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Improved cancer survival in states with ACA Medicaid expansion
compared with patients in states that did not adopt the expansion.
The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.
The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.
Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.
“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”
The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.
As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.
An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
Improved survival with expansion
In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.
The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.
Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states.
During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).
Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.
The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.
This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.
For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.
“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”
A version of this article first appeared on Medscape.com.
compared with patients in states that did not adopt the expansion.
The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.
The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.
Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.
“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”
The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.
As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.
An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
Improved survival with expansion
In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.
The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.
Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states.
During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).
Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.
The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.
This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.
For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.
“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”
A version of this article first appeared on Medscape.com.
compared with patients in states that did not adopt the expansion.
The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.
The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.
Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.
“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”
The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.
As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.
An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
Improved survival with expansion
In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.
The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.
Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states.
During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).
Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.
The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.
This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.
For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.
“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”
A version of this article first appeared on Medscape.com.
Doc faces U.S. federal charges for hacking, ransomware
According to a statement from the U.S. Department of Justice, 55-year-old Moises Luis Zagala Gonzalez, MD, is charged with creating and distributing ransomware with a “doomsday” clock and sharing in profits from ransomware attacks.
Dr. Zagala, also known as “Nosophoros,” “Aesculapius,” and “Nebuchadnezzar,” is a citizen of France and Venezuela who currently lives in Ciudad Bolivar, Venezuela.
Breon Peace, U.S. attorney for the Eastern District of New York, and Michael J. Driscoll, assistant director in charge of the Federal Bureau of Investigaton’s New York Field Office, announced the charges.
“As alleged, the multitasking doctor treated patients, created and named his cyber tool after death, profited from a global ransomware ecosystem in which he sold the tools for conducting ransomware attacks, trained the attackers about how to extort victims, and then boasted about successful attacks, including by malicious actors associated with the government of Iran,” Mr. Peace said in the news release from the DOJ.
“We allege Zagala not only created and sold ransomware products to hackers, but also trained them in their use. Our actions today will prevent Zagala from further victimizing users,” Mr. Driscoll said. “However, many other malicious criminals are searching for businesses and organizations that haven’t taken steps to protect their systems – which is an incredibly vital step in stopping the next ransomware attack.”
Ransomware tools are malicious software that cybercriminals use to extort money from companies, nonprofits, and other institutions by encrypting their files and then demanding a ransom for the decryption keys.
One of Dr. Zagala’s early ransomware tools, called “Jigsaw v. 2,” had what Dr. Zagala described as a doomsday counter that kept track of how many times the user tried to remove the ransomware. “If the user kills the ransomware too many times, then it’s clear he won’t pay so better erase the whole hard drive,” Dr. Zagala wrote.
According to the DOJ, beginning in late 2019, Dr. Zagala began advertising a new tool as a “private ransomware builder,” which he called Thanos. The name appears to be in reference to a fictional villain responsible for destroying half of all life in the universe and to “Thanatos” from Greek mythology, who is associated with death.
Dr. Zagala’s Thanos software allows users to create their own unique ransomware software for personal use or to rent to other cybercriminals.
Dr. Zagala allegedly not only sold or rented out his ransomware tools to cybercriminals, but he also taught users how to deploy the tools, steal passwords from victim computers, and set up a Bitcoin address for ransom payments.
Dr. Zagala’s customers were happy with his products, the DOJ release noted. In a message posted in July 2020, one user said the ransomware was “very powerful” and claimed that he had used it to infect a network of roughly 3,000 computers.
In December 2020, another user wrote a post in Russian: “We have been working with this product for over a month now, we have a good profit! Best support I’ve met.”
Earlier in May, law enforcement agents interviewed a relative of Dr. Zagala who lives in Florida and whose PayPal account was used by Dr. Zagala to receive illicit proceeds.
According to the DOJ, the relative confirmed that Dr. Zagala lives in Venezuela and had taught himself computer programming. The relative also showed agents contact information for Dr. Zagala that matched the registered email for malicious infrastructure associated with the Thanos ransomware.
Dr. Zagala, who remains in Venezuela, faces up to 10 years in prison for attempted computer intrusions and conspiracy charges if brought to justice in the United States.
A version of this article first appeared on Medscape.com.
According to a statement from the U.S. Department of Justice, 55-year-old Moises Luis Zagala Gonzalez, MD, is charged with creating and distributing ransomware with a “doomsday” clock and sharing in profits from ransomware attacks.
Dr. Zagala, also known as “Nosophoros,” “Aesculapius,” and “Nebuchadnezzar,” is a citizen of France and Venezuela who currently lives in Ciudad Bolivar, Venezuela.
Breon Peace, U.S. attorney for the Eastern District of New York, and Michael J. Driscoll, assistant director in charge of the Federal Bureau of Investigaton’s New York Field Office, announced the charges.
“As alleged, the multitasking doctor treated patients, created and named his cyber tool after death, profited from a global ransomware ecosystem in which he sold the tools for conducting ransomware attacks, trained the attackers about how to extort victims, and then boasted about successful attacks, including by malicious actors associated with the government of Iran,” Mr. Peace said in the news release from the DOJ.
“We allege Zagala not only created and sold ransomware products to hackers, but also trained them in their use. Our actions today will prevent Zagala from further victimizing users,” Mr. Driscoll said. “However, many other malicious criminals are searching for businesses and organizations that haven’t taken steps to protect their systems – which is an incredibly vital step in stopping the next ransomware attack.”
Ransomware tools are malicious software that cybercriminals use to extort money from companies, nonprofits, and other institutions by encrypting their files and then demanding a ransom for the decryption keys.
One of Dr. Zagala’s early ransomware tools, called “Jigsaw v. 2,” had what Dr. Zagala described as a doomsday counter that kept track of how many times the user tried to remove the ransomware. “If the user kills the ransomware too many times, then it’s clear he won’t pay so better erase the whole hard drive,” Dr. Zagala wrote.
According to the DOJ, beginning in late 2019, Dr. Zagala began advertising a new tool as a “private ransomware builder,” which he called Thanos. The name appears to be in reference to a fictional villain responsible for destroying half of all life in the universe and to “Thanatos” from Greek mythology, who is associated with death.
Dr. Zagala’s Thanos software allows users to create their own unique ransomware software for personal use or to rent to other cybercriminals.
Dr. Zagala allegedly not only sold or rented out his ransomware tools to cybercriminals, but he also taught users how to deploy the tools, steal passwords from victim computers, and set up a Bitcoin address for ransom payments.
Dr. Zagala’s customers were happy with his products, the DOJ release noted. In a message posted in July 2020, one user said the ransomware was “very powerful” and claimed that he had used it to infect a network of roughly 3,000 computers.
In December 2020, another user wrote a post in Russian: “We have been working with this product for over a month now, we have a good profit! Best support I’ve met.”
Earlier in May, law enforcement agents interviewed a relative of Dr. Zagala who lives in Florida and whose PayPal account was used by Dr. Zagala to receive illicit proceeds.
According to the DOJ, the relative confirmed that Dr. Zagala lives in Venezuela and had taught himself computer programming. The relative also showed agents contact information for Dr. Zagala that matched the registered email for malicious infrastructure associated with the Thanos ransomware.
Dr. Zagala, who remains in Venezuela, faces up to 10 years in prison for attempted computer intrusions and conspiracy charges if brought to justice in the United States.
A version of this article first appeared on Medscape.com.
According to a statement from the U.S. Department of Justice, 55-year-old Moises Luis Zagala Gonzalez, MD, is charged with creating and distributing ransomware with a “doomsday” clock and sharing in profits from ransomware attacks.
Dr. Zagala, also known as “Nosophoros,” “Aesculapius,” and “Nebuchadnezzar,” is a citizen of France and Venezuela who currently lives in Ciudad Bolivar, Venezuela.
Breon Peace, U.S. attorney for the Eastern District of New York, and Michael J. Driscoll, assistant director in charge of the Federal Bureau of Investigaton’s New York Field Office, announced the charges.
“As alleged, the multitasking doctor treated patients, created and named his cyber tool after death, profited from a global ransomware ecosystem in which he sold the tools for conducting ransomware attacks, trained the attackers about how to extort victims, and then boasted about successful attacks, including by malicious actors associated with the government of Iran,” Mr. Peace said in the news release from the DOJ.
“We allege Zagala not only created and sold ransomware products to hackers, but also trained them in their use. Our actions today will prevent Zagala from further victimizing users,” Mr. Driscoll said. “However, many other malicious criminals are searching for businesses and organizations that haven’t taken steps to protect their systems – which is an incredibly vital step in stopping the next ransomware attack.”
Ransomware tools are malicious software that cybercriminals use to extort money from companies, nonprofits, and other institutions by encrypting their files and then demanding a ransom for the decryption keys.
One of Dr. Zagala’s early ransomware tools, called “Jigsaw v. 2,” had what Dr. Zagala described as a doomsday counter that kept track of how many times the user tried to remove the ransomware. “If the user kills the ransomware too many times, then it’s clear he won’t pay so better erase the whole hard drive,” Dr. Zagala wrote.
According to the DOJ, beginning in late 2019, Dr. Zagala began advertising a new tool as a “private ransomware builder,” which he called Thanos. The name appears to be in reference to a fictional villain responsible for destroying half of all life in the universe and to “Thanatos” from Greek mythology, who is associated with death.
Dr. Zagala’s Thanos software allows users to create their own unique ransomware software for personal use or to rent to other cybercriminals.
Dr. Zagala allegedly not only sold or rented out his ransomware tools to cybercriminals, but he also taught users how to deploy the tools, steal passwords from victim computers, and set up a Bitcoin address for ransom payments.
Dr. Zagala’s customers were happy with his products, the DOJ release noted. In a message posted in July 2020, one user said the ransomware was “very powerful” and claimed that he had used it to infect a network of roughly 3,000 computers.
In December 2020, another user wrote a post in Russian: “We have been working with this product for over a month now, we have a good profit! Best support I’ve met.”
Earlier in May, law enforcement agents interviewed a relative of Dr. Zagala who lives in Florida and whose PayPal account was used by Dr. Zagala to receive illicit proceeds.
According to the DOJ, the relative confirmed that Dr. Zagala lives in Venezuela and had taught himself computer programming. The relative also showed agents contact information for Dr. Zagala that matched the registered email for malicious infrastructure associated with the Thanos ransomware.
Dr. Zagala, who remains in Venezuela, faces up to 10 years in prison for attempted computer intrusions and conspiracy charges if brought to justice in the United States.
A version of this article first appeared on Medscape.com.
Finding ‘bright lights’: Why family physician continues to love practicing mid-career
A few years ago I tracked down my medical school interviewer to thank him for giving me the opportunity to do what I felt I was called to do. I was surprised that, after 15 years, he actually remembered me and remembered details like walking to the courtyard to meet my father who’d driven me to the interview.
Sharing my gratitude and letting him know I was happy felt important to me.
