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Lessons Learned: What Docs Wish Med Students Knew
Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.
Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.
“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.
We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead.
You Won’t Know Everything, and That’s Okay
When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.
David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”
Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.
You’ll Take Your Work Home With You
Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan.
“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”
When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”
Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home.
“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”
Burnout Is Real — Make Self-Care a Priority
As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said.
The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”
That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”
Avoid Relying Too Heavily on Tech
Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”
It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.
“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.
Partner With Your Patients, Even When It’s Difficult
Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.
“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”
Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”
Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”
At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.
“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”
A version of this article first appeared on Medscape.com.
Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.
Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.
“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.
We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead.
You Won’t Know Everything, and That’s Okay
When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.
David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”
Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.
You’ll Take Your Work Home With You
Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan.
“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”
When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”
Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home.
“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”
Burnout Is Real — Make Self-Care a Priority
As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said.
The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”
That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”
Avoid Relying Too Heavily on Tech
Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”
It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.
“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.
Partner With Your Patients, Even When It’s Difficult
Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.
“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”
Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”
Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”
At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.
“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”
A version of this article first appeared on Medscape.com.
Despite 4 years of med school and 3-7 years in residency, when you enter the workforce as a doctor, you still have much to learn. There is only so much your professors and attending physicians can pack in. Going forward, you’ll continue to learn on the job and via continuing education.
Some of that lifelong learning will involve soft skills — how to compassionately work with your patients and their families, for instance. Other lessons will get down to the business of medicine — the paperwork, the work/life balance, and the moral dilemmas you never saw coming. And still others will involve learning how to take care of yourself in the middle of seemingly endless hours on the job.
“We all have things we wish we had known upon starting our careers,” said Daniel Opris, MD, a primary care physician at Ohio-based Executive Medical Centers.
We tapped several veteran physicians and an educator to learn what they wish med students knew as they enter the workforce. We’ve compiled them here to give you a head start on the lessons ahead.
You Won’t Know Everything, and That’s Okay
When you go through your medical training, it can feel overwhelming to absorb all the knowledge your professors and attendings impart. The bottom line, said Shoshana Ungerleider, MD, an internal medicine specialist, is that you shouldn’t worry about it.
David Lenihan, PhD, CEO at Ponce Health Sciences University, agrees. “What we’ve lost in recent years, is the ability to apply your skill set and say, ‘let me take a day and get back to you,’” he said. “Doctors love it when you do that because it shows you can pitch in and work as part of a team.”
Medicine is a collaborative field, said Ungerleider, and learning from others, whether peers, nurses, or specialists, is “not a weakness.” She recommends embracing uncertainty and getting comfortable with the unknown.
You’ll Take Your Work Home With You
Doctors enter the field because they care about their patients and want to help. Successful outcomes are never guaranteed, however, no matter how much you try. The result? Some days you’ll bring home those upsetting and haunting cases, said Lenihan.
“We often believe that we should leave our work at the office, but sometimes you need to bring it home and think it through,” he said. “It can’t overwhelm you, but you should digest what happened.”
When you do, said Lenihan, you’ll come out the other end more empathetic and that helps the healthcare system in the long run. “The more you reflect on your day, the better you’ll get at reading the room and treating your patients.”
Drew Remignanti, MD, a retired emergency medicine physician from New Hampshire, agrees, but puts a different spin on bringing work home.
“We revisit the patient care decisions we made, second-guess ourselves, and worry about our patients’ welfare and outcomes,” he said. “I think it can only lead to better outcomes down the road, however, if you learn from that bad decision, preventing you from committing a similar mistake.”
Burnout Is Real — Make Self-Care a Priority
As a retired physician who spent 40 years practicing medicine, Remignanti experienced the evolution of healthcare as it has become what he calls a “consumer-provider” model. “Productivity didn’t use to be part of the equation, but now it’s the focus,” he said.
The result is burnout, a very real threat to incoming physicians. Remignanti holds that if you are aware of the risk, you can resist it. Part of avoiding burnout is self-care, according to Ungerleider. “The sooner you prioritize your mental, emotional, and physical well-being, the better,” she said. “Balancing work and life may feel impossible at times but taking care of yourself is essential to being a better physician in the long run.”
That means carving out time for exercise, hobbies, and connections outside of the medical field. It also means making sleep and nutrition a priority, even when that feels hard to accomplish. “If you don’t take care of yourself, you can’t take care of others,” added Opris. “It’s so common to lose yourself in your career, but you need to hold onto your physical, emotional, and spiritual self.”
Avoid Relying Too Heavily on Tech
Technology is invading every aspect of our lives — often for the greater good — but in medicine, it’s important to always return to your core knowledge above all else. Case in point, said Opris, the UpToDate app. While it can be a useful tool, it’s important not to become too reliant on it. “UpToDate is expert opinion-based guidance, and it’s a fantastic resource,” he said. “But you need to use your references and knowledge in every case.”
It’s key to remember that every patient is different, and their case may not line up perfectly with the guidance presented in UpToDate or other technology source. Piggybacking on that, Ungerleider added that it’s important to remember medicine is about people, not just conditions.
“It’s easy to focus on mastering the science, but the real art of medicine comes from seeing the whole person in front of you,” she said. “Your patients are more than their diagnoses — they come with complex emotions, life stories, and needs.” Being compassionate, listening carefully, and building trust should match up to your clinical skills.
Partner With Your Patients, Even When It’s Difficult
Perhaps the most difficult lesson of all is remembering that your patients may not always agree with your recommendations and choose to ignore them. After all your years spent learning, there may be times when it feels your education is going to waste.
“Remember that the landscape today is so varied, and that bleeds into medicine,” said Opris. “We go into cases with our own biases, and it’s important to take a step back to reset, every time.”
Opris reminds himself of Sir William Osler’s famous essay, “Aequanimitas,” in which he tells graduating medical students to practice with “coolness and presence of mind under all circumstances.”
Remignanti offers this advice: “Physicians need to be able to partner with their patients and jointly decide which courses of action are most effective,” he said. “Cling to the idea that you are forming a partnership with your patients — what can we together determine is the best course?”
At the same time, the path the patient chooses may not be what’s best for them — potentially even leading to a poor outcome.
“You may not always understand their choices,” said Opris. “But they do have a choice. Think of yourself almost like a consultant.”
A version of this article first appeared on Medscape.com.
Fine Particulate Matter Exposure During Pregnancy Linked to Increased Risk for Spontaneous Preterm Birth
TOPLINE:
Exposure to fine particulate matter (PM2.5) during pregnancy is associated with an increased risk for spontaneous preterm birth, with peak vulnerability in the second trimester. Lower socioeconomic status, limited green space exposure, and extreme heat amplify this risk, whereas living around more trees provides protective effects.
METHODOLOGY:
- The researchers conducted a population-based retrospective cohort study to examine the associations of exposures to total PM2.5 and five constituents (black carbon, nitrate, organic matter, and sulfate) during pregnancy with spontaneous preterm birth.
- They included 409,037 singleton live births from the Kaiser Permanente Southern California health care system between 2008 and 2018, with mothers having a mean age of 30.3 years at delivery (51% Hispanic).
- Daily total PM2.5 concentrations and monthly data on the constituents in California were obtained; mean exposures during the entire pregnancy and in each trimester were calculated.
