Exciting advances in HR-positive breast cancer: Top five picks from SABCS

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SAN ANTONIO – A wide range of research on hormone receptor (HR)–positive breast cancer was presented at the San Antonio Breast Cancer Symposium.

This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Jason A. Mouabbi, MD, of the University of Texas MD Anderson Cancer Center, Houston, about their top five picks on HR-positive disease – the research they were most excited about and what the findings could mean for clinical practice and patient outcomes.
 

1. Addressing an unmet need

Data from the phase 3 CAPItello-291 clinical trial showed that the addition of the investigational AKT inhibitor capivasertib to fulvestrant resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) among 708 patients with HR-positive, HER2-negative advanced breast cancer, compared with those who received placebo plus fulvestrant (GS3-04).

For patients treated with capivasertib plus fulvestrant, median PFS was 7.2 months, compared with 3.6 months for those who received placebo plus fulvestrant (hazard ratio, 0.60). Among patients assigned to the capivasertib group, 41% had tumors with AKT pathway mutations. In this group, the median PFS was 7.3 months vs. 3.1 months in the placebo cohort. The objective response rate among patients with measurable disease was 23% overall in the capivasertib group, compared with 12.2% in the placebo arm; it was 28.8% vs. 9.7% among the patients with AKT alterations.

Dr. Mouabbi noted that the study “met its primary endpoint” and that, importantly, it “addresses an area of unmet need.”

“The study’s treatment targets the PI3K/AKT/mTOR pathway, which is a very active pathway in hormone-positive metastatic breast cancer,” Dr. Mouabbi explained. He noted, “We’ve always wanted to tackle that pathway effectively, and it looks like this drug can do that.”
 

2. Next-generation SERD

Data from the phase 2 SERENA-2 trial offers evidence that camizestrant, a next-generation selective estrogen-receptor degrader (SERD), improved PFS compared with fulvestrant for patients with HR-positive, HER2-negative breast cancer (GS3-02).

Overall, 240 patients were randomly assigned to receive camizestrant monotherapy at various doses or fulvestrant at 500 mg. Among patients who received camizestrant 75 mg, median PFS was 7.2 months; among those who received camizestrant 150 mg, PFS was slightly longer, at 7.7 months vs. 3.7 months for patients treated with fulvestrant. Compared with fulvestrant, camizestrant reduced the risk of disease progression by 42% at 75 mg (HR, 0.58) and by 33% at 150 mg (HR, 0.67). In a subgroup of patients with ESR1 mutations, camizestrant reduced the risk of disease progression by 67% in the group that received 75 mg and by 45% in the group that received 150 mg, compared with fulvestrant (median PFS, 6.3, 9.2, and 2.2 months, respectively).

“In this trial, camizestrant looks like a more beneficial treatment in the target group,” said Dr. Kaklamani. “This is significant because it means that camizestrant could be used in the future in HR-positive metastatic breast cancer instead of fulvestrant.” In addition, “camizestrant is taken orally and is much more convenient for patients, unlike fulvestrant, which is taken intramuscularly.”
 

 

 

3. Pregnancy risks

Can endocrine therapy be safely interrupted for women with breast cancer who wish to become pregnant? That’s what researchers tried to glean in a recent prospective trial presented at the meeting (GS4-09).

The study enrolled over 500 women for whom endocrine therapy had been stopped in the hopes of their becoming pregnant. Almost all (93.4%) had stage I/II HR-positive breast cancer. The primary objective was to determine the risk of breast cancer relapse associated with interrupting therapy for about 2 years. The authors defined no more than 46 breast cancer–free interval (BCFI) events as the safety threshold. A BCFI event was defined as local, regional, or distant recurrence or a new invasive contralateral breast cancer.

Among 497 women, 368 (74%) had at least one pregnancy and 317 (64%) had at least one live birth, for a total of 365 babies born. At a median follow-up of 41 months, 44 participants experienced a BCFI event, in line with the safety threshold. The 3-year BCFI failure rate was 8.9%, similar to the 9.2% rate in an external control cohort from the SOFT/TEXT trials. In addition, 76.3% of patients resumed endocrine therapy; 15.4% had not yet resumed therapy.

“This trial is more confirmatory but an extremely important step for young women who want to get pregnant after diagnosis and recovery from HR-positive breast cancer,” Dr. Kaklamani said. “It seems that stopping endocrine therapy to become pregnant did not cause any adverse outcomes or increase the risk of reoccurrence of cancer in the women in the study.”

Dr. Mouabbi agreed, noting, “Many of our patients are afraid that they will miss the window to get pregnant because they have to be on treatment for so long. This is the first study that let us know pregnancy and safety outcomes in patients who took a break from endocrine therapy to get pregnant. The results are promising and will be exciting for many of our patients.”
 

4. Assay identifies OFS benefit

A genomic assay was able to distinguish premenopausal patients with early-stage HR-positive breast cancer who benefited from the addition of ovarian function suppression (OFS) to adjuvant endocrine therapy, according to new data presented at the meeting (GS1-06).

In the study, investigators analyzed 1,717 patient tumor samples from the landmark Suppression of Ovarian Function Trial (SOFT) trial. The Breast Cancer Index identified 58% of women who benefited from the addition of ovarian function suppression to tamoxifen or exemestane therapy. They experienced an absolute benefit of 11.6% (42% did not benefit), compared with those with received tamoxifen alone. The predictive benefit was observed regardless of age, lymph node involvement, and receipt of chemotherapy.

Dr. Kaklamani highlighted this study’s importance, saying, “Ovarian suppression is associated with severe adverse events for patients. Obviously, the women who will get a benefit should continue, but this research is important because it will hopefully show us who to recommend ovarian suppression to while not exposing patients who are likely to get little benefit to unneeded toxicity.”
 

 

 

5. Optimizing elacestrant PFS

Last year, data from the Emerald trial showed that elacestrant is superior to standard-of-care therapy for HR-positive metastatic breast cancer. An update that Dr. Kaklamani presented at SABCS (GS3-01) explored whether the duration of a prior CDK4/6 inhibitor affects PFS.

The study was a randomized, open-label, phase 3 trial in which 478 patients with ER-positive/HER2-negative metastatic breast cancer received either elacestrant or standard of care. These patients had previously received one or two lines of endocrine therapy, a CDK4/6 inhibitor, and ≤ 1 line of chemotherapy.

Overall, the duration of prior CDK4/6 inhibitor in the metastatic setting was positively associated with PFS – the longer the duration of prior CDK4/6 inhibitor therapy, the longer the PFS with elacestrant. PFS outcomes were even stronger among patients with ESR1 mutations.

“What we found was that the women who benefit most from elacestrant had previously received a CDK4/6 inhibitor for at least 6 months,” Dr. Kaklamani said. These data can help us determine who may do best on the drug, she added.

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

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SAN ANTONIO – A wide range of research on hormone receptor (HR)–positive breast cancer was presented at the San Antonio Breast Cancer Symposium.

This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Jason A. Mouabbi, MD, of the University of Texas MD Anderson Cancer Center, Houston, about their top five picks on HR-positive disease – the research they were most excited about and what the findings could mean for clinical practice and patient outcomes.
 

1. Addressing an unmet need

Data from the phase 3 CAPItello-291 clinical trial showed that the addition of the investigational AKT inhibitor capivasertib to fulvestrant resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) among 708 patients with HR-positive, HER2-negative advanced breast cancer, compared with those who received placebo plus fulvestrant (GS3-04).

For patients treated with capivasertib plus fulvestrant, median PFS was 7.2 months, compared with 3.6 months for those who received placebo plus fulvestrant (hazard ratio, 0.60). Among patients assigned to the capivasertib group, 41% had tumors with AKT pathway mutations. In this group, the median PFS was 7.3 months vs. 3.1 months in the placebo cohort. The objective response rate among patients with measurable disease was 23% overall in the capivasertib group, compared with 12.2% in the placebo arm; it was 28.8% vs. 9.7% among the patients with AKT alterations.

Dr. Mouabbi noted that the study “met its primary endpoint” and that, importantly, it “addresses an area of unmet need.”

“The study’s treatment targets the PI3K/AKT/mTOR pathway, which is a very active pathway in hormone-positive metastatic breast cancer,” Dr. Mouabbi explained. He noted, “We’ve always wanted to tackle that pathway effectively, and it looks like this drug can do that.”
 

2. Next-generation SERD

Data from the phase 2 SERENA-2 trial offers evidence that camizestrant, a next-generation selective estrogen-receptor degrader (SERD), improved PFS compared with fulvestrant for patients with HR-positive, HER2-negative breast cancer (GS3-02).

Overall, 240 patients were randomly assigned to receive camizestrant monotherapy at various doses or fulvestrant at 500 mg. Among patients who received camizestrant 75 mg, median PFS was 7.2 months; among those who received camizestrant 150 mg, PFS was slightly longer, at 7.7 months vs. 3.7 months for patients treated with fulvestrant. Compared with fulvestrant, camizestrant reduced the risk of disease progression by 42% at 75 mg (HR, 0.58) and by 33% at 150 mg (HR, 0.67). In a subgroup of patients with ESR1 mutations, camizestrant reduced the risk of disease progression by 67% in the group that received 75 mg and by 45% in the group that received 150 mg, compared with fulvestrant (median PFS, 6.3, 9.2, and 2.2 months, respectively).

“In this trial, camizestrant looks like a more beneficial treatment in the target group,” said Dr. Kaklamani. “This is significant because it means that camizestrant could be used in the future in HR-positive metastatic breast cancer instead of fulvestrant.” In addition, “camizestrant is taken orally and is much more convenient for patients, unlike fulvestrant, which is taken intramuscularly.”
 

 

 

3. Pregnancy risks

Can endocrine therapy be safely interrupted for women with breast cancer who wish to become pregnant? That’s what researchers tried to glean in a recent prospective trial presented at the meeting (GS4-09).

The study enrolled over 500 women for whom endocrine therapy had been stopped in the hopes of their becoming pregnant. Almost all (93.4%) had stage I/II HR-positive breast cancer. The primary objective was to determine the risk of breast cancer relapse associated with interrupting therapy for about 2 years. The authors defined no more than 46 breast cancer–free interval (BCFI) events as the safety threshold. A BCFI event was defined as local, regional, or distant recurrence or a new invasive contralateral breast cancer.

Among 497 women, 368 (74%) had at least one pregnancy and 317 (64%) had at least one live birth, for a total of 365 babies born. At a median follow-up of 41 months, 44 participants experienced a BCFI event, in line with the safety threshold. The 3-year BCFI failure rate was 8.9%, similar to the 9.2% rate in an external control cohort from the SOFT/TEXT trials. In addition, 76.3% of patients resumed endocrine therapy; 15.4% had not yet resumed therapy.

“This trial is more confirmatory but an extremely important step for young women who want to get pregnant after diagnosis and recovery from HR-positive breast cancer,” Dr. Kaklamani said. “It seems that stopping endocrine therapy to become pregnant did not cause any adverse outcomes or increase the risk of reoccurrence of cancer in the women in the study.”

