Ob.Gyn. News

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

• Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
• The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
• Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

• A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
• After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
• The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

• Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
• The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
• Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

• A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
• After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
• The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

• Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
• The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
• Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

• A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
• After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
• The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti).

The biosimilar was also granted interchangeability status, which allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Sandoz announced the approval on March 5, 2024. The lower dosage of denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February. 

The FDA approval “is based on robust clinical studies and accompanied by labeling with safety warnings,” according to the press release. Like the reference products Prolia and Xgeva, denosumab-bddz is approved for two indications at separate doses.

Wyost (120-mg/1.7-mL injection) is approved to:

• Prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
• Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
• Treat hypercalcemia of cancer that is refractory to bisphosphonate therapy

Jubbonti (60-mg/1-mL injection) is approved to:

• Treat postmenopausal women with osteoporosis who are at high risk for fracture
• Increase bone mass in men with osteoporosis who are at high risk for fracture
• Treat glucocorticoid-induced osteoporosis in men and women who are at high risk for fracture
• Increase bone mass in men who are at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Increase bone mass in women who are at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Both doses are contraindicated for hypocalcemia and known clinically significant hypersensitivity to denosumab products. Exposure to denosumab products during pregnancy can cause fetal harm, so women of reproductive potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose of denosumab-bddz.

Sandoz did not provide information on US launch details, citing “ongoing patent litigation around these products.”

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti).

The biosimilar was also granted interchangeability status, which allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Sandoz announced the approval on March 5, 2024. The lower dosage of denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February. 

The FDA approval “is based on robust clinical studies and accompanied by labeling with safety warnings,” according to the press release. Like the reference products Prolia and Xgeva, denosumab-bddz is approved for two indications at separate doses.

Wyost (120-mg/1.7-mL injection) is approved to:

• Prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
• Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
• Treat hypercalcemia of cancer that is refractory to bisphosphonate therapy

Jubbonti (60-mg/1-mL injection) is approved to:

• Treat postmenopausal women with osteoporosis who are at high risk for fracture
• Increase bone mass in men with osteoporosis who are at high risk for fracture
• Treat glucocorticoid-induced osteoporosis in men and women who are at high risk for fracture
• Increase bone mass in men who are at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Increase bone mass in women who are at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Both doses are contraindicated for hypocalcemia and known clinically significant hypersensitivity to denosumab products. Exposure to denosumab products during pregnancy can cause fetal harm, so women of reproductive potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose of denosumab-bddz.

Sandoz did not provide information on US launch details, citing “ongoing patent litigation around these products.”

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti).

The biosimilar was also granted interchangeability status, which allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Sandoz announced the approval on March 5, 2024. The lower dosage of denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February. 

The FDA approval “is based on robust clinical studies and accompanied by labeling with safety warnings,” according to the press release. Like the reference products Prolia and Xgeva, denosumab-bddz is approved for two indications at separate doses.

Wyost (120-mg/1.7-mL injection) is approved to:

• Prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
• Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
• Treat hypercalcemia of cancer that is refractory to bisphosphonate therapy

Jubbonti (60-mg/1-mL injection) is approved to:

• Treat postmenopausal women with osteoporosis who are at high risk for fracture
• Increase bone mass in men with osteoporosis who are at high risk for fracture
• Treat glucocorticoid-induced osteoporosis in men and women who are at high risk for fracture
• Increase bone mass in men who are at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Increase bone mass in women who are at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Both doses are contraindicated for hypocalcemia and known clinically significant hypersensitivity to denosumab products. Exposure to denosumab products during pregnancy can cause fetal harm, so women of reproductive potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose of denosumab-bddz.

Sandoz did not provide information on US launch details, citing “ongoing patent litigation around these products.”

A version of this article appeared on Medscape.com.

Do I deserve to be here? Am I doing what I’m supposed to be doing? Is anyone going to tell me if I’m terrible?

Kerri Palamara McGrath, MD, remembered worrying over these questions as chief resident at Massachusetts General Hospital, Boston, Massachusetts, in 2009. Having graduated from New York Medical College, she felt out of step with her peers from Ivy League medical schools and considered herself lucky to be there. In order to measure up, she felt she had to work twice as hard as everybody else.

But as Dr. McGrath moved through residency and spoke with other trainees, she had a realization. Her constant fears, the nagging voice in her head saying she wasn’t good enough, these issues weren’t exclusive to her; they were pervasive.

Today, Dr. McGrath is the director of the Center for Physician Well-Being at Massachusetts General Hospital. The facility aims to address physician stress and equip doctors with the tools to navigate personal and professional issues. Dr. McGrath is also a physician coach, a growing nonclinical field, helping doctors identify their own stressors, values, and measures of success. This type of internal work, Dr. McGrath feels, can help alleviate imposter syndrome, that inner refrain saying: I’ll never be good enough.

What Is Imposter Syndrome?

While not a formal medical diagnosis, imposter syndrome has been defined as «an internal experience of intellectual phoniness.» It›s considered an inability to internalize success and a tendency to attribute gains to external factors — for example, being in the right place at the right time.

“Many people describe imposter phenomena in medicine as fearing that others are going to realize that they don’t belong somewhere or question why they’re there,” said Dr. McGrath.

It’s a “fear of being found out,” added Jessi Gold, MD, a psychiatrist who treats physicians. “In many ways, imposter syndrome shows up as a conflict between the outer self — the metaphorical mask you’re ‘putting on’ [in order] to achieve, and the inner self — how you feel like you’re not measuring up.”

Dr. McGrath said she experienced imposter syndrome before her medical career even began. She applied to 26 medical schools. Only one accepted her. “The whole time, I was like, ‘This is the only school you got into, so you’re obviously not good enough,’” she recalled. Later, having been chosen by a “coveted” institution like Mass General, “you assume that, at some point, someone will realize that the gig is up, that everybody’s better than you.”

Where Does Imposter Syndrome Come From?

Dr. McGrath felt that in medicine, high expectations are often coupled with low self-compassion. “We are so hard on ourselves, and when we set our expectations so high, we’re constantly disappointed in ourselves,” she said. External markers of success — papers published, promotions, or even social media — can further fuel this.

It can feel like “striving for excellence in a sea of excellence,” Dr. McGrath added, and this can invite comparison.

Ravi Parikh, MD, a medical oncologist and physician-scientist at the University of Pennsylvania, Philadelphia, Pennsylvania, remembered struggling with imposter syndrome early in his career. As a new doctor, he had a ton of questions, and yet those above him seemed able to make weighty decisions on their own. The comparison shook his confidence. “I remember thinking that when I became an attending, I would just magically not have to run decisions by people,” said Dr. Parikh. But even then, the “magical” self-assurance didn’t materialize.

