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Gastric cancer prevalent in hereditary breast cancer patients
a prospective cohort study has shown.
“In short, what we are putting forward with these data is that pathogenic/likely pathogenic (P/LP) variants in the CDH1 gene confer a very high risk, at the very least, of occult early-stage gastric cancer in patients with HLBC,” said Jeremy Davis, MD, of the surgical oncology program, Center for Cancer Research at the National Cancer Institute.
“So patients that are referred to as ‘HLBC’ due to a CDH1 variant should at least undergo annual endoscopic surveillance but the real questions is whether or not they should also consider prophylactic total gastrectomy – as many patients in our study did,” he said.
The study, which was published online Oct. 13, 2021, in JAMA Surgery, included a cohort of 151 families totaling 283 patients with a CDH1 pathogenic or likely pathogenic (P/LP) variant. Analyses were conducted on three patient groups, which included those with HLBC and a family history of breast cancer but no gastric cancer, those with hereditary diffuse gastric cancer (HDGC) but no history of breast cancer, and those with a family history of both gastric and breast cancer in the mixed group. Of these, 15.5% had a history of HLBC, 16.2% had a history of HDGC, and 52.6% made up the mixed group.
“We examined the HLBC group with specific attention to CDH1 genotype and prevalence of occult gastric cancer,” the authors explained. The group consisted of 31 families with 19 CDH1 variants, 10 of which were also present in the HDGC and mixed groups.
Among this group of patients, almost 73% underwent one or more surveillance endoscopies and on endoscopy, occult signet ring cell carcinoma was detected in over one-third of patients.
The median age at the time of endoscopic carcinoma detection was only 33 years.
“Nearly all of the patients with HLBC (93.8%) ... who elected for risk-reducing total gastrectomy owing to their underlying CDH1 P/LP variant harbored occult signet ring cell gastric adenocarcinoma on final pathology,” investigators observed.
The median age at the time patients elected to undergo total gastrectomy was 50 years.
The prevalence of occult gastric cancer among asymptomatic patients in the HDGC group was similarly high, affecting almost 95% of this group of patients.
Some 18 out of 19 CDH1 P/LP variants were responsible for this high prevalence of occult gastric cancer, as the investigators pointed out.
“Hereditary cancer risk is informed by the presence of a germline gene variant more so than by family history of cancer,” the authors stressed. “[And we found that] germline CDH1 P/LP variants appear to have a highly penetrant gastric phenotype irrespective of family history.”
Given this finding, the authors stressed that it is “paramount” patients previously assigned a diagnosis of HLBC not be excluded from undergoing gastric cancer risk assessment and counseling.
Furthermore, “the mere presence of a germline CDH1 P/LP variant, regardless of family history, may be reason enough to consider prophylactic total gastrectomy,” the authors wrote.
Limitations of the study included the fact that the disease phenotype was established from family pedigrees which has the potential for recall bias by family members.
The study was supported in part by the Intramural Research Program of the National Cancer Institute. None of the authors had conflicts of interest to disclose.
a prospective cohort study has shown.
“In short, what we are putting forward with these data is that pathogenic/likely pathogenic (P/LP) variants in the CDH1 gene confer a very high risk, at the very least, of occult early-stage gastric cancer in patients with HLBC,” said Jeremy Davis, MD, of the surgical oncology program, Center for Cancer Research at the National Cancer Institute.
“So patients that are referred to as ‘HLBC’ due to a CDH1 variant should at least undergo annual endoscopic surveillance but the real questions is whether or not they should also consider prophylactic total gastrectomy – as many patients in our study did,” he said.
The study, which was published online Oct. 13, 2021, in JAMA Surgery, included a cohort of 151 families totaling 283 patients with a CDH1 pathogenic or likely pathogenic (P/LP) variant. Analyses were conducted on three patient groups, which included those with HLBC and a family history of breast cancer but no gastric cancer, those with hereditary diffuse gastric cancer (HDGC) but no history of breast cancer, and those with a family history of both gastric and breast cancer in the mixed group. Of these, 15.5% had a history of HLBC, 16.2% had a history of HDGC, and 52.6% made up the mixed group.
“We examined the HLBC group with specific attention to CDH1 genotype and prevalence of occult gastric cancer,” the authors explained. The group consisted of 31 families with 19 CDH1 variants, 10 of which were also present in the HDGC and mixed groups.
Among this group of patients, almost 73% underwent one or more surveillance endoscopies and on endoscopy, occult signet ring cell carcinoma was detected in over one-third of patients.
The median age at the time of endoscopic carcinoma detection was only 33 years.
“Nearly all of the patients with HLBC (93.8%) ... who elected for risk-reducing total gastrectomy owing to their underlying CDH1 P/LP variant harbored occult signet ring cell gastric adenocarcinoma on final pathology,” investigators observed.
The median age at the time patients elected to undergo total gastrectomy was 50 years.
The prevalence of occult gastric cancer among asymptomatic patients in the HDGC group was similarly high, affecting almost 95% of this group of patients.
Some 18 out of 19 CDH1 P/LP variants were responsible for this high prevalence of occult gastric cancer, as the investigators pointed out.
“Hereditary cancer risk is informed by the presence of a germline gene variant more so than by family history of cancer,” the authors stressed. “[And we found that] germline CDH1 P/LP variants appear to have a highly penetrant gastric phenotype irrespective of family history.”
Given this finding, the authors stressed that it is “paramount” patients previously assigned a diagnosis of HLBC not be excluded from undergoing gastric cancer risk assessment and counseling.
Furthermore, “the mere presence of a germline CDH1 P/LP variant, regardless of family history, may be reason enough to consider prophylactic total gastrectomy,” the authors wrote.
Limitations of the study included the fact that the disease phenotype was established from family pedigrees which has the potential for recall bias by family members.
The study was supported in part by the Intramural Research Program of the National Cancer Institute. None of the authors had conflicts of interest to disclose.
a prospective cohort study has shown.
“In short, what we are putting forward with these data is that pathogenic/likely pathogenic (P/LP) variants in the CDH1 gene confer a very high risk, at the very least, of occult early-stage gastric cancer in patients with HLBC,” said Jeremy Davis, MD, of the surgical oncology program, Center for Cancer Research at the National Cancer Institute.
“So patients that are referred to as ‘HLBC’ due to a CDH1 variant should at least undergo annual endoscopic surveillance but the real questions is whether or not they should also consider prophylactic total gastrectomy – as many patients in our study did,” he said.
The study, which was published online Oct. 13, 2021, in JAMA Surgery, included a cohort of 151 families totaling 283 patients with a CDH1 pathogenic or likely pathogenic (P/LP) variant. Analyses were conducted on three patient groups, which included those with HLBC and a family history of breast cancer but no gastric cancer, those with hereditary diffuse gastric cancer (HDGC) but no history of breast cancer, and those with a family history of both gastric and breast cancer in the mixed group. Of these, 15.5% had a history of HLBC, 16.2% had a history of HDGC, and 52.6% made up the mixed group.
“We examined the HLBC group with specific attention to CDH1 genotype and prevalence of occult gastric cancer,” the authors explained. The group consisted of 31 families with 19 CDH1 variants, 10 of which were also present in the HDGC and mixed groups.
Among this group of patients, almost 73% underwent one or more surveillance endoscopies and on endoscopy, occult signet ring cell carcinoma was detected in over one-third of patients.
The median age at the time of endoscopic carcinoma detection was only 33 years.
“Nearly all of the patients with HLBC (93.8%) ... who elected for risk-reducing total gastrectomy owing to their underlying CDH1 P/LP variant harbored occult signet ring cell gastric adenocarcinoma on final pathology,” investigators observed.
The median age at the time patients elected to undergo total gastrectomy was 50 years.
The prevalence of occult gastric cancer among asymptomatic patients in the HDGC group was similarly high, affecting almost 95% of this group of patients.
Some 18 out of 19 CDH1 P/LP variants were responsible for this high prevalence of occult gastric cancer, as the investigators pointed out.
“Hereditary cancer risk is informed by the presence of a germline gene variant more so than by family history of cancer,” the authors stressed. “[And we found that] germline CDH1 P/LP variants appear to have a highly penetrant gastric phenotype irrespective of family history.”
Given this finding, the authors stressed that it is “paramount” patients previously assigned a diagnosis of HLBC not be excluded from undergoing gastric cancer risk assessment and counseling.
Furthermore, “the mere presence of a germline CDH1 P/LP variant, regardless of family history, may be reason enough to consider prophylactic total gastrectomy,” the authors wrote.
Limitations of the study included the fact that the disease phenotype was established from family pedigrees which has the potential for recall bias by family members.
The study was supported in part by the Intramural Research Program of the National Cancer Institute. None of the authors had conflicts of interest to disclose.
FROM JAMA SURGERY
Chemotherapy with FOLFOX superior to TACE in liver cancer
Hepatic arterial infusion chemotherapy (HAIC) with FOLFOX led to superior patient outcomes and less toxicity than standard of care transarterial chemoembolization (TACE) for patients with large, unresectable hepatocellular carcinoma (HCC), a randomized, phase 3 trial has shown.
In a group of 315 patients with unresectable tumors at least 7 cm in diameter and no macrovascular invasion or extrahepatic spread, overall survival (OS) was 42% longer at 23.1 months for patients treated with FOLFOX-HAIC, compared with 16.1 months for TACE, at a hazard ratio of 0.58 (P < .001), Ming Shi, MD, Sun Yat-sen University, Guangzhou, China, and colleagues reported recently in the Journal of Clinical Oncology.
Similarly, median progression-free survival (PFS) was also longer for FOLFOX-HAIC patients at 9.6 months, compared with 5.4 months for TACE patients, as was median symptomatic PFS at 17.9 months, compared with 10.4 months, respectively (P < .001).
The frequency of grade 3-4 elevated liver ALT at 8% versus 19% (P = .005), elevated AST at 18% versus 28%, and hyperbilirubinemia at 1% versus 6% (P = .01) were all significantly higher in the TACE group than in the FOLFOX-HAIC group as was the overall incidence of serious adverse events at 30% versus 19%, respectively (P = .03).
The frequency of treatment delay and discontinuation of TACE because of adverse events were also higher than that in the FOLFOX-HAIC group.
“Transarterial chemoembolization (TACE) is the current standard of care for intermediate-stage hepatocellular carcinoma ... but the efficacy of TACE is largely dependent upon tumor size ... and for patients with particularly large tumors (>7 cm), the OS after TACE is only 11.2-13.2 months,” Dr. Shi and colleagues explained.
“Although the need for technical expertise may limit its generalizability, hepatic arterial infusion chemotherapy represents an appropriate frontline locoregional intervention in select patients with large unresectable hepatocellular carcinoma,” they observed.
TACE vs. HAIC
During TACE, a catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography, after which a microcatheter was selectively placed into the feeding arteries of the tumors.
“Chemolipiodolization was performed using 50 mg of epirubicin and 50 mg of lobaplatin mixed with lipiodol,” the investigators noted, and subsequent embolization was done with the injection of polyvinyl alcohol particles.
TACE was repeated every 6 weeks.
HAIC in turn was divided into 3-week cycles during which a microcatheter was advanced into the hepatic artery on day 1 of each treatment cycle and FOLFOX was infused via the hepatic artery. FOLFOX consisted of oxaliplatin, 130 mg/m2; leucovorin, 400 mg/m2; and fluorouracil, 400 mg/m2, all given on day 1.
Subgroup analyses showed that HAIC provided a clinical benefit for PFS in most subgroups except females; those with a Child-Pug score of 6, and those who were negative for HBV.
The main drawback to the FOLFOX-HAIC regimen appears to be abdominal pain which some patients experienced when oxaliplatin was injected but which subsequently resolved when the injection was stopped.
As the authors pointed out, the overall response rate at 46% among patients treated with FOLFOX-HAIC was more than twice that with TACE at 18%.
“One possible reason is that FOLFOX-HAIC can provide stable local high concentrations of the chemotherapy agents in the tumor for more than 24 hours,” they speculated, “whereas most chemotherapeutic agents delivered through TACE ... will be released into the systemic circulation within less than 1 hour.”
Recently, drugs such as atezolizumab (Tecentriq, Roche) plus bevacizumab (Avastin, Genentech) have been shown to lead to high response rates in intermediate-stage HCC, as shown by the IMbrave 150 study.
“Therefore, in some latest practice guidelines and expert consensus statements, a switch of first-line treatment modality from TACE to systemic treatment is proposed for these patients,” the researchers noted.
