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Promising new neoadjuvant strategy in luminal B breast cancer
SAN ANTONIO – The combination of ribociclib and letrozole proved to be an attractive alternative to standard multidrug neoadjuvant chemotherapy for women with high-risk luminal B breast cancer in the exploratory phase 2 SOLTI-1402/CORALLEEN trial.
Neoadjuvant therapy with ribociclib (Kisqali), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), in combination with the aromatase inhibitor letrozole (Femara) proved as effective for presurgical molecular disease downstaging as standard multiagent chemotherapy, but with considerably less toxicity, Joaquín Gavilá, MD, reported at the San Antonio Breast Cancer Symposium.
“We believe that these results suggest that in clinically high-risk luminal B disease, a chemotherapy-free treatment strategy based upon CDK4/6 inhibition is worth exploring in future neoadjuvant trials,” declared Dr. Gavilá, a medical oncologist at the Valencia (Spain) Institute of Oncology.
SOLTI-1402/CORALLEEN was an open-label, multicenter trial involving 106 postmenopausal women with hormone receptor–positive and HER2-negative stage I-IIIA breast cancer, an operable tumor size of at least 2 cm measured by MRI, and high-risk luminal B subtype disease as defined via the Prosigna genomic tumor profiling test, also known as PAM50, on which they had a baseline median Risk of Recurrence (ROR) score of 74 out of a possible 100 points. The luminal B subtype accounts for 30%-40% of all hormone receptor–positive/HER2-negative breast cancer and carries a greater than 10% risk of distant recurrence at 10 years.
The women were randomized to 6 months of neoadjuvant therapy involving one of two regimens: six 28-day cycles of oral ribociclib at 600 mg once daily for 3 weeks followed by 1 week off plus daily oral letrozole at 2.5 mg/day; or four cycles of intravenous doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every 21 days, then weekly intravenous paclitaxel at 80 mg/m2 for 12 weeks.
The primary study endpoint was achievement of a low ROR score at the time of surgery: that is, a score below 40 points if pathologically node-negative at surgery, and below 15 with one to three positive nodes, which are the cutoffs for a less than 10% risk of distant recurrence at 10 years. A low ROR score was accomplished in 47% of the ribociclib/letrozole group and 46% of patients on standard multiagent chemotherapy. The median ROR score improved from 74 points at baseline to 18 in the investigational treatment arm and 25 in the standard chemotherapy arm.
“In other words, we observed that nearly half of the patients were downstaged from high risk to low risk in both treatment arms,” Dr. Gavilá noted.
Another 31% of patients in both treatment arms were ROR-intermediate at surgery.
The reduction in ROR score at day 15 of the study was more pronounced in the ribociclib/letrozole group than in the chemotherapy arm.
Turning to secondary outcomes, Dr. Gavilá noted that a Residual Cancer Burden score of 0 or 1, correlating with a pathologic complete response or minimal residual disease at time of surgery, was documented in 6% of the ribociclib/letrozole group and 12% of the chemotherapy group. A Preoperative Endocrine Prognostic Index (PEPI) score of 0 was attained in 22% of the novel treatment group and similarly in 17% of those on chemotherapy. Median levels of the tumor cell proliferation biomarker Ki 67 improved from 32% at baseline to 3% in the ribociclib/letrozole group and 10% in the chemotherapy arm. Eighty-eight percent of the ribociclib/letrozole group converted from luminal B to the less aggressive luminal A intrinsic subtype, as did 83% of patients following neoadjuvant chemotherapy.
The rate of serious adverse events was 4% in the ribociclib/letrozole group and 15% in the chemotherapy arm. The most common grade 3 or higher adverse event was neutropenia in both study arms, followed by increased transaminase levels in the ribociclib/letrozole group and febrile neutropenia in the chemotherapy arm. Fifty-nine percent of the ribociclib/letrozole group experienced an adverse event leading to dose reduction or temporary interruption of treatment, as did 83% of the chemotherapy group.
The SOLTI-1402/CORALLEEN trial was sponsored by Novartis, the Breast Cancer Research Foundation, The American Association for Cancer Research, and the Breast Cancer Now Career Catalyst. Dr. Gavilá reported serving as a consultant to Novartis, Roche, and MSD.
Simultaneously with Dr. Gavilá’s presentation in San Antonio, the study results were published online in The Lancet Oncology.
In an accompanying editorial, Massimo Cristofanilli, MD, opined that while the novel neoadjuvant treatment strategy tested in SOLTI-1402/CORALLEEN is promising, the most important concept introduced in the study is that a molecular subtyping tool such the Prosigna test can be used to assess the success of neoadjuvant therapy.
“The increasing availability of molecular testing in both the primary and metastatic setting is contributing to a change in the ability to stratify, select, and monitor disease biology and molecular evolution. This is resulting in the introduction of new frameworks in breast cancer treatments with potentially profound effects on patient outcomes and quality of life,” according to Dr. Cristofanilli, professor of medicine at Northwestern University, Chicago.
SOURCE: Gavilá J. SABCS 2019 Abstract GS2-06.
SAN ANTONIO – The combination of ribociclib and letrozole proved to be an attractive alternative to standard multidrug neoadjuvant chemotherapy for women with high-risk luminal B breast cancer in the exploratory phase 2 SOLTI-1402/CORALLEEN trial.
Neoadjuvant therapy with ribociclib (Kisqali), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), in combination with the aromatase inhibitor letrozole (Femara) proved as effective for presurgical molecular disease downstaging as standard multiagent chemotherapy, but with considerably less toxicity, Joaquín Gavilá, MD, reported at the San Antonio Breast Cancer Symposium.
“We believe that these results suggest that in clinically high-risk luminal B disease, a chemotherapy-free treatment strategy based upon CDK4/6 inhibition is worth exploring in future neoadjuvant trials,” declared Dr. Gavilá, a medical oncologist at the Valencia (Spain) Institute of Oncology.
SOLTI-1402/CORALLEEN was an open-label, multicenter trial involving 106 postmenopausal women with hormone receptor–positive and HER2-negative stage I-IIIA breast cancer, an operable tumor size of at least 2 cm measured by MRI, and high-risk luminal B subtype disease as defined via the Prosigna genomic tumor profiling test, also known as PAM50, on which they had a baseline median Risk of Recurrence (ROR) score of 74 out of a possible 100 points. The luminal B subtype accounts for 30%-40% of all hormone receptor–positive/HER2-negative breast cancer and carries a greater than 10% risk of distant recurrence at 10 years.
The women were randomized to 6 months of neoadjuvant therapy involving one of two regimens: six 28-day cycles of oral ribociclib at 600 mg once daily for 3 weeks followed by 1 week off plus daily oral letrozole at 2.5 mg/day; or four cycles of intravenous doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every 21 days, then weekly intravenous paclitaxel at 80 mg/m2 for 12 weeks.
The primary study endpoint was achievement of a low ROR score at the time of surgery: that is, a score below 40 points if pathologically node-negative at surgery, and below 15 with one to three positive nodes, which are the cutoffs for a less than 10% risk of distant recurrence at 10 years. A low ROR score was accomplished in 47% of the ribociclib/letrozole group and 46% of patients on standard multiagent chemotherapy. The median ROR score improved from 74 points at baseline to 18 in the investigational treatment arm and 25 in the standard chemotherapy arm.
“In other words, we observed that nearly half of the patients were downstaged from high risk to low risk in both treatment arms,” Dr. Gavilá noted.
Another 31% of patients in both treatment arms were ROR-intermediate at surgery.
The reduction in ROR score at day 15 of the study was more pronounced in the ribociclib/letrozole group than in the chemotherapy arm.
Turning to secondary outcomes, Dr. Gavilá noted that a Residual Cancer Burden score of 0 or 1, correlating with a pathologic complete response or minimal residual disease at time of surgery, was documented in 6% of the ribociclib/letrozole group and 12% of the chemotherapy group. A Preoperative Endocrine Prognostic Index (PEPI) score of 0 was attained in 22% of the novel treatment group and similarly in 17% of those on chemotherapy. Median levels of the tumor cell proliferation biomarker Ki 67 improved from 32% at baseline to 3% in the ribociclib/letrozole group and 10% in the chemotherapy arm. Eighty-eight percent of the ribociclib/letrozole group converted from luminal B to the less aggressive luminal A intrinsic subtype, as did 83% of patients following neoadjuvant chemotherapy.
The rate of serious adverse events was 4% in the ribociclib/letrozole group and 15% in the chemotherapy arm. The most common grade 3 or higher adverse event was neutropenia in both study arms, followed by increased transaminase levels in the ribociclib/letrozole group and febrile neutropenia in the chemotherapy arm. Fifty-nine percent of the ribociclib/letrozole group experienced an adverse event leading to dose reduction or temporary interruption of treatment, as did 83% of the chemotherapy group.
The SOLTI-1402/CORALLEEN trial was sponsored by Novartis, the Breast Cancer Research Foundation, The American Association for Cancer Research, and the Breast Cancer Now Career Catalyst. Dr. Gavilá reported serving as a consultant to Novartis, Roche, and MSD.
Simultaneously with Dr. Gavilá’s presentation in San Antonio, the study results were published online in The Lancet Oncology.
In an accompanying editorial, Massimo Cristofanilli, MD, opined that while the novel neoadjuvant treatment strategy tested in SOLTI-1402/CORALLEEN is promising, the most important concept introduced in the study is that a molecular subtyping tool such the Prosigna test can be used to assess the success of neoadjuvant therapy.
“The increasing availability of molecular testing in both the primary and metastatic setting is contributing to a change in the ability to stratify, select, and monitor disease biology and molecular evolution. This is resulting in the introduction of new frameworks in breast cancer treatments with potentially profound effects on patient outcomes and quality of life,” according to Dr. Cristofanilli, professor of medicine at Northwestern University, Chicago.
SOURCE: Gavilá J. SABCS 2019 Abstract GS2-06.
SAN ANTONIO – The combination of ribociclib and letrozole proved to be an attractive alternative to standard multidrug neoadjuvant chemotherapy for women with high-risk luminal B breast cancer in the exploratory phase 2 SOLTI-1402/CORALLEEN trial.
Neoadjuvant therapy with ribociclib (Kisqali), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), in combination with the aromatase inhibitor letrozole (Femara) proved as effective for presurgical molecular disease downstaging as standard multiagent chemotherapy, but with considerably less toxicity, Joaquín Gavilá, MD, reported at the San Antonio Breast Cancer Symposium.
“We believe that these results suggest that in clinically high-risk luminal B disease, a chemotherapy-free treatment strategy based upon CDK4/6 inhibition is worth exploring in future neoadjuvant trials,” declared Dr. Gavilá, a medical oncologist at the Valencia (Spain) Institute of Oncology.
SOLTI-1402/CORALLEEN was an open-label, multicenter trial involving 106 postmenopausal women with hormone receptor–positive and HER2-negative stage I-IIIA breast cancer, an operable tumor size of at least 2 cm measured by MRI, and high-risk luminal B subtype disease as defined via the Prosigna genomic tumor profiling test, also known as PAM50, on which they had a baseline median Risk of Recurrence (ROR) score of 74 out of a possible 100 points. The luminal B subtype accounts for 30%-40% of all hormone receptor–positive/HER2-negative breast cancer and carries a greater than 10% risk of distant recurrence at 10 years.
The women were randomized to 6 months of neoadjuvant therapy involving one of two regimens: six 28-day cycles of oral ribociclib at 600 mg once daily for 3 weeks followed by 1 week off plus daily oral letrozole at 2.5 mg/day; or four cycles of intravenous doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every 21 days, then weekly intravenous paclitaxel at 80 mg/m2 for 12 weeks.
The primary study endpoint was achievement of a low ROR score at the time of surgery: that is, a score below 40 points if pathologically node-negative at surgery, and below 15 with one to three positive nodes, which are the cutoffs for a less than 10% risk of distant recurrence at 10 years. A low ROR score was accomplished in 47% of the ribociclib/letrozole group and 46% of patients on standard multiagent chemotherapy. The median ROR score improved from 74 points at baseline to 18 in the investigational treatment arm and 25 in the standard chemotherapy arm.
“In other words, we observed that nearly half of the patients were downstaged from high risk to low risk in both treatment arms,” Dr. Gavilá noted.
Another 31% of patients in both treatment arms were ROR-intermediate at surgery.
The reduction in ROR score at day 15 of the study was more pronounced in the ribociclib/letrozole group than in the chemotherapy arm.
Turning to secondary outcomes, Dr. Gavilá noted that a Residual Cancer Burden score of 0 or 1, correlating with a pathologic complete response or minimal residual disease at time of surgery, was documented in 6% of the ribociclib/letrozole group and 12% of the chemotherapy group. A Preoperative Endocrine Prognostic Index (PEPI) score of 0 was attained in 22% of the novel treatment group and similarly in 17% of those on chemotherapy. Median levels of the tumor cell proliferation biomarker Ki 67 improved from 32% at baseline to 3% in the ribociclib/letrozole group and 10% in the chemotherapy arm. Eighty-eight percent of the ribociclib/letrozole group converted from luminal B to the less aggressive luminal A intrinsic subtype, as did 83% of patients following neoadjuvant chemotherapy.
The rate of serious adverse events was 4% in the ribociclib/letrozole group and 15% in the chemotherapy arm. The most common grade 3 or higher adverse event was neutropenia in both study arms, followed by increased transaminase levels in the ribociclib/letrozole group and febrile neutropenia in the chemotherapy arm. Fifty-nine percent of the ribociclib/letrozole group experienced an adverse event leading to dose reduction or temporary interruption of treatment, as did 83% of the chemotherapy group.
The SOLTI-1402/CORALLEEN trial was sponsored by Novartis, the Breast Cancer Research Foundation, The American Association for Cancer Research, and the Breast Cancer Now Career Catalyst. Dr. Gavilá reported serving as a consultant to Novartis, Roche, and MSD.
Simultaneously with Dr. Gavilá’s presentation in San Antonio, the study results were published online in The Lancet Oncology.
In an accompanying editorial, Massimo Cristofanilli, MD, opined that while the novel neoadjuvant treatment strategy tested in SOLTI-1402/CORALLEEN is promising, the most important concept introduced in the study is that a molecular subtyping tool such the Prosigna test can be used to assess the success of neoadjuvant therapy.
“The increasing availability of molecular testing in both the primary and metastatic setting is contributing to a change in the ability to stratify, select, and monitor disease biology and molecular evolution. This is resulting in the introduction of new frameworks in breast cancer treatments with potentially profound effects on patient outcomes and quality of life,” according to Dr. Cristofanilli, professor of medicine at Northwestern University, Chicago.
SOURCE: Gavilá J. SABCS 2019 Abstract GS2-06.
REPORTING FROM SABCS 2019
Switch to biologic for RA more about prescribers than patients
The length of time a patient with rheumatoid arthritis takes a conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate before switching to a biologic DMARD varies widely, and the variation is largely related to differences in prescriber preference, researchers say.
They found that 65% of the variation was attributed to differences between prescribers rather than patient variables. Another 4.6% was associated with regional differences in biologic DMARD use, and 30.4% of the variation was unexplained.
“Although disparities in access to biologic DMARDs increased in this study, the overall prescription percentage decreased relative to the population of active medication users with RA. This suggests that despite rheumatologists prescribing fewer biologic DMARDs on average per patient per unit of time, variations in the prescription of biologic DMARDs continue to grow,” the researchers explain.
The clinical implications of these differences in prescriber preferences are unclear, but the findings “show that between-prescriber differences exist in health care delivery for patients with RA, despite identical health insurance coverage,” they continue.
Mark Tatangelo of the University of Toronto and colleagues published their findings online Dec. 6, 2019, in JAMA Network Open.
They examined factors associated with the length of time from first csDMARD to receipt of first biologic in a retrospective cohort study using administrative data for 17,672 patients with RA and identical single-payer health insurance coverage in Ontario.
Patients were aged 67 years or older, had incident RA, and had received at least one csDMARD. The observation window was 2002 to 2015. During the study 719 patients (4.1%) received a first biologic DMARD. The primary outcome was time from first csDMARD to receipt of first biologic DMARD.
In an invited commentary, Natalie McCormick, PhD, from the clinical epidemiology program at Massachusetts General Hospital in Boston, writes: “A distinctive feature of the report by Tatangelo et al. was the emphasis on longer time to initiation of biologic therapy as an ideal outcome.”
Factors associated with a quicker move from csDMARDs to biologic DMARDs included younger age, female sex, living in an urban area close to prescribers, and longer disease duration. The shift to biologic DMARDs was also earlier for prescribers who were more recent graduates, in urban areas, and in areas with a greater supply of rheumatologists.
Dr. McCormick suggests that the association between earlier biologic DMARD use and higher concentration of rheumatologists might indicate that “peer effects” influence prescribing decisions.
Factors associated with a more prolonged time on csDMARDs before beginning a biologic DMARD included older age, male sex, and distance to the nearest rheumatologist.
Immigrants born outside of Canada were 41% less likely to have begun biologic DMARDs. “While its mechanism and implications warrant further investigation, this finding is novel and compelling, and it could become increasingly important,” Dr. McCormick writes.
The variation in highest biologic DMARD use, compared with lowest use among the regions in Ontario rose from 1.8% in 2002 to 8.7% in 2015. In models adjusted for age, sex, calendar year, and all patient and physician covariates, regional differences accounted for 4.6% of the variation in biologic DMARD prescription.
“A 4.6% difference in time to receipt of biologic DMARDs between regions should be considered problematic in the absence of other explanatory factors,” the authors write. “For example, every 1% increase in biologic prescriptions among a population of 72,000 funded patients with RA costs approximately CaD $10.8 million (U.S. $8.25 million) per year (assuming 10% biologics penetration and CaD $15,000 annually per biologic DMARD prescription [U.S. $11,460]).”
They explain that reducing the highest spending region in Ontario to the average spend would save approximately CaD $6 million to $8 million (U.S. $4.6 million to $6.1 million) per year, whereas increasing biologic use in the underserved regions to the population average would cost about CaD $6 million to $8 million (U.S. $4.6 million to $6.1 million).
Dr. McCormick writes that both undertreatment and overtreatment need more study and adds that the age gradient identified in this study “may reflect an ongoing bias against prescribing biologic DMARDs to elderly patients, despite a lack of evidence that older patients have a higher risk of infections or other adverse events.”
Dr. McCormick and the researchers emphasize that the decision to begin biologic DMARDs should not be taken lightly. “[S]mall changes in time to first biologic DMARD have major clinical and economic impacts. From a clinical perspective, the prescription of a biologic DMARD represents a transition to a more complex care plan, with less data to support the next prescription choice after the first biologic DMARD,” the authors warn.
This study was funded by grants from the Canadian Institute of Health Research, the Arthritis Society, the Ontario Drug Policy Research and Effectiveness Network, and the Canadian Institute of Health Research Drug Safety and Effectiveness Network. This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care.