Research found that imposter syndrome is more likely to affect women and groups that are underrepresented in medicine. But overall, the incidence is remarkably high.

A 2023 survey published in the Journal of the American College of Surgeons found that 90% of female surgeons and more than two-thirds of male ones experienced imposter syndrome. In a 2023 study on medical students in JAMA, it was nearly universal; 97% reported feelings of imposter syndrome with women 1.7 times more likely to report it than men and underrepresented groups often three times more likely.

‘I’m Clearly in the Minority Here’

The term “imposter” also suggests a lack of belonging. If medicine doesn’t “look like you,” this can create feelings of pressure, like you’re “representing a whole group with your mere existence,” said Dr. Gold, “and you have to keep proving yourself.”

Chloe Slocum, MD, MPH, an assistant professor of physical medicine and rehabilitation at Harvard Medical School, Boston, Massachusetts, remembered that feeling of conspicuous “otherness.” As a resident, Dr. Slocum began presenting at national meetings and later pursued physician leadership training. Many of her counterparts at these events were older males. “At some programs early on, I’d wonder, ‘I’m clearly in the minority here; did they really make the right decision including me in this?’”

Reactions from those around you can also have an impact. Dr. McGrath — who is 5’ 2” and describes herself as looking “very young” — noted that when she started out, neither patients nor other providers thought she was a doctor.

“I have tried everything in the book to be seen, in somebody else’s eyes, as more consistent with a doctor,” she said. “I’ve dressed down. I’ve dressed up. I’ve worn heels. I’ve worn flats. I’ve worn glasses. I’ve done all the things. When you’re constantly being told you don’t look like a doctor, you start questioning yourself.”

The Emotional Toll

If that sounds mentally exhausting, it is. Research found that imposter syndrome is often linked with burnout, depression, and anxiety.

The need to prove yourself and prevent being “found out” can push some doctors toward traditional measurements of success — promotions or published work, said Dr. Gold. But “if you’re trying to achieve in ways that you don’t value,” she warned, “you’re going to burn out.”

On the other hand, intense self-doubt can also limit advancement. After all, if you don’t think you’re good enough, you may not apply for job opportunities or leadership positions.

This mental burden can persist over years and even decades. A 2020 review of studies on imposter syndrome noted that “it would be reassuring to believe that imposter symptoms decline with age.” Unfortunately, several studies indicated that they do not.

How to Manage Imposter Syndrome

While it can be difficult to overcome imposter syndrome, there are ways to work through it and make it less pervasive or intense. Here are some tips from our experts:

• Prioritize your mental health. This can be difficult for some physicians, but don’t ignore symptoms of depression, anxiety, or burnout. Untreated mental health conditions cloud the ability to reflect on some of the existential questions that will help you navigate imposter syndrome, said Dr. Gold.
• Assess how often you need validation and why. Try to identify what you›re feeling, what needs aren›t being met, and how you can meet those needs. You can then consider where to get that validation either internally or by connecting with a colleague. Dr. McGrath encourages physicians to ask, “What does success look like for me?” and can you make success more personal and meaningful. It might sound shocking, but rather than an unattainable ideal, success should be something that feels good.
• Know the power of teamwork. As Dr. Parikh eventually realized, collaborative care is a common and beneficial part of medicine — not something that makes you a less-than physician. “There’s a lot of opportunity to crowdsource the medical decision-making process in ways that increase your own confidence as a doctor,” he said.
• Practice self-compassion. Critical voices in your head add to an already hard and stressful world. This is where self-compassion comes in. “We don’t have much control over medicine, but we have control over how medicine makes us feel,” Dr. Gold said. Imagine treating yourself how you would treat a friend.
• Consider a physician coach.  suggests that physician coaches can help lower rates of burnout and improve well-being, resilience, professional fulfillment, and self-worth. “Coaching looks into the future to help you envision what things would look like if you were feeling differently. It helps you explore what’s in your control and how you want to shape that,” said Dr. McGrath.
• Amplify the good. Apps and web-based tools can remind you to celebrate your own achievements. The “” exercise created by J. Bryan Sexton, PhD, at the Duke Center for Healthcare Safety & Quality for example, was documented in a . When healthcare workers reflected on three good things that happened each day for 2 weeks, they reported significant improvements in depression, burnout, and work-life balance.
• Do a values check. Dr. Gold often suggested that physicians with imposter syndrome ask themselves what they value, what medicine values, and how the two line up. Pausing to consider this can guide you toward useful strategies. If you value family life but feel like medicine doesn’t, for example, you might talk with a colleague who has navigated this conflict.

Dr. Gold added that reminding yourself of the range of options can be freeing. “There’s no ‘one career’ in medicine,” she said. “There are multiple ways to be happy in medicine; there are multiple ways to be happy outside of medicine. And you’re not a failure for the path you choose.”

A version of this article appeared on Medscape.com.

Do I deserve to be here? Am I doing what I’m supposed to be doing? Is anyone going to tell me if I’m terrible?

Kerri Palamara McGrath, MD, remembered worrying over these questions as chief resident at Massachusetts General Hospital, Boston, Massachusetts, in 2009. Having graduated from New York Medical College, she felt out of step with her peers from Ivy League medical schools and considered herself lucky to be there. In order to measure up, she felt she had to work twice as hard as everybody else.

But as Dr. McGrath moved through residency and spoke with other trainees, she had a realization. Her constant fears, the nagging voice in her head saying she wasn’t good enough, these issues weren’t exclusive to her; they were pervasive.

Today, Dr. McGrath is the director of the Center for Physician Well-Being at Massachusetts General Hospital. The facility aims to address physician stress and equip doctors with the tools to navigate personal and professional issues. Dr. McGrath is also a physician coach, a growing nonclinical field, helping doctors identify their own stressors, values, and measures of success. This type of internal work, Dr. McGrath feels, can help alleviate imposter syndrome, that inner refrain saying: I’ll never be good enough.

What Is Imposter Syndrome?

While not a formal medical diagnosis, imposter syndrome has been defined as «an internal experience of intellectual phoniness.» It›s considered an inability to internalize success and a tendency to attribute gains to external factors — for example, being in the right place at the right time.

“Many people describe imposter phenomena in medicine as fearing that others are going to realize that they don’t belong somewhere or question why they’re there,” said Dr. McGrath.

It’s a “fear of being found out,” added Jessi Gold, MD, a psychiatrist who treats physicians. “In many ways, imposter syndrome shows up as a conflict between the outer self — the metaphorical mask you’re ‘putting on’ [in order] to achieve, and the inner self — how you feel like you’re not measuring up.”