Limitations of the study include its open-label design and the fact that more patients in the FOLFOX-HAIC group underwent hepatic resection whereas more patients in the TACE group crossed over to the other treatment arm.
Dr. Shi declared no conflicts of interest.
Hepatic arterial infusion chemotherapy (HAIC) with FOLFOX led to superior patient outcomes and less toxicity than standard of care transarterial chemoembolization (TACE) for patients with large, unresectable hepatocellular carcinoma (HCC), a randomized, phase 3 trial has shown.
In a group of 315 patients with unresectable tumors at least 7 cm in diameter and no macrovascular invasion or extrahepatic spread, overall survival (OS) was 42% longer at 23.1 months for patients treated with FOLFOX-HAIC, compared with 16.1 months for TACE, at a hazard ratio of 0.58 (P < .001), Ming Shi, MD, Sun Yat-sen University, Guangzhou, China, and colleagues reported recently in the Journal of Clinical Oncology.
Similarly, median progression-free survival (PFS) was also longer for FOLFOX-HAIC patients at 9.6 months, compared with 5.4 months for TACE patients, as was median symptomatic PFS at 17.9 months, compared with 10.4 months, respectively (P < .001).
The frequency of grade 3-4 elevated liver ALT at 8% versus 19% (P = .005), elevated AST at 18% versus 28%, and hyperbilirubinemia at 1% versus 6% (P = .01) were all significantly higher in the TACE group than in the FOLFOX-HAIC group as was the overall incidence of serious adverse events at 30% versus 19%, respectively (P = .03).
The frequency of treatment delay and discontinuation of TACE because of adverse events were also higher than that in the FOLFOX-HAIC group.
“Transarterial chemoembolization (TACE) is the current standard of care for intermediate-stage hepatocellular carcinoma ... but the efficacy of TACE is largely dependent upon tumor size ... and for patients with particularly large tumors (>7 cm), the OS after TACE is only 11.2-13.2 months,” Dr. Shi and colleagues explained.
“Although the need for technical expertise may limit its generalizability, hepatic arterial infusion chemotherapy represents an appropriate frontline locoregional intervention in select patients with large unresectable hepatocellular carcinoma,” they observed.
TACE vs. HAIC
During TACE, a catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography, after which a microcatheter was selectively placed into the feeding arteries of the tumors.
“Chemolipiodolization was performed using 50 mg of epirubicin and 50 mg of lobaplatin mixed with lipiodol,” the investigators noted, and subsequent embolization was done with the injection of polyvinyl alcohol particles.
TACE was repeated every 6 weeks.
HAIC in turn was divided into 3-week cycles during which a microcatheter was advanced into the hepatic artery on day 1 of each treatment cycle and FOLFOX was infused via the hepatic artery. FOLFOX consisted of oxaliplatin, 130 mg/m2; leucovorin, 400 mg/m2; and fluorouracil, 400 mg/m2, all given on day 1.
Subgroup analyses showed that HAIC provided a clinical benefit for PFS in most subgroups except females; those with a Child-Pug score of 6, and those who were negative for HBV.
The main drawback to the FOLFOX-HAIC regimen appears to be abdominal pain which some patients experienced when oxaliplatin was injected but which subsequently resolved when the injection was stopped.
As the authors pointed out, the overall response rate at 46% among patients treated with FOLFOX-HAIC was more than twice that with TACE at 18%.
“One possible reason is that FOLFOX-HAIC can provide stable local high concentrations of the chemotherapy agents in the tumor for more than 24 hours,” they speculated, “whereas most chemotherapeutic agents delivered through TACE ... will be released into the systemic circulation within less than 1 hour.”
Recently, drugs such as atezolizumab (Tecentriq, Roche) plus bevacizumab (Avastin, Genentech) have been shown to lead to high response rates in intermediate-stage HCC, as shown by the IMbrave 150 study.
“Therefore, in some latest practice guidelines and expert consensus statements, a switch of first-line treatment modality from TACE to systemic treatment is proposed for these patients,” the researchers noted.
Limitations of the study include its open-label design and the fact that more patients in the FOLFOX-HAIC group underwent hepatic resection whereas more patients in the TACE group crossed over to the other treatment arm.
Dr. Shi declared no conflicts of interest.
Hepatic arterial infusion chemotherapy (HAIC) with FOLFOX led to superior patient outcomes and less toxicity than standard of care transarterial chemoembolization (TACE) for patients with large, unresectable hepatocellular carcinoma (HCC), a randomized, phase 3 trial has shown.
In a group of 315 patients with unresectable tumors at least 7 cm in diameter and no macrovascular invasion or extrahepatic spread, overall survival (OS) was 42% longer at 23.1 months for patients treated with FOLFOX-HAIC, compared with 16.1 months for TACE, at a hazard ratio of 0.58 (P < .001), Ming Shi, MD, Sun Yat-sen University, Guangzhou, China, and colleagues reported recently in the Journal of Clinical Oncology.
Similarly, median progression-free survival (PFS) was also longer for FOLFOX-HAIC patients at 9.6 months, compared with 5.4 months for TACE patients, as was median symptomatic PFS at 17.9 months, compared with 10.4 months, respectively (P < .001).
The frequency of grade 3-4 elevated liver ALT at 8% versus 19% (P = .005), elevated AST at 18% versus 28%, and hyperbilirubinemia at 1% versus 6% (P = .01) were all significantly higher in the TACE group than in the FOLFOX-HAIC group as was the overall incidence of serious adverse events at 30% versus 19%, respectively (P = .03).
The frequency of treatment delay and discontinuation of TACE because of adverse events were also higher than that in the FOLFOX-HAIC group.
“Transarterial chemoembolization (TACE) is the current standard of care for intermediate-stage hepatocellular carcinoma ... but the efficacy of TACE is largely dependent upon tumor size ... and for patients with particularly large tumors (>7 cm), the OS after TACE is only 11.2-13.2 months,” Dr. Shi and colleagues explained.
“Although the need for technical expertise may limit its generalizability, hepatic arterial infusion chemotherapy represents an appropriate frontline locoregional intervention in select patients with large unresectable hepatocellular carcinoma,” they observed.
TACE vs. HAIC
During TACE, a catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography, after which a microcatheter was selectively placed into the feeding arteries of the tumors.
“Chemolipiodolization was performed using 50 mg of epirubicin and 50 mg of lobaplatin mixed with lipiodol,” the investigators noted, and subsequent embolization was done with the injection of polyvinyl alcohol particles.
TACE was repeated every 6 weeks.
HAIC in turn was divided into 3-week cycles during which a microcatheter was advanced into the hepatic artery on day 1 of each treatment cycle and FOLFOX was infused via the hepatic artery. FOLFOX consisted of oxaliplatin, 130 mg/m2; leucovorin, 400 mg/m2; and fluorouracil, 400 mg/m2, all given on day 1.
Subgroup analyses showed that HAIC provided a clinical benefit for PFS in most subgroups except females; those with a Child-Pug score of 6, and those who were negative for HBV.
The main drawback to the FOLFOX-HAIC regimen appears to be abdominal pain which some patients experienced when oxaliplatin was injected but which subsequently resolved when the injection was stopped.
As the authors pointed out, the overall response rate at 46% among patients treated with FOLFOX-HAIC was more than twice that with TACE at 18%.
“One possible reason is that FOLFOX-HAIC can provide stable local high concentrations of the chemotherapy agents in the tumor for more than 24 hours,” they speculated, “whereas most chemotherapeutic agents delivered through TACE ... will be released into the systemic circulation within less than 1 hour.”
Recently, drugs such as atezolizumab (Tecentriq, Roche) plus bevacizumab (Avastin, Genentech) have been shown to lead to high response rates in intermediate-stage HCC, as shown by the IMbrave 150 study.
“Therefore, in some latest practice guidelines and expert consensus statements, a switch of first-line treatment modality from TACE to systemic treatment is proposed for these patients,” the researchers noted.
Limitations of the study include its open-label design and the fact that more patients in the FOLFOX-HAIC group underwent hepatic resection whereas more patients in the TACE group crossed over to the other treatment arm.
Dr. Shi declared no conflicts of interest.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Success in closing racial survival gap in lung and breast cancer
When barriers to completing radiation therapy were identified and addressed in a cohort of patients with early-stage lung and breast cancer, 5-year survival rates improved for all patients and closed the racial disparity gap, researchers reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).
The findings come from the ACCURE clinical trial. This is the first prospective study designed to erase gaps in cancer treatment completion and survival among Black and White patient populations, explained lead author Matthew A. Manning, MD, a radiation oncologist and chief of oncology at Cone Health in Greensboro, N.C.
“Thousands of studies have looked at racial disparities in health care, but until recently, very few studies have implemented interventions to eliminate those disparities,” he said.
“This study shows that the implementation of ‘systems-change’ can eliminate racial disparities in cancer survival while improving survival for all,” he added.
“These results add to a growing body of evidence that health care disparities in cancer outcomes are eliminated or minimized by providing supportive, timely, and guideline-directed care,” said Lannis Hall, MD, MPH, director of radiation oncology, Siteman Cancer Center, and associate professor of radiation oncology at Washington University School of Medicine, St. Louis, who was approached for comment
“This research supports that access to care and timely treatment completion is critical to eliminating health care disparities,” she told this news organization. The system-based intervention in this trial was designed to reduce treatment delays and provide a supportive matrix for patients confronting real-world difficulties like transportation issues, childcare complications, and work absence, she explained.
Eliminating racial disparities
Previous findings from the ACCURE trial showed that it eliminated Black-White disparities in treatment completion rates, which was the study’s primary endpoint (Cancer Med. 2019;8:1095-1102). “It also improved treatment for all patients,” said Dr. Manning. “The current study is a follow-up on the survival of eligible patients treated during the ACCURE enrollment as compared to historical data.”
ACCURE was a multi-institutional trial designed to test a community-created intervention to reduce racial disparities. The intervention involved multiple changes to the way patients were supported while receiving cancer treatment and had four components:
- an electronic health record with automatic alerts to flag missed appointments or unmet milestones in expected care
- a nurse navigator trained in race-specific barriers to help patients overcome obstacles to care when alerts are flagged
- a physician champion to engage health care teams with race-related feedback on treatment completion
- regular health equity education training sessions for staff
The cohort was comprised of 1,413 patients with lung and breast cancer (stage 0-II) who were diagnosed from 2013-2015, and survival was compared to historical cases – 2,016 patients who had been treated from 2007-2011.
The results showed a significant improvement in survival for both Black and White patients with breast and lung cancer over time, and the racial gap in survival was reduced.
The 5-year survival rate for breast cancer increased from 91% for White patients and 89% in Black patients in historical cases, to 94% for both during the study period.
For patients with lung cancer, the 5-year survival rate improved from 43% in White patients and 37% in Black patients to 56% and 54%, respectively.
A subgroup analysis showed that patients with lung cancer who underwent surgery had 5-year survival rates of 78.5% for White and 70.1% for Black patients, whereas for those who underwent stereotactic body radiation therapy (SBRT) the rates were 41.9% and 50% respectively.
“We’ve shown it’s possible to eliminate disparities in cancer treatment completion and that this change has the potential to close cancer survival gaps downstream,” said Dr. Manning. “But we think the application can be much broader.”
The ACCURE study was sponsored by the National Institutes of Health. Dr. Manning and Dr. Hall have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When barriers to completing radiation therapy were identified and addressed in a cohort of patients with early-stage lung and breast cancer, 5-year survival rates improved for all patients and closed the racial disparity gap, researchers reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).
The findings come from the ACCURE clinical trial. This is the first prospective study designed to erase gaps in cancer treatment completion and survival among Black and White patient populations, explained lead author Matthew A. Manning, MD, a radiation oncologist and chief of oncology at Cone Health in Greensboro, N.C.
“Thousands of studies have looked at racial disparities in health care, but until recently, very few studies have implemented interventions to eliminate those disparities,” he said.
“This study shows that the implementation of ‘systems-change’ can eliminate racial disparities in cancer survival while improving survival for all,” he added.
“These results add to a growing body of evidence that health care disparities in cancer outcomes are eliminated or minimized by providing supportive, timely, and guideline-directed care,” said Lannis Hall, MD, MPH, director of radiation oncology, Siteman Cancer Center, and associate professor of radiation oncology at Washington University School of Medicine, St. Louis, who was approached for comment
“This research supports that access to care and timely treatment completion is critical to eliminating health care disparities,” she told this news organization. The system-based intervention in this trial was designed to reduce treatment delays and provide a supportive matrix for patients confronting real-world difficulties like transportation issues, childcare complications, and work absence, she explained.