Dr. Mouabbi agreed, noting, “Many of our patients are afraid that they will miss the window to get pregnant because they have to be on treatment for so long. This is the first study that let us know pregnancy and safety outcomes in patients who took a break from endocrine therapy to get pregnant. The results are promising and will be exciting for many of our patients.”
 

4. Assay identifies OFS benefit

A genomic assay was able to distinguish premenopausal patients with early-stage HR-positive breast cancer who benefited from the addition of ovarian function suppression (OFS) to adjuvant endocrine therapy, according to new data presented at the meeting (GS1-06).

In the study, investigators analyzed 1,717 patient tumor samples from the landmark Suppression of Ovarian Function Trial (SOFT) trial. The Breast Cancer Index identified 58% of women who benefited from the addition of ovarian function suppression to tamoxifen or exemestane therapy. They experienced an absolute benefit of 11.6% (42% did not benefit), compared with those with received tamoxifen alone. The predictive benefit was observed regardless of age, lymph node involvement, and receipt of chemotherapy.

Dr. Kaklamani highlighted this study’s importance, saying, “Ovarian suppression is associated with severe adverse events for patients. Obviously, the women who will get a benefit should continue, but this research is important because it will hopefully show us who to recommend ovarian suppression to while not exposing patients who are likely to get little benefit to unneeded toxicity.”
 

 

 

5. Optimizing elacestrant PFS

Last year, data from the Emerald trial showed that elacestrant is superior to standard-of-care therapy for HR-positive metastatic breast cancer. An update that Dr. Kaklamani presented at SABCS (GS3-01) explored whether the duration of a prior CDK4/6 inhibitor affects PFS.

The study was a randomized, open-label, phase 3 trial in which 478 patients with ER-positive/HER2-negative metastatic breast cancer received either elacestrant or standard of care. These patients had previously received one or two lines of endocrine therapy, a CDK4/6 inhibitor, and ≤ 1 line of chemotherapy.

Overall, the duration of prior CDK4/6 inhibitor in the metastatic setting was positively associated with PFS – the longer the duration of prior CDK4/6 inhibitor therapy, the longer the PFS with elacestrant. PFS outcomes were even stronger among patients with ESR1 mutations.

“What we found was that the women who benefit most from elacestrant had previously received a CDK4/6 inhibitor for at least 6 months,” Dr. Kaklamani said. These data can help us determine who may do best on the drug, she added.

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

SAN ANTONIO – A wide range of research on hormone receptor (HR)–positive breast cancer was presented at the San Antonio Breast Cancer Symposium.

This news organization spoke with SABCS program director Virginia Kaklamani, MD, leader of the Breast Cancer Program at UT Health, San Antonio, and Jason A. Mouabbi, MD, of the University of Texas MD Anderson Cancer Center, Houston, about their top five picks on HR-positive disease – the research they were most excited about and what the findings could mean for clinical practice and patient outcomes.
 

1. Addressing an unmet need

Data from the phase 3 CAPItello-291 clinical trial showed that the addition of the investigational AKT inhibitor capivasertib to fulvestrant resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) among 708 patients with HR-positive, HER2-negative advanced breast cancer, compared with those who received placebo plus fulvestrant (GS3-04).

For patients treated with capivasertib plus fulvestrant, median PFS was 7.2 months, compared with 3.6 months for those who received placebo plus fulvestrant (hazard ratio, 0.60). Among patients assigned to the capivasertib group, 41% had tumors with AKT pathway mutations. In this group, the median PFS was 7.3 months vs. 3.1 months in the placebo cohort. The objective response rate among patients with measurable disease was 23% overall in the capivasertib group, compared with 12.2% in the placebo arm; it was 28.8% vs. 9.7% among the patients with AKT alterations.

Dr. Mouabbi noted that the study “met its primary endpoint” and that, importantly, it “addresses an area of unmet need.”

“The study’s treatment targets the PI3K/AKT/mTOR pathway, which is a very active pathway in hormone-positive metastatic breast cancer,” Dr. Mouabbi explained. He noted, “We’ve always wanted to tackle that pathway effectively, and it looks like this drug can do that.”
 

2. Next-generation SERD

Data from the phase 2 SERENA-2 trial offers evidence that camizestrant, a next-generation selective estrogen-receptor degrader (SERD), improved PFS compared with fulvestrant for patients with HR-positive, HER2-negative breast cancer (GS3-02).

Overall, 240 patients were randomly assigned to receive camizestrant monotherapy at various doses or fulvestrant at 500 mg. Among patients who received camizestrant 75 mg, median PFS was 7.2 months; among those who received camizestrant 150 mg, PFS was slightly longer, at 7.7 months vs. 3.7 months for patients treated with fulvestrant. Compared with fulvestrant, camizestrant reduced the risk of disease progression by 42% at 75 mg (HR, 0.58) and by 33% at 150 mg (HR, 0.67). In a subgroup of patients with ESR1 mutations, camizestrant reduced the risk of disease progression by 67% in the group that received 75 mg and by 45% in the group that received 150 mg, compared with fulvestrant (median PFS, 6.3, 9.2, and 2.2 months, respectively).

“In this trial, camizestrant looks like a more beneficial treatment in the target group,” said Dr. Kaklamani. “This is significant because it means that camizestrant could be used in the future in HR-positive metastatic breast cancer instead of fulvestrant.” In addition, “camizestrant is taken orally and is much more convenient for patients, unlike fulvestrant, which is taken intramuscularly.”
 

 

 

3. Pregnancy risks

Can endocrine therapy be safely interrupted for women with breast cancer who wish to become pregnant? That’s what researchers tried to glean in a recent prospective trial presented at the meeting (GS4-09).

The study enrolled over 500 women for whom endocrine therapy had been stopped in the hopes of their becoming pregnant. Almost all (93.4%) had stage I/II HR-positive breast cancer. The primary objective was to determine the risk of breast cancer relapse associated with interrupting therapy for about 2 years. The authors defined no more than 46 breast cancer–free interval (BCFI) events as the safety threshold. A BCFI event was defined as local, regional, or distant recurrence or a new invasive contralateral breast cancer.

Among 497 women, 368 (74%) had at least one pregnancy and 317 (64%) had at least one live birth, for a total of 365 babies born. At a median follow-up of 41 months, 44 participants experienced a BCFI event, in line with the safety threshold. The 3-year BCFI failure rate was 8.9%, similar to the 9.2% rate in an external control cohort from the SOFT/TEXT trials. In addition, 76.3% of patients resumed endocrine therapy; 15.4% had not yet resumed therapy.

“This trial is more confirmatory but an extremely important step for young women who want to get pregnant after diagnosis and recovery from HR-positive breast cancer,” Dr. Kaklamani said. “It seems that stopping endocrine therapy to become pregnant did not cause any adverse outcomes or increase the risk of reoccurrence of cancer in the women in the study.”

Dr. Mouabbi agreed, noting, “Many of our patients are afraid that they will miss the window to get pregnant because they have to be on treatment for so long. This is the first study that let us know pregnancy and safety outcomes in patients who took a break from endocrine therapy to get pregnant. The results are promising and will be exciting for many of our patients.”
 

4. Assay identifies OFS benefit

A genomic assay was able to distinguish premenopausal patients with early-stage HR-positive breast cancer who benefited from the addition of ovarian function suppression (OFS) to adjuvant endocrine therapy, according to new data presented at the meeting (GS1-06).

In the study, investigators analyzed 1,717 patient tumor samples from the landmark Suppression of Ovarian Function Trial (SOFT) trial. The Breast Cancer Index identified 58% of women who benefited from the addition of ovarian function suppression to tamoxifen or exemestane therapy. They experienced an absolute benefit of 11.6% (42% did not benefit), compared with those with received tamoxifen alone. The predictive benefit was observed regardless of age, lymph node involvement, and receipt of chemotherapy.

Dr. Kaklamani highlighted this study’s importance, saying, “Ovarian suppression is associated with severe adverse events for patients. Obviously, the women who will get a benefit should continue, but this research is important because it will hopefully show us who to recommend ovarian suppression to while not exposing patients who are likely to get little benefit to unneeded toxicity.”
 

 

 

5. Optimizing elacestrant PFS

Last year, data from the Emerald trial showed that elacestrant is superior to standard-of-care therapy for HR-positive metastatic breast cancer. An update that Dr. Kaklamani presented at SABCS (GS3-01) explored whether the duration of a prior CDK4/6 inhibitor affects PFS.

The study was a randomized, open-label, phase 3 trial in which 478 patients with ER-positive/HER2-negative metastatic breast cancer received either elacestrant or standard of care. These patients had previously received one or two lines of endocrine therapy, a CDK4/6 inhibitor, and ≤ 1 line of chemotherapy.

Overall, the duration of prior CDK4/6 inhibitor in the metastatic setting was positively associated with PFS – the longer the duration of prior CDK4/6 inhibitor therapy, the longer the PFS with elacestrant. PFS outcomes were even stronger among patients with ESR1 mutations.

“What we found was that the women who benefit most from elacestrant had previously received a CDK4/6 inhibitor for at least 6 months,” Dr. Kaklamani said. These data can help us determine who may do best on the drug, she added.

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

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Medical degree program put on probation for ‘infrastructure’ issues

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Meharry Medical College, one of the oldest and largest historically Black academic health institutions in the United States, disclosed recently that its MD program had been placed on probationary status after a national accrediting agency’s onsite survey uncovered “infrastructure” problems earlier this year. Those include faculty shortages and inadequate student access to financial aid as well as to career and wellness counseling.

The inspection was conducted by the Liaison Committee on Medical Education (LCME), an accrediting body sponsored by the Association of American Medical Colleges and the American Medical Association.

While participation is voluntary, institutions must comply with 12 standards to maintain their standing. These include hiring qualified faculty and providing students with financial aid and debt management counseling.

Jeannette South-Paul, MD, Meharry’s senior vice president and chief academic officer, said in an interview that the degree program remains fully accredited despite the fact that LCME representatives found “notable areas of concern,” including the “need for some infrastructure updates and additional educational and financial resources for students.”

Specifically, students did not have sufficient access to advising services, broadband internet, and study spaces. In addition, faculty shortages caused delays in student evaluations, she said.

The new status does not affect the ability of students to complete their medical degrees or residency programs, she said. Dr. South-Paul added that school officials have begun addressing several of the issues and anticipate a swift resolution “guided by an aggressive action plan over the next 18-24 months.”

The university, located in Nashville, Tenn., has had accreditation problems before. In January, following a site visit and low scores on annual resident surveys, the Accreditation Council for Graduate Medical Education (ACGME) placed several of the schools’ residency and fellowship programs on probationary status.

At the time, school officials said that all programs would remain accredited, and they committed to expanding available resources, such as hiring additional staff and an independent expert to make program recommendations. A follow-up site visit was scheduled for August.

Regarding the most recent accreditation challenges, Veronica M. Catanese, MD, MBA, co-secretary of LCME, said the organization could only disclose the accreditation status of a medical school.

