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Timing of food intake a novel strategy for treating mood disorders?
new research suggests.
Investigators at Brigham and Women’s Hospital, Boston, created a simulated nightwork schedule for 19 individuals in a laboratory setting. Participants then engaged in two different meal timing models – daytime-only meals (DMI), and meals taken during both daytime and nighttime (DNMC).
Depression- and anxiety-like mood levels increased by 26% and 16%, respectively, among the daytime and nighttime eaters, but there was no such increase in daytime-only eaters.
“Our findings provide evidence for the timing of food intake as a novel strategy to potentially minimize mood vulnerability in individuals experiencing circadian misalignment, such as people engaged in shift work, experiencing jet lag, or suffering from circadian rhythm disorders,” co–corresponding author Frank A.J.L. Scheer, PhD, director of the medical chronobiology program, Brigham and Women’s Hospital, Boston, said in a news release.
The study was published online in the Proceedings of the National Academy of Sciences.
Misaligned circadian clock
“Shift workers often experience a misalignment between their central circadian clock in the brain and daily behaviors, such as sleep/wake and fasting/eating cycles,” senior author Sarah Chellappa, MD, PhD, currently the Alexander Von Humboldt Experienced Fellow in the department of nuclear medicine, University of Cologne (Germany). Dr. Chellappa was a postdoctoral fellow at Brigham and Women’s Hospital when the study was conducted.
“They also have a 25%-40% higher risk of depression and anxiety,” she continued. “Since meal timing is important for physical health and diet is important for mood, we sought to find out whether meal timing can benefit mental health as well.”
Given that impaired glycemic control is a “risk factor for mood disruption,” the researchers tested the prediction that daytime eating “would prevent mood vulnerability, despite simulated night work.”
To investigate the question, they conducted a parallel-design, randomized clinical trial that included a 14-day circadian laboratory protocol with 19 healthy adults (12 men, 7 women; mean age, 26.5 ± 4.1 years) who underwent a forced desynchrony (FD) in dim light for 4 “days,” each of which consisted of 28 hours. Each 28-hour “day” resulted in an additional 4-hour misalignment between the central circadian clock and external behavioral/environmental cycles.
By the fourth day, the participants were misaligned by 12 hours, compared to baseline (that is, the first day). They were then randomly assigned to two groups.
The DNMC group – the control group – had a “typical 28-hour FD protocol,” with behavioral and environmental cycles (sleep/wake, rest/activity, supine/upright posture, dark during scheduled sleep/dim light during wakefulness) scheduled on a 28-hour cycle. Thus, they took their meals during both “daytime” and “nighttime,” which is the typical way that night workers eat.
The DMI group underwent a modified 28-hour FD protocol, with all cycles scheduled on a 28-hour basis, except for the fasting/eating cycle, which was scheduled on a 24-hour basis, resulting in meals consumed only during the “daytime.”
Depression- and anxiety-like mood (which “correspond to an amalgam of mood states typically observed in depression and anxiety) were assessed every hour during the 4 FD days, using computerized visual analogue scales.
Nutritional psychiatry
Participants in the DNMC group experienced an increase from baseline in depression- and anxiety-like mood levels of 26.2% (95% confidence interval, 21-31.5; P = .001; P value using false discovery rate, .01; effect-size r, 0.78) and 16.1% (95% CI, 8.5-23.6; P = .005; PFDR, .001; effect-size r, 0.47), respectively.
By contrast, a similar increase did not take place in the DMI group for either depression- or anxiety-like mood levels (95% CI, –5.7% to 7.4%, P not significant and 95% CI, –3.1% to 9.9%, P not significant, respectively).
The researchers tested “whether increase mood vulnerability during simulated night work was associated with the degree of internal circadian misalignment” — defined as “change in the phase difference between the acrophase of circadian glucose rhythms and the bathyphase of circadian body temperature rhythms.”
They found that a larger degree of internal circadian misalignment was “robustly associated” with more depression-like (r, 0.77; P = .001) and anxiety-like (r, 0.67; P = .002) mood levels during simulated night work.
The findings imply that meal timing had “moderate to large effects in depression-like and anxiety-like mood levels during night work, and that such effects were associated with the degree of internal circadian misalignment,” the authors wrote.
The laboratory protocol of both groups was identical except for the timing of meals. The authors noted that the “relevance of diet on sleep, circadian rhythms, and mental health is receiving growing awareness with the emergence of a new field, nutritional psychiatry.”
People who experience depression “often report poor-quality diets with high carbohydrate intake,” and there is evidence that adherence to the Mediterranean diet is associated “with lower odds of depression, anxiety, and psychological distress.”
They cautioned that although these emerging studies suggest an association between dietary factors and mental health, “experimental studies in individuals with depression and/or anxiety/anxiety-related disorders are required to determine causality and direction of effects.”
They described meal timing as “an emerging aspect of nutrition, with increasing research interest because of its influence on physical health.” However, they noted, “the causal role of the timing of food intake on mental health remains to be tested.”
Novel findings
Commenting for this article, Kathleen Merikangas, PhD, distinguished investigator and chief, genetic epidemiology research branch, intramural research program, National Institute of Mental Health, Bethesda, Md., described the research as important with novel findings.
The research “employs the elegant, carefully controlled laboratory procedures that have unraveled the influence of light and other environmental cues on sleep and circadian rhythms over the past 2 decades,” said Dr. Merikangas, who was not involved with the study.
“One of the most significant contributions of this work is its demonstration of the importance of investigating circadian rhythms of multiple systems rather than solely focusing on sleep, eating, or emotional states that have often been studied in isolation,” she pointed out.
“Growing evidence from basic research highlights the interdependence of multiple human systems that should be built into interventions that tend to focus on one or two domains.”
She recommended that this work be replicated “in more diverse samples ... in both controlled and naturalistic settings...to test both the generalizability and mechanism of these intriguing findings.”
The study was funded by the National Institutes of Health. Individual investigators were funded by the Alexander Von Humboldt Foundation and the American Diabetes Association. Dr. Chellappa disclosed no relevant financial relationships. Dr. Merikangas disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Investigators at Brigham and Women’s Hospital, Boston, created a simulated nightwork schedule for 19 individuals in a laboratory setting. Participants then engaged in two different meal timing models – daytime-only meals (DMI), and meals taken during both daytime and nighttime (DNMC).
Depression- and anxiety-like mood levels increased by 26% and 16%, respectively, among the daytime and nighttime eaters, but there was no such increase in daytime-only eaters.
“Our findings provide evidence for the timing of food intake as a novel strategy to potentially minimize mood vulnerability in individuals experiencing circadian misalignment, such as people engaged in shift work, experiencing jet lag, or suffering from circadian rhythm disorders,” co–corresponding author Frank A.J.L. Scheer, PhD, director of the medical chronobiology program, Brigham and Women’s Hospital, Boston, said in a news release.
The study was published online in the Proceedings of the National Academy of Sciences.
Misaligned circadian clock
“Shift workers often experience a misalignment between their central circadian clock in the brain and daily behaviors, such as sleep/wake and fasting/eating cycles,” senior author Sarah Chellappa, MD, PhD, currently the Alexander Von Humboldt Experienced Fellow in the department of nuclear medicine, University of Cologne (Germany). Dr. Chellappa was a postdoctoral fellow at Brigham and Women’s Hospital when the study was conducted.
“They also have a 25%-40% higher risk of depression and anxiety,” she continued. “Since meal timing is important for physical health and diet is important for mood, we sought to find out whether meal timing can benefit mental health as well.”
Given that impaired glycemic control is a “risk factor for mood disruption,” the researchers tested the prediction that daytime eating “would prevent mood vulnerability, despite simulated night work.”
To investigate the question, they conducted a parallel-design, randomized clinical trial that included a 14-day circadian laboratory protocol with 19 healthy adults (12 men, 7 women; mean age, 26.5 ± 4.1 years) who underwent a forced desynchrony (FD) in dim light for 4 “days,” each of which consisted of 28 hours. Each 28-hour “day” resulted in an additional 4-hour misalignment between the central circadian clock and external behavioral/environmental cycles.
By the fourth day, the participants were misaligned by 12 hours, compared to baseline (that is, the first day). They were then randomly assigned to two groups.
The DNMC group – the control group – had a “typical 28-hour FD protocol,” with behavioral and environmental cycles (sleep/wake, rest/activity, supine/upright posture, dark during scheduled sleep/dim light during wakefulness) scheduled on a 28-hour cycle. Thus, they took their meals during both “daytime” and “nighttime,” which is the typical way that night workers eat.
The DMI group underwent a modified 28-hour FD protocol, with all cycles scheduled on a 28-hour basis, except for the fasting/eating cycle, which was scheduled on a 24-hour basis, resulting in meals consumed only during the “daytime.”
Depression- and anxiety-like mood (which “correspond to an amalgam of mood states typically observed in depression and anxiety) were assessed every hour during the 4 FD days, using computerized visual analogue scales.
Nutritional psychiatry
Participants in the DNMC group experienced an increase from baseline in depression- and anxiety-like mood levels of 26.2% (95% confidence interval, 21-31.5; P = .001; P value using false discovery rate, .01; effect-size r, 0.78) and 16.1% (95% CI, 8.5-23.6; P = .005; PFDR, .001; effect-size r, 0.47), respectively.
By contrast, a similar increase did not take place in the DMI group for either depression- or anxiety-like mood levels (95% CI, –5.7% to 7.4%, P not significant and 95% CI, –3.1% to 9.9%, P not significant, respectively).
The researchers tested “whether increase mood vulnerability during simulated night work was associated with the degree of internal circadian misalignment” — defined as “change in the phase difference between the acrophase of circadian glucose rhythms and the bathyphase of circadian body temperature rhythms.”
They found that a larger degree of internal circadian misalignment was “robustly associated” with more depression-like (r, 0.77; P = .001) and anxiety-like (r, 0.67; P = .002) mood levels during simulated night work.
The findings imply that meal timing had “moderate to large effects in depression-like and anxiety-like mood levels during night work, and that such effects were associated with the degree of internal circadian misalignment,” the authors wrote.
The laboratory protocol of both groups was identical except for the timing of meals. The authors noted that the “relevance of diet on sleep, circadian rhythms, and mental health is receiving growing awareness with the emergence of a new field, nutritional psychiatry.”
People who experience depression “often report poor-quality diets with high carbohydrate intake,” and there is evidence that adherence to the Mediterranean diet is associated “with lower odds of depression, anxiety, and psychological distress.”
They cautioned that although these emerging studies suggest an association between dietary factors and mental health, “experimental studies in individuals with depression and/or anxiety/anxiety-related disorders are required to determine causality and direction of effects.”
They described meal timing as “an emerging aspect of nutrition, with increasing research interest because of its influence on physical health.” However, they noted, “the causal role of the timing of food intake on mental health remains to be tested.”
Novel findings
Commenting for this article, Kathleen Merikangas, PhD, distinguished investigator and chief, genetic epidemiology research branch, intramural research program, National Institute of Mental Health, Bethesda, Md., described the research as important with novel findings.
The research “employs the elegant, carefully controlled laboratory procedures that have unraveled the influence of light and other environmental cues on sleep and circadian rhythms over the past 2 decades,” said Dr. Merikangas, who was not involved with the study.
“One of the most significant contributions of this work is its demonstration of the importance of investigating circadian rhythms of multiple systems rather than solely focusing on sleep, eating, or emotional states that have often been studied in isolation,” she pointed out.
“Growing evidence from basic research highlights the interdependence of multiple human systems that should be built into interventions that tend to focus on one or two domains.”
She recommended that this work be replicated “in more diverse samples ... in both controlled and naturalistic settings...to test both the generalizability and mechanism of these intriguing findings.”
The study was funded by the National Institutes of Health. Individual investigators were funded by the Alexander Von Humboldt Foundation and the American Diabetes Association. Dr. Chellappa disclosed no relevant financial relationships. Dr. Merikangas disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Investigators at Brigham and Women’s Hospital, Boston, created a simulated nightwork schedule for 19 individuals in a laboratory setting. Participants then engaged in two different meal timing models – daytime-only meals (DMI), and meals taken during both daytime and nighttime (DNMC).
Depression- and anxiety-like mood levels increased by 26% and 16%, respectively, among the daytime and nighttime eaters, but there was no such increase in daytime-only eaters.
“Our findings provide evidence for the timing of food intake as a novel strategy to potentially minimize mood vulnerability in individuals experiencing circadian misalignment, such as people engaged in shift work, experiencing jet lag, or suffering from circadian rhythm disorders,” co–corresponding author Frank A.J.L. Scheer, PhD, director of the medical chronobiology program, Brigham and Women’s Hospital, Boston, said in a news release.
The study was published online in the Proceedings of the National Academy of Sciences.
Misaligned circadian clock
“Shift workers often experience a misalignment between their central circadian clock in the brain and daily behaviors, such as sleep/wake and fasting/eating cycles,” senior author Sarah Chellappa, MD, PhD, currently the Alexander Von Humboldt Experienced Fellow in the department of nuclear medicine, University of Cologne (Germany). Dr. Chellappa was a postdoctoral fellow at Brigham and Women’s Hospital when the study was conducted.
“They also have a 25%-40% higher risk of depression and anxiety,” she continued. “Since meal timing is important for physical health and diet is important for mood, we sought to find out whether meal timing can benefit mental health as well.”
Given that impaired glycemic control is a “risk factor for mood disruption,” the researchers tested the prediction that daytime eating “would prevent mood vulnerability, despite simulated night work.”
To investigate the question, they conducted a parallel-design, randomized clinical trial that included a 14-day circadian laboratory protocol with 19 healthy adults (12 men, 7 women; mean age, 26.5 ± 4.1 years) who underwent a forced desynchrony (FD) in dim light for 4 “days,” each of which consisted of 28 hours. Each 28-hour “day” resulted in an additional 4-hour misalignment between the central circadian clock and external behavioral/environmental cycles.
By the fourth day, the participants were misaligned by 12 hours, compared to baseline (that is, the first day). They were then randomly assigned to two groups.
The DNMC group – the control group – had a “typical 28-hour FD protocol,” with behavioral and environmental cycles (sleep/wake, rest/activity, supine/upright posture, dark during scheduled sleep/dim light during wakefulness) scheduled on a 28-hour cycle. Thus, they took their meals during both “daytime” and “nighttime,” which is the typical way that night workers eat.
The DMI group underwent a modified 28-hour FD protocol, with all cycles scheduled on a 28-hour basis, except for the fasting/eating cycle, which was scheduled on a 24-hour basis, resulting in meals consumed only during the “daytime.”
Depression- and anxiety-like mood (which “correspond to an amalgam of mood states typically observed in depression and anxiety) were assessed every hour during the 4 FD days, using computerized visual analogue scales.
Nutritional psychiatry
Participants in the DNMC group experienced an increase from baseline in depression- and anxiety-like mood levels of 26.2% (95% confidence interval, 21-31.5; P = .001; P value using false discovery rate, .01; effect-size r, 0.78) and 16.1% (95% CI, 8.5-23.6; P = .005; PFDR, .001; effect-size r, 0.47), respectively.
