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Testosterone/CVD Risk Debate Revived by New Meta-Analysis
A new systematic literature review adds complexity to the controversy over testosterone’s relationship to risk for myocardial infarction, stroke, cardiovascular death, and all-cause mortality.
Last year, the TRAVERSE (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men) trial was the first randomized, placebo-controlled study designed and powered to determine whether testosterone therapy increased risk for major cardiovascular events in men (ages 45-80 years). Its conclusions provided reassurance that modest use of testosterone therapy short term does not increase CVD risk.
But other studies have had different conclusions and TRAVERSE left unanswered questions, so Bu B. Yeap, MBBS, PhD, an endocrinologist at the University of Western Australia in Crawley, and colleagues completed a literature review with 11 prospective cohort studies of community-dwelling men with sex steroid levels measured with mass spectrometry. Nine of the studies provided individual participation data (IPD); two used aggregate data, and all had at least 5 years of follow-up.
The findings were published in Annals of Internal Medicine .
Dr. Yeap’s team concluded that certain groups of men have higher risk for CVD events. In this study, men with very low testosterone, high luteinizing hormone (LH), or very low estradiol concentrations had higher all-cause mortality. Sex hormone–binding globulin (SHBG) concentration was positively associated and dihydrotestosterone (DHT) levels were nonlinearly associated with all-cause mortality and CVD mortality.
The testosterone level below which men had higher risk of death from any cause was 7.4 nmol/L (213 ng/dL), regardless of LH concentration, the researchers concluded, writing, “This adds to information on reference ranges based on distributions of testosterone in selected samples of healthy men.”
The link between higher SHBG concentrations and higher all-cause mortality “may be related to its role as the major binding protein for sex steroids in the circulation,” the authors wrote. “We found a U-shaped association of DHT with all-cause and CVD-related mortality risks, which were higher at lower and very high DHT concentrations. Men with very low DHT concentrations also had increased risk for incident CVD events. Further investigation into potential underlying mechanisms for these associations is warranted.”
Rigorous Methodology Adds Value
Bradley D. Anawalt, MD, with the University of Washington School of Medicine in Seattle, pointed out in an accompanying editorial that the study’s findings are particularly valuable because of the team’s rigorous methodology. The team measured testosterone with the gold standard, mass spectrometry, which can also measure DHT and estradiol more accurately than widely available commercial immunoassays, which “are inaccurate for measurement of these sex steroids in men, who typically have low serum concentrations of these two metabolites of testosterone,” Dr. Anawalt said.
Also, the researchers obtained raw data from the nine IPD studies and reanalyzed the combined data, which allows for more sophisticated analysis when combining data from multiple studies, Dr. Anawalt explained.
The main finding from the Yeap et al. study, he wrote, is that high testosterone concentrations at baseline were not linked with increased deaths from CVD or from all causes “but very low serum total testosterone concentrations at baseline were.
“It is tempting to hypothesize that testosterone therapy might have cardiovascular benefits solely in patients with very low concentrations of serum total testosterone,” Dr. Anawalt wrote.
He pointed out as particularly interesting the findings for DHT and estradiol.
“The finding that a low serum estradiol concentration is associated with higher all-cause mortality adds another reason (in addition to the adverse effects on body fat and bone health) to avoid aromatase inhibitors that are commonly taken by persons who use anabolic steroids,” he wrote. “The prospect of a U-shaped curve for the relationship between serum DHT and higher cardiovascular risk warrants further study.”
The work is funded by the Government of Western Australia and Lawley Pharmaceuticals. The authors’ and editorial writer’s conflicts of interest are listed in the full study.
A new systematic literature review adds complexity to the controversy over testosterone’s relationship to risk for myocardial infarction, stroke, cardiovascular death, and all-cause mortality.
Last year, the TRAVERSE (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men) trial was the first randomized, placebo-controlled study designed and powered to determine whether testosterone therapy increased risk for major cardiovascular events in men (ages 45-80 years). Its conclusions provided reassurance that modest use of testosterone therapy short term does not increase CVD risk.
But other studies have had different conclusions and TRAVERSE left unanswered questions, so Bu B. Yeap, MBBS, PhD, an endocrinologist at the University of Western Australia in Crawley, and colleagues completed a literature review with 11 prospective cohort studies of community-dwelling men with sex steroid levels measured with mass spectrometry. Nine of the studies provided individual participation data (IPD); two used aggregate data, and all had at least 5 years of follow-up.
The findings were published in Annals of Internal Medicine .
Dr. Yeap’s team concluded that certain groups of men have higher risk for CVD events. In this study, men with very low testosterone, high luteinizing hormone (LH), or very low estradiol concentrations had higher all-cause mortality. Sex hormone–binding globulin (SHBG) concentration was positively associated and dihydrotestosterone (DHT) levels were nonlinearly associated with all-cause mortality and CVD mortality.
The testosterone level below which men had higher risk of death from any cause was 7.4 nmol/L (213 ng/dL), regardless of LH concentration, the researchers concluded, writing, “This adds to information on reference ranges based on distributions of testosterone in selected samples of healthy men.”
The link between higher SHBG concentrations and higher all-cause mortality “may be related to its role as the major binding protein for sex steroids in the circulation,” the authors wrote. “We found a U-shaped association of DHT with all-cause and CVD-related mortality risks, which were higher at lower and very high DHT concentrations. Men with very low DHT concentrations also had increased risk for incident CVD events. Further investigation into potential underlying mechanisms for these associations is warranted.”
Rigorous Methodology Adds Value
Bradley D. Anawalt, MD, with the University of Washington School of Medicine in Seattle, pointed out in an accompanying editorial that the study’s findings are particularly valuable because of the team’s rigorous methodology. The team measured testosterone with the gold standard, mass spectrometry, which can also measure DHT and estradiol more accurately than widely available commercial immunoassays, which “are inaccurate for measurement of these sex steroids in men, who typically have low serum concentrations of these two metabolites of testosterone,” Dr. Anawalt said.
Also, the researchers obtained raw data from the nine IPD studies and reanalyzed the combined data, which allows for more sophisticated analysis when combining data from multiple studies, Dr. Anawalt explained.
The main finding from the Yeap et al. study, he wrote, is that high testosterone concentrations at baseline were not linked with increased deaths from CVD or from all causes “but very low serum total testosterone concentrations at baseline were.
“It is tempting to hypothesize that testosterone therapy might have cardiovascular benefits solely in patients with very low concentrations of serum total testosterone,” Dr. Anawalt wrote.
He pointed out as particularly interesting the findings for DHT and estradiol.
“The finding that a low serum estradiol concentration is associated with higher all-cause mortality adds another reason (in addition to the adverse effects on body fat and bone health) to avoid aromatase inhibitors that are commonly taken by persons who use anabolic steroids,” he wrote. “The prospect of a U-shaped curve for the relationship between serum DHT and higher cardiovascular risk warrants further study.”
The work is funded by the Government of Western Australia and Lawley Pharmaceuticals. The authors’ and editorial writer’s conflicts of interest are listed in the full study.
A new systematic literature review adds complexity to the controversy over testosterone’s relationship to risk for myocardial infarction, stroke, cardiovascular death, and all-cause mortality.
Last year, the TRAVERSE (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men) trial was the first randomized, placebo-controlled study designed and powered to determine whether testosterone therapy increased risk for major cardiovascular events in men (ages 45-80 years). Its conclusions provided reassurance that modest use of testosterone therapy short term does not increase CVD risk.
But other studies have had different conclusions and TRAVERSE left unanswered questions, so Bu B. Yeap, MBBS, PhD, an endocrinologist at the University of Western Australia in Crawley, and colleagues completed a literature review with 11 prospective cohort studies of community-dwelling men with sex steroid levels measured with mass spectrometry. Nine of the studies provided individual participation data (IPD); two used aggregate data, and all had at least 5 years of follow-up.
The findings were published in Annals of Internal Medicine .
Dr. Yeap’s team concluded that certain groups of men have higher risk for CVD events. In this study, men with very low testosterone, high luteinizing hormone (LH), or very low estradiol concentrations had higher all-cause mortality. Sex hormone–binding globulin (SHBG) concentration was positively associated and dihydrotestosterone (DHT) levels were nonlinearly associated with all-cause mortality and CVD mortality.
The testosterone level below which men had higher risk of death from any cause was 7.4 nmol/L (213 ng/dL), regardless of LH concentration, the researchers concluded, writing, “This adds to information on reference ranges based on distributions of testosterone in selected samples of healthy men.”
The link between higher SHBG concentrations and higher all-cause mortality “may be related to its role as the major binding protein for sex steroids in the circulation,” the authors wrote. “We found a U-shaped association of DHT with all-cause and CVD-related mortality risks, which were higher at lower and very high DHT concentrations. Men with very low DHT concentrations also had increased risk for incident CVD events. Further investigation into potential underlying mechanisms for these associations is warranted.”
Rigorous Methodology Adds Value
Bradley D. Anawalt, MD, with the University of Washington School of Medicine in Seattle, pointed out in an accompanying editorial that the study’s findings are particularly valuable because of the team’s rigorous methodology. The team measured testosterone with the gold standard, mass spectrometry, which can also measure DHT and estradiol more accurately than widely available commercial immunoassays, which “are inaccurate for measurement of these sex steroids in men, who typically have low serum concentrations of these two metabolites of testosterone,” Dr. Anawalt said.
Also, the researchers obtained raw data from the nine IPD studies and reanalyzed the combined data, which allows for more sophisticated analysis when combining data from multiple studies, Dr. Anawalt explained.
The main finding from the Yeap et al. study, he wrote, is that high testosterone concentrations at baseline were not linked with increased deaths from CVD or from all causes “but very low serum total testosterone concentrations at baseline were.
“It is tempting to hypothesize that testosterone therapy might have cardiovascular benefits solely in patients with very low concentrations of serum total testosterone,” Dr. Anawalt wrote.
He pointed out as particularly interesting the findings for DHT and estradiol.
“The finding that a low serum estradiol concentration is associated with higher all-cause mortality adds another reason (in addition to the adverse effects on body fat and bone health) to avoid aromatase inhibitors that are commonly taken by persons who use anabolic steroids,” he wrote. “The prospect of a U-shaped curve for the relationship between serum DHT and higher cardiovascular risk warrants further study.”