“LCME is not able to discuss any details concerning the accreditation of individual medical education programs, including the review process, resulting decisions, or survey results,” she said.

Established medical education programs typically undergo a self-study process and a full survey visit every 8 years. According to LCME’s website, a full survey visit may be conducted sooner if concerns arise about the program’s quality or sustainability.

The LCME program directory lists Meharry Medical College’s accreditation status as “full, on probation.” The next survey visit is scheduled for the 2023-2024 school year.

LCME accreditation is a prerequisite for having access to federal grants and programs, such as Title VII funding, which helps increase minority participation in health care careers. In addition, most state licensure boards and ACGME-affiliated residency programs require applicants to graduate from an LCME-accredited school.

Last year, when Meharry Medical College received pandemic aid money as part of the CARES Act, the school distributed nearly $10 million in scholarships to students – many of whom come from modest-income families and struggle to afford college tuition.

But in general, endowments to historically Black colleges and universities (HBCUs) are often at least 70% smaller than those made to non-HBCUs, which raises the question: Does the lack of funding make it more difficult for schools such as Meharry to maintain accreditation standards?

“Many different factors played into this finding by LCME,” said Dr. South-Paul. “It is a well-known fact that HBCUs have historically not been as well funded or possess the same size endowments as their mainstream academic peers. That is true of Meharry, but it would not be accurate to say this probation is because we are an HBCU.”

Similarly, Dr. Catanese said there is no evidence that HBCUs and non-HBCUs differ in their ability to meet LCME accreditation standards.

About half of the school’s residency and fellowship programs continue to have accreditation problems. According to ACGME’s database, the internal medicine program is currently on “continued accreditation with warning” status. The psychiatry and ob.gyn. programs are on “probationary accreditation” after receiving warnings in previous years.

Meharry was chartered in 1915 but was founded in 1876 as one of the first medical schools in the South for Black Americans.

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

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Meharry Medical College, one of the oldest and largest historically Black academic health institutions in the United States, disclosed recently that its MD program had been placed on probationary status after a national accrediting agency’s onsite survey uncovered “infrastructure” problems earlier this year. Those include faculty shortages and inadequate student access to financial aid as well as to career and wellness counseling.

The inspection was conducted by the Liaison Committee on Medical Education (LCME), an accrediting body sponsored by the Association of American Medical Colleges and the American Medical Association.

While participation is voluntary, institutions must comply with 12 standards to maintain their standing. These include hiring qualified faculty and providing students with financial aid and debt management counseling.

Jeannette South-Paul, MD, Meharry’s senior vice president and chief academic officer, said in an interview that the degree program remains fully accredited despite the fact that LCME representatives found “notable areas of concern,” including the “need for some infrastructure updates and additional educational and financial resources for students.”

Specifically, students did not have sufficient access to advising services, broadband internet, and study spaces. In addition, faculty shortages caused delays in student evaluations, she said.

The new status does not affect the ability of students to complete their medical degrees or residency programs, she said. Dr. South-Paul added that school officials have begun addressing several of the issues and anticipate a swift resolution “guided by an aggressive action plan over the next 18-24 months.”

The university, located in Nashville, Tenn., has had accreditation problems before. In January, following a site visit and low scores on annual resident surveys, the Accreditation Council for Graduate Medical Education (ACGME) placed several of the schools’ residency and fellowship programs on probationary status.

At the time, school officials said that all programs would remain accredited, and they committed to expanding available resources, such as hiring additional staff and an independent expert to make program recommendations. A follow-up site visit was scheduled for August.

Regarding the most recent accreditation challenges, Veronica M. Catanese, MD, MBA, co-secretary of LCME, said the organization could only disclose the accreditation status of a medical school.

“LCME is not able to discuss any details concerning the accreditation of individual medical education programs, including the review process, resulting decisions, or survey results,” she said.

Established medical education programs typically undergo a self-study process and a full survey visit every 8 years. According to LCME’s website, a full survey visit may be conducted sooner if concerns arise about the program’s quality or sustainability.

The LCME program directory lists Meharry Medical College’s accreditation status as “full, on probation.” The next survey visit is scheduled for the 2023-2024 school year.

LCME accreditation is a prerequisite for having access to federal grants and programs, such as Title VII funding, which helps increase minority participation in health care careers. In addition, most state licensure boards and ACGME-affiliated residency programs require applicants to graduate from an LCME-accredited school.

Last year, when Meharry Medical College received pandemic aid money as part of the CARES Act, the school distributed nearly $10 million in scholarships to students – many of whom come from modest-income families and struggle to afford college tuition.

But in general, endowments to historically Black colleges and universities (HBCUs) are often at least 70% smaller than those made to non-HBCUs, which raises the question: Does the lack of funding make it more difficult for schools such as Meharry to maintain accreditation standards?

“Many different factors played into this finding by LCME,” said Dr. South-Paul. “It is a well-known fact that HBCUs have historically not been as well funded or possess the same size endowments as their mainstream academic peers. That is true of Meharry, but it would not be accurate to say this probation is because we are an HBCU.”

Similarly, Dr. Catanese said there is no evidence that HBCUs and non-HBCUs differ in their ability to meet LCME accreditation standards.

About half of the school’s residency and fellowship programs continue to have accreditation problems. According to ACGME’s database, the internal medicine program is currently on “continued accreditation with warning” status. The psychiatry and ob.gyn. programs are on “probationary accreditation” after receiving warnings in previous years.

Meharry was chartered in 1915 but was founded in 1876 as one of the first medical schools in the South for Black Americans.

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

Meharry Medical College, one of the oldest and largest historically Black academic health institutions in the United States, disclosed recently that its MD program had been placed on probationary status after a national accrediting agency’s onsite survey uncovered “infrastructure” problems earlier this year. Those include faculty shortages and inadequate student access to financial aid as well as to career and wellness counseling.

The inspection was conducted by the Liaison Committee on Medical Education (LCME), an accrediting body sponsored by the Association of American Medical Colleges and the American Medical Association.

While participation is voluntary, institutions must comply with 12 standards to maintain their standing. These include hiring qualified faculty and providing students with financial aid and debt management counseling.

Jeannette South-Paul, MD, Meharry’s senior vice president and chief academic officer, said in an interview that the degree program remains fully accredited despite the fact that LCME representatives found “notable areas of concern,” including the “need for some infrastructure updates and additional educational and financial resources for students.”

Specifically, students did not have sufficient access to advising services, broadband internet, and study spaces. In addition, faculty shortages caused delays in student evaluations, she said.

The new status does not affect the ability of students to complete their medical degrees or residency programs, she said. Dr. South-Paul added that school officials have begun addressing several of the issues and anticipate a swift resolution “guided by an aggressive action plan over the next 18-24 months.”

The university, located in Nashville, Tenn., has had accreditation problems before. In January, following a site visit and low scores on annual resident surveys, the Accreditation Council for Graduate Medical Education (ACGME) placed several of the schools’ residency and fellowship programs on probationary status.

At the time, school officials said that all programs would remain accredited, and they committed to expanding available resources, such as hiring additional staff and an independent expert to make program recommendations. A follow-up site visit was scheduled for August.

Regarding the most recent accreditation challenges, Veronica M. Catanese, MD, MBA, co-secretary of LCME, said the organization could only disclose the accreditation status of a medical school.

“LCME is not able to discuss any details concerning the accreditation of individual medical education programs, including the review process, resulting decisions, or survey results,” she said.

Established medical education programs typically undergo a self-study process and a full survey visit every 8 years. According to LCME’s website, a full survey visit may be conducted sooner if concerns arise about the program’s quality or sustainability.

The LCME program directory lists Meharry Medical College’s accreditation status as “full, on probation.” The next survey visit is scheduled for the 2023-2024 school year.

LCME accreditation is a prerequisite for having access to federal grants and programs, such as Title VII funding, which helps increase minority participation in health care careers. In addition, most state licensure boards and ACGME-affiliated residency programs require applicants to graduate from an LCME-accredited school.

Last year, when Meharry Medical College received pandemic aid money as part of the CARES Act, the school distributed nearly $10 million in scholarships to students – many of whom come from modest-income families and struggle to afford college tuition.

But in general, endowments to historically Black colleges and universities (HBCUs) are often at least 70% smaller than those made to non-HBCUs, which raises the question: Does the lack of funding make it more difficult for schools such as Meharry to maintain accreditation standards?

“Many different factors played into this finding by LCME,” said Dr. South-Paul. “It is a well-known fact that HBCUs have historically not been as well funded or possess the same size endowments as their mainstream academic peers. That is true of Meharry, but it would not be accurate to say this probation is because we are an HBCU.”

Similarly, Dr. Catanese said there is no evidence that HBCUs and non-HBCUs differ in their ability to meet LCME accreditation standards.

About half of the school’s residency and fellowship programs continue to have accreditation problems. According to ACGME’s database, the internal medicine program is currently on “continued accreditation with warning” status. The psychiatry and ob.gyn. programs are on “probationary accreditation” after receiving warnings in previous years.

Meharry was chartered in 1915 but was founded in 1876 as one of the first medical schools in the South for Black Americans.

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

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Not all children with type 2 diabetes have obesity

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Obesity is not a universal phenotype in children with type 2 diabetes (T2D), a global systematic review and meta-analysis reported. In fact, the study found, as many as one in four children with T2D do not have obesity and some have normal reference-range body mass measurements. Further studies should consider other mechanisms beyond obesity in the genesis of pediatric diabetes, the authors of the international analysis concluded, writing for JAMA Network Open.

“We were aware that some children and adolescents with T2D did not have obesity, but we didn’t know the scale of obesity in T2D, or what variables may impact the occurrence of diabetes in this group,” endocrinologist M. Constantine Samaan, MD, MSc, associate professor of pediatrics at McMaster University in Hamilton, Ont., told this news organization. “So, the analysis did help us understand the body mass distribution of this group in more detail.”

Dr. M. Constantine Samaan
This appears to be the first paper to systematically quantify obesity prevalence in this population. “There is not much known about this small but potentially important group of T2D patients,” Dr. Samaan said.

The international investigators included in their meta-analysis 53 articles with 8,942 participants from multiple world regions and races/ethnicities. The overall prevalence of obesity in pediatric patients with T2D was 75.27% (95% confidence interval [CI], 70.47%-79.78%). The prevalence of obesity at time of diagnosis in 4,688 participants was 77.24% (95% CI, 70.55%-83.34%). Male participants had higher odds of obesity than females: odds ratio, 2.10 (95% CI, 1.33-3.31) – although girls are generally more likely to develop T2D. The highest prevalence of obesity occurred in Whites at 89.86% (95% CI, 71.50%-99.74%), while prevalence was lowest in Asian participants at 64.50% (95% CI, 53.28%-74.99%).

The authors noted that childhood obesity affects approximately 340 million children worldwide and is a major driver of pediatric T2D, an aggressive disease with a high treatment failure rate. Understanding the contribution of body mass to the evolution of insulin resistance, glucose intolerance, and T2D with its attendant comorbidities and complications, such as nonalcoholic fatty liver disease, remains crucial for developing personalized interventions.