Dr. McGrath said she experienced imposter syndrome before her medical career even began. She applied to 26 medical schools. Only one accepted her. “The whole time, I was like, ‘This is the only school you got into, so you’re obviously not good enough,’” she recalled. Later, having been chosen by a “coveted” institution like Mass General, “you assume that, at some point, someone will realize that the gig is up, that everybody’s better than you.”

Where Does Imposter Syndrome Come From?

Dr. McGrath felt that in medicine, high expectations are often coupled with low self-compassion. “We are so hard on ourselves, and when we set our expectations so high, we’re constantly disappointed in ourselves,” she said. External markers of success — papers published, promotions, or even social media — can further fuel this.

It can feel like “striving for excellence in a sea of excellence,” Dr. McGrath added, and this can invite comparison.

Ravi Parikh, MD, a medical oncologist and physician-scientist at the University of Pennsylvania, Philadelphia, Pennsylvania, remembered struggling with imposter syndrome early in his career. As a new doctor, he had a ton of questions, and yet those above him seemed able to make weighty decisions on their own. The comparison shook his confidence. “I remember thinking that when I became an attending, I would just magically not have to run decisions by people,” said Dr. Parikh. But even then, the “magical” self-assurance didn’t materialize.

Research found that imposter syndrome is more likely to affect women and groups that are underrepresented in medicine. But overall, the incidence is remarkably high.

A 2023 survey published in the Journal of the American College of Surgeons found that 90% of female surgeons and more than two-thirds of male ones experienced imposter syndrome. In a 2023 study on medical students in JAMA, it was nearly universal; 97% reported feelings of imposter syndrome with women 1.7 times more likely to report it than men and underrepresented groups often three times more likely.

‘I’m Clearly in the Minority Here’

The term “imposter” also suggests a lack of belonging. If medicine doesn’t “look like you,” this can create feelings of pressure, like you’re “representing a whole group with your mere existence,” said Dr. Gold, “and you have to keep proving yourself.”

Chloe Slocum, MD, MPH, an assistant professor of physical medicine and rehabilitation at Harvard Medical School, Boston, Massachusetts, remembered that feeling of conspicuous “otherness.” As a resident, Dr. Slocum began presenting at national meetings and later pursued physician leadership training. Many of her counterparts at these events were older males. “At some programs early on, I’d wonder, ‘I’m clearly in the minority here; did they really make the right decision including me in this?’”

Reactions from those around you can also have an impact. Dr. McGrath — who is 5’ 2” and describes herself as looking “very young” — noted that when she started out, neither patients nor other providers thought she was a doctor.

“I have tried everything in the book to be seen, in somebody else’s eyes, as more consistent with a doctor,” she said. “I’ve dressed down. I’ve dressed up. I’ve worn heels. I’ve worn flats. I’ve worn glasses. I’ve done all the things. When you’re constantly being told you don’t look like a doctor, you start questioning yourself.”

The Emotional Toll

If that sounds mentally exhausting, it is. Research found that imposter syndrome is often linked with burnout, depression, and anxiety.

The need to prove yourself and prevent being “found out” can push some doctors toward traditional measurements of success — promotions or published work, said Dr. Gold. But “if you’re trying to achieve in ways that you don’t value,” she warned, “you’re going to burn out.”

On the other hand, intense self-doubt can also limit advancement. After all, if you don’t think you’re good enough, you may not apply for job opportunities or leadership positions.

This mental burden can persist over years and even decades. A 2020 review of studies on imposter syndrome noted that “it would be reassuring to believe that imposter symptoms decline with age.” Unfortunately, several studies indicated that they do not.

How to Manage Imposter Syndrome

While it can be difficult to overcome imposter syndrome, there are ways to work through it and make it less pervasive or intense. Here are some tips from our experts:

• Prioritize your mental health. This can be difficult for some physicians, but don’t ignore symptoms of depression, anxiety, or burnout. Untreated mental health conditions cloud the ability to reflect on some of the existential questions that will help you navigate imposter syndrome, said Dr. Gold.
• Assess how often you need validation and why. Try to identify what you›re feeling, what needs aren›t being met, and how you can meet those needs. You can then consider where to get that validation either internally or by connecting with a colleague. Dr. McGrath encourages physicians to ask, “What does success look like for me?” and can you make success more personal and meaningful. It might sound shocking, but rather than an unattainable ideal, success should be something that feels good.
• Know the power of teamwork. As Dr. Parikh eventually realized, collaborative care is a common and beneficial part of medicine — not something that makes you a less-than physician. “There’s a lot of opportunity to crowdsource the medical decision-making process in ways that increase your own confidence as a doctor,” he said.
• Practice self-compassion. Critical voices in your head add to an already hard and stressful world. This is where self-compassion comes in. “We don’t have much control over medicine, but we have control over how medicine makes us feel,” Dr. Gold said. Imagine treating yourself how you would treat a friend.
• Consider a physician coach.  suggests that physician coaches can help lower rates of burnout and improve well-being, resilience, professional fulfillment, and self-worth. “Coaching looks into the future to help you envision what things would look like if you were feeling differently. It helps you explore what’s in your control and how you want to shape that,” said Dr. McGrath.
• Amplify the good. Apps and web-based tools can remind you to celebrate your own achievements. The “” exercise created by J. Bryan Sexton, PhD, at the Duke Center for Healthcare Safety & Quality for example, was documented in a . When healthcare workers reflected on three good things that happened each day for 2 weeks, they reported significant improvements in depression, burnout, and work-life balance.
• Do a values check. Dr. Gold often suggested that physicians with imposter syndrome ask themselves what they value, what medicine values, and how the two line up. Pausing to consider this can guide you toward useful strategies. If you value family life but feel like medicine doesn’t, for example, you might talk with a colleague who has navigated this conflict.

Dr. Gold added that reminding yourself of the range of options can be freeing. “There’s no ‘one career’ in medicine,” she said. “There are multiple ways to be happy in medicine; there are multiple ways to be happy outside of medicine. And you’re not a failure for the path you choose.”

A version of this article appeared on Medscape.com.

Do I deserve to be here? Am I doing what I’m supposed to be doing? Is anyone going to tell me if I’m terrible?

Kerri Palamara McGrath, MD, remembered worrying over these questions as chief resident at Massachusetts General Hospital, Boston, Massachusetts, in 2009. Having graduated from New York Medical College, she felt out of step with her peers from Ivy League medical schools and considered herself lucky to be there. In order to measure up, she felt she had to work twice as hard as everybody else.

But as Dr. McGrath moved through residency and spoke with other trainees, she had a realization. Her constant fears, the nagging voice in her head saying she wasn’t good enough, these issues weren’t exclusive to her; they were pervasive.