The work is funded by the Government of Western Australia and Lawley Pharmaceuticals. The authors’ and editorial writer’s conflicts of interest are listed in the full study.
FROM ANNALS OF INTERNAL MEDICINE
Can Nectin-4 Expression Predict Response to Bladder Cancer Treatment?
Identifying biomarkers to predict how patients will respond to targeted therapies is crucial to improve treatments for patients with cancer, authors Niklas Klümper, MD, with the Department of Urology and Pediatric Urology at University Hospital Bonn, in Germany, and colleagues, wrote in the Journal of Clinical Oncology (doi: 10.1200/JCO.23.01983).
The researchers used a Nectin-4-specific fluorescence in situ hybridization (FISH) assay in an (m)UC cohort of 108 patients to test Nectin-4’s ability to predict responses, analyzing slides with a fluorescence microscope. The copy number variations (CNVs) were correlated with membranous Nectin-4 protein expression, responses to EV treatment, and outcomes.
They also evaluated the prognostic value of Nectin-4 CNVs with biopsies of 103 (m)UC patients not treated with EV. Additionally, they searched The Cancer Genome Atlas (TCGA) data sets (10,712 patients across 32 cancer types) for Nectin-4 CNVs.
Why Was This Study Done?
Urothelial carcinoma accounts for 90% of bladder cancer cases globally. Though EV was approved to treat (m)UC in 2019, lasting benefit has been achieved only in a small subset of patients.
EV is given to all without selecting patients based on biomarkers that may predict how well they will respond to EV. In this study, researchers investigated whether response to EV was better when people had amplification — defined as increased numbers of copies — of Nectin-4.
How Common Is It for Patients With (m)UC to Have Nectin-4 Amplifications?
Nectin-4 amplifications happen frequently in (m)UC; they occurred in about 26% of the (m)UC patients the researchers studied, according to the new paper.
The amplifications are frequent in other cancer types as well, and this study suggests that this biomarker is a promising candidate for developing Nectin-4–targeted antibody-drug conjugates for other cancers.
“Nectin-4 amplifications can be found in 5%-10% of breast cancer and non–small cell lung cancer, both tumor types with a high impact on all-cancer mortality, which are currently being evaluated for EV response,” the authors wrote.
Currently, (m)UC is the only cancer for which EV is approved as standard-of-care, the researchers explain, in their paper.
What Were the Differences Between the EV and Non-EV Groups?
Almost all (27 of the 28) patients in the cohort (96%) who had Nectin-4 amplifications had objective responses to EV compared with 24 of 74 (32%) in the group without amplifications (P less than .001). Among the 96% with a response, 82% had partial response and 14% had a complete response.
The amplifications for those treated with EV were linked with longer progression-free survival (90% 12-month PFS vs 41% for those with nonamplified tumors) and longer overall survival (OS).
For those patients treated with EV who had the amplifications, OS was not reached. This was because the researchers could not calculate the OS at 12 months for this group due to more than half of the patients still being alive at that time. That finding contrasts with a median OS of 8.8 months in those patients treated with EV who did not have the amplifications.
EV-treated patients who had Nectin-4 amplifications had a 92% lower risk of death compared with EV-treated patients without the amplifications, according to an analysis that adjusted for factors including age and sex.
“Importantly, in the non–EV-treated patients with (m)UC, Nectin-4 amplifications have no impact on OS [overall survival], suggesting that Nectin-4 amplifications are neither indicating aggressive nor favorable tumor biology, strengthening its potential value as a pure predictive biomarker,” the researchers wrote.
What Are the Implications of These Findings?
“[O]ur study suggests that Nectin-4 amplification is a simple, valuable, and easy-to-implement predictive biomarker for EV in patients with (m)UC. The frequent occurrence of Nectin-4 amplifications in other cancer types suggests that this biomarker is a promising candidate with broader applicability for clinical development of Nectin-4-targeted ADCs in a tumor-agnostic context.”
Choosing the best therapy sequence for (m)UC is crucial, the authors write. Considering Nectin-4 amplifications could inform EV drug development — even at earlier stages of the disease — by defining which patient subgroup has the highest chance for long-term benefit.
The authors acknowledge that the primary limitation of the study is that it is retrospective, using archived primary and metastatic tumor specimens with varying ranges between the time of tumor sampling and start of EV treatment.
“Therefore, our data are hypothesis-generating and prospective confirmation in larger, biomarker-driven trials is mandatory,” the authors wrote.
They note that EV plus pembrolizumab [Keytruda] (EV/P) was recently approved as the new standard of care in first-line treatment for (m)UC, so the predictive value of Nectin-4 amplification in this new treatment setting warrants further research.
Dr. Klümper reports stock and other ownership interests in Bicycle Therapeutics, Pfizer, Daiichi Sankyo/UCB Japan, and Immatics; and honoraria for Astellas Pharma and MSD Oncology; and consulting or advisory roles with Astellas Pharma, MSD Oncology, and Eisai. He reports travel reimbursements from Ipsen, Photocure, and MSD Oncology. Other author disclosures are available with the full text of the paper.
Identifying biomarkers to predict how patients will respond to targeted therapies is crucial to improve treatments for patients with cancer, authors Niklas Klümper, MD, with the Department of Urology and Pediatric Urology at University Hospital Bonn, in Germany, and colleagues, wrote in the Journal of Clinical Oncology (doi: 10.1200/JCO.23.01983).
The researchers used a Nectin-4-specific fluorescence in situ hybridization (FISH) assay in an (m)UC cohort of 108 patients to test Nectin-4’s ability to predict responses, analyzing slides with a fluorescence microscope. The copy number variations (CNVs) were correlated with membranous Nectin-4 protein expression, responses to EV treatment, and outcomes.
They also evaluated the prognostic value of Nectin-4 CNVs with biopsies of 103 (m)UC patients not treated with EV. Additionally, they searched The Cancer Genome Atlas (TCGA) data sets (10,712 patients across 32 cancer types) for Nectin-4 CNVs.
Why Was This Study Done?
Urothelial carcinoma accounts for 90% of bladder cancer cases globally. Though EV was approved to treat (m)UC in 2019, lasting benefit has been achieved only in a small subset of patients.
EV is given to all without selecting patients based on biomarkers that may predict how well they will respond to EV. In this study, researchers investigated whether response to EV was better when people had amplification — defined as increased numbers of copies — of Nectin-4.
How Common Is It for Patients With (m)UC to Have Nectin-4 Amplifications?
Nectin-4 amplifications happen frequently in (m)UC; they occurred in about 26% of the (m)UC patients the researchers studied, according to the new paper.
The amplifications are frequent in other cancer types as well, and this study suggests that this biomarker is a promising candidate for developing Nectin-4–targeted antibody-drug conjugates for other cancers.
“Nectin-4 amplifications can be found in 5%-10% of breast cancer and non–small cell lung cancer, both tumor types with a high impact on all-cancer mortality, which are currently being evaluated for EV response,” the authors wrote.
Currently, (m)UC is the only cancer for which EV is approved as standard-of-care, the researchers explain, in their paper.
What Were the Differences Between the EV and Non-EV Groups?
Almost all (27 of the 28) patients in the cohort (96%) who had Nectin-4 amplifications had objective responses to EV compared with 24 of 74 (32%) in the group without amplifications (P less than .001). Among the 96% with a response, 82% had partial response and 14% had a complete response.
The amplifications for those treated with EV were linked with longer progression-free survival (90% 12-month PFS vs 41% for those with nonamplified tumors) and longer overall survival (OS).
For those patients treated with EV who had the amplifications, OS was not reached. This was because the researchers could not calculate the OS at 12 months for this group due to more than half of the patients still being alive at that time. That finding contrasts with a median OS of 8.8 months in those patients treated with EV who did not have the amplifications.
EV-treated patients who had Nectin-4 amplifications had a 92% lower risk of death compared with EV-treated patients without the amplifications, according to an analysis that adjusted for factors including age and sex.
“Importantly, in the non–EV-treated patients with (m)UC, Nectin-4 amplifications have no impact on OS [overall survival], suggesting that Nectin-4 amplifications are neither indicating aggressive nor favorable tumor biology, strengthening its potential value as a pure predictive biomarker,” the researchers wrote.
What Are the Implications of These Findings?
“[O]ur study suggests that Nectin-4 amplification is a simple, valuable, and easy-to-implement predictive biomarker for EV in patients with (m)UC. The frequent occurrence of Nectin-4 amplifications in other cancer types suggests that this biomarker is a promising candidate with broader applicability for clinical development of Nectin-4-targeted ADCs in a tumor-agnostic context.”
Choosing the best therapy sequence for (m)UC is crucial, the authors write. Considering Nectin-4 amplifications could inform EV drug development — even at earlier stages of the disease — by defining which patient subgroup has the highest chance for long-term benefit.
The authors acknowledge that the primary limitation of the study is that it is retrospective, using archived primary and metastatic tumor specimens with varying ranges between the time of tumor sampling and start of EV treatment.
“Therefore, our data are hypothesis-generating and prospective confirmation in larger, biomarker-driven trials is mandatory,” the authors wrote.
They note that EV plus pembrolizumab [Keytruda] (EV/P) was recently approved as the new standard of care in first-line treatment for (m)UC, so the predictive value of Nectin-4 amplification in this new treatment setting warrants further research.
Dr. Klümper reports stock and other ownership interests in Bicycle Therapeutics, Pfizer, Daiichi Sankyo/UCB Japan, and Immatics; and honoraria for Astellas Pharma and MSD Oncology; and consulting or advisory roles with Astellas Pharma, MSD Oncology, and Eisai. He reports travel reimbursements from Ipsen, Photocure, and MSD Oncology. Other author disclosures are available with the full text of the paper.
Identifying biomarkers to predict how patients will respond to targeted therapies is crucial to improve treatments for patients with cancer, authors Niklas Klümper, MD, with the Department of Urology and Pediatric Urology at University Hospital Bonn, in Germany, and colleagues, wrote in the Journal of Clinical Oncology (doi: 10.1200/JCO.23.01983).