Known risk factors for T2D include interactions between genetics and the environment, including lifestyle factors such as diet and low physical activity levels, Dr. Samaan noted. Certain ethnic groups have higher T2D risks, as do babies exposed in the womb to maternal obesity or diabetes, he said. “And there are likely many other factors that contribute to the risk of T2D, though these remain to be defined.”

Is “lean” T2D in children without obesity likely then to be hereditary, more severe, and harder to control with lifestyle modification? “That’s a great question, but the answer is we don’t know,” Dr. Samaan said.

Commenting on the study but not involved in it, Timothy J. Joos, MD, a pediatrician in Seattle affiliated with the Swedish Medical Center, said the findings raise the question of how many pediatric T2D patients are being missed because they don’t meet current screening criteria. “In nonobese T2D pediatric patients, genetics (and by proxy family history) obviously play a heavier role. In my practice, I often get parents asking me to screen their skinny teenager for diabetes because of diabetes in a family member. In the past I would begrudgingly comply with a smirk on my face. Now the smirk will be gone.”

Dr. Joos said it would be interesting to see what percentage of these T2D patients without obesity (body mass index < 95th percentile) would still meet the criteria for being overweight (BMI > 85th percentile) as this is the primary criterion for screening according to the American Diabetes Association guidelines. 

Current guidelines generally look for elevated body mass measures as a main screening indication, Dr. Samaan’s group noted. But in their view, while factors such as ethnicity and in utero exposure to diabetes are already used in combination with BMI-based measures to justify screening, more sophisticated prediabetes and diabetes prediction models are needed to support a more comprehensive screening approach.

“Because being overweight is the initial criterion, children with multiple other criteria are not being screened,” Dr. Joos said. He agreed that more research is needed to sort out the other risk factors for pediatric T2D without obesity so these patients may be detected earlier.

New models may need to incorporate lifestyle factors, hormones, puberty, growth, and sex as well, the authors wrote. Markers of insulin resistance, insulin production capacity, and other markers are needed to refine the identification of those who should be screened.

Dr. Samaan’s group is planning to study the findings in more detail to clarify the effect of body mass on the comorbidities and complications of pediatric T2D.

In addition to the study limitation of significant interstudy heterogeneity, the authors acknowledged varying degrees of glycemic control and dyslipidemia among participants.

No specific funding was provided for this review and meta-analysis. The authors disclosed no conflicts of interest. Dr. Joos disclosed no competing interests with regard to his comments.
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Obesity is not a universal phenotype in children with type 2 diabetes (T2D), a global systematic review and meta-analysis reported. In fact, the study found, as many as one in four children with T2D do not have obesity and some have normal reference-range body mass measurements. Further studies should consider other mechanisms beyond obesity in the genesis of pediatric diabetes, the authors of the international analysis concluded, writing for JAMA Network Open.

“We were aware that some children and adolescents with T2D did not have obesity, but we didn’t know the scale of obesity in T2D, or what variables may impact the occurrence of diabetes in this group,” endocrinologist M. Constantine Samaan, MD, MSc, associate professor of pediatrics at McMaster University in Hamilton, Ont., told this news organization. “So, the analysis did help us understand the body mass distribution of this group in more detail.”

Dr. M. Constantine Samaan
This appears to be the first paper to systematically quantify obesity prevalence in this population. “There is not much known about this small but potentially important group of T2D patients,” Dr. Samaan said.

The international investigators included in their meta-analysis 53 articles with 8,942 participants from multiple world regions and races/ethnicities. The overall prevalence of obesity in pediatric patients with T2D was 75.27% (95% confidence interval [CI], 70.47%-79.78%). The prevalence of obesity at time of diagnosis in 4,688 participants was 77.24% (95% CI, 70.55%-83.34%). Male participants had higher odds of obesity than females: odds ratio, 2.10 (95% CI, 1.33-3.31) – although girls are generally more likely to develop T2D. The highest prevalence of obesity occurred in Whites at 89.86% (95% CI, 71.50%-99.74%), while prevalence was lowest in Asian participants at 64.50% (95% CI, 53.28%-74.99%).

The authors noted that childhood obesity affects approximately 340 million children worldwide and is a major driver of pediatric T2D, an aggressive disease with a high treatment failure rate. Understanding the contribution of body mass to the evolution of insulin resistance, glucose intolerance, and T2D with its attendant comorbidities and complications, such as nonalcoholic fatty liver disease, remains crucial for developing personalized interventions.

Known risk factors for T2D include interactions between genetics and the environment, including lifestyle factors such as diet and low physical activity levels, Dr. Samaan noted. Certain ethnic groups have higher T2D risks, as do babies exposed in the womb to maternal obesity or diabetes, he said. “And there are likely many other factors that contribute to the risk of T2D, though these remain to be defined.”

Is “lean” T2D in children without obesity likely then to be hereditary, more severe, and harder to control with lifestyle modification? “That’s a great question, but the answer is we don’t know,” Dr. Samaan said.

Commenting on the study but not involved in it, Timothy J. Joos, MD, a pediatrician in Seattle affiliated with the Swedish Medical Center, said the findings raise the question of how many pediatric T2D patients are being missed because they don’t meet current screening criteria. “In nonobese T2D pediatric patients, genetics (and by proxy family history) obviously play a heavier role. In my practice, I often get parents asking me to screen their skinny teenager for diabetes because of diabetes in a family member. In the past I would begrudgingly comply with a smirk on my face. Now the smirk will be gone.”

Dr. Joos said it would be interesting to see what percentage of these T2D patients without obesity (body mass index < 95th percentile) would still meet the criteria for being overweight (BMI > 85th percentile) as this is the primary criterion for screening according to the American Diabetes Association guidelines. 

Current guidelines generally look for elevated body mass measures as a main screening indication, Dr. Samaan’s group noted. But in their view, while factors such as ethnicity and in utero exposure to diabetes are already used in combination with BMI-based measures to justify screening, more sophisticated prediabetes and diabetes prediction models are needed to support a more comprehensive screening approach.

“Because being overweight is the initial criterion, children with multiple other criteria are not being screened,” Dr. Joos said. He agreed that more research is needed to sort out the other risk factors for pediatric T2D without obesity so these patients may be detected earlier.

New models may need to incorporate lifestyle factors, hormones, puberty, growth, and sex as well, the authors wrote. Markers of insulin resistance, insulin production capacity, and other markers are needed to refine the identification of those who should be screened.

Dr. Samaan’s group is planning to study the findings in more detail to clarify the effect of body mass on the comorbidities and complications of pediatric T2D.

In addition to the study limitation of significant interstudy heterogeneity, the authors acknowledged varying degrees of glycemic control and dyslipidemia among participants.

No specific funding was provided for this review and meta-analysis. The authors disclosed no conflicts of interest. Dr. Joos disclosed no competing interests with regard to his comments.

 

Obesity is not a universal phenotype in children with type 2 diabetes (T2D), a global systematic review and meta-analysis reported. In fact, the study found, as many as one in four children with T2D do not have obesity and some have normal reference-range body mass measurements. Further studies should consider other mechanisms beyond obesity in the genesis of pediatric diabetes, the authors of the international analysis concluded, writing for JAMA Network Open.

“We were aware that some children and adolescents with T2D did not have obesity, but we didn’t know the scale of obesity in T2D, or what variables may impact the occurrence of diabetes in this group,” endocrinologist M. Constantine Samaan, MD, MSc, associate professor of pediatrics at McMaster University in Hamilton, Ont., told this news organization. “So, the analysis did help us understand the body mass distribution of this group in more detail.”

Dr. M. Constantine Samaan
This appears to be the first paper to systematically quantify obesity prevalence in this population. “There is not much known about this small but potentially important group of T2D patients,” Dr. Samaan said.

The international investigators included in their meta-analysis 53 articles with 8,942 participants from multiple world regions and races/ethnicities. The overall prevalence of obesity in pediatric patients with T2D was 75.27% (95% confidence interval [CI], 70.47%-79.78%). The prevalence of obesity at time of diagnosis in 4,688 participants was 77.24% (95% CI, 70.55%-83.34%). Male participants had higher odds of obesity than females: odds ratio, 2.10 (95% CI, 1.33-3.31) – although girls are generally more likely to develop T2D. The highest prevalence of obesity occurred in Whites at 89.86% (95% CI, 71.50%-99.74%), while prevalence was lowest in Asian participants at 64.50% (95% CI, 53.28%-74.99%).

The authors noted that childhood obesity affects approximately 340 million children worldwide and is a major driver of pediatric T2D, an aggressive disease with a high treatment failure rate. Understanding the contribution of body mass to the evolution of insulin resistance, glucose intolerance, and T2D with its attendant comorbidities and complications, such as nonalcoholic fatty liver disease, remains crucial for developing personalized interventions.

Known risk factors for T2D include interactions between genetics and the environment, including lifestyle factors such as diet and low physical activity levels, Dr. Samaan noted. Certain ethnic groups have higher T2D risks, as do babies exposed in the womb to maternal obesity or diabetes, he said. “And there are likely many other factors that contribute to the risk of T2D, though these remain to be defined.”

Is “lean” T2D in children without obesity likely then to be hereditary, more severe, and harder to control with lifestyle modification? “That’s a great question, but the answer is we don’t know,” Dr. Samaan said.

Commenting on the study but not involved in it, Timothy J. Joos, MD, a pediatrician in Seattle affiliated with the Swedish Medical Center, said the findings raise the question of how many pediatric T2D patients are being missed because they don’t meet current screening criteria. “In nonobese T2D pediatric patients, genetics (and by proxy family history) obviously play a heavier role. In my practice, I often get parents asking me to screen their skinny teenager for diabetes because of diabetes in a family member. In the past I would begrudgingly comply with a smirk on my face. Now the smirk will be gone.”

Dr. Joos said it would be interesting to see what percentage of these T2D patients without obesity (body mass index < 95th percentile) would still meet the criteria for being overweight (BMI > 85th percentile) as this is the primary criterion for screening according to the American Diabetes Association guidelines. 

Current guidelines generally look for elevated body mass measures as a main screening indication, Dr. Samaan’s group noted. But in their view, while factors such as ethnicity and in utero exposure to diabetes are already used in combination with BMI-based measures to justify screening, more sophisticated prediabetes and diabetes prediction models are needed to support a more comprehensive screening approach.

“Because being overweight is the initial criterion, children with multiple other criteria are not being screened,” Dr. Joos said. He agreed that more research is needed to sort out the other risk factors for pediatric T2D without obesity so these patients may be detected earlier.

New models may need to incorporate lifestyle factors, hormones, puberty, growth, and sex as well, the authors wrote. Markers of insulin resistance, insulin production capacity, and other markers are needed to refine the identification of those who should be screened.

Dr. Samaan’s group is planning to study the findings in more detail to clarify the effect of body mass on the comorbidities and complications of pediatric T2D.

