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COVID-19 vaccines do not trigger sudden hearing loss: Study
Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots.
The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that
“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.
Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.
They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.
Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.
When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.
“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.
Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.
They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.
“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.
“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.
But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.
Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.
A version of this article first appeared on Medscape.com.
Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots.
The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that
“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.
Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.
They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.
Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.
When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.
“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.
Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.
They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.
“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.
“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.
But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.
Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.
A version of this article first appeared on Medscape.com.
Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots.
The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that
“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.
Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.
They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.
Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.
When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.
“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.
Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.
They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.
“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.
“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.
But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.
Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.
A version of this article first appeared on Medscape.com.
FROM JAMA OTOLARYNGOLOGY – HEAD AND NECK SURGERY
Ukrainian physicians ‘ready to die for their freedom’
Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.
These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).
Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.
Question: Where is your family from, and do you have relatives in the country now?
Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.
I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.
Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?
Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.
But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.
Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?
Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.
Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.
Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?
Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.
A version of this article first appeared on Medscape.com.
Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.
These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).
Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.
Question: Where is your family from, and do you have relatives in the country now?
Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.
I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.
Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?
Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.
But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.
Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?
Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.
Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.
Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?
Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.
A version of this article first appeared on Medscape.com.
Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.
These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).
Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.
Question: Where is your family from, and do you have relatives in the country now?
Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.
I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.
Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?
Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.
But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.
Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?
Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.
Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.
Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?
Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.
A version of this article first appeared on Medscape.com.
The importance of a post-COVID wellness program for medical staff
LAS VEGAS – , according to Jon A. Levenson, MD.
“We can learn from previous pandemics and epidemics, which will be important for us going forward from COVID-19,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.
During the severe acute respiratory syndrome (SARS) epidemic in 2005, 68% of health care workers reported significant job-related stress, including increased workload, changing work duties, redeployment, shortage of medical supplies, concerns about insufficient personal protective equipment (PPE), lack of safety at work, absence of effective treatment protocols, inconsistent organizational support and information and misinformation from hospital management, and witnessing intense pain, isolation, and loss on a daily basis with few opportunities to take breaks (Psychiatr Serv. 2020 Oct 6. doi: 10.1176/appi.ps.202000274).
Personal concerns associated with psychopathological symptoms included spreading infection to family members; feeling responsibility for family members’ social isolation; self-isolating to avoid infecting family, which can lead to increased loneliness and sadness. “For those who were working remotely, this level of work is hard and challenging,” Dr. Levenson said. “For those who are parents, the 24-hour childcare responsibilities exist on top of work. They often found they can’t unwind with friends.”
Across SARS, MERS, Ebola, and swine flu, a wide range of prevalence in symptoms of distress, stress, anxiety, depressive symptoms, and substance use emerged, he continued. During COVID-19, at least three studies reported significant percentages of distress, depression, anxiety, insomnia, and PTSD among health care workers (JAMA Netw Open. 2020;3[3]:e203976, Front Psychol. 2020 Dec 8;11:608986., and Gen Hosp Psychiatry. Sep-Oct 2020;66:1-8).
“Who is at most-increased risk?” Dr. Levenson asked. “Women; those who are younger and have fewer years of work experience; those working on the front lines such as nurses and advanced practice professionals; and people with preexisting vulnerabilities to psychiatric disorders including anxiety, depression, obsessional symptoms, substance use, suicidal behavior, and impulse control disorders are likely to be especially vulnerable to stress-related symptoms.”
At CUIMC, there were certain “tipping points,” to the vulnerability of health care worker well-being in the early stage of the COVID-19 pandemic, he said, including the loss of an emergency medicine physician colleague from death by suicide. “On the national level there were so many other issues going on such as health care disparities of the COVID-19 infection itself, the murder of George Floyd in Minneapolis, other issues of racial injustice, a tense political climate with an upcoming election at the time, and other factors related to the natural climate concerns,” he said. This prompted several faculty members in the CUIMC department of psychiatry including Claude Ann Mellins, PhD, Laurel S. Mayer, MD, and Lourival Baptista-Neto, MD, to partner with ColumbiaDoctors and New York-Presbyterian Hospital and develop a model of care for health care workers known as CopeColumbia, a virtual program intended to address staff burnout and fatigue, with an emphasis on prevention and promotion of resilience.* It launched in March of 2020 and consists of 1:1 peer support, a peer support group program, town halls/webinars, and an active web site.
The 1:1 peer support sessions typically last 20-30 minutes and provide easy access for all distressed hospital and medical center staff. “We have a phone line staffed by Columbia psychiatrists and psychologists so that a distressed staff member can reach support directly,” he said. The format of these sessions includes a brief discussion of challenges and brainstorming around potential coping strategies. “This is not a psychotherapy session,” Dr. Levenson said. “Each session can be individualized to further assess the type of distress or to implement rating scales such as the Generalized Anxiety Disorder-7 scale to assess for signs and symptoms consistent with GAD. There are options to schedule a second or third peer support session, or a prompt referral within Columbia psychiatry when indicated.”
A typical peer support group meeting lasts about 30 minutes and comprises individual divisions or departments. Some goals of the peer groups are to discuss unique challenges of the work environment and to encourage the members of the group to come up with solutions; to promote team support and coping; to teach resilience-enhancing strategies from empirically based treatments such as CBT, “and to end each meeting with expressions of gratitude and of thanks within the group,” he said.
According to Dr. Levenson, sample questions CopeColumbia faculty use to facilitate coping, include “which coping skills are working for you?”; “Are you able to be present?”; “Have you honored loss with any specific ways or traditions?”; “Do you have any work buddies who support you and vice versa?”; “Can your work community build off each other’s individual strengths to help both the individual and the work group cope optimally?”; and “How can your work team help facilitate each other to best support each other?”
Other aspects of the CopeColumbia program include town halls/grand rounds that range from 30 to 60 minutes in length. “It may be a virtual presentation from a mental health professional on specific aspects of coping such as relaxation techniques,” he said. “The focus is how to manage stress, anxiety, trauma, loss, and grief. It also includes an active Q&A to engage staff participants. The advantage of this format is that you can reach many staff in an entire department.” The program also has an active web site for staff with both internal and external support links including mindfulness, meditation, exercise, parenting suggestions/caregiving, and other resources to promote well-being and resilience for staff and family.
To date, certain themes emerged from the 1:1 and peer support group sessions, including expressions of difficulty adapting to “such a new reality,” compared with the pre-COVID era. “Staff would often express anticipatory anxiety and uncertainty, such as is there going to be another surge of COVID-19 cases, and will there be a change in policies?” Dr. Levenson said. “There was a lot of expression of stress and frustration related to politicizing the virus and public containment strategies, both on a local and national level.”
Staff also mentioned the loss of usual coping strategies because of prolonged social isolation, especially for those doing remote work, and the loss of usual support resources that have helped them in the past. “They also reported delayed trauma and grief reactions, including symptoms of depression, anxiety, and posttraumatic stress,” he said. “Health care workers with children mentioned high levels of stress related to childcare, increased workload, and what seems like an impossible work-life balance.” Many reported exhaustion and irritability, “which could affect and cause tension within the work group and challenges to effective team cohesion,” he said. “There were also stressors related to the impact of racial injustices and the [presidential] election that could exacerbate the impact of COVID-19.”
Dr. Levenson hopes that CopeColumbia serves as a model for other health care systems looking for ways to support the mental well-being of their employees. “We want to promote the message that emotional health should have the same priority level as physical health,” he said. “The term that I like to use is total health. Addressing the well-being of health care workers is critical for a healthy workforce and for delivering high-quality patient care.”
He reported having no relevant financial disclosures related to his presentation.
Correction, 2/28/22: An earlier version of this article misstated Dr. Lourival Baptista-Neto's name.
LAS VEGAS – , according to Jon A. Levenson, MD.
“We can learn from previous pandemics and epidemics, which will be important for us going forward from COVID-19,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.
During the severe acute respiratory syndrome (SARS) epidemic in 2005, 68% of health care workers reported significant job-related stress, including increased workload, changing work duties, redeployment, shortage of medical supplies, concerns about insufficient personal protective equipment (PPE), lack of safety at work, absence of effective treatment protocols, inconsistent organizational support and information and misinformation from hospital management, and witnessing intense pain, isolation, and loss on a daily basis with few opportunities to take breaks (Psychiatr Serv. 2020 Oct 6. doi: 10.1176/appi.ps.202000274).
Personal concerns associated with psychopathological symptoms included spreading infection to family members; feeling responsibility for family members’ social isolation; self-isolating to avoid infecting family, which can lead to increased loneliness and sadness. “For those who were working remotely, this level of work is hard and challenging,” Dr. Levenson said. “For those who are parents, the 24-hour childcare responsibilities exist on top of work. They often found they can’t unwind with friends.”
Across SARS, MERS, Ebola, and swine flu, a wide range of prevalence in symptoms of distress, stress, anxiety, depressive symptoms, and substance use emerged, he continued. During COVID-19, at least three studies reported significant percentages of distress, depression, anxiety, insomnia, and PTSD among health care workers (JAMA Netw Open. 2020;3[3]:e203976, Front Psychol. 2020 Dec 8;11:608986., and Gen Hosp Psychiatry. Sep-Oct 2020;66:1-8).
“Who is at most-increased risk?” Dr. Levenson asked. “Women; those who are younger and have fewer years of work experience; those working on the front lines such as nurses and advanced practice professionals; and people with preexisting vulnerabilities to psychiatric disorders including anxiety, depression, obsessional symptoms, substance use, suicidal behavior, and impulse control disorders are likely to be especially vulnerable to stress-related symptoms.”
At CUIMC, there were certain “tipping points,” to the vulnerability of health care worker well-being in the early stage of the COVID-19 pandemic, he said, including the loss of an emergency medicine physician colleague from death by suicide. “On the national level there were so many other issues going on such as health care disparities of the COVID-19 infection itself, the murder of George Floyd in Minneapolis, other issues of racial injustice, a tense political climate with an upcoming election at the time, and other factors related to the natural climate concerns,” he said. This prompted several faculty members in the CUIMC department of psychiatry including Claude Ann Mellins, PhD, Laurel S. Mayer, MD, and Lourival Baptista-Neto, MD, to partner with ColumbiaDoctors and New York-Presbyterian Hospital and develop a model of care for health care workers known as CopeColumbia, a virtual program intended to address staff burnout and fatigue, with an emphasis on prevention and promotion of resilience.* It launched in March of 2020 and consists of 1:1 peer support, a peer support group program, town halls/webinars, and an active web site.
The 1:1 peer support sessions typically last 20-30 minutes and provide easy access for all distressed hospital and medical center staff. “We have a phone line staffed by Columbia psychiatrists and psychologists so that a distressed staff member can reach support directly,” he said. The format of these sessions includes a brief discussion of challenges and brainstorming around potential coping strategies. “This is not a psychotherapy session,” Dr. Levenson said. “Each session can be individualized to further assess the type of distress or to implement rating scales such as the Generalized Anxiety Disorder-7 scale to assess for signs and symptoms consistent with GAD. There are options to schedule a second or third peer support session, or a prompt referral within Columbia psychiatry when indicated.”
A typical peer support group meeting lasts about 30 minutes and comprises individual divisions or departments. Some goals of the peer groups are to discuss unique challenges of the work environment and to encourage the members of the group to come up with solutions; to promote team support and coping; to teach resilience-enhancing strategies from empirically based treatments such as CBT, “and to end each meeting with expressions of gratitude and of thanks within the group,” he said.
According to Dr. Levenson, sample questions CopeColumbia faculty use to facilitate coping, include “which coping skills are working for you?”; “Are you able to be present?”; “Have you honored loss with any specific ways or traditions?”; “Do you have any work buddies who support you and vice versa?”; “Can your work community build off each other’s individual strengths to help both the individual and the work group cope optimally?”; and “How can your work team help facilitate each other to best support each other?”
Other aspects of the CopeColumbia program include town halls/grand rounds that range from 30 to 60 minutes in length. “It may be a virtual presentation from a mental health professional on specific aspects of coping such as relaxation techniques,” he said. “The focus is how to manage stress, anxiety, trauma, loss, and grief. It also includes an active Q&A to engage staff participants. The advantage of this format is that you can reach many staff in an entire department.” The program also has an active web site for staff with both internal and external support links including mindfulness, meditation, exercise, parenting suggestions/caregiving, and other resources to promote well-being and resilience for staff and family.
To date, certain themes emerged from the 1:1 and peer support group sessions, including expressions of difficulty adapting to “such a new reality,” compared with the pre-COVID era. “Staff would often express anticipatory anxiety and uncertainty, such as is there going to be another surge of COVID-19 cases, and will there be a change in policies?” Dr. Levenson said. “There was a lot of expression of stress and frustration related to politicizing the virus and public containment strategies, both on a local and national level.”
Staff also mentioned the loss of usual coping strategies because of prolonged social isolation, especially for those doing remote work, and the loss of usual support resources that have helped them in the past. “They also reported delayed trauma and grief reactions, including symptoms of depression, anxiety, and posttraumatic stress,” he said. “Health care workers with children mentioned high levels of stress related to childcare, increased workload, and what seems like an impossible work-life balance.” Many reported exhaustion and irritability, “which could affect and cause tension within the work group and challenges to effective team cohesion,” he said. “There were also stressors related to the impact of racial injustices and the [presidential] election that could exacerbate the impact of COVID-19.”
Dr. Levenson hopes that CopeColumbia serves as a model for other health care systems looking for ways to support the mental well-being of their employees. “We want to promote the message that emotional health should have the same priority level as physical health,” he said. “The term that I like to use is total health. Addressing the well-being of health care workers is critical for a healthy workforce and for delivering high-quality patient care.”
He reported having no relevant financial disclosures related to his presentation.
Correction, 2/28/22: An earlier version of this article misstated Dr. Lourival Baptista-Neto's name.
LAS VEGAS – , according to Jon A. Levenson, MD.
“We can learn from previous pandemics and epidemics, which will be important for us going forward from COVID-19,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.
During the severe acute respiratory syndrome (SARS) epidemic in 2005, 68% of health care workers reported significant job-related stress, including increased workload, changing work duties, redeployment, shortage of medical supplies, concerns about insufficient personal protective equipment (PPE), lack of safety at work, absence of effective treatment protocols, inconsistent organizational support and information and misinformation from hospital management, and witnessing intense pain, isolation, and loss on a daily basis with few opportunities to take breaks (Psychiatr Serv. 2020 Oct 6. doi: 10.1176/appi.ps.202000274).
Personal concerns associated with psychopathological symptoms included spreading infection to family members; feeling responsibility for family members’ social isolation; self-isolating to avoid infecting family, which can lead to increased loneliness and sadness. “For those who were working remotely, this level of work is hard and challenging,” Dr. Levenson said. “For those who are parents, the 24-hour childcare responsibilities exist on top of work. They often found they can’t unwind with friends.”
Across SARS, MERS, Ebola, and swine flu, a wide range of prevalence in symptoms of distress, stress, anxiety, depressive symptoms, and substance use emerged, he continued. During COVID-19, at least three studies reported significant percentages of distress, depression, anxiety, insomnia, and PTSD among health care workers (JAMA Netw Open. 2020;3[3]:e203976, Front Psychol. 2020 Dec 8;11:608986., and Gen Hosp Psychiatry. Sep-Oct 2020;66:1-8).
“Who is at most-increased risk?” Dr. Levenson asked. “Women; those who are younger and have fewer years of work experience; those working on the front lines such as nurses and advanced practice professionals; and people with preexisting vulnerabilities to psychiatric disorders including anxiety, depression, obsessional symptoms, substance use, suicidal behavior, and impulse control disorders are likely to be especially vulnerable to stress-related symptoms.”
At CUIMC, there were certain “tipping points,” to the vulnerability of health care worker well-being in the early stage of the COVID-19 pandemic, he said, including the loss of an emergency medicine physician colleague from death by suicide. “On the national level there were so many other issues going on such as health care disparities of the COVID-19 infection itself, the murder of George Floyd in Minneapolis, other issues of racial injustice, a tense political climate with an upcoming election at the time, and other factors related to the natural climate concerns,” he said. This prompted several faculty members in the CUIMC department of psychiatry including Claude Ann Mellins, PhD, Laurel S. Mayer, MD, and Lourival Baptista-Neto, MD, to partner with ColumbiaDoctors and New York-Presbyterian Hospital and develop a model of care for health care workers known as CopeColumbia, a virtual program intended to address staff burnout and fatigue, with an emphasis on prevention and promotion of resilience.* It launched in March of 2020 and consists of 1:1 peer support, a peer support group program, town halls/webinars, and an active web site.
The 1:1 peer support sessions typically last 20-30 minutes and provide easy access for all distressed hospital and medical center staff. “We have a phone line staffed by Columbia psychiatrists and psychologists so that a distressed staff member can reach support directly,” he said. The format of these sessions includes a brief discussion of challenges and brainstorming around potential coping strategies. “This is not a psychotherapy session,” Dr. Levenson said. “Each session can be individualized to further assess the type of distress or to implement rating scales such as the Generalized Anxiety Disorder-7 scale to assess for signs and symptoms consistent with GAD. There are options to schedule a second or third peer support session, or a prompt referral within Columbia psychiatry when indicated.”
A typical peer support group meeting lasts about 30 minutes and comprises individual divisions or departments. Some goals of the peer groups are to discuss unique challenges of the work environment and to encourage the members of the group to come up with solutions; to promote team support and coping; to teach resilience-enhancing strategies from empirically based treatments such as CBT, “and to end each meeting with expressions of gratitude and of thanks within the group,” he said.
According to Dr. Levenson, sample questions CopeColumbia faculty use to facilitate coping, include “which coping skills are working for you?”; “Are you able to be present?”; “Have you honored loss with any specific ways or traditions?”; “Do you have any work buddies who support you and vice versa?”; “Can your work community build off each other’s individual strengths to help both the individual and the work group cope optimally?”; and “How can your work team help facilitate each other to best support each other?”
Other aspects of the CopeColumbia program include town halls/grand rounds that range from 30 to 60 minutes in length. “It may be a virtual presentation from a mental health professional on specific aspects of coping such as relaxation techniques,” he said. “The focus is how to manage stress, anxiety, trauma, loss, and grief. It also includes an active Q&A to engage staff participants. The advantage of this format is that you can reach many staff in an entire department.” The program also has an active web site for staff with both internal and external support links including mindfulness, meditation, exercise, parenting suggestions/caregiving, and other resources to promote well-being and resilience for staff and family.
To date, certain themes emerged from the 1:1 and peer support group sessions, including expressions of difficulty adapting to “such a new reality,” compared with the pre-COVID era. “Staff would often express anticipatory anxiety and uncertainty, such as is there going to be another surge of COVID-19 cases, and will there be a change in policies?” Dr. Levenson said. “There was a lot of expression of stress and frustration related to politicizing the virus and public containment strategies, both on a local and national level.”
Staff also mentioned the loss of usual coping strategies because of prolonged social isolation, especially for those doing remote work, and the loss of usual support resources that have helped them in the past. “They also reported delayed trauma and grief reactions, including symptoms of depression, anxiety, and posttraumatic stress,” he said. “Health care workers with children mentioned high levels of stress related to childcare, increased workload, and what seems like an impossible work-life balance.” Many reported exhaustion and irritability, “which could affect and cause tension within the work group and challenges to effective team cohesion,” he said. “There were also stressors related to the impact of racial injustices and the [presidential] election that could exacerbate the impact of COVID-19.”
Dr. Levenson hopes that CopeColumbia serves as a model for other health care systems looking for ways to support the mental well-being of their employees. “We want to promote the message that emotional health should have the same priority level as physical health,” he said. “The term that I like to use is total health. Addressing the well-being of health care workers is critical for a healthy workforce and for delivering high-quality patient care.”
He reported having no relevant financial disclosures related to his presentation.
Correction, 2/28/22: An earlier version of this article misstated Dr. Lourival Baptista-Neto's name.
FROM NPA 2022
More than half of U.S. women enter pregnancy at higher CVD risk
Less than half of women in the United States enter pregnancy in favorable cardiovascular health, new research suggests.
In 2019, among women aged 20 to 44 years with live births in the United States, only 40.2% were in favorable cardiovascular health prior to pregnancy, defined as normal weight, no diabetes, and no hypertension.
Although all regions and states showed a decline in prepregnancy favorable cardiometabolic health, there were significant differences among geographic regions in the country, the authors report. “These data reveal critical deficiencies and geographic disparities in prepregnancy cardiometabolic health,” they conclude.
“One of the things that we know in the U.S. is that the maternal mortality rate has been increasing, and there are significant differences at the state level in both adverse maternal outcomes, such as maternal mortality, as well as adverse pregnancy outcomes,” corresponding author Sadiya S. Khan, MD, MS, FACC, Northwestern University Feinberg School of Medicine, Chicago, told this news organization.
“These outcomes are often related to health factors that predate pregnancy,” Dr. Khan explained, “and the processes that begin at the very, very beginning of conception are informed by health factors prior to pregnancy, in particular cardiometabolic factors like body mass index or obesity, high blood pressure, and diabetes.”
The results were published online on Feb. 14 in a special “Go Red for Women” spotlight issue of Circulation.
Cardiometabolic health factors
Using maternal birth records from live births in the Centers for Disease Control and Prevention Natality Database between 2016 and 2019, the authors analyzed data on 14,174,625 women with live births aged 20 to 44 years. The majority (81.4%) were 20 to 34 years of age, 22.7% were Hispanic or Latina, and 52.7% were non-Hispanic White.
Favorable cardiometabolic health was defined as a BMI of 18 to 24.9 kg/m2, absence of diabetes, and absence of hypertension.
Although all regions and states experienced a decline in favorable cardiometabolic health during the study period of 2016 to 2019, with a drop overall of 3.2% – from 43.5 to 40.2 per 100 live births – it was especially true of the South and Midwest regions.
In 2019, favorable prepregnancy cardiometabolic health was lowest in the South (38.1%) and Midwest (38.8%) and highest in the West (42.2%) and Northeast (43.6%).
State by state, the lowest prevalence of favorable cardiometabolic health was found in Mississippi, at 31.2%, and highest in Utah, at 47.2%.
They also found a correlation between favorable cardiometabolic health and state-level percentages of high-school education or less and enrollment in Medicaid in 2019.
Similar to what has been seen with cardiovascular disease, “we observe that the states with the lowest prevalence of favorable cardiometabolic health were in the Southeast United States,” said Dr. Khan, “and similar geographic variation was observed with some more patterns in education and Medicaid coverage for birth, and these were used as proxies for socioeconomic status in those areas.”
Although Dr. Khan notes that the relationships cannot be determined to be causal from this analysis, she said that “it does suggest that upstream social determinants of health are important determinants of cardiometabolic health.”
Socioeconomic intervention
Dr. Khan noted that policies at the federal and state level can identify ways to “ensure that individuals who are thinking about pregnancy have access to health care and have access to resources, too, from a broad range of health determinants, including housing stability, food security, as well as access to health care be optimized prior to pregnancy.”
The authors note that this analysis may actually overestimate the prevalence of favorable cardiometabolic health, and data on cholesterol, diet, a distinction between type 1 and type 2 diabetes, and physical activity were not available.
Only individuals with live births were included, which could result in the elimination of a potentially high-risk group; however, late pregnancy losses represent less than 0.3% of all pregnancies, they say.
The authors conclude that “future research is needed to equitably improve health prior to pregnancy and quantify the potential benefits in cardiovascular disease outcomes for birthing individuals and their offspring.”
This work was supported by grants from the National Heart, Lung, and Blood Institute and American Heart Association Transformational Project Award awarded to Sadiya S. Khan.
A version of this article first appeared on Medscape.com.
Less than half of women in the United States enter pregnancy in favorable cardiovascular health, new research suggests.
In 2019, among women aged 20 to 44 years with live births in the United States, only 40.2% were in favorable cardiovascular health prior to pregnancy, defined as normal weight, no diabetes, and no hypertension.
Although all regions and states showed a decline in prepregnancy favorable cardiometabolic health, there were significant differences among geographic regions in the country, the authors report. “These data reveal critical deficiencies and geographic disparities in prepregnancy cardiometabolic health,” they conclude.
“One of the things that we know in the U.S. is that the maternal mortality rate has been increasing, and there are significant differences at the state level in both adverse maternal outcomes, such as maternal mortality, as well as adverse pregnancy outcomes,” corresponding author Sadiya S. Khan, MD, MS, FACC, Northwestern University Feinberg School of Medicine, Chicago, told this news organization.
“These outcomes are often related to health factors that predate pregnancy,” Dr. Khan explained, “and the processes that begin at the very, very beginning of conception are informed by health factors prior to pregnancy, in particular cardiometabolic factors like body mass index or obesity, high blood pressure, and diabetes.”
The results were published online on Feb. 14 in a special “Go Red for Women” spotlight issue of Circulation.
Cardiometabolic health factors
Using maternal birth records from live births in the Centers for Disease Control and Prevention Natality Database between 2016 and 2019, the authors analyzed data on 14,174,625 women with live births aged 20 to 44 years. The majority (81.4%) were 20 to 34 years of age, 22.7% were Hispanic or Latina, and 52.7% were non-Hispanic White.
Favorable cardiometabolic health was defined as a BMI of 18 to 24.9 kg/m2, absence of diabetes, and absence of hypertension.
Although all regions and states experienced a decline in favorable cardiometabolic health during the study period of 2016 to 2019, with a drop overall of 3.2% – from 43.5 to 40.2 per 100 live births – it was especially true of the South and Midwest regions.
In 2019, favorable prepregnancy cardiometabolic health was lowest in the South (38.1%) and Midwest (38.8%) and highest in the West (42.2%) and Northeast (43.6%).
State by state, the lowest prevalence of favorable cardiometabolic health was found in Mississippi, at 31.2%, and highest in Utah, at 47.2%.
They also found a correlation between favorable cardiometabolic health and state-level percentages of high-school education or less and enrollment in Medicaid in 2019.
Similar to what has been seen with cardiovascular disease, “we observe that the states with the lowest prevalence of favorable cardiometabolic health were in the Southeast United States,” said Dr. Khan, “and similar geographic variation was observed with some more patterns in education and Medicaid coverage for birth, and these were used as proxies for socioeconomic status in those areas.”
Although Dr. Khan notes that the relationships cannot be determined to be causal from this analysis, she said that “it does suggest that upstream social determinants of health are important determinants of cardiometabolic health.”
Socioeconomic intervention
Dr. Khan noted that policies at the federal and state level can identify ways to “ensure that individuals who are thinking about pregnancy have access to health care and have access to resources, too, from a broad range of health determinants, including housing stability, food security, as well as access to health care be optimized prior to pregnancy.”
The authors note that this analysis may actually overestimate the prevalence of favorable cardiometabolic health, and data on cholesterol, diet, a distinction between type 1 and type 2 diabetes, and physical activity were not available.
Only individuals with live births were included, which could result in the elimination of a potentially high-risk group; however, late pregnancy losses represent less than 0.3% of all pregnancies, they say.
The authors conclude that “future research is needed to equitably improve health prior to pregnancy and quantify the potential benefits in cardiovascular disease outcomes for birthing individuals and their offspring.”
This work was supported by grants from the National Heart, Lung, and Blood Institute and American Heart Association Transformational Project Award awarded to Sadiya S. Khan.
A version of this article first appeared on Medscape.com.
Less than half of women in the United States enter pregnancy in favorable cardiovascular health, new research suggests.
In 2019, among women aged 20 to 44 years with live births in the United States, only 40.2% were in favorable cardiovascular health prior to pregnancy, defined as normal weight, no diabetes, and no hypertension.
Although all regions and states showed a decline in prepregnancy favorable cardiometabolic health, there were significant differences among geographic regions in the country, the authors report. “These data reveal critical deficiencies and geographic disparities in prepregnancy cardiometabolic health,” they conclude.
“One of the things that we know in the U.S. is that the maternal mortality rate has been increasing, and there are significant differences at the state level in both adverse maternal outcomes, such as maternal mortality, as well as adverse pregnancy outcomes,” corresponding author Sadiya S. Khan, MD, MS, FACC, Northwestern University Feinberg School of Medicine, Chicago, told this news organization.
“These outcomes are often related to health factors that predate pregnancy,” Dr. Khan explained, “and the processes that begin at the very, very beginning of conception are informed by health factors prior to pregnancy, in particular cardiometabolic factors like body mass index or obesity, high blood pressure, and diabetes.”
The results were published online on Feb. 14 in a special “Go Red for Women” spotlight issue of Circulation.
Cardiometabolic health factors
Using maternal birth records from live births in the Centers for Disease Control and Prevention Natality Database between 2016 and 2019, the authors analyzed data on 14,174,625 women with live births aged 20 to 44 years. The majority (81.4%) were 20 to 34 years of age, 22.7% were Hispanic or Latina, and 52.7% were non-Hispanic White.
Favorable cardiometabolic health was defined as a BMI of 18 to 24.9 kg/m2, absence of diabetes, and absence of hypertension.
Although all regions and states experienced a decline in favorable cardiometabolic health during the study period of 2016 to 2019, with a drop overall of 3.2% – from 43.5 to 40.2 per 100 live births – it was especially true of the South and Midwest regions.
In 2019, favorable prepregnancy cardiometabolic health was lowest in the South (38.1%) and Midwest (38.8%) and highest in the West (42.2%) and Northeast (43.6%).
State by state, the lowest prevalence of favorable cardiometabolic health was found in Mississippi, at 31.2%, and highest in Utah, at 47.2%.
They also found a correlation between favorable cardiometabolic health and state-level percentages of high-school education or less and enrollment in Medicaid in 2019.
Similar to what has been seen with cardiovascular disease, “we observe that the states with the lowest prevalence of favorable cardiometabolic health were in the Southeast United States,” said Dr. Khan, “and similar geographic variation was observed with some more patterns in education and Medicaid coverage for birth, and these were used as proxies for socioeconomic status in those areas.”
Although Dr. Khan notes that the relationships cannot be determined to be causal from this analysis, she said that “it does suggest that upstream social determinants of health are important determinants of cardiometabolic health.”
Socioeconomic intervention
Dr. Khan noted that policies at the federal and state level can identify ways to “ensure that individuals who are thinking about pregnancy have access to health care and have access to resources, too, from a broad range of health determinants, including housing stability, food security, as well as access to health care be optimized prior to pregnancy.”
The authors note that this analysis may actually overestimate the prevalence of favorable cardiometabolic health, and data on cholesterol, diet, a distinction between type 1 and type 2 diabetes, and physical activity were not available.
Only individuals with live births were included, which could result in the elimination of a potentially high-risk group; however, late pregnancy losses represent less than 0.3% of all pregnancies, they say.
The authors conclude that “future research is needed to equitably improve health prior to pregnancy and quantify the potential benefits in cardiovascular disease outcomes for birthing individuals and their offspring.”
This work was supported by grants from the National Heart, Lung, and Blood Institute and American Heart Association Transformational Project Award awarded to Sadiya S. Khan.
A version of this article first appeared on Medscape.com.
Excess sodium in soluble acetaminophen tied to CVD risk, death
a large observational study of more than 300,000 adults suggests.
“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.
The study was published online Feb. 24 in the European Heart Journal.
‘Compelling results’
Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.
Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).
“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.
Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).
After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).
A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.
The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).
There was also evidence of a dose-response relationship.
In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.
Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).
“The results are compelling,” write the authors of an editorial published with the study.
“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.
“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.
The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a large observational study of more than 300,000 adults suggests.
“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.
The study was published online Feb. 24 in the European Heart Journal.
‘Compelling results’
Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.
Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).
“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.
Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).
After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).
A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.
The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).
There was also evidence of a dose-response relationship.
In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.
Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).
“The results are compelling,” write the authors of an editorial published with the study.
“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.
“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.
The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a large observational study of more than 300,000 adults suggests.
“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.
The study was published online Feb. 24 in the European Heart Journal.
‘Compelling results’
Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.
Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).
“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.
Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).
After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).
A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.
The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).
There was also evidence of a dose-response relationship.
In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.
Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).
“The results are compelling,” write the authors of an editorial published with the study.
“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.
“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.
The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE EUROPEAN HEART JOURNAL
First recording of dying brain shows memory, meditation patterns
Although only a single case study, researchers say the recording raises the possibility that as we die, our lives really do flash before our eyes.
“The same neurophysiological activity patterns that occur in our brains when we dream, remember, meditate, concentrate – these same patterns also appear just before we die,” study investigator Ajmal Zemmar, MD, PhD, assistant professor of neurosurgery at the University of Louisville (Ky.), said in an interview.
The research was published online Feb. 22, 2022, in the Frontiers in Aging Neuroscience.
Accidental finding
The recording of brain activity was captured inadvertently in 2016 when neuroscientists used continuous EEG to detect and treat seizures in an 87-year-old man who had developed epilepsy after a traumatic brain injury, While undergoing the EEG, the patient had a cardiac arrest and died.