The researchers used a Nectin-4-specific fluorescence in situ hybridization (FISH) assay in an (m)UC cohort of 108 patients to test Nectin-4’s ability to predict responses, analyzing slides with a fluorescence microscope. The copy number variations (CNVs) were correlated with membranous Nectin-4 protein expression, responses to EV treatment, and outcomes.
They also evaluated the prognostic value of Nectin-4 CNVs with biopsies of 103 (m)UC patients not treated with EV. Additionally, they searched The Cancer Genome Atlas (TCGA) data sets (10,712 patients across 32 cancer types) for Nectin-4 CNVs.
Why Was This Study Done?
Urothelial carcinoma accounts for 90% of bladder cancer cases globally. Though EV was approved to treat (m)UC in 2019, lasting benefit has been achieved only in a small subset of patients.
EV is given to all without selecting patients based on biomarkers that may predict how well they will respond to EV. In this study, researchers investigated whether response to EV was better when people had amplification — defined as increased numbers of copies — of Nectin-4.
How Common Is It for Patients With (m)UC to Have Nectin-4 Amplifications?
Nectin-4 amplifications happen frequently in (m)UC; they occurred in about 26% of the (m)UC patients the researchers studied, according to the new paper.
The amplifications are frequent in other cancer types as well, and this study suggests that this biomarker is a promising candidate for developing Nectin-4–targeted antibody-drug conjugates for other cancers.
“Nectin-4 amplifications can be found in 5%-10% of breast cancer and non–small cell lung cancer, both tumor types with a high impact on all-cancer mortality, which are currently being evaluated for EV response,” the authors wrote.
Currently, (m)UC is the only cancer for which EV is approved as standard-of-care, the researchers explain, in their paper.
What Were the Differences Between the EV and Non-EV Groups?
Almost all (27 of the 28) patients in the cohort (96%) who had Nectin-4 amplifications had objective responses to EV compared with 24 of 74 (32%) in the group without amplifications (P less than .001). Among the 96% with a response, 82% had partial response and 14% had a complete response.
The amplifications for those treated with EV were linked with longer progression-free survival (90% 12-month PFS vs 41% for those with nonamplified tumors) and longer overall survival (OS).
For those patients treated with EV who had the amplifications, OS was not reached. This was because the researchers could not calculate the OS at 12 months for this group due to more than half of the patients still being alive at that time. That finding contrasts with a median OS of 8.8 months in those patients treated with EV who did not have the amplifications.
EV-treated patients who had Nectin-4 amplifications had a 92% lower risk of death compared with EV-treated patients without the amplifications, according to an analysis that adjusted for factors including age and sex.
“Importantly, in the non–EV-treated patients with (m)UC, Nectin-4 amplifications have no impact on OS [overall survival], suggesting that Nectin-4 amplifications are neither indicating aggressive nor favorable tumor biology, strengthening its potential value as a pure predictive biomarker,” the researchers wrote.
What Are the Implications of These Findings?
“[O]ur study suggests that Nectin-4 amplification is a simple, valuable, and easy-to-implement predictive biomarker for EV in patients with (m)UC. The frequent occurrence of Nectin-4 amplifications in other cancer types suggests that this biomarker is a promising candidate with broader applicability for clinical development of Nectin-4-targeted ADCs in a tumor-agnostic context.”
Choosing the best therapy sequence for (m)UC is crucial, the authors write. Considering Nectin-4 amplifications could inform EV drug development — even at earlier stages of the disease — by defining which patient subgroup has the highest chance for long-term benefit.
The authors acknowledge that the primary limitation of the study is that it is retrospective, using archived primary and metastatic tumor specimens with varying ranges between the time of tumor sampling and start of EV treatment.
“Therefore, our data are hypothesis-generating and prospective confirmation in larger, biomarker-driven trials is mandatory,” the authors wrote.
They note that EV plus pembrolizumab [Keytruda] (EV/P) was recently approved as the new standard of care in first-line treatment for (m)UC, so the predictive value of Nectin-4 amplification in this new treatment setting warrants further research.
Dr. Klümper reports stock and other ownership interests in Bicycle Therapeutics, Pfizer, Daiichi Sankyo/UCB Japan, and Immatics; and honoraria for Astellas Pharma and MSD Oncology; and consulting or advisory roles with Astellas Pharma, MSD Oncology, and Eisai. He reports travel reimbursements from Ipsen, Photocure, and MSD Oncology. Other author disclosures are available with the full text of the paper.
FROM JOURNAL OF CLINICAL ONCOLOGY
Starting Points if Patient Chooses Medication Abortion
An evolving legal landscape surrounding medication abortion has left physicians with as many questions as patients. A panel of clinicians at the annual meeting of the American College of Physicians offered guidance on how to help patients who choose medication abortion, which is available to women until 10 weeks of gestation.
Approved in 2000, abortion pills have become the most common method for terminating pregnancy in the United States, accounting for 63% of all abortions in 2023. The US Supreme Court is reviewing access to medication abortions, with a decision expected within months.
According to the Guttmacher Institute, 29 states as of February restrict access to medication abortion, either by limiting or banning the use of the drugs or by curtailing who can prescribe them and under what circumstances.
First, Determine Gestational Age
Cynthia Chuang, MD, MSc, an internist and professor of medicine at Penn State College of Medicine in Hershey, Pennsylvania, said in most cases, a woman can pinpoint the date of the first day of her last menstrual period, and the physician can confirm gestational age is 70 days or less. An ultrasound should be performed if the date of the last period is uncertain, she said, or if ectopic pregnancy is suspected, periods are irregular, or ultrasound is legally required in the state.
Women are not eligible for abortion pills if they have a bleeding or clotting disorder, have an intrauterine device, have adrenal insufficiency or chronic steroid use, or have porphyria or hemoglobin levels < 9 g/dL, she said.
“If the person has a known hemoglobin of less than 9, we would suggest that person have a procedural abortion,” Dr. Chuang said.
Components of Medication
Patients first receive 200 mg of oral mifepristone, which separates the pregnancy from the uterine wall. “Typically, people don’t experience side effects from the mifepristone alone,” Dr. Chaung said.
In the next 48 hours, the patient takes 800 mcg of misoprostol, either vaginally or buccally. “Patients can expect heavy cramping and bleeding 1-2 days after taking misoprostol,” she said. The bleeding should gradually subside over the following week or 2, she said. If the gestational age is 9 weeks or more, a second dose of misoprostol can be administered 3-6 hours after the first dose to improve efficacy.
If mifepristone is not available, misoprostol can be used alone in three doses spaced 3 hours apart, Dr. Chuang said.
The failure rate for mifepristone plus misoprostol has been calculated at 2% if the gestational age is less than 7 weeks. For misoprostol alone, the failure rate varies by the study, depending on gestational age and population analyzed, Dr. Chuang said. A 2023 meta-analysis in Contraception put the failure rate at 11%.
When to Call the Clinician
Dr. Chuang said clinicians should instruct women who have taken abortion pills to call the clinic if they are soaking through two sanitary pads an hour for more than 1 hour, if there is little to no bleeding, or if they think the medication isn’t working after taking the full regimen.
Mindy Sobota, MD, MS, an internist and associate professor of medicine at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, recommended a continuing medical education site for evidence-based guidance on how best to talk with women about medication abortions.
She also recommended physicians and patients consult the Plan C website for guidance on telehealth services and price information on receiving abortion pills by mail in every state. “It’s a very reliable and safe clearing house,” Dr. Sobota said.
Internists should let patients know that whatever their choices are around pregnancy, they are open to discussing those choices and helping them through the process, Dr. Sobota said, adding that she makes those statements in annual visits.
Alexandra Bachorik, MD, EdM, director of education in the Women’s Health Unit and assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, said patients in restrictive states who need financial help related to obtaining abortion services in a less restricted state can visit the National Network of Abortion Funds, which can help people with travel or housing expenses.
Facilitating access to a clinic in a less restrictive state may be helpful to people approaching a gestational age limit, she said.
Adelaide McClintock, MD, an internist and assistant professor of general internal medicine at the University of Washington School of Medicine in Seattle, Washington, noted that even clinicians who cannot legally prescribe abortion pills can support their patients by providing resources and counseling on options before, during, and after pregnancy. Those who live in restrictive states also can provide support to women who have traveled to less restrictive states for an abortion if they have postabortion complications, she said.
She recommended the Reproductive Health Access Project website for a comprehensive guide for evidence-based care and counseling patients about all choices in reproductive healthcare.
Panelists urged clinicians to get familiar with abortion-access resources and keep them at their fingertips in practice. Patient requests for the services are common, she noted, as “one in four women will have an abortion by the age of 45.”
Dr. Chuang, Dr. McClintock, Dr. Sobota, and Dr. Bachorik reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
An evolving legal landscape surrounding medication abortion has left physicians with as many questions as patients. A panel of clinicians at the annual meeting of the American College of Physicians offered guidance on how to help patients who choose medication abortion, which is available to women until 10 weeks of gestation.
Approved in 2000, abortion pills have become the most common method for terminating pregnancy in the United States, accounting for 63% of all abortions in 2023. The US Supreme Court is reviewing access to medication abortions, with a decision expected within months.
According to the Guttmacher Institute, 29 states as of February restrict access to medication abortion, either by limiting or banning the use of the drugs or by curtailing who can prescribe them and under what circumstances.
First, Determine Gestational Age
Cynthia Chuang, MD, MSc, an internist and professor of medicine at Penn State College of Medicine in Hershey, Pennsylvania, said in most cases, a woman can pinpoint the date of the first day of her last menstrual period, and the physician can confirm gestational age is 70 days or less. An ultrasound should be performed if the date of the last period is uncertain, she said, or if ectopic pregnancy is suspected, periods are irregular, or ultrasound is legally required in the state.
Women are not eligible for abortion pills if they have a bleeding or clotting disorder, have an intrauterine device, have adrenal insufficiency or chronic steroid use, or have porphyria or hemoglobin levels < 9 g/dL, she said.
“If the person has a known hemoglobin of less than 9, we would suggest that person have a procedural abortion,” Dr. Chuang said.