Eliminating racial disparities
Previous findings from the ACCURE trial showed that it eliminated Black-White disparities in treatment completion rates, which was the study’s primary endpoint (Cancer Med. 2019;8:1095-1102). “It also improved treatment for all patients,” said Dr. Manning. “The current study is a follow-up on the survival of eligible patients treated during the ACCURE enrollment as compared to historical data.”
ACCURE was a multi-institutional trial designed to test a community-created intervention to reduce racial disparities. The intervention involved multiple changes to the way patients were supported while receiving cancer treatment and had four components:
- an electronic health record with automatic alerts to flag missed appointments or unmet milestones in expected care
- a nurse navigator trained in race-specific barriers to help patients overcome obstacles to care when alerts are flagged
- a physician champion to engage health care teams with race-related feedback on treatment completion
- regular health equity education training sessions for staff
The cohort was comprised of 1,413 patients with lung and breast cancer (stage 0-II) who were diagnosed from 2013-2015, and survival was compared to historical cases – 2,016 patients who had been treated from 2007-2011.
The results showed a significant improvement in survival for both Black and White patients with breast and lung cancer over time, and the racial gap in survival was reduced.
The 5-year survival rate for breast cancer increased from 91% for White patients and 89% in Black patients in historical cases, to 94% for both during the study period.
For patients with lung cancer, the 5-year survival rate improved from 43% in White patients and 37% in Black patients to 56% and 54%, respectively.
A subgroup analysis showed that patients with lung cancer who underwent surgery had 5-year survival rates of 78.5% for White and 70.1% for Black patients, whereas for those who underwent stereotactic body radiation therapy (SBRT) the rates were 41.9% and 50% respectively.
“We’ve shown it’s possible to eliminate disparities in cancer treatment completion and that this change has the potential to close cancer survival gaps downstream,” said Dr. Manning. “But we think the application can be much broader.”
The ACCURE study was sponsored by the National Institutes of Health. Dr. Manning and Dr. Hall have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When barriers to completing radiation therapy were identified and addressed in a cohort of patients with early-stage lung and breast cancer, 5-year survival rates improved for all patients and closed the racial disparity gap, researchers reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).
The findings come from the ACCURE clinical trial. This is the first prospective study designed to erase gaps in cancer treatment completion and survival among Black and White patient populations, explained lead author Matthew A. Manning, MD, a radiation oncologist and chief of oncology at Cone Health in Greensboro, N.C.
“Thousands of studies have looked at racial disparities in health care, but until recently, very few studies have implemented interventions to eliminate those disparities,” he said.
“This study shows that the implementation of ‘systems-change’ can eliminate racial disparities in cancer survival while improving survival for all,” he added.
“These results add to a growing body of evidence that health care disparities in cancer outcomes are eliminated or minimized by providing supportive, timely, and guideline-directed care,” said Lannis Hall, MD, MPH, director of radiation oncology, Siteman Cancer Center, and associate professor of radiation oncology at Washington University School of Medicine, St. Louis, who was approached for comment
“This research supports that access to care and timely treatment completion is critical to eliminating health care disparities,” she told this news organization. The system-based intervention in this trial was designed to reduce treatment delays and provide a supportive matrix for patients confronting real-world difficulties like transportation issues, childcare complications, and work absence, she explained.
Eliminating racial disparities
Previous findings from the ACCURE trial showed that it eliminated Black-White disparities in treatment completion rates, which was the study’s primary endpoint (Cancer Med. 2019;8:1095-1102). “It also improved treatment for all patients,” said Dr. Manning. “The current study is a follow-up on the survival of eligible patients treated during the ACCURE enrollment as compared to historical data.”
ACCURE was a multi-institutional trial designed to test a community-created intervention to reduce racial disparities. The intervention involved multiple changes to the way patients were supported while receiving cancer treatment and had four components:
- an electronic health record with automatic alerts to flag missed appointments or unmet milestones in expected care
- a nurse navigator trained in race-specific barriers to help patients overcome obstacles to care when alerts are flagged
- a physician champion to engage health care teams with race-related feedback on treatment completion
- regular health equity education training sessions for staff
The cohort was comprised of 1,413 patients with lung and breast cancer (stage 0-II) who were diagnosed from 2013-2015, and survival was compared to historical cases – 2,016 patients who had been treated from 2007-2011.
The results showed a significant improvement in survival for both Black and White patients with breast and lung cancer over time, and the racial gap in survival was reduced.
The 5-year survival rate for breast cancer increased from 91% for White patients and 89% in Black patients in historical cases, to 94% for both during the study period.
For patients with lung cancer, the 5-year survival rate improved from 43% in White patients and 37% in Black patients to 56% and 54%, respectively.
A subgroup analysis showed that patients with lung cancer who underwent surgery had 5-year survival rates of 78.5% for White and 70.1% for Black patients, whereas for those who underwent stereotactic body radiation therapy (SBRT) the rates were 41.9% and 50% respectively.
“We’ve shown it’s possible to eliminate disparities in cancer treatment completion and that this change has the potential to close cancer survival gaps downstream,” said Dr. Manning. “But we think the application can be much broader.”
The ACCURE study was sponsored by the National Institutes of Health. Dr. Manning and Dr. Hall have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASTRO 2021
What does it mean to be a trustworthy male ally?
“If you want to be trusted, be trustworthy” – Stephen Covey
A few years ago, while working in my office, a female colleague stopped by for a casual chat. During the course of the conversation, she noticed that I did not have any diplomas or certificates hanging on my office walls. Instead, there were clusters of pictures drawn by my children, family photos, and a white board with my “to-do” list. The only wall art was a print of Banksy’s “The Thinker Monkey,” which depicts a monkey with its fist to its chin similar to Rodin’s famous sculpture, “Le Penseur.”
When asked why I didn’t hang any diplomas or awards, I replied that I preferred to keep my office atmosphere light and fun, and to focus on future goals rather than past accomplishments. I could see her jaw tense. Her frustration appeared deep, but it was for reasons beyond just my self-righteous tone. She said, “You know, I appreciate your focus on future goals, but it’s a pretty privileged position to not have to worry about sharing your accomplishments publicly.”
What followed was a discussion that was generative, enlightening, uncomfortable, and necessary. I had never considered what I chose to hang (or not hang) on my office walls as a privilege, and that was exactly the point. She described numerous episodes when her accomplishments were overlooked or (worse) attributed to a male colleague because she was a woman. I began to understand that graceful self-promotion is not optional for many women in medicine, it is a necessary skill.
This is just one example of how my privilege as a male in medicine contributed to my ignorance of the gender inequities that my female coworkers have faced throughout their careers. My colleague showed a lot of grace by taking the time to help me navigate my male privilege in a constructive manner. I decided to learn more about gender inequities, and eventually determined that I was woefully inadequate as a male ally, not by refusal but by ignorance. I wanted to start earning my colleague’s trust that I would be an ally that she could count on.
Trustworthiness
I wanted to be a trustworthy ally, but what does that entail? Perhaps we can learn from medical education. Trust is a complex construct that is increasingly used as a framework for assessing medical students and residents, such as with entrustable professional activities (EPAs).1,2 Multiple studies have examined the characteristics that make a learner “trustworthy” when determining how much supervision is required.3-8 Ten Cate and Chen performed an interpretivist, narrative review to synthesize the medical education literature on learner trustworthiness in the past 15 years,9 developing five major themes that contribute to trustworthiness: Humility, Capability, Agency, Reliability, and Integrity. Let’s examine each of these through the lens of male allyship.
Humility
Humility involves knowing one’s limits, asking for help, and being receptive to feedback.9 The first thing men need to do is to put their egos in check and recognize that women do not need rescuing; they need partnership. Systemic inequities have led to men holding the majority of leadership positions and significant sociopolitical capital, and correcting these inequities is more feasible when those in leadership and positions of power contribute. Women don’t need knights in shining armor, they need collaborative activism.
Humility also means a willingness to admit fallibility and to ask for help. Men often don’t know what they don’t know (see my foibles in the opening). As David G. Smith, PhD, and W. Brad Johnson, PhD, write in their book, “Good Guys,” “There are no perfect allies. As you work to become a better ally for the women around you, you will undoubtedly make a mistake.”10 Men must accept feedback on their shortcomings as allies without feeling as though they are losing their sociopolitical standing. Allyship for women does not mean there is a devaluing of men. We must escape a “zero-sum” mindset. Mistakes are where growth happens, but only if we approach our missteps with humility.
Capability
Capability entails having the necessary knowledge, skills, and attitudes to be a strong ally. Allyship is not intuitive for most men for several reasons. Many men do not experience the same biases or systemic inequities that women do, and therefore perceive them less frequently. I want to acknowledge that men can be victims of other systemic biases such as those against one’s race, ethnicity, gender identity, sexual orientation, religion, or any number of factors. Men who face inequities for these other reasons may be more cognizant of the biases women face. Even so, allyship is a skill that few men have been explicitly taught. Even if taught, few standard or organized mechanisms for feedback on allyship capability exist. How, then, can men become capable allies?
Just like in medical education, men must become self-directed learners who seek to build capability and receive feedback on their performance as allies. Men should seek allyship training through local women-in-medicine programs or organizations, or through the increasing number of national education options such as the recent ADVANCE PHM Gender Equity Symposium. As with learning any skill, men should go to the literature, seeking knowledge from experts in the field. I recommend starting with “Good Guys: How Men Can Be Better Allies for Women in the Workplace10 or “Athena Rising: How and Why Men Should Mentor Women.”11 Both books, by Dr. Smith and Dr. Johnson, are great entry points into the gender allyship literature. Seek out other resources from local experts on gender equity and allyship. Both aforementioned books were recommended to me by a friend and gender equity expert; without her guidance I would not have known where to start.
Agency
Agency involves being proactive and engaged rather than passive or apathetic. Men must be enthusiastic allies who seek out opportunities to mentor and sponsor women rather than waiting for others to ask. Agency requires being curious and passionate about improving. Most men in medicine are not openly and explicitly misogynistic or sexist, but many are only passive when it comes to gender equity and allyship. Trustworthy allyship entails turning passive support into active change. Not sure how to start? A good first step is to ask female colleagues questions such as, “What can I do to be a better ally for you in the workplace?” or “What are some things at work that are most challenging to you, but I might not notice because I’m a man?” Curiosity is the springboard toward agency.
Reliability
Reliability means being conscientious, accountable, and doing what we say we will do. Nothing undermines trustworthiness faster than making a commitment and not following through. Allyship cannot be a show or an attempt to get public plaudits. It is a longitudinal commitment to supporting women through individual mentorship and sponsorship, and to work toward institutional and systems change.
Reliability also means taking an equitable approach to what Dr. Smith and Dr. Johnson call “office housework.” They define this as “administrative work that is necessary but undervalued, unlikely to lead to promotion, and disproportionately assigned to women.”10 In medicine, these tasks include organizing meetings, taking notes, planning social events, and remembering to celebrate colleagues’ achievements and milestones. Men should take on more of these tasks and advocate for change when the distribution of office housework in their workplace is inequitably directed toward women.
Integrity
Integrity involves honesty, professionalism, and benevolence. It is about making the morally correct choice even if there is potential risk. When men see gender inequity, they have an obligation to speak up. Whether it is overtly misogynistic behavior, subtle sexism, use of gendered language, inequitable distribution of office housework, lack of inclusivity and recognition for women, or another form of inequity, men must act with integrity and make it clear that they are partnering with women for change. Integrity means being an ally even when women are not present, and advocating that women be “at the table” for important conversations.
Beyond the individual
Allyship cannot end with individual actions; systems changes that build trustworthy institutions are necessary. Organizational leaders must approach gender conversations with humility to critically examine inequities and agency to implement meaningful changes. Workplace cultures and institutional policies should be reviewed with an eye toward system-level integrity and reliability for promoting and supporting women. Ongoing faculty and staff development programs must provide men with the knowledge, skills, and attitudes (capability) to be strong allies. We have a long history of male-dominated institutions that are unfair or (worse) unsafe for women. Many systems are designed in a way that disadvantages women. These systems must be redesigned through an equity lens to start building trust with women in medicine.
Becoming trustworthy is a process
Even the best male allies have room to improve their trustworthiness. Many men (myself included) have a LOT of room to improve, but they should not get discouraged by the amount of ground to be gained. Steady, deliberate improvement in men’s humility, capability, agency, reliability, and integrity can build the foundation of trust with female colleagues. Trust takes time. It takes effort. It takes vulnerability. It is an ongoing, developmental process that requires deliberate practice, frequent reflection, and feedback from our female colleagues.