Several study authors report receiving consulting fees from Amgen, Covance, Roche, Novartis, Sanofi, Merck, and Eli Lilly; grants and consulting fees from AbbVie, Janssen Pharmaceuticals, Hospira, Merck, Pfizer, Sanofi, and Novartis; and grants from Amgen, Eli Lilly, Celgene, Medexus, Medreleaf, Roche, and Union Chimique Belge.
Dr. McCormick reports a fellowship award from the Canadian Institutes of Health Research.
SOURCES: Tatangelo M et al. JAMA Netw Open. 2019;2(12):e1917053. doi: 10.1001/jamanetworkopen.2019.17053; McCormick N. JAMA Netw Open. 2019;2(12):e1917065. doi: 10.1001/jamanetworkopen.2019.17065
This story first appeared on Medscape.com.
The length of time a patient with rheumatoid arthritis takes a conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate before switching to a biologic DMARD varies widely, and the variation is largely related to differences in prescriber preference, researchers say.
They found that 65% of the variation was attributed to differences between prescribers rather than patient variables. Another 4.6% was associated with regional differences in biologic DMARD use, and 30.4% of the variation was unexplained.
“Although disparities in access to biologic DMARDs increased in this study, the overall prescription percentage decreased relative to the population of active medication users with RA. This suggests that despite rheumatologists prescribing fewer biologic DMARDs on average per patient per unit of time, variations in the prescription of biologic DMARDs continue to grow,” the researchers explain.
The clinical implications of these differences in prescriber preferences are unclear, but the findings “show that between-prescriber differences exist in health care delivery for patients with RA, despite identical health insurance coverage,” they continue.
Mark Tatangelo of the University of Toronto and colleagues published their findings online Dec. 6, 2019, in JAMA Network Open.
They examined factors associated with the length of time from first csDMARD to receipt of first biologic in a retrospective cohort study using administrative data for 17,672 patients with RA and identical single-payer health insurance coverage in Ontario.
Patients were aged 67 years or older, had incident RA, and had received at least one csDMARD. The observation window was 2002 to 2015. During the study 719 patients (4.1%) received a first biologic DMARD. The primary outcome was time from first csDMARD to receipt of first biologic DMARD.
In an invited commentary, Natalie McCormick, PhD, from the clinical epidemiology program at Massachusetts General Hospital in Boston, writes: “A distinctive feature of the report by Tatangelo et al. was the emphasis on longer time to initiation of biologic therapy as an ideal outcome.”
Factors associated with a quicker move from csDMARDs to biologic DMARDs included younger age, female sex, living in an urban area close to prescribers, and longer disease duration. The shift to biologic DMARDs was also earlier for prescribers who were more recent graduates, in urban areas, and in areas with a greater supply of rheumatologists.
Dr. McCormick suggests that the association between earlier biologic DMARD use and higher concentration of rheumatologists might indicate that “peer effects” influence prescribing decisions.
Factors associated with a more prolonged time on csDMARDs before beginning a biologic DMARD included older age, male sex, and distance to the nearest rheumatologist.
Immigrants born outside of Canada were 41% less likely to have begun biologic DMARDs. “While its mechanism and implications warrant further investigation, this finding is novel and compelling, and it could become increasingly important,” Dr. McCormick writes.
The variation in highest biologic DMARD use, compared with lowest use among the regions in Ontario rose from 1.8% in 2002 to 8.7% in 2015. In models adjusted for age, sex, calendar year, and all patient and physician covariates, regional differences accounted for 4.6% of the variation in biologic DMARD prescription.
“A 4.6% difference in time to receipt of biologic DMARDs between regions should be considered problematic in the absence of other explanatory factors,” the authors write. “For example, every 1% increase in biologic prescriptions among a population of 72,000 funded patients with RA costs approximately CaD $10.8 million (U.S. $8.25 million) per year (assuming 10% biologics penetration and CaD $15,000 annually per biologic DMARD prescription [U.S. $11,460]).”
They explain that reducing the highest spending region in Ontario to the average spend would save approximately CaD $6 million to $8 million (U.S. $4.6 million to $6.1 million) per year, whereas increasing biologic use in the underserved regions to the population average would cost about CaD $6 million to $8 million (U.S. $4.6 million to $6.1 million).
Dr. McCormick writes that both undertreatment and overtreatment need more study and adds that the age gradient identified in this study “may reflect an ongoing bias against prescribing biologic DMARDs to elderly patients, despite a lack of evidence that older patients have a higher risk of infections or other adverse events.”
Dr. McCormick and the researchers emphasize that the decision to begin biologic DMARDs should not be taken lightly. “[S]mall changes in time to first biologic DMARD have major clinical and economic impacts. From a clinical perspective, the prescription of a biologic DMARD represents a transition to a more complex care plan, with less data to support the next prescription choice after the first biologic DMARD,” the authors warn.
This study was funded by grants from the Canadian Institute of Health Research, the Arthritis Society, the Ontario Drug Policy Research and Effectiveness Network, and the Canadian Institute of Health Research Drug Safety and Effectiveness Network. This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care.
Several study authors report receiving consulting fees from Amgen, Covance, Roche, Novartis, Sanofi, Merck, and Eli Lilly; grants and consulting fees from AbbVie, Janssen Pharmaceuticals, Hospira, Merck, Pfizer, Sanofi, and Novartis; and grants from Amgen, Eli Lilly, Celgene, Medexus, Medreleaf, Roche, and Union Chimique Belge.
Dr. McCormick reports a fellowship award from the Canadian Institutes of Health Research.
SOURCES: Tatangelo M et al. JAMA Netw Open. 2019;2(12):e1917053. doi: 10.1001/jamanetworkopen.2019.17053; McCormick N. JAMA Netw Open. 2019;2(12):e1917065. doi: 10.1001/jamanetworkopen.2019.17065
This story first appeared on Medscape.com.
The length of time a patient with rheumatoid arthritis takes a conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate before switching to a biologic DMARD varies widely, and the variation is largely related to differences in prescriber preference, researchers say.
They found that 65% of the variation was attributed to differences between prescribers rather than patient variables. Another 4.6% was associated with regional differences in biologic DMARD use, and 30.4% of the variation was unexplained.
“Although disparities in access to biologic DMARDs increased in this study, the overall prescription percentage decreased relative to the population of active medication users with RA. This suggests that despite rheumatologists prescribing fewer biologic DMARDs on average per patient per unit of time, variations in the prescription of biologic DMARDs continue to grow,” the researchers explain.
The clinical implications of these differences in prescriber preferences are unclear, but the findings “show that between-prescriber differences exist in health care delivery for patients with RA, despite identical health insurance coverage,” they continue.
Mark Tatangelo of the University of Toronto and colleagues published their findings online Dec. 6, 2019, in JAMA Network Open.
They examined factors associated with the length of time from first csDMARD to receipt of first biologic in a retrospective cohort study using administrative data for 17,672 patients with RA and identical single-payer health insurance coverage in Ontario.
Patients were aged 67 years or older, had incident RA, and had received at least one csDMARD. The observation window was 2002 to 2015. During the study 719 patients (4.1%) received a first biologic DMARD. The primary outcome was time from first csDMARD to receipt of first biologic DMARD.
In an invited commentary, Natalie McCormick, PhD, from the clinical epidemiology program at Massachusetts General Hospital in Boston, writes: “A distinctive feature of the report by Tatangelo et al. was the emphasis on longer time to initiation of biologic therapy as an ideal outcome.”
Factors associated with a quicker move from csDMARDs to biologic DMARDs included younger age, female sex, living in an urban area close to prescribers, and longer disease duration. The shift to biologic DMARDs was also earlier for prescribers who were more recent graduates, in urban areas, and in areas with a greater supply of rheumatologists.
Dr. McCormick suggests that the association between earlier biologic DMARD use and higher concentration of rheumatologists might indicate that “peer effects” influence prescribing decisions.
Factors associated with a more prolonged time on csDMARDs before beginning a biologic DMARD included older age, male sex, and distance to the nearest rheumatologist.
Immigrants born outside of Canada were 41% less likely to have begun biologic DMARDs. “While its mechanism and implications warrant further investigation, this finding is novel and compelling, and it could become increasingly important,” Dr. McCormick writes.
The variation in highest biologic DMARD use, compared with lowest use among the regions in Ontario rose from 1.8% in 2002 to 8.7% in 2015. In models adjusted for age, sex, calendar year, and all patient and physician covariates, regional differences accounted for 4.6% of the variation in biologic DMARD prescription.
“A 4.6% difference in time to receipt of biologic DMARDs between regions should be considered problematic in the absence of other explanatory factors,” the authors write. “For example, every 1% increase in biologic prescriptions among a population of 72,000 funded patients with RA costs approximately CaD $10.8 million (U.S. $8.25 million) per year (assuming 10% biologics penetration and CaD $15,000 annually per biologic DMARD prescription [U.S. $11,460]).”
They explain that reducing the highest spending region in Ontario to the average spend would save approximately CaD $6 million to $8 million (U.S. $4.6 million to $6.1 million) per year, whereas increasing biologic use in the underserved regions to the population average would cost about CaD $6 million to $8 million (U.S. $4.6 million to $6.1 million).
Dr. McCormick writes that both undertreatment and overtreatment need more study and adds that the age gradient identified in this study “may reflect an ongoing bias against prescribing biologic DMARDs to elderly patients, despite a lack of evidence that older patients have a higher risk of infections or other adverse events.”
Dr. McCormick and the researchers emphasize that the decision to begin biologic DMARDs should not be taken lightly. “[S]mall changes in time to first biologic DMARD have major clinical and economic impacts. From a clinical perspective, the prescription of a biologic DMARD represents a transition to a more complex care plan, with less data to support the next prescription choice after the first biologic DMARD,” the authors warn.
This study was funded by grants from the Canadian Institute of Health Research, the Arthritis Society, the Ontario Drug Policy Research and Effectiveness Network, and the Canadian Institute of Health Research Drug Safety and Effectiveness Network. This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care.
Several study authors report receiving consulting fees from Amgen, Covance, Roche, Novartis, Sanofi, Merck, and Eli Lilly; grants and consulting fees from AbbVie, Janssen Pharmaceuticals, Hospira, Merck, Pfizer, Sanofi, and Novartis; and grants from Amgen, Eli Lilly, Celgene, Medexus, Medreleaf, Roche, and Union Chimique Belge.
Dr. McCormick reports a fellowship award from the Canadian Institutes of Health Research.
SOURCES: Tatangelo M et al. JAMA Netw Open. 2019;2(12):e1917053. doi: 10.1001/jamanetworkopen.2019.17053; McCormick N. JAMA Netw Open. 2019;2(12):e1917065. doi: 10.1001/jamanetworkopen.2019.17065
This story first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
APHINITY 6-year data: Benefit ongoing in HER2+ early BC, no significant OS benefit
SAN ANTONIO – Adding pertuzumab to trastuzumab and chemotherapy after surgery for HER2-positive early breast cancer continued to show a slight, but statistically nonsignificant overall survival benefit, compared with placebo, at a preplanned 6-year interim analysis of the phase 3 APHINITY trial.
Invasive disease-free survival (IDFS) was significantly improved with pertuzumab at this second interim analysis, and node-positive patients continued to derive the greatest benefit, as was the case in the primary analysis reported in the New England Journal of Medicine in 2017, Martine Piccart, MD, PhD, reported at the San Antonio Breast Cancer Symposium.
At a median of 74.1 months of follow-up, overall survival (OS) was 94.8% in 2,400 patients in the pertuzumab arm, compared with 93.9% in 2,405 patients in the placebo arm (hazard ratio, 0.85), said Dr. Piccart of Institut Jules Bordet, Brussels.
She noted that a “very stringent” P value of.0012 was required for statistical significance in this interim OS analysis.
IDFS rates at follow-up were 90.6% vs. 87.8% in the intent-to-treat population, a difference caused mainly by a reduction in distant and loco-regional recurrence, she noted.
“[That translates] to a 2.8% absolute improvement with pertuzumab at 6 years,” she said, adding that the risk of both distant and loco-regional recurrences was reduced with pertuzumab. “The rate of [central nervous system] metastases, contralateral invasive breast cancers, and death without a prior event – not different between the two treatment groups.”
In the node-positive cohort, the 6-year IDFS rates were 87.9% vs. 83.4% with pertuzumab vs. placebo (4.5% absolute benefit; HR, 0.72), showing a clear benefit.
“In contrast, no treatment effect is detected in the node-negative population [95.0% and 94.9%, respectively; HR, 1.02],” she said.
Importantly, the clinical benefits were seen regardless of hormone receptor status (HRs, 0.73 and 0.83 for hormone receptor–positive and –negative disease, respectively), she said, noting that this finding differs from the 3-year analysis, which suggested an enhanced benefit only in the hormone receptor–negative cohort.
“These [hormone receptor–negative] patients still benefit from pertuzumab ... but interestingly, now the curves are diverging in the hormone receptor–positive population, and there is a benefit emerging,” she said.
An updated descriptive analysis of cardiac safety was also performed, and no new safety concerns emerged, Dr. Piccart said.
“What is important to remember is the rate of severe cardiac events is below 1% in both groups (0.8% and 0.3% with pertuzumab and placebo),” she said.
APHINITY is a randomized, multicenter, double-blind, placebo-controlled trial which previously demonstrated that pertuzumab added to standard chemotherapy plus 1 year of trastuzumab in operable HER2-positive breast cancer was associated with modest but statistically significant improvement in IDFS, compared with placebo and chemotherapy plus trastuzumab (HR, 0.81; P = .04).
The effect was more pronounced in node-negative patients (HR, 0.77) and hormone receptor–negative patients (HR, 0.76).
Patients with node-positive or high-risk node-negative, HER2-positive, operable early breast cancer were enrolled between November 2011 and August 2013, and the primary analysis was conducted at 45.4 months of follow-up. Based on those findings, pertuzumab in combination with trastuzumab was approved for high-risk early HER2-positive breast cancer patients.
The first interim OS analysis was conducted at that time, and no significant treatment effect was observed, Dr. Piccart said.
The 6-year findings demonstrate that the small OS benefit and the statistically significant IDFS benefit with pertuzumab in this setting is maintained, with the node-positive population deriving the greatest benefit.
“Further follow-up will be very important to determine whether there is a survival benefit associated with pertuzumab administration in early HER2-positive breast cancer,” she said, noting that a calendar-driven third interim OS analysis is planned in 2.5 years.
The APHINITY trial is funded by Roche. Dr. Piccart reported receiving consulting fees from Roche and research funding to her institution from Roche and several other companies. She also is a consultant for the advisory boards of AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Huya Bioscience International, and Immunomedics.
SOURCE: Piccart M et al. SABCS 2019, Abstract GS1-04.
SAN ANTONIO – Adding pertuzumab to trastuzumab and chemotherapy after surgery for HER2-positive early breast cancer continued to show a slight, but statistically nonsignificant overall survival benefit, compared with placebo, at a preplanned 6-year interim analysis of the phase 3 APHINITY trial.
Invasive disease-free survival (IDFS) was significantly improved with pertuzumab at this second interim analysis, and node-positive patients continued to derive the greatest benefit, as was the case in the primary analysis reported in the New England Journal of Medicine in 2017, Martine Piccart, MD, PhD, reported at the San Antonio Breast Cancer Symposium.
At a median of 74.1 months of follow-up, overall survival (OS) was 94.8% in 2,400 patients in the pertuzumab arm, compared with 93.9% in 2,405 patients in the placebo arm (hazard ratio, 0.85), said Dr. Piccart of Institut Jules Bordet, Brussels.
She noted that a “very stringent” P value of.0012 was required for statistical significance in this interim OS analysis.
IDFS rates at follow-up were 90.6% vs. 87.8% in the intent-to-treat population, a difference caused mainly by a reduction in distant and loco-regional recurrence, she noted.
“[That translates] to a 2.8% absolute improvement with pertuzumab at 6 years,” she said, adding that the risk of both distant and loco-regional recurrences was reduced with pertuzumab. “The rate of [central nervous system] metastases, contralateral invasive breast cancers, and death without a prior event – not different between the two treatment groups.”
In the node-positive cohort, the 6-year IDFS rates were 87.9% vs. 83.4% with pertuzumab vs. placebo (4.5% absolute benefit; HR, 0.72), showing a clear benefit.
“In contrast, no treatment effect is detected in the node-negative population [95.0% and 94.9%, respectively; HR, 1.02],” she said.
Importantly, the clinical benefits were seen regardless of hormone receptor status (HRs, 0.73 and 0.83 for hormone receptor–positive and –negative disease, respectively), she said, noting that this finding differs from the 3-year analysis, which suggested an enhanced benefit only in the hormone receptor–negative cohort.
“These [hormone receptor–negative] patients still benefit from pertuzumab ... but interestingly, now the curves are diverging in the hormone receptor–positive population, and there is a benefit emerging,” she said.
An updated descriptive analysis of cardiac safety was also performed, and no new safety concerns emerged, Dr. Piccart said.
“What is important to remember is the rate of severe cardiac events is below 1% in both groups (0.8% and 0.3% with pertuzumab and placebo),” she said.
APHINITY is a randomized, multicenter, double-blind, placebo-controlled trial which previously demonstrated that pertuzumab added to standard chemotherapy plus 1 year of trastuzumab in operable HER2-positive breast cancer was associated with modest but statistically significant improvement in IDFS, compared with placebo and chemotherapy plus trastuzumab (HR, 0.81; P = .04).
The effect was more pronounced in node-negative patients (HR, 0.77) and hormone receptor–negative patients (HR, 0.76).
Patients with node-positive or high-risk node-negative, HER2-positive, operable early breast cancer were enrolled between November 2011 and August 2013, and the primary analysis was conducted at 45.4 months of follow-up. Based on those findings, pertuzumab in combination with trastuzumab was approved for high-risk early HER2-positive breast cancer patients.
The first interim OS analysis was conducted at that time, and no significant treatment effect was observed, Dr. Piccart said.
The 6-year findings demonstrate that the small OS benefit and the statistically significant IDFS benefit with pertuzumab in this setting is maintained, with the node-positive population deriving the greatest benefit.
“Further follow-up will be very important to determine whether there is a survival benefit associated with pertuzumab administration in early HER2-positive breast cancer,” she said, noting that a calendar-driven third interim OS analysis is planned in 2.5 years.
The APHINITY trial is funded by Roche. Dr. Piccart reported receiving consulting fees from Roche and research funding to her institution from Roche and several other companies. She also is a consultant for the advisory boards of AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Huya Bioscience International, and Immunomedics.
SOURCE: Piccart M et al. SABCS 2019, Abstract GS1-04.