Components of Medication
Patients first receive 200 mg of oral mifepristone, which separates the pregnancy from the uterine wall. “Typically, people don’t experience side effects from the mifepristone alone,” Dr. Chaung said.
In the next 48 hours, the patient takes 800 mcg of misoprostol, either vaginally or buccally. “Patients can expect heavy cramping and bleeding 1-2 days after taking misoprostol,” she said. The bleeding should gradually subside over the following week or 2, she said. If the gestational age is 9 weeks or more, a second dose of misoprostol can be administered 3-6 hours after the first dose to improve efficacy.
If mifepristone is not available, misoprostol can be used alone in three doses spaced 3 hours apart, Dr. Chuang said.
The failure rate for mifepristone plus misoprostol has been calculated at 2% if the gestational age is less than 7 weeks. For misoprostol alone, the failure rate varies by the study, depending on gestational age and population analyzed, Dr. Chuang said. A 2023 meta-analysis in Contraception put the failure rate at 11%.
When to Call the Clinician
Dr. Chuang said clinicians should instruct women who have taken abortion pills to call the clinic if they are soaking through two sanitary pads an hour for more than 1 hour, if there is little to no bleeding, or if they think the medication isn’t working after taking the full regimen.
Mindy Sobota, MD, MS, an internist and associate professor of medicine at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, recommended a continuing medical education site for evidence-based guidance on how best to talk with women about medication abortions.
She also recommended physicians and patients consult the Plan C website for guidance on telehealth services and price information on receiving abortion pills by mail in every state. “It’s a very reliable and safe clearing house,” Dr. Sobota said.
Internists should let patients know that whatever their choices are around pregnancy, they are open to discussing those choices and helping them through the process, Dr. Sobota said, adding that she makes those statements in annual visits.
Alexandra Bachorik, MD, EdM, director of education in the Women’s Health Unit and assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, said patients in restrictive states who need financial help related to obtaining abortion services in a less restricted state can visit the National Network of Abortion Funds, which can help people with travel or housing expenses.
Facilitating access to a clinic in a less restrictive state may be helpful to people approaching a gestational age limit, she said.
Adelaide McClintock, MD, an internist and assistant professor of general internal medicine at the University of Washington School of Medicine in Seattle, Washington, noted that even clinicians who cannot legally prescribe abortion pills can support their patients by providing resources and counseling on options before, during, and after pregnancy. Those who live in restrictive states also can provide support to women who have traveled to less restrictive states for an abortion if they have postabortion complications, she said.
She recommended the Reproductive Health Access Project website for a comprehensive guide for evidence-based care and counseling patients about all choices in reproductive healthcare.
Panelists urged clinicians to get familiar with abortion-access resources and keep them at their fingertips in practice. Patient requests for the services are common, she noted, as “one in four women will have an abortion by the age of 45.”
Dr. Chuang, Dr. McClintock, Dr. Sobota, and Dr. Bachorik reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
An evolving legal landscape surrounding medication abortion has left physicians with as many questions as patients. A panel of clinicians at the annual meeting of the American College of Physicians offered guidance on how to help patients who choose medication abortion, which is available to women until 10 weeks of gestation.
Approved in 2000, abortion pills have become the most common method for terminating pregnancy in the United States, accounting for 63% of all abortions in 2023. The US Supreme Court is reviewing access to medication abortions, with a decision expected within months.
According to the Guttmacher Institute, 29 states as of February restrict access to medication abortion, either by limiting or banning the use of the drugs or by curtailing who can prescribe them and under what circumstances.
First, Determine Gestational Age
Cynthia Chuang, MD, MSc, an internist and professor of medicine at Penn State College of Medicine in Hershey, Pennsylvania, said in most cases, a woman can pinpoint the date of the first day of her last menstrual period, and the physician can confirm gestational age is 70 days or less. An ultrasound should be performed if the date of the last period is uncertain, she said, or if ectopic pregnancy is suspected, periods are irregular, or ultrasound is legally required in the state.
Women are not eligible for abortion pills if they have a bleeding or clotting disorder, have an intrauterine device, have adrenal insufficiency or chronic steroid use, or have porphyria or hemoglobin levels < 9 g/dL, she said.
“If the person has a known hemoglobin of less than 9, we would suggest that person have a procedural abortion,” Dr. Chuang said.
Components of Medication
Patients first receive 200 mg of oral mifepristone, which separates the pregnancy from the uterine wall. “Typically, people don’t experience side effects from the mifepristone alone,” Dr. Chaung said.
In the next 48 hours, the patient takes 800 mcg of misoprostol, either vaginally or buccally. “Patients can expect heavy cramping and bleeding 1-2 days after taking misoprostol,” she said. The bleeding should gradually subside over the following week or 2, she said. If the gestational age is 9 weeks or more, a second dose of misoprostol can be administered 3-6 hours after the first dose to improve efficacy.
If mifepristone is not available, misoprostol can be used alone in three doses spaced 3 hours apart, Dr. Chuang said.
The failure rate for mifepristone plus misoprostol has been calculated at 2% if the gestational age is less than 7 weeks. For misoprostol alone, the failure rate varies by the study, depending on gestational age and population analyzed, Dr. Chuang said. A 2023 meta-analysis in Contraception put the failure rate at 11%.
When to Call the Clinician
Dr. Chuang said clinicians should instruct women who have taken abortion pills to call the clinic if they are soaking through two sanitary pads an hour for more than 1 hour, if there is little to no bleeding, or if they think the medication isn’t working after taking the full regimen.
Mindy Sobota, MD, MS, an internist and associate professor of medicine at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, recommended a continuing medical education site for evidence-based guidance on how best to talk with women about medication abortions.
She also recommended physicians and patients consult the Plan C website for guidance on telehealth services and price information on receiving abortion pills by mail in every state. “It’s a very reliable and safe clearing house,” Dr. Sobota said.
Internists should let patients know that whatever their choices are around pregnancy, they are open to discussing those choices and helping them through the process, Dr. Sobota said, adding that she makes those statements in annual visits.
Alexandra Bachorik, MD, EdM, director of education in the Women’s Health Unit and assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, said patients in restrictive states who need financial help related to obtaining abortion services in a less restricted state can visit the National Network of Abortion Funds, which can help people with travel or housing expenses.
Facilitating access to a clinic in a less restrictive state may be helpful to people approaching a gestational age limit, she said.
Adelaide McClintock, MD, an internist and assistant professor of general internal medicine at the University of Washington School of Medicine in Seattle, Washington, noted that even clinicians who cannot legally prescribe abortion pills can support their patients by providing resources and counseling on options before, during, and after pregnancy. Those who live in restrictive states also can provide support to women who have traveled to less restrictive states for an abortion if they have postabortion complications, she said.
She recommended the Reproductive Health Access Project website for a comprehensive guide for evidence-based care and counseling patients about all choices in reproductive healthcare.
Panelists urged clinicians to get familiar with abortion-access resources and keep them at their fingertips in practice. Patient requests for the services are common, she noted, as “one in four women will have an abortion by the age of 45.”
Dr. Chuang, Dr. McClintock, Dr. Sobota, and Dr. Bachorik reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
FROM INTERNAL MEDICINE 2024
Clinical Guidelines: Start Screening at Age 50 for Age-Related Hearing Loss
Clinical guidelines on age-related hearing loss (ARHL), published in Otolaryngology–Head and Neck Surgery, highlight referral recommendations for all clinicians, including primary care doctors, who often are the first clinicians to screen for and address the condition.
Betty S. Tsai Do, MD, with the department of head & neck surgery at Kaiser Permanente in Walnut Creek, California, is the first author for the guidelines, which recommend screening patients 50 years or older at the time of a healthcare encounter. They also detail when to test and refer.
Three ‘Strong Recommendations’
Three of the action points are labeled “strong recommendations.” They are:
- If screening suggests hearing loss, clinicians should conduct an audiogram or refer to a clinician who can conduct one.
- Clinicians should offer, or refer to a specialist who can offer, appropriately fit amplification, such as hearing aids.
- If patients have appropriately fit amplification and still have trouble with hearing and understanding speech, clinicians should refer patients to see if they are good candidates for a cochlear implant.
The authors note that ARHL is the most common sensory deficit seen in older patients, but it is underdiagnosed and undertreated. “Between ages 65 and 74, one in three adults experience hearing loss and almost 50% of those 75 years of age or older will report hearing loss according to the National Institute on Deafness and Other Communication Disorders.” Consequences of the untreated deficit, in addition to limiting ability to communicate, include higher risk of dementia, cardiovascular disease, depression, falls, and workplace marginalization.
Until now, there have been no evidence-based clinical guidelines on when to screen, test, and refer. Though previously proposed quality improvement measures have defined ARHL as starting at age 60, these guidelines include those 50 and older to promote earlier detection.
Guidelines Only Part of the Solution
While the guidelines are a step in the right direction, they won’t address some persistent barriers to changing practice, said Michael McKee, MD, MPH, a family medicine physician and co-director of the Center for Disability Health and Wellness at the University of Michigan in Ann Arbor, who was not part of the guideline team.
“I think [the guidelines] will raise the awareness on why it’s important to address hearing loss,” he says. “Many primary care providers don’t elevate hearing loss as a priority topic. The problem is that we’re struggling with getting things in place to have a more supportive system to carry out those recommendations.”
Lack of Training and Support
The problems include lack of training on hearing loss for physicians, starting with medical school. Another complication is time: A conversation about hearing loss adds to the multitude of conversations a primary care provider is expected to have with their patients in a short visit.
Additionally, when hearing loss is suspected, an audiologist may be hard to find to perform the audiogram, Dr. McKee says. If patients agree to see an audiologist and that specialist finds hearing loss, patients may not want to wear a device due to stigma or may not be able to afford a device that will fit properly and truly benefit them because Medicare does not cover hearing aids.
“Only about 20-plus percent of those eligible for hearing aids get them,” he said. Hearing aids available over the counter help some people, but may be difficult to fit properly and may be hard for some to use correctly, he added.
“That comes back to the primary care provider, so it’s unfortunately a very unsatisfying course,” he said.
‘Primary Care Providers Do Value Guidelines’
However, “Primary care providers do value guidelines. They do value strong recommendations,” he said. We are trying to figure out how we can support people with unaddressed hearing loss in the primary care setting, Dr. McKee said. “Once we get there, we need to advocate for an expansion of coverage,” he said.