- Spontaneous preterm births were identified through the evaluation of preterm labor visits and were defined as a delivery occurring before 37 weeks following the onset of spontaneous labor, without pregnancy complications, and within 7 days of the last preterm labor visit.
- The analysis also examined the effect of factors such as race and ethnicity, education, median household income, exposure to green spaces, wildfire smoke, and temperature.
TAKEAWAY:
- Each 2.76 µg/m3 increase in total PM2.5 exposure during pregnancy raised the risk for spontaneous preterm birth by 15% (P < .001), with black carbon showing the highest risk (adjusted odds ratio [aOR], 1.15; 95% CI, 1.12-1.18; P < .001).
- Exposure to PM2.5 during the second trimester showed the highest association with spontaneous preterm birth (aOR, 1.10; P < .001), followed by that during the third (aOR, 1.09; P < .001) and first (aOR, 1.07; P < .001) trimesters.
- Individuals with lower education levels showed a higher risk for spontaneous preterm birth than those with more than 4 years of college education (P = .003).
- Exposure to extreme heat (P < .001) and lower exposure to total green space (P = .003) increased the risk for spontaneous preterm abortion.
IN PRACTICE:
“Targeted and preventive public health interventions among these subpopulations with high risk may be critical for minimizing the burden of spontaneous preterm birth,” the authors wrote.
SOURCE:
The study was led by Anqi Jiao of the program in public health at the Department of Environmental and Occupational Health at the University of California, Irvine. It was published online in JAMA Network Open.
LIMITATIONS:
According to the authors, exposure misclassification was inevitable as individual exposure to PM2.5 was estimated according to census tract-level data without considering personal activity patterns. Only five major PM2.5 constituents were measured due to data availability. Additionally, street-view green space data were considered spatial snapshots, which cannot capture temporal variations, possibly leading to exposure misclassification and biased associations in either direction.
DISCLOSURES:
The study was supported by the National Institute of Environmental Health Sciences and the California Air Resources Board. One author reported receiving research funding from pharmaceutical and biopharmaceutical companies, which was paid to the institute. Another author reported receiving grants from a medical technology company outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Exposure to fine particulate matter (PM2.5) during pregnancy is associated with an increased risk for spontaneous preterm birth, with peak vulnerability in the second trimester. Lower socioeconomic status, limited green space exposure, and extreme heat amplify this risk, whereas living around more trees provides protective effects.
METHODOLOGY:
- The researchers conducted a population-based retrospective cohort study to examine the associations of exposures to total PM2.5 and five constituents (black carbon, nitrate, organic matter, and sulfate) during pregnancy with spontaneous preterm birth.
- They included 409,037 singleton live births from the Kaiser Permanente Southern California health care system between 2008 and 2018, with mothers having a mean age of 30.3 years at delivery (51% Hispanic).
- Daily total PM2.5 concentrations and monthly data on the constituents in California were obtained; mean exposures during the entire pregnancy and in each trimester were calculated.
- Spontaneous preterm births were identified through the evaluation of preterm labor visits and were defined as a delivery occurring before 37 weeks following the onset of spontaneous labor, without pregnancy complications, and within 7 days of the last preterm labor visit.
- The analysis also examined the effect of factors such as race and ethnicity, education, median household income, exposure to green spaces, wildfire smoke, and temperature.
TAKEAWAY:
- Each 2.76 µg/m3 increase in total PM2.5 exposure during pregnancy raised the risk for spontaneous preterm birth by 15% (P < .001), with black carbon showing the highest risk (adjusted odds ratio [aOR], 1.15; 95% CI, 1.12-1.18; P < .001).
- Exposure to PM2.5 during the second trimester showed the highest association with spontaneous preterm birth (aOR, 1.10; P < .001), followed by that during the third (aOR, 1.09; P < .001) and first (aOR, 1.07; P < .001) trimesters.
- Individuals with lower education levels showed a higher risk for spontaneous preterm birth than those with more than 4 years of college education (P = .003).
- Exposure to extreme heat (P < .001) and lower exposure to total green space (P = .003) increased the risk for spontaneous preterm abortion.
IN PRACTICE:
“Targeted and preventive public health interventions among these subpopulations with high risk may be critical for minimizing the burden of spontaneous preterm birth,” the authors wrote.
SOURCE:
The study was led by Anqi Jiao of the program in public health at the Department of Environmental and Occupational Health at the University of California, Irvine. It was published online in JAMA Network Open.
LIMITATIONS:
According to the authors, exposure misclassification was inevitable as individual exposure to PM2.5 was estimated according to census tract-level data without considering personal activity patterns. Only five major PM2.5 constituents were measured due to data availability. Additionally, street-view green space data were considered spatial snapshots, which cannot capture temporal variations, possibly leading to exposure misclassification and biased associations in either direction.
DISCLOSURES:
The study was supported by the National Institute of Environmental Health Sciences and the California Air Resources Board. One author reported receiving research funding from pharmaceutical and biopharmaceutical companies, which was paid to the institute. Another author reported receiving grants from a medical technology company outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Exposure to fine particulate matter (PM2.5) during pregnancy is associated with an increased risk for spontaneous preterm birth, with peak vulnerability in the second trimester. Lower socioeconomic status, limited green space exposure, and extreme heat amplify this risk, whereas living around more trees provides protective effects.
METHODOLOGY:
- The researchers conducted a population-based retrospective cohort study to examine the associations of exposures to total PM2.5 and five constituents (black carbon, nitrate, organic matter, and sulfate) during pregnancy with spontaneous preterm birth.
- They included 409,037 singleton live births from the Kaiser Permanente Southern California health care system between 2008 and 2018, with mothers having a mean age of 30.3 years at delivery (51% Hispanic).
- Daily total PM2.5 concentrations and monthly data on the constituents in California were obtained; mean exposures during the entire pregnancy and in each trimester were calculated.
- Spontaneous preterm births were identified through the evaluation of preterm labor visits and were defined as a delivery occurring before 37 weeks following the onset of spontaneous labor, without pregnancy complications, and within 7 days of the last preterm labor visit.
- The analysis also examined the effect of factors such as race and ethnicity, education, median household income, exposure to green spaces, wildfire smoke, and temperature.
TAKEAWAY:
- Each 2.76 µg/m3 increase in total PM2.5 exposure during pregnancy raised the risk for spontaneous preterm birth by 15% (P < .001), with black carbon showing the highest risk (adjusted odds ratio [aOR], 1.15; 95% CI, 1.12-1.18; P < .001).
- Exposure to PM2.5 during the second trimester showed the highest association with spontaneous preterm birth (aOR, 1.10; P < .001), followed by that during the third (aOR, 1.09; P < .001) and first (aOR, 1.07; P < .001) trimesters.
- Individuals with lower education levels showed a higher risk for spontaneous preterm birth than those with more than 4 years of college education (P = .003).
- Exposure to extreme heat (P < .001) and lower exposure to total green space (P = .003) increased the risk for spontaneous preterm abortion.
IN PRACTICE:
“Targeted and preventive public health interventions among these subpopulations with high risk may be critical for minimizing the burden of spontaneous preterm birth,” the authors wrote.
SOURCE:
The study was led by Anqi Jiao of the program in public health at the Department of Environmental and Occupational Health at the University of California, Irvine. It was published online in JAMA Network Open.