Dr. Kinnear is associate professor of internal medicine and pediatrics in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center. He is associate program director for the Med-Peds and Internal Medicine residency programs.
References
1. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013 Mar;5(1):157-8. doi: 10.4300/JGME-D-12-00380.1.
2. Ten Cate O. Entrustment decisions: Bringing the patient into the assessment equation. Acad Med. 2017 Jun;92(6):736-8. doi: 10.1097/ACM.0000000000001623.
3. Kennedy TJT et al. Point-of-care assessment of medical trainee competence for independent clinical work. Acad Med. 2008 Oct;83(10 Suppl):S89-92. doi: 10.1097/ACM.0b013e318183c8b7.
4. Choo KJ et al. How do supervising physicians decide to entrust residents with unsupervised tasks? A qualitative analysis. J Hosp Med. 2014 Mar;9(3):169-75. doi: 10.1002/jhm.2150.
5. Hauer KE et al. How clinical supervisors develop trust in their trainees: A qualitative study. Med Educ. 2015 Aug;49(8):783-95. doi: 10.1111/medu.12745.
6. Sterkenburg A et al. When do supervising physicians decide to entrust residents with unsupervised tasks? Acad Med. 2010 Sep;85(9):1408-17. doi: 10.1097/ACM.0b013e3181eab0ec.
7. Sheu L et al. How supervisor experience influences trust, supervision, and trainee learning: A qualitative study. Acad Med. 2017 Sep;92(9):1320-7. doi: 10.1097/ACM.0000000000001560.
8. Pingree EW et al. Encouraging entrustment: A qualitative study of resident behaviors that promote entrustment. Acad Med. 2020 Nov;95(11):1718-25. doi: 10.1097/ACM.0000000000003487.
9. Ten Cate O, Chen HC. The ingredients of a rich entrustment decision. Med Teach. 2020 Dec;42(12):1413-20. doi: 10.1080/0142159X.2020.1817348.
10. Smith DG, Johnson WB. Good guys: How men can be better allies for women in the workplace: Harvard Business School Publishing Corporation 2020.
11. Johnson WB, Smith D. Athena rising: How and why men should mentor women: Routledge 2016.
“If you want to be trusted, be trustworthy” – Stephen Covey
A few years ago, while working in my office, a female colleague stopped by for a casual chat. During the course of the conversation, she noticed that I did not have any diplomas or certificates hanging on my office walls. Instead, there were clusters of pictures drawn by my children, family photos, and a white board with my “to-do” list. The only wall art was a print of Banksy’s “The Thinker Monkey,” which depicts a monkey with its fist to its chin similar to Rodin’s famous sculpture, “Le Penseur.”
When asked why I didn’t hang any diplomas or awards, I replied that I preferred to keep my office atmosphere light and fun, and to focus on future goals rather than past accomplishments. I could see her jaw tense. Her frustration appeared deep, but it was for reasons beyond just my self-righteous tone. She said, “You know, I appreciate your focus on future goals, but it’s a pretty privileged position to not have to worry about sharing your accomplishments publicly.”
What followed was a discussion that was generative, enlightening, uncomfortable, and necessary. I had never considered what I chose to hang (or not hang) on my office walls as a privilege, and that was exactly the point. She described numerous episodes when her accomplishments were overlooked or (worse) attributed to a male colleague because she was a woman. I began to understand that graceful self-promotion is not optional for many women in medicine, it is a necessary skill.
This is just one example of how my privilege as a male in medicine contributed to my ignorance of the gender inequities that my female coworkers have faced throughout their careers. My colleague showed a lot of grace by taking the time to help me navigate my male privilege in a constructive manner. I decided to learn more about gender inequities, and eventually determined that I was woefully inadequate as a male ally, not by refusal but by ignorance. I wanted to start earning my colleague’s trust that I would be an ally that she could count on.
Trustworthiness
I wanted to be a trustworthy ally, but what does that entail? Perhaps we can learn from medical education. Trust is a complex construct that is increasingly used as a framework for assessing medical students and residents, such as with entrustable professional activities (EPAs).1,2 Multiple studies have examined the characteristics that make a learner “trustworthy” when determining how much supervision is required.3-8 Ten Cate and Chen performed an interpretivist, narrative review to synthesize the medical education literature on learner trustworthiness in the past 15 years,9 developing five major themes that contribute to trustworthiness: Humility, Capability, Agency, Reliability, and Integrity. Let’s examine each of these through the lens of male allyship.
Humility
Humility involves knowing one’s limits, asking for help, and being receptive to feedback.9 The first thing men need to do is to put their egos in check and recognize that women do not need rescuing; they need partnership. Systemic inequities have led to men holding the majority of leadership positions and significant sociopolitical capital, and correcting these inequities is more feasible when those in leadership and positions of power contribute. Women don’t need knights in shining armor, they need collaborative activism.
Humility also means a willingness to admit fallibility and to ask for help. Men often don’t know what they don’t know (see my foibles in the opening). As David G. Smith, PhD, and W. Brad Johnson, PhD, write in their book, “Good Guys,” “There are no perfect allies. As you work to become a better ally for the women around you, you will undoubtedly make a mistake.”10 Men must accept feedback on their shortcomings as allies without feeling as though they are losing their sociopolitical standing. Allyship for women does not mean there is a devaluing of men. We must escape a “zero-sum” mindset. Mistakes are where growth happens, but only if we approach our missteps with humility.
Capability
Capability entails having the necessary knowledge, skills, and attitudes to be a strong ally. Allyship is not intuitive for most men for several reasons. Many men do not experience the same biases or systemic inequities that women do, and therefore perceive them less frequently. I want to acknowledge that men can be victims of other systemic biases such as those against one’s race, ethnicity, gender identity, sexual orientation, religion, or any number of factors. Men who face inequities for these other reasons may be more cognizant of the biases women face. Even so, allyship is a skill that few men have been explicitly taught. Even if taught, few standard or organized mechanisms for feedback on allyship capability exist. How, then, can men become capable allies?
Just like in medical education, men must become self-directed learners who seek to build capability and receive feedback on their performance as allies. Men should seek allyship training through local women-in-medicine programs or organizations, or through the increasing number of national education options such as the recent ADVANCE PHM Gender Equity Symposium. As with learning any skill, men should go to the literature, seeking knowledge from experts in the field. I recommend starting with “Good Guys: How Men Can Be Better Allies for Women in the Workplace10 or “Athena Rising: How and Why Men Should Mentor Women.”11 Both books, by Dr. Smith and Dr. Johnson, are great entry points into the gender allyship literature. Seek out other resources from local experts on gender equity and allyship. Both aforementioned books were recommended to me by a friend and gender equity expert; without her guidance I would not have known where to start.
Agency
Agency involves being proactive and engaged rather than passive or apathetic. Men must be enthusiastic allies who seek out opportunities to mentor and sponsor women rather than waiting for others to ask. Agency requires being curious and passionate about improving. Most men in medicine are not openly and explicitly misogynistic or sexist, but many are only passive when it comes to gender equity and allyship. Trustworthy allyship entails turning passive support into active change. Not sure how to start? A good first step is to ask female colleagues questions such as, “What can I do to be a better ally for you in the workplace?” or “What are some things at work that are most challenging to you, but I might not notice because I’m a man?” Curiosity is the springboard toward agency.
Reliability
Reliability means being conscientious, accountable, and doing what we say we will do. Nothing undermines trustworthiness faster than making a commitment and not following through. Allyship cannot be a show or an attempt to get public plaudits. It is a longitudinal commitment to supporting women through individual mentorship and sponsorship, and to work toward institutional and systems change.
Reliability also means taking an equitable approach to what Dr. Smith and Dr. Johnson call “office housework.” They define this as “administrative work that is necessary but undervalued, unlikely to lead to promotion, and disproportionately assigned to women.”10 In medicine, these tasks include organizing meetings, taking notes, planning social events, and remembering to celebrate colleagues’ achievements and milestones. Men should take on more of these tasks and advocate for change when the distribution of office housework in their workplace is inequitably directed toward women.
Integrity
Integrity involves honesty, professionalism, and benevolence. It is about making the morally correct choice even if there is potential risk. When men see gender inequity, they have an obligation to speak up. Whether it is overtly misogynistic behavior, subtle sexism, use of gendered language, inequitable distribution of office housework, lack of inclusivity and recognition for women, or another form of inequity, men must act with integrity and make it clear that they are partnering with women for change. Integrity means being an ally even when women are not present, and advocating that women be “at the table” for important conversations.
Beyond the individual
Allyship cannot end with individual actions; systems changes that build trustworthy institutions are necessary. Organizational leaders must approach gender conversations with humility to critically examine inequities and agency to implement meaningful changes. Workplace cultures and institutional policies should be reviewed with an eye toward system-level integrity and reliability for promoting and supporting women. Ongoing faculty and staff development programs must provide men with the knowledge, skills, and attitudes (capability) to be strong allies. We have a long history of male-dominated institutions that are unfair or (worse) unsafe for women. Many systems are designed in a way that disadvantages women. These systems must be redesigned through an equity lens to start building trust with women in medicine.
Becoming trustworthy is a process
Even the best male allies have room to improve their trustworthiness. Many men (myself included) have a LOT of room to improve, but they should not get discouraged by the amount of ground to be gained. Steady, deliberate improvement in men’s humility, capability, agency, reliability, and integrity can build the foundation of trust with female colleagues. Trust takes time. It takes effort. It takes vulnerability. It is an ongoing, developmental process that requires deliberate practice, frequent reflection, and feedback from our female colleagues.
Dr. Kinnear is associate professor of internal medicine and pediatrics in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center. He is associate program director for the Med-Peds and Internal Medicine residency programs.
References
1. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013 Mar;5(1):157-8. doi: 10.4300/JGME-D-12-00380.1.
2. Ten Cate O. Entrustment decisions: Bringing the patient into the assessment equation. Acad Med. 2017 Jun;92(6):736-8. doi: 10.1097/ACM.0000000000001623.
3. Kennedy TJT et al. Point-of-care assessment of medical trainee competence for independent clinical work. Acad Med. 2008 Oct;83(10 Suppl):S89-92. doi: 10.1097/ACM.0b013e318183c8b7.
4. Choo KJ et al. How do supervising physicians decide to entrust residents with unsupervised tasks? A qualitative analysis. J Hosp Med. 2014 Mar;9(3):169-75. doi: 10.1002/jhm.2150.
5. Hauer KE et al. How clinical supervisors develop trust in their trainees: A qualitative study. Med Educ. 2015 Aug;49(8):783-95. doi: 10.1111/medu.12745.
6. Sterkenburg A et al. When do supervising physicians decide to entrust residents with unsupervised tasks? Acad Med. 2010 Sep;85(9):1408-17. doi: 10.1097/ACM.0b013e3181eab0ec.
7. Sheu L et al. How supervisor experience influences trust, supervision, and trainee learning: A qualitative study. Acad Med. 2017 Sep;92(9):1320-7. doi: 10.1097/ACM.0000000000001560.
8. Pingree EW et al. Encouraging entrustment: A qualitative study of resident behaviors that promote entrustment. Acad Med. 2020 Nov;95(11):1718-25. doi: 10.1097/ACM.0000000000003487.
9. Ten Cate O, Chen HC. The ingredients of a rich entrustment decision. Med Teach. 2020 Dec;42(12):1413-20. doi: 10.1080/0142159X.2020.1817348.
10. Smith DG, Johnson WB. Good guys: How men can be better allies for women in the workplace: Harvard Business School Publishing Corporation 2020.
11. Johnson WB, Smith D. Athena rising: How and why men should mentor women: Routledge 2016.
“If you want to be trusted, be trustworthy” – Stephen Covey
A few years ago, while working in my office, a female colleague stopped by for a casual chat. During the course of the conversation, she noticed that I did not have any diplomas or certificates hanging on my office walls. Instead, there were clusters of pictures drawn by my children, family photos, and a white board with my “to-do” list. The only wall art was a print of Banksy’s “The Thinker Monkey,” which depicts a monkey with its fist to its chin similar to Rodin’s famous sculpture, “Le Penseur.”
When asked why I didn’t hang any diplomas or awards, I replied that I preferred to keep my office atmosphere light and fun, and to focus on future goals rather than past accomplishments. I could see her jaw tense. Her frustration appeared deep, but it was for reasons beyond just my self-righteous tone. She said, “You know, I appreciate your focus on future goals, but it’s a pretty privileged position to not have to worry about sharing your accomplishments publicly.”