The authors note that the messages in the guidelines are important for all clinicians.
“The impact of hearing loss and screening should not be the sole responsibility of an audiologist, an otolaryngologist, nor primary care provider. Any time and place that a patient interacts with the healthcare system is an opportunity for preventive healthcare, such as hearing screening, to occur,” they write.
Funding for this research was provided by the American Academy of Otolaryngology–Head and Neck Surgery Foundation. Dr. Do and Dr. McKee report no relevant financial relationships. Full disclosures of the co-authors are listed with the full text of the paper.
Clinical guidelines on age-related hearing loss (ARHL), published in Otolaryngology–Head and Neck Surgery, highlight referral recommendations for all clinicians, including primary care doctors, who often are the first clinicians to screen for and address the condition.
Betty S. Tsai Do, MD, with the department of head & neck surgery at Kaiser Permanente in Walnut Creek, California, is the first author for the guidelines, which recommend screening patients 50 years or older at the time of a healthcare encounter. They also detail when to test and refer.
Three ‘Strong Recommendations’
Three of the action points are labeled “strong recommendations.” They are:
- If screening suggests hearing loss, clinicians should conduct an audiogram or refer to a clinician who can conduct one.
- Clinicians should offer, or refer to a specialist who can offer, appropriately fit amplification, such as hearing aids.
- If patients have appropriately fit amplification and still have trouble with hearing and understanding speech, clinicians should refer patients to see if they are good candidates for a cochlear implant.
The authors note that ARHL is the most common sensory deficit seen in older patients, but it is underdiagnosed and undertreated. “Between ages 65 and 74, one in three adults experience hearing loss and almost 50% of those 75 years of age or older will report hearing loss according to the National Institute on Deafness and Other Communication Disorders.” Consequences of the untreated deficit, in addition to limiting ability to communicate, include higher risk of dementia, cardiovascular disease, depression, falls, and workplace marginalization.
Until now, there have been no evidence-based clinical guidelines on when to screen, test, and refer. Though previously proposed quality improvement measures have defined ARHL as starting at age 60, these guidelines include those 50 and older to promote earlier detection.
Guidelines Only Part of the Solution
While the guidelines are a step in the right direction, they won’t address some persistent barriers to changing practice, said Michael McKee, MD, MPH, a family medicine physician and co-director of the Center for Disability Health and Wellness at the University of Michigan in Ann Arbor, who was not part of the guideline team.
“I think [the guidelines] will raise the awareness on why it’s important to address hearing loss,” he says. “Many primary care providers don’t elevate hearing loss as a priority topic. The problem is that we’re struggling with getting things in place to have a more supportive system to carry out those recommendations.”
Lack of Training and Support
The problems include lack of training on hearing loss for physicians, starting with medical school. Another complication is time: A conversation about hearing loss adds to the multitude of conversations a primary care provider is expected to have with their patients in a short visit.
Additionally, when hearing loss is suspected, an audiologist may be hard to find to perform the audiogram, Dr. McKee says. If patients agree to see an audiologist and that specialist finds hearing loss, patients may not want to wear a device due to stigma or may not be able to afford a device that will fit properly and truly benefit them because Medicare does not cover hearing aids.
“Only about 20-plus percent of those eligible for hearing aids get them,” he said. Hearing aids available over the counter help some people, but may be difficult to fit properly and may be hard for some to use correctly, he added.
“That comes back to the primary care provider, so it’s unfortunately a very unsatisfying course,” he said.
‘Primary Care Providers Do Value Guidelines’
However, “Primary care providers do value guidelines. They do value strong recommendations,” he said. We are trying to figure out how we can support people with unaddressed hearing loss in the primary care setting, Dr. McKee said. “Once we get there, we need to advocate for an expansion of coverage,” he said.
The authors note that the messages in the guidelines are important for all clinicians.
“The impact of hearing loss and screening should not be the sole responsibility of an audiologist, an otolaryngologist, nor primary care provider. Any time and place that a patient interacts with the healthcare system is an opportunity for preventive healthcare, such as hearing screening, to occur,” they write.
Funding for this research was provided by the American Academy of Otolaryngology–Head and Neck Surgery Foundation. Dr. Do and Dr. McKee report no relevant financial relationships. Full disclosures of the co-authors are listed with the full text of the paper.
Clinical guidelines on age-related hearing loss (ARHL), published in Otolaryngology–Head and Neck Surgery, highlight referral recommendations for all clinicians, including primary care doctors, who often are the first clinicians to screen for and address the condition.
Betty S. Tsai Do, MD, with the department of head & neck surgery at Kaiser Permanente in Walnut Creek, California, is the first author for the guidelines, which recommend screening patients 50 years or older at the time of a healthcare encounter. They also detail when to test and refer.
Three ‘Strong Recommendations’
Three of the action points are labeled “strong recommendations.” They are:
- If screening suggests hearing loss, clinicians should conduct an audiogram or refer to a clinician who can conduct one.
- Clinicians should offer, or refer to a specialist who can offer, appropriately fit amplification, such as hearing aids.
- If patients have appropriately fit amplification and still have trouble with hearing and understanding speech, clinicians should refer patients to see if they are good candidates for a cochlear implant.
The authors note that ARHL is the most common sensory deficit seen in older patients, but it is underdiagnosed and undertreated. “Between ages 65 and 74, one in three adults experience hearing loss and almost 50% of those 75 years of age or older will report hearing loss according to the National Institute on Deafness and Other Communication Disorders.” Consequences of the untreated deficit, in addition to limiting ability to communicate, include higher risk of dementia, cardiovascular disease, depression, falls, and workplace marginalization.
Until now, there have been no evidence-based clinical guidelines on when to screen, test, and refer. Though previously proposed quality improvement measures have defined ARHL as starting at age 60, these guidelines include those 50 and older to promote earlier detection.
Guidelines Only Part of the Solution
While the guidelines are a step in the right direction, they won’t address some persistent barriers to changing practice, said Michael McKee, MD, MPH, a family medicine physician and co-director of the Center for Disability Health and Wellness at the University of Michigan in Ann Arbor, who was not part of the guideline team.
“I think [the guidelines] will raise the awareness on why it’s important to address hearing loss,” he says. “Many primary care providers don’t elevate hearing loss as a priority topic. The problem is that we’re struggling with getting things in place to have a more supportive system to carry out those recommendations.”
Lack of Training and Support
The problems include lack of training on hearing loss for physicians, starting with medical school. Another complication is time: A conversation about hearing loss adds to the multitude of conversations a primary care provider is expected to have with their patients in a short visit.
Additionally, when hearing loss is suspected, an audiologist may be hard to find to perform the audiogram, Dr. McKee says. If patients agree to see an audiologist and that specialist finds hearing loss, patients may not want to wear a device due to stigma or may not be able to afford a device that will fit properly and truly benefit them because Medicare does not cover hearing aids.
“Only about 20-plus percent of those eligible for hearing aids get them,” he said. Hearing aids available over the counter help some people, but may be difficult to fit properly and may be hard for some to use correctly, he added.
“That comes back to the primary care provider, so it’s unfortunately a very unsatisfying course,” he said.
‘Primary Care Providers Do Value Guidelines’
However, “Primary care providers do value guidelines. They do value strong recommendations,” he said. We are trying to figure out how we can support people with unaddressed hearing loss in the primary care setting, Dr. McKee said. “Once we get there, we need to advocate for an expansion of coverage,” he said.
The authors note that the messages in the guidelines are important for all clinicians.
“The impact of hearing loss and screening should not be the sole responsibility of an audiologist, an otolaryngologist, nor primary care provider. Any time and place that a patient interacts with the healthcare system is an opportunity for preventive healthcare, such as hearing screening, to occur,” they write.
Funding for this research was provided by the American Academy of Otolaryngology–Head and Neck Surgery Foundation. Dr. Do and Dr. McKee report no relevant financial relationships. Full disclosures of the co-authors are listed with the full text of the paper.
FROM OTOLARYNGOLOGY–HEAD AND NECK SURGERY
Three Conditions for Which Cannabis Appears to Help
The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.
Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.
Dearth of Research Persists
Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.
Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
No Evidence in OUD
Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.
Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
Potential Harms
If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug.
But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
Use With Other Controlled Substances
Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.
Dr. Grossman reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.
Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.
Dearth of Research Persists
Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.
Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
No Evidence in OUD
Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.
Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
Potential Harms
If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug.
But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
Use With Other Controlled Substances
Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.
Dr. Grossman reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.
Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.
Dearth of Research Persists
Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.
Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
No Evidence in OUD
Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.
Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
Potential Harms
If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug.
But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
Use With Other Controlled Substances
Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.
Dr. Grossman reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Avian Flu Threat Still Low and Vaccine Measures Are Ready
After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.
From the sequencing data, “we can expect and anticipate that [the candidate vaccine viruses] will provide good protection,” she explained.
Establishing candidate vaccine viruses “are the precursor to moving into large-scale vaccine production,” Dr. Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.
The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dr. Dugan said.
The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.
The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person’s household contacts, Dr. Olsen said.
Person With the Virus Has Recovered
The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Dr. Olsen explained.
Since 1997, when the first case of human infection was reported globally, “there have been 909 [human cases] reported from 23 countries,” Dr. Olsen said. “About half [52%] of the human cases have resulted in death.” Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.
Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection — in January 2022 — was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.
In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that “it remains very much an avian virus. It’s not becoming a bovine virus,” Dr. Sifford reported.
Detected in Cattle
Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.
“As of today, there are affected herds in 33 farms across eight states,” reported Dr. Olsen.
Tests are ongoing to determine how the virus is traveling, but “what we can say is that there’s a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds,” Dr. Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.
“We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible,” she says.
Milk Is Likely the Source of Transmission
“We haven’t seen anything that would change our assessment that the commercial milk supply is safe,” says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).
In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.
Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:
- What level of virus might be leaving the farms from shedding by apparently healthy cows?
- Does any live virus survive the pasteurization process?
- Do different methods of pasteurization and dairy production have different effects on the viability of H5N1?
- Are effects different in various forms of dairy products, such as cheese and cream?