By contrast, a similar increase did not take place in the DMI group for either depression- or anxiety-like mood levels (95% CI, –5.7% to 7.4%, P not significant and 95% CI, –3.1% to 9.9%, P not significant, respectively).
The researchers tested “whether increase mood vulnerability during simulated night work was associated with the degree of internal circadian misalignment” — defined as “change in the phase difference between the acrophase of circadian glucose rhythms and the bathyphase of circadian body temperature rhythms.”
They found that a larger degree of internal circadian misalignment was “robustly associated” with more depression-like (r, 0.77; P = .001) and anxiety-like (r, 0.67; P = .002) mood levels during simulated night work.
The findings imply that meal timing had “moderate to large effects in depression-like and anxiety-like mood levels during night work, and that such effects were associated with the degree of internal circadian misalignment,” the authors wrote.
The laboratory protocol of both groups was identical except for the timing of meals. The authors noted that the “relevance of diet on sleep, circadian rhythms, and mental health is receiving growing awareness with the emergence of a new field, nutritional psychiatry.”
People who experience depression “often report poor-quality diets with high carbohydrate intake,” and there is evidence that adherence to the Mediterranean diet is associated “with lower odds of depression, anxiety, and psychological distress.”
They cautioned that although these emerging studies suggest an association between dietary factors and mental health, “experimental studies in individuals with depression and/or anxiety/anxiety-related disorders are required to determine causality and direction of effects.”
They described meal timing as “an emerging aspect of nutrition, with increasing research interest because of its influence on physical health.” However, they noted, “the causal role of the timing of food intake on mental health remains to be tested.”
Novel findings
Commenting for this article, Kathleen Merikangas, PhD, distinguished investigator and chief, genetic epidemiology research branch, intramural research program, National Institute of Mental Health, Bethesda, Md., described the research as important with novel findings.
The research “employs the elegant, carefully controlled laboratory procedures that have unraveled the influence of light and other environmental cues on sleep and circadian rhythms over the past 2 decades,” said Dr. Merikangas, who was not involved with the study.
“One of the most significant contributions of this work is its demonstration of the importance of investigating circadian rhythms of multiple systems rather than solely focusing on sleep, eating, or emotional states that have often been studied in isolation,” she pointed out.
“Growing evidence from basic research highlights the interdependence of multiple human systems that should be built into interventions that tend to focus on one or two domains.”
She recommended that this work be replicated “in more diverse samples ... in both controlled and naturalistic settings...to test both the generalizability and mechanism of these intriguing findings.”
The study was funded by the National Institutes of Health. Individual investigators were funded by the Alexander Von Humboldt Foundation and the American Diabetes Association. Dr. Chellappa disclosed no relevant financial relationships. Dr. Merikangas disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCE
Weight gain linked to cancer survival in men and women
Cancer cachexia is a syndrome of weight loss that frequently occurs during cancer treatment. Consequences can include skeletal muscle loss, fatigue, functional impairment, worse quality of life, and worse survival. On the other hand, weight gain during cancer treatment has been tied to better survival.
Few studies have examined the relationship between weight gain and outcomes by sex.
“The finding that weight gain occurred in subsets of males and females is a new observation. The fact that weight gain occurs in cancer patients during anticancer treatment could confound results of clinical [trials] evaluating novel anticachexia treatments. Simultaneously studying longitudinal body weights and serum and cellular biomarkers in cancer patients might provide insights into mechanisms involved in cachexia. Increased understanding of mechanisms driving cachexia could lead to new therapeutic strategies,” said study coauthor Philip Bonomi, MD, who is an oncologist at Rush Medical College, Chicago.
“This data, although it appears to be very basic, is critically important, especially as we consider our novel interventions in the treatment of cancer cachexia,” said Eric Roeland, MD, during his presentation of the study at the annual meeting of European Society for Medical Oncology. Dr. Roeland is a medical oncologist at Oregon Health & Science University, Portland.
Dr. Roeland is also the lead author of cancer cachexia guidelines published by the American Society of Clinical Oncology in 2020. The guidelines suggest that dietary counseling can be offered to patients, but warns against routine use of enteral feeding tubes and parenteral nutrition. Although no specific drug can be recommended for cancer cachexia, progesterone analogs and corticosteroids used over the short term (weeks) can be used on a trial base to improve appetite and weight gain. While not approved in the United States, anamorelin was approved in 2020 in Japan for cancer cachexia in NSCLC, gastric cancer, pancreatic cancer, and colorectal cancer.
The new study should raise awareness of the importance of adverse effects of cancer treatments, said Karin Jordan, MD, University Hospital Heidelberg (Germany). She served as a discussant following the presentation. “As a medical oncologist, we focus a bit too much on the benefits of antineoplastic therapy, both on cure and on the survival benefit. But what is also very, very important to do is a balanced oncology treatment to focus on the risks of oncology therapies,” she said.
The study is limited by its retrospective nature and potential for bias. “The hypothesis that weight gain leads to improved survival is not really proven as it likewise may be the other way around,” Dr. Jordan said.
However, in oncology research, a phenomenon called the “obesity paradox” is increasingly catching the interest of investigators. Observational studies have shown that overweight patients with certain cancers (specifically, colorectal, endometrial and lung cancer). actually have improved overall survival as compared with normal-weight patients.
Details from the new study
The researchers pooled data 1,030 patients who participated in three phase 3 clinical trials conducted between 2005 and 2011. The patients all received platinum-based chemotherapy as part of control arms. 304 were female and 726 were male. The median age was 62. 16.7% were Asian, the mean body mass index was 24.6 kg/m2, 88.5% had stage 4 disease, 36.9% had adenocarcinoma, and 86.3% were current or former smokers.
Males and females had similar magnitudes and rate of weight gain over the course of treatment. Any weight gain was associated with improved overall survival in both males (12.7 vs. 8.0 months; hazard ratio, 0.60; P < .001) and females (16.2 vs. 10.1 months; HR, 0.65; P = .0028). Patients who had a weight gain of 2.5% of body weight or more saw an improvement in overall survival in both males (14.0 vs. 8.2 months; HR, 0.57; P < .001) and females (16.7 vs. 11.3 months; HR, 0.61; P = .0041).
Patients with a weight gain of 5% or more was associated with improved survival in males (13.6 vs. 8.9 months; HR, 0.62; P = .0001), but there was no statistically significant association in females (16.7 vs. 12.6 months; HR, 0.69; P = .1107).
Regardless of weight-gain status, males had lower survival rates than females. All of the associations were independent of smoking status.
The study was funded by Pfizer. Dr. Bonomi has received honoraria from Pfizer and Helsinn for participation in scientific advisory boards. Dr. Jordan has consulted for Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, and BD Solution. She has received research funding from Deutsche Krebshilfe. She has received honoraria from MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, Pomme-med, PharmaMar, arttemoi, OnkoUpdate, Stemline, and Roche.
Cancer cachexia is a syndrome of weight loss that frequently occurs during cancer treatment. Consequences can include skeletal muscle loss, fatigue, functional impairment, worse quality of life, and worse survival. On the other hand, weight gain during cancer treatment has been tied to better survival.
Few studies have examined the relationship between weight gain and outcomes by sex.
“The finding that weight gain occurred in subsets of males and females is a new observation. The fact that weight gain occurs in cancer patients during anticancer treatment could confound results of clinical [trials] evaluating novel anticachexia treatments. Simultaneously studying longitudinal body weights and serum and cellular biomarkers in cancer patients might provide insights into mechanisms involved in cachexia. Increased understanding of mechanisms driving cachexia could lead to new therapeutic strategies,” said study coauthor Philip Bonomi, MD, who is an oncologist at Rush Medical College, Chicago.
“This data, although it appears to be very basic, is critically important, especially as we consider our novel interventions in the treatment of cancer cachexia,” said Eric Roeland, MD, during his presentation of the study at the annual meeting of European Society for Medical Oncology. Dr. Roeland is a medical oncologist at Oregon Health & Science University, Portland.
Dr. Roeland is also the lead author of cancer cachexia guidelines published by the American Society of Clinical Oncology in 2020. The guidelines suggest that dietary counseling can be offered to patients, but warns against routine use of enteral feeding tubes and parenteral nutrition. Although no specific drug can be recommended for cancer cachexia, progesterone analogs and corticosteroids used over the short term (weeks) can be used on a trial base to improve appetite and weight gain. While not approved in the United States, anamorelin was approved in 2020 in Japan for cancer cachexia in NSCLC, gastric cancer, pancreatic cancer, and colorectal cancer.
The new study should raise awareness of the importance of adverse effects of cancer treatments, said Karin Jordan, MD, University Hospital Heidelberg (Germany). She served as a discussant following the presentation. “As a medical oncologist, we focus a bit too much on the benefits of antineoplastic therapy, both on cure and on the survival benefit. But what is also very, very important to do is a balanced oncology treatment to focus on the risks of oncology therapies,” she said.
The study is limited by its retrospective nature and potential for bias. “The hypothesis that weight gain leads to improved survival is not really proven as it likewise may be the other way around,” Dr. Jordan said.
However, in oncology research, a phenomenon called the “obesity paradox” is increasingly catching the interest of investigators. Observational studies have shown that overweight patients with certain cancers (specifically, colorectal, endometrial and lung cancer). actually have improved overall survival as compared with normal-weight patients.
Details from the new study
The researchers pooled data 1,030 patients who participated in three phase 3 clinical trials conducted between 2005 and 2011. The patients all received platinum-based chemotherapy as part of control arms. 304 were female and 726 were male. The median age was 62. 16.7% were Asian, the mean body mass index was 24.6 kg/m2, 88.5% had stage 4 disease, 36.9% had adenocarcinoma, and 86.3% were current or former smokers.
Males and females had similar magnitudes and rate of weight gain over the course of treatment. Any weight gain was associated with improved overall survival in both males (12.7 vs. 8.0 months; hazard ratio, 0.60; P < .001) and females (16.2 vs. 10.1 months; HR, 0.65; P = .0028). Patients who had a weight gain of 2.5% of body weight or more saw an improvement in overall survival in both males (14.0 vs. 8.2 months; HR, 0.57; P < .001) and females (16.7 vs. 11.3 months; HR, 0.61; P = .0041).
Patients with a weight gain of 5% or more was associated with improved survival in males (13.6 vs. 8.9 months; HR, 0.62; P = .0001), but there was no statistically significant association in females (16.7 vs. 12.6 months; HR, 0.69; P = .1107).
Regardless of weight-gain status, males had lower survival rates than females. All of the associations were independent of smoking status.
The study was funded by Pfizer. Dr. Bonomi has received honoraria from Pfizer and Helsinn for participation in scientific advisory boards. Dr. Jordan has consulted for Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, and BD Solution. She has received research funding from Deutsche Krebshilfe. She has received honoraria from MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, Pomme-med, PharmaMar, arttemoi, OnkoUpdate, Stemline, and Roche.
Cancer cachexia is a syndrome of weight loss that frequently occurs during cancer treatment. Consequences can include skeletal muscle loss, fatigue, functional impairment, worse quality of life, and worse survival. On the other hand, weight gain during cancer treatment has been tied to better survival.
Few studies have examined the relationship between weight gain and outcomes by sex.
“The finding that weight gain occurred in subsets of males and females is a new observation. The fact that weight gain occurs in cancer patients during anticancer treatment could confound results of clinical [trials] evaluating novel anticachexia treatments. Simultaneously studying longitudinal body weights and serum and cellular biomarkers in cancer patients might provide insights into mechanisms involved in cachexia. Increased understanding of mechanisms driving cachexia could lead to new therapeutic strategies,” said study coauthor Philip Bonomi, MD, who is an oncologist at Rush Medical College, Chicago.
“This data, although it appears to be very basic, is critically important, especially as we consider our novel interventions in the treatment of cancer cachexia,” said Eric Roeland, MD, during his presentation of the study at the annual meeting of European Society for Medical Oncology. Dr. Roeland is a medical oncologist at Oregon Health & Science University, Portland.
Dr. Roeland is also the lead author of cancer cachexia guidelines published by the American Society of Clinical Oncology in 2020. The guidelines suggest that dietary counseling can be offered to patients, but warns against routine use of enteral feeding tubes and parenteral nutrition. Although no specific drug can be recommended for cancer cachexia, progesterone analogs and corticosteroids used over the short term (weeks) can be used on a trial base to improve appetite and weight gain. While not approved in the United States, anamorelin was approved in 2020 in Japan for cancer cachexia in NSCLC, gastric cancer, pancreatic cancer, and colorectal cancer.
The new study should raise awareness of the importance of adverse effects of cancer treatments, said Karin Jordan, MD, University Hospital Heidelberg (Germany). She served as a discussant following the presentation. “As a medical oncologist, we focus a bit too much on the benefits of antineoplastic therapy, both on cure and on the survival benefit. But what is also very, very important to do is a balanced oncology treatment to focus on the risks of oncology therapies,” she said.
The study is limited by its retrospective nature and potential for bias. “The hypothesis that weight gain leads to improved survival is not really proven as it likewise may be the other way around,” Dr. Jordan said.
However, in oncology research, a phenomenon called the “obesity paradox” is increasingly catching the interest of investigators. Observational studies have shown that overweight patients with certain cancers (specifically, colorectal, endometrial and lung cancer). actually have improved overall survival as compared with normal-weight patients.
Details from the new study
The researchers pooled data 1,030 patients who participated in three phase 3 clinical trials conducted between 2005 and 2011. The patients all received platinum-based chemotherapy as part of control arms. 304 were female and 726 were male. The median age was 62. 16.7% were Asian, the mean body mass index was 24.6 kg/m2, 88.5% had stage 4 disease, 36.9% had adenocarcinoma, and 86.3% were current or former smokers.
Males and females had similar magnitudes and rate of weight gain over the course of treatment. Any weight gain was associated with improved overall survival in both males (12.7 vs. 8.0 months; hazard ratio, 0.60; P < .001) and females (16.2 vs. 10.1 months; HR, 0.65; P = .0028). Patients who had a weight gain of 2.5% of body weight or more saw an improvement in overall survival in both males (14.0 vs. 8.2 months; HR, 0.57; P < .001) and females (16.7 vs. 11.3 months; HR, 0.61; P = .0041).
Patients with a weight gain of 5% or more was associated with improved survival in males (13.6 vs. 8.9 months; HR, 0.62; P = .0001), but there was no statistically significant association in females (16.7 vs. 12.6 months; HR, 0.69; P = .1107).
Regardless of weight-gain status, males had lower survival rates than females. All of the associations were independent of smoking status.
The study was funded by Pfizer. Dr. Bonomi has received honoraria from Pfizer and Helsinn for participation in scientific advisory boards. Dr. Jordan has consulted for Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, and BD Solution. She has received research funding from Deutsche Krebshilfe. She has received honoraria from MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Voluntis, Pfizer, Pomme-med, PharmaMar, arttemoi, OnkoUpdate, Stemline, and Roche.
FROM ESMO CONGRESS 2022
Corticosteroids found to curb progression in community-acquired pneumonia
Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.
Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.
Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.
In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.
Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).
Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).
“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.
The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.
Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.
Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.
In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.
Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).
Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).