What followed was a discussion that was generative, enlightening, uncomfortable, and necessary. I had never considered what I chose to hang (or not hang) on my office walls as a privilege, and that was exactly the point. She described numerous episodes when her accomplishments were overlooked or (worse) attributed to a male colleague because she was a woman. I began to understand that graceful self-promotion is not optional for many women in medicine, it is a necessary skill.
This is just one example of how my privilege as a male in medicine contributed to my ignorance of the gender inequities that my female coworkers have faced throughout their careers. My colleague showed a lot of grace by taking the time to help me navigate my male privilege in a constructive manner. I decided to learn more about gender inequities, and eventually determined that I was woefully inadequate as a male ally, not by refusal but by ignorance. I wanted to start earning my colleague’s trust that I would be an ally that she could count on.
Trustworthiness
I wanted to be a trustworthy ally, but what does that entail? Perhaps we can learn from medical education. Trust is a complex construct that is increasingly used as a framework for assessing medical students and residents, such as with entrustable professional activities (EPAs).1,2 Multiple studies have examined the characteristics that make a learner “trustworthy” when determining how much supervision is required.3-8 Ten Cate and Chen performed an interpretivist, narrative review to synthesize the medical education literature on learner trustworthiness in the past 15 years,9 developing five major themes that contribute to trustworthiness: Humility, Capability, Agency, Reliability, and Integrity. Let’s examine each of these through the lens of male allyship.
Humility
Humility involves knowing one’s limits, asking for help, and being receptive to feedback.9 The first thing men need to do is to put their egos in check and recognize that women do not need rescuing; they need partnership. Systemic inequities have led to men holding the majority of leadership positions and significant sociopolitical capital, and correcting these inequities is more feasible when those in leadership and positions of power contribute. Women don’t need knights in shining armor, they need collaborative activism.
Humility also means a willingness to admit fallibility and to ask for help. Men often don’t know what they don’t know (see my foibles in the opening). As David G. Smith, PhD, and W. Brad Johnson, PhD, write in their book, “Good Guys,” “There are no perfect allies. As you work to become a better ally for the women around you, you will undoubtedly make a mistake.”10 Men must accept feedback on their shortcomings as allies without feeling as though they are losing their sociopolitical standing. Allyship for women does not mean there is a devaluing of men. We must escape a “zero-sum” mindset. Mistakes are where growth happens, but only if we approach our missteps with humility.
Capability
Capability entails having the necessary knowledge, skills, and attitudes to be a strong ally. Allyship is not intuitive for most men for several reasons. Many men do not experience the same biases or systemic inequities that women do, and therefore perceive them less frequently. I want to acknowledge that men can be victims of other systemic biases such as those against one’s race, ethnicity, gender identity, sexual orientation, religion, or any number of factors. Men who face inequities for these other reasons may be more cognizant of the biases women face. Even so, allyship is a skill that few men have been explicitly taught. Even if taught, few standard or organized mechanisms for feedback on allyship capability exist. How, then, can men become capable allies?
Just like in medical education, men must become self-directed learners who seek to build capability and receive feedback on their performance as allies. Men should seek allyship training through local women-in-medicine programs or organizations, or through the increasing number of national education options such as the recent ADVANCE PHM Gender Equity Symposium. As with learning any skill, men should go to the literature, seeking knowledge from experts in the field. I recommend starting with “Good Guys: How Men Can Be Better Allies for Women in the Workplace10 or “Athena Rising: How and Why Men Should Mentor Women.”11 Both books, by Dr. Smith and Dr. Johnson, are great entry points into the gender allyship literature. Seek out other resources from local experts on gender equity and allyship. Both aforementioned books were recommended to me by a friend and gender equity expert; without her guidance I would not have known where to start.
Agency
Agency involves being proactive and engaged rather than passive or apathetic. Men must be enthusiastic allies who seek out opportunities to mentor and sponsor women rather than waiting for others to ask. Agency requires being curious and passionate about improving. Most men in medicine are not openly and explicitly misogynistic or sexist, but many are only passive when it comes to gender equity and allyship. Trustworthy allyship entails turning passive support into active change. Not sure how to start? A good first step is to ask female colleagues questions such as, “What can I do to be a better ally for you in the workplace?” or “What are some things at work that are most challenging to you, but I might not notice because I’m a man?” Curiosity is the springboard toward agency.
Reliability
Reliability means being conscientious, accountable, and doing what we say we will do. Nothing undermines trustworthiness faster than making a commitment and not following through. Allyship cannot be a show or an attempt to get public plaudits. It is a longitudinal commitment to supporting women through individual mentorship and sponsorship, and to work toward institutional and systems change.
Reliability also means taking an equitable approach to what Dr. Smith and Dr. Johnson call “office housework.” They define this as “administrative work that is necessary but undervalued, unlikely to lead to promotion, and disproportionately assigned to women.”10 In medicine, these tasks include organizing meetings, taking notes, planning social events, and remembering to celebrate colleagues’ achievements and milestones. Men should take on more of these tasks and advocate for change when the distribution of office housework in their workplace is inequitably directed toward women.
Integrity
Integrity involves honesty, professionalism, and benevolence. It is about making the morally correct choice even if there is potential risk. When men see gender inequity, they have an obligation to speak up. Whether it is overtly misogynistic behavior, subtle sexism, use of gendered language, inequitable distribution of office housework, lack of inclusivity and recognition for women, or another form of inequity, men must act with integrity and make it clear that they are partnering with women for change. Integrity means being an ally even when women are not present, and advocating that women be “at the table” for important conversations.
Beyond the individual
Allyship cannot end with individual actions; systems changes that build trustworthy institutions are necessary. Organizational leaders must approach gender conversations with humility to critically examine inequities and agency to implement meaningful changes. Workplace cultures and institutional policies should be reviewed with an eye toward system-level integrity and reliability for promoting and supporting women. Ongoing faculty and staff development programs must provide men with the knowledge, skills, and attitudes (capability) to be strong allies. We have a long history of male-dominated institutions that are unfair or (worse) unsafe for women. Many systems are designed in a way that disadvantages women. These systems must be redesigned through an equity lens to start building trust with women in medicine.
Becoming trustworthy is a process
Even the best male allies have room to improve their trustworthiness. Many men (myself included) have a LOT of room to improve, but they should not get discouraged by the amount of ground to be gained. Steady, deliberate improvement in men’s humility, capability, agency, reliability, and integrity can build the foundation of trust with female colleagues. Trust takes time. It takes effort. It takes vulnerability. It is an ongoing, developmental process that requires deliberate practice, frequent reflection, and feedback from our female colleagues.
Dr. Kinnear is associate professor of internal medicine and pediatrics in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center and University of Cincinnati Medical Center. He is associate program director for the Med-Peds and Internal Medicine residency programs.
References
1. Ten Cate O. Nuts and bolts of entrustable professional activities. J Grad Med Educ. 2013 Mar;5(1):157-8. doi: 10.4300/JGME-D-12-00380.1.
2. Ten Cate O. Entrustment decisions: Bringing the patient into the assessment equation. Acad Med. 2017 Jun;92(6):736-8. doi: 10.1097/ACM.0000000000001623.
3. Kennedy TJT et al. Point-of-care assessment of medical trainee competence for independent clinical work. Acad Med. 2008 Oct;83(10 Suppl):S89-92. doi: 10.1097/ACM.0b013e318183c8b7.
4. Choo KJ et al. How do supervising physicians decide to entrust residents with unsupervised tasks? A qualitative analysis. J Hosp Med. 2014 Mar;9(3):169-75. doi: 10.1002/jhm.2150.
5. Hauer KE et al. How clinical supervisors develop trust in their trainees: A qualitative study. Med Educ. 2015 Aug;49(8):783-95. doi: 10.1111/medu.12745.
6. Sterkenburg A et al. When do supervising physicians decide to entrust residents with unsupervised tasks? Acad Med. 2010 Sep;85(9):1408-17. doi: 10.1097/ACM.0b013e3181eab0ec.
7. Sheu L et al. How supervisor experience influences trust, supervision, and trainee learning: A qualitative study. Acad Med. 2017 Sep;92(9):1320-7. doi: 10.1097/ACM.0000000000001560.
8. Pingree EW et al. Encouraging entrustment: A qualitative study of resident behaviors that promote entrustment. Acad Med. 2020 Nov;95(11):1718-25. doi: 10.1097/ACM.0000000000003487.
9. Ten Cate O, Chen HC. The ingredients of a rich entrustment decision. Med Teach. 2020 Dec;42(12):1413-20. doi: 10.1080/0142159X.2020.1817348.
10. Smith DG, Johnson WB. Good guys: How men can be better allies for women in the workplace: Harvard Business School Publishing Corporation 2020.
11. Johnson WB, Smith D. Athena rising: How and why men should mentor women: Routledge 2016.
A pediatrician’s guide to screening for and treating depression
On Oct. 19, the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association jointly declared a “national emergency in children’s mental health,” calling upon policy makers to take actions that could help address “soaring rates” of anxiety and depression.
Knowing that increasing the work force or creating new programs will come slowly if at all, they called for the integration of mental health care into primary care pediatrics and efforts to reduce the risk of suicide in children and adolescents.
Our clinical experience suggests that adolescent depression, which can lead to profoundly impaired function, impaired development, and even suicide, is a major concern in your practice. We hope to do our part by reviewing the screening, diagnosis, and management of depression that can reasonably happen in the pediatrician’s office.
Depression
Depression affects as many as 20% of adolescents, with girls experiencing major depressive disorder (MDD) twice as often as boys. The incidence of depression increases fourfold after puberty, and there is substantial evidence, but no clear cause, that it has increased by nearly 50% over the past decade, rising from a rate of 8% of U.S. adolescents in 2007 to 13% in 2017.1 In that same time period, the rate of completed suicides among U.S. youth aged 10-24 increased 57.4%, after being stable for the prior decade.2 Adolescent depression is also linked to increased substance use and high-risk behaviors such as drunk driving. In 2020, mental health–related emergency department visits by adolescents aged 12-17 increased by 31%. Visits for suicide attempts among adolescent girls in 2021 jumped by 51% from 2019.3 Clearly, MDD in adolescence is a common, potentially life-threatening problem
.
Screening and assessment
At annual checkups with patients 12 and older or at sick visits of patients with emotional, sleep, or vague somatic concerns, it should be standard practice to screen for depression. The Patient Health Questionnaire 9 modified for Adolescents (PHQ9-A) is a reliable, validated, and free screening instrument that your patients can fill out in the waiting room. (The PHQ9 can be used for your patients who are 18 and older.) It takes only 5 minutes to complete and is very easy to score. It establishes whether your patient meets DSM-5 criteria for MDD, and the degree of severity (5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, and 20-27 is severe). It also screens for thoughts about suicide and past suicide attempts. You might add the more comprehensive parent-completed Pediatric Symptom Checklist, which includes a depression screen.4
These screening instruments can be completed electronically prior to or at the visit and should have a preamble explaining why depression screening is relevant. If screening is positive, interview your adolescent patients alone. This will give you the time to gather more detail about how impaired their function is at school, with friends, and in family relationships. Have they been missing school? Have their grades changed? Are they failing to hand in homework? Have they withdrawn from sports or activities? Are they less likely to hang out with friends? Do they participate in family activities? Have others noticed any changes? You should also check for associated anxiety symptoms (ruminative worries, panic attacks) and drug and alcohol use. Of course, you should ask about any suicidal thoughts (from vague morbid thoughts to specific plans, with intent and factors that have prevented them) and actual attempts. Remember, asking about suicidal thoughts and attempts will not cause or worsen them. On the contrary, your patients may feel shame, but will be relieved to not be alone with these thoughts. And this knowledge will be essential as you decide what to do next. When you meet with the parents, ask them about a family history of depression or suicide attempts, and then offer supportive interventions.
Supportive interventions
For all adolescents with depression, supportive interventions are helpful, and for those with mild symptoms, they are often adequate treatment. This begins with education for your patient and their parents about depression. It is an illness, not a problem of character or discipline. Advise your patients that adequate, restful sleep every night is critical to recovery. Regular exercise (daily is best, but at least three times weekly for 30 minutes) is often effective in mild to moderate depression. Patience and compassion for feelings of sadness, irritability, or disinterest are important at home, and maintaining connections with those people who offer support (friends, coaches, parents, etc.) is essential. They should also be told that “depression lies.” Feelings of guilt and self-reproach are a normal part of the illness, not facts. Organizations such as the National Alliance on Mental Illness (NAMI) and the American Academy of Child and Adolescent Psychiatry (AACAP) offer written materials through their websites that are very helpful educational resources. Connect them with sources of counseling support (through school, for example). For those with mild, brief, and uncomplicated depression, supportive interventions alone should offer relief within 4-6 weeks. It is hard to predict the trajectory of depression, so follow-up visits are relevant to determine if they are improving or worsening.
Psychotherapy
For your patients with moderate depression, or with hopelessness or suicidality, a referral for evidence-based psychotherapy is indicated. Both cognitive behavioral therapy and interpersonal therapy have demonstrated efficacy in treating depression in adolescents. If there is a history of trauma or high family conflict, supportive psychotherapy that will enhance communication skills within the family is very important to recovery. Identify various sources for high-quality psychotherapy services (individual, family, and group) in your community. While this may sound easier said than done, online services such as Psychology Today’s therapist locator can help. If your local university has a graduate program in social work or psychology, connect with them as they may have easier access to high-quality services through their training programs. If there is a group practice of therapists in your community, invite them to meet with your team to learn about whether they use evidence-based therapies and can support families as well as individual youth.
Pharmacologic options
For those adolescents with moderate to severe depression, psychotherapy alone is usually inadequate. Indeed, they may be so impaired that they simply cannot meaningfully engage in the work of psychotherapy. These patients require psychopharmacologic treatment first. First-line treatment is with selective serotonin reuptake inhibitors (SSRIs) (both fluoxetine and escitalopram are approved for use in adolescent depression). While many pediatricians remain reluctant about initiating SSRI treatment of depression since the Food and Drug Administration’s 2004 boxed warning was issued, the risks of untreated severe depression are more marked than are the risks of SSRI treatment. As prescription rates dipped in the following decade, rates of suicide attempts in adolescents with severe depression climbed. Subsequent research on the nature of the risk of “increased suicidality” indicated it is substantially lower than originally thought.
The AAP’s Guidelines for Adolescent Depression in Primary Care offer reassuring guidance: They recommend that pediatricians initiate treatment at a very low dose of SSRI (5 mg of fluoxetine, 12.5 mg of sertraline, or 5 mg of escitalopram) and aim to get to a therapeutic dose within 4 weeks.5 Educate the patient and parent about likely side effects (gastrointestinal upset, sleep disruption, akathisia or restlessness, and activation), which indicate the dose should be held steady until the side effects subside. Patients should be seen weekly until they get to a therapeutic dose, then biweekly to monitor for response. At these regular check-ins, the PHQ9A can follow symptom severity. You should monitor changes in function and for any change in suicidal thoughts. If your patient does not respond with at least energy improvement within 4 weeks, you should cross-taper to a different SSRI.
Managing risk
Suicidal thoughts are a common symptom of depression and an important marker of severity. Adolescents have more limited impulse control than do adults, elevating their risk for impulsively acting on these thoughts. Adolescents who are using alcohol or other substances, or who have a history of impulsivity, are at higher risk. Further compounding the degree of risk are a history of suicide attempts, impulsive aggression or psychotic symptoms, or a family history of completed suicide. In managing risk, it is critical that you assess and discuss these risk factors and discuss the need to have a safety plan.
This planning should include both patient and parent. Help the parent to identify lethal means at home (guns, rope, medications, and knives or box cutters) and make plans to secure or remove them. It includes helping your patient list those strategies that can be helpful if they are feeling more distressed (distracting with music or television, exercise, or connecting with select friends). A safety plan is not a promise or a contract to not do something, rather it is a practical set of strategies the patient and family can employ if they are feeling worse. It depends on the adolescent having a secure, trusting connection with the adults at home and with your office.
If your patient fails to improve, if the diagnosis appears complicated, or if you feel the patient is not safe, you should refer to child psychiatry or, if needed, a local emergency department. If you cannot find access to a psychiatrist, start with your state’s child psychiatric consultation hotline for access to telephone support: www.nncpap.org.
Although the suggestions outlined above are grounded in evidence and need, treating moderate to severe depression is likely a new challenge for many pediatricians. Managing the risk of suicide can be stressful, without a doubt. In our own work as child psychiatrists, we recognize that there is no single, reliable method to predict suicide and therefore no specific approach to ensuring prevention. We appreciate this burden of worry when treating a severely depressed adolescent, and follow the rule, “never worry alone” – share your concerns with parents and/or a mental health consultant (hopefully co-located in your office), or obtain a second opinion, even consult a child psychiatrist on a hotline. Offering supportive care for those with mild depression can prevent it from becoming severe, and beginning treatment for those with severe depression can make a profound difference in the course of a young person’s illness.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Pew Research Center. National Survey on Drug Use and Health (2017).
2. Curtin SC. Natl Vital Stat Rep. 2020 Sep;69(11):1-10.
3. Yard E et al. MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):888-94.
4. Jellinek M et al. J Pediatr. 2021 Jun;233:220-6.e1.
5. Zuckerbrot RA et al. Pediatrics. 2018 Mar;141(3):e20174081.
On Oct. 19, the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association jointly declared a “national emergency in children’s mental health,” calling upon policy makers to take actions that could help address “soaring rates” of anxiety and depression.
Knowing that increasing the work force or creating new programs will come slowly if at all, they called for the integration of mental health care into primary care pediatrics and efforts to reduce the risk of suicide in children and adolescents.
Our clinical experience suggests that adolescent depression, which can lead to profoundly impaired function, impaired development, and even suicide, is a major concern in your practice. We hope to do our part by reviewing the screening, diagnosis, and management of depression that can reasonably happen in the pediatrician’s office.
Depression
Depression affects as many as 20% of adolescents, with girls experiencing major depressive disorder (MDD) twice as often as boys. The incidence of depression increases fourfold after puberty, and there is substantial evidence, but no clear cause, that it has increased by nearly 50% over the past decade, rising from a rate of 8% of U.S. adolescents in 2007 to 13% in 2017.1 In that same time period, the rate of completed suicides among U.S. youth aged 10-24 increased 57.4%, after being stable for the prior decade.2 Adolescent depression is also linked to increased substance use and high-risk behaviors such as drunk driving. In 2020, mental health–related emergency department visits by adolescents aged 12-17 increased by 31%. Visits for suicide attempts among adolescent girls in 2021 jumped by 51% from 2019.3 Clearly, MDD in adolescence is a common, potentially life-threatening problem
.
Screening and assessment
At annual checkups with patients 12 and older or at sick visits of patients with emotional, sleep, or vague somatic concerns, it should be standard practice to screen for depression. The Patient Health Questionnaire 9 modified for Adolescents (PHQ9-A) is a reliable, validated, and free screening instrument that your patients can fill out in the waiting room. (The PHQ9 can be used for your patients who are 18 and older.) It takes only 5 minutes to complete and is very easy to score. It establishes whether your patient meets DSM-5 criteria for MDD, and the degree of severity (5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, and 20-27 is severe). It also screens for thoughts about suicide and past suicide attempts. You might add the more comprehensive parent-completed Pediatric Symptom Checklist, which includes a depression screen.4
These screening instruments can be completed electronically prior to or at the visit and should have a preamble explaining why depression screening is relevant. If screening is positive, interview your adolescent patients alone. This will give you the time to gather more detail about how impaired their function is at school, with friends, and in family relationships. Have they been missing school? Have their grades changed? Are they failing to hand in homework? Have they withdrawn from sports or activities? Are they less likely to hang out with friends? Do they participate in family activities? Have others noticed any changes? You should also check for associated anxiety symptoms (ruminative worries, panic attacks) and drug and alcohol use. Of course, you should ask about any suicidal thoughts (from vague morbid thoughts to specific plans, with intent and factors that have prevented them) and actual attempts. Remember, asking about suicidal thoughts and attempts will not cause or worsen them. On the contrary, your patients may feel shame, but will be relieved to not be alone with these thoughts. And this knowledge will be essential as you decide what to do next. When you meet with the parents, ask them about a family history of depression or suicide attempts, and then offer supportive interventions.
Supportive interventions
For all adolescents with depression, supportive interventions are helpful, and for those with mild symptoms, they are often adequate treatment. This begins with education for your patient and their parents about depression. It is an illness, not a problem of character or discipline. Advise your patients that adequate, restful sleep every night is critical to recovery. Regular exercise (daily is best, but at least three times weekly for 30 minutes) is often effective in mild to moderate depression. Patience and compassion for feelings of sadness, irritability, or disinterest are important at home, and maintaining connections with those people who offer support (friends, coaches, parents, etc.) is essential. They should also be told that “depression lies.” Feelings of guilt and self-reproach are a normal part of the illness, not facts. Organizations such as the National Alliance on Mental Illness (NAMI) and the American Academy of Child and Adolescent Psychiatry (AACAP) offer written materials through their websites that are very helpful educational resources. Connect them with sources of counseling support (through school, for example). For those with mild, brief, and uncomplicated depression, supportive interventions alone should offer relief within 4-6 weeks. It is hard to predict the trajectory of depression, so follow-up visits are relevant to determine if they are improving or worsening.
Psychotherapy
For your patients with moderate depression, or with hopelessness or suicidality, a referral for evidence-based psychotherapy is indicated. Both cognitive behavioral therapy and interpersonal therapy have demonstrated efficacy in treating depression in adolescents. If there is a history of trauma or high family conflict, supportive psychotherapy that will enhance communication skills within the family is very important to recovery. Identify various sources for high-quality psychotherapy services (individual, family, and group) in your community. While this may sound easier said than done, online services such as Psychology Today’s therapist locator can help. If your local university has a graduate program in social work or psychology, connect with them as they may have easier access to high-quality services through their training programs. If there is a group practice of therapists in your community, invite them to meet with your team to learn about whether they use evidence-based therapies and can support families as well as individual youth.
Pharmacologic options
For those adolescents with moderate to severe depression, psychotherapy alone is usually inadequate. Indeed, they may be so impaired that they simply cannot meaningfully engage in the work of psychotherapy. These patients require psychopharmacologic treatment first. First-line treatment is with selective serotonin reuptake inhibitors (SSRIs) (both fluoxetine and escitalopram are approved for use in adolescent depression). While many pediatricians remain reluctant about initiating SSRI treatment of depression since the Food and Drug Administration’s 2004 boxed warning was issued, the risks of untreated severe depression are more marked than are the risks of SSRI treatment. As prescription rates dipped in the following decade, rates of suicide attempts in adolescents with severe depression climbed. Subsequent research on the nature of the risk of “increased suicidality” indicated it is substantially lower than originally thought.
The AAP’s Guidelines for Adolescent Depression in Primary Care offer reassuring guidance: They recommend that pediatricians initiate treatment at a very low dose of SSRI (5 mg of fluoxetine, 12.5 mg of sertraline, or 5 mg of escitalopram) and aim to get to a therapeutic dose within 4 weeks.5 Educate the patient and parent about likely side effects (gastrointestinal upset, sleep disruption, akathisia or restlessness, and activation), which indicate the dose should be held steady until the side effects subside. Patients should be seen weekly until they get to a therapeutic dose, then biweekly to monitor for response. At these regular check-ins, the PHQ9A can follow symptom severity. You should monitor changes in function and for any change in suicidal thoughts. If your patient does not respond with at least energy improvement within 4 weeks, you should cross-taper to a different SSRI.
Managing risk
Suicidal thoughts are a common symptom of depression and an important marker of severity. Adolescents have more limited impulse control than do adults, elevating their risk for impulsively acting on these thoughts. Adolescents who are using alcohol or other substances, or who have a history of impulsivity, are at higher risk. Further compounding the degree of risk are a history of suicide attempts, impulsive aggression or psychotic symptoms, or a family history of completed suicide. In managing risk, it is critical that you assess and discuss these risk factors and discuss the need to have a safety plan.
This planning should include both patient and parent. Help the parent to identify lethal means at home (guns, rope, medications, and knives or box cutters) and make plans to secure or remove them. It includes helping your patient list those strategies that can be helpful if they are feeling more distressed (distracting with music or television, exercise, or connecting with select friends). A safety plan is not a promise or a contract to not do something, rather it is a practical set of strategies the patient and family can employ if they are feeling worse. It depends on the adolescent having a secure, trusting connection with the adults at home and with your office.
If your patient fails to improve, if the diagnosis appears complicated, or if you feel the patient is not safe, you should refer to child psychiatry or, if needed, a local emergency department. If you cannot find access to a psychiatrist, start with your state’s child psychiatric consultation hotline for access to telephone support: www.nncpap.org.
Although the suggestions outlined above are grounded in evidence and need, treating moderate to severe depression is likely a new challenge for many pediatricians. Managing the risk of suicide can be stressful, without a doubt. In our own work as child psychiatrists, we recognize that there is no single, reliable method to predict suicide and therefore no specific approach to ensuring prevention. We appreciate this burden of worry when treating a severely depressed adolescent, and follow the rule, “never worry alone” – share your concerns with parents and/or a mental health consultant (hopefully co-located in your office), or obtain a second opinion, even consult a child psychiatrist on a hotline. Offering supportive care for those with mild depression can prevent it from becoming severe, and beginning treatment for those with severe depression can make a profound difference in the course of a young person’s illness.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Pew Research Center. National Survey on Drug Use and Health (2017).
2. Curtin SC. Natl Vital Stat Rep. 2020 Sep;69(11):1-10.
3. Yard E et al. MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):888-94.
4. Jellinek M et al. J Pediatr. 2021 Jun;233:220-6.e1.
5. Zuckerbrot RA et al. Pediatrics. 2018 Mar;141(3):e20174081.
On Oct. 19, the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association jointly declared a “national emergency in children’s mental health,” calling upon policy makers to take actions that could help address “soaring rates” of anxiety and depression.
Knowing that increasing the work force or creating new programs will come slowly if at all, they called for the integration of mental health care into primary care pediatrics and efforts to reduce the risk of suicide in children and adolescents.
Our clinical experience suggests that adolescent depression, which can lead to profoundly impaired function, impaired development, and even suicide, is a major concern in your practice. We hope to do our part by reviewing the screening, diagnosis, and management of depression that can reasonably happen in the pediatrician’s office.
Depression
Depression affects as many as 20% of adolescents, with girls experiencing major depressive disorder (MDD) twice as often as boys. The incidence of depression increases fourfold after puberty, and there is substantial evidence, but no clear cause, that it has increased by nearly 50% over the past decade, rising from a rate of 8% of U.S. adolescents in 2007 to 13% in 2017.1 In that same time period, the rate of completed suicides among U.S. youth aged 10-24 increased 57.4%, after being stable for the prior decade.2 Adolescent depression is also linked to increased substance use and high-risk behaviors such as drunk driving. In 2020, mental health–related emergency department visits by adolescents aged 12-17 increased by 31%. Visits for suicide attempts among adolescent girls in 2021 jumped by 51% from 2019.3 Clearly, MDD in adolescence is a common, potentially life-threatening problem
.
Screening and assessment
At annual checkups with patients 12 and older or at sick visits of patients with emotional, sleep, or vague somatic concerns, it should be standard practice to screen for depression. The Patient Health Questionnaire 9 modified for Adolescents (PHQ9-A) is a reliable, validated, and free screening instrument that your patients can fill out in the waiting room. (The PHQ9 can be used for your patients who are 18 and older.) It takes only 5 minutes to complete and is very easy to score. It establishes whether your patient meets DSM-5 criteria for MDD, and the degree of severity (5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, and 20-27 is severe). It also screens for thoughts about suicide and past suicide attempts. You might add the more comprehensive parent-completed Pediatric Symptom Checklist, which includes a depression screen.4
These screening instruments can be completed electronically prior to or at the visit and should have a preamble explaining why depression screening is relevant. If screening is positive, interview your adolescent patients alone. This will give you the time to gather more detail about how impaired their function is at school, with friends, and in family relationships. Have they been missing school? Have their grades changed? Are they failing to hand in homework? Have they withdrawn from sports or activities? Are they less likely to hang out with friends? Do they participate in family activities? Have others noticed any changes? You should also check for associated anxiety symptoms (ruminative worries, panic attacks) and drug and alcohol use. Of course, you should ask about any suicidal thoughts (from vague morbid thoughts to specific plans, with intent and factors that have prevented them) and actual attempts. Remember, asking about suicidal thoughts and attempts will not cause or worsen them. On the contrary, your patients may feel shame, but will be relieved to not be alone with these thoughts. And this knowledge will be essential as you decide what to do next. When you meet with the parents, ask them about a family history of depression or suicide attempts, and then offer supportive interventions.
Supportive interventions
For all adolescents with depression, supportive interventions are helpful, and for those with mild symptoms, they are often adequate treatment. This begins with education for your patient and their parents about depression. It is an illness, not a problem of character or discipline. Advise your patients that adequate, restful sleep every night is critical to recovery. Regular exercise (daily is best, but at least three times weekly for 30 minutes) is often effective in mild to moderate depression. Patience and compassion for feelings of sadness, irritability, or disinterest are important at home, and maintaining connections with those people who offer support (friends, coaches, parents, etc.) is essential. They should also be told that “depression lies.” Feelings of guilt and self-reproach are a normal part of the illness, not facts. Organizations such as the National Alliance on Mental Illness (NAMI) and the American Academy of Child and Adolescent Psychiatry (AACAP) offer written materials through their websites that are very helpful educational resources. Connect them with sources of counseling support (through school, for example). For those with mild, brief, and uncomplicated depression, supportive interventions alone should offer relief within 4-6 weeks. It is hard to predict the trajectory of depression, so follow-up visits are relevant to determine if they are improving or worsening.
Psychotherapy
For your patients with moderate depression, or with hopelessness or suicidality, a referral for evidence-based psychotherapy is indicated. Both cognitive behavioral therapy and interpersonal therapy have demonstrated efficacy in treating depression in adolescents. If there is a history of trauma or high family conflict, supportive psychotherapy that will enhance communication skills within the family is very important to recovery. Identify various sources for high-quality psychotherapy services (individual, family, and group) in your community. While this may sound easier said than done, online services such as Psychology Today’s therapist locator can help. If your local university has a graduate program in social work or psychology, connect with them as they may have easier access to high-quality services through their training programs. If there is a group practice of therapists in your community, invite them to meet with your team to learn about whether they use evidence-based therapies and can support families as well as individual youth.
Pharmacologic options
For those adolescents with moderate to severe depression, psychotherapy alone is usually inadequate. Indeed, they may be so impaired that they simply cannot meaningfully engage in the work of psychotherapy. These patients require psychopharmacologic treatment first. First-line treatment is with selective serotonin reuptake inhibitors (SSRIs) (both fluoxetine and escitalopram are approved for use in adolescent depression). While many pediatricians remain reluctant about initiating SSRI treatment of depression since the Food and Drug Administration’s 2004 boxed warning was issued, the risks of untreated severe depression are more marked than are the risks of SSRI treatment. As prescription rates dipped in the following decade, rates of suicide attempts in adolescents with severe depression climbed. Subsequent research on the nature of the risk of “increased suicidality” indicated it is substantially lower than originally thought.
The AAP’s Guidelines for Adolescent Depression in Primary Care offer reassuring guidance: They recommend that pediatricians initiate treatment at a very low dose of SSRI (5 mg of fluoxetine, 12.5 mg of sertraline, or 5 mg of escitalopram) and aim to get to a therapeutic dose within 4 weeks.5 Educate the patient and parent about likely side effects (gastrointestinal upset, sleep disruption, akathisia or restlessness, and activation), which indicate the dose should be held steady until the side effects subside. Patients should be seen weekly until they get to a therapeutic dose, then biweekly to monitor for response. At these regular check-ins, the PHQ9A can follow symptom severity. You should monitor changes in function and for any change in suicidal thoughts. If your patient does not respond with at least energy improvement within 4 weeks, you should cross-taper to a different SSRI.
Managing risk
Suicidal thoughts are a common symptom of depression and an important marker of severity. Adolescents have more limited impulse control than do adults, elevating their risk for impulsively acting on these thoughts. Adolescents who are using alcohol or other substances, or who have a history of impulsivity, are at higher risk. Further compounding the degree of risk are a history of suicide attempts, impulsive aggression or psychotic symptoms, or a family history of completed suicide. In managing risk, it is critical that you assess and discuss these risk factors and discuss the need to have a safety plan.
This planning should include both patient and parent. Help the parent to identify lethal means at home (guns, rope, medications, and knives or box cutters) and make plans to secure or remove them. It includes helping your patient list those strategies that can be helpful if they are feeling more distressed (distracting with music or television, exercise, or connecting with select friends). A safety plan is not a promise or a contract to not do something, rather it is a practical set of strategies the patient and family can employ if they are feeling worse. It depends on the adolescent having a secure, trusting connection with the adults at home and with your office.
If your patient fails to improve, if the diagnosis appears complicated, or if you feel the patient is not safe, you should refer to child psychiatry or, if needed, a local emergency department. If you cannot find access to a psychiatrist, start with your state’s child psychiatric consultation hotline for access to telephone support: www.nncpap.org.
Although the suggestions outlined above are grounded in evidence and need, treating moderate to severe depression is likely a new challenge for many pediatricians. Managing the risk of suicide can be stressful, without a doubt. In our own work as child psychiatrists, we recognize that there is no single, reliable method to predict suicide and therefore no specific approach to ensuring prevention. We appreciate this burden of worry when treating a severely depressed adolescent, and follow the rule, “never worry alone” – share your concerns with parents and/or a mental health consultant (hopefully co-located in your office), or obtain a second opinion, even consult a child psychiatrist on a hotline. Offering supportive care for those with mild depression can prevent it from becoming severe, and beginning treatment for those with severe depression can make a profound difference in the course of a young person’s illness.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
References
1. Pew Research Center. National Survey on Drug Use and Health (2017).
2. Curtin SC. Natl Vital Stat Rep. 2020 Sep;69(11):1-10.
3. Yard E et al. MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):888-94.
4. Jellinek M et al. J Pediatr. 2021 Jun;233:220-6.e1.
5. Zuckerbrot RA et al. Pediatrics. 2018 Mar;141(3):e20174081.
A house divided cannot stand
The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.
Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.
Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”
The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”
President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.
I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.
The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.
I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.
Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.
Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.
Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”
The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”
President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.
I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.
The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.
I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.
Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.
Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.
Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”
The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”
President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.
I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.
The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.
I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.
Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Hormone blocker sticker shock – again – as patients lose cheaper drug option
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Genomic classifier is one piece of the ILD diagnosis puzzle
Although genomic testing is useful when an interstitial lung disease diagnosis is uncertain, the testing results themselves aren’t sufficient to make the diagnosis, Daniel Dilling, MD, FCCP, said in a presentation at the annual meeting of the American College of Chest Physicians, which was held virtually.
The genomic classifier (Envisia, Veracyte) helps differentiate idiopathic pulmonary fibrosis (IPF) by detecting usual interstitial pneumonia (UIP), the hallmark pattern of this interstitial lung disease.
However, UIP is just one piece of the larger diagnostic puzzle, according to Dr. Dilling, professor of medicine in the interstitial lung disease program at Loyola University Medical Center in Maywood, Ill.
“Remember, it’s just a pattern, and not a diagnosis of IPF,” Dr. Dilling said in his presentation.
Genomic classifier results correlate well with both histologic and radiographic UIP pattern, studies show.
However, Dr. Dilling said the value of the genomic classifier is not in isolation.
“We don’t use this in a vacuum,” he said. “It increases our confidence and consensus, but it has to be incorporated into a multidisciplinary discussion group.”
Part of the diagnostic pathway
Dr. Dilling said the genomic classifier should be considered part of a diagnostic pathway in uncertain cases, particularly when the risk of surgical lung biopsy is high.
Current clinical practice guidelines recommend surgical lung biopsy for histopathologic diagnosis when clinical and radiologic findings are not definitive for IPF, the speaker said.
However, surgical lung biopsy carries some risk, and sometimes it can’t be done, he added.
In his presentation, Dr. Dilling cited a systematic review and meta-analysis of 23 studies looking at surgical lung biopsy for the diagnosis of interstitial lung diseases.
The postoperative mortality rate was 3.6% in that meta-analysis, published in 2015 in the Journal of Thoracic and Cardiovascular Surgery.
“The final decision regarding whether or not to perform a [surgical lung biopsy] must be based on the balance between benefits to establish a secure diagnosis and the potential risks,” authors wrote at the time.
Mortality risk is higher in immunocompromised and acutely ill patient populations, according to Dr. Dilling, who added that as many of 19% of patients will have complications from surgical lung biopsy.
Genomic classifier studies
In a proof-of-principle study, published in 2017 in the Annals of the American Thoracic Society, authors described how they used machine learning to train an algorithm to distinguish UIP from non-UIP pattern in tissue obtained by transbronchial biopsy (TBB).