A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine “what type of pasteurization criteria” are needed to provide “acceptable public health outcomes,” Dr. Prater said.
The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.
A version of this article appeared on Medscape.com.
After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.
From the sequencing data, “we can expect and anticipate that [the candidate vaccine viruses] will provide good protection,” she explained.
Establishing candidate vaccine viruses “are the precursor to moving into large-scale vaccine production,” Dr. Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.
The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dr. Dugan said.
The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.
The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person’s household contacts, Dr. Olsen said.
Person With the Virus Has Recovered
The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Dr. Olsen explained.
Since 1997, when the first case of human infection was reported globally, “there have been 909 [human cases] reported from 23 countries,” Dr. Olsen said. “About half [52%] of the human cases have resulted in death.” Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.
Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection — in January 2022 — was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.
In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that “it remains very much an avian virus. It’s not becoming a bovine virus,” Dr. Sifford reported.
Detected in Cattle
Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.
“As of today, there are affected herds in 33 farms across eight states,” reported Dr. Olsen.
Tests are ongoing to determine how the virus is traveling, but “what we can say is that there’s a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds,” Dr. Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.
“We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible,” she says.
Milk Is Likely the Source of Transmission
“We haven’t seen anything that would change our assessment that the commercial milk supply is safe,” says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).
In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.
Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:
- What level of virus might be leaving the farms from shedding by apparently healthy cows?
- Does any live virus survive the pasteurization process?
- Do different methods of pasteurization and dairy production have different effects on the viability of H5N1?
- Are effects different in various forms of dairy products, such as cheese and cream?
A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine “what type of pasteurization criteria” are needed to provide “acceptable public health outcomes,” Dr. Prater said.
The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.
A version of this article appeared on Medscape.com.
After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.
From the sequencing data, “we can expect and anticipate that [the candidate vaccine viruses] will provide good protection,” she explained.
Establishing candidate vaccine viruses “are the precursor to moving into large-scale vaccine production,” Dr. Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.
The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dr. Dugan said.
The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.
The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person’s household contacts, Dr. Olsen said.
Person With the Virus Has Recovered
The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Dr. Olsen explained.
Since 1997, when the first case of human infection was reported globally, “there have been 909 [human cases] reported from 23 countries,” Dr. Olsen said. “About half [52%] of the human cases have resulted in death.” Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.
Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection — in January 2022 — was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.
In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that “it remains very much an avian virus. It’s not becoming a bovine virus,” Dr. Sifford reported.
Detected in Cattle
Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.
“As of today, there are affected herds in 33 farms across eight states,” reported Dr. Olsen.
Tests are ongoing to determine how the virus is traveling, but “what we can say is that there’s a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds,” Dr. Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.
“We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible,” she says.
Milk Is Likely the Source of Transmission
“We haven’t seen anything that would change our assessment that the commercial milk supply is safe,” says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).
In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.
Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:
- What level of virus might be leaving the farms from shedding by apparently healthy cows?
- Does any live virus survive the pasteurization process?
- Do different methods of pasteurization and dairy production have different effects on the viability of H5N1?
- Are effects different in various forms of dairy products, such as cheese and cream?
A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine “what type of pasteurization criteria” are needed to provide “acceptable public health outcomes,” Dr. Prater said.
The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.
A version of this article appeared on Medscape.com.
Getting Patients With Opioid Use Disorder Started on Buprenorphine in Primary Care
*The first thing Ann Garment, MD, wants all clinicians to know about buprenorphine is that [where state law permits] any prescriber with a DEA registration number “is able to prescribe buprenorphine and should be ready and willing to prescribe” the medication.
*A change in federal law means that for most providers “there is no longer any extra paperwork or training required to prescribe buprenorphine,” said Dr. Garment, clinical associate professor at New York University and chief of general internal medicine at Bellevue Hospital in New York City, during a presentation on April 19 at the American College of Physicians (ACP-IM) Internal Medicine Meeting 2024.
Dr. Garment, who specializes in opioid use disorder (OUD), described the current “third wave” of increasing opioid overdose deaths fueled by the increase of synthetic opioids in the drug supply. The third wave started in 2013 with the rise in use of fentanyl and tramadol. The 107,000 number of overdose deaths in the United States in 2021 was more than six times that in 1999, and 75% involved opioids.
“Now, more than ever,” Dr. Garment said, “opioid use disorder should be treated from the primary care setting.”
How to Identify OUD
“It’s less sensitive for picking up on people who have a prior opioid use disorder history or are only exhibiting risky opioid use that wouldn’t constitute opioid use disorder yet,” she said.
If someone screens positive, to verify OUD, the Diagnostic and Statistical Manual of Mental Disorders identifies criteria for any substance abuse disorder with two general themes: Loss of control and continued use despite negative consequences.
“If you have a patient who is getting prescribed opioids and they have opioid tolerance or withdrawal, that does not mean they have opioid use disorder,” she said.
Medication for OUD
Medication is the top treatment for OUD, according to Dr. Garment. Psychosocial treatments can help some but not all people with OUD, she said. “It is not a requirement for a patient to engage in psychosocial treatment in order to get a medication for opioid use disorder, so please do not let that be a barrier for your patients,” she said.
Buprenorphine has advantages over other medications for OUD, including methadone and naltrexone.
Methadone must be obtained daily at a methadone clinic instead of at a local pharmacy. And escalating doses of methadone carry an increased risk for overdose and respiratory problems and potential drug-drug interactions, Dr. Garment added.
One downside with naltrexone is loss of tolerance, she said. If a patient has been using naltrexone to treat OUD and they decide to resume taking opioids, “they no longer can use the same amount of opioids that they were using before” because they have lost their tolerance and now are at a risk for overdose with their usual amount, she said. What’s more, naltrexone has not been shown to reduce overdose deaths.
Finally, she said, buprenorphine, “is an incredibly safe medication. If anyone in this room has ever prescribed coumadin or insulin, I’m going to tell you: This is much safer.”
Dr. Garment offered three reasons for buprenorphine’s safety:
- The drug is a partial, as opposed to full, opioid agonist, so as the dose increases, the patient experiences less withdrawal and fewer opioid cravings. As a result, they will hit a ceiling effect that avoids euphoria, respiratory depression, or overdose.
- Buprenorphine is “stickier” than other OUD medications: “If I’m taking buprenorphine and I decide to use some [oxycodone], what’s going to happen is that very little of that, if any, is going to get bound to my opioid receptors because buprenorphine is so sticky and adherent, it’s not going to let other opioids on.”
- Most buprenorphine is co-formulated with naloxone, an opioid antagonist. If a patient tries to get high from buprenorphine and tries to snort or inject it, naloxone will kick in and cancel out the buprenorphine.
Dr. Garment said she obtains urine screens ideally twice a year. If other drugs show up on the test, she said, she speaks with the patient about their drug use. “It’s never a reason to discharge someone from a practice,” she said.
Dr. Garment reported no relevant financial conflicts of interest.
*This story was updated on April 29, 2024.
A version of this article appeared on Medscape.com.
*The first thing Ann Garment, MD, wants all clinicians to know about buprenorphine is that [where state law permits] any prescriber with a DEA registration number “is able to prescribe buprenorphine and should be ready and willing to prescribe” the medication.
*A change in federal law means that for most providers “there is no longer any extra paperwork or training required to prescribe buprenorphine,” said Dr. Garment, clinical associate professor at New York University and chief of general internal medicine at Bellevue Hospital in New York City, during a presentation on April 19 at the American College of Physicians (ACP-IM) Internal Medicine Meeting 2024.
Dr. Garment, who specializes in opioid use disorder (OUD), described the current “third wave” of increasing opioid overdose deaths fueled by the increase of synthetic opioids in the drug supply. The third wave started in 2013 with the rise in use of fentanyl and tramadol. The 107,000 number of overdose deaths in the United States in 2021 was more than six times that in 1999, and 75% involved opioids.
“Now, more than ever,” Dr. Garment said, “opioid use disorder should be treated from the primary care setting.”
How to Identify OUD
“It’s less sensitive for picking up on people who have a prior opioid use disorder history or are only exhibiting risky opioid use that wouldn’t constitute opioid use disorder yet,” she said.
If someone screens positive, to verify OUD, the Diagnostic and Statistical Manual of Mental Disorders identifies criteria for any substance abuse disorder with two general themes: Loss of control and continued use despite negative consequences.
“If you have a patient who is getting prescribed opioids and they have opioid tolerance or withdrawal, that does not mean they have opioid use disorder,” she said.
Medication for OUD
Medication is the top treatment for OUD, according to Dr. Garment. Psychosocial treatments can help some but not all people with OUD, she said. “It is not a requirement for a patient to engage in psychosocial treatment in order to get a medication for opioid use disorder, so please do not let that be a barrier for your patients,” she said.
Buprenorphine has advantages over other medications for OUD, including methadone and naltrexone.
Methadone must be obtained daily at a methadone clinic instead of at a local pharmacy. And escalating doses of methadone carry an increased risk for overdose and respiratory problems and potential drug-drug interactions, Dr. Garment added.
One downside with naltrexone is loss of tolerance, she said. If a patient has been using naltrexone to treat OUD and they decide to resume taking opioids, “they no longer can use the same amount of opioids that they were using before” because they have lost their tolerance and now are at a risk for overdose with their usual amount, she said. What’s more, naltrexone has not been shown to reduce overdose deaths.
Finally, she said, buprenorphine, “is an incredibly safe medication. If anyone in this room has ever prescribed coumadin or insulin, I’m going to tell you: This is much safer.”
Dr. Garment offered three reasons for buprenorphine’s safety:
- The drug is a partial, as opposed to full, opioid agonist, so as the dose increases, the patient experiences less withdrawal and fewer opioid cravings. As a result, they will hit a ceiling effect that avoids euphoria, respiratory depression, or overdose.
- Buprenorphine is “stickier” than other OUD medications: “If I’m taking buprenorphine and I decide to use some [oxycodone], what’s going to happen is that very little of that, if any, is going to get bound to my opioid receptors because buprenorphine is so sticky and adherent, it’s not going to let other opioids on.”