“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.
The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.
Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.
Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.
In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.
Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).
Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).
“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.
The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL CHEST®
Clinic and doc must pay millions after faulty hernia surgery
reports a story in the Bowling Green Daily News.
On May 31, 2013, Alice Duff went to Graves-Gilbert Clinic, a multispecialty group whose main campus is in Bowling Green, for hernia surgery. Her surgeon for the procedure at a nearby facility was Tage Haase, MD, a member of the clinic.
Originally, Mrs. Duff was expected to remain in the facility for 23 hours following the procedure. But her recovery didn’t proceed as expected, and that initial period was extended by roughly 3 days. During this time, Ms. Duff’s husband, Lloyd, allegedly requested multiple times that doctors order a CT scan for his wife.
Ten days after the procedure, and with Ms. Duff out of the hospital, the Duffs successfully urged their family physician to order a CT scan. It showed large amounts of free air in Alice’s abdomen, a condition that’s known as pneumoperitoneum.
On June 10, 2013, Mrs. Duff underwent a second surgery, during which doctors discovered that she had sustained a perforated bowel during the first procedure. As a result, her bowel contents had spilled into her abdomen, causing an infection that required an extended hospital stay and five additional surgeries. The infection also led to retinal damage that has left her legally blind.
In their claim against Graves-Gilbert and Dr. Haase, the Duffs argued that Dr. Haase and an assistant doctor who was not named in the suit had failed to meet the standard of care. Specifically, argued the Duffs, because bowel perforation is a known complication in hernia surgeries, Dr. Haase was negligent in not diagnosing and treating Ms. Duff’s problem earlier.
For their part, Graves-Gilbert and Dr. Haase maintained that there was no indication before the second surgery that Mrs. Duff was demonstrating symptoms that necessitated a follow-up procedure. Dr. Haase further argued that Mrs. Duff’s bowel perforation was probably caused by the sawblade-like effect of the suture material he had used to close her incision.
The jury didn’t see it this way, however. It awarded approximately $1.3 million to Mrs. Duff for past medical expenses, plus another $12 million for pain and suffering. Her husband, Lloyd, received an additional $8 million in damages.
The attorney representing the clinic and Dr. Haase has vowed to pursue “all available remedies to have the verdict vacated and the case set for a new trial.”
Case hinged on proper use of a ‘power morcellator’
A claim for punitive damages has been thrown out against a New Jersey doctor and the hospital he’s affiliated with, in a ruling that could help to clarify the standards for such damages in medical malpractice cases, according to a story first reported on NorthJersey.com.
In October 2014, Howard H. Jones, MD, director of minimally invasive gynecologic surgery at The Valley Hospital, in Ridgewood, N.J., treated a patient from nearby Nyack, N.Y., for uterine fibroid tumors. As part of that treatment at the hospital, Dr. Jones used a “laparoscopic power morcellator,” which during a myomectomy procedure cuts, or morcellates, fibroid tumors into pieces small enough to be removed through an incision that’s generally 2 cm or fewer.
While use of the device offers doctors an alternative to open surgery and its longer recovery times, it also risks spreading previously undiagnosed cancer cells throughout the abdomen, thereby shortening a patient’s life. Because of this risk, which has given rise to a number of malpractice cases around the country, the Food and Drug Administration issued a draft guidance in the spring of 2022 for the use of power morcellators.
One recommendation is that physicians employ a “compatible” containment system to catch morcellated tissue, including any with cancer cells. Another is that the device be used selectively, which is to say on patients who have a minimal cancer risk and who have been informed of the procedure’s possible side effects beforehand.
Within a month of the procedure, the patient was diagnosed with metastatic leiomyosarcoma and died in September 2015. Following her death, her sister, the executor of her estate, sued both The Valley Hospital and Dr. Jones. In her suit, the sister argued that the defendants knew, or should have known, the risks involved in using a power morcellator because of both an earlier (2014) FDA “safety communication” discouraging the use of the device and the death of another of Dr. Jones’ patients following a similar procedure the year before.
The suit further alleged that, even after the FDA had issued its safety caution, the hospital had used the device on 37 other patients, “without informing them of the [FDA] letter or obtaining their informed consent to use the device.”
In light of these alleged lapses, Mirian Rivera, the patient’s sister, sought both compensatory and punitive damages. Historically, punitive damages have been limited to the small number of med-mal cases where a doctor or hospital has been found to have acted with actual malice or “wanton and willful disregard.”
Both Valley and Dr. Jones strongly disagreed with Ms. Rivera’s claim, arguing that prior to the procedure Dr. Jones had in fact met with the patient several times and had conducted the proper cancer-detecting tests. Moreover, the defendants emphasized, the request for punitive damages in the absence of actual malice or other factors would almost certainly establish a dangerous legal precedent. Several industry groups – including the American Medical Association, the Medical Society of New Jersey, and the New Jersey Hospital Association – agreed and filed friend-of-court briefs in support of Valley Hospital and Dr. Jones.
But two lower courts refused to dismiss the plaintiff’s claims for punitive damages. That’s when attorneys for Valley and Dr. Jones appealed to the New Jersey Supreme Court. (Claims against the device manufacturer, a German company, had already been resolved.)
Ruling unanimously, the high court sided with the defendants: “As a matter of law, the evidence presented, even affording plaintiffs all favorable inferences, does not establish that defendants’ acts or omissions were motivated by actual malice or accompanied by wanton and willful disregard for the patient’s health and safety.”
The court also found that Valley had in fact reviewed hospital policy and drafted a patient-consent form after the release of the 2014 FDA safety communication on power morcellators. (The consent form had not been adopted before the surgery in question, however.)
The suit will now go back to Superior Court in Bergen County, New Jersey; unless a settlement is reached beforehand, the jury will weigh claims of negligence and compensatory damages.
At press time, no trial date had been set.
Will med-mal cases get tougher to defend in this state?
Late in August, the Pennsylvania Supreme Court reversed its own longstanding rule that required that medical malpractice cases be filed in the county where the alleged injury occurred, as an Associated Press story on NBCPhiladelphia.com, among other news sites, reports.
More than 2 decades ago, in response to what was then seen as a crisis in the med-mal system, the state legislature overwhelmingly passed MCARE (the Medical Care Availability and Reduction of Error Fund), which among other things restricted the venue of medical suits. The legislation was signed into law in March 2002 by then-Gov. Mark Schweiker.
The following year, the state’s high court adopted a similar venue rule.
Over the years, doctor and hospital groups have been big supporters of the rule, arguing that any attempt to shift cases back to allegedly more plaintiff-friendly courts in Philadelphia and other cities would likely retrigger a crisis of higher med-mal premiums, doctor flight, and worse health care.
But a 2020 report by Pennsylvania’s nonpartisan Legislative Budget and Finance Committee took issue with these conclusions. It said that, following a national trend, the cost of medical professional liability insurance had fallen in the state since 2007. The report concluded that nothing in the available data supports the “conclusion that changes in the availability, cost, and affordability of medical professional liability insurance are the result of changes in Pennsylvania law.”
A more recent report by the high court’s Civil Procedural Rules Committee reached a similar conclusion, noting that med-mal cases should be subject to the same rules as any other type of civil litigation. A majority of the high court agreed.
Predictably, this decision sits well with patient groups and officials representing trial attorneys in the Keystone State.
“Cases should be heard before 12 jurors that do not have a connection to a hospital or surgical center that is often times the largest employer in the county,” said Kila Baldwin, president of the Pennsylvania Association for Justice. “The new rule levels the playing field and will improve access to justice for all Pennsylvanians.”
Doctors, hospitals, and other health care providers, however, have predicted a “ruinous path” ahead.
A version of this article first appeared on Medscape.com.
reports a story in the Bowling Green Daily News.
On May 31, 2013, Alice Duff went to Graves-Gilbert Clinic, a multispecialty group whose main campus is in Bowling Green, for hernia surgery. Her surgeon for the procedure at a nearby facility was Tage Haase, MD, a member of the clinic.
Originally, Mrs. Duff was expected to remain in the facility for 23 hours following the procedure. But her recovery didn’t proceed as expected, and that initial period was extended by roughly 3 days. During this time, Ms. Duff’s husband, Lloyd, allegedly requested multiple times that doctors order a CT scan for his wife.
Ten days after the procedure, and with Ms. Duff out of the hospital, the Duffs successfully urged their family physician to order a CT scan. It showed large amounts of free air in Alice’s abdomen, a condition that’s known as pneumoperitoneum.
On June 10, 2013, Mrs. Duff underwent a second surgery, during which doctors discovered that she had sustained a perforated bowel during the first procedure. As a result, her bowel contents had spilled into her abdomen, causing an infection that required an extended hospital stay and five additional surgeries. The infection also led to retinal damage that has left her legally blind.
In their claim against Graves-Gilbert and Dr. Haase, the Duffs argued that Dr. Haase and an assistant doctor who was not named in the suit had failed to meet the standard of care. Specifically, argued the Duffs, because bowel perforation is a known complication in hernia surgeries, Dr. Haase was negligent in not diagnosing and treating Ms. Duff’s problem earlier.
For their part, Graves-Gilbert and Dr. Haase maintained that there was no indication before the second surgery that Mrs. Duff was demonstrating symptoms that necessitated a follow-up procedure. Dr. Haase further argued that Mrs. Duff’s bowel perforation was probably caused by the sawblade-like effect of the suture material he had used to close her incision.
The jury didn’t see it this way, however. It awarded approximately $1.3 million to Mrs. Duff for past medical expenses, plus another $12 million for pain and suffering. Her husband, Lloyd, received an additional $8 million in damages.
The attorney representing the clinic and Dr. Haase has vowed to pursue “all available remedies to have the verdict vacated and the case set for a new trial.”
Case hinged on proper use of a ‘power morcellator’
A claim for punitive damages has been thrown out against a New Jersey doctor and the hospital he’s affiliated with, in a ruling that could help to clarify the standards for such damages in medical malpractice cases, according to a story first reported on NorthJersey.com.
In October 2014, Howard H. Jones, MD, director of minimally invasive gynecologic surgery at The Valley Hospital, in Ridgewood, N.J., treated a patient from nearby Nyack, N.Y., for uterine fibroid tumors. As part of that treatment at the hospital, Dr. Jones used a “laparoscopic power morcellator,” which during a myomectomy procedure cuts, or morcellates, fibroid tumors into pieces small enough to be removed through an incision that’s generally 2 cm or fewer.
While use of the device offers doctors an alternative to open surgery and its longer recovery times, it also risks spreading previously undiagnosed cancer cells throughout the abdomen, thereby shortening a patient’s life. Because of this risk, which has given rise to a number of malpractice cases around the country, the Food and Drug Administration issued a draft guidance in the spring of 2022 for the use of power morcellators.
One recommendation is that physicians employ a “compatible” containment system to catch morcellated tissue, including any with cancer cells. Another is that the device be used selectively, which is to say on patients who have a minimal cancer risk and who have been informed of the procedure’s possible side effects beforehand.
Within a month of the procedure, the patient was diagnosed with metastatic leiomyosarcoma and died in September 2015. Following her death, her sister, the executor of her estate, sued both The Valley Hospital and Dr. Jones. In her suit, the sister argued that the defendants knew, or should have known, the risks involved in using a power morcellator because of both an earlier (2014) FDA “safety communication” discouraging the use of the device and the death of another of Dr. Jones’ patients following a similar procedure the year before.
The suit further alleged that, even after the FDA had issued its safety caution, the hospital had used the device on 37 other patients, “without informing them of the [FDA] letter or obtaining their informed consent to use the device.”
In light of these alleged lapses, Mirian Rivera, the patient’s sister, sought both compensatory and punitive damages. Historically, punitive damages have been limited to the small number of med-mal cases where a doctor or hospital has been found to have acted with actual malice or “wanton and willful disregard.”
Both Valley and Dr. Jones strongly disagreed with Ms. Rivera’s claim, arguing that prior to the procedure Dr. Jones had in fact met with the patient several times and had conducted the proper cancer-detecting tests. Moreover, the defendants emphasized, the request for punitive damages in the absence of actual malice or other factors would almost certainly establish a dangerous legal precedent. Several industry groups – including the American Medical Association, the Medical Society of New Jersey, and the New Jersey Hospital Association – agreed and filed friend-of-court briefs in support of Valley Hospital and Dr. Jones.
But two lower courts refused to dismiss the plaintiff’s claims for punitive damages. That’s when attorneys for Valley and Dr. Jones appealed to the New Jersey Supreme Court. (Claims against the device manufacturer, a German company, had already been resolved.)
Ruling unanimously, the high court sided with the defendants: “As a matter of law, the evidence presented, even affording plaintiffs all favorable inferences, does not establish that defendants’ acts or omissions were motivated by actual malice or accompanied by wanton and willful disregard for the patient’s health and safety.”
The court also found that Valley had in fact reviewed hospital policy and drafted a patient-consent form after the release of the 2014 FDA safety communication on power morcellators. (The consent form had not been adopted before the surgery in question, however.)
The suit will now go back to Superior Court in Bergen County, New Jersey; unless a settlement is reached beforehand, the jury will weigh claims of negligence and compensatory damages.
At press time, no trial date had been set.
Will med-mal cases get tougher to defend in this state?
Late in August, the Pennsylvania Supreme Court reversed its own longstanding rule that required that medical malpractice cases be filed in the county where the alleged injury occurred, as an Associated Press story on NBCPhiladelphia.com, among other news sites, reports.
More than 2 decades ago, in response to what was then seen as a crisis in the med-mal system, the state legislature overwhelmingly passed MCARE (the Medical Care Availability and Reduction of Error Fund), which among other things restricted the venue of medical suits. The legislation was signed into law in March 2002 by then-Gov. Mark Schweiker.
The following year, the state’s high court adopted a similar venue rule.
Over the years, doctor and hospital groups have been big supporters of the rule, arguing that any attempt to shift cases back to allegedly more plaintiff-friendly courts in Philadelphia and other cities would likely retrigger a crisis of higher med-mal premiums, doctor flight, and worse health care.
But a 2020 report by Pennsylvania’s nonpartisan Legislative Budget and Finance Committee took issue with these conclusions. It said that, following a national trend, the cost of medical professional liability insurance had fallen in the state since 2007. The report concluded that nothing in the available data supports the “conclusion that changes in the availability, cost, and affordability of medical professional liability insurance are the result of changes in Pennsylvania law.”
A more recent report by the high court’s Civil Procedural Rules Committee reached a similar conclusion, noting that med-mal cases should be subject to the same rules as any other type of civil litigation. A majority of the high court agreed.
Predictably, this decision sits well with patient groups and officials representing trial attorneys in the Keystone State.
“Cases should be heard before 12 jurors that do not have a connection to a hospital or surgical center that is often times the largest employer in the county,” said Kila Baldwin, president of the Pennsylvania Association for Justice. “The new rule levels the playing field and will improve access to justice for all Pennsylvanians.”
Doctors, hospitals, and other health care providers, however, have predicted a “ruinous path” ahead.
A version of this article first appeared on Medscape.com.
reports a story in the Bowling Green Daily News.