In addition to the study limitation of significant interstudy heterogeneity, the authors acknowledged varying degrees of glycemic control and dyslipidemia among participants.

No specific funding was provided for this review and meta-analysis. The authors disclosed no conflicts of interest. Dr. Joos disclosed no competing interests with regard to his comments.
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Chlorthalidone, HCTZ equally effective in hypertension: DCP published

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The Diuretic Comparison Project (DCP) trial, showing no difference in reduction of clinical events between the thiazide diuretics chlorthalidone and hydrochlorothiazide when used for the treatment of hypertension, has now been published. 

The trial was first presented at the 2022 annual scientific sessions of the American Heart Association. 

Courtesy April Eilers
Dr. Areef Ishani

In the current paper, published online in the New England Journal of Medicine, the authors, led by Areef Ishani, MD, Minneapolis Veterans Affairs Health Care System, explained that early studies suggested that chlorthalidone was superior to hydrochlorothiazide in patients with hypertension, but more recent observational studies have shown that the two drugs reduced cardiovascular events at a similar rate. Chlorthalidone may be associated with an increased risk of adverse events, including hypokalemia.

They noted that, in 2020, Part D Medicare expenditures showed that approximately 1.5 million persons received prescriptions for chlorthalidone, compared with 11.5 million who received prescriptions for hydrochlorothiazide, despite guidelines that recommended chlorthalidone as the preferred agent. The discrepancy between guideline recommendation and real-world use is possibly related to the belief that chlorthalidone has a greater risk for adverse effects without clear evidence for differences in cardiovascular outcomes, the authors suggested.

They conducted the current study to directly compare the effect of the two agents on cardiovascular outcomes in patients with hypertension.



The pragmatic DCP trial was carried out within the VA Healthcare System, and randomly assigned 13,523 patients (mean age, 72.5 years) with hypertension who were receiving hydrochlorothiazide at baseline (25 or 50 mg per day) to continue hydrochlorothiazide at their baseline dose or to switch to chlorthalidone (12.5 or 25 mg per day).

The mean baseline systolic blood pressure was 139 mm Hg in both trial groups and did not change substantially during the trial.

Over a median follow-up of 2.4 years, there was no difference in the primary outcome – a composite of MI, stroke, hospitalization for heart failure, urgent coronary revascularization for unstable angina, and non–cancer-related death – between the chlorthalidone group (10.4%) and the hydrochlorothiazide group (10.0%), giving a hazard ratio of 1.04 (95% CI, 0.94-1.16; P = .45).

In addition, there were no treatment differences between the two groups in any primary outcome component. Hypokalemia and potassium supplement use were more common in the chlorthalidone group than in the hydrochlorothiazide group.

‘Importance lies in the design’

In an accompanying editorial, Julie R. Ingelfinger, MD, deputy editor of the New England Journal of Medicine, said the results are not surprising and may not change clinical practice. But she suggested that the importance of the trial lies in its design, which shows that a high-quality pragmatic comparative effectiveness trial can be accomplished in a cost-effective manner within a health care system with little disruption in patient care.

Dr. Julie R. Ingelfinger

Dr. Ingelfinger pointed out several limitations of the trial. These include a lower-than-expected occurrence of primary outcome events, and the stipulation that patients were eligible to participate only if they continued to have hypertension while receiving hydrochlorothiazide.

In addition, 95% of the participants were receiving 25 mg of hydrochlorothiazide and only 5% were receiving 50 mg, which limited comparisons of the dose generally used in practice. Also, only approximately 13% of the patients were receiving hydrochlorothiazide alone for the treatment of hypertension at baseline.

She noted that the DCP is the first head-to-head comparison of hydrochlorothiazide and chlorthalidone in a randomized, prospective outcome trial.

“Without an apparent difference in the hazard ratios for the primary outcome in the two groups over the median follow-up of 2.4 years, results suggest that chlorthalidone therapy remains a good choice for hypertension despite the secondary observation that hypokalemia was more common with chlorthalidone than with hydrochlorothiazide,” Dr. Ingelfinger said.

“Although a subgroup analysis suggested that chlorthalidone was better than hydrochlorothiazide for participants with a history of myocardial infarction or stroke, that result may have been by chance,” she added.

As clinicians generally prefer using hydrochlorothiazide, she suggested that these DCP results will not provide any impetus for change.

“Furthermore, combined therapy and polypills may alter therapy beyond the results of this well-done, highly anticipated trial. Thus, its major effect may be as a model for other pragmatic study programs, which are greatly needed,” she concluded.

This study was supported by the Veterans Affairs Cooperative Studies Program through a grant to the Diuretic Comparison Project. Dr. Ishani reported no relevant financial relationships. Dr. Ingelfinger reported book royalties from Springer and from St. Martin’s Press, outside the submitted work, and that she is employed by the New England Journal of Medicine as deputy editor.

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

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The Diuretic Comparison Project (DCP) trial, showing no difference in reduction of clinical events between the thiazide diuretics chlorthalidone and hydrochlorothiazide when used for the treatment of hypertension, has now been published. 

The trial was first presented at the 2022 annual scientific sessions of the American Heart Association. 

Courtesy April Eilers
Dr. Areef Ishani

In the current paper, published online in the New England Journal of Medicine, the authors, led by Areef Ishani, MD, Minneapolis Veterans Affairs Health Care System, explained that early studies suggested that chlorthalidone was superior to hydrochlorothiazide in patients with hypertension, but more recent observational studies have shown that the two drugs reduced cardiovascular events at a similar rate. Chlorthalidone may be associated with an increased risk of adverse events, including hypokalemia.

They noted that, in 2020, Part D Medicare expenditures showed that approximately 1.5 million persons received prescriptions for chlorthalidone, compared with 11.5 million who received prescriptions for hydrochlorothiazide, despite guidelines that recommended chlorthalidone as the preferred agent. The discrepancy between guideline recommendation and real-world use is possibly related to the belief that chlorthalidone has a greater risk for adverse effects without clear evidence for differences in cardiovascular outcomes, the authors suggested.

They conducted the current study to directly compare the effect of the two agents on cardiovascular outcomes in patients with hypertension.



The pragmatic DCP trial was carried out within the VA Healthcare System, and randomly assigned 13,523 patients (mean age, 72.5 years) with hypertension who were receiving hydrochlorothiazide at baseline (25 or 50 mg per day) to continue hydrochlorothiazide at their baseline dose or to switch to chlorthalidone (12.5 or 25 mg per day).

The mean baseline systolic blood pressure was 139 mm Hg in both trial groups and did not change substantially during the trial.

Over a median follow-up of 2.4 years, there was no difference in the primary outcome – a composite of MI, stroke, hospitalization for heart failure, urgent coronary revascularization for unstable angina, and non–cancer-related death – between the chlorthalidone group (10.4%) and the hydrochlorothiazide group (10.0%), giving a hazard ratio of 1.04 (95% CI, 0.94-1.16; P = .45).

In addition, there were no treatment differences between the two groups in any primary outcome component. Hypokalemia and potassium supplement use were more common in the chlorthalidone group than in the hydrochlorothiazide group.

‘Importance lies in the design’

In an accompanying editorial, Julie R. Ingelfinger, MD, deputy editor of the New England Journal of Medicine, said the results are not surprising and may not change clinical practice. But she suggested that the importance of the trial lies in its design, which shows that a high-quality pragmatic comparative effectiveness trial can be accomplished in a cost-effective manner within a health care system with little disruption in patient care.

Dr. Julie R. Ingelfinger

Dr. Ingelfinger pointed out several limitations of the trial. These include a lower-than-expected occurrence of primary outcome events, and the stipulation that patients were eligible to participate only if they continued to have hypertension while receiving hydrochlorothiazide.

In addition, 95% of the participants were receiving 25 mg of hydrochlorothiazide and only 5% were receiving 50 mg, which limited comparisons of the dose generally used in practice. Also, only approximately 13% of the patients were receiving hydrochlorothiazide alone for the treatment of hypertension at baseline.

She noted that the DCP is the first head-to-head comparison of hydrochlorothiazide and chlorthalidone in a randomized, prospective outcome trial.

“Without an apparent difference in the hazard ratios for the primary outcome in the two groups over the median follow-up of 2.4 years, results suggest that chlorthalidone therapy remains a good choice for hypertension despite the secondary observation that hypokalemia was more common with chlorthalidone than with hydrochlorothiazide,” Dr. Ingelfinger said.

“Although a subgroup analysis suggested that chlorthalidone was better than hydrochlorothiazide for participants with a history of myocardial infarction or stroke, that result may have been by chance,” she added.

As clinicians generally prefer using hydrochlorothiazide, she suggested that these DCP results will not provide any impetus for change.

“Furthermore, combined therapy and polypills may alter therapy beyond the results of this well-done, highly anticipated trial. Thus, its major effect may be as a model for other pragmatic study programs, which are greatly needed,” she concluded.

This study was supported by the Veterans Affairs Cooperative Studies Program through a grant to the Diuretic Comparison Project. Dr. Ishani reported no relevant financial relationships. Dr. Ingelfinger reported book royalties from Springer and from St. Martin’s Press, outside the submitted work, and that she is employed by the New England Journal of Medicine as deputy editor.

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

The Diuretic Comparison Project (DCP) trial, showing no difference in reduction of clinical events between the thiazide diuretics chlorthalidone and hydrochlorothiazide when used for the treatment of hypertension, has now been published. 

The trial was first presented at the 2022 annual scientific sessions of the American Heart Association. 

Courtesy April Eilers
Dr. Areef Ishani

In the current paper, published online in the New England Journal of Medicine, the authors, led by Areef Ishani, MD, Minneapolis Veterans Affairs Health Care System, explained that early studies suggested that chlorthalidone was superior to hydrochlorothiazide in patients with hypertension, but more recent observational studies have shown that the two drugs reduced cardiovascular events at a similar rate. Chlorthalidone may be associated with an increased risk of adverse events, including hypokalemia.

They noted that, in 2020, Part D Medicare expenditures showed that approximately 1.5 million persons received prescriptions for chlorthalidone, compared with 11.5 million who received prescriptions for hydrochlorothiazide, despite guidelines that recommended chlorthalidone as the preferred agent. The discrepancy between guideline recommendation and real-world use is possibly related to the belief that chlorthalidone has a greater risk for adverse effects without clear evidence for differences in cardiovascular outcomes, the authors suggested.

They conducted the current study to directly compare the effect of the two agents on cardiovascular outcomes in patients with hypertension.



The pragmatic DCP trial was carried out within the VA Healthcare System, and randomly assigned 13,523 patients (mean age, 72.5 years) with hypertension who were receiving hydrochlorothiazide at baseline (25 or 50 mg per day) to continue hydrochlorothiazide at their baseline dose or to switch to chlorthalidone (12.5 or 25 mg per day).

The mean baseline systolic blood pressure was 139 mm Hg in both trial groups and did not change substantially during the trial.

Over a median follow-up of 2.4 years, there was no difference in the primary outcome – a composite of MI, stroke, hospitalization for heart failure, urgent coronary revascularization for unstable angina, and non–cancer-related death – between the chlorthalidone group (10.4%) and the hydrochlorothiazide group (10.0%), giving a hazard ratio of 1.04 (95% CI, 0.94-1.16; P = .45).

In addition, there were no treatment differences between the two groups in any primary outcome component. Hypokalemia and potassium supplement use were more common in the chlorthalidone group than in the hydrochlorothiazide group.

‘Importance lies in the design’

In an accompanying editorial, Julie R. Ingelfinger, MD, deputy editor of the New England Journal of Medicine, said the results are not surprising and may not change clinical practice. But she suggested that the importance of the trial lies in its design, which shows that a high-quality pragmatic comparative effectiveness trial can be accomplished in a cost-effective manner within a health care system with little disruption in patient care.

Dr. Julie R. Ingelfinger

Dr. Ingelfinger pointed out several limitations of the trial. These include a lower-than-expected occurrence of primary outcome events, and the stipulation that patients were eligible to participate only if they continued to have hypertension while receiving hydrochlorothiazide.

In addition, 95% of the participants were receiving 25 mg of hydrochlorothiazide and only 5% were receiving 50 mg, which limited comparisons of the dose generally used in practice. Also, only approximately 13% of the patients were receiving hydrochlorothiazide alone for the treatment of hypertension at baseline.

She noted that the DCP is the first head-to-head comparison of hydrochlorothiazide and chlorthalidone in a randomized, prospective outcome trial.

“Without an apparent difference in the hazard ratios for the primary outcome in the two groups over the median follow-up of 2.4 years, results suggest that chlorthalidone therapy remains a good choice for hypertension despite the secondary observation that hypokalemia was more common with chlorthalidone than with hydrochlorothiazide,” Dr. Ingelfinger said.

“Although a subgroup analysis suggested that chlorthalidone was better than hydrochlorothiazide for participants with a history of myocardial infarction or stroke, that result may have been by chance,” she added.

As clinicians generally prefer using hydrochlorothiazide, she suggested that these DCP results will not provide any impetus for change.

“Furthermore, combined therapy and polypills may alter therapy beyond the results of this well-done, highly anticipated trial. Thus, its major effect may be as a model for other pragmatic study programs, which are greatly needed,” she concluded.

This study was supported by the Veterans Affairs Cooperative Studies Program through a grant to the Diuretic Comparison Project. Dr. Ishani reported no relevant financial relationships. Dr. Ingelfinger reported book royalties from Springer and from St. Martin’s Press, outside the submitted work, and that she is employed by the New England Journal of Medicine as deputy editor.

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

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Infectious disease fellowship matches nose-dive after pandemic bump

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Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

 

 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

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

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Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

 

 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

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

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

 

 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

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

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Study: Formula-fed extreme preemies need more iron

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Researchers are calling for a revision of neonatal guidelines in light of new study results from Canada showing that most extremely premature infants fed with formula failed to absorb enough iron.

“We were surprised that, despite actually receiving more iron in total each day on average, the formula-fed infants were significantly more iron deficient than breast-fed babies. This is the opposite of what one would expect,” study lead author Grace Power, a medical student at Dalhousie University, Halifax, N.S., said in an interview. She presented the results at the annual meeting of the American Society of Hematology.

courtesy of ASH
Grace Power

According to Ms. Power, there’s limited research into how breastfeeding and formula feeding affect iron levels in preterm infants – especially those born extremely early, between 23 and 30 weeks’ gestation.

“This kind of research is important because preterm infants are highly susceptible to iron deficiency for a number of reasons,” she said. “Iron deficiency early in life is associated with developmental and behavioral problems later on in life. That association still stands, even if the iron deficiency is corrected, so prevention is key in this population. Knowing more about how feeding type affects iron status can help us learn about ways to prevent iron deficiency in these infants in the future.”

For the study, researchers retrospectively analyzed data about all preterm infants (< 31 weeks gestation) in Nova Scotia from 2005 to 2018. Of the 392 infants in this group (55.75% male; average age, about 5 months), 285 were fed with iron-rich formula (mean intake, 1.66 mg/kg per day), and 107 were fully or partially breast fed. The two groups were similar in terms of traits such as mean birth weight and gestational age.

The formula-fed infants were more likely to develop iron deficiency (ID, 36.8%) than the breast-fed infants (20.6%; P = .002). “Mean gestational age and birth weight were both lower in the ID group. The ID group also had a higher percentage of infants born less than 1,100 g (P = .01). More babies in the ID group received at least one blood transfusion,” the researchers reported. “ID infants had a higher daily formula intake, daily iron intake from formula, and total daily iron intake combined from formula and supplements.”

Why is there such a gap between formula-fed infants and breast-fed infants? The researchers speculated that infants absorb less iron from formula versus breast milk, possibly because of the presence of lactoferrin in breast milk.

The researchers also wondered whether physicians may pull back on iron supplementation in infants who undergo blood transfusions out of fear of the risk of iron overload, which Ms. Power said can cause infection and poor growth. By doing so, they may inadvertently deprive the babies of their need for iron.

“We don’t want clinicians to assume an infant doesn’t need iron supplementation just because they’ve received a blood transfusion,” she said.

As for an overall message from the research, Ms. Power said clinicians “should be aware that formula feeding can put infants at risk for iron deficiency and consider this when making decisions about supplementation.” And she noted that guidelines from the American Academy of Pediatrics and Canadian Pediatric Society don’t highlight the importance of iron supplementation in formula-fed, very preterm infants.

In an interview, University of Michigan pediatrician Michael K. Georgieff, MD, who has studied iron supplementation, said the study’s primary findings are surprising, although it makes sense that infants with lower gestational age and birth weight would suffer from more ID. Blood transfusion can indeed raise iron levels, but it’s important to consider that these infants may already have low levels of iron.

Dr. Georgieff advised colleagues to understand the potential for various nutritional deficiencies in preterm infants well beyond the first few weeks. When the babies are handed off to other clinicians such as pediatricians, they should undergo nutritional screening at 6 months, not at a year.

Dalhousie University funded the study. The study authors and Dr. Georgieff have no disclosures.

 


 

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Researchers are calling for a revision of neonatal guidelines in light of new study results from Canada showing that most extremely premature infants fed with formula failed to absorb enough iron.

“We were surprised that, despite actually receiving more iron in total each day on average, the formula-fed infants were significantly more iron deficient than breast-fed babies. This is the opposite of what one would expect,” study lead author Grace Power, a medical student at Dalhousie University, Halifax, N.S., said in an interview. She presented the results at the annual meeting of the American Society of Hematology.

courtesy of ASH
Grace Power

According to Ms. Power, there’s limited research into how breastfeeding and formula feeding affect iron levels in preterm infants – especially those born extremely early, between 23 and 30 weeks’ gestation.

“This kind of research is important because preterm infants are highly susceptible to iron deficiency for a number of reasons,” she said. “Iron deficiency early in life is associated with developmental and behavioral problems later on in life. That association still stands, even if the iron deficiency is corrected, so prevention is key in this population. Knowing more about how feeding type affects iron status can help us learn about ways to prevent iron deficiency in these infants in the future.”

For the study, researchers retrospectively analyzed data about all preterm infants (< 31 weeks gestation) in Nova Scotia from 2005 to 2018. Of the 392 infants in this group (55.75% male; average age, about 5 months), 285 were fed with iron-rich formula (mean intake, 1.66 mg/kg per day), and 107 were fully or partially breast fed. The two groups were similar in terms of traits such as mean birth weight and gestational age.

The formula-fed infants were more likely to develop iron deficiency (ID, 36.8%) than the breast-fed infants (20.6%; P = .002). “Mean gestational age and birth weight were both lower in the ID group. The ID group also had a higher percentage of infants born less than 1,100 g (P = .01). More babies in the ID group received at least one blood transfusion,” the researchers reported. “ID infants had a higher daily formula intake, daily iron intake from formula, and total daily iron intake combined from formula and supplements.”

Why is there such a gap between formula-fed infants and breast-fed infants? The researchers speculated that infants absorb less iron from formula versus breast milk, possibly because of the presence of lactoferrin in breast milk.

The researchers also wondered whether physicians may pull back on iron supplementation in infants who undergo blood transfusions out of fear of the risk of iron overload, which Ms. Power said can cause infection and poor growth. By doing so, they may inadvertently deprive the babies of their need for iron.

“We don’t want clinicians to assume an infant doesn’t need iron supplementation just because they’ve received a blood transfusion,” she said.

As for an overall message from the research, Ms. Power said clinicians “should be aware that formula feeding can put infants at risk for iron deficiency and consider this when making decisions about supplementation.” And she noted that guidelines from the American Academy of Pediatrics and Canadian Pediatric Society don’t highlight the importance of iron supplementation in formula-fed, very preterm infants.

In an interview, University of Michigan pediatrician Michael K. Georgieff, MD, who has studied iron supplementation, said the study’s primary findings are surprising, although it makes sense that infants with lower gestational age and birth weight would suffer from more ID. Blood transfusion can indeed raise iron levels, but it’s important to consider that these infants may already have low levels of iron.

Dr. Georgieff advised colleagues to understand the potential for various nutritional deficiencies in preterm infants well beyond the first few weeks. When the babies are handed off to other clinicians such as pediatricians, they should undergo nutritional screening at 6 months, not at a year.

Dalhousie University funded the study. The study authors and Dr. Georgieff have no disclosures.

 


 

Researchers are calling for a revision of neonatal guidelines in light of new study results from Canada showing that most extremely premature infants fed with formula failed to absorb enough iron.

“We were surprised that, despite actually receiving more iron in total each day on average, the formula-fed infants were significantly more iron deficient than breast-fed babies. This is the opposite of what one would expect,” study lead author Grace Power, a medical student at Dalhousie University, Halifax, N.S., said in an interview. She presented the results at the annual meeting of the American Society of Hematology.

courtesy of ASH
Grace Power

According to Ms. Power, there’s limited research into how breastfeeding and formula feeding affect iron levels in preterm infants – especially those born extremely early, between 23 and 30 weeks’ gestation.

“This kind of research is important because preterm infants are highly susceptible to iron deficiency for a number of reasons,” she said. “Iron deficiency early in life is associated with developmental and behavioral problems later on in life. That association still stands, even if the iron deficiency is corrected, so prevention is key in this population. Knowing more about how feeding type affects iron status can help us learn about ways to prevent iron deficiency in these infants in the future.”

For the study, researchers retrospectively analyzed data about all preterm infants (< 31 weeks gestation) in Nova Scotia from 2005 to 2018. Of the 392 infants in this group (55.75% male; average age, about 5 months), 285 were fed with iron-rich formula (mean intake, 1.66 mg/kg per day), and 107 were fully or partially breast fed. The two groups were similar in terms of traits such as mean birth weight and gestational age.