The top-performing algorithm distinguished UIP from non-UIP conditions in single TBB samples with specificity of 86% and sensitivity of 63%, according to investigators, who said at the time that independent validation would be needed before the genomic classifier could be applied in clinical settings.
In a prospective validation study, published in 2019 in The Lancet Respiratory Medicine, the genomic classifier identified UIP in TBB samples from 49 patients with a specificity of 88% and sensitivity of 70%.
Excluding patients with definite or probable UIP as shown on high-resolution computed tomography, results show that the classifier had a sensitivity of 76%, specificity of 88%, and positive predictive value of 81%.
“The performance of the test is good, even in that scenario,” Dr. Dilling said.
Real-world results
Dr. Dilling also highlighted a “real-world” study, published earlier in 2021, demonstrating that UIP pattern recognized by a genomic classifier had encouraging sensitivity and specificity when combined with high-resolution CT and clinical factors.
That study included 96 patients who had both diagnostic lung pathology and a transbronchial lung biopsy for molecular testing with the classifier.
The classifier had a sensitivity of 60.3% and a specificity of 92.1% for histology-proven UIP pattern, investigators said in their report, which appears in the American Journal of Respiratory and Critical Care Medicine.
Local radiologists identified UIP with a sensitivity of 34.0% and specificity of 96.9%. But adding genomic classifier testing to local radiology testing increased the diagnostic yield, investigators said, with a sensitivity of 79.2% and specificity of 90.6%.
“This might suggest that the implementation of this into a local [multidisciplinary discussion] with your local radiology expertise might really improve your recognition of UIP,” Dr. Dilling said.
Dr. Dilling reported disclosures related to Bellerophon, Boehringer Ingelheim, Genentech, Nitto Denko, and Lung Bioengineering.
Although genomic testing is useful when an interstitial lung disease diagnosis is uncertain, the testing results themselves aren’t sufficient to make the diagnosis, Daniel Dilling, MD, FCCP, said in a presentation at the annual meeting of the American College of Chest Physicians, which was held virtually.
The genomic classifier (Envisia, Veracyte) helps differentiate idiopathic pulmonary fibrosis (IPF) by detecting usual interstitial pneumonia (UIP), the hallmark pattern of this interstitial lung disease.
However, UIP is just one piece of the larger diagnostic puzzle, according to Dr. Dilling, professor of medicine in the interstitial lung disease program at Loyola University Medical Center in Maywood, Ill.
“Remember, it’s just a pattern, and not a diagnosis of IPF,” Dr. Dilling said in his presentation.
Genomic classifier results correlate well with both histologic and radiographic UIP pattern, studies show.
However, Dr. Dilling said the value of the genomic classifier is not in isolation.
“We don’t use this in a vacuum,” he said. “It increases our confidence and consensus, but it has to be incorporated into a multidisciplinary discussion group.”
Part of the diagnostic pathway
Dr. Dilling said the genomic classifier should be considered part of a diagnostic pathway in uncertain cases, particularly when the risk of surgical lung biopsy is high.
Current clinical practice guidelines recommend surgical lung biopsy for histopathologic diagnosis when clinical and radiologic findings are not definitive for IPF, the speaker said.
However, surgical lung biopsy carries some risk, and sometimes it can’t be done, he added.
In his presentation, Dr. Dilling cited a systematic review and meta-analysis of 23 studies looking at surgical lung biopsy for the diagnosis of interstitial lung diseases.
The postoperative mortality rate was 3.6% in that meta-analysis, published in 2015 in the Journal of Thoracic and Cardiovascular Surgery.
“The final decision regarding whether or not to perform a [surgical lung biopsy] must be based on the balance between benefits to establish a secure diagnosis and the potential risks,” authors wrote at the time.
Mortality risk is higher in immunocompromised and acutely ill patient populations, according to Dr. Dilling, who added that as many of 19% of patients will have complications from surgical lung biopsy.
Genomic classifier studies
In a proof-of-principle study, published in 2017 in the Annals of the American Thoracic Society, authors described how they used machine learning to train an algorithm to distinguish UIP from non-UIP pattern in tissue obtained by transbronchial biopsy (TBB).
The top-performing algorithm distinguished UIP from non-UIP conditions in single TBB samples with specificity of 86% and sensitivity of 63%, according to investigators, who said at the time that independent validation would be needed before the genomic classifier could be applied in clinical settings.
In a prospective validation study, published in 2019 in The Lancet Respiratory Medicine, the genomic classifier identified UIP in TBB samples from 49 patients with a specificity of 88% and sensitivity of 70%.
Excluding patients with definite or probable UIP as shown on high-resolution computed tomography, results show that the classifier had a sensitivity of 76%, specificity of 88%, and positive predictive value of 81%.
“The performance of the test is good, even in that scenario,” Dr. Dilling said.
Real-world results
Dr. Dilling also highlighted a “real-world” study, published earlier in 2021, demonstrating that UIP pattern recognized by a genomic classifier had encouraging sensitivity and specificity when combined with high-resolution CT and clinical factors.
That study included 96 patients who had both diagnostic lung pathology and a transbronchial lung biopsy for molecular testing with the classifier.
The classifier had a sensitivity of 60.3% and a specificity of 92.1% for histology-proven UIP pattern, investigators said in their report, which appears in the American Journal of Respiratory and Critical Care Medicine.
Local radiologists identified UIP with a sensitivity of 34.0% and specificity of 96.9%. But adding genomic classifier testing to local radiology testing increased the diagnostic yield, investigators said, with a sensitivity of 79.2% and specificity of 90.6%.
“This might suggest that the implementation of this into a local [multidisciplinary discussion] with your local radiology expertise might really improve your recognition of UIP,” Dr. Dilling said.
Dr. Dilling reported disclosures related to Bellerophon, Boehringer Ingelheim, Genentech, Nitto Denko, and Lung Bioengineering.
Although genomic testing is useful when an interstitial lung disease diagnosis is uncertain, the testing results themselves aren’t sufficient to make the diagnosis, Daniel Dilling, MD, FCCP, said in a presentation at the annual meeting of the American College of Chest Physicians, which was held virtually.
The genomic classifier (Envisia, Veracyte) helps differentiate idiopathic pulmonary fibrosis (IPF) by detecting usual interstitial pneumonia (UIP), the hallmark pattern of this interstitial lung disease.
However, UIP is just one piece of the larger diagnostic puzzle, according to Dr. Dilling, professor of medicine in the interstitial lung disease program at Loyola University Medical Center in Maywood, Ill.
“Remember, it’s just a pattern, and not a diagnosis of IPF,” Dr. Dilling said in his presentation.
Genomic classifier results correlate well with both histologic and radiographic UIP pattern, studies show.
However, Dr. Dilling said the value of the genomic classifier is not in isolation.
“We don’t use this in a vacuum,” he said. “It increases our confidence and consensus, but it has to be incorporated into a multidisciplinary discussion group.”
Part of the diagnostic pathway
Dr. Dilling said the genomic classifier should be considered part of a diagnostic pathway in uncertain cases, particularly when the risk of surgical lung biopsy is high.
Current clinical practice guidelines recommend surgical lung biopsy for histopathologic diagnosis when clinical and radiologic findings are not definitive for IPF, the speaker said.
However, surgical lung biopsy carries some risk, and sometimes it can’t be done, he added.
In his presentation, Dr. Dilling cited a systematic review and meta-analysis of 23 studies looking at surgical lung biopsy for the diagnosis of interstitial lung diseases.
The postoperative mortality rate was 3.6% in that meta-analysis, published in 2015 in the Journal of Thoracic and Cardiovascular Surgery.
“The final decision regarding whether or not to perform a [surgical lung biopsy] must be based on the balance between benefits to establish a secure diagnosis and the potential risks,” authors wrote at the time.
Mortality risk is higher in immunocompromised and acutely ill patient populations, according to Dr. Dilling, who added that as many of 19% of patients will have complications from surgical lung biopsy.
Genomic classifier studies
In a proof-of-principle study, published in 2017 in the Annals of the American Thoracic Society, authors described how they used machine learning to train an algorithm to distinguish UIP from non-UIP pattern in tissue obtained by transbronchial biopsy (TBB).
The top-performing algorithm distinguished UIP from non-UIP conditions in single TBB samples with specificity of 86% and sensitivity of 63%, according to investigators, who said at the time that independent validation would be needed before the genomic classifier could be applied in clinical settings.
In a prospective validation study, published in 2019 in The Lancet Respiratory Medicine, the genomic classifier identified UIP in TBB samples from 49 patients with a specificity of 88% and sensitivity of 70%.
Excluding patients with definite or probable UIP as shown on high-resolution computed tomography, results show that the classifier had a sensitivity of 76%, specificity of 88%, and positive predictive value of 81%.
“The performance of the test is good, even in that scenario,” Dr. Dilling said.
Real-world results
Dr. Dilling also highlighted a “real-world” study, published earlier in 2021, demonstrating that UIP pattern recognized by a genomic classifier had encouraging sensitivity and specificity when combined with high-resolution CT and clinical factors.
That study included 96 patients who had both diagnostic lung pathology and a transbronchial lung biopsy for molecular testing with the classifier.
The classifier had a sensitivity of 60.3% and a specificity of 92.1% for histology-proven UIP pattern, investigators said in their report, which appears in the American Journal of Respiratory and Critical Care Medicine.
Local radiologists identified UIP with a sensitivity of 34.0% and specificity of 96.9%. But adding genomic classifier testing to local radiology testing increased the diagnostic yield, investigators said, with a sensitivity of 79.2% and specificity of 90.6%.
“This might suggest that the implementation of this into a local [multidisciplinary discussion] with your local radiology expertise might really improve your recognition of UIP,” Dr. Dilling said.
Dr. Dilling reported disclosures related to Bellerophon, Boehringer Ingelheim, Genentech, Nitto Denko, and Lung Bioengineering.
FROM CHEST 2021
Should you tell your doctor that you’re a doctor?
The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”
She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”
The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.
“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.”
“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.
“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”
Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:
“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.
Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”
“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.
Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.
For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”
@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”
Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”
Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.
“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.
Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”
Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”
Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.
“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.
To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.
Still others offered suggestions on how to broach the subject more directly when presenting as a patient:
‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.
@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”
A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.
“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.
Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”
That’s typically a sign that the Tweet is relatable for a lot of people, she said.
“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.
The debate begs the question: Is there a duty or ethical reason to disclose?
“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”
If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.
“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”
Knowing how to share the information is another story.
“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”
“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested.
A version of this article first appeared on Medscape.com.
The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”
She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”
The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.
“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.”
“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.
“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”
Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:
“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.
Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”
“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.
Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.
For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”
@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”
Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”
Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.
“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.
Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”
Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”
Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.
“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.
To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.
Still others offered suggestions on how to broach the subject more directly when presenting as a patient:
‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.
@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”
A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.
“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.
Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”
That’s typically a sign that the Tweet is relatable for a lot of people, she said.
“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.
The debate begs the question: Is there a duty or ethical reason to disclose?
“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”
If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.
“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”
Knowing how to share the information is another story.
“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”
“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested.
A version of this article first appeared on Medscape.com.
The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”
She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”
The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.
“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.”
“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.
“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”
Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:
“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.
Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”
“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.
Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.
For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”
@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”
Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”
Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.
“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.
Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”
Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”
Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.
“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.
To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.
Still others offered suggestions on how to broach the subject more directly when presenting as a patient:
‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.
@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”
A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.
“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.
Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”
That’s typically a sign that the Tweet is relatable for a lot of people, she said.
“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.
The debate begs the question: Is there a duty or ethical reason to disclose?
“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”
If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.
“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”
Knowing how to share the information is another story.
“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”
“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested.
A version of this article first appeared on Medscape.com.
Fast foods contain endocrine-disrupting chemicals
, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.
The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.
“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.
“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.
A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.
Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.
“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”
The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
Fast foods containing meat had highest concentrations of chemicals
Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.
Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.
The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).
Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.
“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.
The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.
Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.
“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”
Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.
“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”
The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.
The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.
“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.
“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.
A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.
Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.
“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”
The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
Fast foods containing meat had highest concentrations of chemicals
Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.
Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.
The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).
Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.
“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.
The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.
Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.
“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”
Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.
“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”
The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.
The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.
“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.
“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.
A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.
Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.
“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”
The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
Fast foods containing meat had highest concentrations of chemicals
Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.
Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.
The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).
Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.
“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.
The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.
Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.
“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”
Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.
“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”
The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF EXPOSURE SCIENCE & ENVIRONMENTAL EPIDEMIOLOGY