients with a CIED, treatment with an SGLT2 inhibitor was tied to a significant 23% relative reduction in atrial arrhythmia events and a 44% relative drop in all-cause death, he reported.
Effect mediated by reduced left atrial pressure?
“Other heart failure drugs have shown some decrease in the rate of sudden cardiac death, but this is the first [heart failure] drug to associate with a reduction in atrial arrhythmias,” Dr. Goldenberg noted. “We think that a reduction in left atrial pressure” produced by treatment with an SGLT2 inhibitor “may be linked to the reduction in atrial arrhythmias.”
The study did not show an association of SGLT2-inhibitor use and a change in ventricular arrhythmias, compared with patients with CIEDs who did not receive an agent from this class.
The findings suggest “expanding the possible indications for SGLT2 inhibitors,” commented Harriette G.C. Van Spall, MD, a cardiologist at McMaster University, Hamilton, Ont., who moderated the session where Dr. Goldenberg gave his report.
The study included 13,890 consecutive, prospectively enrolled patients who received a CIED during January 2015–April 2020 at any of five hospitals operated by either of two tertiary health care systems, one run by the University of Rochester and the second based at Sheba Medical Center in Tel HaShomer, Israel. The devices that made patients eligible for the study included permanent pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and implantable cardiac monitors. A blinded adjudication committee composed of electrophysiologists identified the arrhythmic episodes.
At entry into the study (the time of device implantation), 12,992 patients were not receiving an SGLT2 inhibitor (94%) and 898 (6%) were receiving a drug from this class. Of those, 39% were on dapagliflozin (Farxiga), 35% were on empagliflozin (Jardiance), and 26% were on canagliflozin (Invokana).
Patients receiving an SGLT2 inhibitor at baseline were on average substantially younger than the patients not on this drug class (59 years vs. 69 years); they had a substantially higher prevalence of diabetes (78% vs. 25%), and ischemic cardiomyopathy (63% vs. 39%). Patients on an SGLT2 inhibitor at baseline also had more modestly higher prevalence rates of prior heart failure (38% vs. 31%), and hypertension (69% vs. 63%). Prevalence of a history of atrial fibrillation (AFib) was nearly the same in both groups: 31% in patients on an SGLT2 inhibitor and 35% in those not on these drugs.
The study’s primary endpoint was the total number of arrhythmia events during follow-up of 24,442 patient-years, during which patients exhibited 19,633 atrial arrhythmia events and 3,231 ventricular arrhythmia events.
1% absolute reduction in atrial arrhythmias
A multivariate analysis of the entire population – adjusted for baseline differences in age, diabetes, sex, and history of AFib – showed that treatment with an SGLT2 inhibitor at baseline was linked with a significant 24% relative reduction in incident atrial arrhythmia events, a significant 24% reduction in both atrial and ventricular arrhythmia events, and a 42% relative reduction in all-cause deaths, compared with no SGLT2-inhibitor treatment.
The only analyzed endpoint that showed no significant between-group difference was incidence of ventricular arrhythmias, which was a relative 7% lower in the SGLT2-inhibitor group.
On an absolute basis, treatment with an SGLT2 inhibitor was tied to about a 1% lower rate of atrial arrhythmia events per year, a reduction from a 2.5% rate in those not on an SGLT2 inhibitor to about a 1.5% rate in those taking this drug class.
A second, confirmatory analysis used propensity score matching to identify 5,323 patients not on an SGLT2 inhibitor at baseline who closely matched the 898 patients on an SGLT2 inhibitor. The multivariate modeling for this analysis also adjusted for age, diabetes, sex, and history of AFib.
The results of these analyses closely matched the calculations that used the entire study population. Relative to patients not on an SGLT2 inhibitor those on a drug from this class had 23% fewer atrial arrhythmias, 44% fewer total death, and 22% fewer atrial or ventricular arrhythmias, all significant differences. However, ventricular arrhythmias only reduced by a relative 5%, a nonsignificant difference.
In the propensity score–matched analysis, the absolute reduction in atrial arrhythmias in those on an SGLT2 inhibitor at baseline was roughly 1.3% fewer per year, compared with those not on this drug class.
The study was funded by an unrestricted grant to the University of Rochester from AstraZeneca, the company that markets the SGLT2 inhibitor dapagliflozin (Farxiga). Dr. Goldenberg and Dr. Van Spall had no disclosures.
Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years.
The findings suggest that use of an agent from the class of SGLT2 inhibitors “is associated with a pronounced reduction in atrial arrhythmia burden and all-cause mortality in patients with a CIED in a real-world setting,” said Ilan Goldenberg, MD, at the American Heart Association scientific sessions. “These data indicate possible antiarrhythmic properties of SGLT2 inhibitors that are incremental to the beneficial effects of the drug on heart failure outcomes,” added Dr. Goldenberg, director of the Clinical Cardiovascular Research Center at the University of Rochester (N.Y.).