Today, Dr. McGrath is the director of the Center for Physician Well-Being at Massachusetts General Hospital. The facility aims to address physician stress and equip doctors with the tools to navigate personal and professional issues. Dr. McGrath is also a physician coach, a growing nonclinical field, helping doctors identify their own stressors, values, and measures of success. This type of internal work, Dr. McGrath feels, can help alleviate imposter syndrome, that inner refrain saying: I’ll never be good enough.

What Is Imposter Syndrome?

While not a formal medical diagnosis, imposter syndrome has been defined as «an internal experience of intellectual phoniness.» It›s considered an inability to internalize success and a tendency to attribute gains to external factors — for example, being in the right place at the right time.

“Many people describe imposter phenomena in medicine as fearing that others are going to realize that they don’t belong somewhere or question why they’re there,” said Dr. McGrath.

It’s a “fear of being found out,” added Jessi Gold, MD, a psychiatrist who treats physicians. “In many ways, imposter syndrome shows up as a conflict between the outer self — the metaphorical mask you’re ‘putting on’ [in order] to achieve, and the inner self — how you feel like you’re not measuring up.”

Dr. McGrath said she experienced imposter syndrome before her medical career even began. She applied to 26 medical schools. Only one accepted her. “The whole time, I was like, ‘This is the only school you got into, so you’re obviously not good enough,’” she recalled. Later, having been chosen by a “coveted” institution like Mass General, “you assume that, at some point, someone will realize that the gig is up, that everybody’s better than you.”

Where Does Imposter Syndrome Come From?

Dr. McGrath felt that in medicine, high expectations are often coupled with low self-compassion. “We are so hard on ourselves, and when we set our expectations so high, we’re constantly disappointed in ourselves,” she said. External markers of success — papers published, promotions, or even social media — can further fuel this.

It can feel like “striving for excellence in a sea of excellence,” Dr. McGrath added, and this can invite comparison.

Ravi Parikh, MD, a medical oncologist and physician-scientist at the University of Pennsylvania, Philadelphia, Pennsylvania, remembered struggling with imposter syndrome early in his career. As a new doctor, he had a ton of questions, and yet those above him seemed able to make weighty decisions on their own. The comparison shook his confidence. “I remember thinking that when I became an attending, I would just magically not have to run decisions by people,” said Dr. Parikh. But even then, the “magical” self-assurance didn’t materialize.

Research found that imposter syndrome is more likely to affect women and groups that are underrepresented in medicine. But overall, the incidence is remarkably high.

A 2023 survey published in the Journal of the American College of Surgeons found that 90% of female surgeons and more than two-thirds of male ones experienced imposter syndrome. In a 2023 study on medical students in JAMA, it was nearly universal; 97% reported feelings of imposter syndrome with women 1.7 times more likely to report it than men and underrepresented groups often three times more likely.

‘I’m Clearly in the Minority Here’

The term “imposter” also suggests a lack of belonging. If medicine doesn’t “look like you,” this can create feelings of pressure, like you’re “representing a whole group with your mere existence,” said Dr. Gold, “and you have to keep proving yourself.”

Chloe Slocum, MD, MPH, an assistant professor of physical medicine and rehabilitation at Harvard Medical School, Boston, Massachusetts, remembered that feeling of conspicuous “otherness.” As a resident, Dr. Slocum began presenting at national meetings and later pursued physician leadership training. Many of her counterparts at these events were older males. “At some programs early on, I’d wonder, ‘I’m clearly in the minority here; did they really make the right decision including me in this?’”

Reactions from those around you can also have an impact. Dr. McGrath — who is 5’ 2” and describes herself as looking “very young” — noted that when she started out, neither patients nor other providers thought she was a doctor.

“I have tried everything in the book to be seen, in somebody else’s eyes, as more consistent with a doctor,” she said. “I’ve dressed down. I’ve dressed up. I’ve worn heels. I’ve worn flats. I’ve worn glasses. I’ve done all the things. When you’re constantly being told you don’t look like a doctor, you start questioning yourself.”

The Emotional Toll

If that sounds mentally exhausting, it is. Research found that imposter syndrome is often linked with burnout, depression, and anxiety.

The need to prove yourself and prevent being “found out” can push some doctors toward traditional measurements of success — promotions or published work, said Dr. Gold. But “if you’re trying to achieve in ways that you don’t value,” she warned, “you’re going to burn out.”

On the other hand, intense self-doubt can also limit advancement. After all, if you don’t think you’re good enough, you may not apply for job opportunities or leadership positions.

This mental burden can persist over years and even decades. A 2020 review of studies on imposter syndrome noted that “it would be reassuring to believe that imposter symptoms decline with age.” Unfortunately, several studies indicated that they do not.

How to Manage Imposter Syndrome

While it can be difficult to overcome imposter syndrome, there are ways to work through it and make it less pervasive or intense. Here are some tips from our experts:

• Prioritize your mental health. This can be difficult for some physicians, but don’t ignore symptoms of depression, anxiety, or burnout. Untreated mental health conditions cloud the ability to reflect on some of the existential questions that will help you navigate imposter syndrome, said Dr. Gold.
• Assess how often you need validation and why. Try to identify what you›re feeling, what needs aren›t being met, and how you can meet those needs. You can then consider where to get that validation either internally or by connecting with a colleague. Dr. McGrath encourages physicians to ask, “What does success look like for me?” and can you make success more personal and meaningful. It might sound shocking, but rather than an unattainable ideal, success should be something that feels good.
• Know the power of teamwork. As Dr. Parikh eventually realized, collaborative care is a common and beneficial part of medicine — not something that makes you a less-than physician. “There’s a lot of opportunity to crowdsource the medical decision-making process in ways that increase your own confidence as a doctor,” he said.
• Practice self-compassion. Critical voices in your head add to an already hard and stressful world. This is where self-compassion comes in. “We don’t have much control over medicine, but we have control over how medicine makes us feel,” Dr. Gold said. Imagine treating yourself how you would treat a friend.
• Consider a physician coach.  suggests that physician coaches can help lower rates of burnout and improve well-being, resilience, professional fulfillment, and self-worth. “Coaching looks into the future to help you envision what things would look like if you were feeling differently. It helps you explore what’s in your control and how you want to shape that,” said Dr. McGrath.
• Amplify the good. Apps and web-based tools can remind you to celebrate your own achievements. The “” exercise created by J. Bryan Sexton, PhD, at the Duke Center for Healthcare Safety & Quality for example, was documented in a . When healthcare workers reflected on three good things that happened each day for 2 weeks, they reported significant improvements in depression, burnout, and work-life balance.
• Do a values check. Dr. Gold often suggested that physicians with imposter syndrome ask themselves what they value, what medicine values, and how the two line up. Pausing to consider this can guide you toward useful strategies. If you value family life but feel like medicine doesn’t, for example, you might talk with a colleague who has navigated this conflict.

Dr. Gold added that reminding yourself of the range of options can be freeing. “There’s no ‘one career’ in medicine,” she said. “There are multiple ways to be happy in medicine; there are multiple ways to be happy outside of medicine. And you’re not a failure for the path you choose.”

A version of this article appeared on Medscape.com.

California’s efforts to expand access to abortion care are enabling more types of medical practitioners to perform certain abortion procedures — potentially a boon for patients in rural areas especially, but a source of concern for doctors’ groups that have long fought efforts to expand the role of non-physicians.

The latest move is a law that enables trained physician assistants, also known as physician associates, to perform first-trimester abortions without a supervising physician present. The measure, which passed last year and took effect Jan. 1, also lets PAs who have been disciplined or convicted solely for performing an abortion in a state where the practice is restricted apply for a license in California.

Physician assistants are now on par with nurse practitioners and certified nurse midwives trained in abortion care, who in 2022 won the ability to perform abortions without a doctor present.

The need for more abortion care practitioners is being driven by efforts in many states to gut abortion rights following the Supreme Court’s 2022 decision ending constitutional protection for the procedure. Thirty-one states have implemented abortion restrictions that range from cutting federal funding for abortion coverage to outright bans, according to the Guttmacher Institute, a research organization concerned with reproductive health.

With the new law, “there will be fewer barriers, and shorter wait times for this essential service,” said Jeremy Meis, president-elect of the California Academy of Physician Associates. While it is unclear how many of California’s 16,000 PAs will be trained in performing abortions, research shows that PAs are more likely than physicians to practice in rural areas where access to abortion is limited. More than 40% of counties in California lack clinics that provide abortion.

Comparing data from the first six months of 2020 with the same period in 2023, the number of abortions jumped from 77,030 to 92,600 a 20% increase as the state became a refuge for women seeking abortions. California has passed a suite of reproductive health laws to build in protections and increase access, and a dozen other states, including Oregon, Minnesota, and New York, have mounted similar efforts. Seventeen states, including California, now allow PAs to perform first-trimester abortions, according to the American Academy of Physician Associates.

There was little opposition to the new California law, with two physicians’ groups supporting it. But the American Medical Association, the country’s most powerful doctors’ lobby, has fought vigorously against what it calls “scope creep” — that is, changes that allow clinicians like PAs to do medical procedures independent of physicians.

“Our policy stance is the same on scope of practice expansion regardless of procedure,” noted Kelly Jakubek, the AMA’s media relations manager. The AMA’s website points to legislative victories in 2023, including striking down “legislation allowing physician assistants to practice independently without physician oversight,” in states including Arizona and New York. The AMA did not take a formal position on the California legislation. Its local chapter, the California Medical Association, took a neutral position on the legislation.

In preparation for the new law, one physician assistant at Planned Parenthood Pasadena & San Gabriel Valley began learning how to perform aspiration abortions — a procedure also known as dilation and curettage that uses gentle suction to end a pregnancy — at the end of last year. The PA, who requested anonymity due to concerns about safety, said that with abortion restrictions in place around the country, “I just think it’s really important to be able to provide a comfortable, safe, and very effective way to terminate a pregnancy for patients.”

She is now one of six PAs and midwives at her clinic who can offer aspiration abortions. To reach competency, she participated in 50 procedures and learned how to administer medication that eases pain and anxiety. Such conscious sedation, as it is known, is frequently used for first-trimester abortions. Now she, like any other advanced practice clinician who has obtained skills in performing abortions, can train her peers — another feature of the new law.

The length of time for training and the number of procedures to reach competency varies based on a practitioner’s previous experience.

“It’s encouraging this cross-profession training and collaborations, which is really important when we’re looking at increasing access to essential services,” said Jessica Dieseldorff, senior program manager of abortion services at Planned Parenthood Mar Monte in Santa Cruz.

In December, California committed $18 million to help accelerate training in abortion and reproductive care for practitioners, including PAs, through the Reproductive Health Care Access Initiative.

Dieseldorff, a nurse practitioner who trains other advanced-practice clinicians in abortion care, said that rural communities, in particular, will reap the benefits since many rely solely on physician assistants and other allied clinicians.

Reflecting on her career, she said much has changed since she became a nurse 25 years ago. At that time, she worked only as support staff to doctors providing abortions.

“When I began, medication abortions did not exist in this country,” she said, referring to the practice of using two drugs often prescribed to induce abortions. “It’s been gratifying to be able to progress and become a provider myself, provide non-stigmatizing and compassionate and safe care to patients; and now, at this stage in my career to be training others to do the same.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

California’s efforts to expand access to abortion care are enabling more types of medical practitioners to perform certain abortion procedures — potentially a boon for patients in rural areas especially, but a source of concern for doctors’ groups that have long fought efforts to expand the role of non-physicians.

The latest move is a law that enables trained physician assistants, also known as physician associates, to perform first-trimester abortions without a supervising physician present. The measure, which passed last year and took effect Jan. 1, also lets PAs who have been disciplined or convicted solely for performing an abortion in a state where the practice is restricted apply for a license in California.

Physician assistants are now on par with nurse practitioners and certified nurse midwives trained in abortion care, who in 2022 won the ability to perform abortions without a doctor present.

The need for more abortion care practitioners is being driven by efforts in many states to gut abortion rights following the Supreme Court’s 2022 decision ending constitutional protection for the procedure. Thirty-one states have implemented abortion restrictions that range from cutting federal funding for abortion coverage to outright bans, according to the Guttmacher Institute, a research organization concerned with reproductive health.

With the new law, “there will be fewer barriers, and shorter wait times for this essential service,” said Jeremy Meis, president-elect of the California Academy of Physician Associates. While it is unclear how many of California’s 16,000 PAs will be trained in performing abortions, research shows that PAs are more likely than physicians to practice in rural areas where access to abortion is limited. More than 40% of counties in California lack clinics that provide abortion.

Comparing data from the first six months of 2020 with the same period in 2023, the number of abortions jumped from 77,030 to 92,600 a 20% increase as the state became a refuge for women seeking abortions. California has passed a suite of reproductive health laws to build in protections and increase access, and a dozen other states, including Oregon, Minnesota, and New York, have mounted similar efforts. Seventeen states, including California, now allow PAs to perform first-trimester abortions, according to the American Academy of Physician Associates.

There was little opposition to the new California law, with two physicians’ groups supporting it. But the American Medical Association, the country’s most powerful doctors’ lobby, has fought vigorously against what it calls “scope creep” — that is, changes that allow clinicians like PAs to do medical procedures independent of physicians.