SAN ANTONIO – Adding pertuzumab to trastuzumab and chemotherapy after surgery for HER2-positive early breast cancer continued to show a slight, but statistically nonsignificant overall survival benefit, compared with placebo, at a preplanned 6-year interim analysis of the phase 3 APHINITY trial.
Invasive disease-free survival (IDFS) was significantly improved with pertuzumab at this second interim analysis, and node-positive patients continued to derive the greatest benefit, as was the case in the primary analysis reported in the New England Journal of Medicine in 2017, Martine Piccart, MD, PhD, reported at the San Antonio Breast Cancer Symposium.
At a median of 74.1 months of follow-up, overall survival (OS) was 94.8% in 2,400 patients in the pertuzumab arm, compared with 93.9% in 2,405 patients in the placebo arm (hazard ratio, 0.85), said Dr. Piccart of Institut Jules Bordet, Brussels.
She noted that a “very stringent” P value of.0012 was required for statistical significance in this interim OS analysis.
IDFS rates at follow-up were 90.6% vs. 87.8% in the intent-to-treat population, a difference caused mainly by a reduction in distant and loco-regional recurrence, she noted.
“[That translates] to a 2.8% absolute improvement with pertuzumab at 6 years,” she said, adding that the risk of both distant and loco-regional recurrences was reduced with pertuzumab. “The rate of [central nervous system] metastases, contralateral invasive breast cancers, and death without a prior event – not different between the two treatment groups.”
In the node-positive cohort, the 6-year IDFS rates were 87.9% vs. 83.4% with pertuzumab vs. placebo (4.5% absolute benefit; HR, 0.72), showing a clear benefit.
“In contrast, no treatment effect is detected in the node-negative population [95.0% and 94.9%, respectively; HR, 1.02],” she said.
Importantly, the clinical benefits were seen regardless of hormone receptor status (HRs, 0.73 and 0.83 for hormone receptor–positive and –negative disease, respectively), she said, noting that this finding differs from the 3-year analysis, which suggested an enhanced benefit only in the hormone receptor–negative cohort.
“These [hormone receptor–negative] patients still benefit from pertuzumab ... but interestingly, now the curves are diverging in the hormone receptor–positive population, and there is a benefit emerging,” she said.
An updated descriptive analysis of cardiac safety was also performed, and no new safety concerns emerged, Dr. Piccart said.
“What is important to remember is the rate of severe cardiac events is below 1% in both groups (0.8% and 0.3% with pertuzumab and placebo),” she said.
APHINITY is a randomized, multicenter, double-blind, placebo-controlled trial which previously demonstrated that pertuzumab added to standard chemotherapy plus 1 year of trastuzumab in operable HER2-positive breast cancer was associated with modest but statistically significant improvement in IDFS, compared with placebo and chemotherapy plus trastuzumab (HR, 0.81; P = .04).
The effect was more pronounced in node-negative patients (HR, 0.77) and hormone receptor–negative patients (HR, 0.76).
Patients with node-positive or high-risk node-negative, HER2-positive, operable early breast cancer were enrolled between November 2011 and August 2013, and the primary analysis was conducted at 45.4 months of follow-up. Based on those findings, pertuzumab in combination with trastuzumab was approved for high-risk early HER2-positive breast cancer patients.
The first interim OS analysis was conducted at that time, and no significant treatment effect was observed, Dr. Piccart said.
The 6-year findings demonstrate that the small OS benefit and the statistically significant IDFS benefit with pertuzumab in this setting is maintained, with the node-positive population deriving the greatest benefit.
“Further follow-up will be very important to determine whether there is a survival benefit associated with pertuzumab administration in early HER2-positive breast cancer,” she said, noting that a calendar-driven third interim OS analysis is planned in 2.5 years.
The APHINITY trial is funded by Roche. Dr. Piccart reported receiving consulting fees from Roche and research funding to her institution from Roche and several other companies. She also is a consultant for the advisory boards of AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Huya Bioscience International, and Immunomedics.
SOURCE: Piccart M et al. SABCS 2019, Abstract GS1-04.
REPORTING FROM SABCS 2019
Emergency physicians not yet embracing buprenorphine for opioid users
SAN DIEGO – Emergency physicians can be persuaded to follow a recommended strategy to prescribe buprenorphine to patients with opioid addictions and to refer them to follow-up care, Kathryn F. Hawk, MD, said at the annual meeting of the American Academy of Addiction Psychiatry.
“People are willing to change their practices and evolve as long as they have the support to do so,” Dr. Hawk, assistant professor of emergency medicine at Yale University, New Haven, Conn., said at the meeting.
Dr. Hawk highlighted a landmark 2015 study led by Yale colleagues that compared three strategies to treating patients with opioid use disorder in the emergency department. Researchers randomly assigned 329 patients to 1) referral to treatment; 2) brief intervention and facilitated referral to community-based treatment services; and 3) emergency department-initiated treatment with buprenorphine/naloxone (Suboxone) plus referral to primary care for 10-week follow-up.
At 30 days, 78% of patients in the third group were in addiction treatment vs. 37% in the first group and 45% in the second group. (P less than .001). However, the percentage of patients in the groups who had negative urine screens for opioids were not statistically different (JAMA. 2015. Apr 28;313[16]:1636-44).
Both the American College of Emergency Physicians (ACEP) and the American College of Medical Toxicology have endorsed the use of buprenorphine in the ED “as a bridge to long-term addiction treatment,” said Dr. Hawk, who also is affiliated with Yale New Haven Hospital.
Emergency department physicians, however, have been reluctant to start prescribing buprenorphine and get more deeply involved in referrals to care, said E. Jennifer Edelman, MD, associate professor of general internal medicine at Yale. She described the results of a 2017-2019 survey of 268 medical professionals at urban emergency departments in Seattle, Cincinnati, New York City, and Baltimore. Only 20% of the survey respondents said they were “ready” to initiate the buprenorphine treatment protocol.
Researchers also held focus groups with 74 clinicians who offered insight into their hesitation. “That’s not something that we’re even really taught in medical school and certainly not in our training as emergency physicians,” one faculty member said. “It is this detox black box across the street, and that’s how it is in many places.”
Another faculty member expressed regret about the current system: “I feel like this is particularly vulnerable patient population [and] we’re just saying, ‘Here’s a sheet. Call some numbers. Good luck.’ That’s the way it feels when I discharge these folks.” And a resident said: “We can’t provide all of that care up front. It’s just too time-consuming, and there are other patients to see.”
But not all of the findings were grim.
Dr. Edelman said.
According to her, strategies aimed at boosting the Suboxone approach include establishing protocols, and providing leadership support and resources. Addiction psychiatrists also can be helpful, she said.
“Let’s think about partnering together to bridge that gap,” she said. One idea: Invite emergency physicians to observe a treatment initiation.
“Showing how you counsel patients to start medication at home would be really a wonderful way to facilitate practices in the emergency department,” she said.
Another idea, she said, is to “give them feedback on their patients.” If an emergency physician refers a patient and they walk in the door, “let them know how they did. That’s going to be really, really powerful.”
ACEP and the American Society of Addiction Medicine have created a tool aimed at helping facilitate the use of buprenorphine and naloxone in the emergency department.
Dr. Hawk and Dr. Edelman reported no relevant disclosures.
SAN DIEGO – Emergency physicians can be persuaded to follow a recommended strategy to prescribe buprenorphine to patients with opioid addictions and to refer them to follow-up care, Kathryn F. Hawk, MD, said at the annual meeting of the American Academy of Addiction Psychiatry.
“People are willing to change their practices and evolve as long as they have the support to do so,” Dr. Hawk, assistant professor of emergency medicine at Yale University, New Haven, Conn., said at the meeting.
Dr. Hawk highlighted a landmark 2015 study led by Yale colleagues that compared three strategies to treating patients with opioid use disorder in the emergency department. Researchers randomly assigned 329 patients to 1) referral to treatment; 2) brief intervention and facilitated referral to community-based treatment services; and 3) emergency department-initiated treatment with buprenorphine/naloxone (Suboxone) plus referral to primary care for 10-week follow-up.
At 30 days, 78% of patients in the third group were in addiction treatment vs. 37% in the first group and 45% in the second group. (P less than .001). However, the percentage of patients in the groups who had negative urine screens for opioids were not statistically different (JAMA. 2015. Apr 28;313[16]:1636-44).
Both the American College of Emergency Physicians (ACEP) and the American College of Medical Toxicology have endorsed the use of buprenorphine in the ED “as a bridge to long-term addiction treatment,” said Dr. Hawk, who also is affiliated with Yale New Haven Hospital.
Emergency department physicians, however, have been reluctant to start prescribing buprenorphine and get more deeply involved in referrals to care, said E. Jennifer Edelman, MD, associate professor of general internal medicine at Yale. She described the results of a 2017-2019 survey of 268 medical professionals at urban emergency departments in Seattle, Cincinnati, New York City, and Baltimore. Only 20% of the survey respondents said they were “ready” to initiate the buprenorphine treatment protocol.
Researchers also held focus groups with 74 clinicians who offered insight into their hesitation. “That’s not something that we’re even really taught in medical school and certainly not in our training as emergency physicians,” one faculty member said. “It is this detox black box across the street, and that’s how it is in many places.”
Another faculty member expressed regret about the current system: “I feel like this is particularly vulnerable patient population [and] we’re just saying, ‘Here’s a sheet. Call some numbers. Good luck.’ That’s the way it feels when I discharge these folks.” And a resident said: “We can’t provide all of that care up front. It’s just too time-consuming, and there are other patients to see.”
But not all of the findings were grim.
Dr. Edelman said.
According to her, strategies aimed at boosting the Suboxone approach include establishing protocols, and providing leadership support and resources. Addiction psychiatrists also can be helpful, she said.
“Let’s think about partnering together to bridge that gap,” she said. One idea: Invite emergency physicians to observe a treatment initiation.
“Showing how you counsel patients to start medication at home would be really a wonderful way to facilitate practices in the emergency department,” she said.
Another idea, she said, is to “give them feedback on their patients.” If an emergency physician refers a patient and they walk in the door, “let them know how they did. That’s going to be really, really powerful.”
ACEP and the American Society of Addiction Medicine have created a tool aimed at helping facilitate the use of buprenorphine and naloxone in the emergency department.
Dr. Hawk and Dr. Edelman reported no relevant disclosures.
SAN DIEGO – Emergency physicians can be persuaded to follow a recommended strategy to prescribe buprenorphine to patients with opioid addictions and to refer them to follow-up care, Kathryn F. Hawk, MD, said at the annual meeting of the American Academy of Addiction Psychiatry.
“People are willing to change their practices and evolve as long as they have the support to do so,” Dr. Hawk, assistant professor of emergency medicine at Yale University, New Haven, Conn., said at the meeting.
Dr. Hawk highlighted a landmark 2015 study led by Yale colleagues that compared three strategies to treating patients with opioid use disorder in the emergency department. Researchers randomly assigned 329 patients to 1) referral to treatment; 2) brief intervention and facilitated referral to community-based treatment services; and 3) emergency department-initiated treatment with buprenorphine/naloxone (Suboxone) plus referral to primary care for 10-week follow-up.
At 30 days, 78% of patients in the third group were in addiction treatment vs. 37% in the first group and 45% in the second group. (P less than .001). However, the percentage of patients in the groups who had negative urine screens for opioids were not statistically different (JAMA. 2015. Apr 28;313[16]:1636-44).
Both the American College of Emergency Physicians (ACEP) and the American College of Medical Toxicology have endorsed the use of buprenorphine in the ED “as a bridge to long-term addiction treatment,” said Dr. Hawk, who also is affiliated with Yale New Haven Hospital.
Emergency department physicians, however, have been reluctant to start prescribing buprenorphine and get more deeply involved in referrals to care, said E. Jennifer Edelman, MD, associate professor of general internal medicine at Yale. She described the results of a 2017-2019 survey of 268 medical professionals at urban emergency departments in Seattle, Cincinnati, New York City, and Baltimore. Only 20% of the survey respondents said they were “ready” to initiate the buprenorphine treatment protocol.
Researchers also held focus groups with 74 clinicians who offered insight into their hesitation. “That’s not something that we’re even really taught in medical school and certainly not in our training as emergency physicians,” one faculty member said. “It is this detox black box across the street, and that’s how it is in many places.”
Another faculty member expressed regret about the current system: “I feel like this is particularly vulnerable patient population [and] we’re just saying, ‘Here’s a sheet. Call some numbers. Good luck.’ That’s the way it feels when I discharge these folks.” And a resident said: “We can’t provide all of that care up front. It’s just too time-consuming, and there are other patients to see.”
But not all of the findings were grim.
Dr. Edelman said.
According to her, strategies aimed at boosting the Suboxone approach include establishing protocols, and providing leadership support and resources. Addiction psychiatrists also can be helpful, she said.
“Let’s think about partnering together to bridge that gap,” she said. One idea: Invite emergency physicians to observe a treatment initiation.
“Showing how you counsel patients to start medication at home would be really a wonderful way to facilitate practices in the emergency department,” she said.
Another idea, she said, is to “give them feedback on their patients.” If an emergency physician refers a patient and they walk in the door, “let them know how they did. That’s going to be really, really powerful.”
ACEP and the American Society of Addiction Medicine have created a tool aimed at helping facilitate the use of buprenorphine and naloxone in the emergency department.
Dr. Hawk and Dr. Edelman reported no relevant disclosures.
REPORTING FROM AAAP 2019
Albinism awareness goes global in dermatologists’ nonprofit work
A dermatologist-led nonprofit organization has entered into a
Representatives from the New York–based NYDG Foundation, including dermatologist David Colbert, MD, recently signed the agreement with the United Nations High Commissioner for Human Rights. At the center of the inclusivity efforts is the foundation’s ColorFull campaign, which aims to shape a collective response to the discrimination and violence that individuals with albinism face around the world.
“We really need to build more inclusive and communal health care systems for all. Partnering with the United Nations will help us to reach our goals and build stronger bonds with those health care providers working with one of the most marginalized and vulnerable groups in Africa,” Dr. Colbert said in an interview.
Stylish images of individuals with albinism, including prominent model Diandra Forrest, anchor the ColorFull campaign’s messaging; Ms. Forrest is featured in a video posted by the United Nations in November announcing the joint human rights campaign. Because the consequences of albinism can be deadly serious for affected individuals in many parts of the world, awareness is desperately needed, participants in NYDG’s work and in Standing Voice, another nonprofit that provides resources for people with albinism in East Africa, emphasized in interviews.
Striving to do good work
Stephan Bognar, a seasoned leader of international nonprofits, has teamed up with Dr. Colbert, NYDG Foundation’s founding physician, to craft the international campaign to raise awareness of albinism and increase acceptance of those with the condition. “You don’t always have to stand alone to break down the walls of exclusion. The fight for social justice and human rights for persons with albinism requires a collective responsibility,” Mr. Bognar said in an interview.
Dr. Colbert, senior partner of the New York Dermatology Group, a large Manhattan-based practice, founded the nonprofit when he became involved in wound-care efforts in Haiti following the 2010 earthquake. The foundation has since supported such philanthropic efforts as helping people with albinism, offering scholarships, and raising awareness of the importance of sun protection among youth athletes.
“One day, 3 years ago or so, I was reading the New York Times and I came across this article – it was called ‘The Hunted,’ ” Dr. Colbert recalled. “It was something I knew nothing about. In Eastern Africa, people with albinism are often hunted down for body parts and their lives are at risk” from being hunted and murdered – but also because their body parts are used for witchcraft and magic, he noted.
“I was captivated by that, and I remember I called Stephan, and I said, ‘I have a project for you.’ ” Because of extensive previous work with international nongovernmental organizations and the United Nations, Mr. Bognar, who is now the executive director of the NYDG Foundation, “had the pedigree to make things happen instead of spinning our wheels,” Dr. Colbert said.
Albinism is more common by a factor of about 10 in certain sub-Saharan African populations in Tanzania and Malawi, compared with worldwide prevalence. The condition is stigmatized, but people with albinism are also believed to possess some magical powers. People with albinism are attacked, maimed, and even killed for their body parts, which are used by traditional “witch doctors” in ceremonies designed to generate wealth and good fortune. Raping a woman with albinism is thought by some to cure HIV/AIDS and infertility.
If African individuals with albinism escapes these horrors, they are still at high risk of developing a disfiguring, or even fatal, skin cancer. Even in higher-resource countries and in places farther from the equator, though, people with albinism still need stringent sun-exposure precautions and frequent dermatologic surveillance.
Philanthropic work in dermatology
Despite his busy practice, Dr. Colbert said he has found great satisfaction in pursuing philanthropic work. For physicians considering similar efforts, he said that genuine engagement with the issue is critical and global travel isn’t necessary to make a real difference.
“I think that, first, this should be something that you’re interested in and that you have the means to make some impact,” Dr. Colbert said. “Doing something doesn’t need to be a global campaign. You don’t need to have a home run – every little thing counts. Catching one squamous cell cancer on one patient with albinism makes a difference. But if you want to go bigger, you have to look at your community and see who has the resources and who might also be interested” in a cause you’re passionate about.
He added that a busy physician shouldn’t expect to do it all. “You have to find the right partner because we as physicians are taking care of our patients and paying the rent, so taking on a partner who is trained to do that can ... help you achieve what you envision.”
Though the NYDG Foundation has funded trips to Africa and participates in teledermatology there, Dr. Colbert said that the awareness campaign the NYDG is cosponsoring with the United Nations is of fundamental importance as well. “This is a really great example of the positive impact that social media can have on our society – in a good way, instead of a negative or self-serving way,” he said.
“I think that the ColorFull campaign will normalize the idea of people who are living without melanin in their skin. It keeps it out of the realm of ‘Don’t say anything.’ People don’t know what it means, so if we bring out the science, and show successful people who have normal lives, who have children, and we explain what it is, it demystifies it – and everybody wins. ... We’re all just people, no matter how many melanin granules we have.”
Dr. Colbert reported that he has no relevant conflicts of interest.
Standing Voice also provides resources in East Africa
The work of other nongovernmental organizations is also making a difference for people in East Africa with albinism.
Standing Voice is a United Kingdom–based nonprofit that provides education and resources that include sunscreen, as well as assessment and treatment of skin conditions for people with albinism in Tanzania and Malawi.
This and other work by Standing Voice were on display in an exhibit at the World Congress of Dermatology meeting in Milan in June 2019. In an interview at the meeting, Dr. Sharp, who spent his childhood in East Africa, contrasted access to dermatology care in the United States and United Kingdom with that in Africa, where an entire country may have hardly more than a few dermatologists.
“I go about three times a year, for about a week,” explained Dr. Sharp. “I’ll do a workshop to teach basic skin surgery techniques – excisions and biopsies. Very simple stuff. I’ll teach skin grafting as well because some of these patients have large lesions that won’t close directly,” he said. “On the whole, we like to use good grafts, rather than flaps, because often a local flap is just moving sun-damaged skin.”