- Most buprenorphine is co-formulated with naloxone, an opioid antagonist. If a patient tries to get high from buprenorphine and tries to snort or inject it, naloxone will kick in and cancel out the buprenorphine.
Dr. Garment said she obtains urine screens ideally twice a year. If other drugs show up on the test, she said, she speaks with the patient about their drug use. “It’s never a reason to discharge someone from a practice,” she said.
Dr. Garment reported no relevant financial conflicts of interest.
*This story was updated on April 29, 2024.
A version of this article appeared on Medscape.com.
*The first thing Ann Garment, MD, wants all clinicians to know about buprenorphine is that [where state law permits] any prescriber with a DEA registration number “is able to prescribe buprenorphine and should be ready and willing to prescribe” the medication.
*A change in federal law means that for most providers “there is no longer any extra paperwork or training required to prescribe buprenorphine,” said Dr. Garment, clinical associate professor at New York University and chief of general internal medicine at Bellevue Hospital in New York City, during a presentation on April 19 at the American College of Physicians (ACP-IM) Internal Medicine Meeting 2024.
Dr. Garment, who specializes in opioid use disorder (OUD), described the current “third wave” of increasing opioid overdose deaths fueled by the increase of synthetic opioids in the drug supply. The third wave started in 2013 with the rise in use of fentanyl and tramadol. The 107,000 number of overdose deaths in the United States in 2021 was more than six times that in 1999, and 75% involved opioids.
“Now, more than ever,” Dr. Garment said, “opioid use disorder should be treated from the primary care setting.”
How to Identify OUD
“It’s less sensitive for picking up on people who have a prior opioid use disorder history or are only exhibiting risky opioid use that wouldn’t constitute opioid use disorder yet,” she said.
If someone screens positive, to verify OUD, the Diagnostic and Statistical Manual of Mental Disorders identifies criteria for any substance abuse disorder with two general themes: Loss of control and continued use despite negative consequences.
“If you have a patient who is getting prescribed opioids and they have opioid tolerance or withdrawal, that does not mean they have opioid use disorder,” she said.
Medication for OUD
Medication is the top treatment for OUD, according to Dr. Garment. Psychosocial treatments can help some but not all people with OUD, she said. “It is not a requirement for a patient to engage in psychosocial treatment in order to get a medication for opioid use disorder, so please do not let that be a barrier for your patients,” she said.
Buprenorphine has advantages over other medications for OUD, including methadone and naltrexone.
Methadone must be obtained daily at a methadone clinic instead of at a local pharmacy. And escalating doses of methadone carry an increased risk for overdose and respiratory problems and potential drug-drug interactions, Dr. Garment added.
One downside with naltrexone is loss of tolerance, she said. If a patient has been using naltrexone to treat OUD and they decide to resume taking opioids, “they no longer can use the same amount of opioids that they were using before” because they have lost their tolerance and now are at a risk for overdose with their usual amount, she said. What’s more, naltrexone has not been shown to reduce overdose deaths.
Finally, she said, buprenorphine, “is an incredibly safe medication. If anyone in this room has ever prescribed coumadin or insulin, I’m going to tell you: This is much safer.”
Dr. Garment offered three reasons for buprenorphine’s safety:
- The drug is a partial, as opposed to full, opioid agonist, so as the dose increases, the patient experiences less withdrawal and fewer opioid cravings. As a result, they will hit a ceiling effect that avoids euphoria, respiratory depression, or overdose.
- Buprenorphine is “stickier” than other OUD medications: “If I’m taking buprenorphine and I decide to use some [oxycodone], what’s going to happen is that very little of that, if any, is going to get bound to my opioid receptors because buprenorphine is so sticky and adherent, it’s not going to let other opioids on.”
- Most buprenorphine is co-formulated with naloxone, an opioid antagonist. If a patient tries to get high from buprenorphine and tries to snort or inject it, naloxone will kick in and cancel out the buprenorphine.
Dr. Garment said she obtains urine screens ideally twice a year. If other drugs show up on the test, she said, she speaks with the patient about their drug use. “It’s never a reason to discharge someone from a practice,” she said.
Dr. Garment reported no relevant financial conflicts of interest.
*This story was updated on April 29, 2024.
A version of this article appeared on Medscape.com.
First Consensus Statement on Improving Healthcare for Children with Neurodevelopmental Disabilities
The statement was published in Pediatrics.
The disparities in healthcare culture, mindset, and practice often start in childhood for young people with conditions including autism spectrum disorder (ASD), intellectual disability, and attention-deficit/hyperactivity disorder (ADHD), wrote co–first authors Carol Weitzman, MD, co-director of the Autism Spectrum Center at Boston Children’s Hospital, Boston, Massachusetts, and Cy Nadler, PhD, section chief of Autism Psychology at Children’s Mercy in Kansas City, Missouri, and colleagues.
Without better access to safe and appropriate care, people with NDDs experience more seclusion, accidents, restraints, and injury in healthcare encounters, the researchers wrote.
‘Accessible, Humane, Effective Care’
“At the heart of this consensus statement is an affirmation that all people are entitled to healthcare that is accessible, humane, and effective,” they wrote.
The consensus statement was developed as part of the Supporting Access for Everyone (SAFE) Initiative, launched by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. The consensus panel comprised professionals, caregivers, and adults with NDDs. After a 2-day public forum, the consensus panel held a conference and developed a statement on SAFE care, an NDD Health Care Bill of Rights and Transition Considerations. They developed 10 statements across five domains: training; communication; access and planning; diversity, equity, inclusion, belonging, and anti-ableism; and policy and structural change.
Asking the Patient ‘What do You Need?’
One theme in the statement that may have the most impact is “the importance of asking the person in front of you what they need,” and building a care plan around that, said senior author Marilyn Augustyn, MD, Director of the Division of Developmental and Behavioral Pediatrics at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts. “The medical community hasn’t done that very well for individuals with neurodevelopmental disabilities.”
Dr. Weitzman added: “Traditionally in healthcare settings, we’ve asked people to check their disabilities at the door.” Many people with neurodevelopmental disabilities often have “invisible disabilities,” she said, explaining that patients may have accommodation needs that aren’t immediately obvious, but could improve their access to care, so asking them what they need is critical.
Examples of ‘Ableism’
The consensus statement also calls attention to structural “ableism” or policies or practices that favor able-bodied people over those with disabilities and details the need for more training and changed policies.
The paper gives some examples of ableism, such as inappropriately excluding people with NDDs from research; staff assuming nonspeaking patients have no capacity for communication; or lack of awareness of sensory needs before using cold stethoscopes or flashing direct light into eyes.
Dr. Weitzman says this work is just the beginning of a complex process. It is intended to be the driver for developing curriculum to train all clinicians and others working with patients about neurodevelopmental disabilities. The hope is it will lead to more research to formalize best practices and make policies mandatory rather than optional.
The urgency in highlighting these issues is partly related to the prevalence of children and adolescents with neurodevelopmental disabilities, which the paper states is approximately 1 in 6.
But there are personal reasons as well for the team who developed the statement.
“We just believe that it is just a human right,” Dr. Weitzman said. “Having a neurodevelopmental disability does not make you any less entitled to good care. “
Dr. Augustyn added, “The children I’ve had the honor of caring for for the last 30 years deserve all this care and more. I think it’s time.”
This work was supported by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. Dr. Weitzman is a past consultant for Helios/Meliora. The other authors report no relevant financial relationships.
The statement was published in Pediatrics.
The disparities in healthcare culture, mindset, and practice often start in childhood for young people with conditions including autism spectrum disorder (ASD), intellectual disability, and attention-deficit/hyperactivity disorder (ADHD), wrote co–first authors Carol Weitzman, MD, co-director of the Autism Spectrum Center at Boston Children’s Hospital, Boston, Massachusetts, and Cy Nadler, PhD, section chief of Autism Psychology at Children’s Mercy in Kansas City, Missouri, and colleagues.
Without better access to safe and appropriate care, people with NDDs experience more seclusion, accidents, restraints, and injury in healthcare encounters, the researchers wrote.
‘Accessible, Humane, Effective Care’
“At the heart of this consensus statement is an affirmation that all people are entitled to healthcare that is accessible, humane, and effective,” they wrote.
The consensus statement was developed as part of the Supporting Access for Everyone (SAFE) Initiative, launched by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. The consensus panel comprised professionals, caregivers, and adults with NDDs. After a 2-day public forum, the consensus panel held a conference and developed a statement on SAFE care, an NDD Health Care Bill of Rights and Transition Considerations. They developed 10 statements across five domains: training; communication; access and planning; diversity, equity, inclusion, belonging, and anti-ableism; and policy and structural change.
Asking the Patient ‘What do You Need?’
One theme in the statement that may have the most impact is “the importance of asking the person in front of you what they need,” and building a care plan around that, said senior author Marilyn Augustyn, MD, Director of the Division of Developmental and Behavioral Pediatrics at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts. “The medical community hasn’t done that very well for individuals with neurodevelopmental disabilities.”
Dr. Weitzman added: “Traditionally in healthcare settings, we’ve asked people to check their disabilities at the door.” Many people with neurodevelopmental disabilities often have “invisible disabilities,” she said, explaining that patients may have accommodation needs that aren’t immediately obvious, but could improve their access to care, so asking them what they need is critical.
Examples of ‘Ableism’
The consensus statement also calls attention to structural “ableism” or policies or practices that favor able-bodied people over those with disabilities and details the need for more training and changed policies.
The paper gives some examples of ableism, such as inappropriately excluding people with NDDs from research; staff assuming nonspeaking patients have no capacity for communication; or lack of awareness of sensory needs before using cold stethoscopes or flashing direct light into eyes.
Dr. Weitzman says this work is just the beginning of a complex process. It is intended to be the driver for developing curriculum to train all clinicians and others working with patients about neurodevelopmental disabilities. The hope is it will lead to more research to formalize best practices and make policies mandatory rather than optional.
The urgency in highlighting these issues is partly related to the prevalence of children and adolescents with neurodevelopmental disabilities, which the paper states is approximately 1 in 6.
But there are personal reasons as well for the team who developed the statement.
“We just believe that it is just a human right,” Dr. Weitzman said. “Having a neurodevelopmental disability does not make you any less entitled to good care. “
Dr. Augustyn added, “The children I’ve had the honor of caring for for the last 30 years deserve all this care and more. I think it’s time.”