“Our policy stance is the same on scope of practice expansion regardless of procedure,” noted Kelly Jakubek, the AMA’s media relations manager. The AMA’s website points to legislative victories in 2023, including striking down “legislation allowing physician assistants to practice independently without physician oversight,” in states including Arizona and New York. The AMA did not take a formal position on the California legislation. Its local chapter, the California Medical Association, took a neutral position on the legislation.

In preparation for the new law, one physician assistant at Planned Parenthood Pasadena & San Gabriel Valley began learning how to perform aspiration abortions — a procedure also known as dilation and curettage that uses gentle suction to end a pregnancy — at the end of last year. The PA, who requested anonymity due to concerns about safety, said that with abortion restrictions in place around the country, “I just think it’s really important to be able to provide a comfortable, safe, and very effective way to terminate a pregnancy for patients.”

She is now one of six PAs and midwives at her clinic who can offer aspiration abortions. To reach competency, she participated in 50 procedures and learned how to administer medication that eases pain and anxiety. Such conscious sedation, as it is known, is frequently used for first-trimester abortions. Now she, like any other advanced practice clinician who has obtained skills in performing abortions, can train her peers — another feature of the new law.

The length of time for training and the number of procedures to reach competency varies based on a practitioner’s previous experience.

“It’s encouraging this cross-profession training and collaborations, which is really important when we’re looking at increasing access to essential services,” said Jessica Dieseldorff, senior program manager of abortion services at Planned Parenthood Mar Monte in Santa Cruz.

In December, California committed $18 million to help accelerate training in abortion and reproductive care for practitioners, including PAs, through the Reproductive Health Care Access Initiative.

Dieseldorff, a nurse practitioner who trains other advanced-practice clinicians in abortion care, said that rural communities, in particular, will reap the benefits since many rely solely on physician assistants and other allied clinicians.

Reflecting on her career, she said much has changed since she became a nurse 25 years ago. At that time, she worked only as support staff to doctors providing abortions.

“When I began, medication abortions did not exist in this country,” she said, referring to the practice of using two drugs often prescribed to induce abortions. “It’s been gratifying to be able to progress and become a provider myself, provide non-stigmatizing and compassionate and safe care to patients; and now, at this stage in my career to be training others to do the same.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

California’s efforts to expand access to abortion care are enabling more types of medical practitioners to perform certain abortion procedures — potentially a boon for patients in rural areas especially, but a source of concern for doctors’ groups that have long fought efforts to expand the role of non-physicians.

The latest move is a law that enables trained physician assistants, also known as physician associates, to perform first-trimester abortions without a supervising physician present. The measure, which passed last year and took effect Jan. 1, also lets PAs who have been disciplined or convicted solely for performing an abortion in a state where the practice is restricted apply for a license in California.

Physician assistants are now on par with nurse practitioners and certified nurse midwives trained in abortion care, who in 2022 won the ability to perform abortions without a doctor present.

The need for more abortion care practitioners is being driven by efforts in many states to gut abortion rights following the Supreme Court’s 2022 decision ending constitutional protection for the procedure. Thirty-one states have implemented abortion restrictions that range from cutting federal funding for abortion coverage to outright bans, according to the Guttmacher Institute, a research organization concerned with reproductive health.

With the new law, “there will be fewer barriers, and shorter wait times for this essential service,” said Jeremy Meis, president-elect of the California Academy of Physician Associates. While it is unclear how many of California’s 16,000 PAs will be trained in performing abortions, research shows that PAs are more likely than physicians to practice in rural areas where access to abortion is limited. More than 40% of counties in California lack clinics that provide abortion.

Comparing data from the first six months of 2020 with the same period in 2023, the number of abortions jumped from 77,030 to 92,600 a 20% increase as the state became a refuge for women seeking abortions. California has passed a suite of reproductive health laws to build in protections and increase access, and a dozen other states, including Oregon, Minnesota, and New York, have mounted similar efforts. Seventeen states, including California, now allow PAs to perform first-trimester abortions, according to the American Academy of Physician Associates.

There was little opposition to the new California law, with two physicians’ groups supporting it. But the American Medical Association, the country’s most powerful doctors’ lobby, has fought vigorously against what it calls “scope creep” — that is, changes that allow clinicians like PAs to do medical procedures independent of physicians.

“Our policy stance is the same on scope of practice expansion regardless of procedure,” noted Kelly Jakubek, the AMA’s media relations manager. The AMA’s website points to legislative victories in 2023, including striking down “legislation allowing physician assistants to practice independently without physician oversight,” in states including Arizona and New York. The AMA did not take a formal position on the California legislation. Its local chapter, the California Medical Association, took a neutral position on the legislation.

In preparation for the new law, one physician assistant at Planned Parenthood Pasadena & San Gabriel Valley began learning how to perform aspiration abortions — a procedure also known as dilation and curettage that uses gentle suction to end a pregnancy — at the end of last year. The PA, who requested anonymity due to concerns about safety, said that with abortion restrictions in place around the country, “I just think it’s really important to be able to provide a comfortable, safe, and very effective way to terminate a pregnancy for patients.”

She is now one of six PAs and midwives at her clinic who can offer aspiration abortions. To reach competency, she participated in 50 procedures and learned how to administer medication that eases pain and anxiety. Such conscious sedation, as it is known, is frequently used for first-trimester abortions. Now she, like any other advanced practice clinician who has obtained skills in performing abortions, can train her peers — another feature of the new law.

The length of time for training and the number of procedures to reach competency varies based on a practitioner’s previous experience.

“It’s encouraging this cross-profession training and collaborations, which is really important when we’re looking at increasing access to essential services,” said Jessica Dieseldorff, senior program manager of abortion services at Planned Parenthood Mar Monte in Santa Cruz.

In December, California committed $18 million to help accelerate training in abortion and reproductive care for practitioners, including PAs, through the Reproductive Health Care Access Initiative.

Dieseldorff, a nurse practitioner who trains other advanced-practice clinicians in abortion care, said that rural communities, in particular, will reap the benefits since many rely solely on physician assistants and other allied clinicians.

Reflecting on her career, she said much has changed since she became a nurse 25 years ago. At that time, she worked only as support staff to doctors providing abortions.

“When I began, medication abortions did not exist in this country,” she said, referring to the practice of using two drugs often prescribed to induce abortions. “It’s been gratifying to be able to progress and become a provider myself, provide non-stigmatizing and compassionate and safe care to patients; and now, at this stage in my career to be training others to do the same.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline postexposure prophylaxis (doxy-PEP), according to data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this week.

After a clinical trial showed that doxy-PEP taken after sex reduced the chance of acquiring syphilis, gonorrhea, and chlamydia by about two-thirds, the San Francisco Department of Public Health released the first guidelines in the country in October 2022. 