On May 31, 2013, Alice Duff went to Graves-Gilbert Clinic, a multispecialty group whose main campus is in Bowling Green, for hernia surgery. Her surgeon for the procedure at a nearby facility was Tage Haase, MD, a member of the clinic.
Originally, Mrs. Duff was expected to remain in the facility for 23 hours following the procedure. But her recovery didn’t proceed as expected, and that initial period was extended by roughly 3 days. During this time, Ms. Duff’s husband, Lloyd, allegedly requested multiple times that doctors order a CT scan for his wife.
Ten days after the procedure, and with Ms. Duff out of the hospital, the Duffs successfully urged their family physician to order a CT scan. It showed large amounts of free air in Alice’s abdomen, a condition that’s known as pneumoperitoneum.
On June 10, 2013, Mrs. Duff underwent a second surgery, during which doctors discovered that she had sustained a perforated bowel during the first procedure. As a result, her bowel contents had spilled into her abdomen, causing an infection that required an extended hospital stay and five additional surgeries. The infection also led to retinal damage that has left her legally blind.
In their claim against Graves-Gilbert and Dr. Haase, the Duffs argued that Dr. Haase and an assistant doctor who was not named in the suit had failed to meet the standard of care. Specifically, argued the Duffs, because bowel perforation is a known complication in hernia surgeries, Dr. Haase was negligent in not diagnosing and treating Ms. Duff’s problem earlier.
For their part, Graves-Gilbert and Dr. Haase maintained that there was no indication before the second surgery that Mrs. Duff was demonstrating symptoms that necessitated a follow-up procedure. Dr. Haase further argued that Mrs. Duff’s bowel perforation was probably caused by the sawblade-like effect of the suture material he had used to close her incision.
The jury didn’t see it this way, however. It awarded approximately $1.3 million to Mrs. Duff for past medical expenses, plus another $12 million for pain and suffering. Her husband, Lloyd, received an additional $8 million in damages.
The attorney representing the clinic and Dr. Haase has vowed to pursue “all available remedies to have the verdict vacated and the case set for a new trial.”
Case hinged on proper use of a ‘power morcellator’
A claim for punitive damages has been thrown out against a New Jersey doctor and the hospital he’s affiliated with, in a ruling that could help to clarify the standards for such damages in medical malpractice cases, according to a story first reported on NorthJersey.com.
In October 2014, Howard H. Jones, MD, director of minimally invasive gynecologic surgery at The Valley Hospital, in Ridgewood, N.J., treated a patient from nearby Nyack, N.Y., for uterine fibroid tumors. As part of that treatment at the hospital, Dr. Jones used a “laparoscopic power morcellator,” which during a myomectomy procedure cuts, or morcellates, fibroid tumors into pieces small enough to be removed through an incision that’s generally 2 cm or fewer.
While use of the device offers doctors an alternative to open surgery and its longer recovery times, it also risks spreading previously undiagnosed cancer cells throughout the abdomen, thereby shortening a patient’s life. Because of this risk, which has given rise to a number of malpractice cases around the country, the Food and Drug Administration issued a draft guidance in the spring of 2022 for the use of power morcellators.
One recommendation is that physicians employ a “compatible” containment system to catch morcellated tissue, including any with cancer cells. Another is that the device be used selectively, which is to say on patients who have a minimal cancer risk and who have been informed of the procedure’s possible side effects beforehand.
Within a month of the procedure, the patient was diagnosed with metastatic leiomyosarcoma and died in September 2015. Following her death, her sister, the executor of her estate, sued both The Valley Hospital and Dr. Jones. In her suit, the sister argued that the defendants knew, or should have known, the risks involved in using a power morcellator because of both an earlier (2014) FDA “safety communication” discouraging the use of the device and the death of another of Dr. Jones’ patients following a similar procedure the year before.
The suit further alleged that, even after the FDA had issued its safety caution, the hospital had used the device on 37 other patients, “without informing them of the [FDA] letter or obtaining their informed consent to use the device.”
In light of these alleged lapses, Mirian Rivera, the patient’s sister, sought both compensatory and punitive damages. Historically, punitive damages have been limited to the small number of med-mal cases where a doctor or hospital has been found to have acted with actual malice or “wanton and willful disregard.”
Both Valley and Dr. Jones strongly disagreed with Ms. Rivera’s claim, arguing that prior to the procedure Dr. Jones had in fact met with the patient several times and had conducted the proper cancer-detecting tests. Moreover, the defendants emphasized, the request for punitive damages in the absence of actual malice or other factors would almost certainly establish a dangerous legal precedent. Several industry groups – including the American Medical Association, the Medical Society of New Jersey, and the New Jersey Hospital Association – agreed and filed friend-of-court briefs in support of Valley Hospital and Dr. Jones.
But two lower courts refused to dismiss the plaintiff’s claims for punitive damages. That’s when attorneys for Valley and Dr. Jones appealed to the New Jersey Supreme Court. (Claims against the device manufacturer, a German company, had already been resolved.)
Ruling unanimously, the high court sided with the defendants: “As a matter of law, the evidence presented, even affording plaintiffs all favorable inferences, does not establish that defendants’ acts or omissions were motivated by actual malice or accompanied by wanton and willful disregard for the patient’s health and safety.”
The court also found that Valley had in fact reviewed hospital policy and drafted a patient-consent form after the release of the 2014 FDA safety communication on power morcellators. (The consent form had not been adopted before the surgery in question, however.)
The suit will now go back to Superior Court in Bergen County, New Jersey; unless a settlement is reached beforehand, the jury will weigh claims of negligence and compensatory damages.
At press time, no trial date had been set.
Will med-mal cases get tougher to defend in this state?
Late in August, the Pennsylvania Supreme Court reversed its own longstanding rule that required that medical malpractice cases be filed in the county where the alleged injury occurred, as an Associated Press story on NBCPhiladelphia.com, among other news sites, reports.
More than 2 decades ago, in response to what was then seen as a crisis in the med-mal system, the state legislature overwhelmingly passed MCARE (the Medical Care Availability and Reduction of Error Fund), which among other things restricted the venue of medical suits. The legislation was signed into law in March 2002 by then-Gov. Mark Schweiker.
The following year, the state’s high court adopted a similar venue rule.
Over the years, doctor and hospital groups have been big supporters of the rule, arguing that any attempt to shift cases back to allegedly more plaintiff-friendly courts in Philadelphia and other cities would likely retrigger a crisis of higher med-mal premiums, doctor flight, and worse health care.
But a 2020 report by Pennsylvania’s nonpartisan Legislative Budget and Finance Committee took issue with these conclusions. It said that, following a national trend, the cost of medical professional liability insurance had fallen in the state since 2007. The report concluded that nothing in the available data supports the “conclusion that changes in the availability, cost, and affordability of medical professional liability insurance are the result of changes in Pennsylvania law.”
A more recent report by the high court’s Civil Procedural Rules Committee reached a similar conclusion, noting that med-mal cases should be subject to the same rules as any other type of civil litigation. A majority of the high court agreed.
Predictably, this decision sits well with patient groups and officials representing trial attorneys in the Keystone State.
“Cases should be heard before 12 jurors that do not have a connection to a hospital or surgical center that is often times the largest employer in the county,” said Kila Baldwin, president of the Pennsylvania Association for Justice. “The new rule levels the playing field and will improve access to justice for all Pennsylvanians.”
Doctors, hospitals, and other health care providers, however, have predicted a “ruinous path” ahead.
A version of this article first appeared on Medscape.com.
CRP levels could predict SSRI success
C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.
In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.
CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).
The researchers compared efficacy in different groups according to CRP levels.
Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).
A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.
“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.
No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.
No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.
The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.
However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.
In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.
CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).
The researchers compared efficacy in different groups according to CRP levels.
Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).
A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.
“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.
No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.
No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.
The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.
However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.
In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.
CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).
The researchers compared efficacy in different groups according to CRP levels.
Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).
A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.
“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.
No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.
No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.
The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.
However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Desperate long COVID patients turn to unproven alternative therapies
Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, N.Y., businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.
“Even a simple task such as unloading the dishwasher became a major challenge,” she says.
Over the next several months, Ms. McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.
“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”
Ms. McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.
She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.
It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.
Ms. McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.
“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”
Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”
Sniffing out the snake oil
With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or “the bends.” It’s also being touted by some clinics as an effective treatment for long COVID.
A very small trial of 73 patients with long COVID, published in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Dr. Schamess.
“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.
In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the U.S. Food and Drug Administration.
One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the department of physical medicine and rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.
The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.
“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Dr. Bell. It’s also prohibitively expensive – one Cayman Islands–based company advertises its treatment for as much as $25,000.
Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to the BMJ.
It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Dr. Bell says.
Sorting through supplements
Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.
“There’s no data on them, and in large quantities, they may even be harmful,” she says.
Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.
“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Dr. Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”
This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.
Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Dr. Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.
But a small preprint study published in The Lancet, of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery, compared with those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.
Another is probiotics. A small study, published in the journal Infectious Diseases Diagnosis & Treatment, found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.
One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone who works with long COVID patients. Researchers at the Mount Sinai School of Medicine, New York, are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.
Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.
“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Dr. Flanagan.
A 2022 study, published in BMJ Open, found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.
“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”
A version of this article first appeared on WebMD.com.
Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, N.Y., businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.
“Even a simple task such as unloading the dishwasher became a major challenge,” she says.
Over the next several months, Ms. McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.
“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”
Ms. McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.
She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.
It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.
Ms. McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.
“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”
Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”
Sniffing out the snake oil
With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or “the bends.” It’s also being touted by some clinics as an effective treatment for long COVID.
A very small trial of 73 patients with long COVID, published in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Dr. Schamess.
“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.
In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the U.S. Food and Drug Administration.
One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the department of physical medicine and rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.
The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.
“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Dr. Bell. It’s also prohibitively expensive – one Cayman Islands–based company advertises its treatment for as much as $25,000.
Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to the BMJ.
It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Dr. Bell says.
Sorting through supplements
Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.
“There’s no data on them, and in large quantities, they may even be harmful,” she says.
Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.
“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Dr. Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”
This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.
Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Dr. Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.
But a small preprint study published in The Lancet, of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery, compared with those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.
Another is probiotics. A small study, published in the journal Infectious Diseases Diagnosis & Treatment, found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.
One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone who works with long COVID patients. Researchers at the Mount Sinai School of Medicine, New York, are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.
Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.
“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Dr. Flanagan.
A 2022 study, published in BMJ Open, found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.
“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”
A version of this article first appeared on WebMD.com.
Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, N.Y., businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.
“Even a simple task such as unloading the dishwasher became a major challenge,” she says.
Over the next several months, Ms. McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.
“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”
Ms. McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.
She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.
It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.
Ms. McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.
“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”
Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”
Sniffing out the snake oil
With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or “the bends.” It’s also being touted by some clinics as an effective treatment for long COVID.
A very small trial of 73 patients with long COVID, published in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Dr. Schamess.
“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.
In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the U.S. Food and Drug Administration.
One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the department of physical medicine and rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.
The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.
“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Dr. Bell. It’s also prohibitively expensive – one Cayman Islands–based company advertises its treatment for as much as $25,000.
Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to the BMJ.
It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Dr. Bell says.
Sorting through supplements
Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.
“There’s no data on them, and in large quantities, they may even be harmful,” she says.
Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.
“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Dr. Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”
This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.
Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Dr. Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.
But a small preprint study published in The Lancet, of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery, compared with those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.
Another is probiotics. A small study, published in the journal Infectious Diseases Diagnosis & Treatment, found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.
One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone who works with long COVID patients. Researchers at the Mount Sinai School of Medicine, New York, are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.
Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.
“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Dr. Flanagan.
A 2022 study, published in BMJ Open, found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.
“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”
A version of this article first appeared on WebMD.com.
Can we eliminate measles and rubella worldwide?
A study in The Lancet Global Health takes a pessimistic view of our ability to eradicate measles by 2100, although rubella forecasts look a bit more promising.
So far, measles has been eliminated in 81 countries and rubella in 93. But factors such as antivaccination sentiment and misinformation linking vaccination to autism have led to occasional outbreaks. In addition, because the COVID-19 pandemic fueled lower routine vaccination coverage and postponed public health campaigns, some countries have also lost previously gained ground.
The study, which is slated for publication in the Oct. 1 issue of the Lancet Global Health, explored the likelihood of eliminating measles and rubella, based on vaccination strategies in 93 countries with the highest measles and rubella burden, under two vaccination scenarios: 1) a “business as usual” approach, that is, continuing current vaccination coverage via routine childhood immunization schedules and intermittent vaccination campaigns that target age groups to vaccinate quickly (known as SIAs); and 2) an “intensified investment approach” that scales up SIA vaccination coverage into the future.
Both vaccination scenarios were evaluated within the context of two national models (Johns Hopkins University and Public Health England), and one subnational model (Nigeria) for rubella transmission.
Lead author Amy Winter, PhD, assistant professor of epidemiology and biostatistics, University of Georgia College of Public Health, Athens, told this news organization that “under the intensified investment scenario, rubella elimination is likely to be achieved in all 93 countries that were modeled [but] measles elimination is likely in some but not all countries.”
This is especially the case if the goal is cessation of vaccination campaigns, study authors noted when placing the research in context.
But Dr. Winter also emphasized that Nigeria offered specific lessons not seen in the national models.
For one,
In addition, she stressed a need to improve vaccine equity by focusing on areas with really low coverage and then moving into areas with higher coverage.
“The Nigerian subnational analysis definitely illustrates the importance of achieving equitable vaccination and the need for potentially targeted strategies to improve vaccination,” she said. “The initial focus should be on getting areas with low coverage up to par.”
Still, “even with the intensified investment approach, we won’t be able to eradicate measles,” William Moss, MD, professor of epidemiology and executive director, International Vaccine Access Center, Johns Hopkins University, Baltimore, who was not directly involved in the study, told this news organization.
Pandemic interruptions, future strategies
In a related editorial (The Lancet Global Health. 2022 Oct 1. doi: 10.1016/S2214-109X[22]00388-6), the authors noted that COVID-19 has markedly disrupted vaccination campaigns globally.
In 2017, 118 (61%) countries achieved the Global Vaccine Action Plan 2020 target of 90% or more national MCV1 (first dose of measles vaccine) coverage. Since that time, measles coverage has declined from 84%-85% in 2017 to 81% in 2021, leaving 24.7 million completely unprotected (also known as zero-dose children) and 14.7 million children underimmunized (that is, recipients of only 1 dose).
Notably, this is the lowest immunization level since 2008, with more than 5 million more children missing their first measles dose.
Dr. Moss has previously written on the biological feasibility of measles eradication and said that it’s not tenable to rely on increased vaccination coverage alone.
We need “new tools and the new strategies. One of the ones that we’re most excited about [is] microarray patches,” he said, noting that they are thermostable and can be administered by anyone.
Dr. Moss also said that, while he is hoping for point-of-care rapid diagnostics, the focus of the efforts needs to change.
“Where’s [the] measles virus coming from? Where’s it being exported from and where is it being imported to?” he posited, adding that the focus should be on these areas “to try to shut down transmission … a radical kind of second phase of a measles eradication puts aside equity and focuses on sources and sinks.”