This work was supported by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. Dr. Weitzman is a past consultant for Helios/Meliora. The other authors report no relevant financial relationships.
The statement was published in Pediatrics.
The disparities in healthcare culture, mindset, and practice often start in childhood for young people with conditions including autism spectrum disorder (ASD), intellectual disability, and attention-deficit/hyperactivity disorder (ADHD), wrote co–first authors Carol Weitzman, MD, co-director of the Autism Spectrum Center at Boston Children’s Hospital, Boston, Massachusetts, and Cy Nadler, PhD, section chief of Autism Psychology at Children’s Mercy in Kansas City, Missouri, and colleagues.
Without better access to safe and appropriate care, people with NDDs experience more seclusion, accidents, restraints, and injury in healthcare encounters, the researchers wrote.
‘Accessible, Humane, Effective Care’
“At the heart of this consensus statement is an affirmation that all people are entitled to healthcare that is accessible, humane, and effective,” they wrote.
The consensus statement was developed as part of the Supporting Access for Everyone (SAFE) Initiative, launched by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. The consensus panel comprised professionals, caregivers, and adults with NDDs. After a 2-day public forum, the consensus panel held a conference and developed a statement on SAFE care, an NDD Health Care Bill of Rights and Transition Considerations. They developed 10 statements across five domains: training; communication; access and planning; diversity, equity, inclusion, belonging, and anti-ableism; and policy and structural change.
Asking the Patient ‘What do You Need?’
One theme in the statement that may have the most impact is “the importance of asking the person in front of you what they need,” and building a care plan around that, said senior author Marilyn Augustyn, MD, Director of the Division of Developmental and Behavioral Pediatrics at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts. “The medical community hasn’t done that very well for individuals with neurodevelopmental disabilities.”
Dr. Weitzman added: “Traditionally in healthcare settings, we’ve asked people to check their disabilities at the door.” Many people with neurodevelopmental disabilities often have “invisible disabilities,” she said, explaining that patients may have accommodation needs that aren’t immediately obvious, but could improve their access to care, so asking them what they need is critical.
Examples of ‘Ableism’
The consensus statement also calls attention to structural “ableism” or policies or practices that favor able-bodied people over those with disabilities and details the need for more training and changed policies.
The paper gives some examples of ableism, such as inappropriately excluding people with NDDs from research; staff assuming nonspeaking patients have no capacity for communication; or lack of awareness of sensory needs before using cold stethoscopes or flashing direct light into eyes.
Dr. Weitzman says this work is just the beginning of a complex process. It is intended to be the driver for developing curriculum to train all clinicians and others working with patients about neurodevelopmental disabilities. The hope is it will lead to more research to formalize best practices and make policies mandatory rather than optional.
The urgency in highlighting these issues is partly related to the prevalence of children and adolescents with neurodevelopmental disabilities, which the paper states is approximately 1 in 6.
But there are personal reasons as well for the team who developed the statement.
“We just believe that it is just a human right,” Dr. Weitzman said. “Having a neurodevelopmental disability does not make you any less entitled to good care. “
Dr. Augustyn added, “The children I’ve had the honor of caring for for the last 30 years deserve all this care and more. I think it’s time.”
This work was supported by the Developmental Behavioral Pediatric Research Network and the Association of University Centers on Disability. Dr. Weitzman is a past consultant for Helios/Meliora. The other authors report no relevant financial relationships.
Children With ASD May Have Earlier Onset of Suicidal Thoughts, Behaviors
, according to a research letter in JAMA Pediatrics.
Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket. Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.
People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.
Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.
They found the following reported lifetime STB incidence:
- 392 (40.5%) reported wanting to die
- 187 (19.3%) reported wanting to end their own lives
- 72 (7.4%) reported having a suicide plan
Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.
Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
Disturbing Findings
“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.
The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.
Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
Thoughts Come at a ‘Shockingly Young Age’
Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”
The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.
Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.
This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.
“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
Current Screening Recommendations
Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.
This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.
Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.
“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.
Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.
Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”
Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.
, according to a research letter in JAMA Pediatrics.
Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket. Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.
People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.
Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.
They found the following reported lifetime STB incidence:
- 392 (40.5%) reported wanting to die
- 187 (19.3%) reported wanting to end their own lives
- 72 (7.4%) reported having a suicide plan
Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.
Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
Disturbing Findings
“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.
The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.
Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
Thoughts Come at a ‘Shockingly Young Age’
Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”
The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.
Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.
This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.
“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
Current Screening Recommendations
Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.
This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.
Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.
“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.
Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.
Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”
Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.
, according to a research letter in JAMA Pediatrics.
Suicide rates among all US children ages 10-14 years tripled between 2007 and 2021, becoming the second leading cause of death for this age bracket. Between 2018 and 2021, 315 suicides were reported among US children ages 5 to 11 years.
People with ASD show increased rates of STB, although prevalence estimates vary by study, which led the authors to study the issue.
Lead author Benjamin Joffe Schindel, MD, MPH, a fellow in neurodevelopmental medicine at the Kennedy Krieger Institute in Columbia, Maryland, and colleagues, analyzed responses from 968 caregivers of children ages 8-25 with ASD.
They found the following reported lifetime STB incidence:
- 392 (40.5%) reported wanting to die
- 187 (19.3%) reported wanting to end their own lives
- 72 (7.4%) reported having a suicide plan
Among those answering affirmatively to each of the above questions regarding STB, onset at 8 years or younger was reported in 142 (36.2%); 66 (35.3%); and 13 (18.1%) of the children, respectively. Included in the findings was one suicide attempt by cutting in an 8-year-old child.
Dr. Schindel said though there is no direct comparison with age of these thoughts among the general population, a previous study in 2013 showed that through age 10 prevalence of suicide ideation is very low (< 1%), then increases slowly through age 12 and then more rapidly until age 17.
Disturbing Findings
“The unexpectedly high frequency of STBs among children with ASD who were 8 years or younger is particularly disturbing given the lack of validated suicide risk screening tools and interventions for this age group,” the authors wrote. They added that early start of STB in children with ASD is important as this population has been underrepresented in suicide research and prevention efforts.
The average child age in this study was 13.4; 84.8% were White; and 81% were male. More than half of the children (54.8%) were taking medications for emotional, behavioral, or mood-related issues.
Data were collected from May to October 2017 from responses to the Mental Health and Suicidal Behaviors Questionnaire, an online caregiver-answered survey. The survey was created and distributed by the Interactive Autism Network (IAN), an international autism registry, from 2006 to 2019 with approximately 55, 000 participating families.
Thoughts Come at a ‘Shockingly Young Age’
Suzanne Rybczynski, MD, chief medical officer at East Tennessee Children’s Hospital in Knoxville, who was not part of the research, said the study was small but will help get the message out that “kids start thinking about suicide, especially kids with autism,” at a “shockingly young age.”
The results demonstrate the great demand for studying thoughts and behaviors especially in younger children and in children with neurodiversity — autism or other neurodevelopmental disabilities.
Studying children with ASD in relation to suicidal thoughts is difficult, Dr. Rybczynski said, because the way they think about death and how much is understood about the finality of suicide has not been well studied. It’s also uncertain how well the children understood the questions in this study, she added.
This retrospective study also asked for responses from caregivers who may remember or interpret a child’s thoughts and words differently from the child’s true intent, Dr. Rybczynski said.
“We need more studies like this asking questions to kids directly,” she said, so researchers can figure what children think it means to die.
Current Screening Recommendations
Current recommendations from the American Academy of Pediatrics (AAP) are to screen children universally for suicide risk at age 12 using a validated tool and if there are behavioral health concerns, screen as needed from ages 8 to 12.
This study suggests that screening needs to start earlier, Dr. Rybczynski said. “But we also need to know that we’re asking the right questions” and whether questions might be different for children with different abilities.
Children who are less verbal are often not included in screening. Screening studies often specifically exclude children with neurodisabilities, she explained. Getting these youngsters involved and making appropriate screening available “would be lifesaving,” she said.
“There are no validated (screening) tools down to age 8, which is not to say that some organizations don’t use them, but they’re not validated,” she said.
Dr. Rybczynski pointed out that most of the children were White and male and future work investigating these thoughts in girls and other racial/ethnic groups with ASD will be important as well. In addition, it will be important to revisit the issue post-pandemic with the rise in mental health issues with COVID-19.
Identifying children struggling with thoughts of suicide is the key to preventing tragedy, Dr. Rybczynski said, adding, “All those deaths are avoidable.”
Various study coauthors disclosed ties to the Simons Foundation, the Patient-Centered Outcomes Research Institute, the US Social Security Administration, American Foundation for Suicide Prevention, and Sarepta. No other disclosures were reported. Dr. Rybczynski, who provided commentary on the study, has no relevant financial relationships.
FROM JAMA PEDIATRICS
Safety Risks Persist with Out-of-Hospital Births
Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.
In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).
Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.
“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
Birth Certificate Data Analyzed
The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.
The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.
“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.
Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:
- Appropriate patient selection for out-of-hospital births through standardized guidelines.
- Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
- Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
- Standardized guidelines on when transport to a hospital is necessary.
“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.
Incorporating Patient Preferences Into Delivery Models
Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.
“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”
Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.
“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.
Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”
The authors and Dr. Afshar have no relevant financial disclosures.
Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.
In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).
Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.
“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
Birth Certificate Data Analyzed
The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.
The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.
“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.
Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:
- Appropriate patient selection for out-of-hospital births through standardized guidelines.
- Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
- Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
- Standardized guidelines on when transport to a hospital is necessary.
“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.
Incorporating Patient Preferences Into Delivery Models
Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.
“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”
Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.
“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.
Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”
The authors and Dr. Afshar have no relevant financial disclosures.
Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.
In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).
Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.
“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
Birth Certificate Data Analyzed
The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.
The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.
“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.
Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:
- Appropriate patient selection for out-of-hospital births through standardized guidelines.
- Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
- Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
- Standardized guidelines on when transport to a hospital is necessary.
“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.
Incorporating Patient Preferences Into Delivery Models
Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.
“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”
Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.
“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.
Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”
The authors and Dr. Afshar have no relevant financial disclosures.
FROM AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY