MDedge Rheumatology

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Some young women can present with very low bone density and multiple fragility fractures. While multiple FDA-approved therapies exist for post-menopausal osteoporosis, pre-menopausal osteoporosis remains an “orphan disease.” Previous evidence suggests that bone anabolic agents such as teriparatide may be useful for women with idiopathic pre-menopausal osteoporosis (IOP). In a phase 2 randomized clinical trial from New York and Nebraska, 41 women with IOP and multiple fractures were randomized to receive placebo or teriparatide in a cross-over study design. The primary endpoint was bone density in the spine and hip after 6 months of treatment, which was significantly increased by teriparatide versus placebo. In addition, bone biopsies were obtained for measurement of bone formation rate using quadruple labeling with tetracycline and demeclocycline three months into treatment. As expected, biopsies showed that teriparatide treatment increased bone formation rates using this ‘gold standard’ method. This prospective randomized study adds to a growing body of evidence that teriparatide may be a safe method to boost bone density in women with IOP. Future studies are needed to assess the impact of this therapy on fracture risk in this specific patient population.

Type 2 diabetes and osteoporosis are both major problems in our aging population. While some diabetes medications such as thiazolidinediones clearly increase fracture risk, the effects of newer diabetes medications on bone biology and fracture risk remain incompletely understood. In addition to beneficial effects on glycemic control, SGLT2 inhibitors show promise with improving cardiovascular and renal outcomes, even in patients without diabetes. Some studies have suggested adverse effects of SGLT2 inhibitor monotherapy on bone density and fracture risk. However, the impact of combined therapy with SGLT2 inhibitors and metformin on fracture risk remains to be established. In this meta-analysis of 25 randomized controlled trials involving 19,500 patients, fracture risk was assessed, based on available information, for individuals who received metformin monotherapy or metformin plus SGLT2 inhibitor treatment. In general, combination therapy did not increase fracture risk compared to metformin alone. Only 6 of the 25 RCTs included in the meta-analysis investigated bone density or bone turnover markers. In these 6 studies, no obvious changes in skeletal outcomes were noted when comparing metformin alone versus metformin plus SGLT2 inhibitor therapy. Although these data are somewhat reassuring for the skeletal safety of combination metformin/SGLT2 inhibitor therapy, confidence is limited by relatively short follow-up time and lack of detailed information about fractures in these studies which focused primarily on diabetes-related outcomes. Future prospective studies are needed to specifically address the skeletal impact of this commonly-used combination of diabetes medications.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

Some young women can present with very low bone density and multiple fragility fractures. While multiple FDA-approved therapies exist for post-menopausal osteoporosis, pre-menopausal osteoporosis remains an “orphan disease.” Previous evidence suggests that bone anabolic agents such as teriparatide may be useful for women with idiopathic pre-menopausal osteoporosis (IOP). In a phase 2 randomized clinical trial from New York and Nebraska, 41 women with IOP and multiple fractures were randomized to receive placebo or teriparatide in a cross-over study design. The primary endpoint was bone density in the spine and hip after 6 months of treatment, which was significantly increased by teriparatide versus placebo. In addition, bone biopsies were obtained for measurement of bone formation rate using quadruple labeling with tetracycline and demeclocycline three months into treatment. As expected, biopsies showed that teriparatide treatment increased bone formation rates using this ‘gold standard’ method. This prospective randomized study adds to a growing body of evidence that teriparatide may be a safe method to boost bone density in women with IOP. Future studies are needed to assess the impact of this therapy on fracture risk in this specific patient population.

Type 2 diabetes and osteoporosis are both major problems in our aging population. While some diabetes medications such as thiazolidinediones clearly increase fracture risk, the effects of newer diabetes medications on bone biology and fracture risk remain incompletely understood. In addition to beneficial effects on glycemic control, SGLT2 inhibitors show promise with improving cardiovascular and renal outcomes, even in patients without diabetes. Some studies have suggested adverse effects of SGLT2 inhibitor monotherapy on bone density and fracture risk. However, the impact of combined therapy with SGLT2 inhibitors and metformin on fracture risk remains to be established. In this meta-analysis of 25 randomized controlled trials involving 19,500 patients, fracture risk was assessed, based on available information, for individuals who received metformin monotherapy or metformin plus SGLT2 inhibitor treatment. In general, combination therapy did not increase fracture risk compared to metformin alone. Only 6 of the 25 RCTs included in the meta-analysis investigated bone density or bone turnover markers. In these 6 studies, no obvious changes in skeletal outcomes were noted when comparing metformin alone versus metformin plus SGLT2 inhibitor therapy. Although these data are somewhat reassuring for the skeletal safety of combination metformin/SGLT2 inhibitor therapy, confidence is limited by relatively short follow-up time and lack of detailed information about fractures in these studies which focused primarily on diabetes-related outcomes. Future prospective studies are needed to specifically address the skeletal impact of this commonly-used combination of diabetes medications.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

Some young women can present with very low bone density and multiple fragility fractures. While multiple FDA-approved therapies exist for post-menopausal osteoporosis, pre-menopausal osteoporosis remains an “orphan disease.” Previous evidence suggests that bone anabolic agents such as teriparatide may be useful for women with idiopathic pre-menopausal osteoporosis (IOP). In a phase 2 randomized clinical trial from New York and Nebraska, 41 women with IOP and multiple fractures were randomized to receive placebo or teriparatide in a cross-over study design. The primary endpoint was bone density in the spine and hip after 6 months of treatment, which was significantly increased by teriparatide versus placebo. In addition, bone biopsies were obtained for measurement of bone formation rate using quadruple labeling with tetracycline and demeclocycline three months into treatment. As expected, biopsies showed that teriparatide treatment increased bone formation rates using this ‘gold standard’ method. This prospective randomized study adds to a growing body of evidence that teriparatide may be a safe method to boost bone density in women with IOP. Future studies are needed to assess the impact of this therapy on fracture risk in this specific patient population.

Type 2 diabetes and osteoporosis are both major problems in our aging population. While some diabetes medications such as thiazolidinediones clearly increase fracture risk, the effects of newer diabetes medications on bone biology and fracture risk remain incompletely understood. In addition to beneficial effects on glycemic control, SGLT2 inhibitors show promise with improving cardiovascular and renal outcomes, even in patients without diabetes. Some studies have suggested adverse effects of SGLT2 inhibitor monotherapy on bone density and fracture risk. However, the impact of combined therapy with SGLT2 inhibitors and metformin on fracture risk remains to be established. In this meta-analysis of 25 randomized controlled trials involving 19,500 patients, fracture risk was assessed, based on available information, for individuals who received metformin monotherapy or metformin plus SGLT2 inhibitor treatment. In general, combination therapy did not increase fracture risk compared to metformin alone. Only 6 of the 25 RCTs included in the meta-analysis investigated bone density or bone turnover markers. In these 6 studies, no obvious changes in skeletal outcomes were noted when comparing metformin alone versus metformin plus SGLT2 inhibitor therapy. Although these data are somewhat reassuring for the skeletal safety of combination metformin/SGLT2 inhibitor therapy, confidence is limited by relatively short follow-up time and lack of detailed information about fractures in these studies which focused primarily on diabetes-related outcomes. Future prospective studies are needed to specifically address the skeletal impact of this commonly-used combination of diabetes medications.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School