User login
Can immunotherapy replace surgery for stomach cancer?
GERCOR NEONIPIGA was a phase 2 study with no comparator group and only 32 patients, but even so, after a 6-cycle course of nivolumab and ipilimumab, there was no sign of tumor in 17 of the 29 patients (59%) who had surgery specimens evaluable by pathology.
Indeed, two patients refused surgery after their preop endoscopic biopsies came back clear with no tumor cells. Surgery was called off in a third patient who developed metastases beforehand.
After a median of 12 months follow-up, there’s was no recurrence or progression in 30 patients (94%). The remaining two included the metastatic patient and one who died 3 days after surgery from cardiovascular complications.
If the findings pan out with additional research, the approach could be a boon for people who respond. “Avoiding surgery is a dream for these patients,” said lead investigator Thierry Andre, MD, a medical oncology professor at Sorbonne University, Paris, when he presented the findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
The trial “raises the question whether surgery can be delayed or avoided in some patients with localized” disease. Given the findings, “it seems possible not for all but probably for half, maybe more.” As in the two subjects who opted out of surgery, preop endoscopic biopsies could be used to identify complete responders with active surveillance afterwards, he said.
The study included 16 patients with gastric cancer and 16 with esophagogastric adenocarcinoma. They were mismatch repair deficient, which Dr. Andre said predicts response to immunotherapy.
At baseline, 22 had stage T3 disease and four had stage T2 disease, and stage was not evaluable by echo-endoscopy in 6. Nodal status was unknown, but the patients had no metastases at baseline.
They underwent six nivolumab 240-mg infusions and two ipilimumab 1–mg/kg infusions over 12 weeks, followed by R0 resections a median of 5 weeks after the last nivolumab injection.
Surgical specimens from 17 patients (59%) showed a complete pathological response to neoadjuvant immunotherapy (Becker tumor regression grade (TRG) 1a, ypT0N0). TRG was 1b – less than 10% residual tumor in tumor bed in four patients. TRG was 2 in two patients with 10%-50% of residual tumor remaining, and six had a TRG of 3 with more than half of the tumor remaining after immunotherapy.
Based on tumor response, 25 patients had nine additional nivolumab infusions after surgery with 480 mg infused monthly.
Dr. Andre explained that people want to avoid surgery because of the substantial morbidity that was shown in the study, plus 54% of patients had complications, including anastomotic leaks, pancreatitis, pneumonia, and other problems.
There were no new safety signals with neoadjuvant therapy; 25% of patients had grade 3 or 4 events.
The study was conducted in 10 centers in France. About three-quarters of the subjects were men and the median age was 65 years.
Bristol Meyers Squibb supplied the nivolumab and ipilimumab and partially funded the work. Many of the investigators had ties to the company, including Dr. Andre, who is a consultant for BMS and reported payments from the company.
GERCOR NEONIPIGA was a phase 2 study with no comparator group and only 32 patients, but even so, after a 6-cycle course of nivolumab and ipilimumab, there was no sign of tumor in 17 of the 29 patients (59%) who had surgery specimens evaluable by pathology.
Indeed, two patients refused surgery after their preop endoscopic biopsies came back clear with no tumor cells. Surgery was called off in a third patient who developed metastases beforehand.
After a median of 12 months follow-up, there’s was no recurrence or progression in 30 patients (94%). The remaining two included the metastatic patient and one who died 3 days after surgery from cardiovascular complications.
If the findings pan out with additional research, the approach could be a boon for people who respond. “Avoiding surgery is a dream for these patients,” said lead investigator Thierry Andre, MD, a medical oncology professor at Sorbonne University, Paris, when he presented the findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
The trial “raises the question whether surgery can be delayed or avoided in some patients with localized” disease. Given the findings, “it seems possible not for all but probably for half, maybe more.” As in the two subjects who opted out of surgery, preop endoscopic biopsies could be used to identify complete responders with active surveillance afterwards, he said.
The study included 16 patients with gastric cancer and 16 with esophagogastric adenocarcinoma. They were mismatch repair deficient, which Dr. Andre said predicts response to immunotherapy.
At baseline, 22 had stage T3 disease and four had stage T2 disease, and stage was not evaluable by echo-endoscopy in 6. Nodal status was unknown, but the patients had no metastases at baseline.
They underwent six nivolumab 240-mg infusions and two ipilimumab 1–mg/kg infusions over 12 weeks, followed by R0 resections a median of 5 weeks after the last nivolumab injection.
Surgical specimens from 17 patients (59%) showed a complete pathological response to neoadjuvant immunotherapy (Becker tumor regression grade (TRG) 1a, ypT0N0). TRG was 1b – less than 10% residual tumor in tumor bed in four patients. TRG was 2 in two patients with 10%-50% of residual tumor remaining, and six had a TRG of 3 with more than half of the tumor remaining after immunotherapy.
Based on tumor response, 25 patients had nine additional nivolumab infusions after surgery with 480 mg infused monthly.
Dr. Andre explained that people want to avoid surgery because of the substantial morbidity that was shown in the study, plus 54% of patients had complications, including anastomotic leaks, pancreatitis, pneumonia, and other problems.
There were no new safety signals with neoadjuvant therapy; 25% of patients had grade 3 or 4 events.
The study was conducted in 10 centers in France. About three-quarters of the subjects were men and the median age was 65 years.
Bristol Meyers Squibb supplied the nivolumab and ipilimumab and partially funded the work. Many of the investigators had ties to the company, including Dr. Andre, who is a consultant for BMS and reported payments from the company.
GERCOR NEONIPIGA was a phase 2 study with no comparator group and only 32 patients, but even so, after a 6-cycle course of nivolumab and ipilimumab, there was no sign of tumor in 17 of the 29 patients (59%) who had surgery specimens evaluable by pathology.
Indeed, two patients refused surgery after their preop endoscopic biopsies came back clear with no tumor cells. Surgery was called off in a third patient who developed metastases beforehand.
After a median of 12 months follow-up, there’s was no recurrence or progression in 30 patients (94%). The remaining two included the metastatic patient and one who died 3 days after surgery from cardiovascular complications.
If the findings pan out with additional research, the approach could be a boon for people who respond. “Avoiding surgery is a dream for these patients,” said lead investigator Thierry Andre, MD, a medical oncology professor at Sorbonne University, Paris, when he presented the findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
The trial “raises the question whether surgery can be delayed or avoided in some patients with localized” disease. Given the findings, “it seems possible not for all but probably for half, maybe more.” As in the two subjects who opted out of surgery, preop endoscopic biopsies could be used to identify complete responders with active surveillance afterwards, he said.
The study included 16 patients with gastric cancer and 16 with esophagogastric adenocarcinoma. They were mismatch repair deficient, which Dr. Andre said predicts response to immunotherapy.
At baseline, 22 had stage T3 disease and four had stage T2 disease, and stage was not evaluable by echo-endoscopy in 6. Nodal status was unknown, but the patients had no metastases at baseline.
They underwent six nivolumab 240-mg infusions and two ipilimumab 1–mg/kg infusions over 12 weeks, followed by R0 resections a median of 5 weeks after the last nivolumab injection.
Surgical specimens from 17 patients (59%) showed a complete pathological response to neoadjuvant immunotherapy (Becker tumor regression grade (TRG) 1a, ypT0N0). TRG was 1b – less than 10% residual tumor in tumor bed in four patients. TRG was 2 in two patients with 10%-50% of residual tumor remaining, and six had a TRG of 3 with more than half of the tumor remaining after immunotherapy.
Based on tumor response, 25 patients had nine additional nivolumab infusions after surgery with 480 mg infused monthly.
Dr. Andre explained that people want to avoid surgery because of the substantial morbidity that was shown in the study, plus 54% of patients had complications, including anastomotic leaks, pancreatitis, pneumonia, and other problems.
There were no new safety signals with neoadjuvant therapy; 25% of patients had grade 3 or 4 events.
The study was conducted in 10 centers in France. About three-quarters of the subjects were men and the median age was 65 years.
Bristol Meyers Squibb supplied the nivolumab and ipilimumab and partially funded the work. Many of the investigators had ties to the company, including Dr. Andre, who is a consultant for BMS and reported payments from the company.
FROM GI CANCERS SYMPOSIUM 2022
This doc still supports NP/PA-led care ... with caveats
Two years ago, I argued that independent care from nurse practitioners (NPs) and physician assistants (PAs) would not have ill effects on health outcomes. To the surprise of no one, NPs and PAs embraced the argument; physicians clobbered it.
My case had three pegs: One was that medicine isn’t rocket science and clinicians control a lot less than we think we do. The second peg was that technology levels the playing field of clinical care. High-sensitivity troponin assays, for instance, make missing MI a lot less likely. The third peg was empirical: Studies have found little difference in MD versus non–MD-led care. Looking back, I now see empiricism as the weakest part of the argument because the studies had so many limitations.
I update this viewpoint now because health care is increasingly delivered by NPs and PAs. And there are two concerning trends regarding NP education and experience. First is that nurses are turning to advanced practitioner training earlier in their careers – without gathering much bedside experience. And these training programs are increasingly likely to be online, with minimal hands-on clinical tutoring.
Education and experience pop in my head often. Not every day, but many days I think back to my lucky 7 years in Indiana learning under the supervision of master clinicians – at a time when trainees were allowed the leeway to make decisions ... and mistakes. Then, when I joined private practice, I continued to learn from experienced practitioners.
It would be foolish to argue that training and experience aren’t important.
But here’s the thing:
I will make three points: First, I will bolster two of my old arguments as to why we shouldn’t be worried about non-MD clinicians, then I will propose some ideas to increase confidence in NP and PA care.
Health care does not equal health
On the matter of how much clinicians affect outcomes, a recently published randomized controlled trial performed in India found that subsidizing insurance care led to increased utilization of hospital services but had no significant effect on health outcomes. This follows the RAND and Oregon Health Insurance studies in the United States, which largely reported similar results.
We should also not dismiss the fact that – despite the massive technology gains over the past half-century in digital health and artificial intelligence and increased use of quality measures, new drugs and procedures, and mega-medical centers – the average lifespan of Americans is flat to declining (in most ethnic and racial groups). Worse than no gains in longevity, perhaps, is that death from diseases like dementia and Parkinson’s disease are on the rise.
A neutral Martian would look down and wonder why all this health care hasn’t translated to longer and better lives. The causes of this paradox remain speculative, and are for another column, but the point remains that – on average – more health care is clearly not delivering more health. And if that is true, one may deduce that much of U.S. health care is marginal when it comes to affecting major outcomes.
It’s about the delta
Logos trumps pathos. Sure, my physician colleagues can tell scary anecdotes of bad outcomes caused by an inexperienced NP or PA. I would counter that by saying I have sat on our hospital’s peer review committee for 2 decades, including the era before NPs or PAs were practicing, and I have plenty of stories of physician errors. These include, of course, my own errors.
Logos: We must consider the difference between non–MD-led care and MD-led care.
My arguments from 2020 remain relevant today. Most medical problems are not engineering puzzles. Many, perhaps most, patients fall into an easy protocol – say, chest pain, dyspnea, or atrial fibrillation. With basic training, a motivated serious person quickly gains skill in recognizing and treating everyday problems.
And just 2 years on, technology further levels the playing field. Consider radiology in 2022 – it’s easy to take for granted the speed of the CT scan, the fidelity of the MRI, and the easy access to both in the U.S. hospital system. Less experienced clinicians have never had more tools to assist with diagnostics and therapeutics.
The expansion of team-based care has also mitigated the effects of inexperience. It took Americans longer than Canadians to figure out how helpful pharmacists could be. Pharmacists in my hospital now help us dose complicated medicines and protect us against prescribing errors.
Then there is the immediate access to online information. Gone are the days when you had to memorize long-QT syndromes. Book knowledge – that I spent years acquiring – now comes in seconds. The other day an NP corrected me. I asked, Are you sure? Boom, she took out her phone and showed me the evidence.
In sum, if it were even possible to measure the clinical competence of care from NP and PA versus physicians, there would be two bell-shaped curves with a tremendous amount of overlap. And that overlap would steadily increase as a given NP or PA gathered experience. (The NP in our electrophysiology division has more than 25 years’ experience in heart rhythm care, and it is common for colleagues to call her before one of us docs. Rightly so.)
Three basic proposals regarding NP and PA care
To ensure quality of care, I have three proposals.
It has always seemed strange to me that an NP or PA can flip from one field to another without a period of training. I can’t just change practice from electrophysiology to dermatology without doing a residency. But NPs and PAs can.
My first proposal would be that NPs and PAs spend a substantial period of training in a field before practice – a legit apprenticeship. The duration of this period is a matter of debate, but it ought to be standardized.
My second proposal is that, if physicians are required to pass certification exams, so should NPs. (PAs have an exam every 10 years.) The exam should be the same as (or very similar to) the physician exam, and it should be specific to their field of practice.
While I have argued (and still feel) that the American Board of Internal Medicine brand of certification is dubious, the fact remains that physicians must maintain proficiency in their field. Requiring NPs and PAs to do the same would help foster specialization. And while I can’t cite empirical evidence, specialization seems super-important. We have NPs at my hospital who have been in the same area for years, and they exude clinical competence.
Finally, I have come to believe that the best way for nearly any clinician to practice medicine is as part of a team. (The exception being primary care in rural areas where there are clinician shortages.)
On the matter of team care, I’ve practiced for a long time, but nearly every day I run situations by a colleague; often this person is an NP. The economist Friedrich Hayek proposed that dispersed knowledge always outpaces the wisdom of any individual. That notion pertains well to the increasing complexities and specialization of modern medical practice.
A person who commits to learning one area of medicine, enjoys helping people, asks often for help, and has the support of colleagues is set up to be a successful clinician – whether the letters after their name are APRN, PA, DO, or MD.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky. He did not report any relevant financial disclosures. A version of this article first appeared on Medscape.com.
Two years ago, I argued that independent care from nurse practitioners (NPs) and physician assistants (PAs) would not have ill effects on health outcomes. To the surprise of no one, NPs and PAs embraced the argument; physicians clobbered it.
My case had three pegs: One was that medicine isn’t rocket science and clinicians control a lot less than we think we do. The second peg was that technology levels the playing field of clinical care. High-sensitivity troponin assays, for instance, make missing MI a lot less likely. The third peg was empirical: Studies have found little difference in MD versus non–MD-led care. Looking back, I now see empiricism as the weakest part of the argument because the studies had so many limitations.
I update this viewpoint now because health care is increasingly delivered by NPs and PAs. And there are two concerning trends regarding NP education and experience. First is that nurses are turning to advanced practitioner training earlier in their careers – without gathering much bedside experience. And these training programs are increasingly likely to be online, with minimal hands-on clinical tutoring.
Education and experience pop in my head often. Not every day, but many days I think back to my lucky 7 years in Indiana learning under the supervision of master clinicians – at a time when trainees were allowed the leeway to make decisions ... and mistakes. Then, when I joined private practice, I continued to learn from experienced practitioners.
It would be foolish to argue that training and experience aren’t important.
But here’s the thing:
I will make three points: First, I will bolster two of my old arguments as to why we shouldn’t be worried about non-MD clinicians, then I will propose some ideas to increase confidence in NP and PA care.
Health care does not equal health
On the matter of how much clinicians affect outcomes, a recently published randomized controlled trial performed in India found that subsidizing insurance care led to increased utilization of hospital services but had no significant effect on health outcomes. This follows the RAND and Oregon Health Insurance studies in the United States, which largely reported similar results.
We should also not dismiss the fact that – despite the massive technology gains over the past half-century in digital health and artificial intelligence and increased use of quality measures, new drugs and procedures, and mega-medical centers – the average lifespan of Americans is flat to declining (in most ethnic and racial groups). Worse than no gains in longevity, perhaps, is that death from diseases like dementia and Parkinson’s disease are on the rise.
A neutral Martian would look down and wonder why all this health care hasn’t translated to longer and better lives. The causes of this paradox remain speculative, and are for another column, but the point remains that – on average – more health care is clearly not delivering more health. And if that is true, one may deduce that much of U.S. health care is marginal when it comes to affecting major outcomes.
It’s about the delta
Logos trumps pathos. Sure, my physician colleagues can tell scary anecdotes of bad outcomes caused by an inexperienced NP or PA. I would counter that by saying I have sat on our hospital’s peer review committee for 2 decades, including the era before NPs or PAs were practicing, and I have plenty of stories of physician errors. These include, of course, my own errors.
Logos: We must consider the difference between non–MD-led care and MD-led care.
My arguments from 2020 remain relevant today. Most medical problems are not engineering puzzles. Many, perhaps most, patients fall into an easy protocol – say, chest pain, dyspnea, or atrial fibrillation. With basic training, a motivated serious person quickly gains skill in recognizing and treating everyday problems.
And just 2 years on, technology further levels the playing field. Consider radiology in 2022 – it’s easy to take for granted the speed of the CT scan, the fidelity of the MRI, and the easy access to both in the U.S. hospital system. Less experienced clinicians have never had more tools to assist with diagnostics and therapeutics.
The expansion of team-based care has also mitigated the effects of inexperience. It took Americans longer than Canadians to figure out how helpful pharmacists could be. Pharmacists in my hospital now help us dose complicated medicines and protect us against prescribing errors.
Then there is the immediate access to online information. Gone are the days when you had to memorize long-QT syndromes. Book knowledge – that I spent years acquiring – now comes in seconds. The other day an NP corrected me. I asked, Are you sure? Boom, she took out her phone and showed me the evidence.
In sum, if it were even possible to measure the clinical competence of care from NP and PA versus physicians, there would be two bell-shaped curves with a tremendous amount of overlap. And that overlap would steadily increase as a given NP or PA gathered experience. (The NP in our electrophysiology division has more than 25 years’ experience in heart rhythm care, and it is common for colleagues to call her before one of us docs. Rightly so.)
Three basic proposals regarding NP and PA care
To ensure quality of care, I have three proposals.
It has always seemed strange to me that an NP or PA can flip from one field to another without a period of training. I can’t just change practice from electrophysiology to dermatology without doing a residency. But NPs and PAs can.
My first proposal would be that NPs and PAs spend a substantial period of training in a field before practice – a legit apprenticeship. The duration of this period is a matter of debate, but it ought to be standardized.
My second proposal is that, if physicians are required to pass certification exams, so should NPs. (PAs have an exam every 10 years.) The exam should be the same as (or very similar to) the physician exam, and it should be specific to their field of practice.
While I have argued (and still feel) that the American Board of Internal Medicine brand of certification is dubious, the fact remains that physicians must maintain proficiency in their field. Requiring NPs and PAs to do the same would help foster specialization. And while I can’t cite empirical evidence, specialization seems super-important. We have NPs at my hospital who have been in the same area for years, and they exude clinical competence.
Finally, I have come to believe that the best way for nearly any clinician to practice medicine is as part of a team. (The exception being primary care in rural areas where there are clinician shortages.)
On the matter of team care, I’ve practiced for a long time, but nearly every day I run situations by a colleague; often this person is an NP. The economist Friedrich Hayek proposed that dispersed knowledge always outpaces the wisdom of any individual. That notion pertains well to the increasing complexities and specialization of modern medical practice.
A person who commits to learning one area of medicine, enjoys helping people, asks often for help, and has the support of colleagues is set up to be a successful clinician – whether the letters after their name are APRN, PA, DO, or MD.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky. He did not report any relevant financial disclosures. A version of this article first appeared on Medscape.com.
Two years ago, I argued that independent care from nurse practitioners (NPs) and physician assistants (PAs) would not have ill effects on health outcomes. To the surprise of no one, NPs and PAs embraced the argument; physicians clobbered it.
My case had three pegs: One was that medicine isn’t rocket science and clinicians control a lot less than we think we do. The second peg was that technology levels the playing field of clinical care. High-sensitivity troponin assays, for instance, make missing MI a lot less likely. The third peg was empirical: Studies have found little difference in MD versus non–MD-led care. Looking back, I now see empiricism as the weakest part of the argument because the studies had so many limitations.
I update this viewpoint now because health care is increasingly delivered by NPs and PAs. And there are two concerning trends regarding NP education and experience. First is that nurses are turning to advanced practitioner training earlier in their careers – without gathering much bedside experience. And these training programs are increasingly likely to be online, with minimal hands-on clinical tutoring.
Education and experience pop in my head often. Not every day, but many days I think back to my lucky 7 years in Indiana learning under the supervision of master clinicians – at a time when trainees were allowed the leeway to make decisions ... and mistakes. Then, when I joined private practice, I continued to learn from experienced practitioners.
It would be foolish to argue that training and experience aren’t important.
But here’s the thing:
I will make three points: First, I will bolster two of my old arguments as to why we shouldn’t be worried about non-MD clinicians, then I will propose some ideas to increase confidence in NP and PA care.
Health care does not equal health
On the matter of how much clinicians affect outcomes, a recently published randomized controlled trial performed in India found that subsidizing insurance care led to increased utilization of hospital services but had no significant effect on health outcomes. This follows the RAND and Oregon Health Insurance studies in the United States, which largely reported similar results.
We should also not dismiss the fact that – despite the massive technology gains over the past half-century in digital health and artificial intelligence and increased use of quality measures, new drugs and procedures, and mega-medical centers – the average lifespan of Americans is flat to declining (in most ethnic and racial groups). Worse than no gains in longevity, perhaps, is that death from diseases like dementia and Parkinson’s disease are on the rise.
A neutral Martian would look down and wonder why all this health care hasn’t translated to longer and better lives. The causes of this paradox remain speculative, and are for another column, but the point remains that – on average – more health care is clearly not delivering more health. And if that is true, one may deduce that much of U.S. health care is marginal when it comes to affecting major outcomes.
It’s about the delta
Logos trumps pathos. Sure, my physician colleagues can tell scary anecdotes of bad outcomes caused by an inexperienced NP or PA. I would counter that by saying I have sat on our hospital’s peer review committee for 2 decades, including the era before NPs or PAs were practicing, and I have plenty of stories of physician errors. These include, of course, my own errors.
Logos: We must consider the difference between non–MD-led care and MD-led care.
My arguments from 2020 remain relevant today. Most medical problems are not engineering puzzles. Many, perhaps most, patients fall into an easy protocol – say, chest pain, dyspnea, or atrial fibrillation. With basic training, a motivated serious person quickly gains skill in recognizing and treating everyday problems.
And just 2 years on, technology further levels the playing field. Consider radiology in 2022 – it’s easy to take for granted the speed of the CT scan, the fidelity of the MRI, and the easy access to both in the U.S. hospital system. Less experienced clinicians have never had more tools to assist with diagnostics and therapeutics.
The expansion of team-based care has also mitigated the effects of inexperience. It took Americans longer than Canadians to figure out how helpful pharmacists could be. Pharmacists in my hospital now help us dose complicated medicines and protect us against prescribing errors.
Then there is the immediate access to online information. Gone are the days when you had to memorize long-QT syndromes. Book knowledge – that I spent years acquiring – now comes in seconds. The other day an NP corrected me. I asked, Are you sure? Boom, she took out her phone and showed me the evidence.
In sum, if it were even possible to measure the clinical competence of care from NP and PA versus physicians, there would be two bell-shaped curves with a tremendous amount of overlap. And that overlap would steadily increase as a given NP or PA gathered experience. (The NP in our electrophysiology division has more than 25 years’ experience in heart rhythm care, and it is common for colleagues to call her before one of us docs. Rightly so.)
Three basic proposals regarding NP and PA care
To ensure quality of care, I have three proposals.
It has always seemed strange to me that an NP or PA can flip from one field to another without a period of training. I can’t just change practice from electrophysiology to dermatology without doing a residency. But NPs and PAs can.
My first proposal would be that NPs and PAs spend a substantial period of training in a field before practice – a legit apprenticeship. The duration of this period is a matter of debate, but it ought to be standardized.
My second proposal is that, if physicians are required to pass certification exams, so should NPs. (PAs have an exam every 10 years.) The exam should be the same as (or very similar to) the physician exam, and it should be specific to their field of practice.
While I have argued (and still feel) that the American Board of Internal Medicine brand of certification is dubious, the fact remains that physicians must maintain proficiency in their field. Requiring NPs and PAs to do the same would help foster specialization. And while I can’t cite empirical evidence, specialization seems super-important. We have NPs at my hospital who have been in the same area for years, and they exude clinical competence.
Finally, I have come to believe that the best way for nearly any clinician to practice medicine is as part of a team. (The exception being primary care in rural areas where there are clinician shortages.)
On the matter of team care, I’ve practiced for a long time, but nearly every day I run situations by a colleague; often this person is an NP. The economist Friedrich Hayek proposed that dispersed knowledge always outpaces the wisdom of any individual. That notion pertains well to the increasing complexities and specialization of modern medical practice.
A person who commits to learning one area of medicine, enjoys helping people, asks often for help, and has the support of colleagues is set up to be a successful clinician – whether the letters after their name are APRN, PA, DO, or MD.
Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky. He did not report any relevant financial disclosures. A version of this article first appeared on Medscape.com.
No amount of alcohol safe for the heart: WHF
The widely held notion that consuming small to moderate amounts of alcohol is good for cardiovascular health is not supported by the data, the World Heart Federation says in a new policy brief.
In fact, the evidence is clear that any level of drinking can contribute to loss of a healthy life, the organization says.
“Over the past several decades, the prevalence of cardiovascular disease has nearly doubled, and alcohol has played a major role in the incidence of much of it,” the WHF said in the brief.
“The portrayal of alcohol as necessary for a vibrant social life has diverted attention from the harms of alcohol use, as have the frequent and widely publicized claims that moderate drinking, such as a glass of red wine a day, can offer protection against cardiovascular disease,” Monika Arora, PhD, member of the WHF advocacy committee and coauthor of the brief, said in a news release.
“These claims are at best misinformed and at worst an attempt by the alcohol industry to mislead the public about the danger of their product,” Dr. Arora added.
The WHF conclusions follow a report in the Lancet based on the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), which found that there is no safe level of alcohol consumption.
In 2019, nearly 2.4 million deaths were attributed to alcohol, accounting for 4.3% of all deaths globally and 12.6% of deaths in men 15 to 49 years of age.
Even small amounts of alcohol have been shown to raise the risk for cardiovascular disease, including coronary disease, stroke, heart failure, hypertensive heart disease, cardiomyopathy, atrial fibrillation, and aneurysm, the WHF notes.
Studies that claim otherwise are largely based on purely observational research, which fails to account for relevant cofactors, the organization writes.
Based on their summary of the evidence to date, there is no reliable correlation between moderate alcohol consumption and a lower risk for cardiovascular disease.
Alcohol use is also a “major avoidable risk factor” for cancer, digestive diseases, intentional and unintentional injuries, and several infectious diseases, the WHF says.
Alcohol use also has significant economic and social costs, which include costs to individuals and health systems, productivity losses, as well as the increased risk for violence, homelessness, and criminal activity.
The WHF policy brief calls for “urgent and decisive action” to tackle the unprecedented rise in alcohol-related death and disability worldwide.
Recommended actions include boosting restrictions on alcohol availability; advancing and enforcing drinking and driving countermeasures; increasing access to screening, brief interventions, and treatment for alcohol use disorder; enforcing bans on alcohol advertising; establishing a uniform minimum legal drinking age; and mandating health warnings on alcohol products.
A version of this article first appeared on Medscape.com.
The widely held notion that consuming small to moderate amounts of alcohol is good for cardiovascular health is not supported by the data, the World Heart Federation says in a new policy brief.
In fact, the evidence is clear that any level of drinking can contribute to loss of a healthy life, the organization says.
“Over the past several decades, the prevalence of cardiovascular disease has nearly doubled, and alcohol has played a major role in the incidence of much of it,” the WHF said in the brief.
“The portrayal of alcohol as necessary for a vibrant social life has diverted attention from the harms of alcohol use, as have the frequent and widely publicized claims that moderate drinking, such as a glass of red wine a day, can offer protection against cardiovascular disease,” Monika Arora, PhD, member of the WHF advocacy committee and coauthor of the brief, said in a news release.
“These claims are at best misinformed and at worst an attempt by the alcohol industry to mislead the public about the danger of their product,” Dr. Arora added.
The WHF conclusions follow a report in the Lancet based on the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), which found that there is no safe level of alcohol consumption.
In 2019, nearly 2.4 million deaths were attributed to alcohol, accounting for 4.3% of all deaths globally and 12.6% of deaths in men 15 to 49 years of age.
Even small amounts of alcohol have been shown to raise the risk for cardiovascular disease, including coronary disease, stroke, heart failure, hypertensive heart disease, cardiomyopathy, atrial fibrillation, and aneurysm, the WHF notes.
Studies that claim otherwise are largely based on purely observational research, which fails to account for relevant cofactors, the organization writes.
Based on their summary of the evidence to date, there is no reliable correlation between moderate alcohol consumption and a lower risk for cardiovascular disease.
Alcohol use is also a “major avoidable risk factor” for cancer, digestive diseases, intentional and unintentional injuries, and several infectious diseases, the WHF says.
Alcohol use also has significant economic and social costs, which include costs to individuals and health systems, productivity losses, as well as the increased risk for violence, homelessness, and criminal activity.
The WHF policy brief calls for “urgent and decisive action” to tackle the unprecedented rise in alcohol-related death and disability worldwide.
Recommended actions include boosting restrictions on alcohol availability; advancing and enforcing drinking and driving countermeasures; increasing access to screening, brief interventions, and treatment for alcohol use disorder; enforcing bans on alcohol advertising; establishing a uniform minimum legal drinking age; and mandating health warnings on alcohol products.
A version of this article first appeared on Medscape.com.
The widely held notion that consuming small to moderate amounts of alcohol is good for cardiovascular health is not supported by the data, the World Heart Federation says in a new policy brief.
In fact, the evidence is clear that any level of drinking can contribute to loss of a healthy life, the organization says.
“Over the past several decades, the prevalence of cardiovascular disease has nearly doubled, and alcohol has played a major role in the incidence of much of it,” the WHF said in the brief.
“The portrayal of alcohol as necessary for a vibrant social life has diverted attention from the harms of alcohol use, as have the frequent and widely publicized claims that moderate drinking, such as a glass of red wine a day, can offer protection against cardiovascular disease,” Monika Arora, PhD, member of the WHF advocacy committee and coauthor of the brief, said in a news release.
“These claims are at best misinformed and at worst an attempt by the alcohol industry to mislead the public about the danger of their product,” Dr. Arora added.
The WHF conclusions follow a report in the Lancet based on the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), which found that there is no safe level of alcohol consumption.
In 2019, nearly 2.4 million deaths were attributed to alcohol, accounting for 4.3% of all deaths globally and 12.6% of deaths in men 15 to 49 years of age.
Even small amounts of alcohol have been shown to raise the risk for cardiovascular disease, including coronary disease, stroke, heart failure, hypertensive heart disease, cardiomyopathy, atrial fibrillation, and aneurysm, the WHF notes.
Studies that claim otherwise are largely based on purely observational research, which fails to account for relevant cofactors, the organization writes.
Based on their summary of the evidence to date, there is no reliable correlation between moderate alcohol consumption and a lower risk for cardiovascular disease.
Alcohol use is also a “major avoidable risk factor” for cancer, digestive diseases, intentional and unintentional injuries, and several infectious diseases, the WHF says.
Alcohol use also has significant economic and social costs, which include costs to individuals and health systems, productivity losses, as well as the increased risk for violence, homelessness, and criminal activity.
The WHF policy brief calls for “urgent and decisive action” to tackle the unprecedented rise in alcohol-related death and disability worldwide.
Recommended actions include boosting restrictions on alcohol availability; advancing and enforcing drinking and driving countermeasures; increasing access to screening, brief interventions, and treatment for alcohol use disorder; enforcing bans on alcohol advertising; establishing a uniform minimum legal drinking age; and mandating health warnings on alcohol products.
A version of this article first appeared on Medscape.com.
Docs pen open letter to support Fauci against partisan ‘attacks’
“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.
Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.
“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.
Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).
At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”
Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
‘Sagacious counsel’
The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.
“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.
“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.
“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”
“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.
A version of this article first appeared on Medscape.com.
“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.
Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.
“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.
Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).
At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”
Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
‘Sagacious counsel’
The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.
“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.
“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.
“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”
“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.
A version of this article first appeared on Medscape.com.
“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.
Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.
“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.
Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).
At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”
Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
‘Sagacious counsel’
The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.
“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.
“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.
“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”
“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.
A version of this article first appeared on Medscape.com.
NPs, PAs say stop attacks and support health care colleagues
This commentary was submitted as a rebuttal to “PA name change bad for patients and the profession.”
To the Editor:
At a time when COVID-19 cases are climbing and health care workers are struggling to meet the needs of our nation’s healthcare system, the commentary by Rebekah Bernard, MD, divides health care providers and demeans the education, experience, and value of physician associates (PA) and nurse practitioners (NP) in our opinion.
The ill timing of this negative message is equally matched by her mischaracterization of the PA title change and PA efforts to eliminate outdated administrative barriers, as well as her baseless attack on NP education and clinical training.
Let us be clear about one thing: What patients really want and deserve is access to high-quality care delivered by the health care provider of their choice. Patients deserve health care providers who are committed to modern, integrated, and coordinated health care delivery, led by professionals who are dedicated to ensuring that everyone is practicing to the full extent of their education, clinical experience, and scope of practice. Patients deserve health care providers who respect each other and work together to embrace solutions that will improve health care for the future.
Decades of research confirm the high quality of PA- and NP-delivered health care. The evidence is in, and it is irrefutable: PA- and NP-delivered care is associated with improved access to care, lower health care costs, and fewer avoidable emergency room visits.
With regard to the PA title change, the fact is this: Changing the profession’s title does not change what PAs do or affect a PA’s scope of practice. The new title – physician associate – directly addresses the common misperception that PAs merely “assist” physicians. It is in the best interest of patients and the health care system for PAs to hold a professional title that ensures clarity about the work that PAs do.
For the sake of patients, we urge Bernard and her organization to stop continuously attacking other professions and focus on what really matters – providing access to safe, effective, equitable, high-quality care to all patients.
We are committed to patient-centered, coordinated health care, and we continue to work with like-minded physicians and other colleagues to make this a reality.
Ms. Orozco is president and chair of the board of directors for the American Academy of Physician Associates. Dr. Kapu is president of the American Association of Nurse Practitioners.
A version of this article first appeared on Medscape.com.
This commentary was submitted as a rebuttal to “PA name change bad for patients and the profession.”
To the Editor:
At a time when COVID-19 cases are climbing and health care workers are struggling to meet the needs of our nation’s healthcare system, the commentary by Rebekah Bernard, MD, divides health care providers and demeans the education, experience, and value of physician associates (PA) and nurse practitioners (NP) in our opinion.
The ill timing of this negative message is equally matched by her mischaracterization of the PA title change and PA efforts to eliminate outdated administrative barriers, as well as her baseless attack on NP education and clinical training.
Let us be clear about one thing: What patients really want and deserve is access to high-quality care delivered by the health care provider of their choice. Patients deserve health care providers who are committed to modern, integrated, and coordinated health care delivery, led by professionals who are dedicated to ensuring that everyone is practicing to the full extent of their education, clinical experience, and scope of practice. Patients deserve health care providers who respect each other and work together to embrace solutions that will improve health care for the future.
Decades of research confirm the high quality of PA- and NP-delivered health care. The evidence is in, and it is irrefutable: PA- and NP-delivered care is associated with improved access to care, lower health care costs, and fewer avoidable emergency room visits.
With regard to the PA title change, the fact is this: Changing the profession’s title does not change what PAs do or affect a PA’s scope of practice. The new title – physician associate – directly addresses the common misperception that PAs merely “assist” physicians. It is in the best interest of patients and the health care system for PAs to hold a professional title that ensures clarity about the work that PAs do.
For the sake of patients, we urge Bernard and her organization to stop continuously attacking other professions and focus on what really matters – providing access to safe, effective, equitable, high-quality care to all patients.
We are committed to patient-centered, coordinated health care, and we continue to work with like-minded physicians and other colleagues to make this a reality.
Ms. Orozco is president and chair of the board of directors for the American Academy of Physician Associates. Dr. Kapu is president of the American Association of Nurse Practitioners.
A version of this article first appeared on Medscape.com.
This commentary was submitted as a rebuttal to “PA name change bad for patients and the profession.”
To the Editor:
At a time when COVID-19 cases are climbing and health care workers are struggling to meet the needs of our nation’s healthcare system, the commentary by Rebekah Bernard, MD, divides health care providers and demeans the education, experience, and value of physician associates (PA) and nurse practitioners (NP) in our opinion.
The ill timing of this negative message is equally matched by her mischaracterization of the PA title change and PA efforts to eliminate outdated administrative barriers, as well as her baseless attack on NP education and clinical training.
Let us be clear about one thing: What patients really want and deserve is access to high-quality care delivered by the health care provider of their choice. Patients deserve health care providers who are committed to modern, integrated, and coordinated health care delivery, led by professionals who are dedicated to ensuring that everyone is practicing to the full extent of their education, clinical experience, and scope of practice. Patients deserve health care providers who respect each other and work together to embrace solutions that will improve health care for the future.
Decades of research confirm the high quality of PA- and NP-delivered health care. The evidence is in, and it is irrefutable: PA- and NP-delivered care is associated with improved access to care, lower health care costs, and fewer avoidable emergency room visits.
With regard to the PA title change, the fact is this: Changing the profession’s title does not change what PAs do or affect a PA’s scope of practice. The new title – physician associate – directly addresses the common misperception that PAs merely “assist” physicians. It is in the best interest of patients and the health care system for PAs to hold a professional title that ensures clarity about the work that PAs do.
For the sake of patients, we urge Bernard and her organization to stop continuously attacking other professions and focus on what really matters – providing access to safe, effective, equitable, high-quality care to all patients.
We are committed to patient-centered, coordinated health care, and we continue to work with like-minded physicians and other colleagues to make this a reality.
Ms. Orozco is president and chair of the board of directors for the American Academy of Physician Associates. Dr. Kapu is president of the American Association of Nurse Practitioners.
A version of this article first appeared on Medscape.com.
Cardiac inflammation can be present after mild COVID infection
Myocardial inflammation is present in a small proportion of patients who have recovered from relatively mild cases of COVID-19 infection, a new study shows.
“Our findings suggest that even in patients who have had relatively mild cases of COVID-19, some will have inflammatory changes to the heart, and these changes can be present without any cardiac symptoms,” senior author, Paaladinesh Thavendiranathan, MD, University of Toronto, told this news organization.
“While our data suggest that this inflammation improves over time, and the outcomes seem positive, we don’t know if there will be any long-term consequences,” he added.
Noting that even a short period of inflammation in the heart may be associated with symptoms or arrhythmias in the longer term, Dr. Thavendiranathan said: “I would recommend that it is best to avoid getting the infection if there is any chance of heart inflammation.”
The study was published online in JAMA Cardiology on Jan. 12.
The authors explain that among patients hospitalized with COVID, early studies suggested that approximately one in four experience cardiovascular injury, defined as an elevation in troponin levels, which was associated with a 5- to 10-fold increase in the risk for death. But there is limited information on cardiac injury in patients who do not require hospitalization.
Although a broad range of abnormal myocardial tissue has been reported in several cardiac MRI studies of patients recovered from COVID infection, there is little understanding of persistent changes in myocardial metabolism in recovered patients, which is a potential concern, given that COVID-19 is associated with systemic inflammation during the acute illness, they say.
For the current study, the researchers examined myocardial inflammation measured using two different methods – cardiac MRI and fluorodeoxyglucose–positron emission tomography (FDG-PET) – in individuals who had recovered from COVID-19 infection and looked at how this related to changes in inflammatory blood markers.
Lead author Kate Hanneman, MD, also from the University of Toronto, explained that FDG-PET imaging is more sensitive than MRI in detecting active inflammation. “Inflammatory cells have a higher uptake of glucose, and FDG-PET imaging is used to look for metabolically active inflammatory tissue that takes up glucose. It gives complementary information to MRI. Cardiac MRI shows structural or functional changes, such as scarring or edema, whereas FDG-PET imaging directly measures metabolic activity related to inflammatory cells.”
The study involved 47 individuals, 51% female, with a mean age of 43 years, who had recently recovered from COVID-19 infection. Of these, the majority had had relatively mild COVID disease, with 85% not requiring hospitalization.
Cardiac imaging was performed a mean of 67 days after the diagnosis of COVID-19. At the time of imaging, 19 participants (40%) reported at least one cardiac symptom, including palpitations, chest pain, and shortness of breath.
Results showed that eight patients (17%) had focal FDG uptake on PET consistent with myocardial inflammation. Compared with those without FDG uptake, patients with focal FDG uptake had higher regional T2, T1, and extracellular volume (colocalizing with focal FDG uptake), higher prevalence of late gadolinium enhancement indicating fibrosis, lower left ventricular ejection fraction, worse global longitudinal and circumferential strain, and higher systemic inflammatory blood markers, including interleukin (IL)-6, IL- 8, an high-sensitivity C-reactive protein.
Of the 47 patients in the study, 13 had received at least one dose of a COVID-19 vaccine. There was no significant difference in the proportion of patients who were PET-positive among those who had received a COVID-19 vaccine and those who had not.
There was also no difference in inflammation in patients who had been hospitalized with COVID-19 and those who had managed their infection at home.
Among patients with focal FDG uptake, PET, MRI, and inflammatory blood markers improved at follow-up imaging performed a mean of 52 days after the first imaging. The authors say this suggests that these abnormalities were not related to pre-existing cardiovascular disease.
Of the eight patients with positive FDG-PET results, two did not show any MRI abnormalities. These two patients also had elevated inflammatory biomarkers. “PET is a more sensitive method of measuring cardiac inflammation, and our results show that these changes may not always translate into functional changes seen on MRI,” Dr. Thavendiranathan noted.
The only cardiac risk factor that was more common in participants with FDG uptake was hypertension. Although cardiac symptoms were nearly twice as common in participants with focal FDG uptake, this difference was not statistically significant.
“Given the growing number of survivors with similar symptoms, these interesting findings warrant further investigation,” the authors say.
Noting that FDG uptake correlated with elevations in systemic inflammatory biomarkers, the researchers suggest that “a more intense systemic inflammatory process may be contributing to cardiac inflammation and the consequential alteration to regional and global myocardial function in PET-positive participants.”
On repeat imaging 2 months later, all eight patients who showed FDG uptake showed improvement or resolution of inflammation without any treatment, although two patients still had some signs of inflammation. Blood biomarkers also improved on follow-up.
“This is encouraging information, but we need longer-term data to see if there are any long-term repercussions of this inflammation,” Dr. Hanneman said.
“Overall, the study findings suggest an imaging phenotype that is expected to have good prognosis. However, longer-term follow-up studies are required to understand the need for ongoing cardiac surveillance, relationship to cardiac symptoms, guidance for safe return to exercise and sports participation, and long-term cardiovascular disease risk,” the researchers state.
This study was funded by grants from the Joint Department of Medical Imaging Academic Incentive Fund, Peter Munk Cardiac Center Innovation Committee, and Ted Rogers Center for Heart Research. Dr. Hanneman reports personal fees from Sanofi Genzyme, Amicus, and Medscape outside the submitted work.
A version of this article first appeared on Medscape.com.
Myocardial inflammation is present in a small proportion of patients who have recovered from relatively mild cases of COVID-19 infection, a new study shows.
“Our findings suggest that even in patients who have had relatively mild cases of COVID-19, some will have inflammatory changes to the heart, and these changes can be present without any cardiac symptoms,” senior author, Paaladinesh Thavendiranathan, MD, University of Toronto, told this news organization.
“While our data suggest that this inflammation improves over time, and the outcomes seem positive, we don’t know if there will be any long-term consequences,” he added.
Noting that even a short period of inflammation in the heart may be associated with symptoms or arrhythmias in the longer term, Dr. Thavendiranathan said: “I would recommend that it is best to avoid getting the infection if there is any chance of heart inflammation.”
The study was published online in JAMA Cardiology on Jan. 12.
The authors explain that among patients hospitalized with COVID, early studies suggested that approximately one in four experience cardiovascular injury, defined as an elevation in troponin levels, which was associated with a 5- to 10-fold increase in the risk for death. But there is limited information on cardiac injury in patients who do not require hospitalization.
Although a broad range of abnormal myocardial tissue has been reported in several cardiac MRI studies of patients recovered from COVID infection, there is little understanding of persistent changes in myocardial metabolism in recovered patients, which is a potential concern, given that COVID-19 is associated with systemic inflammation during the acute illness, they say.
For the current study, the researchers examined myocardial inflammation measured using two different methods – cardiac MRI and fluorodeoxyglucose–positron emission tomography (FDG-PET) – in individuals who had recovered from COVID-19 infection and looked at how this related to changes in inflammatory blood markers.
Lead author Kate Hanneman, MD, also from the University of Toronto, explained that FDG-PET imaging is more sensitive than MRI in detecting active inflammation. “Inflammatory cells have a higher uptake of glucose, and FDG-PET imaging is used to look for metabolically active inflammatory tissue that takes up glucose. It gives complementary information to MRI. Cardiac MRI shows structural or functional changes, such as scarring or edema, whereas FDG-PET imaging directly measures metabolic activity related to inflammatory cells.”
The study involved 47 individuals, 51% female, with a mean age of 43 years, who had recently recovered from COVID-19 infection. Of these, the majority had had relatively mild COVID disease, with 85% not requiring hospitalization.
Cardiac imaging was performed a mean of 67 days after the diagnosis of COVID-19. At the time of imaging, 19 participants (40%) reported at least one cardiac symptom, including palpitations, chest pain, and shortness of breath.
Results showed that eight patients (17%) had focal FDG uptake on PET consistent with myocardial inflammation. Compared with those without FDG uptake, patients with focal FDG uptake had higher regional T2, T1, and extracellular volume (colocalizing with focal FDG uptake), higher prevalence of late gadolinium enhancement indicating fibrosis, lower left ventricular ejection fraction, worse global longitudinal and circumferential strain, and higher systemic inflammatory blood markers, including interleukin (IL)-6, IL- 8, an high-sensitivity C-reactive protein.
Of the 47 patients in the study, 13 had received at least one dose of a COVID-19 vaccine. There was no significant difference in the proportion of patients who were PET-positive among those who had received a COVID-19 vaccine and those who had not.
There was also no difference in inflammation in patients who had been hospitalized with COVID-19 and those who had managed their infection at home.
Among patients with focal FDG uptake, PET, MRI, and inflammatory blood markers improved at follow-up imaging performed a mean of 52 days after the first imaging. The authors say this suggests that these abnormalities were not related to pre-existing cardiovascular disease.
Of the eight patients with positive FDG-PET results, two did not show any MRI abnormalities. These two patients also had elevated inflammatory biomarkers. “PET is a more sensitive method of measuring cardiac inflammation, and our results show that these changes may not always translate into functional changes seen on MRI,” Dr. Thavendiranathan noted.
The only cardiac risk factor that was more common in participants with FDG uptake was hypertension. Although cardiac symptoms were nearly twice as common in participants with focal FDG uptake, this difference was not statistically significant.
“Given the growing number of survivors with similar symptoms, these interesting findings warrant further investigation,” the authors say.
Noting that FDG uptake correlated with elevations in systemic inflammatory biomarkers, the researchers suggest that “a more intense systemic inflammatory process may be contributing to cardiac inflammation and the consequential alteration to regional and global myocardial function in PET-positive participants.”
On repeat imaging 2 months later, all eight patients who showed FDG uptake showed improvement or resolution of inflammation without any treatment, although two patients still had some signs of inflammation. Blood biomarkers also improved on follow-up.
“This is encouraging information, but we need longer-term data to see if there are any long-term repercussions of this inflammation,” Dr. Hanneman said.
“Overall, the study findings suggest an imaging phenotype that is expected to have good prognosis. However, longer-term follow-up studies are required to understand the need for ongoing cardiac surveillance, relationship to cardiac symptoms, guidance for safe return to exercise and sports participation, and long-term cardiovascular disease risk,” the researchers state.
This study was funded by grants from the Joint Department of Medical Imaging Academic Incentive Fund, Peter Munk Cardiac Center Innovation Committee, and Ted Rogers Center for Heart Research. Dr. Hanneman reports personal fees from Sanofi Genzyme, Amicus, and Medscape outside the submitted work.
A version of this article first appeared on Medscape.com.
Myocardial inflammation is present in a small proportion of patients who have recovered from relatively mild cases of COVID-19 infection, a new study shows.
“Our findings suggest that even in patients who have had relatively mild cases of COVID-19, some will have inflammatory changes to the heart, and these changes can be present without any cardiac symptoms,” senior author, Paaladinesh Thavendiranathan, MD, University of Toronto, told this news organization.
“While our data suggest that this inflammation improves over time, and the outcomes seem positive, we don’t know if there will be any long-term consequences,” he added.
Noting that even a short period of inflammation in the heart may be associated with symptoms or arrhythmias in the longer term, Dr. Thavendiranathan said: “I would recommend that it is best to avoid getting the infection if there is any chance of heart inflammation.”
The study was published online in JAMA Cardiology on Jan. 12.
The authors explain that among patients hospitalized with COVID, early studies suggested that approximately one in four experience cardiovascular injury, defined as an elevation in troponin levels, which was associated with a 5- to 10-fold increase in the risk for death. But there is limited information on cardiac injury in patients who do not require hospitalization.
Although a broad range of abnormal myocardial tissue has been reported in several cardiac MRI studies of patients recovered from COVID infection, there is little understanding of persistent changes in myocardial metabolism in recovered patients, which is a potential concern, given that COVID-19 is associated with systemic inflammation during the acute illness, they say.
For the current study, the researchers examined myocardial inflammation measured using two different methods – cardiac MRI and fluorodeoxyglucose–positron emission tomography (FDG-PET) – in individuals who had recovered from COVID-19 infection and looked at how this related to changes in inflammatory blood markers.
Lead author Kate Hanneman, MD, also from the University of Toronto, explained that FDG-PET imaging is more sensitive than MRI in detecting active inflammation. “Inflammatory cells have a higher uptake of glucose, and FDG-PET imaging is used to look for metabolically active inflammatory tissue that takes up glucose. It gives complementary information to MRI. Cardiac MRI shows structural or functional changes, such as scarring or edema, whereas FDG-PET imaging directly measures metabolic activity related to inflammatory cells.”
The study involved 47 individuals, 51% female, with a mean age of 43 years, who had recently recovered from COVID-19 infection. Of these, the majority had had relatively mild COVID disease, with 85% not requiring hospitalization.
Cardiac imaging was performed a mean of 67 days after the diagnosis of COVID-19. At the time of imaging, 19 participants (40%) reported at least one cardiac symptom, including palpitations, chest pain, and shortness of breath.
Results showed that eight patients (17%) had focal FDG uptake on PET consistent with myocardial inflammation. Compared with those without FDG uptake, patients with focal FDG uptake had higher regional T2, T1, and extracellular volume (colocalizing with focal FDG uptake), higher prevalence of late gadolinium enhancement indicating fibrosis, lower left ventricular ejection fraction, worse global longitudinal and circumferential strain, and higher systemic inflammatory blood markers, including interleukin (IL)-6, IL- 8, an high-sensitivity C-reactive protein.
Of the 47 patients in the study, 13 had received at least one dose of a COVID-19 vaccine. There was no significant difference in the proportion of patients who were PET-positive among those who had received a COVID-19 vaccine and those who had not.
There was also no difference in inflammation in patients who had been hospitalized with COVID-19 and those who had managed their infection at home.
Among patients with focal FDG uptake, PET, MRI, and inflammatory blood markers improved at follow-up imaging performed a mean of 52 days after the first imaging. The authors say this suggests that these abnormalities were not related to pre-existing cardiovascular disease.
Of the eight patients with positive FDG-PET results, two did not show any MRI abnormalities. These two patients also had elevated inflammatory biomarkers. “PET is a more sensitive method of measuring cardiac inflammation, and our results show that these changes may not always translate into functional changes seen on MRI,” Dr. Thavendiranathan noted.
The only cardiac risk factor that was more common in participants with FDG uptake was hypertension. Although cardiac symptoms were nearly twice as common in participants with focal FDG uptake, this difference was not statistically significant.
“Given the growing number of survivors with similar symptoms, these interesting findings warrant further investigation,” the authors say.
Noting that FDG uptake correlated with elevations in systemic inflammatory biomarkers, the researchers suggest that “a more intense systemic inflammatory process may be contributing to cardiac inflammation and the consequential alteration to regional and global myocardial function in PET-positive participants.”
On repeat imaging 2 months later, all eight patients who showed FDG uptake showed improvement or resolution of inflammation without any treatment, although two patients still had some signs of inflammation. Blood biomarkers also improved on follow-up.
“This is encouraging information, but we need longer-term data to see if there are any long-term repercussions of this inflammation,” Dr. Hanneman said.
“Overall, the study findings suggest an imaging phenotype that is expected to have good prognosis. However, longer-term follow-up studies are required to understand the need for ongoing cardiac surveillance, relationship to cardiac symptoms, guidance for safe return to exercise and sports participation, and long-term cardiovascular disease risk,” the researchers state.
This study was funded by grants from the Joint Department of Medical Imaging Academic Incentive Fund, Peter Munk Cardiac Center Innovation Committee, and Ted Rogers Center for Heart Research. Dr. Hanneman reports personal fees from Sanofi Genzyme, Amicus, and Medscape outside the submitted work.
A version of this article first appeared on Medscape.com.
Medicare intends to limit payment for controversial Alzheimer’s drug
, federal officials announced Jan. 11.
On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
‘Unusual but appropriate’ step
The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.
On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”
The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.
“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
Biogen disappointed
Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.
“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.
In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.
“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.
Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
Others weigh in
BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.
However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.
In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.
“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.
A version of this article first appeared on Medscape.com.
, federal officials announced Jan. 11.
On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
‘Unusual but appropriate’ step
The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.
On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”
The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.
“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
Biogen disappointed
Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.
“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.
In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.
“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.
Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
Others weigh in
BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.
However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.
In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.
“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.
A version of this article first appeared on Medscape.com.
, federal officials announced Jan. 11.
On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
‘Unusual but appropriate’ step
The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.
On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”
The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.
“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
Biogen disappointed
Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.
“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.
In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.
“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.
Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
Others weigh in
BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.
However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.
In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.
“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.
A version of this article first appeared on Medscape.com.
Responding to the Pandemic: How is the VA doing?
The VA’s Coronavirus Disease 2019 Response Report is now in its third iteration as the pandemic continues. On the bright side, as Steven Lieberman, MD, deputy under secretary for health at the US Department of Veterans Affairs (VA), writes in the report’s introduction, “we have learned a great deal about mounting a national response to a public health crisis.”
“Annex B” covers January 1, 2021 to July 31, 2021, building on the 2 previous reports. All 3 have sought to capture and share lessons learned, with updated information on vaccination, elder care, health equity, mental health, health care ethics, preparedness, and other topics.
As the pandemic evolved, so did the VA efforts to cope with it. This iteration, for instance, deals with details of the campaign that vaccinated more than 2.5 million people “while sustaining all other aspects of the pandemic response and veteran health services,” and how the VA implemented a vaccine mandate for all VA employees in health care roles—the first federal agency to do so. In addition to vaccinating veterans, the Strengthening and Amplifying Vaccination Efforts to Locally Immunize All Veterans and Every Spouse (SAVE LIVES) Act led to nearly 80,000 other vaccinations among families, caregivers, and veterans who do not use VHA services.
The VA also conducted extensive COVID-19 testing, processing as many as 70,000 to 90,000 tests per week. It enhanced telehealth services to reach home-based and rural veterans, for an almost 2,500% increase in home-based primary care. Recognizing the added stress the pandemic put on people at risk for suicide, the VHA used predictive analytic tools specific to veterans with COVID-19 and monitored “high-risk flags,” using them to identify veterans for tailored outreach.
The response also included carrying out 158 Federal Emergency Management Agency Fourth Mission assignments. The report highlights the contributions of the more than 1,600 Veterans Health Administration (VHA) employees who volunteered to deploy across the country, often multiple times.
In addition to active response, more than 300 studies on COVID-19 have been published by VA researchers.
The current status report discusses how to expand what worked and to improve what did not. For instance, one unsurprising finding was that “the sustained pandemic response has imposed stress on the workforce, most evident in the nursing workforce.” The recommendation: Develop a comprehensive strategy with metrics and actions to monitor and mitigate stress on the health care workforce, facilitate wellness, and enhance retention.
The finding that VHA has demonstrated that telehealth usage for care to elderly veterans is “beneficial and feasible with the right technical support” led to recommendations for expanded research to identify effective COVID-19 prevention and intervention measures for elderly veterans residing at home or in long-term care facilities.
The research found that VHA processes for protecting community living center (CLC) residents during the pandemic “have succeeded in keeping rates of CLC-onset COVID-19 at the same rate as for the population of enrolled veterans over 65,” the report says. The recommendation based on that finding is to develop an information system to facilitate monitoring of state-run veterans homes for indicators of infectious disease risk, combining periodic assessment results with epidemiologic community data.
However, the report also acknowledges unexpected detours or blocks. “Planning for the mass vaccination campaign was highly effective, but did not anticipate the complexity of interagency support.” And “[t[he inability to access state vaccination data left VHA with an incomplete picture of the vaccination status of enrolled veterans.” In response, the VA recommends incorporating interagency support into planning templates and pursuing legislative action to enable the VA to obtain vaccination data from states.
Overall, the report gives the VA high marks for managing a “well-coordinated response” to an overwhelming crisis. But the lessons are not over.
“As we continue to address the pandemic and as new variants arise,” Dr. Lieberman said in comments, “it is clear that continuous learning and improvement are essential to a successful COVID-19 response. We will continue to update this report to document our efforts so veterans, doctors, and the public can understand and learn from what we’ve discovered to better serve our veterans and communities.” Stay tuned for Annex C.
The VA’s Coronavirus Disease 2019 Response Report is now in its third iteration as the pandemic continues. On the bright side, as Steven Lieberman, MD, deputy under secretary for health at the US Department of Veterans Affairs (VA), writes in the report’s introduction, “we have learned a great deal about mounting a national response to a public health crisis.”
“Annex B” covers January 1, 2021 to July 31, 2021, building on the 2 previous reports. All 3 have sought to capture and share lessons learned, with updated information on vaccination, elder care, health equity, mental health, health care ethics, preparedness, and other topics.
As the pandemic evolved, so did the VA efforts to cope with it. This iteration, for instance, deals with details of the campaign that vaccinated more than 2.5 million people “while sustaining all other aspects of the pandemic response and veteran health services,” and how the VA implemented a vaccine mandate for all VA employees in health care roles—the first federal agency to do so. In addition to vaccinating veterans, the Strengthening and Amplifying Vaccination Efforts to Locally Immunize All Veterans and Every Spouse (SAVE LIVES) Act led to nearly 80,000 other vaccinations among families, caregivers, and veterans who do not use VHA services.
The VA also conducted extensive COVID-19 testing, processing as many as 70,000 to 90,000 tests per week. It enhanced telehealth services to reach home-based and rural veterans, for an almost 2,500% increase in home-based primary care. Recognizing the added stress the pandemic put on people at risk for suicide, the VHA used predictive analytic tools specific to veterans with COVID-19 and monitored “high-risk flags,” using them to identify veterans for tailored outreach.
The response also included carrying out 158 Federal Emergency Management Agency Fourth Mission assignments. The report highlights the contributions of the more than 1,600 Veterans Health Administration (VHA) employees who volunteered to deploy across the country, often multiple times.
In addition to active response, more than 300 studies on COVID-19 have been published by VA researchers.
The current status report discusses how to expand what worked and to improve what did not. For instance, one unsurprising finding was that “the sustained pandemic response has imposed stress on the workforce, most evident in the nursing workforce.” The recommendation: Develop a comprehensive strategy with metrics and actions to monitor and mitigate stress on the health care workforce, facilitate wellness, and enhance retention.
The finding that VHA has demonstrated that telehealth usage for care to elderly veterans is “beneficial and feasible with the right technical support” led to recommendations for expanded research to identify effective COVID-19 prevention and intervention measures for elderly veterans residing at home or in long-term care facilities.
The research found that VHA processes for protecting community living center (CLC) residents during the pandemic “have succeeded in keeping rates of CLC-onset COVID-19 at the same rate as for the population of enrolled veterans over 65,” the report says. The recommendation based on that finding is to develop an information system to facilitate monitoring of state-run veterans homes for indicators of infectious disease risk, combining periodic assessment results with epidemiologic community data.
However, the report also acknowledges unexpected detours or blocks. “Planning for the mass vaccination campaign was highly effective, but did not anticipate the complexity of interagency support.” And “[t[he inability to access state vaccination data left VHA with an incomplete picture of the vaccination status of enrolled veterans.” In response, the VA recommends incorporating interagency support into planning templates and pursuing legislative action to enable the VA to obtain vaccination data from states.
Overall, the report gives the VA high marks for managing a “well-coordinated response” to an overwhelming crisis. But the lessons are not over.
“As we continue to address the pandemic and as new variants arise,” Dr. Lieberman said in comments, “it is clear that continuous learning and improvement are essential to a successful COVID-19 response. We will continue to update this report to document our efforts so veterans, doctors, and the public can understand and learn from what we’ve discovered to better serve our veterans and communities.” Stay tuned for Annex C.
The VA’s Coronavirus Disease 2019 Response Report is now in its third iteration as the pandemic continues. On the bright side, as Steven Lieberman, MD, deputy under secretary for health at the US Department of Veterans Affairs (VA), writes in the report’s introduction, “we have learned a great deal about mounting a national response to a public health crisis.”
“Annex B” covers January 1, 2021 to July 31, 2021, building on the 2 previous reports. All 3 have sought to capture and share lessons learned, with updated information on vaccination, elder care, health equity, mental health, health care ethics, preparedness, and other topics.
As the pandemic evolved, so did the VA efforts to cope with it. This iteration, for instance, deals with details of the campaign that vaccinated more than 2.5 million people “while sustaining all other aspects of the pandemic response and veteran health services,” and how the VA implemented a vaccine mandate for all VA employees in health care roles—the first federal agency to do so. In addition to vaccinating veterans, the Strengthening and Amplifying Vaccination Efforts to Locally Immunize All Veterans and Every Spouse (SAVE LIVES) Act led to nearly 80,000 other vaccinations among families, caregivers, and veterans who do not use VHA services.
The VA also conducted extensive COVID-19 testing, processing as many as 70,000 to 90,000 tests per week. It enhanced telehealth services to reach home-based and rural veterans, for an almost 2,500% increase in home-based primary care. Recognizing the added stress the pandemic put on people at risk for suicide, the VHA used predictive analytic tools specific to veterans with COVID-19 and monitored “high-risk flags,” using them to identify veterans for tailored outreach.
The response also included carrying out 158 Federal Emergency Management Agency Fourth Mission assignments. The report highlights the contributions of the more than 1,600 Veterans Health Administration (VHA) employees who volunteered to deploy across the country, often multiple times.
In addition to active response, more than 300 studies on COVID-19 have been published by VA researchers.
The current status report discusses how to expand what worked and to improve what did not. For instance, one unsurprising finding was that “the sustained pandemic response has imposed stress on the workforce, most evident in the nursing workforce.” The recommendation: Develop a comprehensive strategy with metrics and actions to monitor and mitigate stress on the health care workforce, facilitate wellness, and enhance retention.
The finding that VHA has demonstrated that telehealth usage for care to elderly veterans is “beneficial and feasible with the right technical support” led to recommendations for expanded research to identify effective COVID-19 prevention and intervention measures for elderly veterans residing at home or in long-term care facilities.
The research found that VHA processes for protecting community living center (CLC) residents during the pandemic “have succeeded in keeping rates of CLC-onset COVID-19 at the same rate as for the population of enrolled veterans over 65,” the report says. The recommendation based on that finding is to develop an information system to facilitate monitoring of state-run veterans homes for indicators of infectious disease risk, combining periodic assessment results with epidemiologic community data.
However, the report also acknowledges unexpected detours or blocks. “Planning for the mass vaccination campaign was highly effective, but did not anticipate the complexity of interagency support.” And “[t[he inability to access state vaccination data left VHA with an incomplete picture of the vaccination status of enrolled veterans.” In response, the VA recommends incorporating interagency support into planning templates and pursuing legislative action to enable the VA to obtain vaccination data from states.
Overall, the report gives the VA high marks for managing a “well-coordinated response” to an overwhelming crisis. But the lessons are not over.
“As we continue to address the pandemic and as new variants arise,” Dr. Lieberman said in comments, “it is clear that continuous learning and improvement are essential to a successful COVID-19 response. We will continue to update this report to document our efforts so veterans, doctors, and the public can understand and learn from what we’ve discovered to better serve our veterans and communities.” Stay tuned for Annex C.
Olive oil intake tied to reduced mortality
Compared with men and women who rarely or never consumed olive oil (the lowest intake), those who consumed greater than 0.5 tablespoon/day or more than 7 g/day (the highest intake) had a 19% lower mortality risk over a 28-year follow-up, starting from an average age of 56 years.
Moreover, compared with those with the lowest olive oil intake, those with the highest intake had a 19% lower cardiovascular disease (CVD) mortality, a 17% lower risk of dying from cancer, a 29% lower risk of dying from neurodegenerative disease, and an 18% lower risk of dying from respiratory disease during follow-up.
The researchers estimate that replacing 10 g/day of margarine, butter, mayonnaise, or dairy fat with the same amount of olive oil is associated with an 8%-34% lower risk of death from various causes.
The study by Marta Guasch-Ferré, PhD, and colleagues was published online Jan. 10 in the Journal of the American College of Cardiology.
Results support plant-based dietary fat recommendations
“Our results support current dietary recommendations to increase the intake of olive oil and other unsaturated vegetable oils in place of other fats to improve overall health and longevity,” the researchers summarize.
However, “I wouldn’t say that olive oil is the only way to help you live longer,” Dr. Guasch-Ferré, a senior research scientist in the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, cautioned in an interview with this news organization.
“Other things are very important, such as not smoking, doing physical activity, etc., but one recommendation could be to try to eat more plant-based food including olive oil and healthy fat,” she added, and to use it for cooking, salad dressing, and baking, and substitute it for saturated fat or animal fat, especially for cooking.
The study suggests that people should “consume a more plant-based diet and prioritize fatty acids such as olive oil because they have a better nutritional composition (high in phenols and antioxidants), instead of using butter or margarines or other animal fats that have been shown to have detrimental effects for health,” she added, which is consistent with recommendations in the Dietary Guidelines for Americans.
“That said,” Dr. Guasch-Ferré summarized, “replication is needed in other cohorts and populations to see if the results are similar.”
In an accompanying editorial, Susanna C. Larsson, PhD, writes that “this was a well-designed study, with long-term follow-up and repeated measurements of dietary intake and other risk factors for diseases.”
“However, the difference in olive oil consumption between those with the highest and those with the lowest/no olive oil consumption was very low (0.5 tablespoon) and a [12%] reduced mortality risk was observed already at a much lower intake (0.5 teaspoon, about 1.5 g/day) of olive oil,” she noted in an email to this news organization.
“It’s a bit hard to believe that such a small amount could have an independent effect on mortality risk,” Dr. Larsson, associate professor of epidemiology at the Karolinska Institutet, Stockholm, cautioned.
Like Dr. Guasch-Ferré, she noted that “just adding one or two teaspoons of olive oil to the diet each day will likely not change the risk of mortality.”
Rather, “people may need to make larger changes in the whole diet, not focus on fat only. An overall healthier diet, rich in nonrefined plant-based foods (vegetables, whole grains, nuts), low/no intake of processed foods, and a switch to healthier fat (eg, olive oil) is needed.”
Importantly, “this study cannot say anything about causality, that is, whether it’s olive oil specifically that reduces mortality risk or if there are many other beneficial factors that act together to reduce mortality rate among those with high olive oil consumption.”
The researchers acknowledge this observational study limitation and that the findings may not be generalizable to other populations.
Novel findings regarding Alzheimer’s and respiratory disease
Dr. Larsson highlights two novel findings of this study.
First, it showed a 27% reduction in risk of dementia-related mortality for those in the highest versus lowest category of olive oil consumption. “Considering the lack of preventive strategies for Alzheimer’s disease and the high morbidity and mortality related to this disease, this finding, if confirmed, is of great public health importance,” she said.
Second, the study reported an inverse association of olive oil consumption with risk of respiratory disease mortality. “Because residual confounding from smoking cannot be ruled out,” Dr. Larsson said, “this finding is tentative and requires confirmation in a study that is less susceptible to confounding, such as a randomized trial.”
And although the current study and previous studies have found that consumption of olive oil may have health benefits, she identified several remaining questions.
“Are the associations causal or spurious?” she noted. Is olive oil consumption protective for certain cardiovascular diseases like stroke or atrial fibrillation only, as has been shown in other studies, or also for other major diseases and causes of death, she added. What is the amount of olive oil required for a protective effect?
Further, is the potential effect related to monounsaturated fatty acids (MUFAs) or phenolic compounds; that is, “is the protective effect confined to polyphenol-rich extra-virgin olive oil or are refined olive oil and other vegetable oils as beneficial? More research is needed to address these questions,” she concludes.
“Further studies are needed,” the researchers agree, “to confirm the association of olive oil consumption with reduced mortality, clarify the mechanisms responsible, and quantify the dose/volume boundaries around this effect.”
Virgin olive oil has more polyphenols
Olive oil, a key component of the Mediterranean diet, is high in MUFAs, especially oleic acid, as well as vitamin E and polyphenols, which contribute to its anti-inflammatory and antioxidant properties, the researchers explain.
Virgin olive oil, produced by mechanically pressing ripe olives, contains multiple bioactive and antioxidant components and has an acidity of less than 1.5%. And extra-virgin olive oil is produced the same way but has a higher quality, more intense taste, and lower acidity (less than 1%).
Refined or processed olive oil contains less phytochemicals, as some are lost during processing; it usually contains more than 80% refined oil, plus virgin oil added back to enhance flavor, and may also be labeled “pure” or “light.” However, refined olive oil “still has a good amount of healthy fatty acids but less bioactive compounds,” Dr. Guasch-Ferré noted.
Until now, no large prospective study has examined the link between olive oil intake and all-cause and cause-specific mortality in a U.S. population, where olive oil consumption is limited, compared with Mediterranean countries.
The researchers identified 60,582 women in the Nurses’ Health Study and 31,801 men in the Health Professionals Follow-up Study who were free of CVD or cancer in 1990, the first year that food frequency questionnaires in these studies asked about olive oil.
Participants replied to questionnaires every 4 years that asked about use of olive oil (for salad dressing, baking, frying, sautéing, and spreading on bread), other vegetable oils (for example, corn, safflower, soybean, canola oil), margarine, butter, and dairy fat. The researchers averaged the consumption of these fats during the follow-up years.
From 1990 to 2019, the average consumption of olive oil increased from 1.6 g/day to 4 g/day. Margarine in the 1990s contained saturated fat and trans fats, whereas more recently margarine contains beneficial olive oil or vegetable fat, Dr. Guasch-Ferré noted.
Baseline olive oil consumption in this U.S. population “differed remarkably” from that in the Spanish population in the PREDIMED (Prevención con Dieta Mediterránea) trial, which was, on average, 20-22 g/day of extra-virgin olive oil and 16-18 g/day of refined/mixed olive oil, Larsson pointed out.
Because olive oil consumption was so low in this U.S. study, the researchers did not distinguish between virgin/extra-virgin olive oil and refined/processed olive oil.
The participants were almost all White (99%) and were generally healthier than the average U.S. population; on average, they had a body mass index of 25.3-25.8 kg/m2 and ate 4.8-7.2 fruits and vegetables/day.
Those with the highest olive oil consumption were more physically active, had a healthier diet, were more likely to have Southern European or Mediterranean ancestry, and were less likely to smoke.
During 28 years of follow-up, 36,856 participants died. The researchers classified the deaths into five categories: CVD, cancer, neurodegenerative disease (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis), respiratory disease (such as chronic obstructive pulmonary disease), and all other causes (including suicide, injury, infections, diabetes, and kidney disease).
After adjusting for multiple confounders, compared with participants who rarely or never consumed olive oil, those in the highest quartile for olive oil consumption had a decreased risk of death from all causes (hazard ratio, 0.81; 95% confidence interval, 0.78 - 0.84) and from CVD (HR, 0.81; 95% CI, 0.75-0.87), cancer (HR, 0.83; 95% CI, 0.78-0.89), neurodegenerative disease (HR, 0.71; 95% CI, 0.64-0.78), and respiratory disease (HR, 0.82; 95% CI, 0.72-0.93).
There was no decrease in mortality in models where the researchers substituted olive oil for vegetable oil, suggesting that vegetable oils may provide similar health benefits as olive oil.
The research was supported by grants from the National Institutes of Health. Dr. Guasch-Ferré was supported by the American Diabetes Association. Coauthor Salas-Salvadó is partially supported by the Catalan Institution for Research and Advanced Studies and received the virgin olive oil that was used in the PREDIMED and PREDIMED-Plus studies from the Patrimonio Communal Olivalero and Hojiblanca (Málaga, Spain). The other study authors and Dr. Larsson have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Compared with men and women who rarely or never consumed olive oil (the lowest intake), those who consumed greater than 0.5 tablespoon/day or more than 7 g/day (the highest intake) had a 19% lower mortality risk over a 28-year follow-up, starting from an average age of 56 years.
Moreover, compared with those with the lowest olive oil intake, those with the highest intake had a 19% lower cardiovascular disease (CVD) mortality, a 17% lower risk of dying from cancer, a 29% lower risk of dying from neurodegenerative disease, and an 18% lower risk of dying from respiratory disease during follow-up.
The researchers estimate that replacing 10 g/day of margarine, butter, mayonnaise, or dairy fat with the same amount of olive oil is associated with an 8%-34% lower risk of death from various causes.
The study by Marta Guasch-Ferré, PhD, and colleagues was published online Jan. 10 in the Journal of the American College of Cardiology.
Results support plant-based dietary fat recommendations
“Our results support current dietary recommendations to increase the intake of olive oil and other unsaturated vegetable oils in place of other fats to improve overall health and longevity,” the researchers summarize.
However, “I wouldn’t say that olive oil is the only way to help you live longer,” Dr. Guasch-Ferré, a senior research scientist in the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, cautioned in an interview with this news organization.
“Other things are very important, such as not smoking, doing physical activity, etc., but one recommendation could be to try to eat more plant-based food including olive oil and healthy fat,” she added, and to use it for cooking, salad dressing, and baking, and substitute it for saturated fat or animal fat, especially for cooking.
The study suggests that people should “consume a more plant-based diet and prioritize fatty acids such as olive oil because they have a better nutritional composition (high in phenols and antioxidants), instead of using butter or margarines or other animal fats that have been shown to have detrimental effects for health,” she added, which is consistent with recommendations in the Dietary Guidelines for Americans.
“That said,” Dr. Guasch-Ferré summarized, “replication is needed in other cohorts and populations to see if the results are similar.”
In an accompanying editorial, Susanna C. Larsson, PhD, writes that “this was a well-designed study, with long-term follow-up and repeated measurements of dietary intake and other risk factors for diseases.”
“However, the difference in olive oil consumption between those with the highest and those with the lowest/no olive oil consumption was very low (0.5 tablespoon) and a [12%] reduced mortality risk was observed already at a much lower intake (0.5 teaspoon, about 1.5 g/day) of olive oil,” she noted in an email to this news organization.
“It’s a bit hard to believe that such a small amount could have an independent effect on mortality risk,” Dr. Larsson, associate professor of epidemiology at the Karolinska Institutet, Stockholm, cautioned.
Like Dr. Guasch-Ferré, she noted that “just adding one or two teaspoons of olive oil to the diet each day will likely not change the risk of mortality.”
Rather, “people may need to make larger changes in the whole diet, not focus on fat only. An overall healthier diet, rich in nonrefined plant-based foods (vegetables, whole grains, nuts), low/no intake of processed foods, and a switch to healthier fat (eg, olive oil) is needed.”
Importantly, “this study cannot say anything about causality, that is, whether it’s olive oil specifically that reduces mortality risk or if there are many other beneficial factors that act together to reduce mortality rate among those with high olive oil consumption.”
The researchers acknowledge this observational study limitation and that the findings may not be generalizable to other populations.
Novel findings regarding Alzheimer’s and respiratory disease
Dr. Larsson highlights two novel findings of this study.
First, it showed a 27% reduction in risk of dementia-related mortality for those in the highest versus lowest category of olive oil consumption. “Considering the lack of preventive strategies for Alzheimer’s disease and the high morbidity and mortality related to this disease, this finding, if confirmed, is of great public health importance,” she said.
Second, the study reported an inverse association of olive oil consumption with risk of respiratory disease mortality. “Because residual confounding from smoking cannot be ruled out,” Dr. Larsson said, “this finding is tentative and requires confirmation in a study that is less susceptible to confounding, such as a randomized trial.”
And although the current study and previous studies have found that consumption of olive oil may have health benefits, she identified several remaining questions.
“Are the associations causal or spurious?” she noted. Is olive oil consumption protective for certain cardiovascular diseases like stroke or atrial fibrillation only, as has been shown in other studies, or also for other major diseases and causes of death, she added. What is the amount of olive oil required for a protective effect?
Further, is the potential effect related to monounsaturated fatty acids (MUFAs) or phenolic compounds; that is, “is the protective effect confined to polyphenol-rich extra-virgin olive oil or are refined olive oil and other vegetable oils as beneficial? More research is needed to address these questions,” she concludes.
“Further studies are needed,” the researchers agree, “to confirm the association of olive oil consumption with reduced mortality, clarify the mechanisms responsible, and quantify the dose/volume boundaries around this effect.”
Virgin olive oil has more polyphenols
Olive oil, a key component of the Mediterranean diet, is high in MUFAs, especially oleic acid, as well as vitamin E and polyphenols, which contribute to its anti-inflammatory and antioxidant properties, the researchers explain.
Virgin olive oil, produced by mechanically pressing ripe olives, contains multiple bioactive and antioxidant components and has an acidity of less than 1.5%. And extra-virgin olive oil is produced the same way but has a higher quality, more intense taste, and lower acidity (less than 1%).
Refined or processed olive oil contains less phytochemicals, as some are lost during processing; it usually contains more than 80% refined oil, plus virgin oil added back to enhance flavor, and may also be labeled “pure” or “light.” However, refined olive oil “still has a good amount of healthy fatty acids but less bioactive compounds,” Dr. Guasch-Ferré noted.
Until now, no large prospective study has examined the link between olive oil intake and all-cause and cause-specific mortality in a U.S. population, where olive oil consumption is limited, compared with Mediterranean countries.
The researchers identified 60,582 women in the Nurses’ Health Study and 31,801 men in the Health Professionals Follow-up Study who were free of CVD or cancer in 1990, the first year that food frequency questionnaires in these studies asked about olive oil.
Participants replied to questionnaires every 4 years that asked about use of olive oil (for salad dressing, baking, frying, sautéing, and spreading on bread), other vegetable oils (for example, corn, safflower, soybean, canola oil), margarine, butter, and dairy fat. The researchers averaged the consumption of these fats during the follow-up years.
From 1990 to 2019, the average consumption of olive oil increased from 1.6 g/day to 4 g/day. Margarine in the 1990s contained saturated fat and trans fats, whereas more recently margarine contains beneficial olive oil or vegetable fat, Dr. Guasch-Ferré noted.
Baseline olive oil consumption in this U.S. population “differed remarkably” from that in the Spanish population in the PREDIMED (Prevención con Dieta Mediterránea) trial, which was, on average, 20-22 g/day of extra-virgin olive oil and 16-18 g/day of refined/mixed olive oil, Larsson pointed out.
Because olive oil consumption was so low in this U.S. study, the researchers did not distinguish between virgin/extra-virgin olive oil and refined/processed olive oil.
The participants were almost all White (99%) and were generally healthier than the average U.S. population; on average, they had a body mass index of 25.3-25.8 kg/m2 and ate 4.8-7.2 fruits and vegetables/day.
Those with the highest olive oil consumption were more physically active, had a healthier diet, were more likely to have Southern European or Mediterranean ancestry, and were less likely to smoke.
During 28 years of follow-up, 36,856 participants died. The researchers classified the deaths into five categories: CVD, cancer, neurodegenerative disease (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis), respiratory disease (such as chronic obstructive pulmonary disease), and all other causes (including suicide, injury, infections, diabetes, and kidney disease).
After adjusting for multiple confounders, compared with participants who rarely or never consumed olive oil, those in the highest quartile for olive oil consumption had a decreased risk of death from all causes (hazard ratio, 0.81; 95% confidence interval, 0.78 - 0.84) and from CVD (HR, 0.81; 95% CI, 0.75-0.87), cancer (HR, 0.83; 95% CI, 0.78-0.89), neurodegenerative disease (HR, 0.71; 95% CI, 0.64-0.78), and respiratory disease (HR, 0.82; 95% CI, 0.72-0.93).
There was no decrease in mortality in models where the researchers substituted olive oil for vegetable oil, suggesting that vegetable oils may provide similar health benefits as olive oil.
The research was supported by grants from the National Institutes of Health. Dr. Guasch-Ferré was supported by the American Diabetes Association. Coauthor Salas-Salvadó is partially supported by the Catalan Institution for Research and Advanced Studies and received the virgin olive oil that was used in the PREDIMED and PREDIMED-Plus studies from the Patrimonio Communal Olivalero and Hojiblanca (Málaga, Spain). The other study authors and Dr. Larsson have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Compared with men and women who rarely or never consumed olive oil (the lowest intake), those who consumed greater than 0.5 tablespoon/day or more than 7 g/day (the highest intake) had a 19% lower mortality risk over a 28-year follow-up, starting from an average age of 56 years.
Moreover, compared with those with the lowest olive oil intake, those with the highest intake had a 19% lower cardiovascular disease (CVD) mortality, a 17% lower risk of dying from cancer, a 29% lower risk of dying from neurodegenerative disease, and an 18% lower risk of dying from respiratory disease during follow-up.
The researchers estimate that replacing 10 g/day of margarine, butter, mayonnaise, or dairy fat with the same amount of olive oil is associated with an 8%-34% lower risk of death from various causes.
The study by Marta Guasch-Ferré, PhD, and colleagues was published online Jan. 10 in the Journal of the American College of Cardiology.
Results support plant-based dietary fat recommendations
“Our results support current dietary recommendations to increase the intake of olive oil and other unsaturated vegetable oils in place of other fats to improve overall health and longevity,” the researchers summarize.
However, “I wouldn’t say that olive oil is the only way to help you live longer,” Dr. Guasch-Ferré, a senior research scientist in the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, cautioned in an interview with this news organization.
“Other things are very important, such as not smoking, doing physical activity, etc., but one recommendation could be to try to eat more plant-based food including olive oil and healthy fat,” she added, and to use it for cooking, salad dressing, and baking, and substitute it for saturated fat or animal fat, especially for cooking.
The study suggests that people should “consume a more plant-based diet and prioritize fatty acids such as olive oil because they have a better nutritional composition (high in phenols and antioxidants), instead of using butter or margarines or other animal fats that have been shown to have detrimental effects for health,” she added, which is consistent with recommendations in the Dietary Guidelines for Americans.
“That said,” Dr. Guasch-Ferré summarized, “replication is needed in other cohorts and populations to see if the results are similar.”
In an accompanying editorial, Susanna C. Larsson, PhD, writes that “this was a well-designed study, with long-term follow-up and repeated measurements of dietary intake and other risk factors for diseases.”
“However, the difference in olive oil consumption between those with the highest and those with the lowest/no olive oil consumption was very low (0.5 tablespoon) and a [12%] reduced mortality risk was observed already at a much lower intake (0.5 teaspoon, about 1.5 g/day) of olive oil,” she noted in an email to this news organization.
“It’s a bit hard to believe that such a small amount could have an independent effect on mortality risk,” Dr. Larsson, associate professor of epidemiology at the Karolinska Institutet, Stockholm, cautioned.
Like Dr. Guasch-Ferré, she noted that “just adding one or two teaspoons of olive oil to the diet each day will likely not change the risk of mortality.”
Rather, “people may need to make larger changes in the whole diet, not focus on fat only. An overall healthier diet, rich in nonrefined plant-based foods (vegetables, whole grains, nuts), low/no intake of processed foods, and a switch to healthier fat (eg, olive oil) is needed.”
Importantly, “this study cannot say anything about causality, that is, whether it’s olive oil specifically that reduces mortality risk or if there are many other beneficial factors that act together to reduce mortality rate among those with high olive oil consumption.”
The researchers acknowledge this observational study limitation and that the findings may not be generalizable to other populations.
Novel findings regarding Alzheimer’s and respiratory disease
Dr. Larsson highlights two novel findings of this study.
First, it showed a 27% reduction in risk of dementia-related mortality for those in the highest versus lowest category of olive oil consumption. “Considering the lack of preventive strategies for Alzheimer’s disease and the high morbidity and mortality related to this disease, this finding, if confirmed, is of great public health importance,” she said.
Second, the study reported an inverse association of olive oil consumption with risk of respiratory disease mortality. “Because residual confounding from smoking cannot be ruled out,” Dr. Larsson said, “this finding is tentative and requires confirmation in a study that is less susceptible to confounding, such as a randomized trial.”
And although the current study and previous studies have found that consumption of olive oil may have health benefits, she identified several remaining questions.
“Are the associations causal or spurious?” she noted. Is olive oil consumption protective for certain cardiovascular diseases like stroke or atrial fibrillation only, as has been shown in other studies, or also for other major diseases and causes of death, she added. What is the amount of olive oil required for a protective effect?
Further, is the potential effect related to monounsaturated fatty acids (MUFAs) or phenolic compounds; that is, “is the protective effect confined to polyphenol-rich extra-virgin olive oil or are refined olive oil and other vegetable oils as beneficial? More research is needed to address these questions,” she concludes.
“Further studies are needed,” the researchers agree, “to confirm the association of olive oil consumption with reduced mortality, clarify the mechanisms responsible, and quantify the dose/volume boundaries around this effect.”
Virgin olive oil has more polyphenols
Olive oil, a key component of the Mediterranean diet, is high in MUFAs, especially oleic acid, as well as vitamin E and polyphenols, which contribute to its anti-inflammatory and antioxidant properties, the researchers explain.
Virgin olive oil, produced by mechanically pressing ripe olives, contains multiple bioactive and antioxidant components and has an acidity of less than 1.5%. And extra-virgin olive oil is produced the same way but has a higher quality, more intense taste, and lower acidity (less than 1%).
Refined or processed olive oil contains less phytochemicals, as some are lost during processing; it usually contains more than 80% refined oil, plus virgin oil added back to enhance flavor, and may also be labeled “pure” or “light.” However, refined olive oil “still has a good amount of healthy fatty acids but less bioactive compounds,” Dr. Guasch-Ferré noted.
Until now, no large prospective study has examined the link between olive oil intake and all-cause and cause-specific mortality in a U.S. population, where olive oil consumption is limited, compared with Mediterranean countries.
The researchers identified 60,582 women in the Nurses’ Health Study and 31,801 men in the Health Professionals Follow-up Study who were free of CVD or cancer in 1990, the first year that food frequency questionnaires in these studies asked about olive oil.
Participants replied to questionnaires every 4 years that asked about use of olive oil (for salad dressing, baking, frying, sautéing, and spreading on bread), other vegetable oils (for example, corn, safflower, soybean, canola oil), margarine, butter, and dairy fat. The researchers averaged the consumption of these fats during the follow-up years.
From 1990 to 2019, the average consumption of olive oil increased from 1.6 g/day to 4 g/day. Margarine in the 1990s contained saturated fat and trans fats, whereas more recently margarine contains beneficial olive oil or vegetable fat, Dr. Guasch-Ferré noted.
Baseline olive oil consumption in this U.S. population “differed remarkably” from that in the Spanish population in the PREDIMED (Prevención con Dieta Mediterránea) trial, which was, on average, 20-22 g/day of extra-virgin olive oil and 16-18 g/day of refined/mixed olive oil, Larsson pointed out.
Because olive oil consumption was so low in this U.S. study, the researchers did not distinguish between virgin/extra-virgin olive oil and refined/processed olive oil.
The participants were almost all White (99%) and were generally healthier than the average U.S. population; on average, they had a body mass index of 25.3-25.8 kg/m2 and ate 4.8-7.2 fruits and vegetables/day.
Those with the highest olive oil consumption were more physically active, had a healthier diet, were more likely to have Southern European or Mediterranean ancestry, and were less likely to smoke.
During 28 years of follow-up, 36,856 participants died. The researchers classified the deaths into five categories: CVD, cancer, neurodegenerative disease (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis), respiratory disease (such as chronic obstructive pulmonary disease), and all other causes (including suicide, injury, infections, diabetes, and kidney disease).
After adjusting for multiple confounders, compared with participants who rarely or never consumed olive oil, those in the highest quartile for olive oil consumption had a decreased risk of death from all causes (hazard ratio, 0.81; 95% confidence interval, 0.78 - 0.84) and from CVD (HR, 0.81; 95% CI, 0.75-0.87), cancer (HR, 0.83; 95% CI, 0.78-0.89), neurodegenerative disease (HR, 0.71; 95% CI, 0.64-0.78), and respiratory disease (HR, 0.82; 95% CI, 0.72-0.93).
There was no decrease in mortality in models where the researchers substituted olive oil for vegetable oil, suggesting that vegetable oils may provide similar health benefits as olive oil.
The research was supported by grants from the National Institutes of Health. Dr. Guasch-Ferré was supported by the American Diabetes Association. Coauthor Salas-Salvadó is partially supported by the Catalan Institution for Research and Advanced Studies and received the virgin olive oil that was used in the PREDIMED and PREDIMED-Plus studies from the Patrimonio Communal Olivalero and Hojiblanca (Málaga, Spain). The other study authors and Dr. Larsson have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
What if the National Guard Can’t Help?
What if the National Guard Can’t Help?
In early January, Ohio not only set a state record for COVID-19 hospitalizations—it had the fourth highest rate in the country, with 6,747 hospitalized coronavirus patients on January 10, a 40% increase over the previous 21 days. Most were unvaccinated. To help overwhelmed hospitals cope, Ohio Gov. Mike DeWine turned to the National Guard. Unfortunately, nearly half of the Ohio National Guard also were unvaccinated.
By US Department of Defense (DoD) directive, National Guard members must have a COVID-19 vaccination to be deployed on hospital missions. Thus, in COVID hotspots across the nation, governors are on the horns of a dilemma. They want and need to deploy the National Guard to give medical and nonclinical support but aren’t sure whether they will be able to or, indeed, whether they should.
So far, vaccinated teams are already on the ground in a number of states. In Indiana, where hospitalizations jumped 50% over 2 weeks in December, the National Guard sent 6-person teams, all fully vaccinated. In New Hampshire, 70 guards are being deployed to help hospitals with food service, clerical work, and other nonmedical functions. New York Governor Kathy Hochul has deployed guard members for help to ease the strain on nursing homes. Massachusetts Governor Charlie Baker has activated up to 500 guard members; some will be supporting 55 acute care hospital and 12 ambulance services. In Maine, where cases have peaked, Governor Janet Mills activated guard members to support nursing facilities and administer monoclonal antibodies. The Louisiana National Guard has administered more than 542,000 COVID-19 tests and 206,300 vaccines. As many as 1,000 Maryland Air and Army National Guardsmen are being activated to help with testing and other missions.
However, as in Ohio, other states are facing problematic scenarios. For instance, about 40% of the more than 20,000 Texas National Guard are refusing to get vaccinated, challenging the Biden Administration vaccine requirement for all military.
And a court showdown over federal vaccine mandates, started by Governor Kevin Stitt of Oklahoma and joined by the Republican governors of Wyoming, Iowa, Alaska, Nebraska, and Mississippi, came to a head in December. Last November, Stitt asked Defense Secretary Lloyd Austin to exempt Oklahoma’s National Guard from the vaccine mandate. He claimed the requirement violated the personal freedoms of many Oklahomans and could cause them to “potentially sacrifice their personal beliefs.” But in a memo to the Joint Chiefs chairmen, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds could not be used to pay for duties performed under Title 32 for members of the Guard who do not comply with the military’s vaccine requirement. (Title 32 refers to Guard operations under state orders.) Austin also said National Guard members must be vaccinated to participate in drills, training, and other duty conducted under Title 32.
Stitt, maintaining that he is commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders, put out his own memo stipulating that no Guard member was required to get vaccinated. He also ordered Brig. Gen. Thomas Mancino, newly appointed commander of the Oklahoma National Guard, to not enforce the mandate. Subsequently, Mancino issued a statement pointing out that current state law is limited in protecting troops who opt out of the shot. Moreover, if the Guard were called up under federal orders, he said, he would enforce the mandate. Training events, schools, and mobilizations were going to “eventually force you out of that safe harbor,” he wrote, “…This is reality.”
In late December, a federal judge denied Oklahoma’s motion to enjoin the mandate. The Oklahoma Attorney General’s office responded, “We will not be surprised if the President’s vaccine mandate actually reduces the nation’s military readiness instead of promoting it.”
In a press briefing, Pentagon press secretary John Kirby said, “The Secretary has the authorities he needs to require this vaccine across the force, including the National Guard. …[E]ven when they’re in a Title 32 status.” He added, “It is a lawful order for National Guardsmen to receive the COVID vaccine. It’s a lawful order, and refusing to do that, absent of an improved exemption, puts them in the same potential [position] as active-duty members who refuse the vaccine.” That could mean, for instance, loss of pay and membership in the National Guard.
A core rationale for the mandate, according to Secretary Austin, is the need for military readiness—meaning Guard members must be healthy and fit for duty. And that extends to being healthy and fit for missions like transporting at-risk patients. Ohio National Guard Adjutant General Major General John Harris Jr. said, “I would never put a soldier or airman in harm’s way without the best protection we could put on them—body armor, helmets. And this medical readiness is the exact same thing. We’re putting folks into harm’s way.” He has moved the deadline from the Pentagon’s June 30 date to March 31—a move that boosted the vaccination rate from 53% to 56% in one week.
Ohio Governor DeWine has expressed frustration that almost half of the Ohio Army National Guard personnel can’t be deployed on this mission because they’re unvaccinated. “In some of our testing places, 40 to 50% of the people are testing positive,” he said. “So this is a high-risk operation. You need to be protected. The best way for you to be protected is to get the vaccination.”
As of December 2021, according to the National Guard Bureau, the National Guard as a whole was 66% fully vaccinated. The percentages vary according to service; for instance, nearly 90% of airmen have been vaccinated, compared with only 40% of Army Guardsmen. Among the states challenging the mandate, the vaccinated rates have been moving upward: In Alaska, about 92% of the Air National Guard have been vaccinated—leaving roughly 11,000 troops who had not met the December 2 deadline. In Iowa, as of Nov. 30, 91% of Air National Guard and 80% of Army National Guard members had been vaccinated, but about 9,000 soldiers had been directed to get the vaccination or risk disciplinary action. Almost 2,200 of the more than 2,800-strong Wyoming National Guard (77%) have received at least 1 dose. Nebraska Air National Guard’s force of 1,000 was 94% fully vaccinated as of December 1. (Maj Scott Ingalsbe, public affairs officer, said, “Vaccinations are tied to individual medical readiness. They provide service members with the best protection available so they can perform missions across the globe.”).
In most states, Army National Guard members have until June 30, 2022, to comply. “Our soldiers …have until [the DoD’s deadline], and some of them are just going to wait close to the deadline,” John Goheen of the National Guard Association of the United States said in a discussion on NPR. “That’s human nature.”
Earlier this month, Texas Governor Greg Abbott told National Guard members they can ignore the Pentagon’s COVID-19 vaccine mandate: “President Biden is not your commander-in-chief.” He has also sued the Biden administration over the requirement.
In the meantime, the hospitals at breaking point must hope for the best and take as much help as they can get.
In early January, Ohio not only set a state record for COVID-19 hospitalizations—it had the fourth highest rate in the country, with 6,747 hospitalized coronavirus patients on January 10, a 40% increase over the previous 21 days. Most were unvaccinated. To help overwhelmed hospitals cope, Ohio Gov. Mike DeWine turned to the National Guard. Unfortunately, nearly half of the Ohio National Guard also were unvaccinated.
By US Department of Defense (DoD) directive, National Guard members must have a COVID-19 vaccination to be deployed on hospital missions. Thus, in COVID hotspots across the nation, governors are on the horns of a dilemma. They want and need to deploy the National Guard to give medical and nonclinical support but aren’t sure whether they will be able to or, indeed, whether they should.
So far, vaccinated teams are already on the ground in a number of states. In Indiana, where hospitalizations jumped 50% over 2 weeks in December, the National Guard sent 6-person teams, all fully vaccinated. In New Hampshire, 70 guards are being deployed to help hospitals with food service, clerical work, and other nonmedical functions. New York Governor Kathy Hochul has deployed guard members for help to ease the strain on nursing homes. Massachusetts Governor Charlie Baker has activated up to 500 guard members; some will be supporting 55 acute care hospital and 12 ambulance services. In Maine, where cases have peaked, Governor Janet Mills activated guard members to support nursing facilities and administer monoclonal antibodies. The Louisiana National Guard has administered more than 542,000 COVID-19 tests and 206,300 vaccines. As many as 1,000 Maryland Air and Army National Guardsmen are being activated to help with testing and other missions.
However, as in Ohio, other states are facing problematic scenarios. For instance, about 40% of the more than 20,000 Texas National Guard are refusing to get vaccinated, challenging the Biden Administration vaccine requirement for all military.
And a court showdown over federal vaccine mandates, started by Governor Kevin Stitt of Oklahoma and joined by the Republican governors of Wyoming, Iowa, Alaska, Nebraska, and Mississippi, came to a head in December. Last November, Stitt asked Defense Secretary Lloyd Austin to exempt Oklahoma’s National Guard from the vaccine mandate. He claimed the requirement violated the personal freedoms of many Oklahomans and could cause them to “potentially sacrifice their personal beliefs.” But in a memo to the Joint Chiefs chairmen, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds could not be used to pay for duties performed under Title 32 for members of the Guard who do not comply with the military’s vaccine requirement. (Title 32 refers to Guard operations under state orders.) Austin also said National Guard members must be vaccinated to participate in drills, training, and other duty conducted under Title 32.
Stitt, maintaining that he is commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders, put out his own memo stipulating that no Guard member was required to get vaccinated. He also ordered Brig. Gen. Thomas Mancino, newly appointed commander of the Oklahoma National Guard, to not enforce the mandate. Subsequently, Mancino issued a statement pointing out that current state law is limited in protecting troops who opt out of the shot. Moreover, if the Guard were called up under federal orders, he said, he would enforce the mandate. Training events, schools, and mobilizations were going to “eventually force you out of that safe harbor,” he wrote, “…This is reality.”
In late December, a federal judge denied Oklahoma’s motion to enjoin the mandate. The Oklahoma Attorney General’s office responded, “We will not be surprised if the President’s vaccine mandate actually reduces the nation’s military readiness instead of promoting it.”
In a press briefing, Pentagon press secretary John Kirby said, “The Secretary has the authorities he needs to require this vaccine across the force, including the National Guard. …[E]ven when they’re in a Title 32 status.” He added, “It is a lawful order for National Guardsmen to receive the COVID vaccine. It’s a lawful order, and refusing to do that, absent of an improved exemption, puts them in the same potential [position] as active-duty members who refuse the vaccine.” That could mean, for instance, loss of pay and membership in the National Guard.
A core rationale for the mandate, according to Secretary Austin, is the need for military readiness—meaning Guard members must be healthy and fit for duty. And that extends to being healthy and fit for missions like transporting at-risk patients. Ohio National Guard Adjutant General Major General John Harris Jr. said, “I would never put a soldier or airman in harm’s way without the best protection we could put on them—body armor, helmets. And this medical readiness is the exact same thing. We’re putting folks into harm’s way.” He has moved the deadline from the Pentagon’s June 30 date to March 31—a move that boosted the vaccination rate from 53% to 56% in one week.
Ohio Governor DeWine has expressed frustration that almost half of the Ohio Army National Guard personnel can’t be deployed on this mission because they’re unvaccinated. “In some of our testing places, 40 to 50% of the people are testing positive,” he said. “So this is a high-risk operation. You need to be protected. The best way for you to be protected is to get the vaccination.”
As of December 2021, according to the National Guard Bureau, the National Guard as a whole was 66% fully vaccinated. The percentages vary according to service; for instance, nearly 90% of airmen have been vaccinated, compared with only 40% of Army Guardsmen. Among the states challenging the mandate, the vaccinated rates have been moving upward: In Alaska, about 92% of the Air National Guard have been vaccinated—leaving roughly 11,000 troops who had not met the December 2 deadline. In Iowa, as of Nov. 30, 91% of Air National Guard and 80% of Army National Guard members had been vaccinated, but about 9,000 soldiers had been directed to get the vaccination or risk disciplinary action. Almost 2,200 of the more than 2,800-strong Wyoming National Guard (77%) have received at least 1 dose. Nebraska Air National Guard’s force of 1,000 was 94% fully vaccinated as of December 1. (Maj Scott Ingalsbe, public affairs officer, said, “Vaccinations are tied to individual medical readiness. They provide service members with the best protection available so they can perform missions across the globe.”).
In most states, Army National Guard members have until June 30, 2022, to comply. “Our soldiers …have until [the DoD’s deadline], and some of them are just going to wait close to the deadline,” John Goheen of the National Guard Association of the United States said in a discussion on NPR. “That’s human nature.”
Earlier this month, Texas Governor Greg Abbott told National Guard members they can ignore the Pentagon’s COVID-19 vaccine mandate: “President Biden is not your commander-in-chief.” He has also sued the Biden administration over the requirement.
In the meantime, the hospitals at breaking point must hope for the best and take as much help as they can get.
In early January, Ohio not only set a state record for COVID-19 hospitalizations—it had the fourth highest rate in the country, with 6,747 hospitalized coronavirus patients on January 10, a 40% increase over the previous 21 days. Most were unvaccinated. To help overwhelmed hospitals cope, Ohio Gov. Mike DeWine turned to the National Guard. Unfortunately, nearly half of the Ohio National Guard also were unvaccinated.
By US Department of Defense (DoD) directive, National Guard members must have a COVID-19 vaccination to be deployed on hospital missions. Thus, in COVID hotspots across the nation, governors are on the horns of a dilemma. They want and need to deploy the National Guard to give medical and nonclinical support but aren’t sure whether they will be able to or, indeed, whether they should.
So far, vaccinated teams are already on the ground in a number of states. In Indiana, where hospitalizations jumped 50% over 2 weeks in December, the National Guard sent 6-person teams, all fully vaccinated. In New Hampshire, 70 guards are being deployed to help hospitals with food service, clerical work, and other nonmedical functions. New York Governor Kathy Hochul has deployed guard members for help to ease the strain on nursing homes. Massachusetts Governor Charlie Baker has activated up to 500 guard members; some will be supporting 55 acute care hospital and 12 ambulance services. In Maine, where cases have peaked, Governor Janet Mills activated guard members to support nursing facilities and administer monoclonal antibodies. The Louisiana National Guard has administered more than 542,000 COVID-19 tests and 206,300 vaccines. As many as 1,000 Maryland Air and Army National Guardsmen are being activated to help with testing and other missions.
However, as in Ohio, other states are facing problematic scenarios. For instance, about 40% of the more than 20,000 Texas National Guard are refusing to get vaccinated, challenging the Biden Administration vaccine requirement for all military.
And a court showdown over federal vaccine mandates, started by Governor Kevin Stitt of Oklahoma and joined by the Republican governors of Wyoming, Iowa, Alaska, Nebraska, and Mississippi, came to a head in December. Last November, Stitt asked Defense Secretary Lloyd Austin to exempt Oklahoma’s National Guard from the vaccine mandate. He claimed the requirement violated the personal freedoms of many Oklahomans and could cause them to “potentially sacrifice their personal beliefs.” But in a memo to the Joint Chiefs chairmen, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds could not be used to pay for duties performed under Title 32 for members of the Guard who do not comply with the military’s vaccine requirement. (Title 32 refers to Guard operations under state orders.) Austin also said National Guard members must be vaccinated to participate in drills, training, and other duty conducted under Title 32.
Stitt, maintaining that he is commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders, put out his own memo stipulating that no Guard member was required to get vaccinated. He also ordered Brig. Gen. Thomas Mancino, newly appointed commander of the Oklahoma National Guard, to not enforce the mandate. Subsequently, Mancino issued a statement pointing out that current state law is limited in protecting troops who opt out of the shot. Moreover, if the Guard were called up under federal orders, he said, he would enforce the mandate. Training events, schools, and mobilizations were going to “eventually force you out of that safe harbor,” he wrote, “…This is reality.”
In late December, a federal judge denied Oklahoma’s motion to enjoin the mandate. The Oklahoma Attorney General’s office responded, “We will not be surprised if the President’s vaccine mandate actually reduces the nation’s military readiness instead of promoting it.”
In a press briefing, Pentagon press secretary John Kirby said, “The Secretary has the authorities he needs to require this vaccine across the force, including the National Guard. …[E]ven when they’re in a Title 32 status.” He added, “It is a lawful order for National Guardsmen to receive the COVID vaccine. It’s a lawful order, and refusing to do that, absent of an improved exemption, puts them in the same potential [position] as active-duty members who refuse the vaccine.” That could mean, for instance, loss of pay and membership in the National Guard.
A core rationale for the mandate, according to Secretary Austin, is the need for military readiness—meaning Guard members must be healthy and fit for duty. And that extends to being healthy and fit for missions like transporting at-risk patients. Ohio National Guard Adjutant General Major General John Harris Jr. said, “I would never put a soldier or airman in harm’s way without the best protection we could put on them—body armor, helmets. And this medical readiness is the exact same thing. We’re putting folks into harm’s way.” He has moved the deadline from the Pentagon’s June 30 date to March 31—a move that boosted the vaccination rate from 53% to 56% in one week.
Ohio Governor DeWine has expressed frustration that almost half of the Ohio Army National Guard personnel can’t be deployed on this mission because they’re unvaccinated. “In some of our testing places, 40 to 50% of the people are testing positive,” he said. “So this is a high-risk operation. You need to be protected. The best way for you to be protected is to get the vaccination.”
As of December 2021, according to the National Guard Bureau, the National Guard as a whole was 66% fully vaccinated. The percentages vary according to service; for instance, nearly 90% of airmen have been vaccinated, compared with only 40% of Army Guardsmen. Among the states challenging the mandate, the vaccinated rates have been moving upward: In Alaska, about 92% of the Air National Guard have been vaccinated—leaving roughly 11,000 troops who had not met the December 2 deadline. In Iowa, as of Nov. 30, 91% of Air National Guard and 80% of Army National Guard members had been vaccinated, but about 9,000 soldiers had been directed to get the vaccination or risk disciplinary action. Almost 2,200 of the more than 2,800-strong Wyoming National Guard (77%) have received at least 1 dose. Nebraska Air National Guard’s force of 1,000 was 94% fully vaccinated as of December 1. (Maj Scott Ingalsbe, public affairs officer, said, “Vaccinations are tied to individual medical readiness. They provide service members with the best protection available so they can perform missions across the globe.”).
In most states, Army National Guard members have until June 30, 2022, to comply. “Our soldiers …have until [the DoD’s deadline], and some of them are just going to wait close to the deadline,” John Goheen of the National Guard Association of the United States said in a discussion on NPR. “That’s human nature.”
Earlier this month, Texas Governor Greg Abbott told National Guard members they can ignore the Pentagon’s COVID-19 vaccine mandate: “President Biden is not your commander-in-chief.” He has also sued the Biden administration over the requirement.
In the meantime, the hospitals at breaking point must hope for the best and take as much help as they can get.
What if the National Guard Can’t Help?
What if the National Guard Can’t Help?