In the 30 seconds before and after blood flow to the brain stopped, the EEG showed an increase in gamma oscillations. These are brain waves known to be involved in high cognitive functions, including conscious perception and memory flashbacks.
Researchers also noted changes in alpha, theta, delta, and beta wave activity just before and just after cardiac arrest, and that changes in one type modulated changes in others. That suggests a coordinated rhythm, which further suggests the activity is more than just the firing of neurons as they die.
“When you observe this and you observe the rhythmic oscillation, you are inclined to think this may be a coordinated activity pattern of the brain rather than a mere discharge when the brain dies,” Dr. Zemmar said.
Although they’ve had the data since 2016, Dr. Zemmar and colleagues held off on publishing in the hopes of finding similar recordings in other individuals. That their 5-year search yielded no results illustrates just how difficult a study like this is to conduct, Dr. Zemmar noted. “We’re trying to figure out how to do this in a predictable way, but obtaining datasets like this is going to be challenging,” he said.
Although Dr. Zemmar was unable to find recordings of activity in the dying brains of other humans, he did find a similar study conducted with rats in 2013. In that research, investigators reported a surge of brain activity in rats just prior to and immediately after experimental cardiac arrest. Changes in high- and low-frequency brain waves mirrored those documented in the current case study.
Bringing a picture together
Commenting on the new study, George Mashour, MD, PhD, professor and chair of anesthesiology and professor of neurosurgery and pharmacology at the University of Michigan, Ann Arbor, said the results are eerily similar to a 2013 study that he coauthored.
Although the current research is just a single case study, Dr. Mashour said when taken with his team’s findings in rats and other work, the new findings are “starting to put a picture together of what might be going on in the dying brain.”
“They were able to record throughout the process of cardiac arrest and death and what they found was strikingly similar to what we found in our highly controlled animal study,” said Dr. Mashour, who is also the founding director of the Center for Consciousness Science at the University of Michigan.
“There was a surge of higher-frequency activity and there was coherence across different parts of the brain,” he added. “That suggests that what we found in the rigorous controlled setting of a laboratory actually translates to humans who are undergoing the clinical process of dying.”
What remains unclear is whether this brain activity explains the near-death experiences described in the literature, which include “life recall” of memories, Dr. Mashour said. “This higher-frequency surge that’s happening around the time of death, is that correlated with experiencing something like this near-death experience? Or is it just a neural feature that can just as easily happen in an unconscious brain?”
The study was funded by the Heidi Demetriades Foundation, the ETH Zürich Foundation, and the Henan Provincial People’s Hospital Outstanding Talents Founding Grant Project. Dr. Zemmar and Dr. Mashour disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although only a single case study, researchers say the recording raises the possibility that as we die, our lives really do flash before our eyes.
“The same neurophysiological activity patterns that occur in our brains when we dream, remember, meditate, concentrate – these same patterns also appear just before we die,” study investigator Ajmal Zemmar, MD, PhD, assistant professor of neurosurgery at the University of Louisville (Ky.), said in an interview.
The research was published online Feb. 22, 2022, in the Frontiers in Aging Neuroscience.
Accidental finding
The recording of brain activity was captured inadvertently in 2016 when neuroscientists used continuous EEG to detect and treat seizures in an 87-year-old man who had developed epilepsy after a traumatic brain injury, While undergoing the EEG, the patient had a cardiac arrest and died.
In the 30 seconds before and after blood flow to the brain stopped, the EEG showed an increase in gamma oscillations. These are brain waves known to be involved in high cognitive functions, including conscious perception and memory flashbacks.
Researchers also noted changes in alpha, theta, delta, and beta wave activity just before and just after cardiac arrest, and that changes in one type modulated changes in others. That suggests a coordinated rhythm, which further suggests the activity is more than just the firing of neurons as they die.
“When you observe this and you observe the rhythmic oscillation, you are inclined to think this may be a coordinated activity pattern of the brain rather than a mere discharge when the brain dies,” Dr. Zemmar said.
Although they’ve had the data since 2016, Dr. Zemmar and colleagues held off on publishing in the hopes of finding similar recordings in other individuals. That their 5-year search yielded no results illustrates just how difficult a study like this is to conduct, Dr. Zemmar noted. “We’re trying to figure out how to do this in a predictable way, but obtaining datasets like this is going to be challenging,” he said.
Although Dr. Zemmar was unable to find recordings of activity in the dying brains of other humans, he did find a similar study conducted with rats in 2013. In that research, investigators reported a surge of brain activity in rats just prior to and immediately after experimental cardiac arrest. Changes in high- and low-frequency brain waves mirrored those documented in the current case study.
Bringing a picture together
Commenting on the new study, George Mashour, MD, PhD, professor and chair of anesthesiology and professor of neurosurgery and pharmacology at the University of Michigan, Ann Arbor, said the results are eerily similar to a 2013 study that he coauthored.
Although the current research is just a single case study, Dr. Mashour said when taken with his team’s findings in rats and other work, the new findings are “starting to put a picture together of what might be going on in the dying brain.”
“They were able to record throughout the process of cardiac arrest and death and what they found was strikingly similar to what we found in our highly controlled animal study,” said Dr. Mashour, who is also the founding director of the Center for Consciousness Science at the University of Michigan.
“There was a surge of higher-frequency activity and there was coherence across different parts of the brain,” he added. “That suggests that what we found in the rigorous controlled setting of a laboratory actually translates to humans who are undergoing the clinical process of dying.”
What remains unclear is whether this brain activity explains the near-death experiences described in the literature, which include “life recall” of memories, Dr. Mashour said. “This higher-frequency surge that’s happening around the time of death, is that correlated with experiencing something like this near-death experience? Or is it just a neural feature that can just as easily happen in an unconscious brain?”
The study was funded by the Heidi Demetriades Foundation, the ETH Zürich Foundation, and the Henan Provincial People’s Hospital Outstanding Talents Founding Grant Project. Dr. Zemmar and Dr. Mashour disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although only a single case study, researchers say the recording raises the possibility that as we die, our lives really do flash before our eyes.
“The same neurophysiological activity patterns that occur in our brains when we dream, remember, meditate, concentrate – these same patterns also appear just before we die,” study investigator Ajmal Zemmar, MD, PhD, assistant professor of neurosurgery at the University of Louisville (Ky.), said in an interview.
The research was published online Feb. 22, 2022, in the Frontiers in Aging Neuroscience.
Accidental finding
The recording of brain activity was captured inadvertently in 2016 when neuroscientists used continuous EEG to detect and treat seizures in an 87-year-old man who had developed epilepsy after a traumatic brain injury, While undergoing the EEG, the patient had a cardiac arrest and died.
In the 30 seconds before and after blood flow to the brain stopped, the EEG showed an increase in gamma oscillations. These are brain waves known to be involved in high cognitive functions, including conscious perception and memory flashbacks.
Researchers also noted changes in alpha, theta, delta, and beta wave activity just before and just after cardiac arrest, and that changes in one type modulated changes in others. That suggests a coordinated rhythm, which further suggests the activity is more than just the firing of neurons as they die.
“When you observe this and you observe the rhythmic oscillation, you are inclined to think this may be a coordinated activity pattern of the brain rather than a mere discharge when the brain dies,” Dr. Zemmar said.
Although they’ve had the data since 2016, Dr. Zemmar and colleagues held off on publishing in the hopes of finding similar recordings in other individuals. That their 5-year search yielded no results illustrates just how difficult a study like this is to conduct, Dr. Zemmar noted. “We’re trying to figure out how to do this in a predictable way, but obtaining datasets like this is going to be challenging,” he said.
Although Dr. Zemmar was unable to find recordings of activity in the dying brains of other humans, he did find a similar study conducted with rats in 2013. In that research, investigators reported a surge of brain activity in rats just prior to and immediately after experimental cardiac arrest. Changes in high- and low-frequency brain waves mirrored those documented in the current case study.
Bringing a picture together
Commenting on the new study, George Mashour, MD, PhD, professor and chair of anesthesiology and professor of neurosurgery and pharmacology at the University of Michigan, Ann Arbor, said the results are eerily similar to a 2013 study that he coauthored.
Although the current research is just a single case study, Dr. Mashour said when taken with his team’s findings in rats and other work, the new findings are “starting to put a picture together of what might be going on in the dying brain.”
“They were able to record throughout the process of cardiac arrest and death and what they found was strikingly similar to what we found in our highly controlled animal study,” said Dr. Mashour, who is also the founding director of the Center for Consciousness Science at the University of Michigan.
“There was a surge of higher-frequency activity and there was coherence across different parts of the brain,” he added. “That suggests that what we found in the rigorous controlled setting of a laboratory actually translates to humans who are undergoing the clinical process of dying.”
What remains unclear is whether this brain activity explains the near-death experiences described in the literature, which include “life recall” of memories, Dr. Mashour said. “This higher-frequency surge that’s happening around the time of death, is that correlated with experiencing something like this near-death experience? Or is it just a neural feature that can just as easily happen in an unconscious brain?”
The study was funded by the Heidi Demetriades Foundation, the ETH Zürich Foundation, and the Henan Provincial People’s Hospital Outstanding Talents Founding Grant Project. Dr. Zemmar and Dr. Mashour disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM FRONTIERS IN AGING NEUROSCIENCE
FDA OKs first condom for anal sex
anal sex has gained Food and Drug Administration approval.
specifically designed for use duringAnal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
anal sex has gained Food and Drug Administration approval.
specifically designed for use duringAnal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
anal sex has gained Food and Drug Administration approval.
specifically designed for use duringAnal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
Ivermectin does not stop progression to severe COVID: randomized trial
Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.
“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.
The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.
Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.
Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
Secondary outcomes
Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.
In all the secondary outcomes, there were no significant differences between groups.
Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).
The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
No difference by vaccine status
The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”
Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).
Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.
The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”
Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.
Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.
In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.
Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.
A version of this article first appeared on Medscape.com.
Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.
“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.
The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.
Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.
Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
Secondary outcomes
Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.
In all the secondary outcomes, there were no significant differences between groups.
Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).
The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
No difference by vaccine status
The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”
Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).
Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.
The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”
Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.
Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.
In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.
Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.
A version of this article first appeared on Medscape.com.
Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.
“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.
The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.
Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.
Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
Secondary outcomes
Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.
In all the secondary outcomes, there were no significant differences between groups.
Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).
The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
No difference by vaccine status
The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”
Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).
Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.
The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”
Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.
Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.
In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.
Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICNE
CMS updates lung screening criteria, more aligned with USPSTF
for Medicare recipients.
According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.
The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.
Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.
“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”
CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.
The American Lung Association applauds the decision to update eligibility.
“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”
While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.
Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.
To read the final decision, visit the CMS website.
A version of this article first appeared on Medscape.com.
for Medicare recipients.
According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.
The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.
Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.
“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”
CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.
The American Lung Association applauds the decision to update eligibility.
“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”
While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.
Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.
To read the final decision, visit the CMS website.
A version of this article first appeared on Medscape.com.
for Medicare recipients.
According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.
The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.
Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.
“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”
CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.
The American Lung Association applauds the decision to update eligibility.
“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”
While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.
Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.
To read the final decision, visit the CMS website.
A version of this article first appeared on Medscape.com.
Organ transplantation: Unvaccinated need not apply
I agree with most advice given by the affable TV character Ted Lasso. “Every choice is a chance,” he said. Pandemic-era physicians must now consider whether a politically motivated choice to decline COVID-19 vaccination should negatively affect the chance to receive an organ donation.
And in confronting these choices, we have a chance to educate the public on the complexities of the organ allocation process.
A well-informed patient’s personal choice should be honored, even if clinicians disagree, if it does not affect the well-being of others. For example, I once had a patient in acute leukemic crisis who declined blood products because she was a Jehovah’s Witness. She died. Her choice affected her longevity only.
Compare that decision with awarding an organ to an individual who has declined readily available protection of that organ. Weigh that choice against the fact that said protection is against an infectious disease that has killed over 5.5 million worldwide.
Some institutions stand strong, others hedge their bets
Admirably, Loyola University Health System understands that difference. They published a firm stand on transplant candidacy and COVID-19 vaccination status in the Journal of Heart and Lung Transplant. Daniel Dilling, MD, medical director of the lung transplantation program , and Mark Kuczewski, PhD, a professor of medical ethics at Loyola University Chicago, Maywood, Ill., wrote that: “We believe that requiring vaccination against COVID-19 should not be controversial when we focus strictly on established frameworks and practices surrounding eligibility for wait-listing to receive a solid organ transplant.”
The Cleveland Clinic apparently agrees. In October 2021, they denied a liver transplant to Michelle Vitullo of Ohio, whose daughter had been deemed “a perfect match.” Her daughter, also unvaccinated, stated: “Being denied for a nonmedical reason for someone’s beliefs that are different to yours, I mean that’s not how that should be.”
But vaccination status is a medical reason, given well-established data regarding increased mortality among the immunosuppressed. Ms. Vitullo then said: “We are trying to get to UPMC [University of Pittsburgh Medical Center] as they don’t require a vaccination.”
The public information page on transplant candidacy from UPMC reads (my italics): It is recommended that all transplant candidates, transplant recipients, and their household members receive COVID-19 vaccination when the vaccine is available to them. It is preferred that transplant candidates are vaccinated more than 2 weeks before transplantation.
I reached out to UPMC for clarification and was told by email that “we do not have a policy regarding COVID-19 vaccination requirement for current transplant candidates.” Houston Methodist shares the same agnostic stance.
Compare these opinions with Brigham and Women’s Hospital, where the requirements are resolute: “Like most other transplant programs across the country, the COVID-19 vaccine is one of several vaccines and lifestyle behaviors that are required for patients awaiting solid organ transplant.”
They add that “transplant candidates must also receive the seasonal influenza and hepatitis B vaccines, follow other healthy behaviors, and demonstrate they can commit to taking the required medications following transplant.”
In January 2022, Brigham and Women’s Hospital declared 31-year-old D.J. Ferguson ineligible for a heart transplant because he declined to be vaccinated against COVID-19. According to the New York Post and ABC News, his physicians resorted to left ventricular assist device support. His mother, Tracy Ferguson, is quoted as saying: “He’s not an antivaxxer. He has all of his vaccines.” I’ll just leave that right there.
Unfortunately, Michelle Vitullo’s obituary was published in December 2021. Regardless of whether she received her liver transplant, the outcome is tragic, and whatever you think of this family’s battle playing out in the glare of the national spotlight, their loss is no less devastating.
The directed-donation aspect of this case poses an interesting question. A news anchor asked the mother and daughter: “If you both accept the risks, why doesn’t the hospital just let you try?” The answers are obvious to us clinicians. Performing a transplantation in an unvaccinated patient could lead to their early death if they became infected because of their immunocompromised state, would open the door for transplantation of any patient who is unvaccinated for anything, including influenza and hepatitis B, which could result in the preventable waste of organs, and puts other vulnerable hospitalized patients at risk during the initial transplant stay and follow-up.
That’s not to mention the potential legal suit. Never has a consent form dissuaded any party from lodging an accusation of wrongful death or medical malpractice. In the face of strong data on higher mortality in unvaccinated, immunocompromised patients, a good lawyer could charge that the institution and transplant surgeons should have known better, regardless of the donor and recipient’s willingness to accept the risks.
The Vitullo and Ferguson cases are among many similar dilemmas surrounding transplant candidacy across the United States.
University of Virginia Health in Charlottesville denied 42-year-old Shamgar Connors a kidney transplant because he is unvaccinated, despite a previous COVID-19 infection. In October 2021, Leilani Lutali of Colorado was denied a kidney by UCHealth because she declined vaccination.
As Ted Lasso says: “There’s a bunch of crazy stuff on Twitter.”
Predictably, social media is full of public outcry. “Some cold-hearted people on here” tweeted one. “What if it was one of your loved ones who needed a transplant?” Another tweeted the Hippocratic oath with the comment that “They all swore under this noble ‘oat’, but I guess it’s been forgotten.” (This was followed with a photo of a box of Quaker Oats in a failed attempt at humor.) These discussions among the Twitterati highlight the depths of misunderstanding on organ transplantation.
To be fair, unless you have been personally involved in the decision-making process for transplant candidacy, there is little opportunity to be educated. I explain to my anxious patients and their families that a donor organ is like a fumbled football. There may be well over 100 patients at all levels of transplant status in many geographic locations diving for that same organ.
The transplant team is tasked with finding the best match, determining who is the sickest, assessing time for transport of that organ, and, above all, who will be the best steward of that organ.