In a propensity score–matched analysis that included more than 5,000 of the enrolled patients with a CIED, treatment with an SGLT2 inhibitor was tied to a significant 23% relative reduction in atrial arrhythmia events and a 44% relative drop in all-cause death, he reported.
Effect mediated by reduced left atrial pressure?
“Other heart failure drugs have shown some decrease in the rate of sudden cardiac death, but this is the first [heart failure] drug to associate with a reduction in atrial arrhythmias,” Dr. Goldenberg noted. “We think that a reduction in left atrial pressure” produced by treatment with an SGLT2 inhibitor “may be linked to the reduction in atrial arrhythmias.”
The study did not show an association of SGLT2-inhibitor use and a change in ventricular arrhythmias, compared with patients with CIEDs who did not receive an agent from this class.
The findings suggest “expanding the possible indications for SGLT2 inhibitors,” commented Harriette G.C. Van Spall, MD, a cardiologist at McMaster University, Hamilton, Ont., who moderated the session where Dr. Goldenberg gave his report.
The study included 13,890 consecutive, prospectively enrolled patients who received a CIED during January 2015–April 2020 at any of five hospitals operated by either of two tertiary health care systems, one run by the University of Rochester and the second based at Sheba Medical Center in Tel HaShomer, Israel. The devices that made patients eligible for the study included permanent pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and implantable cardiac monitors. A blinded adjudication committee composed of electrophysiologists identified the arrhythmic episodes.
At entry into the study (the time of device implantation), 12,992 patients were not receiving an SGLT2 inhibitor (94%) and 898 (6%) were receiving a drug from this class. Of those, 39% were on dapagliflozin (Farxiga), 35% were on empagliflozin (Jardiance), and 26% were on canagliflozin (Invokana).
Patients receiving an SGLT2 inhibitor at baseline were on average substantially younger than the patients not on this drug class (59 years vs. 69 years); they had a substantially higher prevalence of diabetes (78% vs. 25%), and ischemic cardiomyopathy (63% vs. 39%). Patients on an SGLT2 inhibitor at baseline also had more modestly higher prevalence rates of prior heart failure (38% vs. 31%), and hypertension (69% vs. 63%). Prevalence of a history of atrial fibrillation (AFib) was nearly the same in both groups: 31% in patients on an SGLT2 inhibitor and 35% in those not on these drugs.
The study’s primary endpoint was the total number of arrhythmia events during follow-up of 24,442 patient-years, during which patients exhibited 19,633 atrial arrhythmia events and 3,231 ventricular arrhythmia events.
1% absolute reduction in atrial arrhythmias
A multivariate analysis of the entire population – adjusted for baseline differences in age, diabetes, sex, and history of AFib – showed that treatment with an SGLT2 inhibitor at baseline was linked with a significant 24% relative reduction in incident atrial arrhythmia events, a significant 24% reduction in both atrial and ventricular arrhythmia events, and a 42% relative reduction in all-cause deaths, compared with no SGLT2-inhibitor treatment.
The only analyzed endpoint that showed no significant between-group difference was incidence of ventricular arrhythmias, which was a relative 7% lower in the SGLT2-inhibitor group.
On an absolute basis, treatment with an SGLT2 inhibitor was tied to about a 1% lower rate of atrial arrhythmia events per year, a reduction from a 2.5% rate in those not on an SGLT2 inhibitor to about a 1.5% rate in those taking this drug class.
A second, confirmatory analysis used propensity score matching to identify 5,323 patients not on an SGLT2 inhibitor at baseline who closely matched the 898 patients on an SGLT2 inhibitor. The multivariate modeling for this analysis also adjusted for age, diabetes, sex, and history of AFib.
The results of these analyses closely matched the calculations that used the entire study population. Relative to patients not on an SGLT2 inhibitor those on a drug from this class had 23% fewer atrial arrhythmias, 44% fewer total death, and 22% fewer atrial or ventricular arrhythmias, all significant differences. However, ventricular arrhythmias only reduced by a relative 5%, a nonsignificant difference.
In the propensity score–matched analysis, the absolute reduction in atrial arrhythmias in those on an SGLT2 inhibitor at baseline was roughly 1.3% fewer per year, compared with those not on this drug class.
The study was funded by an unrestricted grant to the University of Rochester from AstraZeneca, the company that markets the SGLT2 inhibitor dapagliflozin (Farxiga). Dr. Goldenberg and Dr. Van Spall had no disclosures.
FROM AHA 2021
First Omicron variant case identified in U.S.
He or she was fully vaccinated against COVID-19 and experienced only “mild symptoms that are improving,” officials with the Centers for Disease Control and Prevention said.
The patient, who was not named in the CDC’s announcement of the first U.S. case of the Omicron variant Dec. 1, is self-quarantining.
“All close contacts have been contacted and have tested negative,” officials said.
The announcement comes as no surprise to many as the Omicron variant, first identified in South Africa, has been reported in countries around the world in recent days. Hong Kong, the United Kingdom, and Germany each reported this variant, as have Italy and the Netherlands. Over the weekend, the first North American cases were identified in Canada.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced over the weekend that this newest variant was likely already in the United States, telling ABC’s This Week its appearance here was “inevitable.”
Similar to previous variants, this new strain likely started circulating in the United States before scientists could do genetic tests to confirm its presence.
The World Health Organization named Omicron a “variant of concern” on Nov. 26, even though much remains unknown about how well it spreads, how severe it can be, and how it may resist vaccines. In the meantime, the United States enacted travel bans from multiple South African countries.
It remains to be seen if Omicron will follow the pattern of the Delta variant, which was first identified in the United States in May and became the dominant strain by July. It’s also possible it will follow the path taken by the Mu variant. Mu emerged in March and April to much concern, only to fizzle out by September because it was unable to compete with the Delta variant.
A version of this article first appeared on WebMD.com.
He or she was fully vaccinated against COVID-19 and experienced only “mild symptoms that are improving,” officials with the Centers for Disease Control and Prevention said.
The patient, who was not named in the CDC’s announcement of the first U.S. case of the Omicron variant Dec. 1, is self-quarantining.
“All close contacts have been contacted and have tested negative,” officials said.
The announcement comes as no surprise to many as the Omicron variant, first identified in South Africa, has been reported in countries around the world in recent days. Hong Kong, the United Kingdom, and Germany each reported this variant, as have Italy and the Netherlands. Over the weekend, the first North American cases were identified in Canada.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced over the weekend that this newest variant was likely already in the United States, telling ABC’s This Week its appearance here was “inevitable.”
Similar to previous variants, this new strain likely started circulating in the United States before scientists could do genetic tests to confirm its presence.
The World Health Organization named Omicron a “variant of concern” on Nov. 26, even though much remains unknown about how well it spreads, how severe it can be, and how it may resist vaccines. In the meantime, the United States enacted travel bans from multiple South African countries.
It remains to be seen if Omicron will follow the pattern of the Delta variant, which was first identified in the United States in May and became the dominant strain by July. It’s also possible it will follow the path taken by the Mu variant. Mu emerged in March and April to much concern, only to fizzle out by September because it was unable to compete with the Delta variant.
A version of this article first appeared on WebMD.com.
He or she was fully vaccinated against COVID-19 and experienced only “mild symptoms that are improving,” officials with the Centers for Disease Control and Prevention said.
The patient, who was not named in the CDC’s announcement of the first U.S. case of the Omicron variant Dec. 1, is self-quarantining.
“All close contacts have been contacted and have tested negative,” officials said.
The announcement comes as no surprise to many as the Omicron variant, first identified in South Africa, has been reported in countries around the world in recent days. Hong Kong, the United Kingdom, and Germany each reported this variant, as have Italy and the Netherlands. Over the weekend, the first North American cases were identified in Canada.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, announced over the weekend that this newest variant was likely already in the United States, telling ABC’s This Week its appearance here was “inevitable.”
Similar to previous variants, this new strain likely started circulating in the United States before scientists could do genetic tests to confirm its presence.
The World Health Organization named Omicron a “variant of concern” on Nov. 26, even though much remains unknown about how well it spreads, how severe it can be, and how it may resist vaccines. In the meantime, the United States enacted travel bans from multiple South African countries.
It remains to be seen if Omicron will follow the pattern of the Delta variant, which was first identified in the United States in May and became the dominant strain by July. It’s also possible it will follow the path taken by the Mu variant. Mu emerged in March and April to much concern, only to fizzle out by September because it was unable to compete with the Delta variant.
A version of this article first appeared on WebMD.com.
Bedside frailty assessment can determine when CPR will be nonbeneficial
Background: Although average survival after in-hospital cardiac arrest is 17%-20%, many clinicians feel that survival is lower in older patients or patients with multiple comorbidities. The Clinical Frailty Scale (CFS) is a simple bedside visual tool that encapsulates patients’ mobility and functional status, with a score greater than 4 indicating frailty. How this measure of frailty correlates with outcomes after in-hospital cardiac arrest is unknown.
Study design: Retrospective review.
Setting: Tertiary referral center in England.