The guidelines recommend that a person take two 100-mg pills of doxycycline ideally in the 24 hours after but no more than 72 hours after condomless sex. So far, more than 3700 people in San Francisco have been prescribed doxy-PEP, reports Stephanie Cohen, MD, director of HIV and sexually transmitted infection (STI) prevention in the Disease Prevention and Control Branch of Public Health.

Dr. Cohen and her colleagues spent a year monitoring the uptake of doxy-PEP and used a computer model to predict what the rates of sexually transmitted infection would have been without doxy-PEP. 

In November 2023, 13 months after the guidelines were introduced, they found that monthly chlamydia and early syphilis infections were 50% and 51% lower, respectively, than what was predicted by the model.
 

Fewer Infections

The drop in infections is having a tangible effect on patients in San Francisco, and many clinicians are noting that they are seeing far fewer positive tests. “The results that we’re seeing on a city-wide level are absolutely being experienced by individual providers and patients,” Dr. Cohen said.

However, the analysis showed no effect on rates of gonorrhea. It’s not clear why, although Dr. Cohen points out that doxy-PEP was less effective against gonorrhea in the clinical trial. And “there could be other factors in play,” she added. “Adherence might matter more, or it could be affected by the prevalence of tetracycline resistance in the community.”

With rates of STIs, particularly syphilis, quickly rising in recent years, healthcare providers have been scrambling to find effective interventions. So far, doxy-PEP has shown the most promise. “We’ve known for a while that all of the strategies we’ve been employing don’t seem to be working,” noted Chase Cannon, MD, an infectious disease specialist at the University of Washington in Seattle. “That’s why doxy-PEP is important. We haven’t had anything that can deflect the curve in a long time.”
 

What About the Side Effects?

Some concerns remain, however, about the widespread prophylactic use of antibiotics. There are no long-term safety data on the potential side effects of doxy-PEP, and there is still a lot of stigma around interventions that allow people to have sex the way they want, said Dr. Cannon.

But perhaps, the biggest concern is that doxy-PEP could contribute to antibiotic resistance. Those fears are not misplaced, Dr. Cannon added. The results of one study, presented in a poster at CROI, showed that stool samples from people prescribed doxy-PEP had elevated levels of bacterial genes that can confer resistance to tetracyclines, the class of antibiotics to which doxycycline belongs. There was no change in resistance to other classes of antibiotics and no difference in bacterial diversity over the 6 months of the study.

Dr. Cannon cautioned, however, that we can’t extrapolate these results to clinical outcomes. “We can look for signals [of resistance], but we don’t know if this means someone will fail therapy for chlamydia or syphilis,” he said.

There are still many challenges to overcome before doxy-PEP can be rolled out widely, Dr. Cohen explained. There is a lack of consensus among healthcare professionals about who should be offered doxy-PEP. The clinical trial results and the San Fransisco guidelines only apply to men who have sex with men and to transgender women.

Some clinicians argue that the intervention should be provided to a broader population, whereas others want to see more research to ensure that unnecessary antibiotic use is minimized.

So far just one study has tested doxy-PEP in another population — in women in Kenya — and it was found to not be effective. But the data suggest that adherence to the protocol was poor in that study, so the results may not be reliable, Dr. Cohen said.

“We need effective prevention tools for all genders, especially cis women who bear most of the morbidity,” she said. “It stands to reason that this should work for them, but without high-quality evidence, there is insufficient information to make a recommendation for cis women.”

The US Centers for Disease Control and Prevention is currently reviewing public and expert comments and refining final guidelines for release in the coming months, which should alleviate some of the uncertainty. “Many providers are waiting for that guidance before they will feel confident moving forward,” Dr. Cohen noted.

But despite the risks and uncertainty, doxy-PEP looks set to be a major part of the fight against STIs going forward. “Doxy-PEP is essential for us as a nation to be dealing with the syphilis epidemic,” Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, said in a video introduction to CROI.

A version of this article appeared on Medscape.com.

Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline postexposure prophylaxis (doxy-PEP), according to data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this week.

After a clinical trial showed that doxy-PEP taken after sex reduced the chance of acquiring syphilis, gonorrhea, and chlamydia by about two-thirds, the San Francisco Department of Public Health released the first guidelines in the country in October 2022. 

The guidelines recommend that a person take two 100-mg pills of doxycycline ideally in the 24 hours after but no more than 72 hours after condomless sex. So far, more than 3700 people in San Francisco have been prescribed doxy-PEP, reports Stephanie Cohen, MD, director of HIV and sexually transmitted infection (STI) prevention in the Disease Prevention and Control Branch of Public Health.

Dr. Cohen and her colleagues spent a year monitoring the uptake of doxy-PEP and used a computer model to predict what the rates of sexually transmitted infection would have been without doxy-PEP. 

In November 2023, 13 months after the guidelines were introduced, they found that monthly chlamydia and early syphilis infections were 50% and 51% lower, respectively, than what was predicted by the model.
 

Fewer Infections

The drop in infections is having a tangible effect on patients in San Francisco, and many clinicians are noting that they are seeing far fewer positive tests. “The results that we’re seeing on a city-wide level are absolutely being experienced by individual providers and patients,” Dr. Cohen said.

However, the analysis showed no effect on rates of gonorrhea. It’s not clear why, although Dr. Cohen points out that doxy-PEP was less effective against gonorrhea in the clinical trial. And “there could be other factors in play,” she added. “Adherence might matter more, or it could be affected by the prevalence of tetracycline resistance in the community.”

With rates of STIs, particularly syphilis, quickly rising in recent years, healthcare providers have been scrambling to find effective interventions. So far, doxy-PEP has shown the most promise. “We’ve known for a while that all of the strategies we’ve been employing don’t seem to be working,” noted Chase Cannon, MD, an infectious disease specialist at the University of Washington in Seattle. “That’s why doxy-PEP is important. We haven’t had anything that can deflect the curve in a long time.”
 

What About the Side Effects?

Some concerns remain, however, about the widespread prophylactic use of antibiotics. There are no long-term safety data on the potential side effects of doxy-PEP, and there is still a lot of stigma around interventions that allow people to have sex the way they want, said Dr. Cannon.

But perhaps, the biggest concern is that doxy-PEP could contribute to antibiotic resistance. Those fears are not misplaced, Dr. Cannon added. The results of one study, presented in a poster at CROI, showed that stool samples from people prescribed doxy-PEP had elevated levels of bacterial genes that can confer resistance to tetracyclines, the class of antibiotics to which doxycycline belongs. There was no change in resistance to other classes of antibiotics and no difference in bacterial diversity over the 6 months of the study.

Dr. Cannon cautioned, however, that we can’t extrapolate these results to clinical outcomes. “We can look for signals [of resistance], but we don’t know if this means someone will fail therapy for chlamydia or syphilis,” he said.

There are still many challenges to overcome before doxy-PEP can be rolled out widely, Dr. Cohen explained. There is a lack of consensus among healthcare professionals about who should be offered doxy-PEP. The clinical trial results and the San Fransisco guidelines only apply to men who have sex with men and to transgender women.

Some clinicians argue that the intervention should be provided to a broader population, whereas others want to see more research to ensure that unnecessary antibiotic use is minimized.

So far just one study has tested doxy-PEP in another population — in women in Kenya — and it was found to not be effective. But the data suggest that adherence to the protocol was poor in that study, so the results may not be reliable, Dr. Cohen said.

“We need effective prevention tools for all genders, especially cis women who bear most of the morbidity,” she said. “It stands to reason that this should work for them, but without high-quality evidence, there is insufficient information to make a recommendation for cis women.”

The US Centers for Disease Control and Prevention is currently reviewing public and expert comments and refining final guidelines for release in the coming months, which should alleviate some of the uncertainty. “Many providers are waiting for that guidance before they will feel confident moving forward,” Dr. Cohen noted.

But despite the risks and uncertainty, doxy-PEP looks set to be a major part of the fight against STIs going forward. “Doxy-PEP is essential for us as a nation to be dealing with the syphilis epidemic,” Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, said in a video introduction to CROI.

A version of this article appeared on Medscape.com.

Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline postexposure prophylaxis (doxy-PEP), according to data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this week.

After a clinical trial showed that doxy-PEP taken after sex reduced the chance of acquiring syphilis, gonorrhea, and chlamydia by about two-thirds, the San Francisco Department of Public Health released the first guidelines in the country in October 2022. 

The guidelines recommend that a person take two 100-mg pills of doxycycline ideally in the 24 hours after but no more than 72 hours after condomless sex. So far, more than 3700 people in San Francisco have been prescribed doxy-PEP, reports Stephanie Cohen, MD, director of HIV and sexually transmitted infection (STI) prevention in the Disease Prevention and Control Branch of Public Health.

Dr. Cohen and her colleagues spent a year monitoring the uptake of doxy-PEP and used a computer model to predict what the rates of sexually transmitted infection would have been without doxy-PEP. 

In November 2023, 13 months after the guidelines were introduced, they found that monthly chlamydia and early syphilis infections were 50% and 51% lower, respectively, than what was predicted by the model.
 

Fewer Infections

The drop in infections is having a tangible effect on patients in San Francisco, and many clinicians are noting that they are seeing far fewer positive tests. “The results that we’re seeing on a city-wide level are absolutely being experienced by individual providers and patients,” Dr. Cohen said.

However, the analysis showed no effect on rates of gonorrhea. It’s not clear why, although Dr. Cohen points out that doxy-PEP was less effective against gonorrhea in the clinical trial. And “there could be other factors in play,” she added. “Adherence might matter more, or it could be affected by the prevalence of tetracycline resistance in the community.”

With rates of STIs, particularly syphilis, quickly rising in recent years, healthcare providers have been scrambling to find effective interventions. So far, doxy-PEP has shown the most promise. “We’ve known for a while that all of the strategies we’ve been employing don’t seem to be working,” noted Chase Cannon, MD, an infectious disease specialist at the University of Washington in Seattle. “That’s why doxy-PEP is important. We haven’t had anything that can deflect the curve in a long time.”
 

What About the Side Effects?

Some concerns remain, however, about the widespread prophylactic use of antibiotics. There are no long-term safety data on the potential side effects of doxy-PEP, and there is still a lot of stigma around interventions that allow people to have sex the way they want, said Dr. Cannon.

But perhaps, the biggest concern is that doxy-PEP could contribute to antibiotic resistance. Those fears are not misplaced, Dr. Cannon added. The results of one study, presented in a poster at CROI, showed that stool samples from people prescribed doxy-PEP had elevated levels of bacterial genes that can confer resistance to tetracyclines, the class of antibiotics to which doxycycline belongs. There was no change in resistance to other classes of antibiotics and no difference in bacterial diversity over the 6 months of the study.

Dr. Cannon cautioned, however, that we can’t extrapolate these results to clinical outcomes. “We can look for signals [of resistance], but we don’t know if this means someone will fail therapy for chlamydia or syphilis,” he said.

There are still many challenges to overcome before doxy-PEP can be rolled out widely, Dr. Cohen explained. There is a lack of consensus among healthcare professionals about who should be offered doxy-PEP. The clinical trial results and the San Fransisco guidelines only apply to men who have sex with men and to transgender women.

Some clinicians argue that the intervention should be provided to a broader population, whereas others want to see more research to ensure that unnecessary antibiotic use is minimized.

So far just one study has tested doxy-PEP in another population — in women in Kenya — and it was found to not be effective. But the data suggest that adherence to the protocol was poor in that study, so the results may not be reliable, Dr. Cohen said.

“We need effective prevention tools for all genders, especially cis women who bear most of the morbidity,” she said. “It stands to reason that this should work for them, but without high-quality evidence, there is insufficient information to make a recommendation for cis women.”

The US Centers for Disease Control and Prevention is currently reviewing public and expert comments and refining final guidelines for release in the coming months, which should alleviate some of the uncertainty. “Many providers are waiting for that guidance before they will feel confident moving forward,” Dr. Cohen noted.

But despite the risks and uncertainty, doxy-PEP looks set to be a major part of the fight against STIs going forward. “Doxy-PEP is essential for us as a nation to be dealing with the syphilis epidemic,” Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, said in a video introduction to CROI.

A version of this article appeared on Medscape.com.

Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.

Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
 

What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?

Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).

“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.

In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.

In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.

Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
 

What Does the New Study Add?

The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.

“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.

“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.

The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.

Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.

Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.

The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
 

What Drives the Risk?

Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.

The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
 

What Are the Limitations?

The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.

What Do Oncologists Need to Know About the Study?

The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.

“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.

“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
 

What Are the Next Steps for Research?

“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.

The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.

Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.

Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
 

What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?

Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).

“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.

In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.

In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.

Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
 

What Does the New Study Add?

The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.

“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.

“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.

The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.

Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.

Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.

The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
 

What Drives the Risk?

Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.

The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
 

What Are the Limitations?

The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.

What Do Oncologists Need to Know About the Study?

The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.

“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.

“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
 

What Are the Next Steps for Research?

“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.

The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.

Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.

Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
 

What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?

Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).

“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.

In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.

In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.

Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
 

What Does the New Study Add?

The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.

“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.

“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.

The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.

Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.

Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.

The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
 

What Drives the Risk?

Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.

The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
 

What Are the Limitations?

The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.

What Do Oncologists Need to Know About the Study?

The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.

“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.

“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
 

What Are the Next Steps for Research?

“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.

The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.