In the interim, rubella elimination looks promising.
“It’s not as contagious [as measles] and has a lower sort of herd immunity threshold because of it,” Dr. Winter said.
Dr. Winter and Dr. Moss report no relevant financial relationships. The study was funded by the World Health Organization, Gavi, the Vaccine Alliance, the Centers for Disease Control and Prevention, and the Bill & Melinda Gates Foundation.
A version of this article first appeared on Medscape.com.
A study in The Lancet Global Health takes a pessimistic view of our ability to eradicate measles by 2100, although rubella forecasts look a bit more promising.
So far, measles has been eliminated in 81 countries and rubella in 93. But factors such as antivaccination sentiment and misinformation linking vaccination to autism have led to occasional outbreaks. In addition, because the COVID-19 pandemic fueled lower routine vaccination coverage and postponed public health campaigns, some countries have also lost previously gained ground.
The study, which is slated for publication in the Oct. 1 issue of the Lancet Global Health, explored the likelihood of eliminating measles and rubella, based on vaccination strategies in 93 countries with the highest measles and rubella burden, under two vaccination scenarios: 1) a “business as usual” approach, that is, continuing current vaccination coverage via routine childhood immunization schedules and intermittent vaccination campaigns that target age groups to vaccinate quickly (known as SIAs); and 2) an “intensified investment approach” that scales up SIA vaccination coverage into the future.
Both vaccination scenarios were evaluated within the context of two national models (Johns Hopkins University and Public Health England), and one subnational model (Nigeria) for rubella transmission.
Lead author Amy Winter, PhD, assistant professor of epidemiology and biostatistics, University of Georgia College of Public Health, Athens, told this news organization that “under the intensified investment scenario, rubella elimination is likely to be achieved in all 93 countries that were modeled [but] measles elimination is likely in some but not all countries.”
This is especially the case if the goal is cessation of vaccination campaigns, study authors noted when placing the research in context.
But Dr. Winter also emphasized that Nigeria offered specific lessons not seen in the national models.
For one,
In addition, she stressed a need to improve vaccine equity by focusing on areas with really low coverage and then moving into areas with higher coverage.
“The Nigerian subnational analysis definitely illustrates the importance of achieving equitable vaccination and the need for potentially targeted strategies to improve vaccination,” she said. “The initial focus should be on getting areas with low coverage up to par.”
Still, “even with the intensified investment approach, we won’t be able to eradicate measles,” William Moss, MD, professor of epidemiology and executive director, International Vaccine Access Center, Johns Hopkins University, Baltimore, who was not directly involved in the study, told this news organization.
Pandemic interruptions, future strategies
In a related editorial (The Lancet Global Health. 2022 Oct 1. doi: 10.1016/S2214-109X[22]00388-6), the authors noted that COVID-19 has markedly disrupted vaccination campaigns globally.
In 2017, 118 (61%) countries achieved the Global Vaccine Action Plan 2020 target of 90% or more national MCV1 (first dose of measles vaccine) coverage. Since that time, measles coverage has declined from 84%-85% in 2017 to 81% in 2021, leaving 24.7 million completely unprotected (also known as zero-dose children) and 14.7 million children underimmunized (that is, recipients of only 1 dose).
Notably, this is the lowest immunization level since 2008, with more than 5 million more children missing their first measles dose.
Dr. Moss has previously written on the biological feasibility of measles eradication and said that it’s not tenable to rely on increased vaccination coverage alone.
We need “new tools and the new strategies. One of the ones that we’re most excited about [is] microarray patches,” he said, noting that they are thermostable and can be administered by anyone.
Dr. Moss also said that, while he is hoping for point-of-care rapid diagnostics, the focus of the efforts needs to change.
“Where’s [the] measles virus coming from? Where’s it being exported from and where is it being imported to?” he posited, adding that the focus should be on these areas “to try to shut down transmission … a radical kind of second phase of a measles eradication puts aside equity and focuses on sources and sinks.”
In the interim, rubella elimination looks promising.
“It’s not as contagious [as measles] and has a lower sort of herd immunity threshold because of it,” Dr. Winter said.
Dr. Winter and Dr. Moss report no relevant financial relationships. The study was funded by the World Health Organization, Gavi, the Vaccine Alliance, the Centers for Disease Control and Prevention, and the Bill & Melinda Gates Foundation.
A version of this article first appeared on Medscape.com.
A study in The Lancet Global Health takes a pessimistic view of our ability to eradicate measles by 2100, although rubella forecasts look a bit more promising.
So far, measles has been eliminated in 81 countries and rubella in 93. But factors such as antivaccination sentiment and misinformation linking vaccination to autism have led to occasional outbreaks. In addition, because the COVID-19 pandemic fueled lower routine vaccination coverage and postponed public health campaigns, some countries have also lost previously gained ground.
The study, which is slated for publication in the Oct. 1 issue of the Lancet Global Health, explored the likelihood of eliminating measles and rubella, based on vaccination strategies in 93 countries with the highest measles and rubella burden, under two vaccination scenarios: 1) a “business as usual” approach, that is, continuing current vaccination coverage via routine childhood immunization schedules and intermittent vaccination campaigns that target age groups to vaccinate quickly (known as SIAs); and 2) an “intensified investment approach” that scales up SIA vaccination coverage into the future.
Both vaccination scenarios were evaluated within the context of two national models (Johns Hopkins University and Public Health England), and one subnational model (Nigeria) for rubella transmission.
Lead author Amy Winter, PhD, assistant professor of epidemiology and biostatistics, University of Georgia College of Public Health, Athens, told this news organization that “under the intensified investment scenario, rubella elimination is likely to be achieved in all 93 countries that were modeled [but] measles elimination is likely in some but not all countries.”
This is especially the case if the goal is cessation of vaccination campaigns, study authors noted when placing the research in context.
But Dr. Winter also emphasized that Nigeria offered specific lessons not seen in the national models.
For one,
In addition, she stressed a need to improve vaccine equity by focusing on areas with really low coverage and then moving into areas with higher coverage.
“The Nigerian subnational analysis definitely illustrates the importance of achieving equitable vaccination and the need for potentially targeted strategies to improve vaccination,” she said. “The initial focus should be on getting areas with low coverage up to par.”
Still, “even with the intensified investment approach, we won’t be able to eradicate measles,” William Moss, MD, professor of epidemiology and executive director, International Vaccine Access Center, Johns Hopkins University, Baltimore, who was not directly involved in the study, told this news organization.
Pandemic interruptions, future strategies
In a related editorial (The Lancet Global Health. 2022 Oct 1. doi: 10.1016/S2214-109X[22]00388-6), the authors noted that COVID-19 has markedly disrupted vaccination campaigns globally.
In 2017, 118 (61%) countries achieved the Global Vaccine Action Plan 2020 target of 90% or more national MCV1 (first dose of measles vaccine) coverage. Since that time, measles coverage has declined from 84%-85% in 2017 to 81% in 2021, leaving 24.7 million completely unprotected (also known as zero-dose children) and 14.7 million children underimmunized (that is, recipients of only 1 dose).
Notably, this is the lowest immunization level since 2008, with more than 5 million more children missing their first measles dose.
Dr. Moss has previously written on the biological feasibility of measles eradication and said that it’s not tenable to rely on increased vaccination coverage alone.
We need “new tools and the new strategies. One of the ones that we’re most excited about [is] microarray patches,” he said, noting that they are thermostable and can be administered by anyone.
Dr. Moss also said that, while he is hoping for point-of-care rapid diagnostics, the focus of the efforts needs to change.
“Where’s [the] measles virus coming from? Where’s it being exported from and where is it being imported to?” he posited, adding that the focus should be on these areas “to try to shut down transmission … a radical kind of second phase of a measles eradication puts aside equity and focuses on sources and sinks.”
In the interim, rubella elimination looks promising.
“It’s not as contagious [as measles] and has a lower sort of herd immunity threshold because of it,” Dr. Winter said.
Dr. Winter and Dr. Moss report no relevant financial relationships. The study was funded by the World Health Organization, Gavi, the Vaccine Alliance, the Centers for Disease Control and Prevention, and the Bill & Melinda Gates Foundation.
A version of this article first appeared on Medscape.com.
FROM THE LANCET GLOBAL HEALTH
Noted oncologist ponders death, life, care inequities
In 2020, he published a book aimed at cancer specialists and their patients on how to die “with hope and dignity,” titled “Between Life and Death” (Penguin Random House India).
When Dr. Patel, the CEO of Carolina Blood and Cancer Care Associates in Rock Hill, S.C., became president of the Washington-based Community Oncology Alliance 2 years ago, he stepped into a leadership role in community oncology. As an advocate for health care payment reform on Capitol Hill, the South Carolina legislature, and within his own practice, Dr. Patel has long worked to eliminate disparities in U.S. cancer care.
This news organization spoke with Dr. Patel about his unusual career path.
Question: Your father had a great influence on you. Can you tell us more about him?
Answer: My dad was a hermit and a saint. He lost his dad when he was 4 years old and moved to the big city with his cousins. When he was 9 or so, he got a message saying that his mum was very ill. So, he and his cousin raised some money, got a doctor and one of those old, rugged jeeps, and they started driving to the village, but rains had destroyed the road. So, without penicillin, his mum died of pneumonia.
He felt that roads and doctor access were the two big factors that could have saved her life. He eventually became the Superintending Engineer for four districts in Gujarat State, building roads connecting every village, but he never gave up his simplistic, minimalist life.
When I was in elementary school, every other weekend my dad would literally dump me at the Mahatma Gandhi Ashram and come back in 2 hours. So, I’m looking at Gandhi’s cabinets, his pictures, reading about his life. So, my formative years were born in that.
Q: I read that you were intending to become an engineer and join the space race. How did your father nudge you toward medicine?
A: When I was 9 years old, my favorite movie hero died of cancer. To comfort me, my father inserted the idea into my brain: When you grow up, you can become a doctor to cure cancer. So, when I finished high school, I was 24th in the state and had an option to go to the space school in India. On the day when I was going for the interview, I could see tears in my father’s eyes, and he said, You know what, boy? I thought you’re going to become a doctor and cure cancer. So, to honor him, I went to med school instead.
Q: I understand that your father also triggered your interest in photography?
A: I started photographing Kutchi tribal people in 1977, after I bought a camera from a famous architect [Hasmukh Patel], while traveling with my dad. And then my dad bought me a motorcycle, so I started riding myself. From the time I entered med school in 1978 until I finished my residency in 1987, I made several trips following Kutchi migrant families and livestock. They leave their homeland in Kutch [district] during summer in search of grass and water to keep their livestock alive and walk across the state from the desert of Kutch all the way to central Gujarat until monsoon begins. Then they return, only to resume the journey next year. I would catch them along their journey, would talk to them, drink tea and eat millet crepes with them.
In 1984, between Dr. Patel’s medical school and residency, the Lions Club in his hometown, Ahmedabad, India, sponsored him and three buddies to document people and wildlife in Gujarat state. Traveling by motorcycle, the four friends stayed for free with local families by knocking on doors and explaining that they were medical students. Dr. Patel’s photographs were exhibited by the Lions Club of Ahmedabad and at India’s top art institution, the Lalit Kala gallery.
In the 3rd year of his internal-medicine residency in Bombay (now Mumbai), Dr. Patel approached a national newspaper, The Indian Express, for work. He was immediately sent on assignment to cover a cholera epidemic and filed his story and photographs the following day. He worked as a photojournalist and subeditor for a year.
Q: Among all your thousands of pictures, do you have a favorite?
A: There were two photos of Kutchi people that touched me. There was one photo of a lady. All of her worldly belongings were in the picture and a smile on her face showed that we don’t need so many things to be happy. The second photo is of an elderly lady shifting her water pan on her head to a younger family member. And a little girl looks up with a look of curiosity: Will I be doing this when I grow up? We seek so much materialistic happiness. But when you look at the curiosity, smiles, and happiness [in these photos], you realize we could have a lot of happiness in minimalism, as well.
Q: After you finished your residency in Ahmedabad, how did you get started in oncology?
A: In 1986, Ahmedabad City and Gujarat State did not have structured training programs in oncology, so I went to Bombay [Mumbai], where Dr. B.C. Mehta, a true legend and pioneer in India, had started hematology-oncology training. I was a post-doc research fellow with him for a little over a year but when I started seeing patients, I had to answer to myself, Am I doing everything I can to help these people? I saw that the U.K. had one of the best training programs in hem malignancy, so I started applying. Then something happened that was almost like a miracle.
In April 1992, Dr. Patel was working at the Institute of Kidney Diseases in Ahmedabad. One afternoon, just as the clinic was closing for siesta, a family brought in a young girl. She had drug-induced thrombocytopenia and needed an immediate transfusion. The father offered to sell his wedding ring to pay Dr. Patel if he would supervise the treatment and stay by the girl’s side. Dr. Patel told the man to keep his ring, then he remained in the office with the child. At 4 p.m., the office phone rang. It was Dr. H.K. Parikh, an eminent British physician who was wintering in India and needed to make a medical appointment for his wife. On a normal day, Dr. Patel would have missed the call.
“This is how I got to meet Dr. Parikh, out of the blue,” said Dr. Patel. “His wife came to the office for 6 weeks and after 6 weeks, he said, You’re a smart guy; you should come to England. That was in April. I sent a resume and all the usual paperwork. On July 16, 1992, at 2 in the morning, I got a call from the U.K. saying, Your job is confirmed. I’m going to fax your appointment through the Royal College of Physicians, and you’re coming to Manchester to work with us. I’d been sponsored by the Overseas Doctors Training Program.
“So, it turns out that if I’d declined to see that patient and declined to stay in my clinic that afternoon, if I’d declined to see this doctor’s wife, I would never have been in the U.K. And that opened up the doors for me. I like that story because I’ve found that standing up for people who do not have a voice, who do not have hope, always leads to what is destined for me.”
Q: After working as a registrar in the United Kingdom 4 years, you found yourself in the United States and, once again, had to train as an internist. What was new about U.S. oncology?
A: I took 3 years to get recertified in Jamaica Hospital in Queens, then became a fellow in hematology-oncology at the Thomas Jefferson in Philadelphia. My U.K. training was all based on hematological malignancy. In the United States, I shifted into solid tumors.
Q: You have a long history of advocating for affordable oncology at the community, state, and federal level, and you recently launched a disparities initiative in your center called NOLA (No One Left Alone). What was the trigger for NOLA?
A: In the spring of 2020, when we started seeing the COVID surge and the difference in mortality rate between the multiple races, at the same time I saw the AACR [American Association for Cancer Research] 2020 disparity report showing that 34% of cancer deaths are preventable – one in three – if we took care of disparities. The same year, the Community Oncology Alliance asked me to become the president. So, I felt that there is something herding me, leading me, to this position. Eighty percent of cancer patients are treated in community clinics like ours. It put the onus on me to do something.
I learned from Gandhi that I cannot depend on government, I cannot depend on the policy, I have to act myself.
I said, I would not worry about making money, I would rather lose funding on this. So, we started. I read 400+ papers; I spent over 1,000 hours reading about disparities. And I realized that it’s not complicated. There are five pillars to eliminate disparity: access to care for financial reasons, access to biomarker testing or precision medicine, access to social determinants of health, access to cancer screening, and trials. If we focus on these five, we can at least bring that number from 34% to 20%, if not lower.
So, we put that plan in place. I dedicated three employees whose only role is to ensure that not a single patient has to take financial burden from my practice. And we showed it’s doable.
This has now become my mission for the last quarter of my life.
In 2020, Dr. Patel published a book on dying well titled “Between Life and Death.” It’s framed as a series of his conversations with a former patient, Harry Falls. Harry wanted to understand death better, so Dr. Patel narrated five patient stories, drawing the threads together to help Harry face the inevitable. Dr. Patel now uses a similar approach to train clinicians on having meaningful end-of-life conversations with patients.
Q: Why did you feel the need to write a book about dying?
A: The more I’ve witnessed, the more I’m convinced that there are things that we don’t know about this process, which needs to be explored much more. However, I do feel that there’s a power within all of us to steer the process of leaving this world.
Before I sat down with Harry, I loved to counsel patients, but I didn’t have any structural ideas. It was Harry himself who told me that I now had a simple way to explain dying to a much larger audience.
Q: What is your secret for fitting everything into your life?
A: I’ll tell you, it’s very simple. If I put my soul, heart, mind, actions, and language on the one plane and don’t let my brain and conditioning influence my choices, then I live in the moment. Whenever I let my conditioned mind take all the decisions, those are crooked, because you know, we’re selfish creatures – we can use what we call the convenient lie to hide inconvenient truth. And I try not to do that. I mean, it’s been a journey. It didn’t come overnight. I learned. And I feel that over all these years, the only thing that rewarded me, that opened the door of where I am today, was pure, selfless process, whether it’s the act of talking, speaking, or doing.
In 2020, he published a book aimed at cancer specialists and their patients on how to die “with hope and dignity,” titled “Between Life and Death” (Penguin Random House India).
When Dr. Patel, the CEO of Carolina Blood and Cancer Care Associates in Rock Hill, S.C., became president of the Washington-based Community Oncology Alliance 2 years ago, he stepped into a leadership role in community oncology. As an advocate for health care payment reform on Capitol Hill, the South Carolina legislature, and within his own practice, Dr. Patel has long worked to eliminate disparities in U.S. cancer care.
This news organization spoke with Dr. Patel about his unusual career path.
Question: Your father had a great influence on you. Can you tell us more about him?
Answer: My dad was a hermit and a saint. He lost his dad when he was 4 years old and moved to the big city with his cousins. When he was 9 or so, he got a message saying that his mum was very ill. So, he and his cousin raised some money, got a doctor and one of those old, rugged jeeps, and they started driving to the village, but rains had destroyed the road. So, without penicillin, his mum died of pneumonia.
He felt that roads and doctor access were the two big factors that could have saved her life. He eventually became the Superintending Engineer for four districts in Gujarat State, building roads connecting every village, but he never gave up his simplistic, minimalist life.
When I was in elementary school, every other weekend my dad would literally dump me at the Mahatma Gandhi Ashram and come back in 2 hours. So, I’m looking at Gandhi’s cabinets, his pictures, reading about his life. So, my formative years were born in that.
Q: I read that you were intending to become an engineer and join the space race. How did your father nudge you toward medicine?
A: When I was 9 years old, my favorite movie hero died of cancer. To comfort me, my father inserted the idea into my brain: When you grow up, you can become a doctor to cure cancer. So, when I finished high school, I was 24th in the state and had an option to go to the space school in India. On the day when I was going for the interview, I could see tears in my father’s eyes, and he said, You know what, boy? I thought you’re going to become a doctor and cure cancer. So, to honor him, I went to med school instead.
Q: I understand that your father also triggered your interest in photography?
A: I started photographing Kutchi tribal people in 1977, after I bought a camera from a famous architect [Hasmukh Patel], while traveling with my dad. And then my dad bought me a motorcycle, so I started riding myself. From the time I entered med school in 1978 until I finished my residency in 1987, I made several trips following Kutchi migrant families and livestock. They leave their homeland in Kutch [district] during summer in search of grass and water to keep their livestock alive and walk across the state from the desert of Kutch all the way to central Gujarat until monsoon begins. Then they return, only to resume the journey next year. I would catch them along their journey, would talk to them, drink tea and eat millet crepes with them.
In 1984, between Dr. Patel’s medical school and residency, the Lions Club in his hometown, Ahmedabad, India, sponsored him and three buddies to document people and wildlife in Gujarat state. Traveling by motorcycle, the four friends stayed for free with local families by knocking on doors and explaining that they were medical students. Dr. Patel’s photographs were exhibited by the Lions Club of Ahmedabad and at India’s top art institution, the Lalit Kala gallery.
In the 3rd year of his internal-medicine residency in Bombay (now Mumbai), Dr. Patel approached a national newspaper, The Indian Express, for work. He was immediately sent on assignment to cover a cholera epidemic and filed his story and photographs the following day. He worked as a photojournalist and subeditor for a year.
Q: Among all your thousands of pictures, do you have a favorite?
A: There were two photos of Kutchi people that touched me. There was one photo of a lady. All of her worldly belongings were in the picture and a smile on her face showed that we don’t need so many things to be happy. The second photo is of an elderly lady shifting her water pan on her head to a younger family member. And a little girl looks up with a look of curiosity: Will I be doing this when I grow up? We seek so much materialistic happiness. But when you look at the curiosity, smiles, and happiness [in these photos], you realize we could have a lot of happiness in minimalism, as well.
Q: After you finished your residency in Ahmedabad, how did you get started in oncology?
A: In 1986, Ahmedabad City and Gujarat State did not have structured training programs in oncology, so I went to Bombay [Mumbai], where Dr. B.C. Mehta, a true legend and pioneer in India, had started hematology-oncology training. I was a post-doc research fellow with him for a little over a year but when I started seeing patients, I had to answer to myself, Am I doing everything I can to help these people? I saw that the U.K. had one of the best training programs in hem malignancy, so I started applying. Then something happened that was almost like a miracle.
In April 1992, Dr. Patel was working at the Institute of Kidney Diseases in Ahmedabad. One afternoon, just as the clinic was closing for siesta, a family brought in a young girl. She had drug-induced thrombocytopenia and needed an immediate transfusion. The father offered to sell his wedding ring to pay Dr. Patel if he would supervise the treatment and stay by the girl’s side. Dr. Patel told the man to keep his ring, then he remained in the office with the child. At 4 p.m., the office phone rang. It was Dr. H.K. Parikh, an eminent British physician who was wintering in India and needed to make a medical appointment for his wife. On a normal day, Dr. Patel would have missed the call.
“This is how I got to meet Dr. Parikh, out of the blue,” said Dr. Patel. “His wife came to the office for 6 weeks and after 6 weeks, he said, You’re a smart guy; you should come to England. That was in April. I sent a resume and all the usual paperwork. On July 16, 1992, at 2 in the morning, I got a call from the U.K. saying, Your job is confirmed. I’m going to fax your appointment through the Royal College of Physicians, and you’re coming to Manchester to work with us. I’d been sponsored by the Overseas Doctors Training Program.
“So, it turns out that if I’d declined to see that patient and declined to stay in my clinic that afternoon, if I’d declined to see this doctor’s wife, I would never have been in the U.K. And that opened up the doors for me. I like that story because I’ve found that standing up for people who do not have a voice, who do not have hope, always leads to what is destined for me.”
Q: After working as a registrar in the United Kingdom 4 years, you found yourself in the United States and, once again, had to train as an internist. What was new about U.S. oncology?
A: I took 3 years to get recertified in Jamaica Hospital in Queens, then became a fellow in hematology-oncology at the Thomas Jefferson in Philadelphia. My U.K. training was all based on hematological malignancy. In the United States, I shifted into solid tumors.
Q: You have a long history of advocating for affordable oncology at the community, state, and federal level, and you recently launched a disparities initiative in your center called NOLA (No One Left Alone). What was the trigger for NOLA?
A: In the spring of 2020, when we started seeing the COVID surge and the difference in mortality rate between the multiple races, at the same time I saw the AACR [American Association for Cancer Research] 2020 disparity report showing that 34% of cancer deaths are preventable – one in three – if we took care of disparities. The same year, the Community Oncology Alliance asked me to become the president. So, I felt that there is something herding me, leading me, to this position. Eighty percent of cancer patients are treated in community clinics like ours. It put the onus on me to do something.
I learned from Gandhi that I cannot depend on government, I cannot depend on the policy, I have to act myself.
I said, I would not worry about making money, I would rather lose funding on this. So, we started. I read 400+ papers; I spent over 1,000 hours reading about disparities. And I realized that it’s not complicated. There are five pillars to eliminate disparity: access to care for financial reasons, access to biomarker testing or precision medicine, access to social determinants of health, access to cancer screening, and trials. If we focus on these five, we can at least bring that number from 34% to 20%, if not lower.
So, we put that plan in place. I dedicated three employees whose only role is to ensure that not a single patient has to take financial burden from my practice. And we showed it’s doable.
This has now become my mission for the last quarter of my life.
In 2020, Dr. Patel published a book on dying well titled “Between Life and Death.” It’s framed as a series of his conversations with a former patient, Harry Falls. Harry wanted to understand death better, so Dr. Patel narrated five patient stories, drawing the threads together to help Harry face the inevitable. Dr. Patel now uses a similar approach to train clinicians on having meaningful end-of-life conversations with patients.
Q: Why did you feel the need to write a book about dying?
A: The more I’ve witnessed, the more I’m convinced that there are things that we don’t know about this process, which needs to be explored much more. However, I do feel that there’s a power within all of us to steer the process of leaving this world.
Before I sat down with Harry, I loved to counsel patients, but I didn’t have any structural ideas. It was Harry himself who told me that I now had a simple way to explain dying to a much larger audience.
Q: What is your secret for fitting everything into your life?
A: I’ll tell you, it’s very simple. If I put my soul, heart, mind, actions, and language on the one plane and don’t let my brain and conditioning influence my choices, then I live in the moment. Whenever I let my conditioned mind take all the decisions, those are crooked, because you know, we’re selfish creatures – we can use what we call the convenient lie to hide inconvenient truth. And I try not to do that. I mean, it’s been a journey. It didn’t come overnight. I learned. And I feel that over all these years, the only thing that rewarded me, that opened the door of where I am today, was pure, selfless process, whether it’s the act of talking, speaking, or doing.
In 2020, he published a book aimed at cancer specialists and their patients on how to die “with hope and dignity,” titled “Between Life and Death” (Penguin Random House India).
When Dr. Patel, the CEO of Carolina Blood and Cancer Care Associates in Rock Hill, S.C., became president of the Washington-based Community Oncology Alliance 2 years ago, he stepped into a leadership role in community oncology. As an advocate for health care payment reform on Capitol Hill, the South Carolina legislature, and within his own practice, Dr. Patel has long worked to eliminate disparities in U.S. cancer care.
This news organization spoke with Dr. Patel about his unusual career path.
Question: Your father had a great influence on you. Can you tell us more about him?
Answer: My dad was a hermit and a saint. He lost his dad when he was 4 years old and moved to the big city with his cousins. When he was 9 or so, he got a message saying that his mum was very ill. So, he and his cousin raised some money, got a doctor and one of those old, rugged jeeps, and they started driving to the village, but rains had destroyed the road. So, without penicillin, his mum died of pneumonia.
He felt that roads and doctor access were the two big factors that could have saved her life. He eventually became the Superintending Engineer for four districts in Gujarat State, building roads connecting every village, but he never gave up his simplistic, minimalist life.
When I was in elementary school, every other weekend my dad would literally dump me at the Mahatma Gandhi Ashram and come back in 2 hours. So, I’m looking at Gandhi’s cabinets, his pictures, reading about his life. So, my formative years were born in that.
Q: I read that you were intending to become an engineer and join the space race. How did your father nudge you toward medicine?
A: When I was 9 years old, my favorite movie hero died of cancer. To comfort me, my father inserted the idea into my brain: When you grow up, you can become a doctor to cure cancer. So, when I finished high school, I was 24th in the state and had an option to go to the space school in India. On the day when I was going for the interview, I could see tears in my father’s eyes, and he said, You know what, boy? I thought you’re going to become a doctor and cure cancer. So, to honor him, I went to med school instead.
Q: I understand that your father also triggered your interest in photography?
A: I started photographing Kutchi tribal people in 1977, after I bought a camera from a famous architect [Hasmukh Patel], while traveling with my dad. And then my dad bought me a motorcycle, so I started riding myself. From the time I entered med school in 1978 until I finished my residency in 1987, I made several trips following Kutchi migrant families and livestock. They leave their homeland in Kutch [district] during summer in search of grass and water to keep their livestock alive and walk across the state from the desert of Kutch all the way to central Gujarat until monsoon begins. Then they return, only to resume the journey next year. I would catch them along their journey, would talk to them, drink tea and eat millet crepes with them.
In 1984, between Dr. Patel’s medical school and residency, the Lions Club in his hometown, Ahmedabad, India, sponsored him and three buddies to document people and wildlife in Gujarat state. Traveling by motorcycle, the four friends stayed for free with local families by knocking on doors and explaining that they were medical students. Dr. Patel’s photographs were exhibited by the Lions Club of Ahmedabad and at India’s top art institution, the Lalit Kala gallery.
In the 3rd year of his internal-medicine residency in Bombay (now Mumbai), Dr. Patel approached a national newspaper, The Indian Express, for work. He was immediately sent on assignment to cover a cholera epidemic and filed his story and photographs the following day. He worked as a photojournalist and subeditor for a year.
Q: Among all your thousands of pictures, do you have a favorite?
A: There were two photos of Kutchi people that touched me. There was one photo of a lady. All of her worldly belongings were in the picture and a smile on her face showed that we don’t need so many things to be happy. The second photo is of an elderly lady shifting her water pan on her head to a younger family member. And a little girl looks up with a look of curiosity: Will I be doing this when I grow up? We seek so much materialistic happiness. But when you look at the curiosity, smiles, and happiness [in these photos], you realize we could have a lot of happiness in minimalism, as well.
Q: After you finished your residency in Ahmedabad, how did you get started in oncology?
A: In 1986, Ahmedabad City and Gujarat State did not have structured training programs in oncology, so I went to Bombay [Mumbai], where Dr. B.C. Mehta, a true legend and pioneer in India, had started hematology-oncology training. I was a post-doc research fellow with him for a little over a year but when I started seeing patients, I had to answer to myself, Am I doing everything I can to help these people? I saw that the U.K. had one of the best training programs in hem malignancy, so I started applying. Then something happened that was almost like a miracle.
In April 1992, Dr. Patel was working at the Institute of Kidney Diseases in Ahmedabad. One afternoon, just as the clinic was closing for siesta, a family brought in a young girl. She had drug-induced thrombocytopenia and needed an immediate transfusion. The father offered to sell his wedding ring to pay Dr. Patel if he would supervise the treatment and stay by the girl’s side. Dr. Patel told the man to keep his ring, then he remained in the office with the child. At 4 p.m., the office phone rang. It was Dr. H.K. Parikh, an eminent British physician who was wintering in India and needed to make a medical appointment for his wife. On a normal day, Dr. Patel would have missed the call.
“This is how I got to meet Dr. Parikh, out of the blue,” said Dr. Patel. “His wife came to the office for 6 weeks and after 6 weeks, he said, You’re a smart guy; you should come to England. That was in April. I sent a resume and all the usual paperwork. On July 16, 1992, at 2 in the morning, I got a call from the U.K. saying, Your job is confirmed. I’m going to fax your appointment through the Royal College of Physicians, and you’re coming to Manchester to work with us. I’d been sponsored by the Overseas Doctors Training Program.
“So, it turns out that if I’d declined to see that patient and declined to stay in my clinic that afternoon, if I’d declined to see this doctor’s wife, I would never have been in the U.K. And that opened up the doors for me. I like that story because I’ve found that standing up for people who do not have a voice, who do not have hope, always leads to what is destined for me.”
Q: After working as a registrar in the United Kingdom 4 years, you found yourself in the United States and, once again, had to train as an internist. What was new about U.S. oncology?
A: I took 3 years to get recertified in Jamaica Hospital in Queens, then became a fellow in hematology-oncology at the Thomas Jefferson in Philadelphia. My U.K. training was all based on hematological malignancy. In the United States, I shifted into solid tumors.
Q: You have a long history of advocating for affordable oncology at the community, state, and federal level, and you recently launched a disparities initiative in your center called NOLA (No One Left Alone). What was the trigger for NOLA?
A: In the spring of 2020, when we started seeing the COVID surge and the difference in mortality rate between the multiple races, at the same time I saw the AACR [American Association for Cancer Research] 2020 disparity report showing that 34% of cancer deaths are preventable – one in three – if we took care of disparities. The same year, the Community Oncology Alliance asked me to become the president. So, I felt that there is something herding me, leading me, to this position. Eighty percent of cancer patients are treated in community clinics like ours. It put the onus on me to do something.
I learned from Gandhi that I cannot depend on government, I cannot depend on the policy, I have to act myself.
I said, I would not worry about making money, I would rather lose funding on this. So, we started. I read 400+ papers; I spent over 1,000 hours reading about disparities. And I realized that it’s not complicated. There are five pillars to eliminate disparity: access to care for financial reasons, access to biomarker testing or precision medicine, access to social determinants of health, access to cancer screening, and trials. If we focus on these five, we can at least bring that number from 34% to 20%, if not lower.
So, we put that plan in place. I dedicated three employees whose only role is to ensure that not a single patient has to take financial burden from my practice. And we showed it’s doable.
This has now become my mission for the last quarter of my life.
In 2020, Dr. Patel published a book on dying well titled “Between Life and Death.” It’s framed as a series of his conversations with a former patient, Harry Falls. Harry wanted to understand death better, so Dr. Patel narrated five patient stories, drawing the threads together to help Harry face the inevitable. Dr. Patel now uses a similar approach to train clinicians on having meaningful end-of-life conversations with patients.
Q: Why did you feel the need to write a book about dying?
A: The more I’ve witnessed, the more I’m convinced that there are things that we don’t know about this process, which needs to be explored much more. However, I do feel that there’s a power within all of us to steer the process of leaving this world.
Before I sat down with Harry, I loved to counsel patients, but I didn’t have any structural ideas. It was Harry himself who told me that I now had a simple way to explain dying to a much larger audience.
Q: What is your secret for fitting everything into your life?
A: I’ll tell you, it’s very simple. If I put my soul, heart, mind, actions, and language on the one plane and don’t let my brain and conditioning influence my choices, then I live in the moment. Whenever I let my conditioned mind take all the decisions, those are crooked, because you know, we’re selfish creatures – we can use what we call the convenient lie to hide inconvenient truth. And I try not to do that. I mean, it’s been a journey. It didn’t come overnight. I learned. And I feel that over all these years, the only thing that rewarded me, that opened the door of where I am today, was pure, selfless process, whether it’s the act of talking, speaking, or doing.
Limiting antibiotic overprescription in pandemics: New guidelines
A statement by the Society for Healthcare Epidemiology of America, published online in Infection Control & Hospital Epidemiology, offers health care providers guidelines on how to prevent inappropriate antibiotic use in future pandemics and to avoid some of the negative scenarios that have been seen with COVID-19.
According to the U.S. Centers of Disease Control and Prevention,
The culprit might be the widespread antibiotic overprescription during the current pandemic. A 2022 meta-analysis revealed that in high-income countries, 58% of patients with COVID-19 were given antibiotics, whereas in lower- and middle-income countries, 89% of patients were put on such drugs. Some hospitals in Europe and the United States reported similarly elevated numbers, sometimes approaching 100%.
“We’ve lost control,” Natasha Pettit, PharmD, pharmacy director at University of Chicago Medicine, told this news organization. Dr. Pettit was not involved in the SHEA study. “Even if CDC didn’t come out with that data, I can tell you right now more of my time is spent trying to figure out how to manage these multi-drug–resistant infections, and we are running out of options for these patients,”
“Dealing with uncertainty, exhaustion, [and] critical illness in often young, otherwise healthy patients meant doctors wanted to do something for their patients,” said Tamar Barlam, MD, an infectious diseases expert at the Boston Medical Center who led the development of the SHEA white paper, in an interview.
That something often was a prescription for antibiotics, even without a clear indication that they were actually needed. A British study revealed that in times of pandemic uncertainty, clinicians often reached for antibiotics “just in case” and referred to conservative prescribing as “bravery.”
Studies have shown, however, that bacterial co-infections in COVID-19 are rare. A 2020 meta-analysis of 24 studies concluded that only 3.5% of patients had a bacterial co-infection on presentation, and 14.3% had a secondary infection. Similar patterns had previously been observed in other viral outbreaks. Research on MERS-CoV, for example, documented only 1% of patients with a bacterial co-infection on admission. During the 2009 H1N1 influenza pandemic, that number was 12% of non–ICU hospitalized patients.
Yet, according to Dr. Pettit, even when such data became available, it didn’t necessarily change prescribing patterns. “Information was coming at us so quickly, I think the providers didn’t have a moment to see the data, to understand what it meant for their prescribing. Having external guidance earlier on would have been hugely helpful,” she told this news organization.
That’s where the newly published SHEA statement comes in: It outlines recommendations on when to prescribe antibiotics during a respiratory viral pandemic, what tests to order, and when to de-escalate or discontinue the treatment. These recommendations include, for instance, advice to not trust inflammatory markers as reliable indicators of bacterial or fungal infection and to not use procalcitonin routinely to aid in the decision to initiate antibiotics.
According to Dr. Barlam, one of the crucial lessons here is that if clinicians see patients with symptoms that are consistent with the current pandemic, they should trust their own impressions and avoid reaching for antimicrobials “just in case.”
Another important lesson is that antibiotic stewardship programs have a huge role to play during pandemics. They should not only monitor prescribing but also compile new information on bacterial co-infections as it gets released and make sure it reaches the clinicians in a clear form.
Evidence suggests that such programs and guidelines do work to limit unnecessary antibiotic use. In one medical center in Chicago, for example, before recommendations on when to initiate and discontinue antimicrobials were released, over 74% of COVID-19 patients received antibiotics. After guidelines were put in place, the use of such drugs fell to 42%.
Dr. Pettit believes, however, that it’s important not to leave each medical center to its own devices. “Hindsight is always twenty-twenty,” she said, “but I think it would be great that, if we start hearing about a pathogen that might lead to another pandemic, we should have a mechanism in place to call together an expert body to get guidance for how antimicrobial stewardship programs should get involved.”
One of the authors of the SHEA statement, Susan Seo, reports an investigator-initiated Merck grant on cost-effectiveness of letermovir in hematopoietic stem cell transplant patients. Another author, Graeme Forrest, reports a clinical study grant from Regeneron for inpatient monoclonals against SARS-CoV-2. All other authors report no conflicts of interest. The study was independently supported.
A version of this article first appeared on Medscape.com.
A statement by the Society for Healthcare Epidemiology of America, published online in Infection Control & Hospital Epidemiology, offers health care providers guidelines on how to prevent inappropriate antibiotic use in future pandemics and to avoid some of the negative scenarios that have been seen with COVID-19.
According to the U.S. Centers of Disease Control and Prevention,
The culprit might be the widespread antibiotic overprescription during the current pandemic. A 2022 meta-analysis revealed that in high-income countries, 58% of patients with COVID-19 were given antibiotics, whereas in lower- and middle-income countries, 89% of patients were put on such drugs. Some hospitals in Europe and the United States reported similarly elevated numbers, sometimes approaching 100%.
“We’ve lost control,” Natasha Pettit, PharmD, pharmacy director at University of Chicago Medicine, told this news organization. Dr. Pettit was not involved in the SHEA study. “Even if CDC didn’t come out with that data, I can tell you right now more of my time is spent trying to figure out how to manage these multi-drug–resistant infections, and we are running out of options for these patients,”
“Dealing with uncertainty, exhaustion, [and] critical illness in often young, otherwise healthy patients meant doctors wanted to do something for their patients,” said Tamar Barlam, MD, an infectious diseases expert at the Boston Medical Center who led the development of the SHEA white paper, in an interview.
That something often was a prescription for antibiotics, even without a clear indication that they were actually needed. A British study revealed that in times of pandemic uncertainty, clinicians often reached for antibiotics “just in case” and referred to conservative prescribing as “bravery.”
Studies have shown, however, that bacterial co-infections in COVID-19 are rare. A 2020 meta-analysis of 24 studies concluded that only 3.5% of patients had a bacterial co-infection on presentation, and 14.3% had a secondary infection. Similar patterns had previously been observed in other viral outbreaks. Research on MERS-CoV, for example, documented only 1% of patients with a bacterial co-infection on admission. During the 2009 H1N1 influenza pandemic, that number was 12% of non–ICU hospitalized patients.
Yet, according to Dr. Pettit, even when such data became available, it didn’t necessarily change prescribing patterns. “Information was coming at us so quickly, I think the providers didn’t have a moment to see the data, to understand what it meant for their prescribing. Having external guidance earlier on would have been hugely helpful,” she told this news organization.
That’s where the newly published SHEA statement comes in: It outlines recommendations on when to prescribe antibiotics during a respiratory viral pandemic, what tests to order, and when to de-escalate or discontinue the treatment. These recommendations include, for instance, advice to not trust inflammatory markers as reliable indicators of bacterial or fungal infection and to not use procalcitonin routinely to aid in the decision to initiate antibiotics.
According to Dr. Barlam, one of the crucial lessons here is that if clinicians see patients with symptoms that are consistent with the current pandemic, they should trust their own impressions and avoid reaching for antimicrobials “just in case.”
Another important lesson is that antibiotic stewardship programs have a huge role to play during pandemics. They should not only monitor prescribing but also compile new information on bacterial co-infections as it gets released and make sure it reaches the clinicians in a clear form.
Evidence suggests that such programs and guidelines do work to limit unnecessary antibiotic use. In one medical center in Chicago, for example, before recommendations on when to initiate and discontinue antimicrobials were released, over 74% of COVID-19 patients received antibiotics. After guidelines were put in place, the use of such drugs fell to 42%.
Dr. Pettit believes, however, that it’s important not to leave each medical center to its own devices. “Hindsight is always twenty-twenty,” she said, “but I think it would be great that, if we start hearing about a pathogen that might lead to another pandemic, we should have a mechanism in place to call together an expert body to get guidance for how antimicrobial stewardship programs should get involved.”
One of the authors of the SHEA statement, Susan Seo, reports an investigator-initiated Merck grant on cost-effectiveness of letermovir in hematopoietic stem cell transplant patients. Another author, Graeme Forrest, reports a clinical study grant from Regeneron for inpatient monoclonals against SARS-CoV-2. All other authors report no conflicts of interest. The study was independently supported.
A version of this article first appeared on Medscape.com.
A statement by the Society for Healthcare Epidemiology of America, published online in Infection Control & Hospital Epidemiology, offers health care providers guidelines on how to prevent inappropriate antibiotic use in future pandemics and to avoid some of the negative scenarios that have been seen with COVID-19.
According to the U.S. Centers of Disease Control and Prevention,
The culprit might be the widespread antibiotic overprescription during the current pandemic. A 2022 meta-analysis revealed that in high-income countries, 58% of patients with COVID-19 were given antibiotics, whereas in lower- and middle-income countries, 89% of patients were put on such drugs. Some hospitals in Europe and the United States reported similarly elevated numbers, sometimes approaching 100%.
“We’ve lost control,” Natasha Pettit, PharmD, pharmacy director at University of Chicago Medicine, told this news organization. Dr. Pettit was not involved in the SHEA study. “Even if CDC didn’t come out with that data, I can tell you right now more of my time is spent trying to figure out how to manage these multi-drug–resistant infections, and we are running out of options for these patients,”
“Dealing with uncertainty, exhaustion, [and] critical illness in often young, otherwise healthy patients meant doctors wanted to do something for their patients,” said Tamar Barlam, MD, an infectious diseases expert at the Boston Medical Center who led the development of the SHEA white paper, in an interview.
That something often was a prescription for antibiotics, even without a clear indication that they were actually needed. A British study revealed that in times of pandemic uncertainty, clinicians often reached for antibiotics “just in case” and referred to conservative prescribing as “bravery.”
Studies have shown, however, that bacterial co-infections in COVID-19 are rare. A 2020 meta-analysis of 24 studies concluded that only 3.5% of patients had a bacterial co-infection on presentation, and 14.3% had a secondary infection. Similar patterns had previously been observed in other viral outbreaks. Research on MERS-CoV, for example, documented only 1% of patients with a bacterial co-infection on admission. During the 2009 H1N1 influenza pandemic, that number was 12% of non–ICU hospitalized patients.
Yet, according to Dr. Pettit, even when such data became available, it didn’t necessarily change prescribing patterns. “Information was coming at us so quickly, I think the providers didn’t have a moment to see the data, to understand what it meant for their prescribing. Having external guidance earlier on would have been hugely helpful,” she told this news organization.
That’s where the newly published SHEA statement comes in: It outlines recommendations on when to prescribe antibiotics during a respiratory viral pandemic, what tests to order, and when to de-escalate or discontinue the treatment. These recommendations include, for instance, advice to not trust inflammatory markers as reliable indicators of bacterial or fungal infection and to not use procalcitonin routinely to aid in the decision to initiate antibiotics.
According to Dr. Barlam, one of the crucial lessons here is that if clinicians see patients with symptoms that are consistent with the current pandemic, they should trust their own impressions and avoid reaching for antimicrobials “just in case.”
Another important lesson is that antibiotic stewardship programs have a huge role to play during pandemics. They should not only monitor prescribing but also compile new information on bacterial co-infections as it gets released and make sure it reaches the clinicians in a clear form.
Evidence suggests that such programs and guidelines do work to limit unnecessary antibiotic use. In one medical center in Chicago, for example, before recommendations on when to initiate and discontinue antimicrobials were released, over 74% of COVID-19 patients received antibiotics. After guidelines were put in place, the use of such drugs fell to 42%.
Dr. Pettit believes, however, that it’s important not to leave each medical center to its own devices. “Hindsight is always twenty-twenty,” she said, “but I think it would be great that, if we start hearing about a pathogen that might lead to another pandemic, we should have a mechanism in place to call together an expert body to get guidance for how antimicrobial stewardship programs should get involved.”
One of the authors of the SHEA statement, Susan Seo, reports an investigator-initiated Merck grant on cost-effectiveness of letermovir in hematopoietic stem cell transplant patients. Another author, Graeme Forrest, reports a clinical study grant from Regeneron for inpatient monoclonals against SARS-CoV-2. All other authors report no conflicts of interest. The study was independently supported.
A version of this article first appeared on Medscape.com.
FROM INFECTION CONTROL & HOSPITAL EPIDEMIOLOGY
Pandemic-related CRC screening delays affect older adults most
A 1- or 2-year delay in recommended colorectal cancer (CRC) screenings had little effect on most people’s risk of illness or death from cancer, provided they eventually got screened, according to a modeling study of the impact of pandemic-related screening delays.
Most patients whose screening was delayed still benefited through a reduction in risk of cancer or death, but that benefit was lower than it would have been had they been screened on time, particularly for 65-year-olds who hadn’t ever been screened for CRC.
Extending the upper ages for undergoing screening or substituting fecal immunochemical testing (FIT) for colonoscopies blunted some of this negative effect for 50-year-olds who had never been screened and for previously screened 60-year-olds, but those mitigation strategies weren’t as helpful for never-screened 65-year-olds, report Soham Sinha, MS, of Weill Cornell Medicine, and his colleagues.
Because older patients lose the most benefit from delayed CRC screenings, Mr. Sinha and his colleagues suggest, they should be prioritized when access is reduced.
The findings were published online in Gastroenterology.
Modeling the impact of missed screenings
CRC screenings dropped by as much as 82% at the start of the pandemic, Mr. Sinha and his co-authors note, and screening rates haven’t yet recovered as new COVID variants arise.
The researchers therefore sought to evaluate the potential clinical impact of screenings that were missed because of the pandemic on three groups of people who were at average risk of CRC: people who were 50 years old and had never been screened, people who were 65 and had never been screened, and people who had been screened by age 50 but were due for a colonoscopy screening at age 60.
They modeled the incidence and mortality of colorectal cancer for a 1-year and a 2-year delay in screening, compared with on-time screening with a colonoscopy or an annual FIT through age 75, or colonoscopy surveillance through age 80.
Among never-screened 50-year-olds, waiting a year or two to start colonoscopy screening resulted in a 69% reduction in colorectal cancer incidence instead of the 70% reduction that would have occurred with on-time screening. Similarly, the reduction in risk of death from delayed screening was 75% instead of 76% with on-time screening.
A 1- or 2-year delay in starting FIT screening in this group led to a reduction in the benefit of lower risk by one percentage point: Patients had a 57% lower risk of cancer from a 1-year screening delay and a 56% reduction in risk from a 2-year delay, compared with a 58% reduction in risk without any delays. In terms of mortality, benefit fell by one absolute percentage point for each year of delay.
Restoring the benefits of screening
The most effective way to mitigate each of those lost percentage points from colonoscopy delays was to combine two rescue strategies: using FIT screening instead of colonoscopy when colonoscopy access was reduced and extending the upper ages of colonoscopy screening to age 76-77 and colonoscopy surveillance to age 81-82.
Solely extending the ages for undergoing screening and surveillance was more effective than solely substituting FIT screening for colonoscopies. To offset the impact of an FIT delay, extending the upper age of the screening or surveillance period was effective.
The negative effect of delayed colonoscopy screenings was greater for never-screened 65-year-olds, whose reduction in risk of developing CRC fell to 53%-54%, rather than the 66% reduction in risk they would have had with on-time screening. The reduction in risk of mortality from CRC was 60% instead of 74% if screenings were delayed instead of occurring on time.
“Starting at age 65 afforded individuals two lifetime colonoscopies, as opposed to one at age 66 or later, given that colorectal screening ended at age 75,” the authors write. “Rescue strategies decreased but did not negate the impact of pandemic-related colorectal screening delays.”
For never-screened 65-year-olds who experienced delays in FIT, undergoing screening 1 year late equated to a 41% reduction in cancer risk, and undergoing screening 2 years late resulted in a 38% reduction, compared with a 44% reduction with on-time FIT screening. The reduction in mortality fell from 60% with on-time screening to 57% with a 1-year delay and 54% with a 2-year delay. Though extending the upper age limited reduced this negative effect, it did not eliminate it.
The researchers found that delaying screening by 1 or 2 years among 60-year-olds who had had a colonoscopy at age 50 only modestly reduced the benefit of reduced risk of CRC or death.
“Rescue strategies mitigated or negated impact from colorectal screening delays and included FIT-based screening when colonoscopy was unavailable, with or without extended screening through ages 75 or 76,” the authors report.
One limitation of the study was its lack of cost-effectiveness calculations, which made it impossible to evaluate the economic implications of either the delays in screening or the proposed mitigation strategies.
“Our work suggests that among the 20% of the U.S. population aged 50-75 who are unscreened for colorectal cancer, older adults would experience the most clinical benefit from colorectal cancer screening if resources were limited during the COVID-19 pandemic,” the authors write.
Younger people who hadn’t yet been screened and those who had been screened at least once with a colonoscopy would not experience as dramatic a reduction in benefit once they underwent screening, they conclude.
One author was supported by the National Cancer Institute. One author has advised Universal Dx and Lean Medical and has consulted for Clinical Genomics, Medtronic, Guardant Health, and Freenome. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
A 1- or 2-year delay in recommended colorectal cancer (CRC) screenings had little effect on most people’s risk of illness or death from cancer, provided they eventually got screened, according to a modeling study of the impact of pandemic-related screening delays.
Most patients whose screening was delayed still benefited through a reduction in risk of cancer or death, but that benefit was lower than it would have been had they been screened on time, particularly for 65-year-olds who hadn’t ever been screened for CRC.
Extending the upper ages for undergoing screening or substituting fecal immunochemical testing (FIT) for colonoscopies blunted some of this negative effect for 50-year-olds who had never been screened and for previously screened 60-year-olds, but those mitigation strategies weren’t as helpful for never-screened 65-year-olds, report Soham Sinha, MS, of Weill Cornell Medicine, and his colleagues.
Because older patients lose the most benefit from delayed CRC screenings, Mr. Sinha and his colleagues suggest, they should be prioritized when access is reduced.
The findings were published online in Gastroenterology.
Modeling the impact of missed screenings
CRC screenings dropped by as much as 82% at the start of the pandemic, Mr. Sinha and his co-authors note, and screening rates haven’t yet recovered as new COVID variants arise.
The researchers therefore sought to evaluate the potential clinical impact of screenings that were missed because of the pandemic on three groups of people who were at average risk of CRC: people who were 50 years old and had never been screened, people who were 65 and had never been screened, and people who had been screened by age 50 but were due for a colonoscopy screening at age 60.
They modeled the incidence and mortality of colorectal cancer for a 1-year and a 2-year delay in screening, compared with on-time screening with a colonoscopy or an annual FIT through age 75, or colonoscopy surveillance through age 80.
Among never-screened 50-year-olds, waiting a year or two to start colonoscopy screening resulted in a 69% reduction in colorectal cancer incidence instead of the 70% reduction that would have occurred with on-time screening. Similarly, the reduction in risk of death from delayed screening was 75% instead of 76% with on-time screening.
A 1- or 2-year delay in starting FIT screening in this group led to a reduction in the benefit of lower risk by one percentage point: Patients had a 57% lower risk of cancer from a 1-year screening delay and a 56% reduction in risk from a 2-year delay, compared with a 58% reduction in risk without any delays. In terms of mortality, benefit fell by one absolute percentage point for each year of delay.
Restoring the benefits of screening
The most effective way to mitigate each of those lost percentage points from colonoscopy delays was to combine two rescue strategies: using FIT screening instead of colonoscopy when colonoscopy access was reduced and extending the upper ages of colonoscopy screening to age 76-77 and colonoscopy surveillance to age 81-82.
Solely extending the ages for undergoing screening and surveillance was more effective than solely substituting FIT screening for colonoscopies. To offset the impact of an FIT delay, extending the upper age of the screening or surveillance period was effective.
The negative effect of delayed colonoscopy screenings was greater for never-screened 65-year-olds, whose reduction in risk of developing CRC fell to 53%-54%, rather than the 66% reduction in risk they would have had with on-time screening. The reduction in risk of mortality from CRC was 60% instead of 74% if screenings were delayed instead of occurring on time.
“Starting at age 65 afforded individuals two lifetime colonoscopies, as opposed to one at age 66 or later, given that colorectal screening ended at age 75,” the authors write. “Rescue strategies decreased but did not negate the impact of pandemic-related colorectal screening delays.”
For never-screened 65-year-olds who experienced delays in FIT, undergoing screening 1 year late equated to a 41% reduction in cancer risk, and undergoing screening 2 years late resulted in a 38% reduction, compared with a 44% reduction with on-time FIT screening. The reduction in mortality fell from 60% with on-time screening to 57% with a 1-year delay and 54% with a 2-year delay. Though extending the upper age limited reduced this negative effect, it did not eliminate it.
The researchers found that delaying screening by 1 or 2 years among 60-year-olds who had had a colonoscopy at age 50 only modestly reduced the benefit of reduced risk of CRC or death.
“Rescue strategies mitigated or negated impact from colorectal screening delays and included FIT-based screening when colonoscopy was unavailable, with or without extended screening through ages 75 or 76,” the authors report.
One limitation of the study was its lack of cost-effectiveness calculations, which made it impossible to evaluate the economic implications of either the delays in screening or the proposed mitigation strategies.
“Our work suggests that among the 20% of the U.S. population aged 50-75 who are unscreened for colorectal cancer, older adults would experience the most clinical benefit from colorectal cancer screening if resources were limited during the COVID-19 pandemic,” the authors write.
Younger people who hadn’t yet been screened and those who had been screened at least once with a colonoscopy would not experience as dramatic a reduction in benefit once they underwent screening, they conclude.
One author was supported by the National Cancer Institute. One author has advised Universal Dx and Lean Medical and has consulted for Clinical Genomics, Medtronic, Guardant Health, and Freenome. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
A 1- or 2-year delay in recommended colorectal cancer (CRC) screenings had little effect on most people’s risk of illness or death from cancer, provided they eventually got screened, according to a modeling study of the impact of pandemic-related screening delays.
Most patients whose screening was delayed still benefited through a reduction in risk of cancer or death, but that benefit was lower than it would have been had they been screened on time, particularly for 65-year-olds who hadn’t ever been screened for CRC.
Extending the upper ages for undergoing screening or substituting fecal immunochemical testing (FIT) for colonoscopies blunted some of this negative effect for 50-year-olds who had never been screened and for previously screened 60-year-olds, but those mitigation strategies weren’t as helpful for never-screened 65-year-olds, report Soham Sinha, MS, of Weill Cornell Medicine, and his colleagues.
Because older patients lose the most benefit from delayed CRC screenings, Mr. Sinha and his colleagues suggest, they should be prioritized when access is reduced.
The findings were published online in Gastroenterology.
Modeling the impact of missed screenings
CRC screenings dropped by as much as 82% at the start of the pandemic, Mr. Sinha and his co-authors note, and screening rates haven’t yet recovered as new COVID variants arise.
The researchers therefore sought to evaluate the potential clinical impact of screenings that were missed because of the pandemic on three groups of people who were at average risk of CRC: people who were 50 years old and had never been screened, people who were 65 and had never been screened, and people who had been screened by age 50 but were due for a colonoscopy screening at age 60.
They modeled the incidence and mortality of colorectal cancer for a 1-year and a 2-year delay in screening, compared with on-time screening with a colonoscopy or an annual FIT through age 75, or colonoscopy surveillance through age 80.
Among never-screened 50-year-olds, waiting a year or two to start colonoscopy screening resulted in a 69% reduction in colorectal cancer incidence instead of the 70% reduction that would have occurred with on-time screening. Similarly, the reduction in risk of death from delayed screening was 75% instead of 76% with on-time screening.
A 1- or 2-year delay in starting FIT screening in this group led to a reduction in the benefit of lower risk by one percentage point: Patients had a 57% lower risk of cancer from a 1-year screening delay and a 56% reduction in risk from a 2-year delay, compared with a 58% reduction in risk without any delays. In terms of mortality, benefit fell by one absolute percentage point for each year of delay.
Restoring the benefits of screening
The most effective way to mitigate each of those lost percentage points from colonoscopy delays was to combine two rescue strategies: using FIT screening instead of colonoscopy when colonoscopy access was reduced and extending the upper ages of colonoscopy screening to age 76-77 and colonoscopy surveillance to age 81-82.
Solely extending the ages for undergoing screening and surveillance was more effective than solely substituting FIT screening for colonoscopies. To offset the impact of an FIT delay, extending the upper age of the screening or surveillance period was effective.
The negative effect of delayed colonoscopy screenings was greater for never-screened 65-year-olds, whose reduction in risk of developing CRC fell to 53%-54%, rather than the 66% reduction in risk they would have had with on-time screening. The reduction in risk of mortality from CRC was 60% instead of 74% if screenings were delayed instead of occurring on time.
“Starting at age 65 afforded individuals two lifetime colonoscopies, as opposed to one at age 66 or later, given that colorectal screening ended at age 75,” the authors write. “Rescue strategies decreased but did not negate the impact of pandemic-related colorectal screening delays.”
For never-screened 65-year-olds who experienced delays in FIT, undergoing screening 1 year late equated to a 41% reduction in cancer risk, and undergoing screening 2 years late resulted in a 38% reduction, compared with a 44% reduction with on-time FIT screening. The reduction in mortality fell from 60% with on-time screening to 57% with a 1-year delay and 54% with a 2-year delay. Though extending the upper age limited reduced this negative effect, it did not eliminate it.
The researchers found that delaying screening by 1 or 2 years among 60-year-olds who had had a colonoscopy at age 50 only modestly reduced the benefit of reduced risk of CRC or death.
“Rescue strategies mitigated or negated impact from colorectal screening delays and included FIT-based screening when colonoscopy was unavailable, with or without extended screening through ages 75 or 76,” the authors report.
One limitation of the study was its lack of cost-effectiveness calculations, which made it impossible to evaluate the economic implications of either the delays in screening or the proposed mitigation strategies.
“Our work suggests that among the 20% of the U.S. population aged 50-75 who are unscreened for colorectal cancer, older adults would experience the most clinical benefit from colorectal cancer screening if resources were limited during the COVID-19 pandemic,” the authors write.
Younger people who hadn’t yet been screened and those who had been screened at least once with a colonoscopy would not experience as dramatic a reduction in benefit once they underwent screening, they conclude.
One author was supported by the National Cancer Institute. One author has advised Universal Dx and Lean Medical and has consulted for Clinical Genomics, Medtronic, Guardant Health, and Freenome. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.