Synopsis: The study included patients over 60 years old who received CPR between May 2017 and December 2018. CFS was retroactively applied based on available chart data. The patients’ median age was 77 years old, and 71% were male. The initial cardiac rhythm was nonshockable in 82% of cases, and overall in-hospital mortality was 86%. Frailty was independently associated with increased mortality when controlling for age, comorbidities, and rhythm. No frail patients survived to hospital discharge, while 26% of patients with CFS greater than 4 survived. Although patients with a shockable rhythm had a better chance of survival overall, compared with those with a nonshockable rhythm (92% vs. 23%, P less than .001), 15% of frail patients had a shockable rhythm, and none survived to discharge. Limitations of the study include relatively small sample size and the possibility of confounding variables, such as comorbid conditions.
Bottom line: When adjusted for age and rhythm, no frail patients older than 60 who received CPR for cardiac arrest survived to hospital discharge. Clinicians should discuss the limited chance of survival and potential burdens of resuscitation with frail patients and their families to avoid inappropriate CPR at the end of life.
Citation: Ibitoye SE et al. Frailty status predicts futility of cardiopulmonary resuscitation in older adults. Age Ageing. 2020 Jun 5;[e-pub]. doi: doi.org/10.1093/ageing/afaa104.
Dr. Chokshi is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.
Background: Although average survival after in-hospital cardiac arrest is 17%-20%, many clinicians feel that survival is lower in older patients or patients with multiple comorbidities. The Clinical Frailty Scale (CFS) is a simple bedside visual tool that encapsulates patients’ mobility and functional status, with a score greater than 4 indicating frailty. How this measure of frailty correlates with outcomes after in-hospital cardiac arrest is unknown.
Study design: Retrospective review.
Setting: Tertiary referral center in England.
Synopsis: The study included patients over 60 years old who received CPR between May 2017 and December 2018. CFS was retroactively applied based on available chart data. The patients’ median age was 77 years old, and 71% were male. The initial cardiac rhythm was nonshockable in 82% of cases, and overall in-hospital mortality was 86%. Frailty was independently associated with increased mortality when controlling for age, comorbidities, and rhythm. No frail patients survived to hospital discharge, while 26% of patients with CFS greater than 4 survived. Although patients with a shockable rhythm had a better chance of survival overall, compared with those with a nonshockable rhythm (92% vs. 23%, P less than .001), 15% of frail patients had a shockable rhythm, and none survived to discharge. Limitations of the study include relatively small sample size and the possibility of confounding variables, such as comorbid conditions.
Bottom line: When adjusted for age and rhythm, no frail patients older than 60 who received CPR for cardiac arrest survived to hospital discharge. Clinicians should discuss the limited chance of survival and potential burdens of resuscitation with frail patients and their families to avoid inappropriate CPR at the end of life.
Citation: Ibitoye SE et al. Frailty status predicts futility of cardiopulmonary resuscitation in older adults. Age Ageing. 2020 Jun 5;[e-pub]. doi: doi.org/10.1093/ageing/afaa104.
Dr. Chokshi is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.
Background: Although average survival after in-hospital cardiac arrest is 17%-20%, many clinicians feel that survival is lower in older patients or patients with multiple comorbidities. The Clinical Frailty Scale (CFS) is a simple bedside visual tool that encapsulates patients’ mobility and functional status, with a score greater than 4 indicating frailty. How this measure of frailty correlates with outcomes after in-hospital cardiac arrest is unknown.
Study design: Retrospective review.
Setting: Tertiary referral center in England.
Synopsis: The study included patients over 60 years old who received CPR between May 2017 and December 2018. CFS was retroactively applied based on available chart data. The patients’ median age was 77 years old, and 71% were male. The initial cardiac rhythm was nonshockable in 82% of cases, and overall in-hospital mortality was 86%. Frailty was independently associated with increased mortality when controlling for age, comorbidities, and rhythm. No frail patients survived to hospital discharge, while 26% of patients with CFS greater than 4 survived. Although patients with a shockable rhythm had a better chance of survival overall, compared with those with a nonshockable rhythm (92% vs. 23%, P less than .001), 15% of frail patients had a shockable rhythm, and none survived to discharge. Limitations of the study include relatively small sample size and the possibility of confounding variables, such as comorbid conditions.
Bottom line: When adjusted for age and rhythm, no frail patients older than 60 who received CPR for cardiac arrest survived to hospital discharge. Clinicians should discuss the limited chance of survival and potential burdens of resuscitation with frail patients and their families to avoid inappropriate CPR at the end of life.
Citation: Ibitoye SE et al. Frailty status predicts futility of cardiopulmonary resuscitation in older adults. Age Ageing. 2020 Jun 5;[e-pub]. doi: doi.org/10.1093/ageing/afaa104.
Dr. Chokshi is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.