Many patients have to travel great distances to reach a facility where general anesthesia and a full operating room suite are available, resources that are in high demand in resource-restricted African nations, according to Dr. Sharp. Teaching African practitioners regional anesthesia techniques that can be used for skin cancer surgery also helps ensure that more patients with albinism and squamous cell carcinoma can be treated – and treated closer to home.
Dr. Sharp reported that he has no relevant conflicts of interest.
A dermatologist-led nonprofit organization has entered into a
Representatives from the New York–based NYDG Foundation, including dermatologist David Colbert, MD, recently signed the agreement with the United Nations High Commissioner for Human Rights. At the center of the inclusivity efforts is the foundation’s ColorFull campaign, which aims to shape a collective response to the discrimination and violence that individuals with albinism face around the world.
“We really need to build more inclusive and communal health care systems for all. Partnering with the United Nations will help us to reach our goals and build stronger bonds with those health care providers working with one of the most marginalized and vulnerable groups in Africa,” Dr. Colbert said in an interview.
Stylish images of individuals with albinism, including prominent model Diandra Forrest, anchor the ColorFull campaign’s messaging; Ms. Forrest is featured in a video posted by the United Nations in November announcing the joint human rights campaign. Because the consequences of albinism can be deadly serious for affected individuals in many parts of the world, awareness is desperately needed, participants in NYDG’s work and in Standing Voice, another nonprofit that provides resources for people with albinism in East Africa, emphasized in interviews.
Striving to do good work
Stephan Bognar, a seasoned leader of international nonprofits, has teamed up with Dr. Colbert, NYDG Foundation’s founding physician, to craft the international campaign to raise awareness of albinism and increase acceptance of those with the condition. “You don’t always have to stand alone to break down the walls of exclusion. The fight for social justice and human rights for persons with albinism requires a collective responsibility,” Mr. Bognar said in an interview.
Dr. Colbert, senior partner of the New York Dermatology Group, a large Manhattan-based practice, founded the nonprofit when he became involved in wound-care efforts in Haiti following the 2010 earthquake. The foundation has since supported such philanthropic efforts as helping people with albinism, offering scholarships, and raising awareness of the importance of sun protection among youth athletes.
“One day, 3 years ago or so, I was reading the New York Times and I came across this article – it was called ‘The Hunted,’ ” Dr. Colbert recalled. “It was something I knew nothing about. In Eastern Africa, people with albinism are often hunted down for body parts and their lives are at risk” from being hunted and murdered – but also because their body parts are used for witchcraft and magic, he noted.
“I was captivated by that, and I remember I called Stephan, and I said, ‘I have a project for you.’ ” Because of extensive previous work with international nongovernmental organizations and the United Nations, Mr. Bognar, who is now the executive director of the NYDG Foundation, “had the pedigree to make things happen instead of spinning our wheels,” Dr. Colbert said.
Albinism is more common by a factor of about 10 in certain sub-Saharan African populations in Tanzania and Malawi, compared with worldwide prevalence. The condition is stigmatized, but people with albinism are also believed to possess some magical powers. People with albinism are attacked, maimed, and even killed for their body parts, which are used by traditional “witch doctors” in ceremonies designed to generate wealth and good fortune. Raping a woman with albinism is thought by some to cure HIV/AIDS and infertility.
If African individuals with albinism escapes these horrors, they are still at high risk of developing a disfiguring, or even fatal, skin cancer. Even in higher-resource countries and in places farther from the equator, though, people with albinism still need stringent sun-exposure precautions and frequent dermatologic surveillance.
Philanthropic work in dermatology
Despite his busy practice, Dr. Colbert said he has found great satisfaction in pursuing philanthropic work. For physicians considering similar efforts, he said that genuine engagement with the issue is critical and global travel isn’t necessary to make a real difference.
“I think that, first, this should be something that you’re interested in and that you have the means to make some impact,” Dr. Colbert said. “Doing something doesn’t need to be a global campaign. You don’t need to have a home run – every little thing counts. Catching one squamous cell cancer on one patient with albinism makes a difference. But if you want to go bigger, you have to look at your community and see who has the resources and who might also be interested” in a cause you’re passionate about.
He added that a busy physician shouldn’t expect to do it all. “You have to find the right partner because we as physicians are taking care of our patients and paying the rent, so taking on a partner who is trained to do that can ... help you achieve what you envision.”
Though the NYDG Foundation has funded trips to Africa and participates in teledermatology there, Dr. Colbert said that the awareness campaign the NYDG is cosponsoring with the United Nations is of fundamental importance as well. “This is a really great example of the positive impact that social media can have on our society – in a good way, instead of a negative or self-serving way,” he said.
“I think that the ColorFull campaign will normalize the idea of people who are living without melanin in their skin. It keeps it out of the realm of ‘Don’t say anything.’ People don’t know what it means, so if we bring out the science, and show successful people who have normal lives, who have children, and we explain what it is, it demystifies it – and everybody wins. ... We’re all just people, no matter how many melanin granules we have.”
Dr. Colbert reported that he has no relevant conflicts of interest.
Standing Voice also provides resources in East Africa
The work of other nongovernmental organizations is also making a difference for people in East Africa with albinism.
Standing Voice is a United Kingdom–based nonprofit that provides education and resources that include sunscreen, as well as assessment and treatment of skin conditions for people with albinism in Tanzania and Malawi.
This and other work by Standing Voice were on display in an exhibit at the World Congress of Dermatology meeting in Milan in June 2019. In an interview at the meeting, Dr. Sharp, who spent his childhood in East Africa, contrasted access to dermatology care in the United States and United Kingdom with that in Africa, where an entire country may have hardly more than a few dermatologists.
“I go about three times a year, for about a week,” explained Dr. Sharp. “I’ll do a workshop to teach basic skin surgery techniques – excisions and biopsies. Very simple stuff. I’ll teach skin grafting as well because some of these patients have large lesions that won’t close directly,” he said. “On the whole, we like to use good grafts, rather than flaps, because often a local flap is just moving sun-damaged skin.”
Many patients have to travel great distances to reach a facility where general anesthesia and a full operating room suite are available, resources that are in high demand in resource-restricted African nations, according to Dr. Sharp. Teaching African practitioners regional anesthesia techniques that can be used for skin cancer surgery also helps ensure that more patients with albinism and squamous cell carcinoma can be treated – and treated closer to home.
Dr. Sharp reported that he has no relevant conflicts of interest.
A dermatologist-led nonprofit organization has entered into a
Representatives from the New York–based NYDG Foundation, including dermatologist David Colbert, MD, recently signed the agreement with the United Nations High Commissioner for Human Rights. At the center of the inclusivity efforts is the foundation’s ColorFull campaign, which aims to shape a collective response to the discrimination and violence that individuals with albinism face around the world.
“We really need to build more inclusive and communal health care systems for all. Partnering with the United Nations will help us to reach our goals and build stronger bonds with those health care providers working with one of the most marginalized and vulnerable groups in Africa,” Dr. Colbert said in an interview.
Stylish images of individuals with albinism, including prominent model Diandra Forrest, anchor the ColorFull campaign’s messaging; Ms. Forrest is featured in a video posted by the United Nations in November announcing the joint human rights campaign. Because the consequences of albinism can be deadly serious for affected individuals in many parts of the world, awareness is desperately needed, participants in NYDG’s work and in Standing Voice, another nonprofit that provides resources for people with albinism in East Africa, emphasized in interviews.
Striving to do good work
Stephan Bognar, a seasoned leader of international nonprofits, has teamed up with Dr. Colbert, NYDG Foundation’s founding physician, to craft the international campaign to raise awareness of albinism and increase acceptance of those with the condition. “You don’t always have to stand alone to break down the walls of exclusion. The fight for social justice and human rights for persons with albinism requires a collective responsibility,” Mr. Bognar said in an interview.
Dr. Colbert, senior partner of the New York Dermatology Group, a large Manhattan-based practice, founded the nonprofit when he became involved in wound-care efforts in Haiti following the 2010 earthquake. The foundation has since supported such philanthropic efforts as helping people with albinism, offering scholarships, and raising awareness of the importance of sun protection among youth athletes.
“One day, 3 years ago or so, I was reading the New York Times and I came across this article – it was called ‘The Hunted,’ ” Dr. Colbert recalled. “It was something I knew nothing about. In Eastern Africa, people with albinism are often hunted down for body parts and their lives are at risk” from being hunted and murdered – but also because their body parts are used for witchcraft and magic, he noted.
“I was captivated by that, and I remember I called Stephan, and I said, ‘I have a project for you.’ ” Because of extensive previous work with international nongovernmental organizations and the United Nations, Mr. Bognar, who is now the executive director of the NYDG Foundation, “had the pedigree to make things happen instead of spinning our wheels,” Dr. Colbert said.
Albinism is more common by a factor of about 10 in certain sub-Saharan African populations in Tanzania and Malawi, compared with worldwide prevalence. The condition is stigmatized, but people with albinism are also believed to possess some magical powers. People with albinism are attacked, maimed, and even killed for their body parts, which are used by traditional “witch doctors” in ceremonies designed to generate wealth and good fortune. Raping a woman with albinism is thought by some to cure HIV/AIDS and infertility.
If African individuals with albinism escapes these horrors, they are still at high risk of developing a disfiguring, or even fatal, skin cancer. Even in higher-resource countries and in places farther from the equator, though, people with albinism still need stringent sun-exposure precautions and frequent dermatologic surveillance.
Philanthropic work in dermatology
Despite his busy practice, Dr. Colbert said he has found great satisfaction in pursuing philanthropic work. For physicians considering similar efforts, he said that genuine engagement with the issue is critical and global travel isn’t necessary to make a real difference.
“I think that, first, this should be something that you’re interested in and that you have the means to make some impact,” Dr. Colbert said. “Doing something doesn’t need to be a global campaign. You don’t need to have a home run – every little thing counts. Catching one squamous cell cancer on one patient with albinism makes a difference. But if you want to go bigger, you have to look at your community and see who has the resources and who might also be interested” in a cause you’re passionate about.
He added that a busy physician shouldn’t expect to do it all. “You have to find the right partner because we as physicians are taking care of our patients and paying the rent, so taking on a partner who is trained to do that can ... help you achieve what you envision.”
Though the NYDG Foundation has funded trips to Africa and participates in teledermatology there, Dr. Colbert said that the awareness campaign the NYDG is cosponsoring with the United Nations is of fundamental importance as well. “This is a really great example of the positive impact that social media can have on our society – in a good way, instead of a negative or self-serving way,” he said.
“I think that the ColorFull campaign will normalize the idea of people who are living without melanin in their skin. It keeps it out of the realm of ‘Don’t say anything.’ People don’t know what it means, so if we bring out the science, and show successful people who have normal lives, who have children, and we explain what it is, it demystifies it – and everybody wins. ... We’re all just people, no matter how many melanin granules we have.”
Dr. Colbert reported that he has no relevant conflicts of interest.
Standing Voice also provides resources in East Africa
The work of other nongovernmental organizations is also making a difference for people in East Africa with albinism.
Standing Voice is a United Kingdom–based nonprofit that provides education and resources that include sunscreen, as well as assessment and treatment of skin conditions for people with albinism in Tanzania and Malawi.
This and other work by Standing Voice were on display in an exhibit at the World Congress of Dermatology meeting in Milan in June 2019. In an interview at the meeting, Dr. Sharp, who spent his childhood in East Africa, contrasted access to dermatology care in the United States and United Kingdom with that in Africa, where an entire country may have hardly more than a few dermatologists.
“I go about three times a year, for about a week,” explained Dr. Sharp. “I’ll do a workshop to teach basic skin surgery techniques – excisions and biopsies. Very simple stuff. I’ll teach skin grafting as well because some of these patients have large lesions that won’t close directly,” he said. “On the whole, we like to use good grafts, rather than flaps, because often a local flap is just moving sun-damaged skin.”
Many patients have to travel great distances to reach a facility where general anesthesia and a full operating room suite are available, resources that are in high demand in resource-restricted African nations, according to Dr. Sharp. Teaching African practitioners regional anesthesia techniques that can be used for skin cancer surgery also helps ensure that more patients with albinism and squamous cell carcinoma can be treated – and treated closer to home.
Dr. Sharp reported that he has no relevant conflicts of interest.
Asthma exacerbation in pregnancy impacts mothers, infants
Women with asthma who suffer asthma exacerbation while pregnant are at increased risk for complications during pregnancy and delivery, and their infants are at increased risk for respiratory problems, according to data from a longitudinal study of 58,524 women with asthma.
“Asthma exacerbation during pregnancy has been found to be associated with adverse perinatal and pregnancy outcomes such as low birth weight, small for gestational age, preterm delivery, congenital malformation, preeclampsia, and perinatal mortality,” but previous studies have been small and limited to comparisons of asthmatic and nonasthmatic women, wrote Kawsari Abdullah, PhD, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues.
To determine the impact of asthma exacerbation on maternal and fetal outcomes, the researchers analyzed data from the Ontario Asthma Surveillance Information System to identify women with asthma who had at least one pregnancy resulting in a live or still birth between 2006 and 2012.
Overall, significantly more women with exacerbated asthma had preeclampsia or pregnancy-induced hypertension, compared with asthmatic women who had no exacerbations, at 5% vs. 4% and 7% vs. 5%, respectively (P less than .001), according to the study published in the European Respiratory Journal.
Adverse perinatal outcomes were significantly more likely among babies of mothers with exacerbated asthma, compared with those who had no exacerbations, including low birth weight (7% vs. 5%), small for gestational age (3% vs. 2%), preterm birth (8% vs. 7%), and congenital malformation (6% vs. 5%). All P values were less than .001, except for small for gestational age, which was P = .008.
In addition, significantly more babies of asthmatic women with exacerbated asthma during pregnancy had respiratory problems including asthma and pneumonia, compared with those of asthmatic women who had no exacerbations during pregnancy, at 38% vs. 31% and 24% vs. 22% (P less than .001 for both). The researchers found no significant interactions between maternal age and smoking and asthma exacerbations.
The findings were limited by several factors, including the lack of a validated algorithm for asthma exacerbation, which the researchers defined as five or more visits to a general practice clinician for asthma during pregnancy. Other limitations included the lack of categorizing asthma exacerbation by severity, and the inability to include the potential effects of asthma medication on maternal and fetal outcomes, Dr. Abdullah and colleagues noted.
However, the results were strengthened by the large sample size and ability to follow babies from birth until 5 years of age, they said.
“Targeting women with asthma during pregnancy and ensuring appropriate asthma management and postpartum follow-up may help to reduce the risk of pregnancy complications, adverse perinatal outcomes, and early childhood respiratory disorders,” they concluded.
This study is important because asthma is a common, potentially serious medical condition that complicates approximately 4%-8% of pregnancies, and one in three women with asthma experience an exacerbation during pregnancy, Iris Krishna, MD, a specialist in maternal/fetal medicine at Emory University, Atlanta, said in an interview.
“This study is unique in that it uses population-level data to assess the association between an asthma exacerbation during pregnancy and adverse perinatal outcomes,” Dr. Krishna said. “After adjusting for confounders, and consistent with previous studies, study findings suggest an increased risk for women with asthma who have an asthma exacerbation during pregnancy for preeclampsia [odds ratio, 1.3; P less than .001], pregnancy-induced hypertension [OR, 1.17; P less than .05], low-birth-weight infant [OR, 1.14; P less than .05], preterm birth [OR, 1.14; P less than .05], and congenital malformations [OR, 1.21; P less than .001].”
Dr. Krishna also noted the impact on early childhood outcomes. “In this study, children born to women who had an asthma exacerbation during pregnancy had a 23% higher risk of developing asthma before 5 years of age, which is consistent with previous studies. [The] investigators also reported a 12% higher risk of having pneumonia during the first 5 years of life for children born to women who had an asthma exacerbation during pregnancy.”
“Previous studies have suggested children born to mothers with uncontrolled asthma have an increased risk for respiratory infections, but this study is the first to report an association with pneumonia,” she said. This increased risk for childhood respiratory disorders warrants further study.
Consequently, “Women with asthma during pregnancy should have appropriate management to ensure good control to optimize pregnancy outcome,” Dr. Krishna emphasized. “Women who experience asthma exacerbations in pregnancy are at increased risk for preeclampsia, [pregnancy-induced hypertension], low birth weight, and preterm delivery and may require closer monitoring.”
The study was supported by the Institute for Clinical Evaluative Sciences. The researchers and Dr. Krishna had no financial conflicts to disclose.
SOURCE: Abdullah K et al. Eur Respir J. 2019 Nov 26. doi: 10.1183/13993003.01335-2019.
Women with asthma who suffer asthma exacerbation while pregnant are at increased risk for complications during pregnancy and delivery, and their infants are at increased risk for respiratory problems, according to data from a longitudinal study of 58,524 women with asthma.
“Asthma exacerbation during pregnancy has been found to be associated with adverse perinatal and pregnancy outcomes such as low birth weight, small for gestational age, preterm delivery, congenital malformation, preeclampsia, and perinatal mortality,” but previous studies have been small and limited to comparisons of asthmatic and nonasthmatic women, wrote Kawsari Abdullah, PhD, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues.
To determine the impact of asthma exacerbation on maternal and fetal outcomes, the researchers analyzed data from the Ontario Asthma Surveillance Information System to identify women with asthma who had at least one pregnancy resulting in a live or still birth between 2006 and 2012.
Overall, significantly more women with exacerbated asthma had preeclampsia or pregnancy-induced hypertension, compared with asthmatic women who had no exacerbations, at 5% vs. 4% and 7% vs. 5%, respectively (P less than .001), according to the study published in the European Respiratory Journal.
Adverse perinatal outcomes were significantly more likely among babies of mothers with exacerbated asthma, compared with those who had no exacerbations, including low birth weight (7% vs. 5%), small for gestational age (3% vs. 2%), preterm birth (8% vs. 7%), and congenital malformation (6% vs. 5%). All P values were less than .001, except for small for gestational age, which was P = .008.
In addition, significantly more babies of asthmatic women with exacerbated asthma during pregnancy had respiratory problems including asthma and pneumonia, compared with those of asthmatic women who had no exacerbations during pregnancy, at 38% vs. 31% and 24% vs. 22% (P less than .001 for both). The researchers found no significant interactions between maternal age and smoking and asthma exacerbations.
The findings were limited by several factors, including the lack of a validated algorithm for asthma exacerbation, which the researchers defined as five or more visits to a general practice clinician for asthma during pregnancy. Other limitations included the lack of categorizing asthma exacerbation by severity, and the inability to include the potential effects of asthma medication on maternal and fetal outcomes, Dr. Abdullah and colleagues noted.
However, the results were strengthened by the large sample size and ability to follow babies from birth until 5 years of age, they said.