LIMITATIONS:
According to the authors, exposure misclassification was inevitable as individual exposure to PM2.5 was estimated according to census tract-level data without considering personal activity patterns. Only five major PM2.5 constituents were measured due to data availability. Additionally, street-view green space data were considered spatial snapshots, which cannot capture temporal variations, possibly leading to exposure misclassification and biased associations in either direction.
DISCLOSURES:
The study was supported by the National Institute of Environmental Health Sciences and the California Air Resources Board. One author reported receiving research funding from pharmaceutical and biopharmaceutical companies, which was paid to the institute. Another author reported receiving grants from a medical technology company outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
First Phase 3 Drug Trial in IgG4-Related Disease Has Success
WASHINGTON — The B cell–depleting agent inebilizumab (Uplizna) dramatically reduced the risk of flares and increased year-long remission of IgG4-related disease (RD), new research has found.
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial of 135 adults with active IgG4-RD, treatment with inebilizumab resulted in a significant 87% reduction in flare risk and nearly fivefold greater likelihood of flare-free remission at 1 year. The results were published online November 14 in The New England Journal of Medicine and were presented at the annual meeting of the American College of Rheumatology (ACR).
The drug’s manufacturer, Amgen, released top-line results of the trial, called MITIGATE, in June 2024.
Until now, the mainstay of management for the chronic multiorgan disease IgG4-RD has been glucocorticoids, which can cause numerous adverse effects. “It is hoped that inebilizumab can be used as an important steroid-sparing medication in this disease to reduce steroid toxicity,” lead author John H. Stone, MD, professor of medicine at Harvard Medical School, Boston, Massachusetts, said in an interview, noting that it may not entirely eliminate the need for steroid treatment, but for many, it appears to work after the remission induction period as a monotherapy without steroids.
Asked to comment, Leonard H. Calabrese, DO, head of the Section of Clinical Immunology and manager of the Clinical Immunology Clinic at the Cleveland Clinic, Ohio, said: “There has been anecdotal or observational evidence for some effect with other immunosuppressive agents, including rituximab, but no robust clinical trial until this study. This clearly has demonstrated efficacy by reducing the risk of flares. And most importantly, putting people into remission means no active disease in any given organ. ... This gives us another tool in the toolbox to attack B cell–directed diseases, and I think it really makes a lot of sense.”
Calabrese cautioned, though, that “this is a disease that extends over many years. This is just a 1-year study. Label extensions will be important.”
And several questions remain, Calabrese noted: “How long do patients need to remain on drug? What will happen when the drug is stopped? Can they be retreated? These are the natural questions that arise in any sentinel study like this. But this is extremely encouraging. And I think it’s great for patients. I also think it’s a clarion call to increase awareness about this disease since there’s now strong evidence of effective treatment.”
Underrecognized, Often Misdiagnosed as Cancer
Indeed, IgG4-RD, a chronic, relapsing, autoimmune, fibro-inflammatory multiorgan disease, was only first described in Japan in 2003. Since then, it has been reported all over the world yet remains vastly underrecognized. It is often misdiagnosed as cancer because it produces lesions in multiple organs. It received an ICD-10 code only about a year ago. A previous study estimated a prevalence of about 5.3 persons per 100,000 but that is likely to be a three- to fourfold underestimate, said Stone, who is also executive chairman of the IgG4ward! Foundation.
“Nobody had heard of the disease until about 20 years ago. ... And there are many people in the world who have still not heard of it despite the fact that it is a multiorgan autoimmune disease and is probably as common, or more common, than many other diseases that rheumatologists spend a lot of time thinking about, such as scleroderma.”
While knowledge about the disease is increasing in rheumatology circles, it’s less well-recognized among many of the specialties where patients present, depending on the location of their lesions. These include gastroenterology, ophthalmology, pulmonary medicine, neurology, and nephrology. “All would be likely to see this disease,” Stone said.
The disease can be mistaken for tumors in many of those locations and even as metastatic cancer, he noted, adding that “any time a patient has a mass lesion in a typical organ, the pancreas, the major salivary glands, the lungs, or the kidneys, this should be on the differential diagnosis.”
The diagnosis of IgG4-RD is a clinical one, involving “quadrangulation between clinical features, serological findings, IgG4 levels in the blood, radiology studies, and then pathology biopsies when those are available,” Stone said.
Calabrese characterized the current situation as “we’re all blind men on the elephant. To the neurologist or the neurosurgeon, it’s a mass in the brain. It could present to the ophthalmologist as an [eye] tumor. It can be thyroid gland failure, pulmonary disease, retroperitoneal fibrosis, hepatobiliary disease, and beyond. So, whoever sees that patient, there’s often a long lag time in recognizing it.”
And interestingly, Stone noted that unlike other autoimmune diseases, IgG4-RD primarily affects middle-aged men rather than younger-to-middle-aged women. And when IgG4-RD is diagnosed, glucocorticoid treatment can be particularly toxic when the pancreas is involved, heightening the risk for hyperglycemia and potentially causing diabetes.
Dramatic Improvement in Flares, Remission Achievement
MITIGATE is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial in which 135 adults (mean age 58.2 years, 88 men) with active IgG4-RD were randomized 1:1 to receive 300-mg intravenous infusions of inebilizumab or placebo on days 1 and 15, and again at week 26. At baseline, 62 (45.9%) participants had newly diagnosed IgG4-RD and 73 (54.1%) had recurrent disease.
Both groups received identical glucocorticoid tapers. Overall, 127 (94.1%) completed the 52 weeks of treatment.
By 52 weeks, only seven patients in the inebilizumab group (10%) had experienced disease flares vs 40 (60%) in the placebo group, a significant difference with a hazard ratio of 0.13 (P < .001).
The percentage of participants achieving flare-free, treatment-free complete remission was 59 with inebilizumab (57%), compared with just 15 (22%) in the placebo group (odds ratio [OR], 4.68; P < .001). And for flare-free, glucocorticoid-free complete remission, those proportions were 40 (59%) vs 15 (22%), respectively (OR, 4.96; P < .001).
Excluding the 8-week glucocorticoid taper period, mean total glucocorticoid use was 1264.2 mg less in the inebilizumab than the placebo group, a significant reduction. Overall, 61 participants (90%) were able to entirely discontinue glucocorticoids during the trial, compared with just 25 (37%) in the placebo group.
Adverse events of grade 3 or higher occurred in 12 participants (18%) in the inebilizumab group and 8 (12%) in the placebo group; serious adverse events occurred in 12 (18%) and 6 (9%), respectively. However, no serious adverse event occurred in more than one participant, and there were no deaths. Adverse events led to withdrawal from the trial in six patients (9%) in the inebilizumab group and three patients (4%) in the placebo group.
Adverse events that occurred in more than 10% of participants in the inebilizumab group were COVID-19 in 16 participants (24%), lymphopenia in 11 (16%), and urinary tract infection in 8 (12%).
Importantly, Stone noted, B-cell depletion can reduce responses to vaccines, so patients should receive all recommended vaccinations, including COVID-19, influenza, respiratory syncytial virus, and others, prior to initiating therapy.
Uplizna (inebilizumab-cdon) was approved by the Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder in 2020. In October 2024, the FDA granted Amgen breakthrough therapy designation for use in IgG4-RD. The company is also developing the drug for use in myasthenia gravis.