The formula-fed infants were more likely to develop iron deficiency (ID, 36.8%) than the breast-fed infants (20.6%; P = .002). “Mean gestational age and birth weight were both lower in the ID group. The ID group also had a higher percentage of infants born less than 1,100 g (P = .01). More babies in the ID group received at least one blood transfusion,” the researchers reported. “ID infants had a higher daily formula intake, daily iron intake from formula, and total daily iron intake combined from formula and supplements.”

Why is there such a gap between formula-fed infants and breast-fed infants? The researchers speculated that infants absorb less iron from formula versus breast milk, possibly because of the presence of lactoferrin in breast milk.

The researchers also wondered whether physicians may pull back on iron supplementation in infants who undergo blood transfusions out of fear of the risk of iron overload, which Ms. Power said can cause infection and poor growth. By doing so, they may inadvertently deprive the babies of their need for iron.

“We don’t want clinicians to assume an infant doesn’t need iron supplementation just because they’ve received a blood transfusion,” she said.

As for an overall message from the research, Ms. Power said clinicians “should be aware that formula feeding can put infants at risk for iron deficiency and consider this when making decisions about supplementation.” And she noted that guidelines from the American Academy of Pediatrics and Canadian Pediatric Society don’t highlight the importance of iron supplementation in formula-fed, very preterm infants.

In an interview, University of Michigan pediatrician Michael K. Georgieff, MD, who has studied iron supplementation, said the study’s primary findings are surprising, although it makes sense that infants with lower gestational age and birth weight would suffer from more ID. Blood transfusion can indeed raise iron levels, but it’s important to consider that these infants may already have low levels of iron.

Dr. Georgieff advised colleagues to understand the potential for various nutritional deficiencies in preterm infants well beyond the first few weeks. When the babies are handed off to other clinicians such as pediatricians, they should undergo nutritional screening at 6 months, not at a year.

Dalhousie University funded the study. The study authors and Dr. Georgieff have no disclosures.

 


 

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CLL phase 3 study: Zanubrutinib bests ibrutinib

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Zanubrutinib (Brukinsa) demonstrated superior efficacy and safety over ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to results of the randomized, phase 3 ALPINE study.

Progression-free survival (PFS) was significantly higher for zanubrutinib versus ibrutinib, according to investigator Jennifer R. Brown, MD, PhD, director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, Boston.

Dr. Jennifer R. Brown

Cardiac safety was also better with zanubrutinib, the second-generation Bruton’s tyrosine kinase inhibitor, compared to ibrutinib, the first-in-class Bruton’s tyrosine kinase inhibitor. Dr. Brown noted that ibrutinib has “transformed CLL therapy,” despite toxicity and pharmacokinetics issues which limit its use.

Even in patients with high-risk CLL, there was a clear benefit of zanubrutinib over ibrutinib, according to Dr. Brown, who presented final results of ALPINE in a late-breaking clinical trials session at the annual meeting of the American Society of Hematology.

“I am not aware of a patient population in which I would select ibrutinib as compared to zanubrutinib,” Dr. Brown said in a press briefing on the study at the meeting.

Although not currently indicated in CLL, zanubrutinib received Food and Drug Administration approval for treatment of relapsed/refractory mantle cell lymphoma in late 2019, followed by indications in Waldenström’s macroglobulinemia and relapsed/refractory marginal zone lymphoma in 2021.

But the choice of zanubrutinib over ibrutinib in relapsed/refractory CLL is already supported in current clinical practice guidelines, Dr. Brown said.

The most recent CLL guidelines from the National Comprehensive Cancer Network (NCCN), updated Aug 30, describe zanubrutinib as a “preferred” regimen, while ibrutinib falls into the category of an “other recommended regimen.”

The zanubrutinib recommendation is category 1, meaning that it is based on high-level evidence, with uniform consensus that the intervention in appropriate, according to NCCN.
 

Improved safety, efficacy

Side effects have proved to be an Achilles heel for ibrutinib, which first received an FDA approval in CLL in 2014.

Across CLL studies, between 16% and 23% of CLL patients have discontinued ibrutinib treatment because of toxicities, Dr. Brown, the ALPINE investigator, said at the ASH meeting.

In addition, pharmacokinetic data suggest that at certain times between doses, the amount of ibrutinib in a patient’s system may drop below the level needed to effectively inhibit the target protein, Bruton’s tyrosine kinase.

By contrast, zanubrutinib is designed to have greater specificity for that target protein, Dr. Brown said. Furthermore, the pharmacokinetic studies have demonstrated concentrations of drug consistently above the level needed for effective inhibition – an effect that suggests potential for greater efficacy.

In the ALPINE study, 652 patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL) were randomized to zanubrutinib 160 mg twice daily or ibrutinib once daily.

With a mean follow-up of 29.6 months, zanubrutinib PFS was significantly superior to ibrutinib, according to Dr. Brown, with a hazard ratio (HR) of 0.65 and 95% confidence interval (CI) between 0.49 and 0.86.

Estimated PFS at 2 years was 79.5% in the zanubrutinib arm and 67.3% for ibrutinib, according to the ALPINE data presented.

However, the difference in PFS in favor of zanubrutinib was even more pronounced in high-risk patients, according to Dr. Brown. Among patients with chromosome 17 deletion or TP53 mutation, the PFS at 2 years was 77.6% for zanubrutinib and just 55.7% for ibrutinib, with an HR of 0.52 and 95% CI of 0.30 to 0.88.

Zanubrutinib’s safety profile was superior to ibrutinib, with serious adverse rates of 42.0% and 50.0%, respectively, and significantly lower cardiac toxicity for zanubrutinib, according to the investigators’ presentation.

Only 5.2% of patients on zanubrutinib had atrial fibrillation/flutter on study, compared to 13.3% for ibrutinib (P = .0004), while rates of serious cardiac adverse events were 1.9% and 7.7% , respectively.
 

 

 

Impressive benefit

The PFS benefit of zanubrutinib over ibrutinib was “quite impressive” in ALPINE, and in line with pharmacokinetic differences observed between Bruton’s tyrosine kinase inhibitors, said Stefan K. Barta, MD, associate professor of medicine at the University of Pennsylvania in Philadelphia.

“In the lab, [second-generation Bruton’s tyrosine kinase inhibitors] do hit the target better, but better doesn’t necessarily translate into good outcomes for patients – that’s a different question,” Dr. Barta said in an interview

However, the safety findings of ALPINE are particularly relevant, according to Dr. Barta, since today, many patients with CLL will receive treatment with Bruton’s tyrosine kinase inhibitors indefinitely.

In ALPINE results presented at ASH, zanubrutinib-treated patients had lower rates of atrial fibrillation and serious cardiac events, as well as zero deaths due to cardiac events, compared to six deaths in the ibrutinib group.

“Side effects make a big difference if you are on something for a long time,” Dr. Barta said. “It’s certainly a huge difference already, but then if you get the added bonus of also having an improvement in PFS, that’s a win-win.”

Dr. Brown reported disclosures related to Abbvie, Acerta/AstraZeneca, Beigene, Bristol-Myers Squibb/Juno/Celgene, Catapult, Genentech/Roche, Janssen, MEI Pharma, Morphosys AG, Novartis, Pfizer, Rigel, Gilead, Loxo/Lilly, Verastem/Secura Bio, Sun, TG Therapeutics, Invectys, Grifols Worldwide Operations, Hutchmed, iOnctura, and Pharmacyclics.

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Zanubrutinib (Brukinsa) demonstrated superior efficacy and safety over ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to results of the randomized, phase 3 ALPINE study.

Progression-free survival (PFS) was significantly higher for zanubrutinib versus ibrutinib, according to investigator Jennifer R. Brown, MD, PhD, director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, Boston.

Dr. Jennifer R. Brown

Cardiac safety was also better with zanubrutinib, the second-generation Bruton’s tyrosine kinase inhibitor, compared to ibrutinib, the first-in-class Bruton’s tyrosine kinase inhibitor. Dr. Brown noted that ibrutinib has “transformed CLL therapy,” despite toxicity and pharmacokinetics issues which limit its use.

Even in patients with high-risk CLL, there was a clear benefit of zanubrutinib over ibrutinib, according to Dr. Brown, who presented final results of ALPINE in a late-breaking clinical trials session at the annual meeting of the American Society of Hematology.

“I am not aware of a patient population in which I would select ibrutinib as compared to zanubrutinib,” Dr. Brown said in a press briefing on the study at the meeting.

Although not currently indicated in CLL, zanubrutinib received Food and Drug Administration approval for treatment of relapsed/refractory mantle cell lymphoma in late 2019, followed by indications in Waldenström’s macroglobulinemia and relapsed/refractory marginal zone lymphoma in 2021.

But the choice of zanubrutinib over ibrutinib in relapsed/refractory CLL is already supported in current clinical practice guidelines, Dr. Brown said.

The most recent CLL guidelines from the National Comprehensive Cancer Network (NCCN), updated Aug 30, describe zanubrutinib as a “preferred” regimen, while ibrutinib falls into the category of an “other recommended regimen.”

The zanubrutinib recommendation is category 1, meaning that it is based on high-level evidence, with uniform consensus that the intervention in appropriate, according to NCCN.
 

Improved safety, efficacy

Side effects have proved to be an Achilles heel for ibrutinib, which first received an FDA approval in CLL in 2014.

Across CLL studies, between 16% and 23% of CLL patients have discontinued ibrutinib treatment because of toxicities, Dr. Brown, the ALPINE investigator, said at the ASH meeting.

In addition, pharmacokinetic data suggest that at certain times between doses, the amount of ibrutinib in a patient’s system may drop below the level needed to effectively inhibit the target protein, Bruton’s tyrosine kinase.

By contrast, zanubrutinib is designed to have greater specificity for that target protein, Dr. Brown said. Furthermore, the pharmacokinetic studies have demonstrated concentrations of drug consistently above the level needed for effective inhibition – an effect that suggests potential for greater efficacy.

In the ALPINE study, 652 patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL) were randomized to zanubrutinib 160 mg twice daily or ibrutinib once daily.

With a mean follow-up of 29.6 months, zanubrutinib PFS was significantly superior to ibrutinib, according to Dr. Brown, with a hazard ratio (HR) of 0.65 and 95% confidence interval (CI) between 0.49 and 0.86.

Estimated PFS at 2 years was 79.5% in the zanubrutinib arm and 67.3% for ibrutinib, according to the ALPINE data presented.

However, the difference in PFS in favor of zanubrutinib was even more pronounced in high-risk patients, according to Dr. Brown. Among patients with chromosome 17 deletion or TP53 mutation, the PFS at 2 years was 77.6% for zanubrutinib and just 55.7% for ibrutinib, with an HR of 0.52 and 95% CI of 0.30 to 0.88.

Zanubrutinib’s safety profile was superior to ibrutinib, with serious adverse rates of 42.0% and 50.0%, respectively, and significantly lower cardiac toxicity for zanubrutinib, according to the investigators’ presentation.

Only 5.2% of patients on zanubrutinib had atrial fibrillation/flutter on study, compared to 13.3% for ibrutinib (P = .0004), while rates of serious cardiac adverse events were 1.9% and 7.7% , respectively.
 