“Targeting women with asthma during pregnancy and ensuring appropriate asthma management and postpartum follow-up may help to reduce the risk of pregnancy complications, adverse perinatal outcomes, and early childhood respiratory disorders,” they concluded.
This study is important because asthma is a common, potentially serious medical condition that complicates approximately 4%-8% of pregnancies, and one in three women with asthma experience an exacerbation during pregnancy, Iris Krishna, MD, a specialist in maternal/fetal medicine at Emory University, Atlanta, said in an interview.
“This study is unique in that it uses population-level data to assess the association between an asthma exacerbation during pregnancy and adverse perinatal outcomes,” Dr. Krishna said. “After adjusting for confounders, and consistent with previous studies, study findings suggest an increased risk for women with asthma who have an asthma exacerbation during pregnancy for preeclampsia [odds ratio, 1.3; P less than .001], pregnancy-induced hypertension [OR, 1.17; P less than .05], low-birth-weight infant [OR, 1.14; P less than .05], preterm birth [OR, 1.14; P less than .05], and congenital malformations [OR, 1.21; P less than .001].”
Dr. Krishna also noted the impact on early childhood outcomes. “In this study, children born to women who had an asthma exacerbation during pregnancy had a 23% higher risk of developing asthma before 5 years of age, which is consistent with previous studies. [The] investigators also reported a 12% higher risk of having pneumonia during the first 5 years of life for children born to women who had an asthma exacerbation during pregnancy.”
“Previous studies have suggested children born to mothers with uncontrolled asthma have an increased risk for respiratory infections, but this study is the first to report an association with pneumonia,” she said. This increased risk for childhood respiratory disorders warrants further study.
Consequently, “Women with asthma during pregnancy should have appropriate management to ensure good control to optimize pregnancy outcome,” Dr. Krishna emphasized. “Women who experience asthma exacerbations in pregnancy are at increased risk for preeclampsia, [pregnancy-induced hypertension], low birth weight, and preterm delivery and may require closer monitoring.”
The study was supported by the Institute for Clinical Evaluative Sciences. The researchers and Dr. Krishna had no financial conflicts to disclose.
SOURCE: Abdullah K et al. Eur Respir J. 2019 Nov 26. doi: 10.1183/13993003.01335-2019.
Women with asthma who suffer asthma exacerbation while pregnant are at increased risk for complications during pregnancy and delivery, and their infants are at increased risk for respiratory problems, according to data from a longitudinal study of 58,524 women with asthma.
“Asthma exacerbation during pregnancy has been found to be associated with adverse perinatal and pregnancy outcomes such as low birth weight, small for gestational age, preterm delivery, congenital malformation, preeclampsia, and perinatal mortality,” but previous studies have been small and limited to comparisons of asthmatic and nonasthmatic women, wrote Kawsari Abdullah, PhD, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues.
To determine the impact of asthma exacerbation on maternal and fetal outcomes, the researchers analyzed data from the Ontario Asthma Surveillance Information System to identify women with asthma who had at least one pregnancy resulting in a live or still birth between 2006 and 2012.
Overall, significantly more women with exacerbated asthma had preeclampsia or pregnancy-induced hypertension, compared with asthmatic women who had no exacerbations, at 5% vs. 4% and 7% vs. 5%, respectively (P less than .001), according to the study published in the European Respiratory Journal.
Adverse perinatal outcomes were significantly more likely among babies of mothers with exacerbated asthma, compared with those who had no exacerbations, including low birth weight (7% vs. 5%), small for gestational age (3% vs. 2%), preterm birth (8% vs. 7%), and congenital malformation (6% vs. 5%). All P values were less than .001, except for small for gestational age, which was P = .008.
In addition, significantly more babies of asthmatic women with exacerbated asthma during pregnancy had respiratory problems including asthma and pneumonia, compared with those of asthmatic women who had no exacerbations during pregnancy, at 38% vs. 31% and 24% vs. 22% (P less than .001 for both). The researchers found no significant interactions between maternal age and smoking and asthma exacerbations.
The findings were limited by several factors, including the lack of a validated algorithm for asthma exacerbation, which the researchers defined as five or more visits to a general practice clinician for asthma during pregnancy. Other limitations included the lack of categorizing asthma exacerbation by severity, and the inability to include the potential effects of asthma medication on maternal and fetal outcomes, Dr. Abdullah and colleagues noted.
However, the results were strengthened by the large sample size and ability to follow babies from birth until 5 years of age, they said.
“Targeting women with asthma during pregnancy and ensuring appropriate asthma management and postpartum follow-up may help to reduce the risk of pregnancy complications, adverse perinatal outcomes, and early childhood respiratory disorders,” they concluded.
This study is important because asthma is a common, potentially serious medical condition that complicates approximately 4%-8% of pregnancies, and one in three women with asthma experience an exacerbation during pregnancy, Iris Krishna, MD, a specialist in maternal/fetal medicine at Emory University, Atlanta, said in an interview.
“This study is unique in that it uses population-level data to assess the association between an asthma exacerbation during pregnancy and adverse perinatal outcomes,” Dr. Krishna said. “After adjusting for confounders, and consistent with previous studies, study findings suggest an increased risk for women with asthma who have an asthma exacerbation during pregnancy for preeclampsia [odds ratio, 1.3; P less than .001], pregnancy-induced hypertension [OR, 1.17; P less than .05], low-birth-weight infant [OR, 1.14; P less than .05], preterm birth [OR, 1.14; P less than .05], and congenital malformations [OR, 1.21; P less than .001].”
Dr. Krishna also noted the impact on early childhood outcomes. “In this study, children born to women who had an asthma exacerbation during pregnancy had a 23% higher risk of developing asthma before 5 years of age, which is consistent with previous studies. [The] investigators also reported a 12% higher risk of having pneumonia during the first 5 years of life for children born to women who had an asthma exacerbation during pregnancy.”
“Previous studies have suggested children born to mothers with uncontrolled asthma have an increased risk for respiratory infections, but this study is the first to report an association with pneumonia,” she said. This increased risk for childhood respiratory disorders warrants further study.
Consequently, “Women with asthma during pregnancy should have appropriate management to ensure good control to optimize pregnancy outcome,” Dr. Krishna emphasized. “Women who experience asthma exacerbations in pregnancy are at increased risk for preeclampsia, [pregnancy-induced hypertension], low birth weight, and preterm delivery and may require closer monitoring.”
The study was supported by the Institute for Clinical Evaluative Sciences. The researchers and Dr. Krishna had no financial conflicts to disclose.
SOURCE: Abdullah K et al. Eur Respir J. 2019 Nov 26. doi: 10.1183/13993003.01335-2019.
FROM THE EUROPEAN RESPIRATORY JOURNAL
Do women with diabetes need more CVD risk reduction than men?
BUSAN, SOUTH KOREA – Whether cardiovascular disease risk reduction efforts should be more aggressive in women than men with diabetes depends on how you interpret the data.
Two experts came to different conclusions on this question during a heated, but jovial, debate last week here at the International Diabetes Federation 2019 Congress.
Endocrinologist David Simmons, MB, BChir, Western Sydney University, Campbelltown, Australia, argued that diabetes erases the well-described life expectancy advantage of 4-7 years that women experience over men in the general population.
He also highlighted the fact that the heightened risk is of particular concern in both younger women and those with prior gestational diabetes.
But Timothy Davis, BMedSc, MB, BS, DPhil, an endocrinologist and general physician at Fremantle (Australia) Hospital, countered that the data only show the diabetes-attributable excess cardiovascular risk is higher in women than men, but that the absolute risk is actually greater in men.
Moreover, he argued, at least in type 1 diabetes, there is no evidence that more aggressive cardiovascular risk factor management improves outcomes.
Yes: Diabetes eliminates female CVD protection
Dr. Simmons began by pointing out that, although on average women die at an older age than men, it has been known for over 40 years that this “female protection” is lost in insulin-treated women, particularly as a result of their increased risk for cardiovascular disease.
In a 2015 meta-analysis of 26 studies, women with type 1 diabetes were found to have about a 37% greater risk of all-cause mortality, compared with men with the condition when mortality is contrasted with that of the general population, and twice the risk of both fatal and nonfatal vascular events.
The risk appeared to be greater in women who were younger at the time of diabetes diagnosis. “This is a really important point – the time we would want to intervene,” Dr. Simmons said.
In another meta-analysis of 30 studies including 2,307,694 individuals with type 2 diabetes and 252,491 deaths, the pooled women-to-men ratio of the standardized mortality ratio for all-cause mortality was 1.14.
In those with versus without type 2 diabetes, the pooled standardized mortality ratio in women was 2.30 and in men was 1.94, both significant, compared with those without diabetes.
And in a 2006 meta-analysis of 22 studies involving individuals with type 2 diabetes, the pooled data showed a 46% excess relative risk using standardized mortality ratios in women versus men for fatal coronary artery disease.
Meanwhile, in a 2018 meta-analysis of 68 studies involving nearly 1 million adults examining differences in occlusive vascular disease, after controlling for major vascular risk factors, diabetes roughly doubled the risk for occlusive vascular mortality in men (relative risk, 2.10), but tripled it in women (3.00).
Women with diabetes aged 35-59 years had the highest relative risk for death over follow-up across all age and sex groups: They had 5.5 times the excess risk, compared with those without diabetes, while the excess risk for men of that age was 2.3-fold.
“So very clearly, it’s these young women who are most at risk, “emphasized Dr. Simmons, who is an investigator for Novo Nordisk and a speaker for Medtronic, Novo Nordisk, and Sanofi.
Are disparities because of differences in cvd risk factor management?
The question has arisen whether the female/male differences might be because of differences in cardiovascular risk factor management, Simmons noted.
A 2015 American Heart Association statement laid out the evidence for lower prescribing of statins, aspirin, beta-blockers, and ACE inhibitors in women, compared with men, Dr. Simmons said.
And some studies suggest medication adherence is lower in women than men.
In terms of medications, fenofibrate appears to produce better outcomes in women than men, but there is no evidence of gender differences in the effects of statins, ACE inhibitors, or aspirin, Simmons said.
He also outlined the results of a 2008 study of 78,254 patients with acute myocardial infarction from 420 U.S. hospitals in 2001-2006.
Women were older, had more comorbidities, less often presented with ST-elevation myocardial infarction (STEMI), and had a higher rate of unadjusted in-hospital death (8.2% vs. 5.7%; P less than .0001) than men. Of the participants, 33% of women had diabetes, compared with 28% of men.
The in-hospital mortality difference disappeared after multivariable adjustment, but women with STEMI still had higher adjusted mortality rates than men.
“The underuse of evidence-based treatments and delayed reperfusion in women represent potential opportunities for reducing sex disparities in care and outcome after acute myocardial infarction,” the authors concluded.
“It’s very clear amongst our cardiology colleagues that something needs to be done and that we need more aggressive cardiological risk reduction in women,” Dr. Simmons said.
“The AHA has already decided this. It’s already a policy. So why are we having this debate?” he wondered.
He also pointed out that women with prior gestational diabetes are an exceptionally high–risk group, with a twofold excess risk for cardiovascular disease within the first 10 years post partum.
“We need to do something about this particularly high-risk group, independent of debates about gender,” Dr. Simmons emphasized. “Clearly, women with diabetes warrant more aggressive cardiovascular risk reduction than men with diabetes, especially at those younger ages,” he concluded.
No: Confusion about relative risk within each sex and absolute risk
Dr. Davis began his counterargument by stating that estimation of absolute vascular risk is an established part of strategies to prevent cardiovascular disease, including in diabetes.
And that risk, he stressed, is actually higher in men.
“Male sex is a consistent adverse risk factor in cardiovascular disease event prediction equations in type 2 diabetes. Identifying absolute risk is important,” he said, noting risk calculators include male sex, such as the risk engine derived from the United Kingdom Prospective Diabetes Trial.
And in the Australian population-based Fremantle study, of which Dr. Davis is an author, the absolute 5-year incidence rates for all outcomes – including myocardial infarction, stroke, heart failure, lower extremity amputation, cardiovascular mortality, and all-cause mortality – were consistently higher in men versus women in the first phase, which began in the 1990s and included 1,426 individuals with diabetes (91% had type 2 diabetes).
In the ongoing second phase, which began in 2008 with 1,732 participants, overall rates of those outcomes are lower and the discrepancy between men and women has narrowed, Dr. Davis noted.
Overall, the Fremantle study data “suggest that women with type 2 diabetes do not need more aggressive cardiovascular reduction than men with type 2 diabetes because they are not at increased absolute vascular risk,” he stressed.
And in a “sensitivity analysis” of two areas in Finland, the authors concluded that the stronger effect of type 2 diabetes on the risk of congenital heart disease (CHD) in women, compared with men was in part explained by a heavier risk factor burden and a greater effect of blood pressure and atherogenic dyslipidemia in women with diabetes, he explained.
The Finnish authors wrote, “In terms of absolute risk of CHD death or a major CHD event, diabetes almost completely abolished the female protection from CHD.”
But, Dr. Davis emphasized, rates were not higher in females.
So then, “why is there the view that women with type 2 diabetes need more aggressive cardiovascular risk reduction than men with diabetes?
“It probably comes back to confusion based on absolute risk versus a comparison of relative risk within each sex,” he asserted.
ADA Standards of Medical Care 2019 don’t mention gender
Lastly, in a meta-analysis published just in July this year involving more than 5 million participants, compared with men with diabetes, women with diabetes had a 58% and 13% greater risk of CHD and all-cause mortality, respectively.
“This points to an urgent need to develop sex- and gender-specific risk assessment strategies and therapeutic interventions that target diabetes management in the context of CHD prevention,” the authors concluded.
But, Dr. Davis noted, “It is not absolute vascular risk. It’s a relative risk compared across the two genders. In the paper, there is no mention of absolute vascular risk.
“Greater CVD mortality in women with and without diabetes, versus men, doesn’t mean there’s also an absolute vascular increase in women versus men with diabetes,” he said.
Moreover, Dr. Davis pointed out that in an editorial accompanying the 2015 meta-analysis in type 1 diabetes, Simmons had actually stated that absolute mortality rates are highest in men.
“I don’t know what happened to his epidemiology knowledge in the last 4 years but it seems to have gone backwards,” he joked to his debate opponent.
And, Dr. Davis asserted, even if there were a higher risk in women with type 1 diabetes, there is no evidence that cardiovascular risk reduction measures affect endpoints in that patient population. Only about 8% of people with diabetes in statin trials had type 1 diabetes.
Indeed, he noted, in the American Diabetes Association Standards of Medical Care in Diabetes – 2019, the treatment goals for individual cardiovascular risk factors do not mention gender.
What’s more, Dr. David said, there is evidence that women are significantly less likely than men to take prescribed statins and are more likely to have an eating disorder and underdose insulin, “suggesting significant issues with compliance. ... So, trying to get more intensive risk reduction in women may be a challenge.”
“Women with diabetes do not need more aggressive cardiovascular risk reduction than men with diabetes, irrespective of type,” he concluded.
A version of this story originally appeared on medscape.com.
BUSAN, SOUTH KOREA – Whether cardiovascular disease risk reduction efforts should be more aggressive in women than men with diabetes depends on how you interpret the data.
Two experts came to different conclusions on this question during a heated, but jovial, debate last week here at the International Diabetes Federation 2019 Congress.
Endocrinologist David Simmons, MB, BChir, Western Sydney University, Campbelltown, Australia, argued that diabetes erases the well-described life expectancy advantage of 4-7 years that women experience over men in the general population.
He also highlighted the fact that the heightened risk is of particular concern in both younger women and those with prior gestational diabetes.
But Timothy Davis, BMedSc, MB, BS, DPhil, an endocrinologist and general physician at Fremantle (Australia) Hospital, countered that the data only show the diabetes-attributable excess cardiovascular risk is higher in women than men, but that the absolute risk is actually greater in men.
Moreover, he argued, at least in type 1 diabetes, there is no evidence that more aggressive cardiovascular risk factor management improves outcomes.
Yes: Diabetes eliminates female CVD protection
Dr. Simmons began by pointing out that, although on average women die at an older age than men, it has been known for over 40 years that this “female protection” is lost in insulin-treated women, particularly as a result of their increased risk for cardiovascular disease.
In a 2015 meta-analysis of 26 studies, women with type 1 diabetes were found to have about a 37% greater risk of all-cause mortality, compared with men with the condition when mortality is contrasted with that of the general population, and twice the risk of both fatal and nonfatal vascular events.
The risk appeared to be greater in women who were younger at the time of diabetes diagnosis. “This is a really important point – the time we would want to intervene,” Dr. Simmons said.
In another meta-analysis of 30 studies including 2,307,694 individuals with type 2 diabetes and 252,491 deaths, the pooled women-to-men ratio of the standardized mortality ratio for all-cause mortality was 1.14.
In those with versus without type 2 diabetes, the pooled standardized mortality ratio in women was 2.30 and in men was 1.94, both significant, compared with those without diabetes.
And in a 2006 meta-analysis of 22 studies involving individuals with type 2 diabetes, the pooled data showed a 46% excess relative risk using standardized mortality ratios in women versus men for fatal coronary artery disease.
Meanwhile, in a 2018 meta-analysis of 68 studies involving nearly 1 million adults examining differences in occlusive vascular disease, after controlling for major vascular risk factors, diabetes roughly doubled the risk for occlusive vascular mortality in men (relative risk, 2.10), but tripled it in women (3.00).
Women with diabetes aged 35-59 years had the highest relative risk for death over follow-up across all age and sex groups: They had 5.5 times the excess risk, compared with those without diabetes, while the excess risk for men of that age was 2.3-fold.
“So very clearly, it’s these young women who are most at risk, “emphasized Dr. Simmons, who is an investigator for Novo Nordisk and a speaker for Medtronic, Novo Nordisk, and Sanofi.
Are disparities because of differences in cvd risk factor management?
The question has arisen whether the female/male differences might be because of differences in cardiovascular risk factor management, Simmons noted.
A 2015 American Heart Association statement laid out the evidence for lower prescribing of statins, aspirin, beta-blockers, and ACE inhibitors in women, compared with men, Dr. Simmons said.
And some studies suggest medication adherence is lower in women than men.
In terms of medications, fenofibrate appears to produce better outcomes in women than men, but there is no evidence of gender differences in the effects of statins, ACE inhibitors, or aspirin, Simmons said.
He also outlined the results of a 2008 study of 78,254 patients with acute myocardial infarction from 420 U.S. hospitals in 2001-2006.
Women were older, had more comorbidities, less often presented with ST-elevation myocardial infarction (STEMI), and had a higher rate of unadjusted in-hospital death (8.2% vs. 5.7%; P less than .0001) than men. Of the participants, 33% of women had diabetes, compared with 28% of men.
The in-hospital mortality difference disappeared after multivariable adjustment, but women with STEMI still had higher adjusted mortality rates than men.
“The underuse of evidence-based treatments and delayed reperfusion in women represent potential opportunities for reducing sex disparities in care and outcome after acute myocardial infarction,” the authors concluded.
“It’s very clear amongst our cardiology colleagues that something needs to be done and that we need more aggressive cardiological risk reduction in women,” Dr. Simmons said.
“The AHA has already decided this. It’s already a policy. So why are we having this debate?” he wondered.
He also pointed out that women with prior gestational diabetes are an exceptionally high–risk group, with a twofold excess risk for cardiovascular disease within the first 10 years post partum.
“We need to do something about this particularly high-risk group, independent of debates about gender,” Dr. Simmons emphasized. “Clearly, women with diabetes warrant more aggressive cardiovascular risk reduction than men with diabetes, especially at those younger ages,” he concluded.
No: Confusion about relative risk within each sex and absolute risk
Dr. Davis began his counterargument by stating that estimation of absolute vascular risk is an established part of strategies to prevent cardiovascular disease, including in diabetes.
And that risk, he stressed, is actually higher in men.
“Male sex is a consistent adverse risk factor in cardiovascular disease event prediction equations in type 2 diabetes. Identifying absolute risk is important,” he said, noting risk calculators include male sex, such as the risk engine derived from the United Kingdom Prospective Diabetes Trial.
And in the Australian population-based Fremantle study, of which Dr. Davis is an author, the absolute 5-year incidence rates for all outcomes – including myocardial infarction, stroke, heart failure, lower extremity amputation, cardiovascular mortality, and all-cause mortality – were consistently higher in men versus women in the first phase, which began in the 1990s and included 1,426 individuals with diabetes (91% had type 2 diabetes).
In the ongoing second phase, which began in 2008 with 1,732 participants, overall rates of those outcomes are lower and the discrepancy between men and women has narrowed, Dr. Davis noted.
Overall, the Fremantle study data “suggest that women with type 2 diabetes do not need more aggressive cardiovascular reduction than men with type 2 diabetes because they are not at increased absolute vascular risk,” he stressed.
And in a “sensitivity analysis” of two areas in Finland, the authors concluded that the stronger effect of type 2 diabetes on the risk of congenital heart disease (CHD) in women, compared with men was in part explained by a heavier risk factor burden and a greater effect of blood pressure and atherogenic dyslipidemia in women with diabetes, he explained.
The Finnish authors wrote, “In terms of absolute risk of CHD death or a major CHD event, diabetes almost completely abolished the female protection from CHD.”
But, Dr. Davis emphasized, rates were not higher in females.
So then, “why is there the view that women with type 2 diabetes need more aggressive cardiovascular risk reduction than men with diabetes?
“It probably comes back to confusion based on absolute risk versus a comparison of relative risk within each sex,” he asserted.
ADA Standards of Medical Care 2019 don’t mention gender
Lastly, in a meta-analysis published just in July this year involving more than 5 million participants, compared with men with diabetes, women with diabetes had a 58% and 13% greater risk of CHD and all-cause mortality, respectively.
“This points to an urgent need to develop sex- and gender-specific risk assessment strategies and therapeutic interventions that target diabetes management in the context of CHD prevention,” the authors concluded.
But, Dr. Davis noted, “It is not absolute vascular risk. It’s a relative risk compared across the two genders. In the paper, there is no mention of absolute vascular risk.
“Greater CVD mortality in women with and without diabetes, versus men, doesn’t mean there’s also an absolute vascular increase in women versus men with diabetes,” he said.
Moreover, Dr. Davis pointed out that in an editorial accompanying the 2015 meta-analysis in type 1 diabetes, Simmons had actually stated that absolute mortality rates are highest in men.
“I don’t know what happened to his epidemiology knowledge in the last 4 years but it seems to have gone backwards,” he joked to his debate opponent.
And, Dr. Davis asserted, even if there were a higher risk in women with type 1 diabetes, there is no evidence that cardiovascular risk reduction measures affect endpoints in that patient population. Only about 8% of people with diabetes in statin trials had type 1 diabetes.
Indeed, he noted, in the American Diabetes Association Standards of Medical Care in Diabetes – 2019, the treatment goals for individual cardiovascular risk factors do not mention gender.
What’s more, Dr. David said, there is evidence that women are significantly less likely than men to take prescribed statins and are more likely to have an eating disorder and underdose insulin, “suggesting significant issues with compliance. ... So, trying to get more intensive risk reduction in women may be a challenge.”
“Women with diabetes do not need more aggressive cardiovascular risk reduction than men with diabetes, irrespective of type,” he concluded.
A version of this story originally appeared on medscape.com.
BUSAN, SOUTH KOREA – Whether cardiovascular disease risk reduction efforts should be more aggressive in women than men with diabetes depends on how you interpret the data.
Two experts came to different conclusions on this question during a heated, but jovial, debate last week here at the International Diabetes Federation 2019 Congress.
Endocrinologist David Simmons, MB, BChir, Western Sydney University, Campbelltown, Australia, argued that diabetes erases the well-described life expectancy advantage of 4-7 years that women experience over men in the general population.
He also highlighted the fact that the heightened risk is of particular concern in both younger women and those with prior gestational diabetes.
But Timothy Davis, BMedSc, MB, BS, DPhil, an endocrinologist and general physician at Fremantle (Australia) Hospital, countered that the data only show the diabetes-attributable excess cardiovascular risk is higher in women than men, but that the absolute risk is actually greater in men.
Moreover, he argued, at least in type 1 diabetes, there is no evidence that more aggressive cardiovascular risk factor management improves outcomes.
Yes: Diabetes eliminates female CVD protection
Dr. Simmons began by pointing out that, although on average women die at an older age than men, it has been known for over 40 years that this “female protection” is lost in insulin-treated women, particularly as a result of their increased risk for cardiovascular disease.
In a 2015 meta-analysis of 26 studies, women with type 1 diabetes were found to have about a 37% greater risk of all-cause mortality, compared with men with the condition when mortality is contrasted with that of the general population, and twice the risk of both fatal and nonfatal vascular events.
The risk appeared to be greater in women who were younger at the time of diabetes diagnosis. “This is a really important point – the time we would want to intervene,” Dr. Simmons said.
In another meta-analysis of 30 studies including 2,307,694 individuals with type 2 diabetes and 252,491 deaths, the pooled women-to-men ratio of the standardized mortality ratio for all-cause mortality was 1.14.
In those with versus without type 2 diabetes, the pooled standardized mortality ratio in women was 2.30 and in men was 1.94, both significant, compared with those without diabetes.
And in a 2006 meta-analysis of 22 studies involving individuals with type 2 diabetes, the pooled data showed a 46% excess relative risk using standardized mortality ratios in women versus men for fatal coronary artery disease.
Meanwhile, in a 2018 meta-analysis of 68 studies involving nearly 1 million adults examining differences in occlusive vascular disease, after controlling for major vascular risk factors, diabetes roughly doubled the risk for occlusive vascular mortality in men (relative risk, 2.10), but tripled it in women (3.00).
Women with diabetes aged 35-59 years had the highest relative risk for death over follow-up across all age and sex groups: They had 5.5 times the excess risk, compared with those without diabetes, while the excess risk for men of that age was 2.3-fold.
“So very clearly, it’s these young women who are most at risk, “emphasized Dr. Simmons, who is an investigator for Novo Nordisk and a speaker for Medtronic, Novo Nordisk, and Sanofi.
Are disparities because of differences in cvd risk factor management?
The question has arisen whether the female/male differences might be because of differences in cardiovascular risk factor management, Simmons noted.
A 2015 American Heart Association statement laid out the evidence for lower prescribing of statins, aspirin, beta-blockers, and ACE inhibitors in women, compared with men, Dr. Simmons said.
And some studies suggest medication adherence is lower in women than men.
In terms of medications, fenofibrate appears to produce better outcomes in women than men, but there is no evidence of gender differences in the effects of statins, ACE inhibitors, or aspirin, Simmons said.
He also outlined the results of a 2008 study of 78,254 patients with acute myocardial infarction from 420 U.S. hospitals in 2001-2006.
Women were older, had more comorbidities, less often presented with ST-elevation myocardial infarction (STEMI), and had a higher rate of unadjusted in-hospital death (8.2% vs. 5.7%; P less than .0001) than men. Of the participants, 33% of women had diabetes, compared with 28% of men.
The in-hospital mortality difference disappeared after multivariable adjustment, but women with STEMI still had higher adjusted mortality rates than men.
“The underuse of evidence-based treatments and delayed reperfusion in women represent potential opportunities for reducing sex disparities in care and outcome after acute myocardial infarction,” the authors concluded.
“It’s very clear amongst our cardiology colleagues that something needs to be done and that we need more aggressive cardiological risk reduction in women,” Dr. Simmons said.
“The AHA has already decided this. It’s already a policy. So why are we having this debate?” he wondered.
He also pointed out that women with prior gestational diabetes are an exceptionally high–risk group, with a twofold excess risk for cardiovascular disease within the first 10 years post partum.
“We need to do something about this particularly high-risk group, independent of debates about gender,” Dr. Simmons emphasized. “Clearly, women with diabetes warrant more aggressive cardiovascular risk reduction than men with diabetes, especially at those younger ages,” he concluded.
No: Confusion about relative risk within each sex and absolute risk
Dr. Davis began his counterargument by stating that estimation of absolute vascular risk is an established part of strategies to prevent cardiovascular disease, including in diabetes.
And that risk, he stressed, is actually higher in men.
“Male sex is a consistent adverse risk factor in cardiovascular disease event prediction equations in type 2 diabetes. Identifying absolute risk is important,” he said, noting risk calculators include male sex, such as the risk engine derived from the United Kingdom Prospective Diabetes Trial.
And in the Australian population-based Fremantle study, of which Dr. Davis is an author, the absolute 5-year incidence rates for all outcomes – including myocardial infarction, stroke, heart failure, lower extremity amputation, cardiovascular mortality, and all-cause mortality – were consistently higher in men versus women in the first phase, which began in the 1990s and included 1,426 individuals with diabetes (91% had type 2 diabetes).
In the ongoing second phase, which began in 2008 with 1,732 participants, overall rates of those outcomes are lower and the discrepancy between men and women has narrowed, Dr. Davis noted.
Overall, the Fremantle study data “suggest that women with type 2 diabetes do not need more aggressive cardiovascular reduction than men with type 2 diabetes because they are not at increased absolute vascular risk,” he stressed.
And in a “sensitivity analysis” of two areas in Finland, the authors concluded that the stronger effect of type 2 diabetes on the risk of congenital heart disease (CHD) in women, compared with men was in part explained by a heavier risk factor burden and a greater effect of blood pressure and atherogenic dyslipidemia in women with diabetes, he explained.
The Finnish authors wrote, “In terms of absolute risk of CHD death or a major CHD event, diabetes almost completely abolished the female protection from CHD.”
But, Dr. Davis emphasized, rates were not higher in females.
So then, “why is there the view that women with type 2 diabetes need more aggressive cardiovascular risk reduction than men with diabetes?
“It probably comes back to confusion based on absolute risk versus a comparison of relative risk within each sex,” he asserted.
ADA Standards of Medical Care 2019 don’t mention gender
Lastly, in a meta-analysis published just in July this year involving more than 5 million participants, compared with men with diabetes, women with diabetes had a 58% and 13% greater risk of CHD and all-cause mortality, respectively.
“This points to an urgent need to develop sex- and gender-specific risk assessment strategies and therapeutic interventions that target diabetes management in the context of CHD prevention,” the authors concluded.
But, Dr. Davis noted, “It is not absolute vascular risk. It’s a relative risk compared across the two genders. In the paper, there is no mention of absolute vascular risk.
“Greater CVD mortality in women with and without diabetes, versus men, doesn’t mean there’s also an absolute vascular increase in women versus men with diabetes,” he said.
Moreover, Dr. Davis pointed out that in an editorial accompanying the 2015 meta-analysis in type 1 diabetes, Simmons had actually stated that absolute mortality rates are highest in men.
“I don’t know what happened to his epidemiology knowledge in the last 4 years but it seems to have gone backwards,” he joked to his debate opponent.
And, Dr. Davis asserted, even if there were a higher risk in women with type 1 diabetes, there is no evidence that cardiovascular risk reduction measures affect endpoints in that patient population. Only about 8% of people with diabetes in statin trials had type 1 diabetes.
Indeed, he noted, in the American Diabetes Association Standards of Medical Care in Diabetes – 2019, the treatment goals for individual cardiovascular risk factors do not mention gender.
What’s more, Dr. David said, there is evidence that women are significantly less likely than men to take prescribed statins and are more likely to have an eating disorder and underdose insulin, “suggesting significant issues with compliance. ... So, trying to get more intensive risk reduction in women may be a challenge.”
“Women with diabetes do not need more aggressive cardiovascular risk reduction than men with diabetes, irrespective of type,” he concluded.
A version of this story originally appeared on medscape.com.
Ten-year results support partial breast irradiation
SAN ANTONIO – For patients with early, low-risk breast cancer, accelerated partial breast irradiation (APBI) may be considered a standard alternative to whole breast irradiation, according to investigators.
This conclusion was based on 10-year follow-up results from the APBI IMRT Florence phase III trial, which showed that APBI was associated with significantly fewer adverse events and better cosmetic results than whole breast irradiation without increasing risks of tumor recurrence or mortality, reported lead author Irco Meattini, MD, of the University of Florence, Italy, and colleagues.
“As we well know, recent developments in radiation oncology ... show a move toward a deescalation strategy for early breast cancer, including accelerated and nonaccelerated partial breast irradiation,” Dr. Meattini said during a presentation at the San Antonio Breast Cancer Symposium. “What we have learned from [previous] phase 3 trials [is that with adequate patient selection for] partial breast irradiation, safety profile and cosmetic outcome are strongly associated with technique – the approach, the dose, the number of fractions per day, and the total dose.”
The current phase 3 trial, which enrolled 520 patients with early breast cancer, aimed to determine long-term efficacy, safety, and cosmetic outcomes for partial versus whole breast irradiation. All patients enrolled were at least 40 years of age and had a maximum pathological tumor size of 25 mm. Patients were randomized in a 1:1 ratio to receive either whole breast irradiation (WBI) at a dose of 50 Gy in 25 fractions, followed by 10 Gy in five fractions delivered to the tumor bed; or APBI, which was delivered to the tumor bed at a dose of 30 Gy in five daily fractions.
The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Secondary endpoints were overall survival, breast cancer–specific survival, distant metastasis-free survival, locoregional recurrences, and contralateral breast cancer. Adverse events and cosmesis also were evaluated.
Five-year results, previously reported, revealed no significant difference in survival rates or IBTR between treatment techniques, and results of the present 10-year analysis maintained these findings. Between groups, no significant differences were observed in any of the primary or secondary endpoints, suggesting that major efficacy outcomes were unaffected by type of irradiation delivered.
While major efficacy endpoints were comparable between groups, safety profiles and cosmetic results differed significantly.
Adverse events of all levels of severity were significantly more common with WBI than APBI. Grade 2 or higher acute adverse events occurred in 37.7% of patients treated with WBI, compared with just 2.0% of patients treated with APBI (P = .0001). The rate of grade 2 or higher adverse events was also significantly higher in the WBI group than in the APBI group in the late setting, albeit with a narrower margin than in the acute setting (2.7% vs 0%; P = .015). Skin toxicity rates followed a similar pattern, favoring APBI both in the acute phase (66.5% vs. 21.1%; P = .0001) and the late phase (30.0% vs. 4.5%; P = .0001).
In further support of APBI, cosmetic results, as measured by the Harvard Breast Cosmesis Scale, were significantly better in the APBI group than in the WBI group. Both physicians and patients were significantly more likely to report good or excellent cosmetic results with APBI than WBI.
“APBI might be considered a standard alternative to WBI in low risk and very low risk early breast cancer patients,” Dr. Meattini concluded.
The investigators reported no disclosures.
SOURCE: Meattini et al. SABCS. 2019 Dec 12. Abstract GS4-06.
SAN ANTONIO – For patients with early, low-risk breast cancer, accelerated partial breast irradiation (APBI) may be considered a standard alternative to whole breast irradiation, according to investigators.
This conclusion was based on 10-year follow-up results from the APBI IMRT Florence phase III trial, which showed that APBI was associated with significantly fewer adverse events and better cosmetic results than whole breast irradiation without increasing risks of tumor recurrence or mortality, reported lead author Irco Meattini, MD, of the University of Florence, Italy, and colleagues.
“As we well know, recent developments in radiation oncology ... show a move toward a deescalation strategy for early breast cancer, including accelerated and nonaccelerated partial breast irradiation,” Dr. Meattini said during a presentation at the San Antonio Breast Cancer Symposium. “What we have learned from [previous] phase 3 trials [is that with adequate patient selection for] partial breast irradiation, safety profile and cosmetic outcome are strongly associated with technique – the approach, the dose, the number of fractions per day, and the total dose.”
The current phase 3 trial, which enrolled 520 patients with early breast cancer, aimed to determine long-term efficacy, safety, and cosmetic outcomes for partial versus whole breast irradiation. All patients enrolled were at least 40 years of age and had a maximum pathological tumor size of 25 mm. Patients were randomized in a 1:1 ratio to receive either whole breast irradiation (WBI) at a dose of 50 Gy in 25 fractions, followed by 10 Gy in five fractions delivered to the tumor bed; or APBI, which was delivered to the tumor bed at a dose of 30 Gy in five daily fractions.
The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Secondary endpoints were overall survival, breast cancer–specific survival, distant metastasis-free survival, locoregional recurrences, and contralateral breast cancer. Adverse events and cosmesis also were evaluated.
Five-year results, previously reported, revealed no significant difference in survival rates or IBTR between treatment techniques, and results of the present 10-year analysis maintained these findings. Between groups, no significant differences were observed in any of the primary or secondary endpoints, suggesting that major efficacy outcomes were unaffected by type of irradiation delivered.
While major efficacy endpoints were comparable between groups, safety profiles and cosmetic results differed significantly.
Adverse events of all levels of severity were significantly more common with WBI than APBI. Grade 2 or higher acute adverse events occurred in 37.7% of patients treated with WBI, compared with just 2.0% of patients treated with APBI (P = .0001). The rate of grade 2 or higher adverse events was also significantly higher in the WBI group than in the APBI group in the late setting, albeit with a narrower margin than in the acute setting (2.7% vs 0%; P = .015). Skin toxicity rates followed a similar pattern, favoring APBI both in the acute phase (66.5% vs. 21.1%; P = .0001) and the late phase (30.0% vs. 4.5%; P = .0001).
In further support of APBI, cosmetic results, as measured by the Harvard Breast Cosmesis Scale, were significantly better in the APBI group than in the WBI group. Both physicians and patients were significantly more likely to report good or excellent cosmetic results with APBI than WBI.
“APBI might be considered a standard alternative to WBI in low risk and very low risk early breast cancer patients,” Dr. Meattini concluded.
The investigators reported no disclosures.
SOURCE: Meattini et al. SABCS. 2019 Dec 12. Abstract GS4-06.
SAN ANTONIO – For patients with early, low-risk breast cancer, accelerated partial breast irradiation (APBI) may be considered a standard alternative to whole breast irradiation, according to investigators.
This conclusion was based on 10-year follow-up results from the APBI IMRT Florence phase III trial, which showed that APBI was associated with significantly fewer adverse events and better cosmetic results than whole breast irradiation without increasing risks of tumor recurrence or mortality, reported lead author Irco Meattini, MD, of the University of Florence, Italy, and colleagues.
“As we well know, recent developments in radiation oncology ... show a move toward a deescalation strategy for early breast cancer, including accelerated and nonaccelerated partial breast irradiation,” Dr. Meattini said during a presentation at the San Antonio Breast Cancer Symposium. “What we have learned from [previous] phase 3 trials [is that with adequate patient selection for] partial breast irradiation, safety profile and cosmetic outcome are strongly associated with technique – the approach, the dose, the number of fractions per day, and the total dose.”
The current phase 3 trial, which enrolled 520 patients with early breast cancer, aimed to determine long-term efficacy, safety, and cosmetic outcomes for partial versus whole breast irradiation. All patients enrolled were at least 40 years of age and had a maximum pathological tumor size of 25 mm. Patients were randomized in a 1:1 ratio to receive either whole breast irradiation (WBI) at a dose of 50 Gy in 25 fractions, followed by 10 Gy in five fractions delivered to the tumor bed; or APBI, which was delivered to the tumor bed at a dose of 30 Gy in five daily fractions.
The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Secondary endpoints were overall survival, breast cancer–specific survival, distant metastasis-free survival, locoregional recurrences, and contralateral breast cancer. Adverse events and cosmesis also were evaluated.
Five-year results, previously reported, revealed no significant difference in survival rates or IBTR between treatment techniques, and results of the present 10-year analysis maintained these findings. Between groups, no significant differences were observed in any of the primary or secondary endpoints, suggesting that major efficacy outcomes were unaffected by type of irradiation delivered.
While major efficacy endpoints were comparable between groups, safety profiles and cosmetic results differed significantly.
Adverse events of all levels of severity were significantly more common with WBI than APBI. Grade 2 or higher acute adverse events occurred in 37.7% of patients treated with WBI, compared with just 2.0% of patients treated with APBI (P = .0001). The rate of grade 2 or higher adverse events was also significantly higher in the WBI group than in the APBI group in the late setting, albeit with a narrower margin than in the acute setting (2.7% vs 0%; P = .015). Skin toxicity rates followed a similar pattern, favoring APBI both in the acute phase (66.5% vs. 21.1%; P = .0001) and the late phase (30.0% vs. 4.5%; P = .0001).
In further support of APBI, cosmetic results, as measured by the Harvard Breast Cosmesis Scale, were significantly better in the APBI group than in the WBI group. Both physicians and patients were significantly more likely to report good or excellent cosmetic results with APBI than WBI.
“APBI might be considered a standard alternative to WBI in low risk and very low risk early breast cancer patients,” Dr. Meattini concluded.
The investigators reported no disclosures.
SOURCE: Meattini et al. SABCS. 2019 Dec 12. Abstract GS4-06.
REPORTING FROM SABCS 2019
Improving sepsis-related outcomes
Early diagnosis a key goal
Sepsis is a leading cause of death and disease among patients in hospitals, and it’s the subject of a recent quality improvement study in the Journal for Healthcare Quality.
“The number of cases per year has been increasing in the U.S., and it is the most expensive condition treated in U.S. hospitals,” said lead author M. Courtney Hughes, PhD, of Northern Illinois University in DeKalb.
But early identification of symptoms can be complex and difficult for clinicians, meaning there’s a continuing need for research studies examining sepsis identification and prevention. “The purpose of this study was to examine a quality improvement project that consisted of clinical alerts, audit and feedback, and staff education at an integrated health care system in the Midwest,” she said.
In a retrospective analysis, the researchers examined data from three health systems to determine the impact of a 10-month sepsis quality improvement program that consisted of clinical alerts, audit and feedback, and staff education. The results showed that, compared with the control group, the intervention group significantly decreased length of stay and costs per stay.
“One way to improve sepsis health outcomes and decrease costs may be for hospitals to implement a sepsis quality improvement program,” Dr. Hughes said. “Also, providing sepsis performance data and education to hospital providers and administrators can arm staff with the knowledge and tools necessary for improving processes and performance related to sepsis.”
Dr. Hughes said that she hopes this work will encourage hospitalists to seek sepsis-related performance data and training. “By doing so, they may help achieve earlier diagnosis of sepsis cases and initiation of the Surviving Sepsis Campaign bundle.”
Reference
Hughes MC et al. A quality improvement project to improve sepsis-related outcomes at an integrated healthcare system. J Healthc Qual. Published online 2019 Mar 14. doi: 10.1097/JHQ.0000000000000193.
Early diagnosis a key goal
Early diagnosis a key goal
Sepsis is a leading cause of death and disease among patients in hospitals, and it’s the subject of a recent quality improvement study in the Journal for Healthcare Quality.
“The number of cases per year has been increasing in the U.S., and it is the most expensive condition treated in U.S. hospitals,” said lead author M. Courtney Hughes, PhD, of Northern Illinois University in DeKalb.
But early identification of symptoms can be complex and difficult for clinicians, meaning there’s a continuing need for research studies examining sepsis identification and prevention. “The purpose of this study was to examine a quality improvement project that consisted of clinical alerts, audit and feedback, and staff education at an integrated health care system in the Midwest,” she said.
In a retrospective analysis, the researchers examined data from three health systems to determine the impact of a 10-month sepsis quality improvement program that consisted of clinical alerts, audit and feedback, and staff education. The results showed that, compared with the control group, the intervention group significantly decreased length of stay and costs per stay.
“One way to improve sepsis health outcomes and decrease costs may be for hospitals to implement a sepsis quality improvement program,” Dr. Hughes said. “Also, providing sepsis performance data and education to hospital providers and administrators can arm staff with the knowledge and tools necessary for improving processes and performance related to sepsis.”
Dr. Hughes said that she hopes this work will encourage hospitalists to seek sepsis-related performance data and training. “By doing so, they may help achieve earlier diagnosis of sepsis cases and initiation of the Surviving Sepsis Campaign bundle.”
Reference
Hughes MC et al. A quality improvement project to improve sepsis-related outcomes at an integrated healthcare system. J Healthc Qual. Published online 2019 Mar 14. doi: 10.1097/JHQ.0000000000000193.
Sepsis is a leading cause of death and disease among patients in hospitals, and it’s the subject of a recent quality improvement study in the Journal for Healthcare Quality.
“The number of cases per year has been increasing in the U.S., and it is the most expensive condition treated in U.S. hospitals,” said lead author M. Courtney Hughes, PhD, of Northern Illinois University in DeKalb.
But early identification of symptoms can be complex and difficult for clinicians, meaning there’s a continuing need for research studies examining sepsis identification and prevention. “The purpose of this study was to examine a quality improvement project that consisted of clinical alerts, audit and feedback, and staff education at an integrated health care system in the Midwest,” she said.
In a retrospective analysis, the researchers examined data from three health systems to determine the impact of a 10-month sepsis quality improvement program that consisted of clinical alerts, audit and feedback, and staff education. The results showed that, compared with the control group, the intervention group significantly decreased length of stay and costs per stay.
“One way to improve sepsis health outcomes and decrease costs may be for hospitals to implement a sepsis quality improvement program,” Dr. Hughes said. “Also, providing sepsis performance data and education to hospital providers and administrators can arm staff with the knowledge and tools necessary for improving processes and performance related to sepsis.”
Dr. Hughes said that she hopes this work will encourage hospitalists to seek sepsis-related performance data and training. “By doing so, they may help achieve earlier diagnosis of sepsis cases and initiation of the Surviving Sepsis Campaign bundle.”
Reference
Hughes MC et al. A quality improvement project to improve sepsis-related outcomes at an integrated healthcare system. J Healthc Qual. Published online 2019 Mar 14. doi: 10.1097/JHQ.0000000000000193.
The Great Pretender
Susannah Cahalan’s new book challenges an experiment that changed psychiatry
As an undergraduate psychology major, I was taught about the Rosenhan study in several of my courses. My professors lectured about the shocking findings psychologist David Rosenhan, PhD, documented in a 1973 Science article, “On Being Sane in Insane Places” and these findings lent themselves to lecture hall drama. Eight people presented to hospitals and said they heard voices saying: “empty, hollow, thud.” These “pseudopatients” exhibited no other psychiatric symptoms but were admitted, diagnosed with schizophrenia, and observations of their behavior were made. The charts included notes such as, “Patient exhibits writing behavior,” my professors said. The pseudopatients were kept for an average of 19 days, and one for as long as 51 days. The decades have passed, and there are many things I learned in college that I have since forgotten, but I remember “empty, hollow, thud,” and the famous Rosenhan experiment.
I was eager to read Susannah Cahalan’s book, “The Great Pretender” (Grand Central Publishing, 2019), which puts both Dr. Rosenhan and his pseudopatient study under a microscope. Ms. Cahalan is the author of the page-turner, Brain on Fire: My Month of Madness (Free Press, 2012), where she recounted her own struggle with a psychotic episode. Ms. Cahalan, a young reporter in New York City, became psychotic and then catatonic; her condition perplexed the neurologists who were treating her on an inpatient unit, and they were on the verge of transferring her to psychiatry when a diagnosis of anti-NMDA receptor encephalitis was suspected and then confirmed with a brain biopsy. Ms. Cahalan made a full recovery after treatment with steroids, intravenous immunoglobulin, and plasmapheresis. While Ms. Cahalan’s symptoms were classic for a severe psychotic disorder, there was reason to believe that this was not a primary psychiatric disorder: She was having grand mal seizures. Her book was a bestseller, and she has spoken widely to make others aware of this rare illness that masquerades as psychosis. I heard her speak at the opening session of the American Psychiatric Association’s annual meeting in May of 2017.“My family, like many families before them, fought against the tyranny of the mental illness label,” Ms. Cahalan writes at the very beginning of “The Great Pretender.” She goes on to talk about how psychiatry differs from other medical fields: It’s the only specialty where people can be treated against their will; psychiatry casts judgments on the person; mental illness is poorly defined – perhaps there is no clear divide between normal and mad; and psychiatric disorders are less “real” than other illnesses. Throughout the book she refers to psychiatrists as smug and arrogant.
Ms. Cahalan takes on the task of documenting the horrors of psychiatry’s often sordid history, starting with journalist Nellie Bly’s 1887 journey into to a psychiatric facility to expose the abuses there. Certainly, psychiatry’s history is sordid. Ms. Cahalan talks about inhumane conditions in overcrowded psychiatric hospitals, about our sad chapter of lobotomies, about the influence of psychoanalysis on diagnosis and treatment, and about how homosexuality was once an illness and now is not. She includes “One Flew Over the Cuckoo’s Nest,” “The Myth of Mental Illness,” big pharma, and the Goldwater fiasco. In her recounting of the history, it’s all bad. She mentions Benjamin Rush, MD, only once, as the creator of “ ‘... the tranquilizing chair’ (a case of the worst false advertising ever), a terrifying sensory-deprivation apparatus in which patients were strapped down to a chair with a wooden box placed over their heads to block stimulation, restrict movement, and reduce blood to the brain.” Dr. Rush’s role as the father of American psychiatry who challenged the belief that mental illness was the result of demonic possession, gets no mention. Nor does Ms. Cahalan note that he founded Pennsylvania Hospital, where moral and occupational therapy revolutionized the treatment of those with mental illness.
So there’s her story, her rendition of the history of American psychiatry, and through this she weaves in the story of the Rosenhan experiment.
“ ‘It all started out as a dare,’ Dr. Rosenhan told a local newspaper, ‘I was teaching psychology at Swarthmore, and my students were saying that the course was too conceptual and abstract. So I said, ‘Okay, if you really want to know what mental patients are like, become mental patients.’ ”
Really? I read this and wondered how a psychologist could talk about people who had been hospitalized with psychiatric disorders as though they were aliens. Certainly, some of these students, their family members, or their friends must have been hospitalized at some point. Yet all through, there is this sense that the patients are other, and the discovery of the undercover operation is that the patients are actually human beings! Dr. Rosenhan, who was one of the pseudopatients, goes on to conclude that the label is everything, that once labeled they are treated differently by the nurses in “cages” and the doctors who walk by and avert their gaze. A second man Ms. Cahalan named, also one of the pseudopatients, had a similar experience. A third subject she located was not included in the study: His experience was counter to the findings of the study, his time in the hospital was a positive, he found it comforting, and the experiences he had there had a lasting positive influence on his life.
Ms. Cahalan talks about the publication of “On Being Sane in Insane Places” as a study that was finally scientific, one that changed all of psychiatry, and was the driving force for the creation of the DSM-III and the closure of state hospitals. I wondered if it was as influential as Ms. Cahalan claims, and I asked some psychiatrists who were practicing in 1973 when the article was published. I wanted to know if this study rocked their world.
“At first, with the great amount of publicity the study generated, it was added fodder for the antipsychiatrists, including the Scientologists and Szaszians,” Steven Sharfstein, MD, a former president of the American Psychiatric Association, told me. “But as young psychiatrists in the trenches, business continued to boom, and we continued to do the best job we could with diagnosis, assessment of risk, involuntary commitment, and treatment. And from what I recall, morale was high in the 1970s. We had some new medications and psychotherapies, and there was community activism. Faking symptoms to gain admission seemed to be a no-brainer, but keeping people for long stays was more problematic.”
E. Fuller Torrey, MD, the founder of the Treatment Advocacy Center who worked for many years treating patients at St. Elizabeth’s Hospital, replied: “It is important to remember that this study was published at the height of the deinstitutionalization movement and quite likely accelerated it. As I recall, at the time it seemed odd that all eight patients claimed to have had similar experiences while hospitalized. I think the main effect of the study was to provide ammunition for the antipsychiatrists.”
Ms. Cahalan has bought into the antipsychiatry movement full force. It’s not until the very end that there is any acknowledgment that psychiatry ever helped anyone, and even then, it’s a bit begrudging. Worse, she neglects to mention that people with psychiatric disorders suffer because of their psychic pain; one could get through this book and believe that people with mental illness struggle only because they are labeled and then mistreated, and for someone who has suffered herself, she misses the essence of how awful it is to be ill, and that people are often helped by psychiatric treatments. When she finally adds a paragraph talking about the usefulness of psychotropics, it’s with a caveat. “But I’m not here to rail against the drugs. There are plenty of places you can get that perspective. I see that these drugs help many people lead full and meaningful lives. It would be folly to discount their worth. We also can’t deny that the situation is complicated.”
There are moments in the manuscript where I found it difficult to know what were Dr. Rosenhan’s interpretations and what were Ms. Callahan’s interpretations of Dr. Rosenhan’s experiences. A lot of assumptions are made – particularly about the motivations of the hospital staff – and I wasn’t always sure they were correct. For example, on his second day in the hospital, Dr. Rosenhan asked a nurse for the newspaper. When she tells him it hasn’t come yet, he concludes that the staff is keeping the newspapers from the patients. And when a staff member is initially chatty then later shuns Dr. Rosenhan, he concludes that the man initially mistook him for a psychiatrist because he looks professorial. Both Ms. Cahalan and Dr. Rosenhan approach psychiatry with biases, and they don’t always question their assumptions.
, a professor who didn’t treat patients. This intermixing of the two fields felt contrived to me, and gave too much credence to the idea that no one really knows sane from disordered, and everyone was embracing the antipsychiatry dogma. Surely, someone during the those years must have liked their psychiatrist.
That said, Ms. Cahalan does a phenomenal job of infiltrating the world of the late Dr. Rosenhan. She starts out enamored by him and by his finding that psychiatrists can’t tell real illness from faked disorder. She meets with his friends, his son, his colleagues, his students, and she flies all over the country to meet with those who can help her understand him. She gains access to his personal files and to the book he started to write about the experiment, then abandoned, which eventually resulted in a lawsuit by Doubleday to have the book’s advance returned. At one point, she even hires a private detective.
What is Ms. Cahalan looking for so desperately? She’s looking for these anonymous pseudopatients, the people who were admitted to these unnamed state hospitals, who made observations and took notes, who were diagnosed with schizophrenia and then finally released. She’s looking for the truth, and while she identifies Dr. Rosenhan and two other pseudopatients as people who faked their way into the hospital, she finds a mass of contradictions. The one pseudopatient was excluded from the study – he is the one who felt comforted by his time in the hospital. The other six pseudopatients could not be found, despite Ms. Cahalan’s heroic attempts. Furthermore, she found many inconsistencies in what Dr. Rosenhan reported, and his hospital notes revealed more than a presentation for voices saying “empty, hollow, thud.” He reported it had been going on for months, that he had put copper over his ears to block the sound, and that he felt suicidal.
Ultimately, Ms. Cahalan was left to conclude that the Rosenhan experiment was a lie, that the pseudopatients likely never existed and the article was a fabrication. She brings up other studies that have been proven to be fraudulent, and by this point, our faith in all of science is pretty shaken.
Ms. Cahalan took a long journey to get us to this place, one that spent a lot of effort in bashing psychiatry, finally concluding that, as a result of this fraudulent experiment, too many hospitals have been shuttered – leaving our sickest patients to the streets and to the jails – and that there are not enough mental health professionals. As a psychiatrist – one who is often willing to question our practices – I was distracted by the flagrant antipsychiatry sentiments. Reading past that, Ms. Cahalan’s remarkable detective work and creative intermingling of the Rosenhan experiment layered on the history of psychiatry, further layered on her own experience with psychosis, makes for an amazing story. The Rosenhan study may have rocked the world of psychiatry; the fact that it was fabricated should rock us even more.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Susannah Cahalan’s new book challenges an experiment that changed psychiatry
Susannah Cahalan’s new book challenges an experiment that changed psychiatry
As an undergraduate psychology major, I was taught about the Rosenhan study in several of my courses. My professors lectured about the shocking findings psychologist David Rosenhan, PhD, documented in a 1973 Science article, “On Being Sane in Insane Places” and these findings lent themselves to lecture hall drama. Eight people presented to hospitals and said they heard voices saying: “empty, hollow, thud.” These “pseudopatients” exhibited no other psychiatric symptoms but were admitted, diagnosed with schizophrenia, and observations of their behavior were made. The charts included notes such as, “Patient exhibits writing behavior,” my professors said. The pseudopatients were kept for an average of 19 days, and one for as long as 51 days. The decades have passed, and there are many things I learned in college that I have since forgotten, but I remember “empty, hollow, thud,” and the famous Rosenhan experiment.
I was eager to read Susannah Cahalan’s book, “The Great Pretender” (Grand Central Publishing, 2019), which puts both Dr. Rosenhan and his pseudopatient study under a microscope. Ms. Cahalan is the author of the page-turner, Brain on Fire: My Month of Madness (Free Press, 2012), where she recounted her own struggle with a psychotic episode. Ms. Cahalan, a young reporter in New York City, became psychotic and then catatonic; her condition perplexed the neurologists who were treating her on an inpatient unit, and they were on the verge of transferring her to psychiatry when a diagnosis of anti-NMDA receptor encephalitis was suspected and then confirmed with a brain biopsy. Ms. Cahalan made a full recovery after treatment with steroids, intravenous immunoglobulin, and plasmapheresis. While Ms. Cahalan’s symptoms were classic for a severe psychotic disorder, there was reason to believe that this was not a primary psychiatric disorder: She was having grand mal seizures. Her book was a bestseller, and she has spoken widely to make others aware of this rare illness that masquerades as psychosis. I heard her speak at the opening session of the American Psychiatric Association’s annual meeting in May of 2017.“My family, like many families before them, fought against the tyranny of the mental illness label,” Ms. Cahalan writes at the very beginning of “The Great Pretender.” She goes on to talk about how psychiatry differs from other medical fields: It’s the only specialty where people can be treated against their will; psychiatry casts judgments on the person; mental illness is poorly defined – perhaps there is no clear divide between normal and mad; and psychiatric disorders are less “real” than other illnesses. Throughout the book she refers to psychiatrists as smug and arrogant.
Ms. Cahalan takes on the task of documenting the horrors of psychiatry’s often sordid history, starting with journalist Nellie Bly’s 1887 journey into to a psychiatric facility to expose the abuses there. Certainly, psychiatry’s history is sordid. Ms. Cahalan talks about inhumane conditions in overcrowded psychiatric hospitals, about our sad chapter of lobotomies, about the influence of psychoanalysis on diagnosis and treatment, and about how homosexuality was once an illness and now is not. She includes “One Flew Over the Cuckoo’s Nest,” “The Myth of Mental Illness,” big pharma, and the Goldwater fiasco. In her recounting of the history, it’s all bad. She mentions Benjamin Rush, MD, only once, as the creator of “ ‘... the tranquilizing chair’ (a case of the worst false advertising ever), a terrifying sensory-deprivation apparatus in which patients were strapped down to a chair with a wooden box placed over their heads to block stimulation, restrict movement, and reduce blood to the brain.” Dr. Rush’s role as the father of American psychiatry who challenged the belief that mental illness was the result of demonic possession, gets no mention. Nor does Ms. Cahalan note that he founded Pennsylvania Hospital, where moral and occupational therapy revolutionized the treatment of those with mental illness.
So there’s her story, her rendition of the history of American psychiatry, and through this she weaves in the story of the Rosenhan experiment.
“ ‘It all started out as a dare,’ Dr. Rosenhan told a local newspaper, ‘I was teaching psychology at Swarthmore, and my students were saying that the course was too conceptual and abstract. So I said, ‘Okay, if you really want to know what mental patients are like, become mental patients.’ ”
Really? I read this and wondered how a psychologist could talk about people who had been hospitalized with psychiatric disorders as though they were aliens. Certainly, some of these students, their family members, or their friends must have been hospitalized at some point. Yet all through, there is this sense that the patients are other, and the discovery of the undercover operation is that the patients are actually human beings! Dr. Rosenhan, who was one of the pseudopatients, goes on to conclude that the label is everything, that once labeled they are treated differently by the nurses in “cages” and the doctors who walk by and avert their gaze. A second man Ms. Cahalan named, also one of the pseudopatients, had a similar experience. A third subject she located was not included in the study: His experience was counter to the findings of the study, his time in the hospital was a positive, he found it comforting, and the experiences he had there had a lasting positive influence on his life.
Ms. Cahalan talks about the publication of “On Being Sane in Insane Places” as a study that was finally scientific, one that changed all of psychiatry, and was the driving force for the creation of the DSM-III and the closure of state hospitals. I wondered if it was as influential as Ms. Cahalan claims, and I asked some psychiatrists who were practicing in 1973 when the article was published. I wanted to know if this study rocked their world.
“At first, with the great amount of publicity the study generated, it was added fodder for the antipsychiatrists, including the Scientologists and Szaszians,” Steven Sharfstein, MD, a former president of the American Psychiatric Association, told me. “But as young psychiatrists in the trenches, business continued to boom, and we continued to do the best job we could with diagnosis, assessment of risk, involuntary commitment, and treatment. And from what I recall, morale was high in the 1970s. We had some new medications and psychotherapies, and there was community activism. Faking symptoms to gain admission seemed to be a no-brainer, but keeping people for long stays was more problematic.”
E. Fuller Torrey, MD, the founder of the Treatment Advocacy Center who worked for many years treating patients at St. Elizabeth’s Hospital, replied: “It is important to remember that this study was published at the height of the deinstitutionalization movement and quite likely accelerated it. As I recall, at the time it seemed odd that all eight patients claimed to have had similar experiences while hospitalized. I think the main effect of the study was to provide ammunition for the antipsychiatrists.”
Ms. Cahalan has bought into the antipsychiatry movement full force. It’s not until the very end that there is any acknowledgment that psychiatry ever helped anyone, and even then, it’s a bit begrudging. Worse, she neglects to mention that people with psychiatric disorders suffer because of their psychic pain; one could get through this book and believe that people with mental illness struggle only because they are labeled and then mistreated, and for someone who has suffered herself, she misses the essence of how awful it is to be ill, and that people are often helped by psychiatric treatments. When she finally adds a paragraph talking about the usefulness of psychotropics, it’s with a caveat. “But I’m not here to rail against the drugs. There are plenty of places you can get that perspective. I see that these drugs help many people lead full and meaningful lives. It would be folly to discount their worth. We also can’t deny that the situation is complicated.”
There are moments in the manuscript where I found it difficult to know what were Dr. Rosenhan’s interpretations and what were Ms. Callahan’s interpretations of Dr. Rosenhan’s experiences. A lot of assumptions are made – particularly about the motivations of the hospital staff – and I wasn’t always sure they were correct. For example, on his second day in the hospital, Dr. Rosenhan asked a nurse for the newspaper. When she tells him it hasn’t come yet, he concludes that the staff is keeping the newspapers from the patients. And when a staff member is initially chatty then later shuns Dr. Rosenhan, he concludes that the man initially mistook him for a psychiatrist because he looks professorial. Both Ms. Cahalan and Dr. Rosenhan approach psychiatry with biases, and they don’t always question their assumptions.
, a professor who didn’t treat patients. This intermixing of the two fields felt contrived to me, and gave too much credence to the idea that no one really knows sane from disordered, and everyone was embracing the antipsychiatry dogma. Surely, someone during the those years must have liked their psychiatrist.
That said, Ms. Cahalan does a phenomenal job of infiltrating the world of the late Dr. Rosenhan. She starts out enamored by him and by his finding that psychiatrists can’t tell real illness from faked disorder. She meets with his friends, his son, his colleagues, his students, and she flies all over the country to meet with those who can help her understand him. She gains access to his personal files and to the book he started to write about the experiment, then abandoned, which eventually resulted in a lawsuit by Doubleday to have the book’s advance returned. At one point, she even hires a private detective.
What is Ms. Cahalan looking for so desperately? She’s looking for these anonymous pseudopatients, the people who were admitted to these unnamed state hospitals, who made observations and took notes, who were diagnosed with schizophrenia and then finally released. She’s looking for the truth, and while she identifies Dr. Rosenhan and two other pseudopatients as people who faked their way into the hospital, she finds a mass of contradictions. The one pseudopatient was excluded from the study – he is the one who felt comforted by his time in the hospital. The other six pseudopatients could not be found, despite Ms. Cahalan’s heroic attempts. Furthermore, she found many inconsistencies in what Dr. Rosenhan reported, and his hospital notes revealed more than a presentation for voices saying “empty, hollow, thud.” He reported it had been going on for months, that he had put copper over his ears to block the sound, and that he felt suicidal.
Ultimately, Ms. Cahalan was left to conclude that the Rosenhan experiment was a lie, that the pseudopatients likely never existed and the article was a fabrication. She brings up other studies that have been proven to be fraudulent, and by this point, our faith in all of science is pretty shaken.
Ms. Cahalan took a long journey to get us to this place, one that spent a lot of effort in bashing psychiatry, finally concluding that, as a result of this fraudulent experiment, too many hospitals have been shuttered – leaving our sickest patients to the streets and to the jails – and that there are not enough mental health professionals. As a psychiatrist – one who is often willing to question our practices – I was distracted by the flagrant antipsychiatry sentiments. Reading past that, Ms. Cahalan’s remarkable detective work and creative intermingling of the Rosenhan experiment layered on the history of psychiatry, further layered on her own experience with psychosis, makes for an amazing story. The Rosenhan study may have rocked the world of psychiatry; the fact that it was fabricated should rock us even more.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
As an undergraduate psychology major, I was taught about the Rosenhan study in several of my courses. My professors lectured about the shocking findings psychologist David Rosenhan, PhD, documented in a 1973 Science article, “On Being Sane in Insane Places” and these findings lent themselves to lecture hall drama. Eight people presented to hospitals and said they heard voices saying: “empty, hollow, thud.” These “pseudopatients” exhibited no other psychiatric symptoms but were admitted, diagnosed with schizophrenia, and observations of their behavior were made. The charts included notes such as, “Patient exhibits writing behavior,” my professors said. The pseudopatients were kept for an average of 19 days, and one for as long as 51 days. The decades have passed, and there are many things I learned in college that I have since forgotten, but I remember “empty, hollow, thud,” and the famous Rosenhan experiment.
I was eager to read Susannah Cahalan’s book, “The Great Pretender” (Grand Central Publishing, 2019), which puts both Dr. Rosenhan and his pseudopatient study under a microscope. Ms. Cahalan is the author of the page-turner, Brain on Fire: My Month of Madness (Free Press, 2012), where she recounted her own struggle with a psychotic episode. Ms. Cahalan, a young reporter in New York City, became psychotic and then catatonic; her condition perplexed the neurologists who were treating her on an inpatient unit, and they were on the verge of transferring her to psychiatry when a diagnosis of anti-NMDA receptor encephalitis was suspected and then confirmed with a brain biopsy. Ms. Cahalan made a full recovery after treatment with steroids, intravenous immunoglobulin, and plasmapheresis. While Ms. Cahalan’s symptoms were classic for a severe psychotic disorder, there was reason to believe that this was not a primary psychiatric disorder: She was having grand mal seizures. Her book was a bestseller, and she has spoken widely to make others aware of this rare illness that masquerades as psychosis. I heard her speak at the opening session of the American Psychiatric Association’s annual meeting in May of 2017.“My family, like many families before them, fought against the tyranny of the mental illness label,” Ms. Cahalan writes at the very beginning of “The Great Pretender.” She goes on to talk about how psychiatry differs from other medical fields: It’s the only specialty where people can be treated against their will; psychiatry casts judgments on the person; mental illness is poorly defined – perhaps there is no clear divide between normal and mad; and psychiatric disorders are less “real” than other illnesses. Throughout the book she refers to psychiatrists as smug and arrogant.
Ms. Cahalan takes on the task of documenting the horrors of psychiatry’s often sordid history, starting with journalist Nellie Bly’s 1887 journey into to a psychiatric facility to expose the abuses there. Certainly, psychiatry’s history is sordid. Ms. Cahalan talks about inhumane conditions in overcrowded psychiatric hospitals, about our sad chapter of lobotomies, about the influence of psychoanalysis on diagnosis and treatment, and about how homosexuality was once an illness and now is not. She includes “One Flew Over the Cuckoo’s Nest,” “The Myth of Mental Illness,” big pharma, and the Goldwater fiasco. In her recounting of the history, it’s all bad. She mentions Benjamin Rush, MD, only once, as the creator of “ ‘... the tranquilizing chair’ (a case of the worst false advertising ever), a terrifying sensory-deprivation apparatus in which patients were strapped down to a chair with a wooden box placed over their heads to block stimulation, restrict movement, and reduce blood to the brain.” Dr. Rush’s role as the father of American psychiatry who challenged the belief that mental illness was the result of demonic possession, gets no mention. Nor does Ms. Cahalan note that he founded Pennsylvania Hospital, where moral and occupational therapy revolutionized the treatment of those with mental illness.
So there’s her story, her rendition of the history of American psychiatry, and through this she weaves in the story of the Rosenhan experiment.
“ ‘It all started out as a dare,’ Dr. Rosenhan told a local newspaper, ‘I was teaching psychology at Swarthmore, and my students were saying that the course was too conceptual and abstract. So I said, ‘Okay, if you really want to know what mental patients are like, become mental patients.’ ”
Really? I read this and wondered how a psychologist could talk about people who had been hospitalized with psychiatric disorders as though they were aliens. Certainly, some of these students, their family members, or their friends must have been hospitalized at some point. Yet all through, there is this sense that the patients are other, and the discovery of the undercover operation is that the patients are actually human beings! Dr. Rosenhan, who was one of the pseudopatients, goes on to conclude that the label is everything, that once labeled they are treated differently by the nurses in “cages” and the doctors who walk by and avert their gaze. A second man Ms. Cahalan named, also one of the pseudopatients, had a similar experience. A third subject she located was not included in the study: His experience was counter to the findings of the study, his time in the hospital was a positive, he found it comforting, and the experiences he had there had a lasting positive influence on his life.
Ms. Cahalan talks about the publication of “On Being Sane in Insane Places” as a study that was finally scientific, one that changed all of psychiatry, and was the driving force for the creation of the DSM-III and the closure of state hospitals. I wondered if it was as influential as Ms. Cahalan claims, and I asked some psychiatrists who were practicing in 1973 when the article was published. I wanted to know if this study rocked their world.
“At first, with the great amount of publicity the study generated, it was added fodder for the antipsychiatrists, including the Scientologists and Szaszians,” Steven Sharfstein, MD, a former president of the American Psychiatric Association, told me. “But as young psychiatrists in the trenches, business continued to boom, and we continued to do the best job we could with diagnosis, assessment of risk, involuntary commitment, and treatment. And from what I recall, morale was high in the 1970s. We had some new medications and psychotherapies, and there was community activism. Faking symptoms to gain admission seemed to be a no-brainer, but keeping people for long stays was more problematic.”
E. Fuller Torrey, MD, the founder of the Treatment Advocacy Center who worked for many years treating patients at St. Elizabeth’s Hospital, replied: “It is important to remember that this study was published at the height of the deinstitutionalization movement and quite likely accelerated it. As I recall, at the time it seemed odd that all eight patients claimed to have had similar experiences while hospitalized. I think the main effect of the study was to provide ammunition for the antipsychiatrists.”
Ms. Cahalan has bought into the antipsychiatry movement full force. It’s not until the very end that there is any acknowledgment that psychiatry ever helped anyone, and even then, it’s a bit begrudging. Worse, she neglects to mention that people with psychiatric disorders suffer because of their psychic pain; one could get through this book and believe that people with mental illness struggle only because they are labeled and then mistreated, and for someone who has suffered herself, she misses the essence of how awful it is to be ill, and that people are often helped by psychiatric treatments. When she finally adds a paragraph talking about the usefulness of psychotropics, it’s with a caveat. “But I’m not here to rail against the drugs. There are plenty of places you can get that perspective. I see that these drugs help many people lead full and meaningful lives. It would be folly to discount their worth. We also can’t deny that the situation is complicated.”
There are moments in the manuscript where I found it difficult to know what were Dr. Rosenhan’s interpretations and what were Ms. Callahan’s interpretations of Dr. Rosenhan’s experiences. A lot of assumptions are made – particularly about the motivations of the hospital staff – and I wasn’t always sure they were correct. For example, on his second day in the hospital, Dr. Rosenhan asked a nurse for the newspaper. When she tells him it hasn’t come yet, he concludes that the staff is keeping the newspapers from the patients. And when a staff member is initially chatty then later shuns Dr. Rosenhan, he concludes that the man initially mistook him for a psychiatrist because he looks professorial. Both Ms. Cahalan and Dr. Rosenhan approach psychiatry with biases, and they don’t always question their assumptions.
, a professor who didn’t treat patients. This intermixing of the two fields felt contrived to me, and gave too much credence to the idea that no one really knows sane from disordered, and everyone was embracing the antipsychiatry dogma. Surely, someone during the those years must have liked their psychiatrist.
That said, Ms. Cahalan does a phenomenal job of infiltrating the world of the late Dr. Rosenhan. She starts out enamored by him and by his finding that psychiatrists can’t tell real illness from faked disorder. She meets with his friends, his son, his colleagues, his students, and she flies all over the country to meet with those who can help her understand him. She gains access to his personal files and to the book he started to write about the experiment, then abandoned, which eventually resulted in a lawsuit by Doubleday to have the book’s advance returned. At one point, she even hires a private detective.
What is Ms. Cahalan looking for so desperately? She’s looking for these anonymous pseudopatients, the people who were admitted to these unnamed state hospitals, who made observations and took notes, who were diagnosed with schizophrenia and then finally released. She’s looking for the truth, and while she identifies Dr. Rosenhan and two other pseudopatients as people who faked their way into the hospital, she finds a mass of contradictions. The one pseudopatient was excluded from the study – he is the one who felt comforted by his time in the hospital. The other six pseudopatients could not be found, despite Ms. Cahalan’s heroic attempts. Furthermore, she found many inconsistencies in what Dr. Rosenhan reported, and his hospital notes revealed more than a presentation for voices saying “empty, hollow, thud.” He reported it had been going on for months, that he had put copper over his ears to block the sound, and that he felt suicidal.
Ultimately, Ms. Cahalan was left to conclude that the Rosenhan experiment was a lie, that the pseudopatients likely never existed and the article was a fabrication. She brings up other studies that have been proven to be fraudulent, and by this point, our faith in all of science is pretty shaken.
Ms. Cahalan took a long journey to get us to this place, one that spent a lot of effort in bashing psychiatry, finally concluding that, as a result of this fraudulent experiment, too many hospitals have been shuttered – leaving our sickest patients to the streets and to the jails – and that there are not enough mental health professionals. As a psychiatrist – one who is often willing to question our practices – I was distracted by the flagrant antipsychiatry sentiments. Reading past that, Ms. Cahalan’s remarkable detective work and creative intermingling of the Rosenhan experiment layered on the history of psychiatry, further layered on her own experience with psychosis, makes for an amazing story. The Rosenhan study may have rocked the world of psychiatry; the fact that it was fabricated should rock us even more.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.