The study was funded by Amgen. Stone has reported being a consultant for Amgen, Zenas, Argenx, Bristol Myers Squibb, Novartis, Sanofi, and Horizon Pharma. Calabrese has reported being a consultant and/or speaker for Amgen, AstraZeneca, Jansen, Sanofi, and UCB.
A version of this article first appeared on Medscape.com.
WASHINGTON — The B cell–depleting agent inebilizumab (Uplizna) dramatically reduced the risk of flares and increased year-long remission of IgG4-related disease (RD), new research has found.
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial of 135 adults with active IgG4-RD, treatment with inebilizumab resulted in a significant 87% reduction in flare risk and nearly fivefold greater likelihood of flare-free remission at 1 year. The results were published online November 14 in The New England Journal of Medicine and were presented at the annual meeting of the American College of Rheumatology (ACR).
The drug’s manufacturer, Amgen, released top-line results of the trial, called MITIGATE, in June 2024.
Until now, the mainstay of management for the chronic multiorgan disease IgG4-RD has been glucocorticoids, which can cause numerous adverse effects. “It is hoped that inebilizumab can be used as an important steroid-sparing medication in this disease to reduce steroid toxicity,” lead author John H. Stone, MD, professor of medicine at Harvard Medical School, Boston, Massachusetts, said in an interview, noting that it may not entirely eliminate the need for steroid treatment, but for many, it appears to work after the remission induction period as a monotherapy without steroids.
Asked to comment, Leonard H. Calabrese, DO, head of the Section of Clinical Immunology and manager of the Clinical Immunology Clinic at the Cleveland Clinic, Ohio, said: “There has been anecdotal or observational evidence for some effect with other immunosuppressive agents, including rituximab, but no robust clinical trial until this study. This clearly has demonstrated efficacy by reducing the risk of flares. And most importantly, putting people into remission means no active disease in any given organ. ... This gives us another tool in the toolbox to attack B cell–directed diseases, and I think it really makes a lot of sense.”
Calabrese cautioned, though, that “this is a disease that extends over many years. This is just a 1-year study. Label extensions will be important.”
And several questions remain, Calabrese noted: “How long do patients need to remain on drug? What will happen when the drug is stopped? Can they be retreated? These are the natural questions that arise in any sentinel study like this. But this is extremely encouraging. And I think it’s great for patients. I also think it’s a clarion call to increase awareness about this disease since there’s now strong evidence of effective treatment.”
Underrecognized, Often Misdiagnosed as Cancer
Indeed, IgG4-RD, a chronic, relapsing, autoimmune, fibro-inflammatory multiorgan disease, was only first described in Japan in 2003. Since then, it has been reported all over the world yet remains vastly underrecognized. It is often misdiagnosed as cancer because it produces lesions in multiple organs. It received an ICD-10 code only about a year ago. A previous study estimated a prevalence of about 5.3 persons per 100,000 but that is likely to be a three- to fourfold underestimate, said Stone, who is also executive chairman of the IgG4ward! Foundation.
“Nobody had heard of the disease until about 20 years ago. ... And there are many people in the world who have still not heard of it despite the fact that it is a multiorgan autoimmune disease and is probably as common, or more common, than many other diseases that rheumatologists spend a lot of time thinking about, such as scleroderma.”
While knowledge about the disease is increasing in rheumatology circles, it’s less well-recognized among many of the specialties where patients present, depending on the location of their lesions. These include gastroenterology, ophthalmology, pulmonary medicine, neurology, and nephrology. “All would be likely to see this disease,” Stone said.
The disease can be mistaken for tumors in many of those locations and even as metastatic cancer, he noted, adding that “any time a patient has a mass lesion in a typical organ, the pancreas, the major salivary glands, the lungs, or the kidneys, this should be on the differential diagnosis.”
The diagnosis of IgG4-RD is a clinical one, involving “quadrangulation between clinical features, serological findings, IgG4 levels in the blood, radiology studies, and then pathology biopsies when those are available,” Stone said.
Calabrese characterized the current situation as “we’re all blind men on the elephant. To the neurologist or the neurosurgeon, it’s a mass in the brain. It could present to the ophthalmologist as an [eye] tumor. It can be thyroid gland failure, pulmonary disease, retroperitoneal fibrosis, hepatobiliary disease, and beyond. So, whoever sees that patient, there’s often a long lag time in recognizing it.”
And interestingly, Stone noted that unlike other autoimmune diseases, IgG4-RD primarily affects middle-aged men rather than younger-to-middle-aged women. And when IgG4-RD is diagnosed, glucocorticoid treatment can be particularly toxic when the pancreas is involved, heightening the risk for hyperglycemia and potentially causing diabetes.
Dramatic Improvement in Flares, Remission Achievement
MITIGATE is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial in which 135 adults (mean age 58.2 years, 88 men) with active IgG4-RD were randomized 1:1 to receive 300-mg intravenous infusions of inebilizumab or placebo on days 1 and 15, and again at week 26. At baseline, 62 (45.9%) participants had newly diagnosed IgG4-RD and 73 (54.1%) had recurrent disease.
Both groups received identical glucocorticoid tapers. Overall, 127 (94.1%) completed the 52 weeks of treatment.
By 52 weeks, only seven patients in the inebilizumab group (10%) had experienced disease flares vs 40 (60%) in the placebo group, a significant difference with a hazard ratio of 0.13 (P < .001).
The percentage of participants achieving flare-free, treatment-free complete remission was 59 with inebilizumab (57%), compared with just 15 (22%) in the placebo group (odds ratio [OR], 4.68; P < .001). And for flare-free, glucocorticoid-free complete remission, those proportions were 40 (59%) vs 15 (22%), respectively (OR, 4.96; P < .001).
Excluding the 8-week glucocorticoid taper period, mean total glucocorticoid use was 1264.2 mg less in the inebilizumab than the placebo group, a significant reduction. Overall, 61 participants (90%) were able to entirely discontinue glucocorticoids during the trial, compared with just 25 (37%) in the placebo group.
Adverse events of grade 3 or higher occurred in 12 participants (18%) in the inebilizumab group and 8 (12%) in the placebo group; serious adverse events occurred in 12 (18%) and 6 (9%), respectively. However, no serious adverse event occurred in more than one participant, and there were no deaths. Adverse events led to withdrawal from the trial in six patients (9%) in the inebilizumab group and three patients (4%) in the placebo group.
Adverse events that occurred in more than 10% of participants in the inebilizumab group were COVID-19 in 16 participants (24%), lymphopenia in 11 (16%), and urinary tract infection in 8 (12%).
Importantly, Stone noted, B-cell depletion can reduce responses to vaccines, so patients should receive all recommended vaccinations, including COVID-19, influenza, respiratory syncytial virus, and others, prior to initiating therapy.
Uplizna (inebilizumab-cdon) was approved by the Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder in 2020. In October 2024, the FDA granted Amgen breakthrough therapy designation for use in IgG4-RD. The company is also developing the drug for use in myasthenia gravis.
The study was funded by Amgen. Stone has reported being a consultant for Amgen, Zenas, Argenx, Bristol Myers Squibb, Novartis, Sanofi, and Horizon Pharma. Calabrese has reported being a consultant and/or speaker for Amgen, AstraZeneca, Jansen, Sanofi, and UCB.
A version of this article first appeared on Medscape.com.
WASHINGTON — The B cell–depleting agent inebilizumab (Uplizna) dramatically reduced the risk of flares and increased year-long remission of IgG4-related disease (RD), new research has found.
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial of 135 adults with active IgG4-RD, treatment with inebilizumab resulted in a significant 87% reduction in flare risk and nearly fivefold greater likelihood of flare-free remission at 1 year. The results were published online November 14 in The New England Journal of Medicine and were presented at the annual meeting of the American College of Rheumatology (ACR).
The drug’s manufacturer, Amgen, released top-line results of the trial, called MITIGATE, in June 2024.
Until now, the mainstay of management for the chronic multiorgan disease IgG4-RD has been glucocorticoids, which can cause numerous adverse effects. “It is hoped that inebilizumab can be used as an important steroid-sparing medication in this disease to reduce steroid toxicity,” lead author John H. Stone, MD, professor of medicine at Harvard Medical School, Boston, Massachusetts, said in an interview, noting that it may not entirely eliminate the need for steroid treatment, but for many, it appears to work after the remission induction period as a monotherapy without steroids.
Asked to comment, Leonard H. Calabrese, DO, head of the Section of Clinical Immunology and manager of the Clinical Immunology Clinic at the Cleveland Clinic, Ohio, said: “There has been anecdotal or observational evidence for some effect with other immunosuppressive agents, including rituximab, but no robust clinical trial until this study. This clearly has demonstrated efficacy by reducing the risk of flares. And most importantly, putting people into remission means no active disease in any given organ. ... This gives us another tool in the toolbox to attack B cell–directed diseases, and I think it really makes a lot of sense.”
Calabrese cautioned, though, that “this is a disease that extends over many years. This is just a 1-year study. Label extensions will be important.”
And several questions remain, Calabrese noted: “How long do patients need to remain on drug? What will happen when the drug is stopped? Can they be retreated? These are the natural questions that arise in any sentinel study like this. But this is extremely encouraging. And I think it’s great for patients. I also think it’s a clarion call to increase awareness about this disease since there’s now strong evidence of effective treatment.”
Underrecognized, Often Misdiagnosed as Cancer
Indeed, IgG4-RD, a chronic, relapsing, autoimmune, fibro-inflammatory multiorgan disease, was only first described in Japan in 2003. Since then, it has been reported all over the world yet remains vastly underrecognized. It is often misdiagnosed as cancer because it produces lesions in multiple organs. It received an ICD-10 code only about a year ago. A previous study estimated a prevalence of about 5.3 persons per 100,000 but that is likely to be a three- to fourfold underestimate, said Stone, who is also executive chairman of the IgG4ward! Foundation.
“Nobody had heard of the disease until about 20 years ago. ... And there are many people in the world who have still not heard of it despite the fact that it is a multiorgan autoimmune disease and is probably as common, or more common, than many other diseases that rheumatologists spend a lot of time thinking about, such as scleroderma.”
While knowledge about the disease is increasing in rheumatology circles, it’s less well-recognized among many of the specialties where patients present, depending on the location of their lesions. These include gastroenterology, ophthalmology, pulmonary medicine, neurology, and nephrology. “All would be likely to see this disease,” Stone said.
The disease can be mistaken for tumors in many of those locations and even as metastatic cancer, he noted, adding that “any time a patient has a mass lesion in a typical organ, the pancreas, the major salivary glands, the lungs, or the kidneys, this should be on the differential diagnosis.”
The diagnosis of IgG4-RD is a clinical one, involving “quadrangulation between clinical features, serological findings, IgG4 levels in the blood, radiology studies, and then pathology biopsies when those are available,” Stone said.
Calabrese characterized the current situation as “we’re all blind men on the elephant. To the neurologist or the neurosurgeon, it’s a mass in the brain. It could present to the ophthalmologist as an [eye] tumor. It can be thyroid gland failure, pulmonary disease, retroperitoneal fibrosis, hepatobiliary disease, and beyond. So, whoever sees that patient, there’s often a long lag time in recognizing it.”
And interestingly, Stone noted that unlike other autoimmune diseases, IgG4-RD primarily affects middle-aged men rather than younger-to-middle-aged women. And when IgG4-RD is diagnosed, glucocorticoid treatment can be particularly toxic when the pancreas is involved, heightening the risk for hyperglycemia and potentially causing diabetes.
Dramatic Improvement in Flares, Remission Achievement
MITIGATE is a phase 3, multicenter, double-blind, randomized, placebo-controlled trial in which 135 adults (mean age 58.2 years, 88 men) with active IgG4-RD were randomized 1:1 to receive 300-mg intravenous infusions of inebilizumab or placebo on days 1 and 15, and again at week 26. At baseline, 62 (45.9%) participants had newly diagnosed IgG4-RD and 73 (54.1%) had recurrent disease.
Both groups received identical glucocorticoid tapers. Overall, 127 (94.1%) completed the 52 weeks of treatment.
By 52 weeks, only seven patients in the inebilizumab group (10%) had experienced disease flares vs 40 (60%) in the placebo group, a significant difference with a hazard ratio of 0.13 (P < .001).
The percentage of participants achieving flare-free, treatment-free complete remission was 59 with inebilizumab (57%), compared with just 15 (22%) in the placebo group (odds ratio [OR], 4.68; P < .001). And for flare-free, glucocorticoid-free complete remission, those proportions were 40 (59%) vs 15 (22%), respectively (OR, 4.96; P < .001).
Excluding the 8-week glucocorticoid taper period, mean total glucocorticoid use was 1264.2 mg less in the inebilizumab than the placebo group, a significant reduction. Overall, 61 participants (90%) were able to entirely discontinue glucocorticoids during the trial, compared with just 25 (37%) in the placebo group.
Adverse events of grade 3 or higher occurred in 12 participants (18%) in the inebilizumab group and 8 (12%) in the placebo group; serious adverse events occurred in 12 (18%) and 6 (9%), respectively. However, no serious adverse event occurred in more than one participant, and there were no deaths. Adverse events led to withdrawal from the trial in six patients (9%) in the inebilizumab group and three patients (4%) in the placebo group.
Adverse events that occurred in more than 10% of participants in the inebilizumab group were COVID-19 in 16 participants (24%), lymphopenia in 11 (16%), and urinary tract infection in 8 (12%).
Importantly, Stone noted, B-cell depletion can reduce responses to vaccines, so patients should receive all recommended vaccinations, including COVID-19, influenza, respiratory syncytial virus, and others, prior to initiating therapy.
Uplizna (inebilizumab-cdon) was approved by the Food and Drug Administration (FDA) for the treatment of neuromyelitis optica spectrum disorder in 2020. In October 2024, the FDA granted Amgen breakthrough therapy designation for use in IgG4-RD. The company is also developing the drug for use in myasthenia gravis.
The study was funded by Amgen. Stone has reported being a consultant for Amgen, Zenas, Argenx, Bristol Myers Squibb, Novartis, Sanofi, and Horizon Pharma. Calabrese has reported being a consultant and/or speaker for Amgen, AstraZeneca, Jansen, Sanofi, and UCB.
A version of this article first appeared on Medscape.com.
FROM ACR 2024
‘No Hint of Benefit’ in Large Colchicine Trial
WASHINGTON —
The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.
For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).
There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.
No Difference
No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).
Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).
Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.
“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.
The OASIS 9 Trial
In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.
The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.
Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.
At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.
In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).
However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).
New Data Challenge Guidelines
Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.
Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.
“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.
The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.
Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.
“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.
A version of this article first appeared on Medscape.com.
WASHINGTON —
The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.
For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).
There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.
No Difference
No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).
Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).
Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.
“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.
The OASIS 9 Trial
In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.
The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.
Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.
At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.
In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).
However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).
New Data Challenge Guidelines
Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.
Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.
“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.
The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.
Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.
“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.
A version of this article first appeared on Medscape.com.
WASHINGTON —
The CLEAR SYNERGY (OASIS 9) study, called “the largest trial ever of colchicine in acute MI,” showed no hint of benefit in an adverse event curve for colchicine relative to placebo over 5 years, which suggests that the role of this drug after myocardial infarction (MI) “is uncertain,” Sanjit Jolly, MD, an interventional cardiologist at Hamilton Health Sciences and a professor of medicine at McMaster University in Hamilton, Ontario, Canada, reported at Transcatheter Cardiovascular Therapeutics (TCT) 2024.
For the primary composite outcome — cardiovascular death, MI, stroke, and ischemia-driven revascularization — the event curves in the colchicine and placebo groups remained essentially superimposed over 5 years of follow-up, with only a slight separation after 4 years. The hazard ratio for the primary endpoint showed a 1% difference in favor of colchicine (hazard ratio [HR], 0.99; P = .93).
There were no meaningful differences in any of the individual endpoint components; all 95% CIs straddled the line of unity. Rates of cardiovascular death (3.3% vs 3.2%) and stroke (1.4% vs 1.2%) were numerically higher in the colchicine group than in the placebo group. Rates of MI (2.9% vs 3.1%) and ischemia-driven revascularization (4.6% vs 4.7%) were numerically lower in the colchicine group.
No Difference
No adverse outcomes, including all-cause death (4.6% vs 5.1%), approached significance, with the exception of noncardiovascular death (13.0% vs 1.9%). For this outcome, the 95% CI stopped just short of the line of unity (HR, 0.68; 95% CI, 0.46-0.99).
Rates of adverse events (31.9% vs 31.7%; P = .86), serious adverse events (6.7% vs 7.4%; P = .22), and serious infections (2.5% vs 2.9%; P = .85) were similar in the colchicine and placebo groups, but diarrhea, a known side effect of colchicine, was higher in the colchicine group (10.2% vs 6.6%; P < .001).
Given these results, a panelist questioned the use of the word “uncertain” to describe the findings during the late-breaker session in which these results were presented.
“I think you are selling yourself short,” said J. Dawn Abbott, MD, director of the Interventional Cardiology Fellowship Training Program at the Lifespan Cardiovascular Institute, Brown University in Providence, Rhode Island. Based on the size and conduct of this trial, she called the results “definitive” and suggested that the guidelines should be adjusted.
The OASIS 9 Trial
In OASIS 9, 3528 patients were randomized to colchicine, and 3534 were randomized to placebo. A second randomization in both groups was to spironolactone or placebo; these results will be presented at the upcoming American Heart Association (AHA) 2024 meeting. Both analyses will be published in The New England Journal of Medicine at that time, Jolly reported.
The study involved 104 sites in Australia, Egypt, Europe, Nepal, and North America. Follow-up in both groups exceeded 99%. Most patients had an ST-elevation MI (STEMI), but about 5% of those enrolled had a non-STEMI. Less than 10% of patients had experienced a previous MI.
Less than 5% of patients were discharged on sodium-glucose cotransporter 2 therapy, and more than 95% were discharged on aspirin and a statin. Nearly 80% were discharged on an angiotensin-converting enzyme inhibitor, and most patients received an anticoagulant. More than 95% of patients were implanted with a drug-eluting stent.
At month 3, C-reactive protein levels were significantly lower in the colchicine group than in the placebo group. C-reactive protein is a biomarker for the anti-inflammatory effect that is considered to be colchicine’s primary mechanism of action. An anti-inflammatory effect has been cited as the probable explanation for the positive results shown in the COLCOT and LODOCO2 trials, published in 2019 and 2020, respectively.
In COLCOT, which randomized 4745 patients who experienced an acute MI in the previous 30 days, colchicine was associated with a 23% reduction in a composite major cardiovascular adverse events endpoint relative to placebo (HR, 0.77; P = .02). In LODOCO2, which randomized 5522 patients with chronic coronary disease, colchicine was associated with a 31% reduction in an adverse event composite endpoint (HR, 0.68; P < .0001).
However, two more recent trials — CONVINCE and CHANCE-3 — showed no difference between colchicine and placebo for the endpoint of recurrent stroke at 90 days. CONVINCE, with approximately 3000 patients, was relatively small, whereas CHANCE-3 randomized more than 8000 patients and showed no effect on the risk for stroke (HR, 0.98; 95% CI, 0.83-1.16).
New Data Challenge Guidelines
Of these trials, COLCOT was the most similar to OASIS 9, according to Jolly. Among the differences, OASIS 9 was initiated earlier and was larger than the other trials, so it had more power to address the study question.
Given the absence of benefit, Jolly indicated that OASIS 9 might disrupt both the joint American College of Cardiology and AHA guidelines, which gave colchicine a class 2b recommendation in 2023, and the European Society of Cardiology guidelines, which gave colchicine a 2a recommendation.
“This is a big deal for me,” said Ajay J. Kirtane, director of the Interventional Cardiovascular Care program at Columbia University in New York City. As someone who is now using colchicine routinely, these data have changed his opinion.
The previous data supporting the use of colchicine “were just so-so,” he explained. “Now I have a good rationale” for foregoing the routine use of this therapy.
Jolly said that he had put his own father on colchicine after an acute MI on the basis of the guidelines, but immediately took him off this therapy when the data from OASIS 9 were unblinded.
“The only signal from this trial was an increased risk of diarrhea,” Jolly said. The results, at the very least, suggest that colchicine “is not for everyone” after an acute MI, although he emphasized that these results do not rule out the potential for benefit from anti-inflammatory therapy. Ongoing trials, including one targeting interleukin 6, a cytokine associated with inflammation, remain of interest, he added.
A version of this article first appeared on Medscape.com.
FROM TCT 2024
Does Antibiotic Use During Influenza Infection Worsen Lung Immunity?
TOPLINE:
Antibiotic use during influenza infection increases lung eosinophils, impairing immunity against secondary bacterial pneumonia. This study highlights the detrimental effects of antibiotics on lung health during viral infections.
METHODOLOGY:
- Researchers conducted a murine model study to evaluate the impact of antibiotic use during influenza infection on lung immunity. Mice were treated with a broad-spectrum antibiotic cocktail (vancomycin, neomycin, ampicillin, and metronidazole) starting 7 days before influenza infection.
- The study included intranasal infection with influenza virus followed by a secondary challenge with methicillin-resistant Staphylococcus aureus (MRSA).
- Finally, in sub-study, a total of three cohorts of hospitalized patients were evaluated to correlate eosinophil levels with antibiotic use, systemic inflammation, and outcomes.
TAKEAWAY:
- Antibiotic use during influenza infection impairs lung immunity, leading to increased lung eosinophils and reduced macrophage function.
- The study found that antibiotic treatment during influenza infection caused fungal dysbiosis, driving lung eosinophilia and impairing MRSA clearance.
- The detrimental effects of antibiotics on lung immunity were specific to the two-hit model of influenza followed by MRSA infection in mice.
- In hospitalized patients, eosinophil levels positively correlated with antibiotic use, systemic inflammation, and worsened outcomes.
IN PRACTICE:
“Our study highlights the pernicious effects of antibiotic use during viral infections and defines a mechanism whereby antibiotics perturb the gut mycobiome and result in lung eosinophilia. In turn, lung eosinophils, via release of MBP-1, suppress alveolar macrophage clearance of bacteria,” the authors of the study wrote.
SOURCE:
This study was led by Marilia Sanches Santos Rizzo Zuttion, Cedars-Sinai Medical Center in Los Angeles. It was published online in The Journal of Clinical Investigation.
LIMITATIONS:
This study’s limitations included the use of a murine model, which may not fully replicate human immune responses. Additionally, the study focused on a specific antibiotic cocktail, and results may vary with different antibiotics. The findings were also specific to the two-hit model of influenza followed by MRSA infection, limiting generalizability to other infections.
DISCLOSURES:
This study was supported by grants from the National Institutes of Health. Marilia Sanches Santos Rizzo Zuttion received research funding from Pfizer Inc. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Antibiotic use during influenza infection increases lung eosinophils, impairing immunity against secondary bacterial pneumonia. This study highlights the detrimental effects of antibiotics on lung health during viral infections.
METHODOLOGY:
- Researchers conducted a murine model study to evaluate the impact of antibiotic use during influenza infection on lung immunity. Mice were treated with a broad-spectrum antibiotic cocktail (vancomycin, neomycin, ampicillin, and metronidazole) starting 7 days before influenza infection.
- The study included intranasal infection with influenza virus followed by a secondary challenge with methicillin-resistant Staphylococcus aureus (MRSA).
- Finally, in sub-study, a total of three cohorts of hospitalized patients were evaluated to correlate eosinophil levels with antibiotic use, systemic inflammation, and outcomes.
TAKEAWAY:
- Antibiotic use during influenza infection impairs lung immunity, leading to increased lung eosinophils and reduced macrophage function.
- The study found that antibiotic treatment during influenza infection caused fungal dysbiosis, driving lung eosinophilia and impairing MRSA clearance.
- The detrimental effects of antibiotics on lung immunity were specific to the two-hit model of influenza followed by MRSA infection in mice.
- In hospitalized patients, eosinophil levels positively correlated with antibiotic use, systemic inflammation, and worsened outcomes.
IN PRACTICE:
“Our study highlights the pernicious effects of antibiotic use during viral infections and defines a mechanism whereby antibiotics perturb the gut mycobiome and result in lung eosinophilia. In turn, lung eosinophils, via release of MBP-1, suppress alveolar macrophage clearance of bacteria,” the authors of the study wrote.
SOURCE:
This study was led by Marilia Sanches Santos Rizzo Zuttion, Cedars-Sinai Medical Center in Los Angeles. It was published online in The Journal of Clinical Investigation.
LIMITATIONS:
This study’s limitations included the use of a murine model, which may not fully replicate human immune responses. Additionally, the study focused on a specific antibiotic cocktail, and results may vary with different antibiotics. The findings were also specific to the two-hit model of influenza followed by MRSA infection, limiting generalizability to other infections.
DISCLOSURES:
This study was supported by grants from the National Institutes of Health. Marilia Sanches Santos Rizzo Zuttion received research funding from Pfizer Inc. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Antibiotic use during influenza infection increases lung eosinophils, impairing immunity against secondary bacterial pneumonia. This study highlights the detrimental effects of antibiotics on lung health during viral infections.
METHODOLOGY:
- Researchers conducted a murine model study to evaluate the impact of antibiotic use during influenza infection on lung immunity. Mice were treated with a broad-spectrum antibiotic cocktail (vancomycin, neomycin, ampicillin, and metronidazole) starting 7 days before influenza infection.
- The study included intranasal infection with influenza virus followed by a secondary challenge with methicillin-resistant Staphylococcus aureus (MRSA).
- Finally, in sub-study, a total of three cohorts of hospitalized patients were evaluated to correlate eosinophil levels with antibiotic use, systemic inflammation, and outcomes.
TAKEAWAY:
- Antibiotic use during influenza infection impairs lung immunity, leading to increased lung eosinophils and reduced macrophage function.
- The study found that antibiotic treatment during influenza infection caused fungal dysbiosis, driving lung eosinophilia and impairing MRSA clearance.
- The detrimental effects of antibiotics on lung immunity were specific to the two-hit model of influenza followed by MRSA infection in mice.
- In hospitalized patients, eosinophil levels positively correlated with antibiotic use, systemic inflammation, and worsened outcomes.
IN PRACTICE:
“Our study highlights the pernicious effects of antibiotic use during viral infections and defines a mechanism whereby antibiotics perturb the gut mycobiome and result in lung eosinophilia. In turn, lung eosinophils, via release of MBP-1, suppress alveolar macrophage clearance of bacteria,” the authors of the study wrote.
SOURCE:
This study was led by Marilia Sanches Santos Rizzo Zuttion, Cedars-Sinai Medical Center in Los Angeles. It was published online in The Journal of Clinical Investigation.
LIMITATIONS:
This study’s limitations included the use of a murine model, which may not fully replicate human immune responses. Additionally, the study focused on a specific antibiotic cocktail, and results may vary with different antibiotics. The findings were also specific to the two-hit model of influenza followed by MRSA infection, limiting generalizability to other infections.
DISCLOSURES:
This study was supported by grants from the National Institutes of Health. Marilia Sanches Santos Rizzo Zuttion received research funding from Pfizer Inc. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Retire? Not Me! A Physician’s Journey of Reinvention
I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me.
I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life.
From Private Practice to Being Employed
I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work.
But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”.
My Second ‘Retirement’
My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come.
To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further.
My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated.
I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned.
“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.
“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch.
Finding What Suits Me
If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more.
On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult.
I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year.
Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!”
For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy.
Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life.
I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career.
Until then, my magic erasers, colored pencils and gardening will have to wait.
Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me.
I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life.
From Private Practice to Being Employed
I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work.
But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”.
My Second ‘Retirement’
My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come.
To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further.
My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated.
I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned.
“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.
“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch.
Finding What Suits Me
If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more.
On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult.
I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year.
Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!”
For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy.
Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life.
I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career.
Until then, my magic erasers, colored pencils and gardening will have to wait.
Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
I’ve tried to retire from medicine. Really. Proofs of my sincerity include a true retirement from performing procedures and the closing of two office practices. I even attended the wonderful retirement party my daughters threw for me.
I had great plans for my newfound leisure time. I purchased about a thousand colored pencils to map my family ancestry. I wore out many magic erasers in my cleaning efforts. I cajoled my husband, Tony, to help me build not one, but three, gardens in our yard. Upon realizing I had no more weeds or closets to conquer, I began a Dante-like descent into a dark abyss. I felt my sadness was justified. After all, I had immensely enjoyed my early medical life.
From Private Practice to Being Employed
I had a joint cardiology practice with the great Jim Whiteside, MD, in South Central Kentucky for 24 years. Our schedule was always bursting at the seams in the heart of tobacco country. We opened the first cath lab in our hospital, inspired the purchase of a new nuclear scanner, and expanded the stress echo lab. After a 6-year odyssey, we successfully championed primary PCI without surgery on site (along with Ephraim McDowell Regional Medical Center in Danville, Kentucky). As our services expanded, we remodeled to accommodate three cardiologists and two nurse practitioners. Simultaneously, we lobbied our city council and mayor to pass smoke-free legislation, a lightning rod topic in a culture still loyal to a burning weed whose worth had paled in comparison to the cost of its carnage. We were “running wide open” and believed that we were doing important work.
But then our forward-thinking, appreciative CEO and friend died suddenly, and the open communication and innovation seemingly vanished. Those events inspired my first “retirement.” After this, I became employed for the first time and was blessed once again with a wonderful partner and colleagues. But despite those blessings, the global practice of medicine had begun to change. Physicians were now seen by some as widgets; their worth measured in productivity. A few years in, I needed part-time work to care for my aging parents. My employer needed more, thus inspiring my second “retirement”.
My Second ‘Retirement’
My parents died within 4 months of each other in 2020. Suddenly, I was untethered from both my professional persona and role as caregiver. It was then that my sadness accelerated toward what seemed like the second circle of Hell, with many more to come.
To many, my sadness made no sense. Our accountant reassured us that we no longer “needed” to work, and I was (and still am) happily married to my high school sweetheart. Our beautiful daughters were healthy and thriving. Although I mouthed appreciation for my blessings in prayer, I could not prevent myself from sinking further.
My always supportive husband was worried. Tony had skipped happily into his retirement from teaching. He had hoped I would do that same. “You cannot sit on that couch and mope for the rest of your life,” he said, exasperated.
I thought about doing just that, until one day I answered a phone call to hear, “Doctor, have you ever been to Montana?” Before I could cut her off, the woman charged into the description of a job opening for a locums cardiologist. I immediately sat up. “No office work?” I questioned.
“No, this is strictly hospital call, rounds, and reading studies.” I didn’t know such jobs existed.
“What is the salary, and what do you cover?” I asked trying to conceal the fact that Tony would have gladly paid her to get me off the couch.
Finding What Suits Me
If I’m honest, since my training days, hospital work is all I have ever wanted. I’ve always felt trapped by the imaginary timer that is part of every office visit. I found running a code less challenging than having to stand and end an office visit that might leave a patient wanting more.
On hospital days, there are no scheduled time slots. I can triage patients according to their needs. My deadlines are self-imposed: To have a morning coffee with Tony. To deliver the best care possible. To educate as much as time will allow. To beat the midnight clock, after which billing is a little more difficult.
I will soon begin my seventh year as an inpatient, acute-care cardiologist. Although I was flattered to be considered for full-time work, I couldn’t do that to Tony (who declined to move from Kentucky). We struck a deal that we’d travel to the same facility, where I work seven to nine jobs a year.
Tony golfs while I work and he jokes that he is a “real go-getter,” explaining that “I take her to work in the morning and then at night, I go get her!”
For those considering this line of work, it’s not for the faint of heart. My workday can stretch to over 16 hours. But I work in the best of hospital settings. On morning rounds, we present every single patient on the service. Our ER is staffed 100% of the time with at least four board-certified emergency medicine trained physicians. Everyone I work with shares a patient-first philosophy.
Because of this, I have quite easily ascended from Dante’s inferno. I am happy again in my professional life.
I know I’ll eventually have to retire for real, and I hope it will be at a time of my choosing and not enforced by the failings of modern medicine. I believe that these past few years will help ease that transition. And when that time comes, I’ll able to look back and know that I was blessed with a long and mostly satisfying career.
Until then, my magic erasers, colored pencils and gardening will have to wait.
Dr. Walton-Shirley is a clinical cardiologist from Nashville, Tennessee. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Building an AI Army of Digital Twins to Fight Cancer
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
Many Patients With Cancer Visit EDs Before Diagnosis
Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.
Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.
“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”
The findings were published online on November 4 in CMAJ).
Neurologic Cancers Prominent
In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.
Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.
Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.
Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).
The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.
“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.
The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.
The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
‘Unpacking the Data’
The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.
“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.
“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”
All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.
“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.
This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.
Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.
“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”
The findings were published online on November 4 in CMAJ).
Neurologic Cancers Prominent
In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.
Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.
Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.
Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).
The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.
“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.
The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.
The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
‘Unpacking the Data’
The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.
“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.
“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”
All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.
“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.
This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.
Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.
“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”
The findings were published online on November 4 in CMAJ).
Neurologic Cancers Prominent
In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.
Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.
Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.
Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).
The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.
“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.
The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.
The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
‘Unpacking the Data’
The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.
“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.
“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”
All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.
“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.
This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM CMAJ
Plasma Omega-6 and Omega-3 Fatty Acids Inversely Associated With Cancer
TOPLINE:
Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.
METHODOLOGY:
- Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
- They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
- Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
- Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
- The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.
TAKEAWAY:
- Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
- Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
- Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
- A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.
IN PRACTICE:
“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.
SOURCE:
The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.
LIMITATIONS:
The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants.
DISCLOSURES:
This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.
METHODOLOGY:
- Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
- They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
- Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
- Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
- The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.
TAKEAWAY:
- Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
- Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
- Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
- A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.
IN PRACTICE:
“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.
SOURCE:
The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.
LIMITATIONS:
The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants.
DISCLOSURES:
This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.
METHODOLOGY:
- Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
- They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
- Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
- Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
- The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.
TAKEAWAY:
- Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
- Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
- Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
- A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.
IN PRACTICE:
“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.
SOURCE:
The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.
LIMITATIONS:
The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants.
DISCLOSURES:
This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Digital Danger: How Cyberattacks Put Patients at Risk
On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.
In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.
In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
Healthcare Systems = ‘Soft Targets’
Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”
Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”
Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.
The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
Vulnerable Users
Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.
“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”
Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.
High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
The Impact of Cyberattacks on Patients
Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.
According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:
- 56% of respondents saw a delay in patient tests/procedures
- 53% experienced increased patient complications from medical procedures
- 52% noted a longer patient length of stay
- 44% saw an increase in patient transfers to other facilities
- 28% had an increase in mortality rate
What Hospitals and Physicians Can Do
Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.
Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”
Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
A Continuing Threat
Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”
That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.
A version of this article first appeared on Medscape.com.
On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.
In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.
In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
Healthcare Systems = ‘Soft Targets’
Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”
Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”
Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.
The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
Vulnerable Users
Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.
“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”
Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.
High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
The Impact of Cyberattacks on Patients
Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.
According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:
- 56% of respondents saw a delay in patient tests/procedures
- 53% experienced increased patient complications from medical procedures
- 52% noted a longer patient length of stay
- 44% saw an increase in patient transfers to other facilities
- 28% had an increase in mortality rate
What Hospitals and Physicians Can Do
Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.
Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”
Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
A Continuing Threat
Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”
That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.
A version of this article first appeared on Medscape.com.
On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.
In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.
In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
Healthcare Systems = ‘Soft Targets’
Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”
Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”
Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.
The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
Vulnerable Users
Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.
“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”
Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.
High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
The Impact of Cyberattacks on Patients
Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.
According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:
- 56% of respondents saw a delay in patient tests/procedures
- 53% experienced increased patient complications from medical procedures
- 52% noted a longer patient length of stay
- 44% saw an increase in patient transfers to other facilities
- 28% had an increase in mortality rate
What Hospitals and Physicians Can Do
Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.
Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”
Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
A Continuing Threat
Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”
That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.
A version of this article first appeared on Medscape.com.