Choosing to practice family medicine has a lot to do with why I am happy in my career today.
One of my frustrations with health care had been its emphasis on treatment of sickness, rather than a broader one that incorporated prevention of sickness. During my third year of medical school, I was following a family and sports medicine faculty member who was focusing on aspects of lifestyle medicine to help a patient remain active and age gracefully. Seeing opportunities to practice preventative medicine in family medicine made me realize the specialty was the perfect fit for me.
Food as medicine
While participating in rotations I also realized you can find a subspecialty within family medicine.
During my fourth year of medical school, I followed an attending who was seeing a patient for hypertension, prediabetes and hypercholesterolemia. The attending told the patient to eat “healthier,” gave her a handout, and scheduled a follow up appointment for 6 months later.
My thoughts were: “That’s it? That’s how we counsel patients to improve their dietary habits?”
As the patient was leaving the exam room, I asked her what type of oil she cooked with, and I proceeded to share culinary tips from my mother – who was a self-taught and early adopter of the food-as-medicine movement.
Once I started my residency, I knew I’d want to incorporate lifestyle and dietary approaches at many of my patient visits.
I scheduled patients every month to monitor their weight, follow up on chronic conditions, but more importantly, to engage them in their health and empower them to make small lifestyle changes each month and report their efforts. I felt like I was their health coach and cheerleader.
My career in family medicine
Entering the job market allowed me to form my philosophy of treating patients with a mind, body, and spirit approach. I chose to practice value-based care, which aligns with my lifestyle and preventative medicine approach .
I currently practice in a small family medicine–only clinic that is part of a larger multispecialty system. Primary care specialties in my organization are valued, respected and central to a patient’s well being and care. We are encouraged to spend time with patients, assess barriers to care and work collaboratively with our healthcare team, so that preventative medicine approaches take the lead in a patient’s health. This supportive culture and environment is one where my passion for food as medicine has thrived.
One day I forgot to pack a lunch and instead brought a grocery bag of items to make a salad. When I realized I made too much, I sent an email to my staff to get some “free salad in my office.” This serendipitous moment started an informal office “salad club” each week. Continued support from my staff and leadership, allowed me to consider further extending this teaching to my patients and my colleagues.
Three years ago, I helped adopt a sustainable plant-forward menu for our physician meetings, complete with a recipe from the menu for physicians to replicate at home or give to their patients.
I also pursued adoption of shared medical appointments for our medical group. These appointments apply the “see one, do one, teach one” model in medicine, but with culinary medicine as the focus.
Knowing that my patients are all connected to their families through food, I sought this as an opportunity to dive in further with wellness opportunities at their next meal. After almost 2 years of working on this project, I was able to host my first shared medical appointment with a group of patients on March 12, 2020. The next day schools closed, lockdowns occurred, and the world changed.
Opportunities highlighted by the pandemic
We always knew health care was broken but adding the increasingly longer hours and COVID vaccine–hesitant patients that the pandemic brought made everything look dark at times. What has helped me stay hopeful and energetic for system changes is feeling gratitude and seeking bright lights.
My experiences seeing patients in telehealth visits are examples of some of the bright lights I found in the pandemic. During these visits, patients showed me something from their pantry, and we’d go over nutritional labels together.
Additionally, my patients became engaged with their own conditions and wanted to improve them because of news articles highlighting risk factors for COVID-19, such as obesity. I had an active audience when it came to talking about food-as-medicine approaches to improving risk factors and immunity. And since everyone was listening, I didn’t stop at food. I also talked about physical health, stress resiliency, planetary diets, sleep, connections, and lastly vaccines!
Once the vaccines were distributed, I naturally gravitated to having those conversations with patients and colleagues and on social media. Plus, the pandemic gave us moments of simple times to slow down, take more rests, be less overscheduled, consider work-life priorities, and, lastly, to be okay with not being totally okay.
In practicing primary care, we have a unique role in seeing medicine from a whole body, whole person, whole family perspective. There is an opportunity to highlight what is broken in medicine and aim to make it whole.
I’m currently looking at shared medical appointments as a new standard way to provide care to all patients, because it improves access, provides better quality visits and aligns my values, mission, and purpose.
In the midst of the pandemic, I helped advocate for a sustainable plant-forward menu that was launched throughout four different hospitals in the Sharp HealthCare system, in California, in 2020. Knowing that patients were served a menu I played a role in, gave me solace.
As part of the hospital food and nutrition team, I am grateful for the opportunity I have to work on a broader mission to address social determinants of health and seek opportunities to help the system work for our patients.
Public health communication has been lacking in the pandemic, but another bright light is that we were still the trusted messengers to our patients and our communities. I’m continually honored and humbled to be trusted with a whole family’s health.
Dr. Neison practices family medicine and culinary medicine at Sharp Rees-Stealy Medical Group in San Diego, and is cochair of climate and planetary health for SRS Medical Group. You can follow her on Instagram, LinkedIn, and Facebook @Flavors4WellnessMD.
A few years ago I tracked down my medical school interviewer to thank him for giving me the opportunity to do what I felt I was called to do. I was surprised that, after 15 years, he actually remembered me and remembered details like walking to the courtyard to meet my father who’d driven me to the interview.
Sharing my gratitude and letting him know I was happy felt important to me.
Choosing to practice family medicine has a lot to do with why I am happy in my career today.
One of my frustrations with health care had been its emphasis on treatment of sickness, rather than a broader one that incorporated prevention of sickness. During my third year of medical school, I was following a family and sports medicine faculty member who was focusing on aspects of lifestyle medicine to help a patient remain active and age gracefully. Seeing opportunities to practice preventative medicine in family medicine made me realize the specialty was the perfect fit for me.
Food as medicine
While participating in rotations I also realized you can find a subspecialty within family medicine.
During my fourth year of medical school, I followed an attending who was seeing a patient for hypertension, prediabetes and hypercholesterolemia. The attending told the patient to eat “healthier,” gave her a handout, and scheduled a follow up appointment for 6 months later.
My thoughts were: “That’s it? That’s how we counsel patients to improve their dietary habits?”
As the patient was leaving the exam room, I asked her what type of oil she cooked with, and I proceeded to share culinary tips from my mother – who was a self-taught and early adopter of the food-as-medicine movement.
Once I started my residency, I knew I’d want to incorporate lifestyle and dietary approaches at many of my patient visits.
I scheduled patients every month to monitor their weight, follow up on chronic conditions, but more importantly, to engage them in their health and empower them to make small lifestyle changes each month and report their efforts. I felt like I was their health coach and cheerleader.
My career in family medicine
Entering the job market allowed me to form my philosophy of treating patients with a mind, body, and spirit approach. I chose to practice value-based care, which aligns with my lifestyle and preventative medicine approach .
I currently practice in a small family medicine–only clinic that is part of a larger multispecialty system. Primary care specialties in my organization are valued, respected and central to a patient’s well being and care. We are encouraged to spend time with patients, assess barriers to care and work collaboratively with our healthcare team, so that preventative medicine approaches take the lead in a patient’s health. This supportive culture and environment is one where my passion for food as medicine has thrived.
One day I forgot to pack a lunch and instead brought a grocery bag of items to make a salad. When I realized I made too much, I sent an email to my staff to get some “free salad in my office.” This serendipitous moment started an informal office “salad club” each week. Continued support from my staff and leadership, allowed me to consider further extending this teaching to my patients and my colleagues.
Three years ago, I helped adopt a sustainable plant-forward menu for our physician meetings, complete with a recipe from the menu for physicians to replicate at home or give to their patients.
I also pursued adoption of shared medical appointments for our medical group. These appointments apply the “see one, do one, teach one” model in medicine, but with culinary medicine as the focus.
Knowing that my patients are all connected to their families through food, I sought this as an opportunity to dive in further with wellness opportunities at their next meal. After almost 2 years of working on this project, I was able to host my first shared medical appointment with a group of patients on March 12, 2020. The next day schools closed, lockdowns occurred, and the world changed.
Opportunities highlighted by the pandemic
We always knew health care was broken but adding the increasingly longer hours and COVID vaccine–hesitant patients that the pandemic brought made everything look dark at times. What has helped me stay hopeful and energetic for system changes is feeling gratitude and seeking bright lights.
My experiences seeing patients in telehealth visits are examples of some of the bright lights I found in the pandemic. During these visits, patients showed me something from their pantry, and we’d go over nutritional labels together.
Additionally, my patients became engaged with their own conditions and wanted to improve them because of news articles highlighting risk factors for COVID-19, such as obesity. I had an active audience when it came to talking about food-as-medicine approaches to improving risk factors and immunity. And since everyone was listening, I didn’t stop at food. I also talked about physical health, stress resiliency, planetary diets, sleep, connections, and lastly vaccines!
Once the vaccines were distributed, I naturally gravitated to having those conversations with patients and colleagues and on social media. Plus, the pandemic gave us moments of simple times to slow down, take more rests, be less overscheduled, consider work-life priorities, and, lastly, to be okay with not being totally okay.
In practicing primary care, we have a unique role in seeing medicine from a whole body, whole person, whole family perspective. There is an opportunity to highlight what is broken in medicine and aim to make it whole.
I’m currently looking at shared medical appointments as a new standard way to provide care to all patients, because it improves access, provides better quality visits and aligns my values, mission, and purpose.
In the midst of the pandemic, I helped advocate for a sustainable plant-forward menu that was launched throughout four different hospitals in the Sharp HealthCare system, in California, in 2020. Knowing that patients were served a menu I played a role in, gave me solace.
As part of the hospital food and nutrition team, I am grateful for the opportunity I have to work on a broader mission to address social determinants of health and seek opportunities to help the system work for our patients.
Public health communication has been lacking in the pandemic, but another bright light is that we were still the trusted messengers to our patients and our communities. I’m continually honored and humbled to be trusted with a whole family’s health.
Dr. Neison practices family medicine and culinary medicine at Sharp Rees-Stealy Medical Group in San Diego, and is cochair of climate and planetary health for SRS Medical Group. You can follow her on Instagram, LinkedIn, and Facebook @Flavors4WellnessMD.
A few years ago I tracked down my medical school interviewer to thank him for giving me the opportunity to do what I felt I was called to do. I was surprised that, after 15 years, he actually remembered me and remembered details like walking to the courtyard to meet my father who’d driven me to the interview.
Sharing my gratitude and letting him know I was happy felt important to me.
Choosing to practice family medicine has a lot to do with why I am happy in my career today.
One of my frustrations with health care had been its emphasis on treatment of sickness, rather than a broader one that incorporated prevention of sickness. During my third year of medical school, I was following a family and sports medicine faculty member who was focusing on aspects of lifestyle medicine to help a patient remain active and age gracefully. Seeing opportunities to practice preventative medicine in family medicine made me realize the specialty was the perfect fit for me.
Food as medicine
While participating in rotations I also realized you can find a subspecialty within family medicine.
During my fourth year of medical school, I followed an attending who was seeing a patient for hypertension, prediabetes and hypercholesterolemia. The attending told the patient to eat “healthier,” gave her a handout, and scheduled a follow up appointment for 6 months later.
My thoughts were: “That’s it? That’s how we counsel patients to improve their dietary habits?”
As the patient was leaving the exam room, I asked her what type of oil she cooked with, and I proceeded to share culinary tips from my mother – who was a self-taught and early adopter of the food-as-medicine movement.
Once I started my residency, I knew I’d want to incorporate lifestyle and dietary approaches at many of my patient visits.
I scheduled patients every month to monitor their weight, follow up on chronic conditions, but more importantly, to engage them in their health and empower them to make small lifestyle changes each month and report their efforts. I felt like I was their health coach and cheerleader.
My career in family medicine
Entering the job market allowed me to form my philosophy of treating patients with a mind, body, and spirit approach. I chose to practice value-based care, which aligns with my lifestyle and preventative medicine approach .
I currently practice in a small family medicine–only clinic that is part of a larger multispecialty system. Primary care specialties in my organization are valued, respected and central to a patient’s well being and care. We are encouraged to spend time with patients, assess barriers to care and work collaboratively with our healthcare team, so that preventative medicine approaches take the lead in a patient’s health. This supportive culture and environment is one where my passion for food as medicine has thrived.
One day I forgot to pack a lunch and instead brought a grocery bag of items to make a salad. When I realized I made too much, I sent an email to my staff to get some “free salad in my office.” This serendipitous moment started an informal office “salad club” each week. Continued support from my staff and leadership, allowed me to consider further extending this teaching to my patients and my colleagues.
Three years ago, I helped adopt a sustainable plant-forward menu for our physician meetings, complete with a recipe from the menu for physicians to replicate at home or give to their patients.
I also pursued adoption of shared medical appointments for our medical group. These appointments apply the “see one, do one, teach one” model in medicine, but with culinary medicine as the focus.
Knowing that my patients are all connected to their families through food, I sought this as an opportunity to dive in further with wellness opportunities at their next meal. After almost 2 years of working on this project, I was able to host my first shared medical appointment with a group of patients on March 12, 2020. The next day schools closed, lockdowns occurred, and the world changed.
Opportunities highlighted by the pandemic
We always knew health care was broken but adding the increasingly longer hours and COVID vaccine–hesitant patients that the pandemic brought made everything look dark at times. What has helped me stay hopeful and energetic for system changes is feeling gratitude and seeking bright lights.
My experiences seeing patients in telehealth visits are examples of some of the bright lights I found in the pandemic. During these visits, patients showed me something from their pantry, and we’d go over nutritional labels together.
Additionally, my patients became engaged with their own conditions and wanted to improve them because of news articles highlighting risk factors for COVID-19, such as obesity. I had an active audience when it came to talking about food-as-medicine approaches to improving risk factors and immunity. And since everyone was listening, I didn’t stop at food. I also talked about physical health, stress resiliency, planetary diets, sleep, connections, and lastly vaccines!
Once the vaccines were distributed, I naturally gravitated to having those conversations with patients and colleagues and on social media. Plus, the pandemic gave us moments of simple times to slow down, take more rests, be less overscheduled, consider work-life priorities, and, lastly, to be okay with not being totally okay.
In practicing primary care, we have a unique role in seeing medicine from a whole body, whole person, whole family perspective. There is an opportunity to highlight what is broken in medicine and aim to make it whole.
I’m currently looking at shared medical appointments as a new standard way to provide care to all patients, because it improves access, provides better quality visits and aligns my values, mission, and purpose.
In the midst of the pandemic, I helped advocate for a sustainable plant-forward menu that was launched throughout four different hospitals in the Sharp HealthCare system, in California, in 2020. Knowing that patients were served a menu I played a role in, gave me solace.
As part of the hospital food and nutrition team, I am grateful for the opportunity I have to work on a broader mission to address social determinants of health and seek opportunities to help the system work for our patients.
Public health communication has been lacking in the pandemic, but another bright light is that we were still the trusted messengers to our patients and our communities. I’m continually honored and humbled to be trusted with a whole family’s health.
Dr. Neison practices family medicine and culinary medicine at Sharp Rees-Stealy Medical Group in San Diego, and is cochair of climate and planetary health for SRS Medical Group. You can follow her on Instagram, LinkedIn, and Facebook @Flavors4WellnessMD.
Tool helps health system cut risky scripts for older adults
In the largest implementation yet of the tool, designed by the U.S. Department of Veterans Affairs to decrease the use of potentially inappropriate medications (PIMs), Lifespan, a nonprofit system whose partners include Brown University, Providence, R.I., reported a significant drop in the number of such prescriptions to older adults on discharge from the emergency department (ED).
The number of PIMs among monthly prescriptions fell by roughly 26% at Lifespan’s three adult acute care EDs after the system adopted EQUiPPED – Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department. The VA deployed a version of the tool in 2013 to address the lack of training most emergency clinicians receive in the management of geriatric medications.
The model “should be implemented in other states and, with greater replication, could shape national policy regarding quality of care for older adults,” according to the researchers, who reported the results May 12 at the American Geriatrics Society (AGS) 2022 Annual Scientific Meeting, Orlando.
Older adults are three times as likely as younger patients to wind up in an ED because of medication-related harms. This is in part due to the greater number of prescriptions U.S. adults older than 65 years take daily.
A key quality measure
Although the Centers for Medicare & Medicaid Services and other groups have deemed minimizing PIMs an important quality measure, most EDs lack an expert in geriatric prescribing, Elizabeth Goldberg, MD, an associate professor of emergency medicine at Brown University, told this news organization.
With EQUiPPED, clinicians receive access to geriatric medication order sets embedded in electronic health records, individualized benchmark reports, and education about medication safety in older adults. PIMs are defined by the American Geriatrics Society Beers Criteria and include drugs such as proton-pump inhibitors and antipsychotics.
Lifespan’s program involved 362 clinicians who treat about 230,000 patients annually – 40,000 of them aged 65 and older. Dr. Goldberg said implementing the program in such a large population could “really move the needle for older adults” by reducing falls, improving cognitive function, and preventing harm from the use of medication.
She and fellow researchers examined ED prescribing 13 months before and 16 months after they had implemented EQUiPPED, in August and September of 2019. Of clinicians who participated, 48% were attending physicians, 37% were residents, and 34% were advanced practice providers.
PIM prescribing dropped from 8.93% prior to implementation (95% confidence interval: 8.5%-9.36%) to 6.59% after (95% CI: 6.2%-6.98%; P < .001). Before implementation, 1,495 of 16,681 prescribed medications were considered inappropriate, compared with 1,044 of 15,818 medications after, according to the researchers. The biggest declines in prescribing involved antihistamines, muscle relaxants, and benzodiazepines.
Despite the improvements, the system did not meet a goal of reducing PIMs to less than 5%. Dr. Goldberg said educating the large number of clinicians, some of whom rotated in and out of the ED, proved particularly challenging. The COVID-19 pandemic also potentially diverted attention from the quality improvement project, she said.
In addition to its size, the project was notable because it was supported by Blue Cross & Blue Shield of Rhode Island. Dr. Goldberg said obtaining private funding proved to be a quicker and less competitive process than obtaining a government grant. Other institutions interested in running similar studies may need to find insurers that are in the Medicare Advantage market or that have a significant number of younger enrollees with chronic conditions, such as kidney disease, who may benefit from more careful prescribing practices, she said.
The new study builds on previous research, such as a 2017 study that showed that EQUiPPED reduced PIM prescribing at four VA hospitals. Findings from a more recent rollout at three academic health systems suggested that the model might also be effective in targeting the overuse of specific drugs in facilities in which PIM prescribing is already low.
A researcher in those earlier studies, Susan Nicole Hastings, MD, a geriatric medicine specialist at Duke University, Durham, N.C., and the Durham VA Health Care System, told this news organization that Lifespan’s experience supports the idea that “with the right attention to balancing fidelity and tailoring for the new setting, there is tremendous potential for moving successful programs from the VA to other health systems.”
Ann E. Vandenberg, PhD, MPH, a gerontologist at Emory University, Atlanta, said the fragmented nature of the American health care system makes it difficult to disseminate EQUiPPED widely, but interoperability applications that pull data from different electronic health records could help hospital systems to adopt the program without undergoing site-specific customization.
Dr. Hastings and Dr. Vandenberg have received research funding to study EQUiPPED from the Agency for Healthcare Research and Quality. Dr. Hastings also received research funding from the VA.
A version of this article first appeared on Medscape.com.
In the largest implementation yet of the tool, designed by the U.S. Department of Veterans Affairs to decrease the use of potentially inappropriate medications (PIMs), Lifespan, a nonprofit system whose partners include Brown University, Providence, R.I., reported a significant drop in the number of such prescriptions to older adults on discharge from the emergency department (ED).
The number of PIMs among monthly prescriptions fell by roughly 26% at Lifespan’s three adult acute care EDs after the system adopted EQUiPPED – Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department. The VA deployed a version of the tool in 2013 to address the lack of training most emergency clinicians receive in the management of geriatric medications.
The model “should be implemented in other states and, with greater replication, could shape national policy regarding quality of care for older adults,” according to the researchers, who reported the results May 12 at the American Geriatrics Society (AGS) 2022 Annual Scientific Meeting, Orlando.
Older adults are three times as likely as younger patients to wind up in an ED because of medication-related harms. This is in part due to the greater number of prescriptions U.S. adults older than 65 years take daily.
A key quality measure
Although the Centers for Medicare & Medicaid Services and other groups have deemed minimizing PIMs an important quality measure, most EDs lack an expert in geriatric prescribing, Elizabeth Goldberg, MD, an associate professor of emergency medicine at Brown University, told this news organization.
With EQUiPPED, clinicians receive access to geriatric medication order sets embedded in electronic health records, individualized benchmark reports, and education about medication safety in older adults. PIMs are defined by the American Geriatrics Society Beers Criteria and include drugs such as proton-pump inhibitors and antipsychotics.
Lifespan’s program involved 362 clinicians who treat about 230,000 patients annually – 40,000 of them aged 65 and older. Dr. Goldberg said implementing the program in such a large population could “really move the needle for older adults” by reducing falls, improving cognitive function, and preventing harm from the use of medication.
She and fellow researchers examined ED prescribing 13 months before and 16 months after they had implemented EQUiPPED, in August and September of 2019. Of clinicians who participated, 48% were attending physicians, 37% were residents, and 34% were advanced practice providers.
PIM prescribing dropped from 8.93% prior to implementation (95% confidence interval: 8.5%-9.36%) to 6.59% after (95% CI: 6.2%-6.98%; P < .001). Before implementation, 1,495 of 16,681 prescribed medications were considered inappropriate, compared with 1,044 of 15,818 medications after, according to the researchers. The biggest declines in prescribing involved antihistamines, muscle relaxants, and benzodiazepines.
Despite the improvements, the system did not meet a goal of reducing PIMs to less than 5%. Dr. Goldberg said educating the large number of clinicians, some of whom rotated in and out of the ED, proved particularly challenging. The COVID-19 pandemic also potentially diverted attention from the quality improvement project, she said.
In addition to its size, the project was notable because it was supported by Blue Cross & Blue Shield of Rhode Island. Dr. Goldberg said obtaining private funding proved to be a quicker and less competitive process than obtaining a government grant. Other institutions interested in running similar studies may need to find insurers that are in the Medicare Advantage market or that have a significant number of younger enrollees with chronic conditions, such as kidney disease, who may benefit from more careful prescribing practices, she said.
The new study builds on previous research, such as a 2017 study that showed that EQUiPPED reduced PIM prescribing at four VA hospitals. Findings from a more recent rollout at three academic health systems suggested that the model might also be effective in targeting the overuse of specific drugs in facilities in which PIM prescribing is already low.
A researcher in those earlier studies, Susan Nicole Hastings, MD, a geriatric medicine specialist at Duke University, Durham, N.C., and the Durham VA Health Care System, told this news organization that Lifespan’s experience supports the idea that “with the right attention to balancing fidelity and tailoring for the new setting, there is tremendous potential for moving successful programs from the VA to other health systems.”
Ann E. Vandenberg, PhD, MPH, a gerontologist at Emory University, Atlanta, said the fragmented nature of the American health care system makes it difficult to disseminate EQUiPPED widely, but interoperability applications that pull data from different electronic health records could help hospital systems to adopt the program without undergoing site-specific customization.
Dr. Hastings and Dr. Vandenberg have received research funding to study EQUiPPED from the Agency for Healthcare Research and Quality. Dr. Hastings also received research funding from the VA.
A version of this article first appeared on Medscape.com.
In the largest implementation yet of the tool, designed by the U.S. Department of Veterans Affairs to decrease the use of potentially inappropriate medications (PIMs), Lifespan, a nonprofit system whose partners include Brown University, Providence, R.I., reported a significant drop in the number of such prescriptions to older adults on discharge from the emergency department (ED).
The number of PIMs among monthly prescriptions fell by roughly 26% at Lifespan’s three adult acute care EDs after the system adopted EQUiPPED – Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department. The VA deployed a version of the tool in 2013 to address the lack of training most emergency clinicians receive in the management of geriatric medications.
The model “should be implemented in other states and, with greater replication, could shape national policy regarding quality of care for older adults,” according to the researchers, who reported the results May 12 at the American Geriatrics Society (AGS) 2022 Annual Scientific Meeting, Orlando.
Older adults are three times as likely as younger patients to wind up in an ED because of medication-related harms. This is in part due to the greater number of prescriptions U.S. adults older than 65 years take daily.
A key quality measure
Although the Centers for Medicare & Medicaid Services and other groups have deemed minimizing PIMs an important quality measure, most EDs lack an expert in geriatric prescribing, Elizabeth Goldberg, MD, an associate professor of emergency medicine at Brown University, told this news organization.
With EQUiPPED, clinicians receive access to geriatric medication order sets embedded in electronic health records, individualized benchmark reports, and education about medication safety in older adults. PIMs are defined by the American Geriatrics Society Beers Criteria and include drugs such as proton-pump inhibitors and antipsychotics.
Lifespan’s program involved 362 clinicians who treat about 230,000 patients annually – 40,000 of them aged 65 and older. Dr. Goldberg said implementing the program in such a large population could “really move the needle for older adults” by reducing falls, improving cognitive function, and preventing harm from the use of medication.
She and fellow researchers examined ED prescribing 13 months before and 16 months after they had implemented EQUiPPED, in August and September of 2019. Of clinicians who participated, 48% were attending physicians, 37% were residents, and 34% were advanced practice providers.
PIM prescribing dropped from 8.93% prior to implementation (95% confidence interval: 8.5%-9.36%) to 6.59% after (95% CI: 6.2%-6.98%; P < .001). Before implementation, 1,495 of 16,681 prescribed medications were considered inappropriate, compared with 1,044 of 15,818 medications after, according to the researchers. The biggest declines in prescribing involved antihistamines, muscle relaxants, and benzodiazepines.
Despite the improvements, the system did not meet a goal of reducing PIMs to less than 5%. Dr. Goldberg said educating the large number of clinicians, some of whom rotated in and out of the ED, proved particularly challenging. The COVID-19 pandemic also potentially diverted attention from the quality improvement project, she said.
In addition to its size, the project was notable because it was supported by Blue Cross & Blue Shield of Rhode Island. Dr. Goldberg said obtaining private funding proved to be a quicker and less competitive process than obtaining a government grant. Other institutions interested in running similar studies may need to find insurers that are in the Medicare Advantage market or that have a significant number of younger enrollees with chronic conditions, such as kidney disease, who may benefit from more careful prescribing practices, she said.
The new study builds on previous research, such as a 2017 study that showed that EQUiPPED reduced PIM prescribing at four VA hospitals. Findings from a more recent rollout at three academic health systems suggested that the model might also be effective in targeting the overuse of specific drugs in facilities in which PIM prescribing is already low.
A researcher in those earlier studies, Susan Nicole Hastings, MD, a geriatric medicine specialist at Duke University, Durham, N.C., and the Durham VA Health Care System, told this news organization that Lifespan’s experience supports the idea that “with the right attention to balancing fidelity and tailoring for the new setting, there is tremendous potential for moving successful programs from the VA to other health systems.”
Ann E. Vandenberg, PhD, MPH, a gerontologist at Emory University, Atlanta, said the fragmented nature of the American health care system makes it difficult to disseminate EQUiPPED widely, but interoperability applications that pull data from different electronic health records could help hospital systems to adopt the program without undergoing site-specific customization.
Dr. Hastings and Dr. Vandenberg have received research funding to study EQUiPPED from the Agency for Healthcare Research and Quality. Dr. Hastings also received research funding from the VA.
A version of this article first appeared on Medscape.com.
FROM AGS 2022
The baby formula shortage continues
Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.
Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.
“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”
She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”
For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.
Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.
The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.
President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”
But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.
“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.
Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.
This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.
“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.
He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.
According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.
Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.
But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.
“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”
She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.
“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”
In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.
She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.
“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”
Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.
Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.
“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”
She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”
For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.
Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.
The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.
President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”
But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.
“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.
Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.
This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.
“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.
He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.
According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.
Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.
But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.
“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”
She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.
“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”
In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.
She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.
“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”
Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.
Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.
“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”
She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”
For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.
Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.
The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.
President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”
But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.
“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.
Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.
This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.
“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.
He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.
According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.
Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.
But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.
“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”
She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.
“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”
In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.
She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.
“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”
When burnout is moral injury
Several years have passed since I stood among a cohort of eager medical students wearing regalia that signaled a new beginning. Four years of grueling study culminated in a cacophony of unified voices, each reciting a pledge that I had longed to take since early adolescence. Together we celebrated, triumphant despite innumerable exams and various iterations of the Socratic method – all under the guise of assessing knowledge while in truth seeking to insidiously erode the crowd of prospective physicians. Yet our anxiety and uncertainty melted away as names were called, hands firmly clasped, and tassels transposed. For a moment in time, we stood on the precipice of victory, enthusiastic albeit oblivious of the tremendous obstacles that loomed ahead.
Wistfully I reminisce about the unequivocal joy that abounds within the protective shield of naiveté. Specifically, I think about that time when the edict of medicine and the art of being a physician felt congruent. Yet, reality is fickle and often supersedes expectation. Occasionally my thoughts drift to the early days of residency – a time during which the emotional weight of caring for vulnerable patients while learning to master my chosen specialty felt woefully insurmountable. I recall wading blindly through each rotation attempting to emulate the competent and compassionate care so effortlessly demonstrated by senior physicians as they moved through the health care system with apparent ease. They stepped fluidly, as I watched in awe through rose-tinted glasses.
As months passed into years, my perception cleared. What I initially viewed as graceful patient care belied a complex tapestry of health care workers often pressured into arduous decisions, not necessarily in service of a well-constructed treatment plan. Gradually, formidable barriers emerged, guidelines and restrictions embedded within a confining path that suffocated those who dared to cross it. As a result, a field built on the foundations of autonomy, benevolence, and nonmaleficence was slowly engulfed by a system fraught with contrivances. Amid such stressors, physical and psychological health grows tenuous. Classically, this overwhelming feeling of distress is recognized as burnout. Studies reformulated this malady to that which was first described in Vietnam war veterans, a condition known as “moral injury.”
The impact of burnout
To explain the development – and explore the complexities – of moral injury, we must return to 1975 when the term burnout was initially formulated by Herbert Freudenberger, PhD, a psychologist renowned for his work in substance use disorders, psychoanalysis, and clinical education.1 Dr. Freudenberger’s studies noted incidences of heightened emotional and physical distress in his colleagues working in substance abuse and other clinics. He sought to define these experiences as well as understand his own battle with malaise, apathy, and frustration.1 Ultimately, Dr. Freudenberger described burnout as “Becoming exhausted by making excessive demands on energy, strength, or resources in the workplace.”2 Although it characteristically overlaps with depression and anxiety, burnout is conceptualized as a separate entity specifically forged within a context of perfectionism, integrity, and self-sacrifice.2 Such qualities are integral in health care and, as a result, physicians are particularly vulnerable.
Since Dr. Freudenberger published “Burnout: The High Cost of Achievement” in 1980, immense research has assisted in not only identifying critical factors that contribute to its development but also the detrimental effects it has on physiological health.3 These include exhaustion from poor work conditions and extreme commitment to employee responsibilities that in turn precipitate mood destabilization and impaired work performance.3 Furthermore, research has also demonstrated that burnout triggers alterations in neural circuitry via the prefrontal cortex and the amygdala, structures critical for emotional regulation.4 To combat the ill effects of burnout while maintaining productivity and maximizing profit, several high-profile corporations instituted changes focusing on self-care, wellness, benefits, and incentives. Although these modifications are effective in decreasing the rate of employee turnover, such strategies are not easily transferable to health care. In fact, the rate of physician burnout has steadily increased over the past two decades as the business of medicine shifts towards longer hours, decreased reimbursement rates, and inexhaustible insurance stipulations.2,5 Consequently, occupational dissatisfaction increases the risk of cynicism, frustration with patients, internalization of failure, and likelihood of early retirement.5 Moreover, burnout may also fracture interpersonal relationships as well as precipitate errors, negative patient outcomes, malpractice, and development of severe mental health conditions associated with high morbidity and mortality.5,8
Although the concept of burnout is critical in understanding the side effects of stereotypical workplace culture, critics of the concept bemoan a suggestion of individual blame.6,8 In essence, they argue that burnout is explained as a side effect of toxic workplace conditions, but covertly represents a lack of resilience, motivation, and ambition to thrive in a physically or emotionally taxing occupational setting.6,8 Thus, the responsibility of acclimation lies upon the impacted individuals rather than the employer. For this reason, many strategies to ameliorate burnout are focused on the individual, including meditation, wellness retreats, creating or adjusting self-care regimens, or in some cases psychotherapy and psychopharmacology.6 Whereas burnout may respond (at least partially) to such interventions, without altering the causal factors, it is unlikely to remit. This is especially the case in health care, where systemic constraints lie beyond the control of an individual physician. Rather than promoting or specifically relying upon personal improvement and recovery, amendments are needed on multiple levels to affect meaningful change.
Moral injury
Similar to burnout, moral injury was not initially conceived within the scope of health care. In the 1990s Jonathan Shay, MD, PhD, identified veterans presenting with symptoms mimicking PTSD that failed to respond to standard, well established and efficacious treatments.9-11 With further analysis he determined that veterans who demonstrated minimal improvement reported similar histories of guilt, shame, and disgust following perceived injustices enacted or abetted by immoral leaders.10,11 Ultimately Shay identified three components of moral injury: 1. A betrayal of what is morally right; 2. By someone who holds legitimate priority; 3. In a high stakes situation.10
This definition was further modified in 2007 by Brett Linz, PhD, and colleagues as: “Perpetuating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.”10,11 By expanding this description to include distress experienced by physicians and health care workers, Wendy Dean and Simon Talbot (in 2018 and 2019 respectively) explored how the health care system leads practitioners to deliver what they identify as substandard treatment.6-8 This results in disillusionment and lays the foundation for ethical and moral dilemmas in clinicians.
Themes of moral injury are repeatedly cited in various surveys and studies as a cause for occupational dissatisfaction. As physicians and other health care professionals reel from the aftermath of COVID-19, the effects of reconfiguring medicine into a business-oriented framework are glaringly conspicuous. Vast hospital nursing shortages, high patient census exacerbated by the political misuse and polarization of science, and insufficient availability of psychiatric beds, have culminated in a deluge of psychological strain in emergency medical physicians. Furthermore, pressure from administrators, mandated patient satisfaction measures, tedious electronic medical record systems, and copious licensing and certification requirements, contribute to physician distress as they attempt to navigate a system that challenges the vows which they swore to uphold.8 Because the cost of pursuing a medical degree frequently necessitates acquisition of loans that, without a physician income, may be difficult to repay,9 many doctors feel trapped within a seemingly endless cycle of misgiving that contributes to emotional exhaustion, pessimism, and low morale.
In my next series of The Myth of the Superdoctor columns, we will explore various factors that potentiate risk of moral injury. From medical school and residency training to corporate infrastructure and insurance obstacles, I will seek to discern and deliberate strategies for repair and rehabilitation. It is my hope that together we will illuminate the myriad complexities within the business of medicine, and become advocates and harbingers of change not only for physicians and health care workers but also for the sake of our patients and their families.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
References
1. King N. When a Psychologist Succumbed to Stress, He Coined The Term Burnout. 2016 Dec 8. NPR: All Things Considered.
2. Maslach C and Leiter MP. World Psychiatry. 2016 Jun;15(2):103-11. doi: 10.1002/wps.20311.
3. InformedHealth.org and Institute for Quality and Efficiency in Health Care. Depression: What is burnout?. https://www.ncbi.nlm.nih.gov/books/NBK279286/.
4. Michel A. Burnout and the Brain. Observer. 2016 Jan 29. https://www.psychologicalscience.org/observer/burnout-and-the-brain.
5. Patel RS et al. Behav Sci. 2018;8(11):98. doi:10.3390/bs8110098.
6. Dean W and Talbot S. Physicians aren’t ‘burning out.’ They’re suffering from moral injury. Stat. 2018 Jul 26. https://www.statnews.com/2018/07/26/physicians-not-burning-out-they-are-suffering-moral-injury/.
7. Dean W and Talbot S. Moral injury and burnout in medicine: A year of lessons learned. Stat. 2019 Jul 26. https://www.statnews.com/2019/07/26/moral-injury-burnout-medicine-lessons-learned/.
8. Dean W et al. Reframing Clinician Distress: Moral Injury Not Burnout. Fed Pract. 2019 Sep; 36(9):400-2. https://www.mdedge.com/fedprac/article/207458/mental-health/reframing-clinician-distress-moral-injury-not-burnout.
9. Bailey M. Beyond Burnout: Docs Decry ‘Moral Injury’ From Financial Pressures of Health Care. KHN. 2020 Feb 4. https://khn.org/news/beyond-burnout-docs-decry-moral-injury-from-financial-pressures-of-health-care/.
10. Litz B et al. Clin Psychol Rev. 2009 Dec;29(8):695-706. doi: 10.1016/j.cpr.2009.07.003.
11. Norman S and Maguen S. Moral Injury. PTSD: National Center for PTSD. https://www.ptsd.va.gov/professional/treat/cooccurring/moral_injury.asp.
Several years have passed since I stood among a cohort of eager medical students wearing regalia that signaled a new beginning. Four years of grueling study culminated in a cacophony of unified voices, each reciting a pledge that I had longed to take since early adolescence. Together we celebrated, triumphant despite innumerable exams and various iterations of the Socratic method – all under the guise of assessing knowledge while in truth seeking to insidiously erode the crowd of prospective physicians. Yet our anxiety and uncertainty melted away as names were called, hands firmly clasped, and tassels transposed. For a moment in time, we stood on the precipice of victory, enthusiastic albeit oblivious of the tremendous obstacles that loomed ahead.
Wistfully I reminisce about the unequivocal joy that abounds within the protective shield of naiveté. Specifically, I think about that time when the edict of medicine and the art of being a physician felt congruent. Yet, reality is fickle and often supersedes expectation. Occasionally my thoughts drift to the early days of residency – a time during which the emotional weight of caring for vulnerable patients while learning to master my chosen specialty felt woefully insurmountable. I recall wading blindly through each rotation attempting to emulate the competent and compassionate care so effortlessly demonstrated by senior physicians as they moved through the health care system with apparent ease. They stepped fluidly, as I watched in awe through rose-tinted glasses.
As months passed into years, my perception cleared. What I initially viewed as graceful patient care belied a complex tapestry of health care workers often pressured into arduous decisions, not necessarily in service of a well-constructed treatment plan. Gradually, formidable barriers emerged, guidelines and restrictions embedded within a confining path that suffocated those who dared to cross it. As a result, a field built on the foundations of autonomy, benevolence, and nonmaleficence was slowly engulfed by a system fraught with contrivances. Amid such stressors, physical and psychological health grows tenuous. Classically, this overwhelming feeling of distress is recognized as burnout. Studies reformulated this malady to that which was first described in Vietnam war veterans, a condition known as “moral injury.”
The impact of burnout
To explain the development – and explore the complexities – of moral injury, we must return to 1975 when the term burnout was initially formulated by Herbert Freudenberger, PhD, a psychologist renowned for his work in substance use disorders, psychoanalysis, and clinical education.1 Dr. Freudenberger’s studies noted incidences of heightened emotional and physical distress in his colleagues working in substance abuse and other clinics. He sought to define these experiences as well as understand his own battle with malaise, apathy, and frustration.1 Ultimately, Dr. Freudenberger described burnout as “Becoming exhausted by making excessive demands on energy, strength, or resources in the workplace.”2 Although it characteristically overlaps with depression and anxiety, burnout is conceptualized as a separate entity specifically forged within a context of perfectionism, integrity, and self-sacrifice.2 Such qualities are integral in health care and, as a result, physicians are particularly vulnerable.
Since Dr. Freudenberger published “Burnout: The High Cost of Achievement” in 1980, immense research has assisted in not only identifying critical factors that contribute to its development but also the detrimental effects it has on physiological health.3 These include exhaustion from poor work conditions and extreme commitment to employee responsibilities that in turn precipitate mood destabilization and impaired work performance.3 Furthermore, research has also demonstrated that burnout triggers alterations in neural circuitry via the prefrontal cortex and the amygdala, structures critical for emotional regulation.4 To combat the ill effects of burnout while maintaining productivity and maximizing profit, several high-profile corporations instituted changes focusing on self-care, wellness, benefits, and incentives. Although these modifications are effective in decreasing the rate of employee turnover, such strategies are not easily transferable to health care. In fact, the rate of physician burnout has steadily increased over the past two decades as the business of medicine shifts towards longer hours, decreased reimbursement rates, and inexhaustible insurance stipulations.2,5 Consequently, occupational dissatisfaction increases the risk of cynicism, frustration with patients, internalization of failure, and likelihood of early retirement.5 Moreover, burnout may also fracture interpersonal relationships as well as precipitate errors, negative patient outcomes, malpractice, and development of severe mental health conditions associated with high morbidity and mortality.5,8
Although the concept of burnout is critical in understanding the side effects of stereotypical workplace culture, critics of the concept bemoan a suggestion of individual blame.6,8 In essence, they argue that burnout is explained as a side effect of toxic workplace conditions, but covertly represents a lack of resilience, motivation, and ambition to thrive in a physically or emotionally taxing occupational setting.6,8 Thus, the responsibility of acclimation lies upon the impacted individuals rather than the employer. For this reason, many strategies to ameliorate burnout are focused on the individual, including meditation, wellness retreats, creating or adjusting self-care regimens, or in some cases psychotherapy and psychopharmacology.6 Whereas burnout may respond (at least partially) to such interventions, without altering the causal factors, it is unlikely to remit. This is especially the case in health care, where systemic constraints lie beyond the control of an individual physician. Rather than promoting or specifically relying upon personal improvement and recovery, amendments are needed on multiple levels to affect meaningful change.
Moral injury
Similar to burnout, moral injury was not initially conceived within the scope of health care. In the 1990s Jonathan Shay, MD, PhD, identified veterans presenting with symptoms mimicking PTSD that failed to respond to standard, well established and efficacious treatments.9-11 With further analysis he determined that veterans who demonstrated minimal improvement reported similar histories of guilt, shame, and disgust following perceived injustices enacted or abetted by immoral leaders.10,11 Ultimately Shay identified three components of moral injury: 1. A betrayal of what is morally right; 2. By someone who holds legitimate priority; 3. In a high stakes situation.10
This definition was further modified in 2007 by Brett Linz, PhD, and colleagues as: “Perpetuating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.”10,11 By expanding this description to include distress experienced by physicians and health care workers, Wendy Dean and Simon Talbot (in 2018 and 2019 respectively) explored how the health care system leads practitioners to deliver what they identify as substandard treatment.6-8 This results in disillusionment and lays the foundation for ethical and moral dilemmas in clinicians.
Themes of moral injury are repeatedly cited in various surveys and studies as a cause for occupational dissatisfaction. As physicians and other health care professionals reel from the aftermath of COVID-19, the effects of reconfiguring medicine into a business-oriented framework are glaringly conspicuous. Vast hospital nursing shortages, high patient census exacerbated by the political misuse and polarization of science, and insufficient availability of psychiatric beds, have culminated in a deluge of psychological strain in emergency medical physicians. Furthermore, pressure from administrators, mandated patient satisfaction measures, tedious electronic medical record systems, and copious licensing and certification requirements, contribute to physician distress as they attempt to navigate a system that challenges the vows which they swore to uphold.8 Because the cost of pursuing a medical degree frequently necessitates acquisition of loans that, without a physician income, may be difficult to repay,9 many doctors feel trapped within a seemingly endless cycle of misgiving that contributes to emotional exhaustion, pessimism, and low morale.
In my next series of The Myth of the Superdoctor columns, we will explore various factors that potentiate risk of moral injury. From medical school and residency training to corporate infrastructure and insurance obstacles, I will seek to discern and deliberate strategies for repair and rehabilitation. It is my hope that together we will illuminate the myriad complexities within the business of medicine, and become advocates and harbingers of change not only for physicians and health care workers but also for the sake of our patients and their families.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
References
1. King N. When a Psychologist Succumbed to Stress, He Coined The Term Burnout. 2016 Dec 8. NPR: All Things Considered.
2. Maslach C and Leiter MP. World Psychiatry. 2016 Jun;15(2):103-11. doi: 10.1002/wps.20311.
3. InformedHealth.org and Institute for Quality and Efficiency in Health Care. Depression: What is burnout?. https://www.ncbi.nlm.nih.gov/books/NBK279286/.
4. Michel A. Burnout and the Brain. Observer. 2016 Jan 29. https://www.psychologicalscience.org/observer/burnout-and-the-brain.
5. Patel RS et al. Behav Sci. 2018;8(11):98. doi:10.3390/bs8110098.
6. Dean W and Talbot S. Physicians aren’t ‘burning out.’ They’re suffering from moral injury. Stat. 2018 Jul 26. https://www.statnews.com/2018/07/26/physicians-not-burning-out-they-are-suffering-moral-injury/.
7. Dean W and Talbot S. Moral injury and burnout in medicine: A year of lessons learned. Stat. 2019 Jul 26. https://www.statnews.com/2019/07/26/moral-injury-burnout-medicine-lessons-learned/.
8. Dean W et al. Reframing Clinician Distress: Moral Injury Not Burnout. Fed Pract. 2019 Sep; 36(9):400-2. https://www.mdedge.com/fedprac/article/207458/mental-health/reframing-clinician-distress-moral-injury-not-burnout.
9. Bailey M. Beyond Burnout: Docs Decry ‘Moral Injury’ From Financial Pressures of Health Care. KHN. 2020 Feb 4. https://khn.org/news/beyond-burnout-docs-decry-moral-injury-from-financial-pressures-of-health-care/.
10. Litz B et al. Clin Psychol Rev. 2009 Dec;29(8):695-706. doi: 10.1016/j.cpr.2009.07.003.
11. Norman S and Maguen S. Moral Injury. PTSD: National Center for PTSD. https://www.ptsd.va.gov/professional/treat/cooccurring/moral_injury.asp.
Several years have passed since I stood among a cohort of eager medical students wearing regalia that signaled a new beginning. Four years of grueling study culminated in a cacophony of unified voices, each reciting a pledge that I had longed to take since early adolescence. Together we celebrated, triumphant despite innumerable exams and various iterations of the Socratic method – all under the guise of assessing knowledge while in truth seeking to insidiously erode the crowd of prospective physicians. Yet our anxiety and uncertainty melted away as names were called, hands firmly clasped, and tassels transposed. For a moment in time, we stood on the precipice of victory, enthusiastic albeit oblivious of the tremendous obstacles that loomed ahead.
Wistfully I reminisce about the unequivocal joy that abounds within the protective shield of naiveté. Specifically, I think about that time when the edict of medicine and the art of being a physician felt congruent. Yet, reality is fickle and often supersedes expectation. Occasionally my thoughts drift to the early days of residency – a time during which the emotional weight of caring for vulnerable patients while learning to master my chosen specialty felt woefully insurmountable. I recall wading blindly through each rotation attempting to emulate the competent and compassionate care so effortlessly demonstrated by senior physicians as they moved through the health care system with apparent ease. They stepped fluidly, as I watched in awe through rose-tinted glasses.
As months passed into years, my perception cleared. What I initially viewed as graceful patient care belied a complex tapestry of health care workers often pressured into arduous decisions, not necessarily in service of a well-constructed treatment plan. Gradually, formidable barriers emerged, guidelines and restrictions embedded within a confining path that suffocated those who dared to cross it. As a result, a field built on the foundations of autonomy, benevolence, and nonmaleficence was slowly engulfed by a system fraught with contrivances. Amid such stressors, physical and psychological health grows tenuous. Classically, this overwhelming feeling of distress is recognized as burnout. Studies reformulated this malady to that which was first described in Vietnam war veterans, a condition known as “moral injury.”
The impact of burnout
To explain the development – and explore the complexities – of moral injury, we must return to 1975 when the term burnout was initially formulated by Herbert Freudenberger, PhD, a psychologist renowned for his work in substance use disorders, psychoanalysis, and clinical education.1 Dr. Freudenberger’s studies noted incidences of heightened emotional and physical distress in his colleagues working in substance abuse and other clinics. He sought to define these experiences as well as understand his own battle with malaise, apathy, and frustration.1 Ultimately, Dr. Freudenberger described burnout as “Becoming exhausted by making excessive demands on energy, strength, or resources in the workplace.”2 Although it characteristically overlaps with depression and anxiety, burnout is conceptualized as a separate entity specifically forged within a context of perfectionism, integrity, and self-sacrifice.2 Such qualities are integral in health care and, as a result, physicians are particularly vulnerable.
Since Dr. Freudenberger published “Burnout: The High Cost of Achievement” in 1980, immense research has assisted in not only identifying critical factors that contribute to its development but also the detrimental effects it has on physiological health.3 These include exhaustion from poor work conditions and extreme commitment to employee responsibilities that in turn precipitate mood destabilization and impaired work performance.3 Furthermore, research has also demonstrated that burnout triggers alterations in neural circuitry via the prefrontal cortex and the amygdala, structures critical for emotional regulation.4 To combat the ill effects of burnout while maintaining productivity and maximizing profit, several high-profile corporations instituted changes focusing on self-care, wellness, benefits, and incentives. Although these modifications are effective in decreasing the rate of employee turnover, such strategies are not easily transferable to health care. In fact, the rate of physician burnout has steadily increased over the past two decades as the business of medicine shifts towards longer hours, decreased reimbursement rates, and inexhaustible insurance stipulations.2,5 Consequently, occupational dissatisfaction increases the risk of cynicism, frustration with patients, internalization of failure, and likelihood of early retirement.5 Moreover, burnout may also fracture interpersonal relationships as well as precipitate errors, negative patient outcomes, malpractice, and development of severe mental health conditions associated with high morbidity and mortality.5,8
Although the concept of burnout is critical in understanding the side effects of stereotypical workplace culture, critics of the concept bemoan a suggestion of individual blame.6,8 In essence, they argue that burnout is explained as a side effect of toxic workplace conditions, but covertly represents a lack of resilience, motivation, and ambition to thrive in a physically or emotionally taxing occupational setting.6,8 Thus, the responsibility of acclimation lies upon the impacted individuals rather than the employer. For this reason, many strategies to ameliorate burnout are focused on the individual, including meditation, wellness retreats, creating or adjusting self-care regimens, or in some cases psychotherapy and psychopharmacology.6 Whereas burnout may respond (at least partially) to such interventions, without altering the causal factors, it is unlikely to remit. This is especially the case in health care, where systemic constraints lie beyond the control of an individual physician. Rather than promoting or specifically relying upon personal improvement and recovery, amendments are needed on multiple levels to affect meaningful change.
Moral injury
Similar to burnout, moral injury was not initially conceived within the scope of health care. In the 1990s Jonathan Shay, MD, PhD, identified veterans presenting with symptoms mimicking PTSD that failed to respond to standard, well established and efficacious treatments.9-11 With further analysis he determined that veterans who demonstrated minimal improvement reported similar histories of guilt, shame, and disgust following perceived injustices enacted or abetted by immoral leaders.10,11 Ultimately Shay identified three components of moral injury: 1. A betrayal of what is morally right; 2. By someone who holds legitimate priority; 3. In a high stakes situation.10
This definition was further modified in 2007 by Brett Linz, PhD, and colleagues as: “Perpetuating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.”10,11 By expanding this description to include distress experienced by physicians and health care workers, Wendy Dean and Simon Talbot (in 2018 and 2019 respectively) explored how the health care system leads practitioners to deliver what they identify as substandard treatment.6-8 This results in disillusionment and lays the foundation for ethical and moral dilemmas in clinicians.
Themes of moral injury are repeatedly cited in various surveys and studies as a cause for occupational dissatisfaction. As physicians and other health care professionals reel from the aftermath of COVID-19, the effects of reconfiguring medicine into a business-oriented framework are glaringly conspicuous. Vast hospital nursing shortages, high patient census exacerbated by the political misuse and polarization of science, and insufficient availability of psychiatric beds, have culminated in a deluge of psychological strain in emergency medical physicians. Furthermore, pressure from administrators, mandated patient satisfaction measures, tedious electronic medical record systems, and copious licensing and certification requirements, contribute to physician distress as they attempt to navigate a system that challenges the vows which they swore to uphold.8 Because the cost of pursuing a medical degree frequently necessitates acquisition of loans that, without a physician income, may be difficult to repay,9 many doctors feel trapped within a seemingly endless cycle of misgiving that contributes to emotional exhaustion, pessimism, and low morale.
In my next series of The Myth of the Superdoctor columns, we will explore various factors that potentiate risk of moral injury. From medical school and residency training to corporate infrastructure and insurance obstacles, I will seek to discern and deliberate strategies for repair and rehabilitation. It is my hope that together we will illuminate the myriad complexities within the business of medicine, and become advocates and harbingers of change not only for physicians and health care workers but also for the sake of our patients and their families.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
References
1. King N. When a Psychologist Succumbed to Stress, He Coined The Term Burnout. 2016 Dec 8. NPR: All Things Considered.
2. Maslach C and Leiter MP. World Psychiatry. 2016 Jun;15(2):103-11. doi: 10.1002/wps.20311.
3. InformedHealth.org and Institute for Quality and Efficiency in Health Care. Depression: What is burnout?. https://www.ncbi.nlm.nih.gov/books/NBK279286/.
4. Michel A. Burnout and the Brain. Observer. 2016 Jan 29. https://www.psychologicalscience.org/observer/burnout-and-the-brain.
5. Patel RS et al. Behav Sci. 2018;8(11):98. doi:10.3390/bs8110098.
6. Dean W and Talbot S. Physicians aren’t ‘burning out.’ They’re suffering from moral injury. Stat. 2018 Jul 26. https://www.statnews.com/2018/07/26/physicians-not-burning-out-they-are-suffering-moral-injury/.
7. Dean W and Talbot S. Moral injury and burnout in medicine: A year of lessons learned. Stat. 2019 Jul 26. https://www.statnews.com/2019/07/26/moral-injury-burnout-medicine-lessons-learned/.
8. Dean W et al. Reframing Clinician Distress: Moral Injury Not Burnout. Fed Pract. 2019 Sep; 36(9):400-2. https://www.mdedge.com/fedprac/article/207458/mental-health/reframing-clinician-distress-moral-injury-not-burnout.
9. Bailey M. Beyond Burnout: Docs Decry ‘Moral Injury’ From Financial Pressures of Health Care. KHN. 2020 Feb 4. https://khn.org/news/beyond-burnout-docs-decry-moral-injury-from-financial-pressures-of-health-care/.
10. Litz B et al. Clin Psychol Rev. 2009 Dec;29(8):695-706. doi: 10.1016/j.cpr.2009.07.003.
11. Norman S and Maguen S. Moral Injury. PTSD: National Center for PTSD. https://www.ptsd.va.gov/professional/treat/cooccurring/moral_injury.asp.
One weird trick to fight burnout
“Here and now is what counts. So, let’s go to work!” –Walter Orthmann, 100 years old
How long before you retire? If you know the answer in exact years, months, and days, you aren’t alone. For many good reasons, we doctors are more likely to be counting down the years until we retire rather than counting up the years since we started working. For me, if I’m to break the Guinness World Record, I have 69 more years, 3 months and 6 days left to go. That would surpass the current achievement for the longest career at one company, Mr. Walter Orthmann, who has been sitting at the same desk for 84 years. At 100 years old, Mr. Orthmann still shows up every Monday morning, as bright eyed and bushy tailed as a young squirrel. I’ll be 119 when I break his streak, which would also put me past Anthony Mancinelli, a New York barber who at 107 years of age was still brushing off his chair for the next customer. Unbelievable, I know! I wonder, what’s the one weird trick these guys are doing that keeps them going?
Of course, the job itself matters. Some jobs, like being a police officer, aren’t suitable for old people. Or are they? Officer L.C. “Buckshot” Smith was still keeping streets safe from his patrol car at 91 years old. After a bit of searching, I found pretty much any job you can think of has a very long-lasting Energizer Bunny story: A female surgeon who was operating at 90 years old, a 100-year-old rheumatologist who was still teaching at University of California, San Francisco, and a 105-year-old Japanese physician who was still seeing patients. There are plenty of geriatric lawyers, nurses, land surveyors, accountants, judges, you name it. So it seems it’s not the work, but the worker that matters. Why do some older workers recharge daily and carry on while many younger ones say the daily grind is burning them out? What makes the Greatest Generation so great?
We all know colleagues who hung up their white coats early. In my medical group, it’s often financially feasible to retire at 58 and many have chosen that option. Yet, we have loads of Partner Emeritus docs in their 70’s who still log on to EPIC and pitch in everyday.
“So, how do you keep going?” I asked my 105-year-old patient who still walks and manages his affairs. “Just stay healthy,” he advised. A circular argument, yet he’s right. You must both be lucky and also choose to be active mentally and physically. Mr. Mancinelli, who was barbering full time at 107 years old, had no aches and pains and all his teeth. He pruned his own bushes. The data are crystal clear that physical activity adds not only years of life, but also improves cognitive capabilities during those years.
As for beating burnout, it seems the one trick that these ultraworkers do is to focus only on the present. Mr. Orthmann’s pithy advice as quoted by NPR is, “You need to get busy with the present, not the past or the future.” These centenarian employees also frame their work not as stressful but rather as their daily series of problems to be solved.
When I asked my super-geriatric patient how he sleeps so well, he said, “I never worry when I get into bed, I just shut my eyes and sleep. I’ll think about tomorrow when I wake up.” Now if I can do that about 25,000 more times, I’ll have the record.
Dr. Jeff Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com
“Here and now is what counts. So, let’s go to work!” –Walter Orthmann, 100 years old
How long before you retire? If you know the answer in exact years, months, and days, you aren’t alone. For many good reasons, we doctors are more likely to be counting down the years until we retire rather than counting up the years since we started working. For me, if I’m to break the Guinness World Record, I have 69 more years, 3 months and 6 days left to go. That would surpass the current achievement for the longest career at one company, Mr. Walter Orthmann, who has been sitting at the same desk for 84 years. At 100 years old, Mr. Orthmann still shows up every Monday morning, as bright eyed and bushy tailed as a young squirrel. I’ll be 119 when I break his streak, which would also put me past Anthony Mancinelli, a New York barber who at 107 years of age was still brushing off his chair for the next customer. Unbelievable, I know! I wonder, what’s the one weird trick these guys are doing that keeps them going?
Of course, the job itself matters. Some jobs, like being a police officer, aren’t suitable for old people. Or are they? Officer L.C. “Buckshot” Smith was still keeping streets safe from his patrol car at 91 years old. After a bit of searching, I found pretty much any job you can think of has a very long-lasting Energizer Bunny story: A female surgeon who was operating at 90 years old, a 100-year-old rheumatologist who was still teaching at University of California, San Francisco, and a 105-year-old Japanese physician who was still seeing patients. There are plenty of geriatric lawyers, nurses, land surveyors, accountants, judges, you name it. So it seems it’s not the work, but the worker that matters. Why do some older workers recharge daily and carry on while many younger ones say the daily grind is burning them out? What makes the Greatest Generation so great?
We all know colleagues who hung up their white coats early. In my medical group, it’s often financially feasible to retire at 58 and many have chosen that option. Yet, we have loads of Partner Emeritus docs in their 70’s who still log on to EPIC and pitch in everyday.
“So, how do you keep going?” I asked my 105-year-old patient who still walks and manages his affairs. “Just stay healthy,” he advised. A circular argument, yet he’s right. You must both be lucky and also choose to be active mentally and physically. Mr. Mancinelli, who was barbering full time at 107 years old, had no aches and pains and all his teeth. He pruned his own bushes. The data are crystal clear that physical activity adds not only years of life, but also improves cognitive capabilities during those years.
As for beating burnout, it seems the one trick that these ultraworkers do is to focus only on the present. Mr. Orthmann’s pithy advice as quoted by NPR is, “You need to get busy with the present, not the past or the future.” These centenarian employees also frame their work not as stressful but rather as their daily series of problems to be solved.
When I asked my super-geriatric patient how he sleeps so well, he said, “I never worry when I get into bed, I just shut my eyes and sleep. I’ll think about tomorrow when I wake up.” Now if I can do that about 25,000 more times, I’ll have the record.
Dr. Jeff Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com
“Here and now is what counts. So, let’s go to work!” –Walter Orthmann, 100 years old
How long before you retire? If you know the answer in exact years, months, and days, you aren’t alone. For many good reasons, we doctors are more likely to be counting down the years until we retire rather than counting up the years since we started working. For me, if I’m to break the Guinness World Record, I have 69 more years, 3 months and 6 days left to go. That would surpass the current achievement for the longest career at one company, Mr. Walter Orthmann, who has been sitting at the same desk for 84 years. At 100 years old, Mr. Orthmann still shows up every Monday morning, as bright eyed and bushy tailed as a young squirrel. I’ll be 119 when I break his streak, which would also put me past Anthony Mancinelli, a New York barber who at 107 years of age was still brushing off his chair for the next customer. Unbelievable, I know! I wonder, what’s the one weird trick these guys are doing that keeps them going?
Of course, the job itself matters. Some jobs, like being a police officer, aren’t suitable for old people. Or are they? Officer L.C. “Buckshot” Smith was still keeping streets safe from his patrol car at 91 years old. After a bit of searching, I found pretty much any job you can think of has a very long-lasting Energizer Bunny story: A female surgeon who was operating at 90 years old, a 100-year-old rheumatologist who was still teaching at University of California, San Francisco, and a 105-year-old Japanese physician who was still seeing patients. There are plenty of geriatric lawyers, nurses, land surveyors, accountants, judges, you name it. So it seems it’s not the work, but the worker that matters. Why do some older workers recharge daily and carry on while many younger ones say the daily grind is burning them out? What makes the Greatest Generation so great?
We all know colleagues who hung up their white coats early. In my medical group, it’s often financially feasible to retire at 58 and many have chosen that option. Yet, we have loads of Partner Emeritus docs in their 70’s who still log on to EPIC and pitch in everyday.
“So, how do you keep going?” I asked my 105-year-old patient who still walks and manages his affairs. “Just stay healthy,” he advised. A circular argument, yet he’s right. You must both be lucky and also choose to be active mentally and physically. Mr. Mancinelli, who was barbering full time at 107 years old, had no aches and pains and all his teeth. He pruned his own bushes. The data are crystal clear that physical activity adds not only years of life, but also improves cognitive capabilities during those years.
As for beating burnout, it seems the one trick that these ultraworkers do is to focus only on the present. Mr. Orthmann’s pithy advice as quoted by NPR is, “You need to get busy with the present, not the past or the future.” These centenarian employees also frame their work not as stressful but rather as their daily series of problems to be solved.
When I asked my super-geriatric patient how he sleeps so well, he said, “I never worry when I get into bed, I just shut my eyes and sleep. I’ll think about tomorrow when I wake up.” Now if I can do that about 25,000 more times, I’ll have the record.
Dr. Jeff Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com
Poorest children at higher risk for PICU admissions, death
SAN FRANCISCO – Children who live in neighborhoods that are at the bottom of the socioeconomic ladder are at significantly greater risk for being admitted to a pediatric intensive care unit (PICU) and of dying there, a study of Medicaid data showed.
Among more than 4 million children and adolescents in 12 U.S. states, those in the most socioeconomically deprived quartile had a significantly higher risk for PICU admission and in-hospital death, compared with patients from the least-deprived areas.
Black children were also at significantly higher risk for death than children of other races, reported Hannah K. Mitchell, BMBS, MSc, from Evelina Children’s Hospital, London.“I think we need to do better work for trying to understand the mechanisms behind these disparities, ... whether they can be intervened over in a hospital setting, and to try to identify targeted interventions,” she said during a presentation at the American Thoracic Society International Conference 2022.
Medicaid data
During her residency in pediatrics at Children’s Hospital of Philadelphia, Ms. Mitchell and colleagues conducted a study to determine whether there were disparities in PICU admissions and mortality according to socioeconomic deprivation in specific neighborhoods.
They created a retrospective cohort study of Medicaid patients from birth to age 20 who were covered from 2007 through 2014 in 12 U.S. states, using ZIP codes to identify areas of social deprivation.
They restricted the analysis to children from households with annual incomes below 150% of the federal poverty line and divided the cohort into socioeconomic quartiles.
A total of nearly 4.1 million children and adolescents were included in the sample. Of this group, 274,782 were admitted to a PICU during the study period.
The median age of children admitted to a PICU was 4 years (interquartile range 0-15), and slightly more than two-thirds (68.5%) had a chronic complex condition.
In all, 43.5% were identified as White, and 32.1% were identified as Black. Ms. Mitchell noted that one of the limitations of the study was missing data on patients of Hispanic/Latinx origin.
The mortality rate among all patients admitted to a PICU was 2.5%.
In univariate logistic regression analysis, the odds ratio for PICU admission among children living in the most impoverished circumstances was 1.21 (P < .0001).
Among all patients admitted to a PICU, the OR for death for children in the most deprived quartile, compared with the least deprived was 1.12 (P = .0047).
In addition, Black children were significantly more likely than White children to be admitted to a PICU (OR, 1.14; P < .0001) and to die in hospital (OR, 1.18, P < .0001).
Ms. Mitchell said that clinicians need to move beyond describing disparities and should instead begin to focus on interventions to eliminate or reduce them.
She noted that children in poor neighborhoods may be more likely to receive care in lower-quality hospitals or may be treated differently from other children when hospitalized because of their socioeconomic status.
Poor housing, environmental injustice
A pediatric pulmonary specialist who works in a safety net hospital told this news organization that there are multiple factors that contribute to increased risk for PICU admissions and mortality in disadvantaged neighborhoods.
“The overwhelming majority of our patients are not only of low socioeconomic status on an individual level but also live in areas of great socioeconomic deprivation, and all of those social determinants of health are resulting in increased admissions to the PICU,” said Robyn T. Cohen, MD, associate professor of pediatrics at Boston University Medical Center.
“They’re living in poor housing conditions with environmental pollution and experiencing competing priorities that prevent early access to care or the ability to obtain medications. We should be doing better to prevent that from happening” said Dr. Cohen, who co-moderated the session but was not involved with the study.
The study was supported by a grant from the National Institutes of Health. Ms. Mitchell and Dr. Cohen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – Children who live in neighborhoods that are at the bottom of the socioeconomic ladder are at significantly greater risk for being admitted to a pediatric intensive care unit (PICU) and of dying there, a study of Medicaid data showed.
Among more than 4 million children and adolescents in 12 U.S. states, those in the most socioeconomically deprived quartile had a significantly higher risk for PICU admission and in-hospital death, compared with patients from the least-deprived areas.
Black children were also at significantly higher risk for death than children of other races, reported Hannah K. Mitchell, BMBS, MSc, from Evelina Children’s Hospital, London.“I think we need to do better work for trying to understand the mechanisms behind these disparities, ... whether they can be intervened over in a hospital setting, and to try to identify targeted interventions,” she said during a presentation at the American Thoracic Society International Conference 2022.
Medicaid data
During her residency in pediatrics at Children’s Hospital of Philadelphia, Ms. Mitchell and colleagues conducted a study to determine whether there were disparities in PICU admissions and mortality according to socioeconomic deprivation in specific neighborhoods.
They created a retrospective cohort study of Medicaid patients from birth to age 20 who were covered from 2007 through 2014 in 12 U.S. states, using ZIP codes to identify areas of social deprivation.
They restricted the analysis to children from households with annual incomes below 150% of the federal poverty line and divided the cohort into socioeconomic quartiles.
A total of nearly 4.1 million children and adolescents were included in the sample. Of this group, 274,782 were admitted to a PICU during the study period.
The median age of children admitted to a PICU was 4 years (interquartile range 0-15), and slightly more than two-thirds (68.5%) had a chronic complex condition.
In all, 43.5% were identified as White, and 32.1% were identified as Black. Ms. Mitchell noted that one of the limitations of the study was missing data on patients of Hispanic/Latinx origin.
The mortality rate among all patients admitted to a PICU was 2.5%.
In univariate logistic regression analysis, the odds ratio for PICU admission among children living in the most impoverished circumstances was 1.21 (P < .0001).
Among all patients admitted to a PICU, the OR for death for children in the most deprived quartile, compared with the least deprived was 1.12 (P = .0047).
In addition, Black children were significantly more likely than White children to be admitted to a PICU (OR, 1.14; P < .0001) and to die in hospital (OR, 1.18, P < .0001).
Ms. Mitchell said that clinicians need to move beyond describing disparities and should instead begin to focus on interventions to eliminate or reduce them.
She noted that children in poor neighborhoods may be more likely to receive care in lower-quality hospitals or may be treated differently from other children when hospitalized because of their socioeconomic status.
Poor housing, environmental injustice
A pediatric pulmonary specialist who works in a safety net hospital told this news organization that there are multiple factors that contribute to increased risk for PICU admissions and mortality in disadvantaged neighborhoods.
“The overwhelming majority of our patients are not only of low socioeconomic status on an individual level but also live in areas of great socioeconomic deprivation, and all of those social determinants of health are resulting in increased admissions to the PICU,” said Robyn T. Cohen, MD, associate professor of pediatrics at Boston University Medical Center.
“They’re living in poor housing conditions with environmental pollution and experiencing competing priorities that prevent early access to care or the ability to obtain medications. We should be doing better to prevent that from happening” said Dr. Cohen, who co-moderated the session but was not involved with the study.
The study was supported by a grant from the National Institutes of Health. Ms. Mitchell and Dr. Cohen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – Children who live in neighborhoods that are at the bottom of the socioeconomic ladder are at significantly greater risk for being admitted to a pediatric intensive care unit (PICU) and of dying there, a study of Medicaid data showed.
Among more than 4 million children and adolescents in 12 U.S. states, those in the most socioeconomically deprived quartile had a significantly higher risk for PICU admission and in-hospital death, compared with patients from the least-deprived areas.
Black children were also at significantly higher risk for death than children of other races, reported Hannah K. Mitchell, BMBS, MSc, from Evelina Children’s Hospital, London.“I think we need to do better work for trying to understand the mechanisms behind these disparities, ... whether they can be intervened over in a hospital setting, and to try to identify targeted interventions,” she said during a presentation at the American Thoracic Society International Conference 2022.
Medicaid data
During her residency in pediatrics at Children’s Hospital of Philadelphia, Ms. Mitchell and colleagues conducted a study to determine whether there were disparities in PICU admissions and mortality according to socioeconomic deprivation in specific neighborhoods.
They created a retrospective cohort study of Medicaid patients from birth to age 20 who were covered from 2007 through 2014 in 12 U.S. states, using ZIP codes to identify areas of social deprivation.
They restricted the analysis to children from households with annual incomes below 150% of the federal poverty line and divided the cohort into socioeconomic quartiles.
A total of nearly 4.1 million children and adolescents were included in the sample. Of this group, 274,782 were admitted to a PICU during the study period.
The median age of children admitted to a PICU was 4 years (interquartile range 0-15), and slightly more than two-thirds (68.5%) had a chronic complex condition.
In all, 43.5% were identified as White, and 32.1% were identified as Black. Ms. Mitchell noted that one of the limitations of the study was missing data on patients of Hispanic/Latinx origin.
The mortality rate among all patients admitted to a PICU was 2.5%.
In univariate logistic regression analysis, the odds ratio for PICU admission among children living in the most impoverished circumstances was 1.21 (P < .0001).
Among all patients admitted to a PICU, the OR for death for children in the most deprived quartile, compared with the least deprived was 1.12 (P = .0047).
In addition, Black children were significantly more likely than White children to be admitted to a PICU (OR, 1.14; P < .0001) and to die in hospital (OR, 1.18, P < .0001).
Ms. Mitchell said that clinicians need to move beyond describing disparities and should instead begin to focus on interventions to eliminate or reduce them.
She noted that children in poor neighborhoods may be more likely to receive care in lower-quality hospitals or may be treated differently from other children when hospitalized because of their socioeconomic status.
Poor housing, environmental injustice
A pediatric pulmonary specialist who works in a safety net hospital told this news organization that there are multiple factors that contribute to increased risk for PICU admissions and mortality in disadvantaged neighborhoods.
“The overwhelming majority of our patients are not only of low socioeconomic status on an individual level but also live in areas of great socioeconomic deprivation, and all of those social determinants of health are resulting in increased admissions to the PICU,” said Robyn T. Cohen, MD, associate professor of pediatrics at Boston University Medical Center.
“They’re living in poor housing conditions with environmental pollution and experiencing competing priorities that prevent early access to care or the ability to obtain medications. We should be doing better to prevent that from happening” said Dr. Cohen, who co-moderated the session but was not involved with the study.
The study was supported by a grant from the National Institutes of Health. Ms. Mitchell and Dr. Cohen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Student loan forgiveness plans exclude physicians
In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed,
What was the plan?
During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.
The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
Necessary CARES Act extensions
The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.
At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.
The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
Avenues of forgiveness
There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.
The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
What has been proposed?
First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.
The impact of proposed forgiveness plans for physicians
For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.
Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
The bottom line
Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.
For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.
Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.
A version of this article first appeared on Medscape.com.
In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed,
What was the plan?
During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.
The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
Necessary CARES Act extensions
The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.
At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.
The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
Avenues of forgiveness
There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.
The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
What has been proposed?
First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.
The impact of proposed forgiveness plans for physicians
For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.
Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
The bottom line
Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.
For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.
Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.
A version of this article first appeared on Medscape.com.
In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed,
What was the plan?
During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.
The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
Necessary CARES Act extensions
The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.
At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.
The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
Avenues of forgiveness
There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.
The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
What has been proposed?
First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.
The impact of proposed forgiveness plans for physicians
For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.
Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
The bottom line
Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.
For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.
Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.
A version of this article first appeared on Medscape.com.
Why do clinical trials still underrepresent minority groups?
It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.
In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.
It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.
Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.
Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.
One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.
But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.
“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.
The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”
Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.
“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”
In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”
Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.
She quoted one research investigator as saying Black people are less knowledgeable.
“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
Progress over the years
The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.
“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”
In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”
Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.
Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.
“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”
Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.
According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”
A version of this article first appeared on Medscape.com.
It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.
In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.
It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.
Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.
Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.
One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.
But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.
“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.
The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”
Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.
“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”
In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”
Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.
She quoted one research investigator as saying Black people are less knowledgeable.
“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
Progress over the years
The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.
“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”
In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”
Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.
Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.
“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”
Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.
According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”
A version of this article first appeared on Medscape.com.
It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.
In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.
It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.
Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.
Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.
One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.
But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.
“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.
The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”
Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.
“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”
In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”
Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.
She quoted one research investigator as saying Black people are less knowledgeable.
“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
Progress over the years
The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.
“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”
In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”
Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.
Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.
“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”
Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.
According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”
A version of this article first appeared on Medscape.com.