Take heart transplantation, for instance. Approximately 3,500 patients in the United States are awaiting one each year. Instead of facing an almost certain death within 5 years, a transplant recipient has a chance at a median survival of 12-13 years. The cost of a heart transplant is approximately $1.38 million, according to Milliman, a consulting firm. This is “an incredibly resource intensive procedure,” including expenditures for transportation, antirejection medication, office visits, physician fees, ICU stays, rejection surveillance, and acute rejection therapies.
Transplant denial is nothing new
People get turned down for organ transplants all the time. My patient with end-stage dilated cardiomyopathy was denied a heart transplant when it was discovered that he had scores of outstanding parking tickets. This was seen as a surrogate for an inability to afford his antirejection medication.
Another patient swore that her positive cotinine levels were caused by endless hours at the bingo hall where second-hand smoke swirled. She was also denied. Many potential candidates who are in acute decline hold precariously to newfound sobriety. They are denied. A patient’s boyfriend told the transplant team that he couldn’t be relied upon to drive her to her appointments. She was denied.
Many people who engage in antisocial behaviors have no idea that these actions may result in the denial of an organ transplant should their future selves need one. These are hard lines, but everyone should agree that the odds of survival are heavily in favor of the consistently adherent.
We should take this opportunity to educate the public on how complicated obtaining an organ transplant can be. More than 6,000 people die each year waiting for an organ because of the supply-and-demand disparities in the transplantation arena. I’m willing to bet that many of the loudest protesters in favor of unvaccinated transplant recipients have not signed the organ donor box on the back of their driver’s license. This conversation is an opportunity to change that and remind people that organ donation may be their only opportunity to save a fellow human’s life.
Again, to quote Ted Lasso: “If you care about someone and you got a little love in your heart, there ain’t nothing you can’t get through together.” That philosophy should apply to the tasks of selecting the best organ donors as well as the best organ recipients.
And every organ should go to the one who will honor their donor and their donor’s family by taking the best care of that ultimate gift of life, including being vaccinated against COVID-19.
Dr. Walton-Shirley is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.
I agree with most advice given by the affable TV character Ted Lasso. “Every choice is a chance,” he said. Pandemic-era physicians must now consider whether a politically motivated choice to decline COVID-19 vaccination should negatively affect the chance to receive an organ donation.
And in confronting these choices, we have a chance to educate the public on the complexities of the organ allocation process.
A well-informed patient’s personal choice should be honored, even if clinicians disagree, if it does not affect the well-being of others. For example, I once had a patient in acute leukemic crisis who declined blood products because she was a Jehovah’s Witness. She died. Her choice affected her longevity only.
Compare that decision with awarding an organ to an individual who has declined readily available protection of that organ. Weigh that choice against the fact that said protection is against an infectious disease that has killed over 5.5 million worldwide.
Some institutions stand strong, others hedge their bets
Admirably, Loyola University Health System understands that difference. They published a firm stand on transplant candidacy and COVID-19 vaccination status in the Journal of Heart and Lung Transplant. Daniel Dilling, MD, medical director of the lung transplantation program , and Mark Kuczewski, PhD, a professor of medical ethics at Loyola University Chicago, Maywood, Ill., wrote that: “We believe that requiring vaccination against COVID-19 should not be controversial when we focus strictly on established frameworks and practices surrounding eligibility for wait-listing to receive a solid organ transplant.”
The Cleveland Clinic apparently agrees. In October 2021, they denied a liver transplant to Michelle Vitullo of Ohio, whose daughter had been deemed “a perfect match.” Her daughter, also unvaccinated, stated: “Being denied for a nonmedical reason for someone’s beliefs that are different to yours, I mean that’s not how that should be.”
But vaccination status is a medical reason, given well-established data regarding increased mortality among the immunosuppressed. Ms. Vitullo then said: “We are trying to get to UPMC [University of Pittsburgh Medical Center] as they don’t require a vaccination.”
The public information page on transplant candidacy from UPMC reads (my italics): It is recommended that all transplant candidates, transplant recipients, and their household members receive COVID-19 vaccination when the vaccine is available to them. It is preferred that transplant candidates are vaccinated more than 2 weeks before transplantation.
I reached out to UPMC for clarification and was told by email that “we do not have a policy regarding COVID-19 vaccination requirement for current transplant candidates.” Houston Methodist shares the same agnostic stance.
Compare these opinions with Brigham and Women’s Hospital, where the requirements are resolute: “Like most other transplant programs across the country, the COVID-19 vaccine is one of several vaccines and lifestyle behaviors that are required for patients awaiting solid organ transplant.”
They add that “transplant candidates must also receive the seasonal influenza and hepatitis B vaccines, follow other healthy behaviors, and demonstrate they can commit to taking the required medications following transplant.”
In January 2022, Brigham and Women’s Hospital declared 31-year-old D.J. Ferguson ineligible for a heart transplant because he declined to be vaccinated against COVID-19. According to the New York Post and ABC News, his physicians resorted to left ventricular assist device support. His mother, Tracy Ferguson, is quoted as saying: “He’s not an antivaxxer. He has all of his vaccines.” I’ll just leave that right there.
Unfortunately, Michelle Vitullo’s obituary was published in December 2021. Regardless of whether she received her liver transplant, the outcome is tragic, and whatever you think of this family’s battle playing out in the glare of the national spotlight, their loss is no less devastating.
The directed-donation aspect of this case poses an interesting question. A news anchor asked the mother and daughter: “If you both accept the risks, why doesn’t the hospital just let you try?” The answers are obvious to us clinicians. Performing a transplantation in an unvaccinated patient could lead to their early death if they became infected because of their immunocompromised state, would open the door for transplantation of any patient who is unvaccinated for anything, including influenza and hepatitis B, which could result in the preventable waste of organs, and puts other vulnerable hospitalized patients at risk during the initial transplant stay and follow-up.
That’s not to mention the potential legal suit. Never has a consent form dissuaded any party from lodging an accusation of wrongful death or medical malpractice. In the face of strong data on higher mortality in unvaccinated, immunocompromised patients, a good lawyer could charge that the institution and transplant surgeons should have known better, regardless of the donor and recipient’s willingness to accept the risks.
The Vitullo and Ferguson cases are among many similar dilemmas surrounding transplant candidacy across the United States.
University of Virginia Health in Charlottesville denied 42-year-old Shamgar Connors a kidney transplant because he is unvaccinated, despite a previous COVID-19 infection. In October 2021, Leilani Lutali of Colorado was denied a kidney by UCHealth because she declined vaccination.
As Ted Lasso says: “There’s a bunch of crazy stuff on Twitter.”
Predictably, social media is full of public outcry. “Some cold-hearted people on here” tweeted one. “What if it was one of your loved ones who needed a transplant?” Another tweeted the Hippocratic oath with the comment that “They all swore under this noble ‘oat’, but I guess it’s been forgotten.” (This was followed with a photo of a box of Quaker Oats in a failed attempt at humor.) These discussions among the Twitterati highlight the depths of misunderstanding on organ transplantation.
To be fair, unless you have been personally involved in the decision-making process for transplant candidacy, there is little opportunity to be educated. I explain to my anxious patients and their families that a donor organ is like a fumbled football. There may be well over 100 patients at all levels of transplant status in many geographic locations diving for that same organ.
The transplant team is tasked with finding the best match, determining who is the sickest, assessing time for transport of that organ, and, above all, who will be the best steward of that organ.
Take heart transplantation, for instance. Approximately 3,500 patients in the United States are awaiting one each year. Instead of facing an almost certain death within 5 years, a transplant recipient has a chance at a median survival of 12-13 years. The cost of a heart transplant is approximately $1.38 million, according to Milliman, a consulting firm. This is “an incredibly resource intensive procedure,” including expenditures for transportation, antirejection medication, office visits, physician fees, ICU stays, rejection surveillance, and acute rejection therapies.
Transplant denial is nothing new
People get turned down for organ transplants all the time. My patient with end-stage dilated cardiomyopathy was denied a heart transplant when it was discovered that he had scores of outstanding parking tickets. This was seen as a surrogate for an inability to afford his antirejection medication.
Another patient swore that her positive cotinine levels were caused by endless hours at the bingo hall where second-hand smoke swirled. She was also denied. Many potential candidates who are in acute decline hold precariously to newfound sobriety. They are denied. A patient’s boyfriend told the transplant team that he couldn’t be relied upon to drive her to her appointments. She was denied.
Many people who engage in antisocial behaviors have no idea that these actions may result in the denial of an organ transplant should their future selves need one. These are hard lines, but everyone should agree that the odds of survival are heavily in favor of the consistently adherent.
We should take this opportunity to educate the public on how complicated obtaining an organ transplant can be. More than 6,000 people die each year waiting for an organ because of the supply-and-demand disparities in the transplantation arena. I’m willing to bet that many of the loudest protesters in favor of unvaccinated transplant recipients have not signed the organ donor box on the back of their driver’s license. This conversation is an opportunity to change that and remind people that organ donation may be their only opportunity to save a fellow human’s life.
Again, to quote Ted Lasso: “If you care about someone and you got a little love in your heart, there ain’t nothing you can’t get through together.” That philosophy should apply to the tasks of selecting the best organ donors as well as the best organ recipients.
And every organ should go to the one who will honor their donor and their donor’s family by taking the best care of that ultimate gift of life, including being vaccinated against COVID-19.
Dr. Walton-Shirley is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.
I agree with most advice given by the affable TV character Ted Lasso. “Every choice is a chance,” he said. Pandemic-era physicians must now consider whether a politically motivated choice to decline COVID-19 vaccination should negatively affect the chance to receive an organ donation.
And in confronting these choices, we have a chance to educate the public on the complexities of the organ allocation process.
A well-informed patient’s personal choice should be honored, even if clinicians disagree, if it does not affect the well-being of others. For example, I once had a patient in acute leukemic crisis who declined blood products because she was a Jehovah’s Witness. She died. Her choice affected her longevity only.
Compare that decision with awarding an organ to an individual who has declined readily available protection of that organ. Weigh that choice against the fact that said protection is against an infectious disease that has killed over 5.5 million worldwide.
Some institutions stand strong, others hedge their bets
Admirably, Loyola University Health System understands that difference. They published a firm stand on transplant candidacy and COVID-19 vaccination status in the Journal of Heart and Lung Transplant. Daniel Dilling, MD, medical director of the lung transplantation program , and Mark Kuczewski, PhD, a professor of medical ethics at Loyola University Chicago, Maywood, Ill., wrote that: “We believe that requiring vaccination against COVID-19 should not be controversial when we focus strictly on established frameworks and practices surrounding eligibility for wait-listing to receive a solid organ transplant.”
The Cleveland Clinic apparently agrees. In October 2021, they denied a liver transplant to Michelle Vitullo of Ohio, whose daughter had been deemed “a perfect match.” Her daughter, also unvaccinated, stated: “Being denied for a nonmedical reason for someone’s beliefs that are different to yours, I mean that’s not how that should be.”
But vaccination status is a medical reason, given well-established data regarding increased mortality among the immunosuppressed. Ms. Vitullo then said: “We are trying to get to UPMC [University of Pittsburgh Medical Center] as they don’t require a vaccination.”
The public information page on transplant candidacy from UPMC reads (my italics): It is recommended that all transplant candidates, transplant recipients, and their household members receive COVID-19 vaccination when the vaccine is available to them. It is preferred that transplant candidates are vaccinated more than 2 weeks before transplantation.
I reached out to UPMC for clarification and was told by email that “we do not have a policy regarding COVID-19 vaccination requirement for current transplant candidates.” Houston Methodist shares the same agnostic stance.
Compare these opinions with Brigham and Women’s Hospital, where the requirements are resolute: “Like most other transplant programs across the country, the COVID-19 vaccine is one of several vaccines and lifestyle behaviors that are required for patients awaiting solid organ transplant.”
They add that “transplant candidates must also receive the seasonal influenza and hepatitis B vaccines, follow other healthy behaviors, and demonstrate they can commit to taking the required medications following transplant.”
In January 2022, Brigham and Women’s Hospital declared 31-year-old D.J. Ferguson ineligible for a heart transplant because he declined to be vaccinated against COVID-19. According to the New York Post and ABC News, his physicians resorted to left ventricular assist device support. His mother, Tracy Ferguson, is quoted as saying: “He’s not an antivaxxer. He has all of his vaccines.” I’ll just leave that right there.
Unfortunately, Michelle Vitullo’s obituary was published in December 2021. Regardless of whether she received her liver transplant, the outcome is tragic, and whatever you think of this family’s battle playing out in the glare of the national spotlight, their loss is no less devastating.
The directed-donation aspect of this case poses an interesting question. A news anchor asked the mother and daughter: “If you both accept the risks, why doesn’t the hospital just let you try?” The answers are obvious to us clinicians. Performing a transplantation in an unvaccinated patient could lead to their early death if they became infected because of their immunocompromised state, would open the door for transplantation of any patient who is unvaccinated for anything, including influenza and hepatitis B, which could result in the preventable waste of organs, and puts other vulnerable hospitalized patients at risk during the initial transplant stay and follow-up.
That’s not to mention the potential legal suit. Never has a consent form dissuaded any party from lodging an accusation of wrongful death or medical malpractice. In the face of strong data on higher mortality in unvaccinated, immunocompromised patients, a good lawyer could charge that the institution and transplant surgeons should have known better, regardless of the donor and recipient’s willingness to accept the risks.
The Vitullo and Ferguson cases are among many similar dilemmas surrounding transplant candidacy across the United States.
University of Virginia Health in Charlottesville denied 42-year-old Shamgar Connors a kidney transplant because he is unvaccinated, despite a previous COVID-19 infection. In October 2021, Leilani Lutali of Colorado was denied a kidney by UCHealth because she declined vaccination.
As Ted Lasso says: “There’s a bunch of crazy stuff on Twitter.”
Predictably, social media is full of public outcry. “Some cold-hearted people on here” tweeted one. “What if it was one of your loved ones who needed a transplant?” Another tweeted the Hippocratic oath with the comment that “They all swore under this noble ‘oat’, but I guess it’s been forgotten.” (This was followed with a photo of a box of Quaker Oats in a failed attempt at humor.) These discussions among the Twitterati highlight the depths of misunderstanding on organ transplantation.
To be fair, unless you have been personally involved in the decision-making process for transplant candidacy, there is little opportunity to be educated. I explain to my anxious patients and their families that a donor organ is like a fumbled football. There may be well over 100 patients at all levels of transplant status in many geographic locations diving for that same organ.
The transplant team is tasked with finding the best match, determining who is the sickest, assessing time for transport of that organ, and, above all, who will be the best steward of that organ.
Take heart transplantation, for instance. Approximately 3,500 patients in the United States are awaiting one each year. Instead of facing an almost certain death within 5 years, a transplant recipient has a chance at a median survival of 12-13 years. The cost of a heart transplant is approximately $1.38 million, according to Milliman, a consulting firm. This is “an incredibly resource intensive procedure,” including expenditures for transportation, antirejection medication, office visits, physician fees, ICU stays, rejection surveillance, and acute rejection therapies.
Transplant denial is nothing new
People get turned down for organ transplants all the time. My patient with end-stage dilated cardiomyopathy was denied a heart transplant when it was discovered that he had scores of outstanding parking tickets. This was seen as a surrogate for an inability to afford his antirejection medication.
Another patient swore that her positive cotinine levels were caused by endless hours at the bingo hall where second-hand smoke swirled. She was also denied. Many potential candidates who are in acute decline hold precariously to newfound sobriety. They are denied. A patient’s boyfriend told the transplant team that he couldn’t be relied upon to drive her to her appointments. She was denied.
Many people who engage in antisocial behaviors have no idea that these actions may result in the denial of an organ transplant should their future selves need one. These are hard lines, but everyone should agree that the odds of survival are heavily in favor of the consistently adherent.
We should take this opportunity to educate the public on how complicated obtaining an organ transplant can be. More than 6,000 people die each year waiting for an organ because of the supply-and-demand disparities in the transplantation arena. I’m willing to bet that many of the loudest protesters in favor of unvaccinated transplant recipients have not signed the organ donor box on the back of their driver’s license. This conversation is an opportunity to change that and remind people that organ donation may be their only opportunity to save a fellow human’s life.
Again, to quote Ted Lasso: “If you care about someone and you got a little love in your heart, there ain’t nothing you can’t get through together.” That philosophy should apply to the tasks of selecting the best organ donors as well as the best organ recipients.
And every organ should go to the one who will honor their donor and their donor’s family by taking the best care of that ultimate gift of life, including being vaccinated against COVID-19.
Dr. Walton-Shirley is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. She disclosed no relevant conflicts of interest. A version of this article first appeared on Medscape.com.