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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
MRI-Invisible Prostate Lesions: Are They Dangerous?
MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.
But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.
MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.
Some experts believe these MRI-invisible lesions are nothing to worry about.
If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.
Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”
Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.
But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.
Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.
MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.
In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.
Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.
When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.
“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.
The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.
But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”
The genomic profiles of MRI-visible and -invisible cancers bear this out.
According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.
In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.
“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.
Next Steps After Negative MRI Result
What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?
The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.
Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.
The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.
Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.
These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.
Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.
Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.”
According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.
Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.
A version of this article appeared on Medscape.com.
MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.
But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.
MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.
Some experts believe these MRI-invisible lesions are nothing to worry about.
If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.
Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”
Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.
But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.
Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.
MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.
In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.
Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.
When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.
“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.
The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.
But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”
The genomic profiles of MRI-visible and -invisible cancers bear this out.
According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.
In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.
“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.
Next Steps After Negative MRI Result
What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?
The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.
Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.
The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.
Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.
These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.
Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.
Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.”
According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.
Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.
A version of this article appeared on Medscape.com.
MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.
But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.
MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.
Some experts believe these MRI-invisible lesions are nothing to worry about.
If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.
Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”
Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.
But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.
Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.
MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.
In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.
Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.
When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.
“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.
The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.
But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”
The genomic profiles of MRI-visible and -invisible cancers bear this out.
According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.
In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.
“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.
Next Steps After Negative MRI Result
What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?
The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.
Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.
The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.
Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.
These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.
Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.
Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.”
According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.
Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.
A version of this article appeared on Medscape.com.
Cellular Therapies for Solid Tumors: The Next Big Thing?
The cutting edge of treating solid tumors with cell therapies got notably sharper in 2024.
First came the US Food and Drug Administration (FDA) approval in February 2024 of the tumor-infiltrating lymphocyte (TIL) therapy lifileucel in unresectable or metastatic melanoma that had progressed on prior immunotherapy, the first cellular therapy for any solid tumor. Then came the August FDA approval of afamitresgene autoleucel in unresectable or metastatic synovial sarcoma with failed chemotherapy, the first engineered T-cell therapy for cancers in soft tissue.
“This was a pipe dream just a decade ago,” Alison Betof Warner, MD, PhD, lead author of a lifileucel study (NCT05640193), said in an interview with Medscape Medical News. “At the start of 2024, we had no approvals of these kinds of products in solid cancers. Now we have two.”
As the director of Solid Tumor Cell Therapy and leader of Stanford Medicine’s Melanoma and Cutaneous Oncology Clinical Research Group, Betof Warner has been at the forefront of developing commercial cell therapy using tumor-infiltrating lymphocytes (TILs).
“The approval of lifileucel increases confidence that we can get these therapies across the regulatory finish line and to patients,” Betof Warner said during the interview. She was not involved in the development of afamitresgene autoleucel.
‘Reverse Engineering’
In addition to her contributions to the work that led to lifileucel’s approval, Betof Warner was the lead author on the first consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy.
Betof Warner began studying TILs after doing research with her mentors in immuno-oncology, Jedd D. Wolchok and Michael A. Postow. Their investigations — including one that Betof Warner coauthored — into how monoclonal antibodies and checkpoint inhibitors, such as ipilimumab or nivolumab, might extend the lives of people with advanced unresectable or metastatic melanoma inspired her to push further to find ways to minimize treatment while maximizing outcomes for patients. Betof Warner’s interest overall, she said in the interview, is in capitalizing on what can be learned about how the immune system controls cancer.
“What we know is that the immune system has the ability to kill cancer,” Betof Warner said. “Therefore we need to be thinking about how we can increase immune surveillance. How can we enhance that before a patient develops advanced cancer?
Betof Warner said that although TILs are now standard treatment in melanoma, there is about a 30% response rate compared with about a 50% response rate in immunotherapy, and the latter is easier for the patient to withstand.
“Antibodies on the frontline are better than going through a surgery and then waiting weeks to get your therapy,” Betof Warner said in the interview. “You can come into my clinic and get an antibody therapy in 30 minutes and go straight to work. TILs require patients to be in the hospital for weeks at a time and out of work for months at a time.”
In an effort to combine therapies to maximize best outcomes, a phase 3 trial (NCT05727904) is currently recruiting. The TILVANCE-301 trial will compare immunotherapy plus adoptive cell therapy vs immunotherapy alone in untreated unresectable or metastatic melanoma. Betof Warner is not a part of this study.
Cell Therapies Include CAR T Cells and TCRT
In general, adoptive T-cell therapies such as TILs involve the isolation of autologous immune cells that are removed from the body and either expanded or modified to optimize their efficacy in fighting antigens, before their transfer to the patient as a living drug by infusion.
In addition to TILs, adoptive cell therapies for antitumor therapeutics include chimeric antigen receptor (CAR) T cells and engineered T-cell receptor therapy (TCRT).
In CAR T-cell therapy and TCRT, naive T cells are harvested from the patient’s blood then engineered to target a tumor. In TIL therapy, tumor-specific T cells are taken from the patient’s tumor. Once extracted, the respective cells are expanded billions of times and then delivered back to the patient’s body, said Betof Warner.
“The main promise of this approach is to generate responses in what we know as ‘cold’ tumors, or tumors that do not have a lot of endogenous T-cell infiltration or where the T cells are not working well, to bring in tumor targeting T cells and then trigger an immune response,” Betof Warner told an audience at the American Society of Clinical Oncology (ASCO) 2024 annual meeting.
TIL patients also receive interleukin (IL)-2 infusions to further stimulate the cells. In patients being treated with TCRT, they either receive low or no IL-2, Betof Warner said in her ASCO presentation, “Adopting Cutting-Edge Cell Therapies in Melanoma,” part of the session Beyond the Tip of the Iceberg: Next-Generation Cell-Based Therapies.
Decades in the Making
The National Cancer Institute began investigating TILs in the late 1980s, with the current National Cancer Institute (NCI) surgery chief, Steven Rosenberg, MD, PhD, leading the first-ever trials that showed TILs could shrink tumors in people with advanced melanoma.
Since then, NCI staff and others have also investigated TILs beyond melanoma and additional cell therapies based on CAR T cells and TCRT for antitumor therapeutics.
“TCRs are different from CAR Ts because they go after intracellular antigens instead of extracellular antigens,” said Betof Warner. “That has appeal because many of the tumor antigens we’re looking for will be intracellular.”
Because CAR T cells only target extracellular antigens, their utility is somewhat limited. Although several CAR T-cell therapies exist for blood cancers, there currently are no approved CAR T-cell therapies for solid tumors. However, several trials of CAR T cells in gastrointestinal cancers and melanoma are ongoing, said Betof Warner, who is not a part of these studies.
“We are starting to see early-phase efficacy in pediatric gliomas,” Betof Warner said, mentioning a study conducted by colleagues at Stanford who demonstrated potential for anti-GD2 CAR T-cell therapy in deadly pediatric diffuse midline gliomas, tumors on the spine and brain.
In their study, nine out of 11 participants (median age, 15 years) showed benefit from the cell therapy, with one participant’s tumors resolving completely. The results paved the way for the FDA to grant a Regenerative Medicine Advanced Therapy designation for use of anti-GD2 CAR T cells in H3K27M-positive diffuse midline gliomas.
The investigators are now recruiting for a phase 1 trial (NCT04196413). Results of the initial study were published in Nature last month.
Another lesser-known cell therapy expected to advance at some point in the future for solid tumors is use of the body’s natural killer (NK) cells. “They’ve been known about for a long time, but they are more difficult to regulate, which is one reason why it has taken longer to make NK cell therapies,” said Betof Warner, who is not involved in the study of NK cells. “One of their advantages is that, potentially, there could be an ‘off the shelf’ NK product. They don’t necessarily have to be made with autologous cells.”
Risk-Benefit Profiles Depend on Mechanism of Action
If the corresponding TCR sequence of a tumor antigen is known, said Betof Warner, it is possible to use leukapheresis to generate naive circulating lymphocytes. Once infused, the manufactured TCRTs will activate in the body the same as native cells because the signaling is the same.
An advantage to TCRT compared with CAR T-cell therapy is that it targets intracellular proteins, which are significantly present in the tumor, Betof Warner said in her presentation at ASCO 2024. She clarified that tumors will usually be screened for the presence of this antigen before a patient is selected for treatment with that particular therapy, because not all antigens are highly expressed in every tumor.
“Furthermore, the tumor antigen has to be presented by a major histocompatibility complex, meaning there are human leukocyte antigen restrictions, which impacts patient selection,” she said.
A risk with both TCRT and CAR T-cell therapy, according to Betof Warner, is that because there are often shared antigens between tumor and normal tissues, on-target/off-tumor toxicity is a risk.
“TILs are different because they are nonengineered, at least not for antigen recognition. They are polyclonal and go after multiple targets,” Betof Warner said. “TCRs and CARs are engineered to go after one target. So, TILs have much lower rates of on-tumor/off-target effects, vs when you engineer a very high affinity receptor like a TCR or CAR.”
A good example of how this amplification of TCR affinity can lead to poor outcomes is in metastatic melanoma, said Betof Warner.
In investigations (NCI-07-C-0174 and NCI-07-C-0175) of TCRT in metastatic melanoma, for example, the researchers were targeting MART-1 or gp100, which are expressed in melanocytes.
“The problem was that these antigens are also expressed in the eyes and ears, so it caused eye inflammation and hearing loss in a number of patients because it wasn’t specific enough for the tumor,” said Betof Warner. “So, if that target is highly expressed on normal tissue, then you have a high risk.”
Promise of PRAME
Betof Warner said the most promising TCRT at present is the investigational autologous cell therapy IMA203 (NCT03688124), which targets the preferentially expressed antigen (PRAME). Although PRAME is found in many tumors, this testis antigen does not tend to express in normal, healthy adult tissues. Betof Warner is not affiliated with this study.
“It’s maybe the most exciting TCRT cell in melanoma,” Betof Warner told her audience at the ASCO 2024 meeting. Because the expression rate of PRAME in cutaneous and uveal melanoma is at or above 95% and 90%, respectively, she said “it is a really good target in melanoma.”
Phase 1a results reported in late 2023 from a first-in-human trial of IMA203 involving 13 persons with highly advanced melanoma and a median of 5.5 previous treatments showed a 50% objective response rate in the 12 evaluable results. The duration of response ranged between 2.2 and 14.7 months (median follow-up, 14 months).
The safety profile of the treatment was favorable, with no grade 3 adverse events occurring in more than 10% of the cohort, and no grade 5 adverse events at all.
Phase 1b results published in October by maker Immatics showed that in 28 heavily pretreated metastatic melanoma patients, IMA203 had a confirmed objective response rate of 54% with a median duration of response of 12.1 months, while maintaining a favorable tolerability profile.
Accelerated Approvals, Boxed Warnings
The FDA granted accelerated approvals for both lifileucel, the TIL therapy, and afamitresgene autoleucel, the TCRT.
Both were approved with boxed warnings. Lifileucel’s warning is for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment. Afamitresgene autoleucel’s boxed warning is for serious or fatal cytokine release syndrome, which may be severe or life-threatening.
With these approvals, the bar is now raised on TILs and TCRTs, said Betof Warner.
The lifileucel trial studied 73 patients whose melanoma had continued to metastasize despite treatment with a programmed cell death protein (PD-1)/ programmed death-ligand (PD-L1)–targeted immune checkpoint inhibitor and a BRAF inhibitor (if appropriate based on tumor mutation status), and whose lifileucel dose was at least 7.5 billion cells (the approved dose). The cohort also received a median of six IL-2 (aldesleukin) doses.
The objective response rate was 31.5% (95% CI, 21.1-43.4), and median duration of response was not reached (lower bound of 95% CI, 4.1).
In the afamitresgene autoleucel study, 44 of 52 patients with synovial sarcoma received leukapheresis and a single infusion of afamitresgene autoleucel.
The overall response rate was 43.2% (95% CI, 28.4-59.0). The median time to response was 4.9 weeks (95% CI, 4.4-8), and the median duration of response was 6 months (lower bound of 95% CI, 4.6). Among patients who were responsive to the treatment, 45.6% and 39.0% had a duration of response of 6 months or longer and 12 months or longer, respectively.
New Hope for Patients
Betof Warner and her colleagues are now recruiting for an open-label, phase 1/2 investigation of the safety and efficacy of the TIL therapy OBX-115 in adult advanced solid tumors in melanoma or non–small cell lung cancer. The first-in-human results of a previous trial were presented at the ASCO 2024 meeting, and OBX-115 received FDA fast track designation in July.
“I think the results are really promising,” said Betof Warner. “This is an engineered TIL that does not require administering IL-2 to the patient. There were four out of the nine patients who responded to the treatment and there were no dose-limiting toxicities, no cytokine and no intracranial — all of which is excellent.”
For Betof Warner, the possibility that by using their own immune system, patients with advanced and refractory cancers could soon have a one-time treatment with a cell therapy rather than innumerable bouts of chemotherapy pushes her onward.
“The idea that we can treat cancer one time and have it not recur for years — that’s pushing the start of saying there’s a cure of cancer. That a person could move on from cancer like they move on from an infection. That is the potential of this work. We’re not there yet, but that’s where we need to think and dream big,” she said.
Betof Warner disclosed consulting/advisory roles with BluePath Solutions, Bristol-Myers Squibb/Medarex, Immatics, Instil Bio, Iovance Biotherapeutics, Lyell Immunopharma, Merck, Novartis, and Pfizer and research funding and travel expenses from Iovance Biotherapeutics.
A version of this article appeared on Medscape.com.
The cutting edge of treating solid tumors with cell therapies got notably sharper in 2024.
First came the US Food and Drug Administration (FDA) approval in February 2024 of the tumor-infiltrating lymphocyte (TIL) therapy lifileucel in unresectable or metastatic melanoma that had progressed on prior immunotherapy, the first cellular therapy for any solid tumor. Then came the August FDA approval of afamitresgene autoleucel in unresectable or metastatic synovial sarcoma with failed chemotherapy, the first engineered T-cell therapy for cancers in soft tissue.
“This was a pipe dream just a decade ago,” Alison Betof Warner, MD, PhD, lead author of a lifileucel study (NCT05640193), said in an interview with Medscape Medical News. “At the start of 2024, we had no approvals of these kinds of products in solid cancers. Now we have two.”
As the director of Solid Tumor Cell Therapy and leader of Stanford Medicine’s Melanoma and Cutaneous Oncology Clinical Research Group, Betof Warner has been at the forefront of developing commercial cell therapy using tumor-infiltrating lymphocytes (TILs).
“The approval of lifileucel increases confidence that we can get these therapies across the regulatory finish line and to patients,” Betof Warner said during the interview. She was not involved in the development of afamitresgene autoleucel.
‘Reverse Engineering’
In addition to her contributions to the work that led to lifileucel’s approval, Betof Warner was the lead author on the first consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy.
Betof Warner began studying TILs after doing research with her mentors in immuno-oncology, Jedd D. Wolchok and Michael A. Postow. Their investigations — including one that Betof Warner coauthored — into how monoclonal antibodies and checkpoint inhibitors, such as ipilimumab or nivolumab, might extend the lives of people with advanced unresectable or metastatic melanoma inspired her to push further to find ways to minimize treatment while maximizing outcomes for patients. Betof Warner’s interest overall, she said in the interview, is in capitalizing on what can be learned about how the immune system controls cancer.
“What we know is that the immune system has the ability to kill cancer,” Betof Warner said. “Therefore we need to be thinking about how we can increase immune surveillance. How can we enhance that before a patient develops advanced cancer?
Betof Warner said that although TILs are now standard treatment in melanoma, there is about a 30% response rate compared with about a 50% response rate in immunotherapy, and the latter is easier for the patient to withstand.
“Antibodies on the frontline are better than going through a surgery and then waiting weeks to get your therapy,” Betof Warner said in the interview. “You can come into my clinic and get an antibody therapy in 30 minutes and go straight to work. TILs require patients to be in the hospital for weeks at a time and out of work for months at a time.”
In an effort to combine therapies to maximize best outcomes, a phase 3 trial (NCT05727904) is currently recruiting. The TILVANCE-301 trial will compare immunotherapy plus adoptive cell therapy vs immunotherapy alone in untreated unresectable or metastatic melanoma. Betof Warner is not a part of this study.
Cell Therapies Include CAR T Cells and TCRT
In general, adoptive T-cell therapies such as TILs involve the isolation of autologous immune cells that are removed from the body and either expanded or modified to optimize their efficacy in fighting antigens, before their transfer to the patient as a living drug by infusion.
In addition to TILs, adoptive cell therapies for antitumor therapeutics include chimeric antigen receptor (CAR) T cells and engineered T-cell receptor therapy (TCRT).
In CAR T-cell therapy and TCRT, naive T cells are harvested from the patient’s blood then engineered to target a tumor. In TIL therapy, tumor-specific T cells are taken from the patient’s tumor. Once extracted, the respective cells are expanded billions of times and then delivered back to the patient’s body, said Betof Warner.
“The main promise of this approach is to generate responses in what we know as ‘cold’ tumors, or tumors that do not have a lot of endogenous T-cell infiltration or where the T cells are not working well, to bring in tumor targeting T cells and then trigger an immune response,” Betof Warner told an audience at the American Society of Clinical Oncology (ASCO) 2024 annual meeting.
TIL patients also receive interleukin (IL)-2 infusions to further stimulate the cells. In patients being treated with TCRT, they either receive low or no IL-2, Betof Warner said in her ASCO presentation, “Adopting Cutting-Edge Cell Therapies in Melanoma,” part of the session Beyond the Tip of the Iceberg: Next-Generation Cell-Based Therapies.
Decades in the Making
The National Cancer Institute began investigating TILs in the late 1980s, with the current National Cancer Institute (NCI) surgery chief, Steven Rosenberg, MD, PhD, leading the first-ever trials that showed TILs could shrink tumors in people with advanced melanoma.
Since then, NCI staff and others have also investigated TILs beyond melanoma and additional cell therapies based on CAR T cells and TCRT for antitumor therapeutics.
“TCRs are different from CAR Ts because they go after intracellular antigens instead of extracellular antigens,” said Betof Warner. “That has appeal because many of the tumor antigens we’re looking for will be intracellular.”
Because CAR T cells only target extracellular antigens, their utility is somewhat limited. Although several CAR T-cell therapies exist for blood cancers, there currently are no approved CAR T-cell therapies for solid tumors. However, several trials of CAR T cells in gastrointestinal cancers and melanoma are ongoing, said Betof Warner, who is not a part of these studies.
“We are starting to see early-phase efficacy in pediatric gliomas,” Betof Warner said, mentioning a study conducted by colleagues at Stanford who demonstrated potential for anti-GD2 CAR T-cell therapy in deadly pediatric diffuse midline gliomas, tumors on the spine and brain.
In their study, nine out of 11 participants (median age, 15 years) showed benefit from the cell therapy, with one participant’s tumors resolving completely. The results paved the way for the FDA to grant a Regenerative Medicine Advanced Therapy designation for use of anti-GD2 CAR T cells in H3K27M-positive diffuse midline gliomas.
The investigators are now recruiting for a phase 1 trial (NCT04196413). Results of the initial study were published in Nature last month.
Another lesser-known cell therapy expected to advance at some point in the future for solid tumors is use of the body’s natural killer (NK) cells. “They’ve been known about for a long time, but they are more difficult to regulate, which is one reason why it has taken longer to make NK cell therapies,” said Betof Warner, who is not involved in the study of NK cells. “One of their advantages is that, potentially, there could be an ‘off the shelf’ NK product. They don’t necessarily have to be made with autologous cells.”
Risk-Benefit Profiles Depend on Mechanism of Action
If the corresponding TCR sequence of a tumor antigen is known, said Betof Warner, it is possible to use leukapheresis to generate naive circulating lymphocytes. Once infused, the manufactured TCRTs will activate in the body the same as native cells because the signaling is the same.
An advantage to TCRT compared with CAR T-cell therapy is that it targets intracellular proteins, which are significantly present in the tumor, Betof Warner said in her presentation at ASCO 2024. She clarified that tumors will usually be screened for the presence of this antigen before a patient is selected for treatment with that particular therapy, because not all antigens are highly expressed in every tumor.
“Furthermore, the tumor antigen has to be presented by a major histocompatibility complex, meaning there are human leukocyte antigen restrictions, which impacts patient selection,” she said.
A risk with both TCRT and CAR T-cell therapy, according to Betof Warner, is that because there are often shared antigens between tumor and normal tissues, on-target/off-tumor toxicity is a risk.
“TILs are different because they are nonengineered, at least not for antigen recognition. They are polyclonal and go after multiple targets,” Betof Warner said. “TCRs and CARs are engineered to go after one target. So, TILs have much lower rates of on-tumor/off-target effects, vs when you engineer a very high affinity receptor like a TCR or CAR.”
A good example of how this amplification of TCR affinity can lead to poor outcomes is in metastatic melanoma, said Betof Warner.
In investigations (NCI-07-C-0174 and NCI-07-C-0175) of TCRT in metastatic melanoma, for example, the researchers were targeting MART-1 or gp100, which are expressed in melanocytes.
“The problem was that these antigens are also expressed in the eyes and ears, so it caused eye inflammation and hearing loss in a number of patients because it wasn’t specific enough for the tumor,” said Betof Warner. “So, if that target is highly expressed on normal tissue, then you have a high risk.”
Promise of PRAME
Betof Warner said the most promising TCRT at present is the investigational autologous cell therapy IMA203 (NCT03688124), which targets the preferentially expressed antigen (PRAME). Although PRAME is found in many tumors, this testis antigen does not tend to express in normal, healthy adult tissues. Betof Warner is not affiliated with this study.
“It’s maybe the most exciting TCRT cell in melanoma,” Betof Warner told her audience at the ASCO 2024 meeting. Because the expression rate of PRAME in cutaneous and uveal melanoma is at or above 95% and 90%, respectively, she said “it is a really good target in melanoma.”
Phase 1a results reported in late 2023 from a first-in-human trial of IMA203 involving 13 persons with highly advanced melanoma and a median of 5.5 previous treatments showed a 50% objective response rate in the 12 evaluable results. The duration of response ranged between 2.2 and 14.7 months (median follow-up, 14 months).
The safety profile of the treatment was favorable, with no grade 3 adverse events occurring in more than 10% of the cohort, and no grade 5 adverse events at all.
Phase 1b results published in October by maker Immatics showed that in 28 heavily pretreated metastatic melanoma patients, IMA203 had a confirmed objective response rate of 54% with a median duration of response of 12.1 months, while maintaining a favorable tolerability profile.
Accelerated Approvals, Boxed Warnings
The FDA granted accelerated approvals for both lifileucel, the TIL therapy, and afamitresgene autoleucel, the TCRT.
Both were approved with boxed warnings. Lifileucel’s warning is for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment. Afamitresgene autoleucel’s boxed warning is for serious or fatal cytokine release syndrome, which may be severe or life-threatening.
With these approvals, the bar is now raised on TILs and TCRTs, said Betof Warner.
The lifileucel trial studied 73 patients whose melanoma had continued to metastasize despite treatment with a programmed cell death protein (PD-1)/ programmed death-ligand (PD-L1)–targeted immune checkpoint inhibitor and a BRAF inhibitor (if appropriate based on tumor mutation status), and whose lifileucel dose was at least 7.5 billion cells (the approved dose). The cohort also received a median of six IL-2 (aldesleukin) doses.
The objective response rate was 31.5% (95% CI, 21.1-43.4), and median duration of response was not reached (lower bound of 95% CI, 4.1).
In the afamitresgene autoleucel study, 44 of 52 patients with synovial sarcoma received leukapheresis and a single infusion of afamitresgene autoleucel.
The overall response rate was 43.2% (95% CI, 28.4-59.0). The median time to response was 4.9 weeks (95% CI, 4.4-8), and the median duration of response was 6 months (lower bound of 95% CI, 4.6). Among patients who were responsive to the treatment, 45.6% and 39.0% had a duration of response of 6 months or longer and 12 months or longer, respectively.
New Hope for Patients
Betof Warner and her colleagues are now recruiting for an open-label, phase 1/2 investigation of the safety and efficacy of the TIL therapy OBX-115 in adult advanced solid tumors in melanoma or non–small cell lung cancer. The first-in-human results of a previous trial were presented at the ASCO 2024 meeting, and OBX-115 received FDA fast track designation in July.
“I think the results are really promising,” said Betof Warner. “This is an engineered TIL that does not require administering IL-2 to the patient. There were four out of the nine patients who responded to the treatment and there were no dose-limiting toxicities, no cytokine and no intracranial — all of which is excellent.”
For Betof Warner, the possibility that by using their own immune system, patients with advanced and refractory cancers could soon have a one-time treatment with a cell therapy rather than innumerable bouts of chemotherapy pushes her onward.
“The idea that we can treat cancer one time and have it not recur for years — that’s pushing the start of saying there’s a cure of cancer. That a person could move on from cancer like they move on from an infection. That is the potential of this work. We’re not there yet, but that’s where we need to think and dream big,” she said.
Betof Warner disclosed consulting/advisory roles with BluePath Solutions, Bristol-Myers Squibb/Medarex, Immatics, Instil Bio, Iovance Biotherapeutics, Lyell Immunopharma, Merck, Novartis, and Pfizer and research funding and travel expenses from Iovance Biotherapeutics.
A version of this article appeared on Medscape.com.
The cutting edge of treating solid tumors with cell therapies got notably sharper in 2024.
First came the US Food and Drug Administration (FDA) approval in February 2024 of the tumor-infiltrating lymphocyte (TIL) therapy lifileucel in unresectable or metastatic melanoma that had progressed on prior immunotherapy, the first cellular therapy for any solid tumor. Then came the August FDA approval of afamitresgene autoleucel in unresectable or metastatic synovial sarcoma with failed chemotherapy, the first engineered T-cell therapy for cancers in soft tissue.
“This was a pipe dream just a decade ago,” Alison Betof Warner, MD, PhD, lead author of a lifileucel study (NCT05640193), said in an interview with Medscape Medical News. “At the start of 2024, we had no approvals of these kinds of products in solid cancers. Now we have two.”
As the director of Solid Tumor Cell Therapy and leader of Stanford Medicine’s Melanoma and Cutaneous Oncology Clinical Research Group, Betof Warner has been at the forefront of developing commercial cell therapy using tumor-infiltrating lymphocytes (TILs).
“The approval of lifileucel increases confidence that we can get these therapies across the regulatory finish line and to patients,” Betof Warner said during the interview. She was not involved in the development of afamitresgene autoleucel.
‘Reverse Engineering’
In addition to her contributions to the work that led to lifileucel’s approval, Betof Warner was the lead author on the first consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy.
Betof Warner began studying TILs after doing research with her mentors in immuno-oncology, Jedd D. Wolchok and Michael A. Postow. Their investigations — including one that Betof Warner coauthored — into how monoclonal antibodies and checkpoint inhibitors, such as ipilimumab or nivolumab, might extend the lives of people with advanced unresectable or metastatic melanoma inspired her to push further to find ways to minimize treatment while maximizing outcomes for patients. Betof Warner’s interest overall, she said in the interview, is in capitalizing on what can be learned about how the immune system controls cancer.
“What we know is that the immune system has the ability to kill cancer,” Betof Warner said. “Therefore we need to be thinking about how we can increase immune surveillance. How can we enhance that before a patient develops advanced cancer?
Betof Warner said that although TILs are now standard treatment in melanoma, there is about a 30% response rate compared with about a 50% response rate in immunotherapy, and the latter is easier for the patient to withstand.
“Antibodies on the frontline are better than going through a surgery and then waiting weeks to get your therapy,” Betof Warner said in the interview. “You can come into my clinic and get an antibody therapy in 30 minutes and go straight to work. TILs require patients to be in the hospital for weeks at a time and out of work for months at a time.”
In an effort to combine therapies to maximize best outcomes, a phase 3 trial (NCT05727904) is currently recruiting. The TILVANCE-301 trial will compare immunotherapy plus adoptive cell therapy vs immunotherapy alone in untreated unresectable or metastatic melanoma. Betof Warner is not a part of this study.
Cell Therapies Include CAR T Cells and TCRT
In general, adoptive T-cell therapies such as TILs involve the isolation of autologous immune cells that are removed from the body and either expanded or modified to optimize their efficacy in fighting antigens, before their transfer to the patient as a living drug by infusion.
In addition to TILs, adoptive cell therapies for antitumor therapeutics include chimeric antigen receptor (CAR) T cells and engineered T-cell receptor therapy (TCRT).
In CAR T-cell therapy and TCRT, naive T cells are harvested from the patient’s blood then engineered to target a tumor. In TIL therapy, tumor-specific T cells are taken from the patient’s tumor. Once extracted, the respective cells are expanded billions of times and then delivered back to the patient’s body, said Betof Warner.
“The main promise of this approach is to generate responses in what we know as ‘cold’ tumors, or tumors that do not have a lot of endogenous T-cell infiltration or where the T cells are not working well, to bring in tumor targeting T cells and then trigger an immune response,” Betof Warner told an audience at the American Society of Clinical Oncology (ASCO) 2024 annual meeting.
TIL patients also receive interleukin (IL)-2 infusions to further stimulate the cells. In patients being treated with TCRT, they either receive low or no IL-2, Betof Warner said in her ASCO presentation, “Adopting Cutting-Edge Cell Therapies in Melanoma,” part of the session Beyond the Tip of the Iceberg: Next-Generation Cell-Based Therapies.
Decades in the Making
The National Cancer Institute began investigating TILs in the late 1980s, with the current National Cancer Institute (NCI) surgery chief, Steven Rosenberg, MD, PhD, leading the first-ever trials that showed TILs could shrink tumors in people with advanced melanoma.
Since then, NCI staff and others have also investigated TILs beyond melanoma and additional cell therapies based on CAR T cells and TCRT for antitumor therapeutics.
“TCRs are different from CAR Ts because they go after intracellular antigens instead of extracellular antigens,” said Betof Warner. “That has appeal because many of the tumor antigens we’re looking for will be intracellular.”
Because CAR T cells only target extracellular antigens, their utility is somewhat limited. Although several CAR T-cell therapies exist for blood cancers, there currently are no approved CAR T-cell therapies for solid tumors. However, several trials of CAR T cells in gastrointestinal cancers and melanoma are ongoing, said Betof Warner, who is not a part of these studies.
“We are starting to see early-phase efficacy in pediatric gliomas,” Betof Warner said, mentioning a study conducted by colleagues at Stanford who demonstrated potential for anti-GD2 CAR T-cell therapy in deadly pediatric diffuse midline gliomas, tumors on the spine and brain.
In their study, nine out of 11 participants (median age, 15 years) showed benefit from the cell therapy, with one participant’s tumors resolving completely. The results paved the way for the FDA to grant a Regenerative Medicine Advanced Therapy designation for use of anti-GD2 CAR T cells in H3K27M-positive diffuse midline gliomas.
The investigators are now recruiting for a phase 1 trial (NCT04196413). Results of the initial study were published in Nature last month.
Another lesser-known cell therapy expected to advance at some point in the future for solid tumors is use of the body’s natural killer (NK) cells. “They’ve been known about for a long time, but they are more difficult to regulate, which is one reason why it has taken longer to make NK cell therapies,” said Betof Warner, who is not involved in the study of NK cells. “One of their advantages is that, potentially, there could be an ‘off the shelf’ NK product. They don’t necessarily have to be made with autologous cells.”
Risk-Benefit Profiles Depend on Mechanism of Action
If the corresponding TCR sequence of a tumor antigen is known, said Betof Warner, it is possible to use leukapheresis to generate naive circulating lymphocytes. Once infused, the manufactured TCRTs will activate in the body the same as native cells because the signaling is the same.
An advantage to TCRT compared with CAR T-cell therapy is that it targets intracellular proteins, which are significantly present in the tumor, Betof Warner said in her presentation at ASCO 2024. She clarified that tumors will usually be screened for the presence of this antigen before a patient is selected for treatment with that particular therapy, because not all antigens are highly expressed in every tumor.
“Furthermore, the tumor antigen has to be presented by a major histocompatibility complex, meaning there are human leukocyte antigen restrictions, which impacts patient selection,” she said.
A risk with both TCRT and CAR T-cell therapy, according to Betof Warner, is that because there are often shared antigens between tumor and normal tissues, on-target/off-tumor toxicity is a risk.
“TILs are different because they are nonengineered, at least not for antigen recognition. They are polyclonal and go after multiple targets,” Betof Warner said. “TCRs and CARs are engineered to go after one target. So, TILs have much lower rates of on-tumor/off-target effects, vs when you engineer a very high affinity receptor like a TCR or CAR.”
A good example of how this amplification of TCR affinity can lead to poor outcomes is in metastatic melanoma, said Betof Warner.
In investigations (NCI-07-C-0174 and NCI-07-C-0175) of TCRT in metastatic melanoma, for example, the researchers were targeting MART-1 or gp100, which are expressed in melanocytes.
“The problem was that these antigens are also expressed in the eyes and ears, so it caused eye inflammation and hearing loss in a number of patients because it wasn’t specific enough for the tumor,” said Betof Warner. “So, if that target is highly expressed on normal tissue, then you have a high risk.”
Promise of PRAME
Betof Warner said the most promising TCRT at present is the investigational autologous cell therapy IMA203 (NCT03688124), which targets the preferentially expressed antigen (PRAME). Although PRAME is found in many tumors, this testis antigen does not tend to express in normal, healthy adult tissues. Betof Warner is not affiliated with this study.
“It’s maybe the most exciting TCRT cell in melanoma,” Betof Warner told her audience at the ASCO 2024 meeting. Because the expression rate of PRAME in cutaneous and uveal melanoma is at or above 95% and 90%, respectively, she said “it is a really good target in melanoma.”
Phase 1a results reported in late 2023 from a first-in-human trial of IMA203 involving 13 persons with highly advanced melanoma and a median of 5.5 previous treatments showed a 50% objective response rate in the 12 evaluable results. The duration of response ranged between 2.2 and 14.7 months (median follow-up, 14 months).
The safety profile of the treatment was favorable, with no grade 3 adverse events occurring in more than 10% of the cohort, and no grade 5 adverse events at all.
Phase 1b results published in October by maker Immatics showed that in 28 heavily pretreated metastatic melanoma patients, IMA203 had a confirmed objective response rate of 54% with a median duration of response of 12.1 months, while maintaining a favorable tolerability profile.
Accelerated Approvals, Boxed Warnings
The FDA granted accelerated approvals for both lifileucel, the TIL therapy, and afamitresgene autoleucel, the TCRT.
Both were approved with boxed warnings. Lifileucel’s warning is for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment. Afamitresgene autoleucel’s boxed warning is for serious or fatal cytokine release syndrome, which may be severe or life-threatening.
With these approvals, the bar is now raised on TILs and TCRTs, said Betof Warner.
The lifileucel trial studied 73 patients whose melanoma had continued to metastasize despite treatment with a programmed cell death protein (PD-1)/ programmed death-ligand (PD-L1)–targeted immune checkpoint inhibitor and a BRAF inhibitor (if appropriate based on tumor mutation status), and whose lifileucel dose was at least 7.5 billion cells (the approved dose). The cohort also received a median of six IL-2 (aldesleukin) doses.
The objective response rate was 31.5% (95% CI, 21.1-43.4), and median duration of response was not reached (lower bound of 95% CI, 4.1).
In the afamitresgene autoleucel study, 44 of 52 patients with synovial sarcoma received leukapheresis and a single infusion of afamitresgene autoleucel.
The overall response rate was 43.2% (95% CI, 28.4-59.0). The median time to response was 4.9 weeks (95% CI, 4.4-8), and the median duration of response was 6 months (lower bound of 95% CI, 4.6). Among patients who were responsive to the treatment, 45.6% and 39.0% had a duration of response of 6 months or longer and 12 months or longer, respectively.
New Hope for Patients
Betof Warner and her colleagues are now recruiting for an open-label, phase 1/2 investigation of the safety and efficacy of the TIL therapy OBX-115 in adult advanced solid tumors in melanoma or non–small cell lung cancer. The first-in-human results of a previous trial were presented at the ASCO 2024 meeting, and OBX-115 received FDA fast track designation in July.
“I think the results are really promising,” said Betof Warner. “This is an engineered TIL that does not require administering IL-2 to the patient. There were four out of the nine patients who responded to the treatment and there were no dose-limiting toxicities, no cytokine and no intracranial — all of which is excellent.”
For Betof Warner, the possibility that by using their own immune system, patients with advanced and refractory cancers could soon have a one-time treatment with a cell therapy rather than innumerable bouts of chemotherapy pushes her onward.
“The idea that we can treat cancer one time and have it not recur for years — that’s pushing the start of saying there’s a cure of cancer. That a person could move on from cancer like they move on from an infection. That is the potential of this work. We’re not there yet, but that’s where we need to think and dream big,” she said.
Betof Warner disclosed consulting/advisory roles with BluePath Solutions, Bristol-Myers Squibb/Medarex, Immatics, Instil Bio, Iovance Biotherapeutics, Lyell Immunopharma, Merck, Novartis, and Pfizer and research funding and travel expenses from Iovance Biotherapeutics.
A version of this article appeared on Medscape.com.
Obesity Drug Zepbound Approved for Obstructive Sleep Apnea
The Food and Drug Administration (FDA) has approved the obesity treatment tirzepatide (Zepbound, Eli Lilly) for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The new indication is for use in combination with reduced-calorie diet and increased physical activity. The once-weekly injectable is the first-ever drug treatment for OSA.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, MD, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”
Excess weight is a major risk factor for OSA, in which the upper airways become blocked multiple times during sleep and obstruct breathing. The condition causes loud snoring, recurrent awakenings, and daytime sleepiness. It is also associated with cardiovascular disease.
Tirzepatide, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide receptor agonist, was initially approved with brand name Mounjaro in May 2022 for the treatment of type 2 diabetes, and as Zepbound for weight loss in November 2023.
The new OSA approval was based on two phase 3, double-blind randomized controlled trials, SURMOUNT-OSA, in patients with obesity and moderate to severe OSA, conducted at 60 sites in nine countries. Results from both were presented in June 2024 at the annual Scientific Sessions of the American Diabetes Association and were simultaneously published in The New England Journal of Medicine.
The first trial enrolled 469 participants who were unable or unwilling to use PAP therapy, while the second included 234 who had been using PAP for at least 3 months and planned to continue during the trial. In both, the participants randomly received either 10 mg or 15 mg of tirzepatide or placebo once weekly for 52 weeks.
At baseline, 65%-70% of participants had severe OSA, with more than 30 events/h on the apnea-hypopnea index (AHI) and a mean of 51.5 events/h. By 52 weeks, those randomized to tirzepatide had 27-30 fewer events/h, compared with 4-6 fewer events/h for those taking placebo. In addition, significantly more of those on tirzepatide achieved OSA remission or severity reduction to mild.
Those randomized to tirzepatide also averaged up to 20% weight loss, significantly more than with placebo. “The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound,” according to an FDA statement.
Side effects of tirzepatide include nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions (typically fever and rash), burping, hair loss, and gastroesophageal reflux disease.
In an editorial accompanying The New England Journal of Medicine publication of the SURMOUNT-OSA results, Sanjay R. Patel, MD, wrote: “The potential incorporation of tirzepatide into treatment algorithms for obstructive sleep apnea should include consideration of the challenges of adherence to treatment and the imperative to address racial disparities in medical care.”
Patel, who is professor of medicine and epidemiology at the University of Pittsburgh in Pennsylvania, and medical director of the University of Pittsburgh Medical Center’s Comprehensive Sleep Disorders program, pointed out that suboptimal adherence to continuous PAP therapy has been a major limitation, but that adherence to the GLP-1 drug class has also been suboptimal.
“Although adherence to tirzepatide therapy in the SURMOUNT-OSA trial was high, real-world evidence suggests that nearly 50% of patients who begin treatment with a GLP-1 receptor agonist for obesity discontinue therapy within 12 months. Thus, it is likely that any incorporation of tirzepatide into treatment pathways for obstructive sleep apnea will not diminish the importance of long-term strategies to optimize adherence to treatment.”
Moreover, Patel noted, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”
Patel reported consulting for Apnimed, Bayer Pharmaceuticals, Lilly USA, NovaResp Technologies, Philips Respironics, and Powell Mansfield. He is a fiduciary officer of BreathPA.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved the obesity treatment tirzepatide (Zepbound, Eli Lilly) for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The new indication is for use in combination with reduced-calorie diet and increased physical activity. The once-weekly injectable is the first-ever drug treatment for OSA.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, MD, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”
Excess weight is a major risk factor for OSA, in which the upper airways become blocked multiple times during sleep and obstruct breathing. The condition causes loud snoring, recurrent awakenings, and daytime sleepiness. It is also associated with cardiovascular disease.
Tirzepatide, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide receptor agonist, was initially approved with brand name Mounjaro in May 2022 for the treatment of type 2 diabetes, and as Zepbound for weight loss in November 2023.
The new OSA approval was based on two phase 3, double-blind randomized controlled trials, SURMOUNT-OSA, in patients with obesity and moderate to severe OSA, conducted at 60 sites in nine countries. Results from both were presented in June 2024 at the annual Scientific Sessions of the American Diabetes Association and were simultaneously published in The New England Journal of Medicine.
The first trial enrolled 469 participants who were unable or unwilling to use PAP therapy, while the second included 234 who had been using PAP for at least 3 months and planned to continue during the trial. In both, the participants randomly received either 10 mg or 15 mg of tirzepatide or placebo once weekly for 52 weeks.
At baseline, 65%-70% of participants had severe OSA, with more than 30 events/h on the apnea-hypopnea index (AHI) and a mean of 51.5 events/h. By 52 weeks, those randomized to tirzepatide had 27-30 fewer events/h, compared with 4-6 fewer events/h for those taking placebo. In addition, significantly more of those on tirzepatide achieved OSA remission or severity reduction to mild.
Those randomized to tirzepatide also averaged up to 20% weight loss, significantly more than with placebo. “The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound,” according to an FDA statement.
Side effects of tirzepatide include nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions (typically fever and rash), burping, hair loss, and gastroesophageal reflux disease.
In an editorial accompanying The New England Journal of Medicine publication of the SURMOUNT-OSA results, Sanjay R. Patel, MD, wrote: “The potential incorporation of tirzepatide into treatment algorithms for obstructive sleep apnea should include consideration of the challenges of adherence to treatment and the imperative to address racial disparities in medical care.”
Patel, who is professor of medicine and epidemiology at the University of Pittsburgh in Pennsylvania, and medical director of the University of Pittsburgh Medical Center’s Comprehensive Sleep Disorders program, pointed out that suboptimal adherence to continuous PAP therapy has been a major limitation, but that adherence to the GLP-1 drug class has also been suboptimal.
“Although adherence to tirzepatide therapy in the SURMOUNT-OSA trial was high, real-world evidence suggests that nearly 50% of patients who begin treatment with a GLP-1 receptor agonist for obesity discontinue therapy within 12 months. Thus, it is likely that any incorporation of tirzepatide into treatment pathways for obstructive sleep apnea will not diminish the importance of long-term strategies to optimize adherence to treatment.”
Moreover, Patel noted, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”
Patel reported consulting for Apnimed, Bayer Pharmaceuticals, Lilly USA, NovaResp Technologies, Philips Respironics, and Powell Mansfield. He is a fiduciary officer of BreathPA.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved the obesity treatment tirzepatide (Zepbound, Eli Lilly) for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The new indication is for use in combination with reduced-calorie diet and increased physical activity. The once-weekly injectable is the first-ever drug treatment for OSA.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, MD, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”
Excess weight is a major risk factor for OSA, in which the upper airways become blocked multiple times during sleep and obstruct breathing. The condition causes loud snoring, recurrent awakenings, and daytime sleepiness. It is also associated with cardiovascular disease.
Tirzepatide, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide receptor agonist, was initially approved with brand name Mounjaro in May 2022 for the treatment of type 2 diabetes, and as Zepbound for weight loss in November 2023.
The new OSA approval was based on two phase 3, double-blind randomized controlled trials, SURMOUNT-OSA, in patients with obesity and moderate to severe OSA, conducted at 60 sites in nine countries. Results from both were presented in June 2024 at the annual Scientific Sessions of the American Diabetes Association and were simultaneously published in The New England Journal of Medicine.
The first trial enrolled 469 participants who were unable or unwilling to use PAP therapy, while the second included 234 who had been using PAP for at least 3 months and planned to continue during the trial. In both, the participants randomly received either 10 mg or 15 mg of tirzepatide or placebo once weekly for 52 weeks.
At baseline, 65%-70% of participants had severe OSA, with more than 30 events/h on the apnea-hypopnea index (AHI) and a mean of 51.5 events/h. By 52 weeks, those randomized to tirzepatide had 27-30 fewer events/h, compared with 4-6 fewer events/h for those taking placebo. In addition, significantly more of those on tirzepatide achieved OSA remission or severity reduction to mild.
Those randomized to tirzepatide also averaged up to 20% weight loss, significantly more than with placebo. “The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound,” according to an FDA statement.
Side effects of tirzepatide include nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions (typically fever and rash), burping, hair loss, and gastroesophageal reflux disease.
In an editorial accompanying The New England Journal of Medicine publication of the SURMOUNT-OSA results, Sanjay R. Patel, MD, wrote: “The potential incorporation of tirzepatide into treatment algorithms for obstructive sleep apnea should include consideration of the challenges of adherence to treatment and the imperative to address racial disparities in medical care.”
Patel, who is professor of medicine and epidemiology at the University of Pittsburgh in Pennsylvania, and medical director of the University of Pittsburgh Medical Center’s Comprehensive Sleep Disorders program, pointed out that suboptimal adherence to continuous PAP therapy has been a major limitation, but that adherence to the GLP-1 drug class has also been suboptimal.
“Although adherence to tirzepatide therapy in the SURMOUNT-OSA trial was high, real-world evidence suggests that nearly 50% of patients who begin treatment with a GLP-1 receptor agonist for obesity discontinue therapy within 12 months. Thus, it is likely that any incorporation of tirzepatide into treatment pathways for obstructive sleep apnea will not diminish the importance of long-term strategies to optimize adherence to treatment.”
Moreover, Patel noted, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”
Patel reported consulting for Apnimed, Bayer Pharmaceuticals, Lilly USA, NovaResp Technologies, Philips Respironics, and Powell Mansfield. He is a fiduciary officer of BreathPA.
A version of this article first appeared on Medscape.com.
Reality of Night Shifts: How to Stay Sharp and Healthy
Laura Vater remembers sneaking into her home after 12-hour night shifts during medical training while her husband distracted their toddler. The stealthy tag-teaming effort helped her get enough undisturbed sleep before returning to an Indiana University hospital the following night to repeat the pattern.
“He would pretend to take out the trash when I pulled in,” said Vater, MD, now a gastrointestinal oncologist and assistant professor of medicine at IU Health Simon Cancer Center in Indianapolis. “I would sneak in so she [their daughter] wouldn’t see me, and then he would go back in.”
For Vater, prioritizing sleep during the day to combat sleep deprivation common among doctors-in-training on night shifts required enlisting a supportive spouse. It’s just one of the tips she and a few chief residents shared with this news organization for staying sharp and healthy during overnight rotations.
While the pace of patient rounds may slow from the frenetic daytime rush, training as a doctor after the sun goes down can be quite challenging for residents, they told this news organization. From sleep deprivation working while the rest of us slumbers to the after-effects of late-night caffeine, learning to manage night rotations requires a balance of preparation and attention to personal health while caring for others, the residents and adviser said.
Compromised sleep is one of the biggest hurdles residents have to overcome. Sleep loss comes with risks to cardiovascular disease and type 2 diabetes, among other heath conditions, according to Medscape Medical News reports. And night shift workers who sleep 6 or fewer hours a night have at least one sleep disorder.
Sleep deprivation associated with overnight call schedules also can worsen a resident’s mood and motivation while impairing their judgment, leading to medical errors, according to a new study published in JAMA Open Network. The study proposed shorter consecutive night shifts and naps as ways to offset the results of sleep loss, especially for interns or first-year residents.
Residency programs recently have been experimenting with shorter call schedules.
Catching Zzs
Working the night shift demands a disciplined sleep schedule, said Nat deQuillfeldt, MD, a Denver Health chief resident in the University of Colorado’s internal medicine residency program.
“When I was on night admissions, I was very strict about going to sleep at 8 AM and waking at 3 PM every single day. It can be very tempting to try to stay up and spend time with loved ones, but my husband and I both prioritized my physical well-being for those weeks,” said deQuillfeldt, a PGY-4 resident. “It was especially challenging for me because I had to commute about 50 minutes each way and without such a rigid schedule I would have struggled to be on time.”
deQuillfeldt doesn’t have young children at home, a noisy community, or other distractions to interrupt sleep during the day. But it was still difficult for her to sleep while the sun was out. “I used an eye mask and ear plugs but definitely woke up more often than I would at night.”
Blackout curtains may have helped, she added.
“Without adequate sleep, your clinical thinking is not as sharp. When emergencies happen overnight, you’re often the first person to arrive and need to be able to make rapid, accurate assessments and decisions.”
As a chief resident, she chooses never to sleep during night shifts.
“I personally didn’t want to leave my interns alone or make them feel like they were waking me up or bothering me if they needed help, and I also didn’t want to be groggy in case of a rapid response or code blue.”
But napping on night shift is definitely possible, deQuillfeldt said. Between following up on overnight lab results, answering nurses’ questions, and responding to emergencies, she found downtime on night shift to eat and hydrate. She believes others can catch an hour or 2 of shut eye, even if they work in the intensive care unit, or 3-4 hours on rare quiet nights.
Vater suggests residents transitioning from daytime work to night shift prepare by trying to catch an afternoon nap, staying up later the night before the change, and banking sleep hours in advance.
When he knows he’s starting night shifts, Apurva Popat, MD, said he tries to go to sleep an hour or so later nights before to avoid becoming sleep deprived. The chief resident of internal medicine at Marshfield Clinic Health System in Marshfield, Wisconsin, doesn’t recommend sleeping during the night shift.
“I typically try not to sleep, even if I have time, so I can go home and sleep later in the morning,” said Popat, a PGY-3 resident.
To help him snooze, he uses blackout curtains and a fan to block out noise. His wife, a first-year internal medicine intern, often works a different shift, so she helps set up his sleeping environment and he reciprocates when it’s her turn for night shifts.
Some interns may need to catch a 20- to 30-minute nap on the first night shift, he said.
Popat also seeks out brighter areas of the hospital, such as the emergency department, where there are more people and colleagues to keep him alert.
Bypass Vending Machines
Lack of sleep makes it even more difficult to eat healthy on night shift, said Vater, who advises residents about wellness issues at IU and on social media.
“When you are sleep deprived, when you do not get enough sleep, you eat but you don’t feel full,” she said. “It’s hard to eat well on night shift. It’s harder if you go to the break room and there’s candy and junk food.”
Vater said that, as a resident, she brought a lunch bag to the hospital during night shifts. “I never had time to prep food, so I’d bring a whole apple, a whole orange, a whole avocado or nuts. It allowed me to eat more fruits and vegetables than I normally would.”
She advises caution when considering coffee to stay awake, especially after about 9 PM, which could interfere with sleep residents need later when they finish their shifts. Caffeine may help in the moment, but it prevents deep sleep, Vater said. So when residents finally get sleep after their shifts, they may wake up feeling tired, she said.
To avoid sleepiness, Popat brings protein shakes with him to night shifts. They stave off sugar spikes and keep his energy level high, he said. He might have a protein shake and fruit before he leaves home and carry his vegetarian dinner with him to eat in the early morning hours when the hospital is calm.
Eating small and frequent meals also helps ward off sleepiness, deQuillfeldt said.
Take the Stairs
Trying to stay healthy on night shifts, Vater also checked on patients by taking the stairs. “I’d set the timer on my phone for 30 minutes and if I got paged at 15, I’d pause the timer and reset it if I had a moment later. I’d get at least 30 minutes in, although not always continuous. I think some activity is better than none.”
Vater said her hospital had a gym, but it wasn’t practical for her because it was further away from where she worked. “Sometimes my coresidents would be more creative, and we would do squats.”
Popat tries to lift weights 2 hours before his night shift, but he also takes short walks between patients’ rooms in the early morning hours when it’s quietest. He also promotes deep breathing to stay alert.
Ask for a Ride
Vater urges those coming off night shifts, especially those transitioning for the first time from daytime rotations, not to drive if they’re exhausted. “Get an Uber. ... Make sure you get a ride home.”
The CU residency program covers the cost of a ridesharing service when doctors-in-training are too tired to drive home, deQuillfeldt said. “We really try to encourage people to use this to reduce the risk of car accidents.”
Promoting Mental Health
The residency program also links residents with primary care and mental health services. People who really struggle with shift work sleep disorder may qualify for medications to help them stay awake overnight, in addition to sleep hygiene apps and sleep aides.
“Night shifts can put a strain on mental health, especially when you’re only working, eating, and sleeping and not spending any time with family and friends,” deQuillfeldt said. “My husband works late afternoons, so we often would go weeks seeing each other for 15-20 minutes a day.”
“Sleeping when the sun is out often leads to a lack of light exposure which can compound the problem. Seeking mental health support early is really important to avoiding burnout,” she said.
She also recommended planning a fun weekend activity, trip, or celebration with friends or family after night shifts end “so you have something to look forward to…It’s so important to have a light at the end of the tunnel, which will allow you to enjoy the sense of accomplishment even more.”
For more advice on the subject, consider the American Medical Association guide to managing sleep deprivation in residency or Laura Vater’s tips for night shifts.
A version of this article first appeared on Medscape.com.
Laura Vater remembers sneaking into her home after 12-hour night shifts during medical training while her husband distracted their toddler. The stealthy tag-teaming effort helped her get enough undisturbed sleep before returning to an Indiana University hospital the following night to repeat the pattern.
“He would pretend to take out the trash when I pulled in,” said Vater, MD, now a gastrointestinal oncologist and assistant professor of medicine at IU Health Simon Cancer Center in Indianapolis. “I would sneak in so she [their daughter] wouldn’t see me, and then he would go back in.”
For Vater, prioritizing sleep during the day to combat sleep deprivation common among doctors-in-training on night shifts required enlisting a supportive spouse. It’s just one of the tips she and a few chief residents shared with this news organization for staying sharp and healthy during overnight rotations.
While the pace of patient rounds may slow from the frenetic daytime rush, training as a doctor after the sun goes down can be quite challenging for residents, they told this news organization. From sleep deprivation working while the rest of us slumbers to the after-effects of late-night caffeine, learning to manage night rotations requires a balance of preparation and attention to personal health while caring for others, the residents and adviser said.
Compromised sleep is one of the biggest hurdles residents have to overcome. Sleep loss comes with risks to cardiovascular disease and type 2 diabetes, among other heath conditions, according to Medscape Medical News reports. And night shift workers who sleep 6 or fewer hours a night have at least one sleep disorder.
Sleep deprivation associated with overnight call schedules also can worsen a resident’s mood and motivation while impairing their judgment, leading to medical errors, according to a new study published in JAMA Open Network. The study proposed shorter consecutive night shifts and naps as ways to offset the results of sleep loss, especially for interns or first-year residents.
Residency programs recently have been experimenting with shorter call schedules.
Catching Zzs
Working the night shift demands a disciplined sleep schedule, said Nat deQuillfeldt, MD, a Denver Health chief resident in the University of Colorado’s internal medicine residency program.
“When I was on night admissions, I was very strict about going to sleep at 8 AM and waking at 3 PM every single day. It can be very tempting to try to stay up and spend time with loved ones, but my husband and I both prioritized my physical well-being for those weeks,” said deQuillfeldt, a PGY-4 resident. “It was especially challenging for me because I had to commute about 50 minutes each way and without such a rigid schedule I would have struggled to be on time.”
deQuillfeldt doesn’t have young children at home, a noisy community, or other distractions to interrupt sleep during the day. But it was still difficult for her to sleep while the sun was out. “I used an eye mask and ear plugs but definitely woke up more often than I would at night.”
Blackout curtains may have helped, she added.
“Without adequate sleep, your clinical thinking is not as sharp. When emergencies happen overnight, you’re often the first person to arrive and need to be able to make rapid, accurate assessments and decisions.”
As a chief resident, she chooses never to sleep during night shifts.
“I personally didn’t want to leave my interns alone or make them feel like they were waking me up or bothering me if they needed help, and I also didn’t want to be groggy in case of a rapid response or code blue.”
But napping on night shift is definitely possible, deQuillfeldt said. Between following up on overnight lab results, answering nurses’ questions, and responding to emergencies, she found downtime on night shift to eat and hydrate. She believes others can catch an hour or 2 of shut eye, even if they work in the intensive care unit, or 3-4 hours on rare quiet nights.
Vater suggests residents transitioning from daytime work to night shift prepare by trying to catch an afternoon nap, staying up later the night before the change, and banking sleep hours in advance.
When he knows he’s starting night shifts, Apurva Popat, MD, said he tries to go to sleep an hour or so later nights before to avoid becoming sleep deprived. The chief resident of internal medicine at Marshfield Clinic Health System in Marshfield, Wisconsin, doesn’t recommend sleeping during the night shift.
“I typically try not to sleep, even if I have time, so I can go home and sleep later in the morning,” said Popat, a PGY-3 resident.
To help him snooze, he uses blackout curtains and a fan to block out noise. His wife, a first-year internal medicine intern, often works a different shift, so she helps set up his sleeping environment and he reciprocates when it’s her turn for night shifts.
Some interns may need to catch a 20- to 30-minute nap on the first night shift, he said.
Popat also seeks out brighter areas of the hospital, such as the emergency department, where there are more people and colleagues to keep him alert.
Bypass Vending Machines
Lack of sleep makes it even more difficult to eat healthy on night shift, said Vater, who advises residents about wellness issues at IU and on social media.
“When you are sleep deprived, when you do not get enough sleep, you eat but you don’t feel full,” she said. “It’s hard to eat well on night shift. It’s harder if you go to the break room and there’s candy and junk food.”
Vater said that, as a resident, she brought a lunch bag to the hospital during night shifts. “I never had time to prep food, so I’d bring a whole apple, a whole orange, a whole avocado or nuts. It allowed me to eat more fruits and vegetables than I normally would.”
She advises caution when considering coffee to stay awake, especially after about 9 PM, which could interfere with sleep residents need later when they finish their shifts. Caffeine may help in the moment, but it prevents deep sleep, Vater said. So when residents finally get sleep after their shifts, they may wake up feeling tired, she said.
To avoid sleepiness, Popat brings protein shakes with him to night shifts. They stave off sugar spikes and keep his energy level high, he said. He might have a protein shake and fruit before he leaves home and carry his vegetarian dinner with him to eat in the early morning hours when the hospital is calm.
Eating small and frequent meals also helps ward off sleepiness, deQuillfeldt said.
Take the Stairs
Trying to stay healthy on night shifts, Vater also checked on patients by taking the stairs. “I’d set the timer on my phone for 30 minutes and if I got paged at 15, I’d pause the timer and reset it if I had a moment later. I’d get at least 30 minutes in, although not always continuous. I think some activity is better than none.”
Vater said her hospital had a gym, but it wasn’t practical for her because it was further away from where she worked. “Sometimes my coresidents would be more creative, and we would do squats.”
Popat tries to lift weights 2 hours before his night shift, but he also takes short walks between patients’ rooms in the early morning hours when it’s quietest. He also promotes deep breathing to stay alert.
Ask for a Ride
Vater urges those coming off night shifts, especially those transitioning for the first time from daytime rotations, not to drive if they’re exhausted. “Get an Uber. ... Make sure you get a ride home.”
The CU residency program covers the cost of a ridesharing service when doctors-in-training are too tired to drive home, deQuillfeldt said. “We really try to encourage people to use this to reduce the risk of car accidents.”
Promoting Mental Health
The residency program also links residents with primary care and mental health services. People who really struggle with shift work sleep disorder may qualify for medications to help them stay awake overnight, in addition to sleep hygiene apps and sleep aides.
“Night shifts can put a strain on mental health, especially when you’re only working, eating, and sleeping and not spending any time with family and friends,” deQuillfeldt said. “My husband works late afternoons, so we often would go weeks seeing each other for 15-20 minutes a day.”
“Sleeping when the sun is out often leads to a lack of light exposure which can compound the problem. Seeking mental health support early is really important to avoiding burnout,” she said.
She also recommended planning a fun weekend activity, trip, or celebration with friends or family after night shifts end “so you have something to look forward to…It’s so important to have a light at the end of the tunnel, which will allow you to enjoy the sense of accomplishment even more.”
For more advice on the subject, consider the American Medical Association guide to managing sleep deprivation in residency or Laura Vater’s tips for night shifts.
A version of this article first appeared on Medscape.com.
Laura Vater remembers sneaking into her home after 12-hour night shifts during medical training while her husband distracted their toddler. The stealthy tag-teaming effort helped her get enough undisturbed sleep before returning to an Indiana University hospital the following night to repeat the pattern.
“He would pretend to take out the trash when I pulled in,” said Vater, MD, now a gastrointestinal oncologist and assistant professor of medicine at IU Health Simon Cancer Center in Indianapolis. “I would sneak in so she [their daughter] wouldn’t see me, and then he would go back in.”
For Vater, prioritizing sleep during the day to combat sleep deprivation common among doctors-in-training on night shifts required enlisting a supportive spouse. It’s just one of the tips she and a few chief residents shared with this news organization for staying sharp and healthy during overnight rotations.
While the pace of patient rounds may slow from the frenetic daytime rush, training as a doctor after the sun goes down can be quite challenging for residents, they told this news organization. From sleep deprivation working while the rest of us slumbers to the after-effects of late-night caffeine, learning to manage night rotations requires a balance of preparation and attention to personal health while caring for others, the residents and adviser said.
Compromised sleep is one of the biggest hurdles residents have to overcome. Sleep loss comes with risks to cardiovascular disease and type 2 diabetes, among other heath conditions, according to Medscape Medical News reports. And night shift workers who sleep 6 or fewer hours a night have at least one sleep disorder.
Sleep deprivation associated with overnight call schedules also can worsen a resident’s mood and motivation while impairing their judgment, leading to medical errors, according to a new study published in JAMA Open Network. The study proposed shorter consecutive night shifts and naps as ways to offset the results of sleep loss, especially for interns or first-year residents.
Residency programs recently have been experimenting with shorter call schedules.
Catching Zzs
Working the night shift demands a disciplined sleep schedule, said Nat deQuillfeldt, MD, a Denver Health chief resident in the University of Colorado’s internal medicine residency program.
“When I was on night admissions, I was very strict about going to sleep at 8 AM and waking at 3 PM every single day. It can be very tempting to try to stay up and spend time with loved ones, but my husband and I both prioritized my physical well-being for those weeks,” said deQuillfeldt, a PGY-4 resident. “It was especially challenging for me because I had to commute about 50 minutes each way and without such a rigid schedule I would have struggled to be on time.”
deQuillfeldt doesn’t have young children at home, a noisy community, or other distractions to interrupt sleep during the day. But it was still difficult for her to sleep while the sun was out. “I used an eye mask and ear plugs but definitely woke up more often than I would at night.”
Blackout curtains may have helped, she added.
“Without adequate sleep, your clinical thinking is not as sharp. When emergencies happen overnight, you’re often the first person to arrive and need to be able to make rapid, accurate assessments and decisions.”
As a chief resident, she chooses never to sleep during night shifts.
“I personally didn’t want to leave my interns alone or make them feel like they were waking me up or bothering me if they needed help, and I also didn’t want to be groggy in case of a rapid response or code blue.”
But napping on night shift is definitely possible, deQuillfeldt said. Between following up on overnight lab results, answering nurses’ questions, and responding to emergencies, she found downtime on night shift to eat and hydrate. She believes others can catch an hour or 2 of shut eye, even if they work in the intensive care unit, or 3-4 hours on rare quiet nights.
Vater suggests residents transitioning from daytime work to night shift prepare by trying to catch an afternoon nap, staying up later the night before the change, and banking sleep hours in advance.
When he knows he’s starting night shifts, Apurva Popat, MD, said he tries to go to sleep an hour or so later nights before to avoid becoming sleep deprived. The chief resident of internal medicine at Marshfield Clinic Health System in Marshfield, Wisconsin, doesn’t recommend sleeping during the night shift.
“I typically try not to sleep, even if I have time, so I can go home and sleep later in the morning,” said Popat, a PGY-3 resident.
To help him snooze, he uses blackout curtains and a fan to block out noise. His wife, a first-year internal medicine intern, often works a different shift, so she helps set up his sleeping environment and he reciprocates when it’s her turn for night shifts.
Some interns may need to catch a 20- to 30-minute nap on the first night shift, he said.
Popat also seeks out brighter areas of the hospital, such as the emergency department, where there are more people and colleagues to keep him alert.
Bypass Vending Machines
Lack of sleep makes it even more difficult to eat healthy on night shift, said Vater, who advises residents about wellness issues at IU and on social media.
“When you are sleep deprived, when you do not get enough sleep, you eat but you don’t feel full,” she said. “It’s hard to eat well on night shift. It’s harder if you go to the break room and there’s candy and junk food.”
Vater said that, as a resident, she brought a lunch bag to the hospital during night shifts. “I never had time to prep food, so I’d bring a whole apple, a whole orange, a whole avocado or nuts. It allowed me to eat more fruits and vegetables than I normally would.”
She advises caution when considering coffee to stay awake, especially after about 9 PM, which could interfere with sleep residents need later when they finish their shifts. Caffeine may help in the moment, but it prevents deep sleep, Vater said. So when residents finally get sleep after their shifts, they may wake up feeling tired, she said.
To avoid sleepiness, Popat brings protein shakes with him to night shifts. They stave off sugar spikes and keep his energy level high, he said. He might have a protein shake and fruit before he leaves home and carry his vegetarian dinner with him to eat in the early morning hours when the hospital is calm.
Eating small and frequent meals also helps ward off sleepiness, deQuillfeldt said.
Take the Stairs
Trying to stay healthy on night shifts, Vater also checked on patients by taking the stairs. “I’d set the timer on my phone for 30 minutes and if I got paged at 15, I’d pause the timer and reset it if I had a moment later. I’d get at least 30 minutes in, although not always continuous. I think some activity is better than none.”
Vater said her hospital had a gym, but it wasn’t practical for her because it was further away from where she worked. “Sometimes my coresidents would be more creative, and we would do squats.”
Popat tries to lift weights 2 hours before his night shift, but he also takes short walks between patients’ rooms in the early morning hours when it’s quietest. He also promotes deep breathing to stay alert.
Ask for a Ride
Vater urges those coming off night shifts, especially those transitioning for the first time from daytime rotations, not to drive if they’re exhausted. “Get an Uber. ... Make sure you get a ride home.”
The CU residency program covers the cost of a ridesharing service when doctors-in-training are too tired to drive home, deQuillfeldt said. “We really try to encourage people to use this to reduce the risk of car accidents.”
Promoting Mental Health
The residency program also links residents with primary care and mental health services. People who really struggle with shift work sleep disorder may qualify for medications to help them stay awake overnight, in addition to sleep hygiene apps and sleep aides.
“Night shifts can put a strain on mental health, especially when you’re only working, eating, and sleeping and not spending any time with family and friends,” deQuillfeldt said. “My husband works late afternoons, so we often would go weeks seeing each other for 15-20 minutes a day.”
“Sleeping when the sun is out often leads to a lack of light exposure which can compound the problem. Seeking mental health support early is really important to avoiding burnout,” she said.
She also recommended planning a fun weekend activity, trip, or celebration with friends or family after night shifts end “so you have something to look forward to…It’s so important to have a light at the end of the tunnel, which will allow you to enjoy the sense of accomplishment even more.”
For more advice on the subject, consider the American Medical Association guide to managing sleep deprivation in residency or Laura Vater’s tips for night shifts.
A version of this article first appeared on Medscape.com.
How Bird Flu Spread Unchecked, Posing a Pandemic Risk
Keith Poulsen’s jaw dropped when farmers showed him images on their cellphones at the World Dairy Expo in Wisconsin in October. A livestock veterinarian at the University of Wisconsin-Madison, Poulsen had seen sick cows before, with their noses dripping and udders slack.
In 14-hour shifts, dairy workers pumped gallons of electrolyte-rich fluids into ailing cows through metal tubes inserted into the esophagus.
“It was like watching a field hospital on an active battlefront treating hundreds of wounded soldiers,” he said.
Nearly a year into the first outbreak of the bird flu among cattle, the virus shows no sign of slowing. The US government failed to eliminate the virus on dairy farms when it was confined to a handful of states, by quickly identifying infected cows and taking measures to keep their infections from spreading. Now at least 875 herds across 16 states have tested positive.
Experts say they have lost faith in the government’s ability to contain the outbreak.
“We are in a terrible situation and going into a worse situation,” said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. “I don’t know if the bird flu will become a pandemic, but if it does, we are screwed.”
To understand how the bird flu got out of hand, KFF Health News interviewed nearly 70 government officials, farmers and farmworkers, and researchers with expertise in virology, pandemics, veterinary medicine, and more.
Together with emails obtained from local health departments through public records requests, this investigation revealed key problems, including deference to the farm industry, eroded public health budgets, neglect for the safety of agriculture workers, and the sluggish pace of federal interventions.
Case in point: The US Department of Agriculture this month announced a federal order to test milk nationwide. Researchers welcomed the news but said it should have happened months ago — before the virus was so entrenched.
“It’s disheartening to see so many of the same failures that emerged during the COVID-19 crisis reemerge,” said Tom Bollyky, director of the Global Health Program at the Council on Foreign Relations.
Far more bird flu damage is inevitable, but the extent of it will be left to the Trump administration and Mother Nature. Already, the USDA has funneled more than $1.7 billion into tamping down the bird flu on poultry farms since 2022, which includes reimbursing farmers who’ve had to cull their flocks, and more than $430 million into combating the bird flu on dairy farms. In coming years, the bird flu may cost billions of dollars more in expenses and losses. Dairy industry experts say the virus kills roughly 2%-5% of infected dairy cows and reduces a herd’s milk production by about 20%.
Worse, the outbreak poses the threat of a pandemic. More than 60 people in the US have been infected, mainly by cows or poultry, but cases could skyrocket if the virus evolves to spread efficiently from person to person. And the recent news of a person critically ill in Louisiana with the bird flu shows that the virus can be dangerous.
Just a few mutations could allow the bird flu to spread between people. Because viruses mutate within human and animal bodies, each infection is like a pull of a slot machine lever.
“Even if there’s only a 5% chance of a bird flu pandemic happening, we’re talking about a pandemic that probably looks like 2020 or worse,” said Tom Peacock, a bird flu researcher at the Pirbright Institute in the United Kingdom, referring to COVID. “The US knows the risk but hasn’t done anything to slow this down,” he added.
Beyond the bird flu, the federal government’s handling of the outbreak reveals cracks in the US health security system that would allow other risky new pathogens to take root. “This virus may not be the one that takes off,” said Maria Van Kerkhove, director of the emerging diseases group at the World Health Organization. “But this is a real-fire exercise right now, and it demonstrates what needs to be improved.”
A Slow Start
It may have been a grackle, a goose, or some other wild bird that infected a cow in northern Texas. In February, the state’s dairy farmers took note when cows stopped making milk. They worked alongside veterinarians to figure out why. In less than two months, veterinary researchers identified the highly pathogenic H5N1 bird flu virus as the culprit.
Long listed among pathogens with pandemic potential, the bird flu’s unprecedented spread among cows marked a worrying shift. It had evolved to thrive in animals that are more like people biologically than birds.
After the USDA announced the dairy outbreak on March 25, control shifted from farmers, veterinarians, and local officials to state and federal agencies. Collaboration disintegrated almost immediately.
Farmers worried the government might block their milk sales or even demand sick cows be killed, as poultry are, said Kay Russo, a livestock veterinarian in Fort Collins, Colorado.
Instead, Russo and other veterinarians said, they were dismayed by inaction. The USDA didn’t respond to their urgent requests to support studies on dairy farms — and for money and confidentiality policies to protect farmers from financial loss if they agreed to test animals.
The USDA announced that it would conduct studies itself. But researchers grew anxious as weeks passed without results. “Probably the biggest mistake from the USDA was not involving the boots-on-the-ground veterinarians,” Russo said.
Will Clement, a USDA senior adviser for communications, said in an email: “Since first learning of H5N1 in dairy cattle in late March 2024, USDA has worked swiftly and diligently to assess the prevalence of the virus in US dairy herds.” The agency provided research funds to state and national animal health labs beginning in April, he added.
The USDA didn’t require lactating cows to be tested before interstate travel until April 29. By then, the outbreak had spread to eight other states. Farmers often move cattle across great distances, for calving in one place, raising in warm, dry climates, and milking in cooler ones. Analyses of the virus’s genes implied that it spread between cows rather than repeatedly jumping from birds into herds.
Milking equipment was a likely source of infection, and there were hints of other possibilities, such as through the air as cows coughed or in droplets on objects, like work boots. But not enough data had been collected to know how exactly it was happening. Many farmers declined to test their herds, despite an announcement of funds to compensate them for lost milk production in May.
“There is a fear within the dairy farmer community that if they become officially listed as an affected farm, they may lose their milk market,” said Jamie Jonker, chief science officer at the National Milk Producers Federation, an organization that represents dairy farmers. To his knowledge, he added, this hasn’t happened.
Speculation filled knowledge gaps. Zach Riley, head of the Colorado Livestock Association, said he suspected that wild birds may be spreading the virus to herds across the country, despite scientific data suggesting otherwise. Riley said farmers were considering whether to install “floppy inflatable men you see outside of car dealerships” to ward off the birds.
Advisories from agriculture departments to farmers were somewhat speculative, too. Officials recommended biosecurity measures such as disinfecting equipment and limiting visitors. As the virus kept spreading throughout the summer, USDA senior official Eric Deeble said at a press briefing, “The response is adequate.”
The USDA, the Centers for Disease Control and Prevention, and the Food and Drug Administration presented a united front at these briefings, calling it a “One Health” approach. In reality, agriculture agencies took the lead.
This was explicit in an email from a local health department in Colorado to the county’s commissioners. “The State is treating this primarily as an agriculture issue (rightly so) and the public health part is secondary,” wrote Jason Chessher, public health director in Weld County, Colorado. The state’s leading agriculture county, Weld’s livestock and poultry industry produces about $1.9 billion in sales each year.
Patchy Surveillance
In July, the bird flu spread from dairies in Colorado to poultry farms. To contain it, two poultry operations employed about 650 temporary workers — Spanish-speaking immigrants as young as 15 — to cull flocks. Inside hot barns, they caught infected birds, gassed them with carbon dioxide, and disposed of the carcasses. Many did the hazardous job without goggles, face masks, and gloves.
By the time Colorado’s health department asked if workers felt sick, five women and four men had been infected. They all had red, swollen eyes — conjunctivitis — and several had such symptoms as fevers, body aches, and nausea.
State health departments posted online notices offering farms protective gear, but dairy workers in several states told KFF Health News that they had none. They also hadn’t heard about the bird flu, never mind tests for it.
Studies in Colorado, Michigan, and Texas would later show that bird flu cases had gone under the radar. In one analysis, eight dairy workers who hadn’t been tested — 7% of those studied — had antibodies against the virus, a sign that they had been infected.
Missed cases made it impossible to determine how the virus jumped into people and whether it was growing more infectious or dangerous. “I have been distressed and depressed by the lack of epidemiologic data and the lack of surveillance,” said Nicole Lurie, an executive director at the international organization the Coalition for Epidemic Preparedness Innovations, who served as assistant secretary for preparedness and response in the Obama administration.
Citing “insufficient data,” the British government raised its assessment of the risk posed by the US dairy outbreak in July from three to four on a six-tier scale.
Virologists around the world said they were flabbergasted by how poorly the United States was tracking the situation. “You are surrounded by highly pathogenic viruses in the wild and in farm animals,” said Marion Koopmans, head of virology at Erasmus Medical Center in the Netherlands. “If 3 months from now we are at the start of the pandemic, it is nobody’s surprise.”
Although the bird flu is not yet spreading swiftly between people, a shift in that direction could cause immense suffering. The CDC has repeatedly described the cases among farmworkers this year as mild — they weren’t hospitalized. But that doesn’t mean symptoms are a breeze, or that the virus can’t cause worse.
“It does not look pleasant,” wrote Sean Roberts, an emergency services specialist at the Tulare County, California, health department in an email to colleagues in May. He described photographs of an infected dairy worker in another state: “Apparently, the conjunctivitis that this is causing is not a mild one, but rather ruptured blood vessels and bleeding conjunctiva.”
Over the past 30 years, half of around 900 people diagnosed with bird flu around the world have died. Even if the case fatality rate is much lower for this strain of the bird flu, COVID showed how devastating a 1% death rate can be when a virus spreads easily.
Like other cases around the world, the person now hospitalized with the bird flu in Louisiana appears to have gotten the virus directly from birds. After the case was announced, the CDC released a statement saying, “A sporadic case of severe H5N1 bird flu illness in a person is not unexpected.”
‘The Cows Are More Valuable Than Us’
Local health officials were trying hard to track infections, according to hundreds of emails from county health departments in five states. But their efforts were stymied. Even if farmers reported infected herds to the USDA and agriculture agencies told health departments where the infected cows were, health officials had to rely on farm owners for access.
“The agriculture community has dictated the rules of engagement from the start,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “That was a big mistake.”
Some farmers told health officials not to visit and declined to monitor their employees for signs of sickness. Sending workers to clinics for testing could leave them shorthanded when cattle needed care. “Producer refuses to send workers to Sunrise [clinic] to get tested since they’re too busy. He has pink eye, too,” said an email from the Weld, Colorado, health department.
“We know of 386 persons exposed — but we know this is far from the total,” said an email from a public health specialist to officials at Tulare’s health department recounting a call with state health officials. “Employers do not want to run this through worker’s compensation. Workers are hesitant to get tested due to cost,” she wrote.
Jennifer Morse, medical director of the Mid-Michigan District Health Department, said local health officials have been hesitant to apply pressure after the backlash many faced at the peak of COVID. Describing the 19 rural counties she serves as “very minimal government–minded,” she said, “if you try to work against them, it will not go well.”
Rural health departments are also stretched thin. Organizations that specialize in outreach to farmworkers offered to assist health officials early in the outbreak, but months passed without contracts or funding. During the first years of COVID, lagging government funds for outreach to farmworkers and other historically marginalized groups led to a disproportionate toll of the disease among people of color.
Kevin Griffis, director of communications at the CDC, said the agency worked with the National Center for Farmworker Health throughout the summer “to reach every farmworker impacted by H5N1.” But Bethany Boggess Alcauter, the center’s director of public health programs, said it didn’t receive a CDC grant for bird flu outreach until October, to the tune of $4 million. Before then, she said, the group had very limited funds for the task. “We are certainly not reaching ‘every farmworker,’” she added.
Farmworker advocates also pressed the CDC for money to offset workers’ financial concerns about testing, including paying for medical care, sick leave, and the risk of being fired. This amounted to an offer of $75 each. “Outreach is clearly not a huge priority,” Boggess said. “I hear over and over from workers, ‘The cows are more valuable than us.’ ”
The USDA has so far put more than $2.1 billion into reimbursing poultry and dairy farmers for losses due to the bird flu and other measures to control the spread on farms. Federal agencies have also put $292 million into developing and stockpiling bird flu vaccines for animals and people. In a controversial decision, the CDC has advised against offering the ones on hand to farmworkers.
“If you want to keep this from becoming a human pandemic, you focus on protecting farmworkers, since that’s the most likely way that this will enter the human population,” said Peg Seminario, an occupational health researcher in Bethesda, Maryland. “The fact that this isn’t happening drives me crazy.”
Nirav Shah, principal deputy director of the CDC, said the agency aims to keep workers safe. “Widespread awareness does take time,” he said. “And that’s the work we’re committed to doing.”
As President-elect Donald Trump comes into office in January, farmworkers may be even less protected. Trump’s pledge of mass deportations will have repercussions whether they happen or not, said Tania Pacheco-Werner, director of the Central Valley Health Policy Institute in California.
Many dairy and poultry workers are living in the United States without authorization or on temporary visas linked to their employers. Such precarity made people less willing to see doctors about COVID symptoms or complain about unsafe working conditions in 2020. Pacheco-Werner said, “Mass deportation is an astronomical challenge for public health.”
Not ‘Immaculate Conception’
A switch flipped in September among experts who study pandemics as national security threats. A patient in Missouri had the bird flu, and no one knew why. “Evidence points to this being a one-off case,” Shah said at a briefing with journalists. About a month later, the agency revealed it was not.
Antibody tests found that a person who lived with the patient had been infected, too. The CDC didn’t know how the two had gotten the virus, and the possibility of human transmission couldn’t be ruled out.
Nonetheless, at an October briefing, Shah said the public risk remained low and Deeble said he was optimistic that the dairy outbreak could be eliminated.
Experts were perturbed by such confident statements in the face of uncertainty, especially as California’s outbreak spiked and a child was mysteriously infected by the same strain of virus found on dairy farms.
“This wasn’t just immaculate conception,” said Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies. “It came from somewhere and we don’t know where, but that hasn’t triggered any kind of reset in approach — just the same kind of complacency and low energy.”
Sam Scarpino, a disease surveillance specialist in the Boston area, wondered how many other mysterious infections had gone undetected. Surveillance outside of farms was even patchier than on them, and bird flu tests have been hard to get.
Although pandemic experts had identified the CDC’s singular hold on testing for new viruses as a key explanation for why America was hit so hard by COVID in 2020, the system remained the same. Bird flu tests could be run only by the CDC and public health labs until this month, even though commercial and academic diagnostic laboratories had inquired about running tests since April. The CDC and FDA should have tried to help them along months ago, said Ali Khan, a former top CDC official who now leads the University of Nebraska Medical Center College of Public Health.
As winter sets in, the bird flu becomes harder to spot because patient symptoms may be mistaken for the seasonal flu. Flu season also raises a risk that the two flu viruses could swap genes if they infect a person simultaneously. That could form a hybrid bird flu that spreads swiftly through coughs and sneezes.
A sluggish response to emerging outbreaks may simply be a new, unfortunate norm for America, said Bollyky, at the Council on Foreign Relations. If so, the nation has gotten lucky that the bird flu still can’t spread easily between people. Controlling the virus will be much harder and costlier than it would have been when the outbreak was small. But it’s possible.
Agriculture officials could start testing every silo of bulk milk, in every state, monthly, said Poulsen, the livestock veterinarian. “Not one and done,” he added. If they detect the virus, they’d need to determine the affected farm in time to stop sick cows from spreading infections to the rest of the herd — or at least to other farms. Cows can spread the bird flu before they’re sick, he said, so speed is crucial.
Curtailing the virus on farms is the best way to prevent human infections, said Jennifer Nuzzo, director of the Pandemic Center at Brown University, but human surveillance must be stepped up, too. Every clinic serving communities where farmworkers live should have easy access to bird flu tests — and be encouraged to use them. Funds for farmworker outreach must be boosted. And, she added, the CDC should change its position and offer farmworkers bird flu vaccines to protect them and ward off the chance of a hybrid bird flu that spreads quickly.
The rising number of cases not linked to farms signals a need for more testing in general. When patients are positive on a general flu test — a common diagnostic that indicates human, swine, or bird flu — clinics should probe more deeply, Nuzzo said.
The alternative is a wait-and-see approach in which the nation responds only after enormous damage to lives or businesses. This tack tends to rely on mass vaccination. But an effort analogous to Trump’s Operation Warp Speed is not assured, and neither is rollout like that for the first COVID shots, given a rise in vaccine skepticism among Republican lawmakers.
Change may instead need to start from the bottom up — on dairy farms, still the most common source of human infections, said Poulsen. He noticed a shift in attitudes among farmers at the Dairy Expo: “They’re starting to say, ‘How do I save my dairy for the next generation?’ They recognize how severe this is, and that it’s not just going away.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Keith Poulsen’s jaw dropped when farmers showed him images on their cellphones at the World Dairy Expo in Wisconsin in October. A livestock veterinarian at the University of Wisconsin-Madison, Poulsen had seen sick cows before, with their noses dripping and udders slack.
In 14-hour shifts, dairy workers pumped gallons of electrolyte-rich fluids into ailing cows through metal tubes inserted into the esophagus.
“It was like watching a field hospital on an active battlefront treating hundreds of wounded soldiers,” he said.
Nearly a year into the first outbreak of the bird flu among cattle, the virus shows no sign of slowing. The US government failed to eliminate the virus on dairy farms when it was confined to a handful of states, by quickly identifying infected cows and taking measures to keep their infections from spreading. Now at least 875 herds across 16 states have tested positive.
Experts say they have lost faith in the government’s ability to contain the outbreak.
“We are in a terrible situation and going into a worse situation,” said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. “I don’t know if the bird flu will become a pandemic, but if it does, we are screwed.”
To understand how the bird flu got out of hand, KFF Health News interviewed nearly 70 government officials, farmers and farmworkers, and researchers with expertise in virology, pandemics, veterinary medicine, and more.
Together with emails obtained from local health departments through public records requests, this investigation revealed key problems, including deference to the farm industry, eroded public health budgets, neglect for the safety of agriculture workers, and the sluggish pace of federal interventions.
Case in point: The US Department of Agriculture this month announced a federal order to test milk nationwide. Researchers welcomed the news but said it should have happened months ago — before the virus was so entrenched.
“It’s disheartening to see so many of the same failures that emerged during the COVID-19 crisis reemerge,” said Tom Bollyky, director of the Global Health Program at the Council on Foreign Relations.
Far more bird flu damage is inevitable, but the extent of it will be left to the Trump administration and Mother Nature. Already, the USDA has funneled more than $1.7 billion into tamping down the bird flu on poultry farms since 2022, which includes reimbursing farmers who’ve had to cull their flocks, and more than $430 million into combating the bird flu on dairy farms. In coming years, the bird flu may cost billions of dollars more in expenses and losses. Dairy industry experts say the virus kills roughly 2%-5% of infected dairy cows and reduces a herd’s milk production by about 20%.
Worse, the outbreak poses the threat of a pandemic. More than 60 people in the US have been infected, mainly by cows or poultry, but cases could skyrocket if the virus evolves to spread efficiently from person to person. And the recent news of a person critically ill in Louisiana with the bird flu shows that the virus can be dangerous.
Just a few mutations could allow the bird flu to spread between people. Because viruses mutate within human and animal bodies, each infection is like a pull of a slot machine lever.
“Even if there’s only a 5% chance of a bird flu pandemic happening, we’re talking about a pandemic that probably looks like 2020 or worse,” said Tom Peacock, a bird flu researcher at the Pirbright Institute in the United Kingdom, referring to COVID. “The US knows the risk but hasn’t done anything to slow this down,” he added.
Beyond the bird flu, the federal government’s handling of the outbreak reveals cracks in the US health security system that would allow other risky new pathogens to take root. “This virus may not be the one that takes off,” said Maria Van Kerkhove, director of the emerging diseases group at the World Health Organization. “But this is a real-fire exercise right now, and it demonstrates what needs to be improved.”
A Slow Start
It may have been a grackle, a goose, or some other wild bird that infected a cow in northern Texas. In February, the state’s dairy farmers took note when cows stopped making milk. They worked alongside veterinarians to figure out why. In less than two months, veterinary researchers identified the highly pathogenic H5N1 bird flu virus as the culprit.
Long listed among pathogens with pandemic potential, the bird flu’s unprecedented spread among cows marked a worrying shift. It had evolved to thrive in animals that are more like people biologically than birds.
After the USDA announced the dairy outbreak on March 25, control shifted from farmers, veterinarians, and local officials to state and federal agencies. Collaboration disintegrated almost immediately.
Farmers worried the government might block their milk sales or even demand sick cows be killed, as poultry are, said Kay Russo, a livestock veterinarian in Fort Collins, Colorado.
Instead, Russo and other veterinarians said, they were dismayed by inaction. The USDA didn’t respond to their urgent requests to support studies on dairy farms — and for money and confidentiality policies to protect farmers from financial loss if they agreed to test animals.
The USDA announced that it would conduct studies itself. But researchers grew anxious as weeks passed without results. “Probably the biggest mistake from the USDA was not involving the boots-on-the-ground veterinarians,” Russo said.
Will Clement, a USDA senior adviser for communications, said in an email: “Since first learning of H5N1 in dairy cattle in late March 2024, USDA has worked swiftly and diligently to assess the prevalence of the virus in US dairy herds.” The agency provided research funds to state and national animal health labs beginning in April, he added.
The USDA didn’t require lactating cows to be tested before interstate travel until April 29. By then, the outbreak had spread to eight other states. Farmers often move cattle across great distances, for calving in one place, raising in warm, dry climates, and milking in cooler ones. Analyses of the virus’s genes implied that it spread between cows rather than repeatedly jumping from birds into herds.
Milking equipment was a likely source of infection, and there were hints of other possibilities, such as through the air as cows coughed or in droplets on objects, like work boots. But not enough data had been collected to know how exactly it was happening. Many farmers declined to test their herds, despite an announcement of funds to compensate them for lost milk production in May.
“There is a fear within the dairy farmer community that if they become officially listed as an affected farm, they may lose their milk market,” said Jamie Jonker, chief science officer at the National Milk Producers Federation, an organization that represents dairy farmers. To his knowledge, he added, this hasn’t happened.
Speculation filled knowledge gaps. Zach Riley, head of the Colorado Livestock Association, said he suspected that wild birds may be spreading the virus to herds across the country, despite scientific data suggesting otherwise. Riley said farmers were considering whether to install “floppy inflatable men you see outside of car dealerships” to ward off the birds.
Advisories from agriculture departments to farmers were somewhat speculative, too. Officials recommended biosecurity measures such as disinfecting equipment and limiting visitors. As the virus kept spreading throughout the summer, USDA senior official Eric Deeble said at a press briefing, “The response is adequate.”
The USDA, the Centers for Disease Control and Prevention, and the Food and Drug Administration presented a united front at these briefings, calling it a “One Health” approach. In reality, agriculture agencies took the lead.
This was explicit in an email from a local health department in Colorado to the county’s commissioners. “The State is treating this primarily as an agriculture issue (rightly so) and the public health part is secondary,” wrote Jason Chessher, public health director in Weld County, Colorado. The state’s leading agriculture county, Weld’s livestock and poultry industry produces about $1.9 billion in sales each year.
Patchy Surveillance
In July, the bird flu spread from dairies in Colorado to poultry farms. To contain it, two poultry operations employed about 650 temporary workers — Spanish-speaking immigrants as young as 15 — to cull flocks. Inside hot barns, they caught infected birds, gassed them with carbon dioxide, and disposed of the carcasses. Many did the hazardous job without goggles, face masks, and gloves.
By the time Colorado’s health department asked if workers felt sick, five women and four men had been infected. They all had red, swollen eyes — conjunctivitis — and several had such symptoms as fevers, body aches, and nausea.
State health departments posted online notices offering farms protective gear, but dairy workers in several states told KFF Health News that they had none. They also hadn’t heard about the bird flu, never mind tests for it.
Studies in Colorado, Michigan, and Texas would later show that bird flu cases had gone under the radar. In one analysis, eight dairy workers who hadn’t been tested — 7% of those studied — had antibodies against the virus, a sign that they had been infected.
Missed cases made it impossible to determine how the virus jumped into people and whether it was growing more infectious or dangerous. “I have been distressed and depressed by the lack of epidemiologic data and the lack of surveillance,” said Nicole Lurie, an executive director at the international organization the Coalition for Epidemic Preparedness Innovations, who served as assistant secretary for preparedness and response in the Obama administration.
Citing “insufficient data,” the British government raised its assessment of the risk posed by the US dairy outbreak in July from three to four on a six-tier scale.
Virologists around the world said they were flabbergasted by how poorly the United States was tracking the situation. “You are surrounded by highly pathogenic viruses in the wild and in farm animals,” said Marion Koopmans, head of virology at Erasmus Medical Center in the Netherlands. “If 3 months from now we are at the start of the pandemic, it is nobody’s surprise.”
Although the bird flu is not yet spreading swiftly between people, a shift in that direction could cause immense suffering. The CDC has repeatedly described the cases among farmworkers this year as mild — they weren’t hospitalized. But that doesn’t mean symptoms are a breeze, or that the virus can’t cause worse.
“It does not look pleasant,” wrote Sean Roberts, an emergency services specialist at the Tulare County, California, health department in an email to colleagues in May. He described photographs of an infected dairy worker in another state: “Apparently, the conjunctivitis that this is causing is not a mild one, but rather ruptured blood vessels and bleeding conjunctiva.”
Over the past 30 years, half of around 900 people diagnosed with bird flu around the world have died. Even if the case fatality rate is much lower for this strain of the bird flu, COVID showed how devastating a 1% death rate can be when a virus spreads easily.
Like other cases around the world, the person now hospitalized with the bird flu in Louisiana appears to have gotten the virus directly from birds. After the case was announced, the CDC released a statement saying, “A sporadic case of severe H5N1 bird flu illness in a person is not unexpected.”
‘The Cows Are More Valuable Than Us’
Local health officials were trying hard to track infections, according to hundreds of emails from county health departments in five states. But their efforts were stymied. Even if farmers reported infected herds to the USDA and agriculture agencies told health departments where the infected cows were, health officials had to rely on farm owners for access.
“The agriculture community has dictated the rules of engagement from the start,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “That was a big mistake.”
Some farmers told health officials not to visit and declined to monitor their employees for signs of sickness. Sending workers to clinics for testing could leave them shorthanded when cattle needed care. “Producer refuses to send workers to Sunrise [clinic] to get tested since they’re too busy. He has pink eye, too,” said an email from the Weld, Colorado, health department.
“We know of 386 persons exposed — but we know this is far from the total,” said an email from a public health specialist to officials at Tulare’s health department recounting a call with state health officials. “Employers do not want to run this through worker’s compensation. Workers are hesitant to get tested due to cost,” she wrote.
Jennifer Morse, medical director of the Mid-Michigan District Health Department, said local health officials have been hesitant to apply pressure after the backlash many faced at the peak of COVID. Describing the 19 rural counties she serves as “very minimal government–minded,” she said, “if you try to work against them, it will not go well.”
Rural health departments are also stretched thin. Organizations that specialize in outreach to farmworkers offered to assist health officials early in the outbreak, but months passed without contracts or funding. During the first years of COVID, lagging government funds for outreach to farmworkers and other historically marginalized groups led to a disproportionate toll of the disease among people of color.
Kevin Griffis, director of communications at the CDC, said the agency worked with the National Center for Farmworker Health throughout the summer “to reach every farmworker impacted by H5N1.” But Bethany Boggess Alcauter, the center’s director of public health programs, said it didn’t receive a CDC grant for bird flu outreach until October, to the tune of $4 million. Before then, she said, the group had very limited funds for the task. “We are certainly not reaching ‘every farmworker,’” she added.
Farmworker advocates also pressed the CDC for money to offset workers’ financial concerns about testing, including paying for medical care, sick leave, and the risk of being fired. This amounted to an offer of $75 each. “Outreach is clearly not a huge priority,” Boggess said. “I hear over and over from workers, ‘The cows are more valuable than us.’ ”
The USDA has so far put more than $2.1 billion into reimbursing poultry and dairy farmers for losses due to the bird flu and other measures to control the spread on farms. Federal agencies have also put $292 million into developing and stockpiling bird flu vaccines for animals and people. In a controversial decision, the CDC has advised against offering the ones on hand to farmworkers.
“If you want to keep this from becoming a human pandemic, you focus on protecting farmworkers, since that’s the most likely way that this will enter the human population,” said Peg Seminario, an occupational health researcher in Bethesda, Maryland. “The fact that this isn’t happening drives me crazy.”
Nirav Shah, principal deputy director of the CDC, said the agency aims to keep workers safe. “Widespread awareness does take time,” he said. “And that’s the work we’re committed to doing.”
As President-elect Donald Trump comes into office in January, farmworkers may be even less protected. Trump’s pledge of mass deportations will have repercussions whether they happen or not, said Tania Pacheco-Werner, director of the Central Valley Health Policy Institute in California.
Many dairy and poultry workers are living in the United States without authorization or on temporary visas linked to their employers. Such precarity made people less willing to see doctors about COVID symptoms or complain about unsafe working conditions in 2020. Pacheco-Werner said, “Mass deportation is an astronomical challenge for public health.”
Not ‘Immaculate Conception’
A switch flipped in September among experts who study pandemics as national security threats. A patient in Missouri had the bird flu, and no one knew why. “Evidence points to this being a one-off case,” Shah said at a briefing with journalists. About a month later, the agency revealed it was not.
Antibody tests found that a person who lived with the patient had been infected, too. The CDC didn’t know how the two had gotten the virus, and the possibility of human transmission couldn’t be ruled out.
Nonetheless, at an October briefing, Shah said the public risk remained low and Deeble said he was optimistic that the dairy outbreak could be eliminated.
Experts were perturbed by such confident statements in the face of uncertainty, especially as California’s outbreak spiked and a child was mysteriously infected by the same strain of virus found on dairy farms.
“This wasn’t just immaculate conception,” said Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies. “It came from somewhere and we don’t know where, but that hasn’t triggered any kind of reset in approach — just the same kind of complacency and low energy.”
Sam Scarpino, a disease surveillance specialist in the Boston area, wondered how many other mysterious infections had gone undetected. Surveillance outside of farms was even patchier than on them, and bird flu tests have been hard to get.
Although pandemic experts had identified the CDC’s singular hold on testing for new viruses as a key explanation for why America was hit so hard by COVID in 2020, the system remained the same. Bird flu tests could be run only by the CDC and public health labs until this month, even though commercial and academic diagnostic laboratories had inquired about running tests since April. The CDC and FDA should have tried to help them along months ago, said Ali Khan, a former top CDC official who now leads the University of Nebraska Medical Center College of Public Health.
As winter sets in, the bird flu becomes harder to spot because patient symptoms may be mistaken for the seasonal flu. Flu season also raises a risk that the two flu viruses could swap genes if they infect a person simultaneously. That could form a hybrid bird flu that spreads swiftly through coughs and sneezes.
A sluggish response to emerging outbreaks may simply be a new, unfortunate norm for America, said Bollyky, at the Council on Foreign Relations. If so, the nation has gotten lucky that the bird flu still can’t spread easily between people. Controlling the virus will be much harder and costlier than it would have been when the outbreak was small. But it’s possible.
Agriculture officials could start testing every silo of bulk milk, in every state, monthly, said Poulsen, the livestock veterinarian. “Not one and done,” he added. If they detect the virus, they’d need to determine the affected farm in time to stop sick cows from spreading infections to the rest of the herd — or at least to other farms. Cows can spread the bird flu before they’re sick, he said, so speed is crucial.
Curtailing the virus on farms is the best way to prevent human infections, said Jennifer Nuzzo, director of the Pandemic Center at Brown University, but human surveillance must be stepped up, too. Every clinic serving communities where farmworkers live should have easy access to bird flu tests — and be encouraged to use them. Funds for farmworker outreach must be boosted. And, she added, the CDC should change its position and offer farmworkers bird flu vaccines to protect them and ward off the chance of a hybrid bird flu that spreads quickly.
The rising number of cases not linked to farms signals a need for more testing in general. When patients are positive on a general flu test — a common diagnostic that indicates human, swine, or bird flu — clinics should probe more deeply, Nuzzo said.
The alternative is a wait-and-see approach in which the nation responds only after enormous damage to lives or businesses. This tack tends to rely on mass vaccination. But an effort analogous to Trump’s Operation Warp Speed is not assured, and neither is rollout like that for the first COVID shots, given a rise in vaccine skepticism among Republican lawmakers.
Change may instead need to start from the bottom up — on dairy farms, still the most common source of human infections, said Poulsen. He noticed a shift in attitudes among farmers at the Dairy Expo: “They’re starting to say, ‘How do I save my dairy for the next generation?’ They recognize how severe this is, and that it’s not just going away.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Keith Poulsen’s jaw dropped when farmers showed him images on their cellphones at the World Dairy Expo in Wisconsin in October. A livestock veterinarian at the University of Wisconsin-Madison, Poulsen had seen sick cows before, with their noses dripping and udders slack.
In 14-hour shifts, dairy workers pumped gallons of electrolyte-rich fluids into ailing cows through metal tubes inserted into the esophagus.
“It was like watching a field hospital on an active battlefront treating hundreds of wounded soldiers,” he said.
Nearly a year into the first outbreak of the bird flu among cattle, the virus shows no sign of slowing. The US government failed to eliminate the virus on dairy farms when it was confined to a handful of states, by quickly identifying infected cows and taking measures to keep their infections from spreading. Now at least 875 herds across 16 states have tested positive.
Experts say they have lost faith in the government’s ability to contain the outbreak.
“We are in a terrible situation and going into a worse situation,” said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. “I don’t know if the bird flu will become a pandemic, but if it does, we are screwed.”
To understand how the bird flu got out of hand, KFF Health News interviewed nearly 70 government officials, farmers and farmworkers, and researchers with expertise in virology, pandemics, veterinary medicine, and more.
Together with emails obtained from local health departments through public records requests, this investigation revealed key problems, including deference to the farm industry, eroded public health budgets, neglect for the safety of agriculture workers, and the sluggish pace of federal interventions.
Case in point: The US Department of Agriculture this month announced a federal order to test milk nationwide. Researchers welcomed the news but said it should have happened months ago — before the virus was so entrenched.
“It’s disheartening to see so many of the same failures that emerged during the COVID-19 crisis reemerge,” said Tom Bollyky, director of the Global Health Program at the Council on Foreign Relations.
Far more bird flu damage is inevitable, but the extent of it will be left to the Trump administration and Mother Nature. Already, the USDA has funneled more than $1.7 billion into tamping down the bird flu on poultry farms since 2022, which includes reimbursing farmers who’ve had to cull their flocks, and more than $430 million into combating the bird flu on dairy farms. In coming years, the bird flu may cost billions of dollars more in expenses and losses. Dairy industry experts say the virus kills roughly 2%-5% of infected dairy cows and reduces a herd’s milk production by about 20%.
Worse, the outbreak poses the threat of a pandemic. More than 60 people in the US have been infected, mainly by cows or poultry, but cases could skyrocket if the virus evolves to spread efficiently from person to person. And the recent news of a person critically ill in Louisiana with the bird flu shows that the virus can be dangerous.
Just a few mutations could allow the bird flu to spread between people. Because viruses mutate within human and animal bodies, each infection is like a pull of a slot machine lever.
“Even if there’s only a 5% chance of a bird flu pandemic happening, we’re talking about a pandemic that probably looks like 2020 or worse,” said Tom Peacock, a bird flu researcher at the Pirbright Institute in the United Kingdom, referring to COVID. “The US knows the risk but hasn’t done anything to slow this down,” he added.
Beyond the bird flu, the federal government’s handling of the outbreak reveals cracks in the US health security system that would allow other risky new pathogens to take root. “This virus may not be the one that takes off,” said Maria Van Kerkhove, director of the emerging diseases group at the World Health Organization. “But this is a real-fire exercise right now, and it demonstrates what needs to be improved.”
A Slow Start
It may have been a grackle, a goose, or some other wild bird that infected a cow in northern Texas. In February, the state’s dairy farmers took note when cows stopped making milk. They worked alongside veterinarians to figure out why. In less than two months, veterinary researchers identified the highly pathogenic H5N1 bird flu virus as the culprit.
Long listed among pathogens with pandemic potential, the bird flu’s unprecedented spread among cows marked a worrying shift. It had evolved to thrive in animals that are more like people biologically than birds.
After the USDA announced the dairy outbreak on March 25, control shifted from farmers, veterinarians, and local officials to state and federal agencies. Collaboration disintegrated almost immediately.
Farmers worried the government might block their milk sales or even demand sick cows be killed, as poultry are, said Kay Russo, a livestock veterinarian in Fort Collins, Colorado.
Instead, Russo and other veterinarians said, they were dismayed by inaction. The USDA didn’t respond to their urgent requests to support studies on dairy farms — and for money and confidentiality policies to protect farmers from financial loss if they agreed to test animals.
The USDA announced that it would conduct studies itself. But researchers grew anxious as weeks passed without results. “Probably the biggest mistake from the USDA was not involving the boots-on-the-ground veterinarians,” Russo said.
Will Clement, a USDA senior adviser for communications, said in an email: “Since first learning of H5N1 in dairy cattle in late March 2024, USDA has worked swiftly and diligently to assess the prevalence of the virus in US dairy herds.” The agency provided research funds to state and national animal health labs beginning in April, he added.
The USDA didn’t require lactating cows to be tested before interstate travel until April 29. By then, the outbreak had spread to eight other states. Farmers often move cattle across great distances, for calving in one place, raising in warm, dry climates, and milking in cooler ones. Analyses of the virus’s genes implied that it spread between cows rather than repeatedly jumping from birds into herds.
Milking equipment was a likely source of infection, and there were hints of other possibilities, such as through the air as cows coughed or in droplets on objects, like work boots. But not enough data had been collected to know how exactly it was happening. Many farmers declined to test their herds, despite an announcement of funds to compensate them for lost milk production in May.
“There is a fear within the dairy farmer community that if they become officially listed as an affected farm, they may lose their milk market,” said Jamie Jonker, chief science officer at the National Milk Producers Federation, an organization that represents dairy farmers. To his knowledge, he added, this hasn’t happened.
Speculation filled knowledge gaps. Zach Riley, head of the Colorado Livestock Association, said he suspected that wild birds may be spreading the virus to herds across the country, despite scientific data suggesting otherwise. Riley said farmers were considering whether to install “floppy inflatable men you see outside of car dealerships” to ward off the birds.
Advisories from agriculture departments to farmers were somewhat speculative, too. Officials recommended biosecurity measures such as disinfecting equipment and limiting visitors. As the virus kept spreading throughout the summer, USDA senior official Eric Deeble said at a press briefing, “The response is adequate.”
The USDA, the Centers for Disease Control and Prevention, and the Food and Drug Administration presented a united front at these briefings, calling it a “One Health” approach. In reality, agriculture agencies took the lead.
This was explicit in an email from a local health department in Colorado to the county’s commissioners. “The State is treating this primarily as an agriculture issue (rightly so) and the public health part is secondary,” wrote Jason Chessher, public health director in Weld County, Colorado. The state’s leading agriculture county, Weld’s livestock and poultry industry produces about $1.9 billion in sales each year.
Patchy Surveillance
In July, the bird flu spread from dairies in Colorado to poultry farms. To contain it, two poultry operations employed about 650 temporary workers — Spanish-speaking immigrants as young as 15 — to cull flocks. Inside hot barns, they caught infected birds, gassed them with carbon dioxide, and disposed of the carcasses. Many did the hazardous job without goggles, face masks, and gloves.
By the time Colorado’s health department asked if workers felt sick, five women and four men had been infected. They all had red, swollen eyes — conjunctivitis — and several had such symptoms as fevers, body aches, and nausea.
State health departments posted online notices offering farms protective gear, but dairy workers in several states told KFF Health News that they had none. They also hadn’t heard about the bird flu, never mind tests for it.
Studies in Colorado, Michigan, and Texas would later show that bird flu cases had gone under the radar. In one analysis, eight dairy workers who hadn’t been tested — 7% of those studied — had antibodies against the virus, a sign that they had been infected.
Missed cases made it impossible to determine how the virus jumped into people and whether it was growing more infectious or dangerous. “I have been distressed and depressed by the lack of epidemiologic data and the lack of surveillance,” said Nicole Lurie, an executive director at the international organization the Coalition for Epidemic Preparedness Innovations, who served as assistant secretary for preparedness and response in the Obama administration.
Citing “insufficient data,” the British government raised its assessment of the risk posed by the US dairy outbreak in July from three to four on a six-tier scale.
Virologists around the world said they were flabbergasted by how poorly the United States was tracking the situation. “You are surrounded by highly pathogenic viruses in the wild and in farm animals,” said Marion Koopmans, head of virology at Erasmus Medical Center in the Netherlands. “If 3 months from now we are at the start of the pandemic, it is nobody’s surprise.”
Although the bird flu is not yet spreading swiftly between people, a shift in that direction could cause immense suffering. The CDC has repeatedly described the cases among farmworkers this year as mild — they weren’t hospitalized. But that doesn’t mean symptoms are a breeze, or that the virus can’t cause worse.
“It does not look pleasant,” wrote Sean Roberts, an emergency services specialist at the Tulare County, California, health department in an email to colleagues in May. He described photographs of an infected dairy worker in another state: “Apparently, the conjunctivitis that this is causing is not a mild one, but rather ruptured blood vessels and bleeding conjunctiva.”
Over the past 30 years, half of around 900 people diagnosed with bird flu around the world have died. Even if the case fatality rate is much lower for this strain of the bird flu, COVID showed how devastating a 1% death rate can be when a virus spreads easily.
Like other cases around the world, the person now hospitalized with the bird flu in Louisiana appears to have gotten the virus directly from birds. After the case was announced, the CDC released a statement saying, “A sporadic case of severe H5N1 bird flu illness in a person is not unexpected.”
‘The Cows Are More Valuable Than Us’
Local health officials were trying hard to track infections, according to hundreds of emails from county health departments in five states. But their efforts were stymied. Even if farmers reported infected herds to the USDA and agriculture agencies told health departments where the infected cows were, health officials had to rely on farm owners for access.
“The agriculture community has dictated the rules of engagement from the start,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “That was a big mistake.”
Some farmers told health officials not to visit and declined to monitor their employees for signs of sickness. Sending workers to clinics for testing could leave them shorthanded when cattle needed care. “Producer refuses to send workers to Sunrise [clinic] to get tested since they’re too busy. He has pink eye, too,” said an email from the Weld, Colorado, health department.
“We know of 386 persons exposed — but we know this is far from the total,” said an email from a public health specialist to officials at Tulare’s health department recounting a call with state health officials. “Employers do not want to run this through worker’s compensation. Workers are hesitant to get tested due to cost,” she wrote.
Jennifer Morse, medical director of the Mid-Michigan District Health Department, said local health officials have been hesitant to apply pressure after the backlash many faced at the peak of COVID. Describing the 19 rural counties she serves as “very minimal government–minded,” she said, “if you try to work against them, it will not go well.”
Rural health departments are also stretched thin. Organizations that specialize in outreach to farmworkers offered to assist health officials early in the outbreak, but months passed without contracts or funding. During the first years of COVID, lagging government funds for outreach to farmworkers and other historically marginalized groups led to a disproportionate toll of the disease among people of color.
Kevin Griffis, director of communications at the CDC, said the agency worked with the National Center for Farmworker Health throughout the summer “to reach every farmworker impacted by H5N1.” But Bethany Boggess Alcauter, the center’s director of public health programs, said it didn’t receive a CDC grant for bird flu outreach until October, to the tune of $4 million. Before then, she said, the group had very limited funds for the task. “We are certainly not reaching ‘every farmworker,’” she added.
Farmworker advocates also pressed the CDC for money to offset workers’ financial concerns about testing, including paying for medical care, sick leave, and the risk of being fired. This amounted to an offer of $75 each. “Outreach is clearly not a huge priority,” Boggess said. “I hear over and over from workers, ‘The cows are more valuable than us.’ ”
The USDA has so far put more than $2.1 billion into reimbursing poultry and dairy farmers for losses due to the bird flu and other measures to control the spread on farms. Federal agencies have also put $292 million into developing and stockpiling bird flu vaccines for animals and people. In a controversial decision, the CDC has advised against offering the ones on hand to farmworkers.
“If you want to keep this from becoming a human pandemic, you focus on protecting farmworkers, since that’s the most likely way that this will enter the human population,” said Peg Seminario, an occupational health researcher in Bethesda, Maryland. “The fact that this isn’t happening drives me crazy.”
Nirav Shah, principal deputy director of the CDC, said the agency aims to keep workers safe. “Widespread awareness does take time,” he said. “And that’s the work we’re committed to doing.”
As President-elect Donald Trump comes into office in January, farmworkers may be even less protected. Trump’s pledge of mass deportations will have repercussions whether they happen or not, said Tania Pacheco-Werner, director of the Central Valley Health Policy Institute in California.
Many dairy and poultry workers are living in the United States without authorization or on temporary visas linked to their employers. Such precarity made people less willing to see doctors about COVID symptoms or complain about unsafe working conditions in 2020. Pacheco-Werner said, “Mass deportation is an astronomical challenge for public health.”
Not ‘Immaculate Conception’
A switch flipped in September among experts who study pandemics as national security threats. A patient in Missouri had the bird flu, and no one knew why. “Evidence points to this being a one-off case,” Shah said at a briefing with journalists. About a month later, the agency revealed it was not.
Antibody tests found that a person who lived with the patient had been infected, too. The CDC didn’t know how the two had gotten the virus, and the possibility of human transmission couldn’t be ruled out.
Nonetheless, at an October briefing, Shah said the public risk remained low and Deeble said he was optimistic that the dairy outbreak could be eliminated.
Experts were perturbed by such confident statements in the face of uncertainty, especially as California’s outbreak spiked and a child was mysteriously infected by the same strain of virus found on dairy farms.
“This wasn’t just immaculate conception,” said Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies. “It came from somewhere and we don’t know where, but that hasn’t triggered any kind of reset in approach — just the same kind of complacency and low energy.”
Sam Scarpino, a disease surveillance specialist in the Boston area, wondered how many other mysterious infections had gone undetected. Surveillance outside of farms was even patchier than on them, and bird flu tests have been hard to get.
Although pandemic experts had identified the CDC’s singular hold on testing for new viruses as a key explanation for why America was hit so hard by COVID in 2020, the system remained the same. Bird flu tests could be run only by the CDC and public health labs until this month, even though commercial and academic diagnostic laboratories had inquired about running tests since April. The CDC and FDA should have tried to help them along months ago, said Ali Khan, a former top CDC official who now leads the University of Nebraska Medical Center College of Public Health.
As winter sets in, the bird flu becomes harder to spot because patient symptoms may be mistaken for the seasonal flu. Flu season also raises a risk that the two flu viruses could swap genes if they infect a person simultaneously. That could form a hybrid bird flu that spreads swiftly through coughs and sneezes.
A sluggish response to emerging outbreaks may simply be a new, unfortunate norm for America, said Bollyky, at the Council on Foreign Relations. If so, the nation has gotten lucky that the bird flu still can’t spread easily between people. Controlling the virus will be much harder and costlier than it would have been when the outbreak was small. But it’s possible.
Agriculture officials could start testing every silo of bulk milk, in every state, monthly, said Poulsen, the livestock veterinarian. “Not one and done,” he added. If they detect the virus, they’d need to determine the affected farm in time to stop sick cows from spreading infections to the rest of the herd — or at least to other farms. Cows can spread the bird flu before they’re sick, he said, so speed is crucial.
Curtailing the virus on farms is the best way to prevent human infections, said Jennifer Nuzzo, director of the Pandemic Center at Brown University, but human surveillance must be stepped up, too. Every clinic serving communities where farmworkers live should have easy access to bird flu tests — and be encouraged to use them. Funds for farmworker outreach must be boosted. And, she added, the CDC should change its position and offer farmworkers bird flu vaccines to protect them and ward off the chance of a hybrid bird flu that spreads quickly.
The rising number of cases not linked to farms signals a need for more testing in general. When patients are positive on a general flu test — a common diagnostic that indicates human, swine, or bird flu — clinics should probe more deeply, Nuzzo said.
The alternative is a wait-and-see approach in which the nation responds only after enormous damage to lives or businesses. This tack tends to rely on mass vaccination. But an effort analogous to Trump’s Operation Warp Speed is not assured, and neither is rollout like that for the first COVID shots, given a rise in vaccine skepticism among Republican lawmakers.
Change may instead need to start from the bottom up — on dairy farms, still the most common source of human infections, said Poulsen. He noticed a shift in attitudes among farmers at the Dairy Expo: “They’re starting to say, ‘How do I save my dairy for the next generation?’ They recognize how severe this is, and that it’s not just going away.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Management of Children and Adolescents With Long COVID
Current management of children and adolescents with long COVID was the focus of various presentations at the 3rd Long COVID Congress in Berlin in November. In 2024, the focus was on research into long COVID in children and adolescents and how to improve their care.
Uta Behrends, MD, head of the Munich Chronic Fatigue Center, Center for Pediatric and Adolescent Medicine at the Technical University of Munich in Germany, and Nicole Toepfner, MD, a pediatrician at the University Hospital in Dresden, Germany, provided an initial overview.
Prevalence Data Are Limited
Data on the incidence and prevalence of the condition in children and adolescents are limited because most studies have primarily examined adults. A 2022 Swiss study estimated that it affects between 2% and 3.5% of children and adolescents who contract COVID-19. A recent study published in JAMA involving 5367 children and adolescents found that 20% of children aged 6-11 years and 14% of adolescents met the researchers’ criteria for long COVID.
Impaired Mental Health
Initial data from the latest wave of the population-based longitudinal COPSY (Corona and Psyche) study showed that, compared with their peer group, children and adolescents diagnosed with long COVID exhibit significantly higher rates of psychological issues and depressive symptoms. Although no significant differences were found in anxiety levels, study leader Ulrike Ravens-Sieberer, PhD, from the University Medical Center Hamburg-Eppendorf, Germany, told the congress that those with long COVID also report more frequent somatic or psychological health complaints and lower health-related quality of life than peers.
Addressing Data Gaps
Another study due to launch in January 2025 and run through to 2028 is the COVYOUTH data study, which aims to better understand the nature, frequency, and risk factors of COVID-related sequelae in children and adolescents.
Study centers include Ruhr University Bochum, University Hospital Cologne, the Paul-Ehrlich-Institut, and University Medical Center Hamburg-Eppendorf. Using routine data from statutory health insurance and newly developed case definitions, researchers aim to investigate psychological stress caused by COVID-19 measures, post-COVID syndrome and myocarditis, and adverse effects of COVID-19 vaccinations.
Specialized Diagnostics and Care
The Post-COVID Kids Bavaria project offers specialized diagnostics and care for children and adolescents, including a day clinic, telemedical follow-ups, and an inpatient pain therapy module providing age-appropriate care as close to patients’ homes as possible.
MOVE-COVID is a model project for patient-focused research on long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) involving university pediatric hospitals in Freiburg, Heidelberg, Tübingen, and Ulm. It also aims to establish a care network across the state of Baden-Württemberg, including the establishment of long COVID outpatient clinics at social pediatric centers in the network hospitals, as well as enhanced telemedical support and standardized diagnostic and treatment protocols. “MOVE-COVID has successfully consolidated competencies and capacities in patient care, health services research, and patient-focused studies across multiple centers,” Behrends said.
Chronic Pain and Fatigue
Post-COVID syndromes in children and adolescents may feature profound fatigue, unrefreshing sleep, post-exertional malaise, cognitive dysfunction, and orthostatic intolerance and overlap with conditions such as ME/CFS. According to the German patient association Fatigatio, Berlin, research and studies for these conditions in children remain limited compared with those in adults. However, the US Centers for Disease Control estimates that around 2% of ME/CFS patients are children or adolescents, with the majority being teenagers.
Two inpatient treatment concepts, SHARK and TIGER, developed by Lea Höfel, PhD, head of the Centre for Pain Therapy for Young People and the Psychological Service at the Children’s Hospital in Garmisch-Partenkirchen, address chronic pain, fatigue, and ME/CFS in young people. These programs integrate structured breaks and flexible access to multiple therapists as needed. The TIGER program focuses on those with post-exertional malaise, while the SHARK program is designed for adolescents without this symptom. Both programs last 4.5 to 5 weeks and emphasize symptom reduction, education, and energy management.
Preliminary Results
SHARK included 30 participants (7 men; average age, 16 years), of whom 12 had a history of SARS-CoV-2 infection. TIGER involved 100 participants (24 men; average age, 16.7 years), of whom 32 had a SARS-CoV-2 infection as a triggering event. Other triggers included Epstein-Barr virus and other infections.
Preliminary findings from the projects indicate that optimized management with outpatient and follow-up care can yield positive, sometimes lasting effects. No significant differences between SARS-CoV-2 and other triggers emerged, but pain proved more manageable in the SHARK group than in the TIGER group, suggesting they may involve different pathological mechanisms.
Hope for Improved Outcomes
“It’s important to move away from the idea that nothing can be done,” Behrends said. This is a common attitude with children and adolescents displaying these types of symptoms, but it’s simply not true. “Even in pediatrics, we have numerous therapeutic options that may offer relief, from medication to psychosocial interventions.”
This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Current management of children and adolescents with long COVID was the focus of various presentations at the 3rd Long COVID Congress in Berlin in November. In 2024, the focus was on research into long COVID in children and adolescents and how to improve their care.
Uta Behrends, MD, head of the Munich Chronic Fatigue Center, Center for Pediatric and Adolescent Medicine at the Technical University of Munich in Germany, and Nicole Toepfner, MD, a pediatrician at the University Hospital in Dresden, Germany, provided an initial overview.
Prevalence Data Are Limited
Data on the incidence and prevalence of the condition in children and adolescents are limited because most studies have primarily examined adults. A 2022 Swiss study estimated that it affects between 2% and 3.5% of children and adolescents who contract COVID-19. A recent study published in JAMA involving 5367 children and adolescents found that 20% of children aged 6-11 years and 14% of adolescents met the researchers’ criteria for long COVID.
Impaired Mental Health
Initial data from the latest wave of the population-based longitudinal COPSY (Corona and Psyche) study showed that, compared with their peer group, children and adolescents diagnosed with long COVID exhibit significantly higher rates of psychological issues and depressive symptoms. Although no significant differences were found in anxiety levels, study leader Ulrike Ravens-Sieberer, PhD, from the University Medical Center Hamburg-Eppendorf, Germany, told the congress that those with long COVID also report more frequent somatic or psychological health complaints and lower health-related quality of life than peers.
Addressing Data Gaps
Another study due to launch in January 2025 and run through to 2028 is the COVYOUTH data study, which aims to better understand the nature, frequency, and risk factors of COVID-related sequelae in children and adolescents.
Study centers include Ruhr University Bochum, University Hospital Cologne, the Paul-Ehrlich-Institut, and University Medical Center Hamburg-Eppendorf. Using routine data from statutory health insurance and newly developed case definitions, researchers aim to investigate psychological stress caused by COVID-19 measures, post-COVID syndrome and myocarditis, and adverse effects of COVID-19 vaccinations.
Specialized Diagnostics and Care
The Post-COVID Kids Bavaria project offers specialized diagnostics and care for children and adolescents, including a day clinic, telemedical follow-ups, and an inpatient pain therapy module providing age-appropriate care as close to patients’ homes as possible.
MOVE-COVID is a model project for patient-focused research on long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) involving university pediatric hospitals in Freiburg, Heidelberg, Tübingen, and Ulm. It also aims to establish a care network across the state of Baden-Württemberg, including the establishment of long COVID outpatient clinics at social pediatric centers in the network hospitals, as well as enhanced telemedical support and standardized diagnostic and treatment protocols. “MOVE-COVID has successfully consolidated competencies and capacities in patient care, health services research, and patient-focused studies across multiple centers,” Behrends said.
Chronic Pain and Fatigue
Post-COVID syndromes in children and adolescents may feature profound fatigue, unrefreshing sleep, post-exertional malaise, cognitive dysfunction, and orthostatic intolerance and overlap with conditions such as ME/CFS. According to the German patient association Fatigatio, Berlin, research and studies for these conditions in children remain limited compared with those in adults. However, the US Centers for Disease Control estimates that around 2% of ME/CFS patients are children or adolescents, with the majority being teenagers.
Two inpatient treatment concepts, SHARK and TIGER, developed by Lea Höfel, PhD, head of the Centre for Pain Therapy for Young People and the Psychological Service at the Children’s Hospital in Garmisch-Partenkirchen, address chronic pain, fatigue, and ME/CFS in young people. These programs integrate structured breaks and flexible access to multiple therapists as needed. The TIGER program focuses on those with post-exertional malaise, while the SHARK program is designed for adolescents without this symptom. Both programs last 4.5 to 5 weeks and emphasize symptom reduction, education, and energy management.
Preliminary Results
SHARK included 30 participants (7 men; average age, 16 years), of whom 12 had a history of SARS-CoV-2 infection. TIGER involved 100 participants (24 men; average age, 16.7 years), of whom 32 had a SARS-CoV-2 infection as a triggering event. Other triggers included Epstein-Barr virus and other infections.
Preliminary findings from the projects indicate that optimized management with outpatient and follow-up care can yield positive, sometimes lasting effects. No significant differences between SARS-CoV-2 and other triggers emerged, but pain proved more manageable in the SHARK group than in the TIGER group, suggesting they may involve different pathological mechanisms.
Hope for Improved Outcomes
“It’s important to move away from the idea that nothing can be done,” Behrends said. This is a common attitude with children and adolescents displaying these types of symptoms, but it’s simply not true. “Even in pediatrics, we have numerous therapeutic options that may offer relief, from medication to psychosocial interventions.”
This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Current management of children and adolescents with long COVID was the focus of various presentations at the 3rd Long COVID Congress in Berlin in November. In 2024, the focus was on research into long COVID in children and adolescents and how to improve their care.
Uta Behrends, MD, head of the Munich Chronic Fatigue Center, Center for Pediatric and Adolescent Medicine at the Technical University of Munich in Germany, and Nicole Toepfner, MD, a pediatrician at the University Hospital in Dresden, Germany, provided an initial overview.
Prevalence Data Are Limited
Data on the incidence and prevalence of the condition in children and adolescents are limited because most studies have primarily examined adults. A 2022 Swiss study estimated that it affects between 2% and 3.5% of children and adolescents who contract COVID-19. A recent study published in JAMA involving 5367 children and adolescents found that 20% of children aged 6-11 years and 14% of adolescents met the researchers’ criteria for long COVID.
Impaired Mental Health
Initial data from the latest wave of the population-based longitudinal COPSY (Corona and Psyche) study showed that, compared with their peer group, children and adolescents diagnosed with long COVID exhibit significantly higher rates of psychological issues and depressive symptoms. Although no significant differences were found in anxiety levels, study leader Ulrike Ravens-Sieberer, PhD, from the University Medical Center Hamburg-Eppendorf, Germany, told the congress that those with long COVID also report more frequent somatic or psychological health complaints and lower health-related quality of life than peers.
Addressing Data Gaps
Another study due to launch in January 2025 and run through to 2028 is the COVYOUTH data study, which aims to better understand the nature, frequency, and risk factors of COVID-related sequelae in children and adolescents.
Study centers include Ruhr University Bochum, University Hospital Cologne, the Paul-Ehrlich-Institut, and University Medical Center Hamburg-Eppendorf. Using routine data from statutory health insurance and newly developed case definitions, researchers aim to investigate psychological stress caused by COVID-19 measures, post-COVID syndrome and myocarditis, and adverse effects of COVID-19 vaccinations.
Specialized Diagnostics and Care
The Post-COVID Kids Bavaria project offers specialized diagnostics and care for children and adolescents, including a day clinic, telemedical follow-ups, and an inpatient pain therapy module providing age-appropriate care as close to patients’ homes as possible.
MOVE-COVID is a model project for patient-focused research on long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) involving university pediatric hospitals in Freiburg, Heidelberg, Tübingen, and Ulm. It also aims to establish a care network across the state of Baden-Württemberg, including the establishment of long COVID outpatient clinics at social pediatric centers in the network hospitals, as well as enhanced telemedical support and standardized diagnostic and treatment protocols. “MOVE-COVID has successfully consolidated competencies and capacities in patient care, health services research, and patient-focused studies across multiple centers,” Behrends said.
Chronic Pain and Fatigue
Post-COVID syndromes in children and adolescents may feature profound fatigue, unrefreshing sleep, post-exertional malaise, cognitive dysfunction, and orthostatic intolerance and overlap with conditions such as ME/CFS. According to the German patient association Fatigatio, Berlin, research and studies for these conditions in children remain limited compared with those in adults. However, the US Centers for Disease Control estimates that around 2% of ME/CFS patients are children or adolescents, with the majority being teenagers.
Two inpatient treatment concepts, SHARK and TIGER, developed by Lea Höfel, PhD, head of the Centre for Pain Therapy for Young People and the Psychological Service at the Children’s Hospital in Garmisch-Partenkirchen, address chronic pain, fatigue, and ME/CFS in young people. These programs integrate structured breaks and flexible access to multiple therapists as needed. The TIGER program focuses on those with post-exertional malaise, while the SHARK program is designed for adolescents without this symptom. Both programs last 4.5 to 5 weeks and emphasize symptom reduction, education, and energy management.
Preliminary Results
SHARK included 30 participants (7 men; average age, 16 years), of whom 12 had a history of SARS-CoV-2 infection. TIGER involved 100 participants (24 men; average age, 16.7 years), of whom 32 had a SARS-CoV-2 infection as a triggering event. Other triggers included Epstein-Barr virus and other infections.
Preliminary findings from the projects indicate that optimized management with outpatient and follow-up care can yield positive, sometimes lasting effects. No significant differences between SARS-CoV-2 and other triggers emerged, but pain proved more manageable in the SHARK group than in the TIGER group, suggesting they may involve different pathological mechanisms.
Hope for Improved Outcomes
“It’s important to move away from the idea that nothing can be done,” Behrends said. This is a common attitude with children and adolescents displaying these types of symptoms, but it’s simply not true. “Even in pediatrics, we have numerous therapeutic options that may offer relief, from medication to psychosocial interventions.”
This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Physician Union Drives Skyrocketed in 2023 and 2024, Data Show
While fewer than 10% of US physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed in the last 2 years, compared with 2 decades prior, according to a new study.
Researchers counted 21 union drives in 2023 and 12 in the first 5 months of 2024, compared with 0-6 drives each year between 2000 and 2022.
If the 2023 and 2024 drives succeed, unions will represent 3523 new physicians — nearly equal to the 3541 doctors who sought unionization between 2000 and 2022.
“We were able to document a significant uptick in union petitions and success in certification drives,” said corresponding author Hayden Rooke-Ley, JD, of the Center for Advancing Health Policy Through Research, Brown University School of Public Health, Providence, Rhode Island. “We were surprised to see such a marked shift in 2023.”
About 72,000 physicians, an estimated 8% of all US doctors, are covered by unions, including some in the public sector. Physicians who are self-employed, now comprising less than a fifth of all doctors, are not eligible to join labor unions.
The study authors launched their research to better understand trends in physician unionization in light of high-profile union drives, especially among residents. Rooke-Ley said: “We suspected that declining morale and increased corporate employment for physicians were leading them to consider unionization.”
The researchers gathered data from the National Labor Relations Board about union drives by potential bargaining units that included physicians. From 2000 to 2022, 44 union petitions were filed. The number jumped to 33 from 2023-2024.
“Tip of the Iceberg”
“This is the tip of the iceberg,” said ethicist Joseph F. Kras, MD, DDS, MA, an associate professor of anesthesiology at Washington University in St. Louis, Missouri, and corresponding author of a recent Anesthesia & Analgesia report about physician unionization.
“We are independent by nature,” Kras said. “But when you put us in an employed environment and start treating us as widgets, then we will act like employees of Amazon, Starbucks, and other companies and join together to push back against the increasing emphasis on profit over all at the expense of our independent judgment on what’s best for the patient.”
Of the 66 unionization efforts between 2000 and 2024 that were decided, 62% were certified, according to the JAMA study. The drives targeted hospitals (49%), community health centers (38%), and nonhospital corporate owners (13%).
The researchers only analyzed private-sector unionization and did not include physicians who are unionized at public institutions.
What’s Behind Union Drives?
Alyssa Burgart, MD, MA, an ethicist and clinical associate professor of anesthesiology and pediatrics at Stanford University in California, told this news organization that physician unionization “is a big topic with a lot of really strong opinions.”
Many doctors wrongly assume they can’t unionize because they’re physicians, said Burgart, a coauthor of the Anesthesia & Analgesia report.
Supporters of unionization believe it’s a strategy to be “recognized not as simply as a single physician with a concern,” she said. “When you’re among clinicians who can speak as a more unified group, organizations are more likely to take that seriously.”
A union may also be able to hold employers to account in areas such as the gender wage gap, sexual harassment, and bias in hiring and firing, Burgart said. And union supporters believe they’ll make more money if they collectively bargain.
Other factors driving interest in unions include “increasing physician burnout, increasing physician exhaustion, and immense frustration with the ways that private equity is influencing how physicians need to work in order to practice,” she said.
Earlier in 2024, physicians in Delaware’s ChristianaCare health system voted 288-130 to be represented by Doctors Council/Service Employees International, according to the union.
“We have still not been able to staff up enough to where us physicians can get back to just focusing on taking care of patients,” a unionization leader told WHYY.
The JAMA study examined news reports regarding most of the 2023-2024 union drives and found that supporters claimed they were motivated by working conditions (85%), lack of voice in management (81%), patient care concerns (54%), and pay (4%).
Critics Worry They’ll Lose Pay Because of Unions
Skeptics of unionization worry about whether “I’m going to be required to stand by some union stance that is actually out of alignment with my values as a physician,” Burgart said. And, she said, critics such as highly paid surgeons fear that adjustments to salaries because of union contracts could cause them to lose income.
In regard to compensation, a 2024 study surveyed unionized residents — along with faculty and staff — at general surgery programs and found evidence that unionization didn’t improve resident well-being or benefits, although it “provided a mechanism for resident voice and agency.”
“It is critical to study the outcomes of those who unionized to ensure that the reasons for unionizing were realized over time,” said that study’s coauthor Karl Bilimoria, MD, MS, chair of surgery at Indiana University School of Medicine, Indianapolis. “The unintended consequences of unionization must be examined along with the potential improvements.”
Rooke-Ley discloses consulting fees from the American Economic Liberties Project, National Academy of State Health Policy, and 32BJ Funds. Kras and Burgart disclose previous union membership. Bilimoria has no disclosures.
A version of this article first appeared on Medscape.com.
While fewer than 10% of US physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed in the last 2 years, compared with 2 decades prior, according to a new study.
Researchers counted 21 union drives in 2023 and 12 in the first 5 months of 2024, compared with 0-6 drives each year between 2000 and 2022.
If the 2023 and 2024 drives succeed, unions will represent 3523 new physicians — nearly equal to the 3541 doctors who sought unionization between 2000 and 2022.
“We were able to document a significant uptick in union petitions and success in certification drives,” said corresponding author Hayden Rooke-Ley, JD, of the Center for Advancing Health Policy Through Research, Brown University School of Public Health, Providence, Rhode Island. “We were surprised to see such a marked shift in 2023.”
About 72,000 physicians, an estimated 8% of all US doctors, are covered by unions, including some in the public sector. Physicians who are self-employed, now comprising less than a fifth of all doctors, are not eligible to join labor unions.
The study authors launched their research to better understand trends in physician unionization in light of high-profile union drives, especially among residents. Rooke-Ley said: “We suspected that declining morale and increased corporate employment for physicians were leading them to consider unionization.”
The researchers gathered data from the National Labor Relations Board about union drives by potential bargaining units that included physicians. From 2000 to 2022, 44 union petitions were filed. The number jumped to 33 from 2023-2024.
“Tip of the Iceberg”
“This is the tip of the iceberg,” said ethicist Joseph F. Kras, MD, DDS, MA, an associate professor of anesthesiology at Washington University in St. Louis, Missouri, and corresponding author of a recent Anesthesia & Analgesia report about physician unionization.
“We are independent by nature,” Kras said. “But when you put us in an employed environment and start treating us as widgets, then we will act like employees of Amazon, Starbucks, and other companies and join together to push back against the increasing emphasis on profit over all at the expense of our independent judgment on what’s best for the patient.”
Of the 66 unionization efforts between 2000 and 2024 that were decided, 62% were certified, according to the JAMA study. The drives targeted hospitals (49%), community health centers (38%), and nonhospital corporate owners (13%).
The researchers only analyzed private-sector unionization and did not include physicians who are unionized at public institutions.
What’s Behind Union Drives?
Alyssa Burgart, MD, MA, an ethicist and clinical associate professor of anesthesiology and pediatrics at Stanford University in California, told this news organization that physician unionization “is a big topic with a lot of really strong opinions.”
Many doctors wrongly assume they can’t unionize because they’re physicians, said Burgart, a coauthor of the Anesthesia & Analgesia report.
Supporters of unionization believe it’s a strategy to be “recognized not as simply as a single physician with a concern,” she said. “When you’re among clinicians who can speak as a more unified group, organizations are more likely to take that seriously.”
A union may also be able to hold employers to account in areas such as the gender wage gap, sexual harassment, and bias in hiring and firing, Burgart said. And union supporters believe they’ll make more money if they collectively bargain.
Other factors driving interest in unions include “increasing physician burnout, increasing physician exhaustion, and immense frustration with the ways that private equity is influencing how physicians need to work in order to practice,” she said.
Earlier in 2024, physicians in Delaware’s ChristianaCare health system voted 288-130 to be represented by Doctors Council/Service Employees International, according to the union.
“We have still not been able to staff up enough to where us physicians can get back to just focusing on taking care of patients,” a unionization leader told WHYY.
The JAMA study examined news reports regarding most of the 2023-2024 union drives and found that supporters claimed they were motivated by working conditions (85%), lack of voice in management (81%), patient care concerns (54%), and pay (4%).
Critics Worry They’ll Lose Pay Because of Unions
Skeptics of unionization worry about whether “I’m going to be required to stand by some union stance that is actually out of alignment with my values as a physician,” Burgart said. And, she said, critics such as highly paid surgeons fear that adjustments to salaries because of union contracts could cause them to lose income.
In regard to compensation, a 2024 study surveyed unionized residents — along with faculty and staff — at general surgery programs and found evidence that unionization didn’t improve resident well-being or benefits, although it “provided a mechanism for resident voice and agency.”
“It is critical to study the outcomes of those who unionized to ensure that the reasons for unionizing were realized over time,” said that study’s coauthor Karl Bilimoria, MD, MS, chair of surgery at Indiana University School of Medicine, Indianapolis. “The unintended consequences of unionization must be examined along with the potential improvements.”
Rooke-Ley discloses consulting fees from the American Economic Liberties Project, National Academy of State Health Policy, and 32BJ Funds. Kras and Burgart disclose previous union membership. Bilimoria has no disclosures.
A version of this article first appeared on Medscape.com.
While fewer than 10% of US physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed in the last 2 years, compared with 2 decades prior, according to a new study.
Researchers counted 21 union drives in 2023 and 12 in the first 5 months of 2024, compared with 0-6 drives each year between 2000 and 2022.
If the 2023 and 2024 drives succeed, unions will represent 3523 new physicians — nearly equal to the 3541 doctors who sought unionization between 2000 and 2022.
“We were able to document a significant uptick in union petitions and success in certification drives,” said corresponding author Hayden Rooke-Ley, JD, of the Center for Advancing Health Policy Through Research, Brown University School of Public Health, Providence, Rhode Island. “We were surprised to see such a marked shift in 2023.”
About 72,000 physicians, an estimated 8% of all US doctors, are covered by unions, including some in the public sector. Physicians who are self-employed, now comprising less than a fifth of all doctors, are not eligible to join labor unions.
The study authors launched their research to better understand trends in physician unionization in light of high-profile union drives, especially among residents. Rooke-Ley said: “We suspected that declining morale and increased corporate employment for physicians were leading them to consider unionization.”
The researchers gathered data from the National Labor Relations Board about union drives by potential bargaining units that included physicians. From 2000 to 2022, 44 union petitions were filed. The number jumped to 33 from 2023-2024.
“Tip of the Iceberg”
“This is the tip of the iceberg,” said ethicist Joseph F. Kras, MD, DDS, MA, an associate professor of anesthesiology at Washington University in St. Louis, Missouri, and corresponding author of a recent Anesthesia & Analgesia report about physician unionization.
“We are independent by nature,” Kras said. “But when you put us in an employed environment and start treating us as widgets, then we will act like employees of Amazon, Starbucks, and other companies and join together to push back against the increasing emphasis on profit over all at the expense of our independent judgment on what’s best for the patient.”
Of the 66 unionization efforts between 2000 and 2024 that were decided, 62% were certified, according to the JAMA study. The drives targeted hospitals (49%), community health centers (38%), and nonhospital corporate owners (13%).
The researchers only analyzed private-sector unionization and did not include physicians who are unionized at public institutions.
What’s Behind Union Drives?
Alyssa Burgart, MD, MA, an ethicist and clinical associate professor of anesthesiology and pediatrics at Stanford University in California, told this news organization that physician unionization “is a big topic with a lot of really strong opinions.”
Many doctors wrongly assume they can’t unionize because they’re physicians, said Burgart, a coauthor of the Anesthesia & Analgesia report.
Supporters of unionization believe it’s a strategy to be “recognized not as simply as a single physician with a concern,” she said. “When you’re among clinicians who can speak as a more unified group, organizations are more likely to take that seriously.”
A union may also be able to hold employers to account in areas such as the gender wage gap, sexual harassment, and bias in hiring and firing, Burgart said. And union supporters believe they’ll make more money if they collectively bargain.
Other factors driving interest in unions include “increasing physician burnout, increasing physician exhaustion, and immense frustration with the ways that private equity is influencing how physicians need to work in order to practice,” she said.
Earlier in 2024, physicians in Delaware’s ChristianaCare health system voted 288-130 to be represented by Doctors Council/Service Employees International, according to the union.
“We have still not been able to staff up enough to where us physicians can get back to just focusing on taking care of patients,” a unionization leader told WHYY.
The JAMA study examined news reports regarding most of the 2023-2024 union drives and found that supporters claimed they were motivated by working conditions (85%), lack of voice in management (81%), patient care concerns (54%), and pay (4%).
Critics Worry They’ll Lose Pay Because of Unions
Skeptics of unionization worry about whether “I’m going to be required to stand by some union stance that is actually out of alignment with my values as a physician,” Burgart said. And, she said, critics such as highly paid surgeons fear that adjustments to salaries because of union contracts could cause them to lose income.
In regard to compensation, a 2024 study surveyed unionized residents — along with faculty and staff — at general surgery programs and found evidence that unionization didn’t improve resident well-being or benefits, although it “provided a mechanism for resident voice and agency.”
“It is critical to study the outcomes of those who unionized to ensure that the reasons for unionizing were realized over time,” said that study’s coauthor Karl Bilimoria, MD, MS, chair of surgery at Indiana University School of Medicine, Indianapolis. “The unintended consequences of unionization must be examined along with the potential improvements.”
Rooke-Ley discloses consulting fees from the American Economic Liberties Project, National Academy of State Health Policy, and 32BJ Funds. Kras and Burgart disclose previous union membership. Bilimoria has no disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA
Popular Diabetes Drug May Raise Vascular Surgery Risk
TOPLINE:
Among older veterans with type 2 diabetes (T2D), the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors as an add-on therapy is associated with a higher risk for peripheral artery disease (PAD)-related surgical events than the use of dipeptidyl peptidase 4 (DPP-4) inhibitors.
METHODOLOGY:
- Some placebo-controlled randomized trials have reported an increased risk for amputation with the use of SGLT2 inhibitors in patients with underlying cardiovascular diseases; however, the evidence remains unconfirmed by other subsequent trials.
- Researchers conducted a retrospective study of US veterans with T2D initiating SGLT2 inhibitors or DPP-4 inhibitors (a reference drug) as an add-on to metformin, sulfonylurea, or insulin treatment alone or in combination.
- The primary outcome was the time to the first surgical event for PAD (amputation, peripheral revascularization and bypass, or peripheral vascular stent).
- A Cox proportional hazards model was used to compare PAD event risk between the SGLT2 inhibitor and DPP-4 inhibitor groups, allowing events up to 90 days or 360 days after stopping SGLT2 inhibitors.
TAKEAWAY:
- After propensity score weighting, 76,072 episodes of SGLT2 inhibitor use (94% empagliflozin, 4% canagliflozin, and 2% dapagliflozin) and 75,833 episodes of DPP-4 inhibitor use (45% saxagliptin, 34% alogliptin, 15% sitagliptin, and 6% linagliptin) were included.
- Participants had a median age of 69 years and a median duration of diabetes of 10.1 years.
- SGLT2 inhibitor users had higher PAD-related surgical events than DPP-4 inhibitor users (874 vs 780), with event rates of 11.2 vs 10.0 per 1000 person-years (adjusted hazard ratio [aHR], 1.18).
- The results remained consistent after 90 and 360 days of stopping SGLT2 inhibitors.
- SGLT2 inhibitor use was also associated with a higher risk for amputation (aHR, 1.15) and revascularization (aHR, 1.25) events than DPP-4 inhibitor use.
IN PRACTICE:
“These results underscore the need to determine the safety of [SGLT2 inhibitor] use among patients with diabetes who remain at very high risk for PAD,” the authors wrote.
SOURCE:
This study was led by Katherine E. Griffin, Geriatric Research Education and Clinical Center, Tennessee Valley Healthcare System, Nashville, and published online in Diabetes Care.
LIMITATIONS:
The study excluded patients whose initial diabetes treatment was not metformin, insulin, or sulfonylurea, which might have influenced the interpretation of the results. The median follow-up period of approximately 0.7 years for both groups may have affected the number of amputations and revascularization events observed. The study population primarily comprised White men, limiting generalizability to women and other demographic groups.
DISCLOSURES:
The study received funding through an investigator-initiated grant from the Veterans Affairs Clinical Science Research and Development. Two authors received partial research support through a grant from the Center for Diabetes Translation Research. All authors received partial support from the VETWISE-LHS Center of Innovation. No potential conflicts of interest relevant to the article were reported.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Among older veterans with type 2 diabetes (T2D), the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors as an add-on therapy is associated with a higher risk for peripheral artery disease (PAD)-related surgical events than the use of dipeptidyl peptidase 4 (DPP-4) inhibitors.
METHODOLOGY:
- Some placebo-controlled randomized trials have reported an increased risk for amputation with the use of SGLT2 inhibitors in patients with underlying cardiovascular diseases; however, the evidence remains unconfirmed by other subsequent trials.
- Researchers conducted a retrospective study of US veterans with T2D initiating SGLT2 inhibitors or DPP-4 inhibitors (a reference drug) as an add-on to metformin, sulfonylurea, or insulin treatment alone or in combination.
- The primary outcome was the time to the first surgical event for PAD (amputation, peripheral revascularization and bypass, or peripheral vascular stent).
- A Cox proportional hazards model was used to compare PAD event risk between the SGLT2 inhibitor and DPP-4 inhibitor groups, allowing events up to 90 days or 360 days after stopping SGLT2 inhibitors.
TAKEAWAY:
- After propensity score weighting, 76,072 episodes of SGLT2 inhibitor use (94% empagliflozin, 4% canagliflozin, and 2% dapagliflozin) and 75,833 episodes of DPP-4 inhibitor use (45% saxagliptin, 34% alogliptin, 15% sitagliptin, and 6% linagliptin) were included.
- Participants had a median age of 69 years and a median duration of diabetes of 10.1 years.
- SGLT2 inhibitor users had higher PAD-related surgical events than DPP-4 inhibitor users (874 vs 780), with event rates of 11.2 vs 10.0 per 1000 person-years (adjusted hazard ratio [aHR], 1.18).
- The results remained consistent after 90 and 360 days of stopping SGLT2 inhibitors.
- SGLT2 inhibitor use was also associated with a higher risk for amputation (aHR, 1.15) and revascularization (aHR, 1.25) events than DPP-4 inhibitor use.
IN PRACTICE:
“These results underscore the need to determine the safety of [SGLT2 inhibitor] use among patients with diabetes who remain at very high risk for PAD,” the authors wrote.
SOURCE:
This study was led by Katherine E. Griffin, Geriatric Research Education and Clinical Center, Tennessee Valley Healthcare System, Nashville, and published online in Diabetes Care.
LIMITATIONS:
The study excluded patients whose initial diabetes treatment was not metformin, insulin, or sulfonylurea, which might have influenced the interpretation of the results. The median follow-up period of approximately 0.7 years for both groups may have affected the number of amputations and revascularization events observed. The study population primarily comprised White men, limiting generalizability to women and other demographic groups.
DISCLOSURES:
The study received funding through an investigator-initiated grant from the Veterans Affairs Clinical Science Research and Development. Two authors received partial research support through a grant from the Center for Diabetes Translation Research. All authors received partial support from the VETWISE-LHS Center of Innovation. No potential conflicts of interest relevant to the article were reported.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Among older veterans with type 2 diabetes (T2D), the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors as an add-on therapy is associated with a higher risk for peripheral artery disease (PAD)-related surgical events than the use of dipeptidyl peptidase 4 (DPP-4) inhibitors.
METHODOLOGY:
- Some placebo-controlled randomized trials have reported an increased risk for amputation with the use of SGLT2 inhibitors in patients with underlying cardiovascular diseases; however, the evidence remains unconfirmed by other subsequent trials.
- Researchers conducted a retrospective study of US veterans with T2D initiating SGLT2 inhibitors or DPP-4 inhibitors (a reference drug) as an add-on to metformin, sulfonylurea, or insulin treatment alone or in combination.
- The primary outcome was the time to the first surgical event for PAD (amputation, peripheral revascularization and bypass, or peripheral vascular stent).
- A Cox proportional hazards model was used to compare PAD event risk between the SGLT2 inhibitor and DPP-4 inhibitor groups, allowing events up to 90 days or 360 days after stopping SGLT2 inhibitors.
TAKEAWAY:
- After propensity score weighting, 76,072 episodes of SGLT2 inhibitor use (94% empagliflozin, 4% canagliflozin, and 2% dapagliflozin) and 75,833 episodes of DPP-4 inhibitor use (45% saxagliptin, 34% alogliptin, 15% sitagliptin, and 6% linagliptin) were included.
- Participants had a median age of 69 years and a median duration of diabetes of 10.1 years.
- SGLT2 inhibitor users had higher PAD-related surgical events than DPP-4 inhibitor users (874 vs 780), with event rates of 11.2 vs 10.0 per 1000 person-years (adjusted hazard ratio [aHR], 1.18).
- The results remained consistent after 90 and 360 days of stopping SGLT2 inhibitors.
- SGLT2 inhibitor use was also associated with a higher risk for amputation (aHR, 1.15) and revascularization (aHR, 1.25) events than DPP-4 inhibitor use.
IN PRACTICE:
“These results underscore the need to determine the safety of [SGLT2 inhibitor] use among patients with diabetes who remain at very high risk for PAD,” the authors wrote.
SOURCE:
This study was led by Katherine E. Griffin, Geriatric Research Education and Clinical Center, Tennessee Valley Healthcare System, Nashville, and published online in Diabetes Care.
LIMITATIONS:
The study excluded patients whose initial diabetes treatment was not metformin, insulin, or sulfonylurea, which might have influenced the interpretation of the results. The median follow-up period of approximately 0.7 years for both groups may have affected the number of amputations and revascularization events observed. The study population primarily comprised White men, limiting generalizability to women and other demographic groups.
DISCLOSURES:
The study received funding through an investigator-initiated grant from the Veterans Affairs Clinical Science Research and Development. Two authors received partial research support through a grant from the Center for Diabetes Translation Research. All authors received partial support from the VETWISE-LHS Center of Innovation. No potential conflicts of interest relevant to the article were reported.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Cultural Respect vs Individual Patient Autonomy: A Delicate Balancing Act
Cultural competency is one of the most important values in the practice of medicine. Defined as the “ability to collaborate effectively with individuals from different cultures,” this type of competence “improves healthcare experiences and outcomes.” But within the context of cultural familiarity, it’s equally important to “understand that each person is an individual and may or may not adhere to certain cultural beliefs or practices common in his or her culture,” according to the Agency for Healthcare Research and Quality’s (AHRQ’s) Health Literacy Universal Precautions Toolkit.
Sarah Candler, MD, MPH, an internal medicine physician specializing in primary care for older adults in Washington, DC, said that the medical code of ethics consists of several pillars, with patient autonomy as the “first and most primary of those pillars.” She calls the balance of patient autonomy and cultural respect a “complicated tightrope to walk,” but says that these ethical principles can inform medical decisions and the patient-physician relationship.
Cultural Familiarity
It’s important to be as familiar as possible with the patient’s culture, Santina Wheat, MD, program director, Northwestern McGaw Family Medicine Residency at Delnor Hospital, Geneva, told this news organization. “For example, we serve many Orthodox Jewish patients. We had a meeting with rabbis from the community to present to us what religious laws might affect our patients. Until recently, I was delivering babies, and there was always a 24-hour emergency rabbi on call if an Orthodox patient wanted the input of a rabbi into her decisions.”
Jay W. Lee, MD, MPH, a member of the board of directors of the American Academy of Family Physicians, also sets out to educate himself about the cultural norms of his patients if they come from populations he’s not familiar with. “For example, this comes up when a new refugee population comes to the United States — most recently, there was a population of Afghan refugees,” Lee told this news organization.
Lee spent “a lot of time trying to learn about their cultural norms,” which prepared him to “ask more targeted questions about the patient’s understanding of the tests we were ordering or treatment options we were bringing forward.”
Lee, also the medical director at Integrated Health Partners of Southern California and associate clinical professor of family medicine at the University of California, Irvine, said it might be best if the physician is “language congruent or culturally similar.” Lee is of Asian descent and also speaks Spanish fluently. “I enjoy cultural exchanges with my patients, and I encourage patients to find a physician who’s the best fit.” But being from the same culture isn’t absolutely necessary for building relationships with the patient. “The key is offering the patient autonomy” while understanding the cultural context.
Don’t Assume ... Always Ask
Cultural familiarity doesn’t equate with stereotyping, Wheat emphasized. “Proceeding without assumptions opens the opportunity to ask questions for clarification and understanding and to improve patient care,” said Lee.
Sara Glass, PhD, LCSW, agrees. She’s the clinical director of Soul Wellness NYC, New York City, a psychotherapy practice that specializes in treating trauma. Based on her own experiences, she knows that some physicians and other healthcare professionals confuse cultural sensitivity with cultural stereotyping.
Glass, formerly Hasidic and ultra-Orthodox, shared an example from her own life. During the delivery of her second child, she sustained a vaginal tear. At her 6-week postpartum visit, her ob/gyn said, “Just remind me when you’re in your ninth month next time, and I can sew it up right after you deliver.”
Much of this physician’s practice “consisted of Hasidic women who looked just like me, wearing the same garb — head coverings such as wigs and scarves and long skirts. Most women in that community have multiple pregnancies,” Glass told this news organization. “My sister has 10 children, and that’s not unusual. The doctor simply assumed I’d be going on to have more babies without asking if that’s what I wanted.”
Glass says she was also never given information by her physician about the range of available contraceptive options. The rabbis of the Hasidic sect to which Glass belonged allowed women to practice contraception for 6 months following childbirth, or for longer, in the setting of certain medical conditions, but only certain types of birth control were religiously permissible. Other options were not mentioned to her by her physician, and she didn’t know that they existed.
Making no assumptions applies not only to patients from other cultures but also to all patients — including members of “mainstream American culture.”
Candler recalls a young patient with a new baby, who shared “how exhausted she was and how much time, energy, and work it took to care for children,” Candler recounted. “To me, it sounded as though she didn’t want another child, and I was about to offer contraception when it occurred to me to first ask if she wanted to have more children.” Candler was surprised when the patient said that, although she wasn’t actively looking to become pregnant again, she didn’t want to take preventive measures. “I’m so glad I asked, rather than simply assuming.”
Culture Is Mutable
Important questions to ask patients include whether there are aspects of their culture or religion that might affect their care — which can include medications they may feel uncomfortable using — and what family members they want to have involved in clinical discussions and decisions, said Wheat.
Lee described treating a refugee from Afghanistan who was in her sixth month of pregnancy. “I quickly needed to learn about what her expectations were for her care and my presence as a male on her care team,” he recounted. Lee arranged for the patient to receive prenatal care from a different clinician and arranged for follow-up for her husband and children. “Everyone had good results.”
Candler noted that some patients choose their physician specifically because that practitioner is conversant with their culture and respectful of its mores — especially when physicians share the same culture as the patient. But that level of familiarity can make it easy to forget to ask questions about the experience of the individual patient within that culture.
Moreover, Glass suggested, some physicians who treat patients from a particular culture or religious group may be concerned about offending them or antagonizing religious leaders if they discuss medical options that aren’t accepted or practiced in that community or culture, such as vasectomy for male contraception. “But that deprives patients of knowing what choices are available and making truly informed decisions.”
This is especially important because “culture is mutable,” said Candler, and religious or cultural practices can “look one way on paper but be implemented, adopted, or executed in a completely different way by every human being who lives in that culture.” The best cultural competency “comes from continuing to build relationships with our patients. But even in a single visit, a single hospitalization, we should get to know patients as human beings, not just members of a given culture.”
There are cultures in which families want to be the liaison between the patient and the physician and to make decisions on the patient’s behalf. “I always ask patients what role they want their family members to play even if the cultural expectation is that the family will be heavily involved,” Candler said.
Sometimes, this can be awkward, and families might become upset. Candler described an elderly, frail patient who was diagnosed with end-stage cancer. She had always relied heavily on family to care for her. Concerned about overburdening them, she didn’t want them to know her diagnosis. The patient was mentally competent to make that decision.
“Usually, I would have had the family at the bedside so I could be sure everyone was appropriately informed and prepared for what lay ahead, but in this case, I couldn’t do so,” Candler said. “I had to inform her entire care team not to discuss the cancer diagnosis with any family members because this was the patient’s express wish. And when the family asked me if the diagnosis was cancer, I had to respond, ‘I’m so sorry, but your loved one doesn’t want us to discuss details of her diagnosis.’”
Other patients don’t want to know their own diagnosis and specifically ask Candler to inform a family member. “I’ve had patients request that I tell their children. They want their children to make decisions on their behalf.”
The main thing, Candler emphasized, is to “ask the patient, make sure the patient is competent to make that decision, thoroughly document the patient’s decision in the chart, and respect whatever that decision is.”
You Can Revisit the Questions
Having a longitudinal relationship means that the physician can revisit the same questions at different junctures because people’s perspectives sometimes change over time. “Discussing what a patient wants isn’t necessarily a one-time occurrence,” Wheat said. For example, “I’ve had situations where a patient has been a member of Jehovah’s Witnesses and won’t accept blood products — like transfusions — in treatment. I tell these patients that if an emergent situation arises, I would like to have the conversation again.”
Of course, sometimes patients are seen in the emergency department or in other situations where the physician has no prior relationship with them. “I always go into a room, especially with new patients, aiming to build rapport, communicate with a high level of respect, introduce myself, explain my approach, and understand the patient’s wishes,” Lee said. “As scenarios play out, I ask in multiple ways for the patient to confirm those wishes.”
He acknowledges that this can be time-consuming, “but it helps ensure the care that patient receives is complete, thorough, comprehensive, and respectful of the patient’s values and wishes.”
Candler disclosed paid part-time clinical work at CuraCapitol Primary Care Services, volunteer advocacy (reimbursed for travel) for the American College of Physicians, volunteer advocacy (reimbursed for travel) for the American Medical Association while serving on their Task Force to Preserve the Patient-Physician Relationship, and serving as a partner representative (reimbursed for time) for the AHRQ’s Person-Centered Care Planning Partnership, representing the American College of Physicians. Lee, Wheat, and Glass disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cultural competency is one of the most important values in the practice of medicine. Defined as the “ability to collaborate effectively with individuals from different cultures,” this type of competence “improves healthcare experiences and outcomes.” But within the context of cultural familiarity, it’s equally important to “understand that each person is an individual and may or may not adhere to certain cultural beliefs or practices common in his or her culture,” according to the Agency for Healthcare Research and Quality’s (AHRQ’s) Health Literacy Universal Precautions Toolkit.
Sarah Candler, MD, MPH, an internal medicine physician specializing in primary care for older adults in Washington, DC, said that the medical code of ethics consists of several pillars, with patient autonomy as the “first and most primary of those pillars.” She calls the balance of patient autonomy and cultural respect a “complicated tightrope to walk,” but says that these ethical principles can inform medical decisions and the patient-physician relationship.
Cultural Familiarity
It’s important to be as familiar as possible with the patient’s culture, Santina Wheat, MD, program director, Northwestern McGaw Family Medicine Residency at Delnor Hospital, Geneva, told this news organization. “For example, we serve many Orthodox Jewish patients. We had a meeting with rabbis from the community to present to us what religious laws might affect our patients. Until recently, I was delivering babies, and there was always a 24-hour emergency rabbi on call if an Orthodox patient wanted the input of a rabbi into her decisions.”
Jay W. Lee, MD, MPH, a member of the board of directors of the American Academy of Family Physicians, also sets out to educate himself about the cultural norms of his patients if they come from populations he’s not familiar with. “For example, this comes up when a new refugee population comes to the United States — most recently, there was a population of Afghan refugees,” Lee told this news organization.
Lee spent “a lot of time trying to learn about their cultural norms,” which prepared him to “ask more targeted questions about the patient’s understanding of the tests we were ordering or treatment options we were bringing forward.”
Lee, also the medical director at Integrated Health Partners of Southern California and associate clinical professor of family medicine at the University of California, Irvine, said it might be best if the physician is “language congruent or culturally similar.” Lee is of Asian descent and also speaks Spanish fluently. “I enjoy cultural exchanges with my patients, and I encourage patients to find a physician who’s the best fit.” But being from the same culture isn’t absolutely necessary for building relationships with the patient. “The key is offering the patient autonomy” while understanding the cultural context.
Don’t Assume ... Always Ask
Cultural familiarity doesn’t equate with stereotyping, Wheat emphasized. “Proceeding without assumptions opens the opportunity to ask questions for clarification and understanding and to improve patient care,” said Lee.
Sara Glass, PhD, LCSW, agrees. She’s the clinical director of Soul Wellness NYC, New York City, a psychotherapy practice that specializes in treating trauma. Based on her own experiences, she knows that some physicians and other healthcare professionals confuse cultural sensitivity with cultural stereotyping.
Glass, formerly Hasidic and ultra-Orthodox, shared an example from her own life. During the delivery of her second child, she sustained a vaginal tear. At her 6-week postpartum visit, her ob/gyn said, “Just remind me when you’re in your ninth month next time, and I can sew it up right after you deliver.”
Much of this physician’s practice “consisted of Hasidic women who looked just like me, wearing the same garb — head coverings such as wigs and scarves and long skirts. Most women in that community have multiple pregnancies,” Glass told this news organization. “My sister has 10 children, and that’s not unusual. The doctor simply assumed I’d be going on to have more babies without asking if that’s what I wanted.”
Glass says she was also never given information by her physician about the range of available contraceptive options. The rabbis of the Hasidic sect to which Glass belonged allowed women to practice contraception for 6 months following childbirth, or for longer, in the setting of certain medical conditions, but only certain types of birth control were religiously permissible. Other options were not mentioned to her by her physician, and she didn’t know that they existed.
Making no assumptions applies not only to patients from other cultures but also to all patients — including members of “mainstream American culture.”
Candler recalls a young patient with a new baby, who shared “how exhausted she was and how much time, energy, and work it took to care for children,” Candler recounted. “To me, it sounded as though she didn’t want another child, and I was about to offer contraception when it occurred to me to first ask if she wanted to have more children.” Candler was surprised when the patient said that, although she wasn’t actively looking to become pregnant again, she didn’t want to take preventive measures. “I’m so glad I asked, rather than simply assuming.”
Culture Is Mutable
Important questions to ask patients include whether there are aspects of their culture or religion that might affect their care — which can include medications they may feel uncomfortable using — and what family members they want to have involved in clinical discussions and decisions, said Wheat.
Lee described treating a refugee from Afghanistan who was in her sixth month of pregnancy. “I quickly needed to learn about what her expectations were for her care and my presence as a male on her care team,” he recounted. Lee arranged for the patient to receive prenatal care from a different clinician and arranged for follow-up for her husband and children. “Everyone had good results.”
Candler noted that some patients choose their physician specifically because that practitioner is conversant with their culture and respectful of its mores — especially when physicians share the same culture as the patient. But that level of familiarity can make it easy to forget to ask questions about the experience of the individual patient within that culture.
Moreover, Glass suggested, some physicians who treat patients from a particular culture or religious group may be concerned about offending them or antagonizing religious leaders if they discuss medical options that aren’t accepted or practiced in that community or culture, such as vasectomy for male contraception. “But that deprives patients of knowing what choices are available and making truly informed decisions.”
This is especially important because “culture is mutable,” said Candler, and religious or cultural practices can “look one way on paper but be implemented, adopted, or executed in a completely different way by every human being who lives in that culture.” The best cultural competency “comes from continuing to build relationships with our patients. But even in a single visit, a single hospitalization, we should get to know patients as human beings, not just members of a given culture.”
There are cultures in which families want to be the liaison between the patient and the physician and to make decisions on the patient’s behalf. “I always ask patients what role they want their family members to play even if the cultural expectation is that the family will be heavily involved,” Candler said.
Sometimes, this can be awkward, and families might become upset. Candler described an elderly, frail patient who was diagnosed with end-stage cancer. She had always relied heavily on family to care for her. Concerned about overburdening them, she didn’t want them to know her diagnosis. The patient was mentally competent to make that decision.
“Usually, I would have had the family at the bedside so I could be sure everyone was appropriately informed and prepared for what lay ahead, but in this case, I couldn’t do so,” Candler said. “I had to inform her entire care team not to discuss the cancer diagnosis with any family members because this was the patient’s express wish. And when the family asked me if the diagnosis was cancer, I had to respond, ‘I’m so sorry, but your loved one doesn’t want us to discuss details of her diagnosis.’”
Other patients don’t want to know their own diagnosis and specifically ask Candler to inform a family member. “I’ve had patients request that I tell their children. They want their children to make decisions on their behalf.”
The main thing, Candler emphasized, is to “ask the patient, make sure the patient is competent to make that decision, thoroughly document the patient’s decision in the chart, and respect whatever that decision is.”
You Can Revisit the Questions
Having a longitudinal relationship means that the physician can revisit the same questions at different junctures because people’s perspectives sometimes change over time. “Discussing what a patient wants isn’t necessarily a one-time occurrence,” Wheat said. For example, “I’ve had situations where a patient has been a member of Jehovah’s Witnesses and won’t accept blood products — like transfusions — in treatment. I tell these patients that if an emergent situation arises, I would like to have the conversation again.”
Of course, sometimes patients are seen in the emergency department or in other situations where the physician has no prior relationship with them. “I always go into a room, especially with new patients, aiming to build rapport, communicate with a high level of respect, introduce myself, explain my approach, and understand the patient’s wishes,” Lee said. “As scenarios play out, I ask in multiple ways for the patient to confirm those wishes.”
He acknowledges that this can be time-consuming, “but it helps ensure the care that patient receives is complete, thorough, comprehensive, and respectful of the patient’s values and wishes.”
Candler disclosed paid part-time clinical work at CuraCapitol Primary Care Services, volunteer advocacy (reimbursed for travel) for the American College of Physicians, volunteer advocacy (reimbursed for travel) for the American Medical Association while serving on their Task Force to Preserve the Patient-Physician Relationship, and serving as a partner representative (reimbursed for time) for the AHRQ’s Person-Centered Care Planning Partnership, representing the American College of Physicians. Lee, Wheat, and Glass disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cultural competency is one of the most important values in the practice of medicine. Defined as the “ability to collaborate effectively with individuals from different cultures,” this type of competence “improves healthcare experiences and outcomes.” But within the context of cultural familiarity, it’s equally important to “understand that each person is an individual and may or may not adhere to certain cultural beliefs or practices common in his or her culture,” according to the Agency for Healthcare Research and Quality’s (AHRQ’s) Health Literacy Universal Precautions Toolkit.
Sarah Candler, MD, MPH, an internal medicine physician specializing in primary care for older adults in Washington, DC, said that the medical code of ethics consists of several pillars, with patient autonomy as the “first and most primary of those pillars.” She calls the balance of patient autonomy and cultural respect a “complicated tightrope to walk,” but says that these ethical principles can inform medical decisions and the patient-physician relationship.
Cultural Familiarity
It’s important to be as familiar as possible with the patient’s culture, Santina Wheat, MD, program director, Northwestern McGaw Family Medicine Residency at Delnor Hospital, Geneva, told this news organization. “For example, we serve many Orthodox Jewish patients. We had a meeting with rabbis from the community to present to us what religious laws might affect our patients. Until recently, I was delivering babies, and there was always a 24-hour emergency rabbi on call if an Orthodox patient wanted the input of a rabbi into her decisions.”
Jay W. Lee, MD, MPH, a member of the board of directors of the American Academy of Family Physicians, also sets out to educate himself about the cultural norms of his patients if they come from populations he’s not familiar with. “For example, this comes up when a new refugee population comes to the United States — most recently, there was a population of Afghan refugees,” Lee told this news organization.
Lee spent “a lot of time trying to learn about their cultural norms,” which prepared him to “ask more targeted questions about the patient’s understanding of the tests we were ordering or treatment options we were bringing forward.”
Lee, also the medical director at Integrated Health Partners of Southern California and associate clinical professor of family medicine at the University of California, Irvine, said it might be best if the physician is “language congruent or culturally similar.” Lee is of Asian descent and also speaks Spanish fluently. “I enjoy cultural exchanges with my patients, and I encourage patients to find a physician who’s the best fit.” But being from the same culture isn’t absolutely necessary for building relationships with the patient. “The key is offering the patient autonomy” while understanding the cultural context.
Don’t Assume ... Always Ask
Cultural familiarity doesn’t equate with stereotyping, Wheat emphasized. “Proceeding without assumptions opens the opportunity to ask questions for clarification and understanding and to improve patient care,” said Lee.
Sara Glass, PhD, LCSW, agrees. She’s the clinical director of Soul Wellness NYC, New York City, a psychotherapy practice that specializes in treating trauma. Based on her own experiences, she knows that some physicians and other healthcare professionals confuse cultural sensitivity with cultural stereotyping.
Glass, formerly Hasidic and ultra-Orthodox, shared an example from her own life. During the delivery of her second child, she sustained a vaginal tear. At her 6-week postpartum visit, her ob/gyn said, “Just remind me when you’re in your ninth month next time, and I can sew it up right after you deliver.”
Much of this physician’s practice “consisted of Hasidic women who looked just like me, wearing the same garb — head coverings such as wigs and scarves and long skirts. Most women in that community have multiple pregnancies,” Glass told this news organization. “My sister has 10 children, and that’s not unusual. The doctor simply assumed I’d be going on to have more babies without asking if that’s what I wanted.”
Glass says she was also never given information by her physician about the range of available contraceptive options. The rabbis of the Hasidic sect to which Glass belonged allowed women to practice contraception for 6 months following childbirth, or for longer, in the setting of certain medical conditions, but only certain types of birth control were religiously permissible. Other options were not mentioned to her by her physician, and she didn’t know that they existed.
Making no assumptions applies not only to patients from other cultures but also to all patients — including members of “mainstream American culture.”
Candler recalls a young patient with a new baby, who shared “how exhausted she was and how much time, energy, and work it took to care for children,” Candler recounted. “To me, it sounded as though she didn’t want another child, and I was about to offer contraception when it occurred to me to first ask if she wanted to have more children.” Candler was surprised when the patient said that, although she wasn’t actively looking to become pregnant again, she didn’t want to take preventive measures. “I’m so glad I asked, rather than simply assuming.”
Culture Is Mutable
Important questions to ask patients include whether there are aspects of their culture or religion that might affect their care — which can include medications they may feel uncomfortable using — and what family members they want to have involved in clinical discussions and decisions, said Wheat.
Lee described treating a refugee from Afghanistan who was in her sixth month of pregnancy. “I quickly needed to learn about what her expectations were for her care and my presence as a male on her care team,” he recounted. Lee arranged for the patient to receive prenatal care from a different clinician and arranged for follow-up for her husband and children. “Everyone had good results.”
Candler noted that some patients choose their physician specifically because that practitioner is conversant with their culture and respectful of its mores — especially when physicians share the same culture as the patient. But that level of familiarity can make it easy to forget to ask questions about the experience of the individual patient within that culture.
Moreover, Glass suggested, some physicians who treat patients from a particular culture or religious group may be concerned about offending them or antagonizing religious leaders if they discuss medical options that aren’t accepted or practiced in that community or culture, such as vasectomy for male contraception. “But that deprives patients of knowing what choices are available and making truly informed decisions.”
This is especially important because “culture is mutable,” said Candler, and religious or cultural practices can “look one way on paper but be implemented, adopted, or executed in a completely different way by every human being who lives in that culture.” The best cultural competency “comes from continuing to build relationships with our patients. But even in a single visit, a single hospitalization, we should get to know patients as human beings, not just members of a given culture.”
There are cultures in which families want to be the liaison between the patient and the physician and to make decisions on the patient’s behalf. “I always ask patients what role they want their family members to play even if the cultural expectation is that the family will be heavily involved,” Candler said.
Sometimes, this can be awkward, and families might become upset. Candler described an elderly, frail patient who was diagnosed with end-stage cancer. She had always relied heavily on family to care for her. Concerned about overburdening them, she didn’t want them to know her diagnosis. The patient was mentally competent to make that decision.
“Usually, I would have had the family at the bedside so I could be sure everyone was appropriately informed and prepared for what lay ahead, but in this case, I couldn’t do so,” Candler said. “I had to inform her entire care team not to discuss the cancer diagnosis with any family members because this was the patient’s express wish. And when the family asked me if the diagnosis was cancer, I had to respond, ‘I’m so sorry, but your loved one doesn’t want us to discuss details of her diagnosis.’”
Other patients don’t want to know their own diagnosis and specifically ask Candler to inform a family member. “I’ve had patients request that I tell their children. They want their children to make decisions on their behalf.”
The main thing, Candler emphasized, is to “ask the patient, make sure the patient is competent to make that decision, thoroughly document the patient’s decision in the chart, and respect whatever that decision is.”
You Can Revisit the Questions
Having a longitudinal relationship means that the physician can revisit the same questions at different junctures because people’s perspectives sometimes change over time. “Discussing what a patient wants isn’t necessarily a one-time occurrence,” Wheat said. For example, “I’ve had situations where a patient has been a member of Jehovah’s Witnesses and won’t accept blood products — like transfusions — in treatment. I tell these patients that if an emergent situation arises, I would like to have the conversation again.”
Of course, sometimes patients are seen in the emergency department or in other situations where the physician has no prior relationship with them. “I always go into a room, especially with new patients, aiming to build rapport, communicate with a high level of respect, introduce myself, explain my approach, and understand the patient’s wishes,” Lee said. “As scenarios play out, I ask in multiple ways for the patient to confirm those wishes.”
He acknowledges that this can be time-consuming, “but it helps ensure the care that patient receives is complete, thorough, comprehensive, and respectful of the patient’s values and wishes.”
Candler disclosed paid part-time clinical work at CuraCapitol Primary Care Services, volunteer advocacy (reimbursed for travel) for the American College of Physicians, volunteer advocacy (reimbursed for travel) for the American Medical Association while serving on their Task Force to Preserve the Patient-Physician Relationship, and serving as a partner representative (reimbursed for time) for the AHRQ’s Person-Centered Care Planning Partnership, representing the American College of Physicians. Lee, Wheat, and Glass disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.