 

 

Impressive benefit

The PFS benefit of zanubrutinib over ibrutinib was “quite impressive” in ALPINE, and in line with pharmacokinetic differences observed between Bruton’s tyrosine kinase inhibitors, said Stefan K. Barta, MD, associate professor of medicine at the University of Pennsylvania in Philadelphia.

“In the lab, [second-generation Bruton’s tyrosine kinase inhibitors] do hit the target better, but better doesn’t necessarily translate into good outcomes for patients – that’s a different question,” Dr. Barta said in an interview

However, the safety findings of ALPINE are particularly relevant, according to Dr. Barta, since today, many patients with CLL will receive treatment with Bruton’s tyrosine kinase inhibitors indefinitely.

In ALPINE results presented at ASH, zanubrutinib-treated patients had lower rates of atrial fibrillation and serious cardiac events, as well as zero deaths due to cardiac events, compared to six deaths in the ibrutinib group.

“Side effects make a big difference if you are on something for a long time,” Dr. Barta said. “It’s certainly a huge difference already, but then if you get the added bonus of also having an improvement in PFS, that’s a win-win.”

Dr. Brown reported disclosures related to Abbvie, Acerta/AstraZeneca, Beigene, Bristol-Myers Squibb/Juno/Celgene, Catapult, Genentech/Roche, Janssen, MEI Pharma, Morphosys AG, Novartis, Pfizer, Rigel, Gilead, Loxo/Lilly, Verastem/Secura Bio, Sun, TG Therapeutics, Invectys, Grifols Worldwide Operations, Hutchmed, iOnctura, and Pharmacyclics.

Zanubrutinib (Brukinsa) demonstrated superior efficacy and safety over ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to results of the randomized, phase 3 ALPINE study.

Progression-free survival (PFS) was significantly higher for zanubrutinib versus ibrutinib, according to investigator Jennifer R. Brown, MD, PhD, director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, Boston.

Dr. Jennifer R. Brown

Cardiac safety was also better with zanubrutinib, the second-generation Bruton’s tyrosine kinase inhibitor, compared to ibrutinib, the first-in-class Bruton’s tyrosine kinase inhibitor. Dr. Brown noted that ibrutinib has “transformed CLL therapy,” despite toxicity and pharmacokinetics issues which limit its use.

Even in patients with high-risk CLL, there was a clear benefit of zanubrutinib over ibrutinib, according to Dr. Brown, who presented final results of ALPINE in a late-breaking clinical trials session at the annual meeting of the American Society of Hematology.

“I am not aware of a patient population in which I would select ibrutinib as compared to zanubrutinib,” Dr. Brown said in a press briefing on the study at the meeting.

Although not currently indicated in CLL, zanubrutinib received Food and Drug Administration approval for treatment of relapsed/refractory mantle cell lymphoma in late 2019, followed by indications in Waldenström’s macroglobulinemia and relapsed/refractory marginal zone lymphoma in 2021.

But the choice of zanubrutinib over ibrutinib in relapsed/refractory CLL is already supported in current clinical practice guidelines, Dr. Brown said.

The most recent CLL guidelines from the National Comprehensive Cancer Network (NCCN), updated Aug 30, describe zanubrutinib as a “preferred” regimen, while ibrutinib falls into the category of an “other recommended regimen.”

The zanubrutinib recommendation is category 1, meaning that it is based on high-level evidence, with uniform consensus that the intervention in appropriate, according to NCCN.
 

Improved safety, efficacy

Side effects have proved to be an Achilles heel for ibrutinib, which first received an FDA approval in CLL in 2014.

Across CLL studies, between 16% and 23% of CLL patients have discontinued ibrutinib treatment because of toxicities, Dr. Brown, the ALPINE investigator, said at the ASH meeting.

In addition, pharmacokinetic data suggest that at certain times between doses, the amount of ibrutinib in a patient’s system may drop below the level needed to effectively inhibit the target protein, Bruton’s tyrosine kinase.

By contrast, zanubrutinib is designed to have greater specificity for that target protein, Dr. Brown said. Furthermore, the pharmacokinetic studies have demonstrated concentrations of drug consistently above the level needed for effective inhibition – an effect that suggests potential for greater efficacy.

In the ALPINE study, 652 patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL) were randomized to zanubrutinib 160 mg twice daily or ibrutinib once daily.

With a mean follow-up of 29.6 months, zanubrutinib PFS was significantly superior to ibrutinib, according to Dr. Brown, with a hazard ratio (HR) of 0.65 and 95% confidence interval (CI) between 0.49 and 0.86.

Estimated PFS at 2 years was 79.5% in the zanubrutinib arm and 67.3% for ibrutinib, according to the ALPINE data presented.

However, the difference in PFS in favor of zanubrutinib was even more pronounced in high-risk patients, according to Dr. Brown. Among patients with chromosome 17 deletion or TP53 mutation, the PFS at 2 years was 77.6% for zanubrutinib and just 55.7% for ibrutinib, with an HR of 0.52 and 95% CI of 0.30 to 0.88.

Zanubrutinib’s safety profile was superior to ibrutinib, with serious adverse rates of 42.0% and 50.0%, respectively, and significantly lower cardiac toxicity for zanubrutinib, according to the investigators’ presentation.

Only 5.2% of patients on zanubrutinib had atrial fibrillation/flutter on study, compared to 13.3% for ibrutinib (P = .0004), while rates of serious cardiac adverse events were 1.9% and 7.7% , respectively.
 

 

 

Impressive benefit

The PFS benefit of zanubrutinib over ibrutinib was “quite impressive” in ALPINE, and in line with pharmacokinetic differences observed between Bruton’s tyrosine kinase inhibitors, said Stefan K. Barta, MD, associate professor of medicine at the University of Pennsylvania in Philadelphia.

“In the lab, [second-generation Bruton’s tyrosine kinase inhibitors] do hit the target better, but better doesn’t necessarily translate into good outcomes for patients – that’s a different question,” Dr. Barta said in an interview

However, the safety findings of ALPINE are particularly relevant, according to Dr. Barta, since today, many patients with CLL will receive treatment with Bruton’s tyrosine kinase inhibitors indefinitely.

In ALPINE results presented at ASH, zanubrutinib-treated patients had lower rates of atrial fibrillation and serious cardiac events, as well as zero deaths due to cardiac events, compared to six deaths in the ibrutinib group.

“Side effects make a big difference if you are on something for a long time,” Dr. Barta said. “It’s certainly a huge difference already, but then if you get the added bonus of also having an improvement in PFS, that’s a win-win.”

Dr. Brown reported disclosures related to Abbvie, Acerta/AstraZeneca, Beigene, Bristol-Myers Squibb/Juno/Celgene, Catapult, Genentech/Roche, Janssen, MEI Pharma, Morphosys AG, Novartis, Pfizer, Rigel, Gilead, Loxo/Lilly, Verastem/Secura Bio, Sun, TG Therapeutics, Invectys, Grifols Worldwide Operations, Hutchmed, iOnctura, and Pharmacyclics.

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FDA approves Idacio as eighth adalimumab biosimilar in U.S.

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A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

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A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

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Rheumatology workforce shortage demands multipronged approach

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– New rheumatology fellowships in underserved areas. Rheumatology training for nonspecialists. Telemedicine training, tools, and resources. These are a few of the remedies the American College of Rheumatology’s new Workforce Solutions Committee has concocted to address a shrinking U.S. rheumatology workforce in the face of a rising population of patients with rheumatologic diseases.

In two sessions at the ACR’s annual meeting, committee members provided insights on current workforce projections since the most recent ACR workforce study in 2015. They also outlined the 1-year-old committee’s response to bridge the looming gap in patient care. Some projects are already underway, while others have yet to be implemented and require sustained monetary and project coordination commitments to make their impacts felt across the targeted regions.

Jeff Evans/MDedge News
Dr. Daniel Battafarano

“At the current pace of physician departures from the workforce, even with fellows graduating from adult and pediatric rheumatology training programs, the subspecialty cannot be sustained,” said Daniel Battafarano, DO, chair of the Workforce Solution Committee, professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md., and adjunct professor at the University of Texas Health Science Center, San Antonio.

The Northwest is an example of the problem at hand. “For an adult, there’s 1.65 rheumatologists per 100,000 in 2015. In 2025, there’s going to be 0.5 [adult] rheumatologists per 100,000. That’s a problem. If you look at every region in the United States, every single region is decrementing significantly,” he said.

Even the Northeast, which boasted 3.07 adult rheumatologists per 100,000 in 2015, will drop to 1.61 in 2025. Other regions are much worse off. The Southwest will drop from 1.28 to 0.64, and North Central will drop from 1.64 to 0.69, projections show.

The situation for pediatrics “has been in a crisis since 2015,” Dr. Battafarano said. It is much worse off than the situation for adult rheumatology, with 2015 figures going from 0.17 to 0.20 in the Southwest and from 0.03 to 0.04 in the South Central region by 2025, and in the Northwest from 0.67 to 0.13 and Northeast from 0.83 to 0.16.

“The ill effects of the pandemic are immeasurable to this point, but anecdotally we know we lost colleagues to part-time employment, we saw early retirements, and that happened across the full spectrum of the United States,” he said. It’s possible that up to 10% of full-time equivalents of physicians left practice in the United States since the pandemic began.

Rheumatologists largely practice in the 392 U.S. metropolitan statistical areas (MSAs), which are defined as a “core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.” The smallest MSA has nearly 59,000 people. This distribution leaves many people in the Northwest, Southwest, South Central, and North Central regions with few rheumatologists. Over 86% of locations where rheumatologists train and work are in MSAs.

“By definition, if you get into a region where there’s 60,000 people or less, you can’t support a rheumatologist,” Dr. Battafarano said. He also noted that all pediatric hospitals tend to be in dense MSAs where rheumatologists might be.
 

 

 

South Central region serves as an example

People in certain MSAs of the South Central region (Oklahoma, Texas, Arkansas) such as Laredo, Tex., population 281,805 – where there is no adult rheumatologist – have to drive nearly 2.5 hours to the nearest well-served MSA (San Antonio) where there is a rheumatology fellowship program and medical school.

“Texas may have rheumatologists, but it depends on where you live,” Dr. Battafarano said. “The same applies to Waco, Texas; Texarkana, Arkansas; Lawton, Oklahoma; Pine Bluff, Arkansas; and Enid, Oklahoma, and you can see the range of traveling is between 45 minutes and 2.5 hours. That’s adult rheumatology.”

People in Laredo have an even longer drive to find a pediatric rheumatologist. In pediatrics, he said, “we don’t even look at towns, we look at pediatrics by state. You can see there’s a pediatric fellowship program in Dallas, and there’s one in Houston. There’s one or two [pediatric] rheumatologists in Austin. It just depends on how quickly they burn out and how long they stay. I’m in San Antonio. We don’t have a pediatric rheumatologist in San Antonio, the seventh-largest city in the United States.”

Pediatric rheumatologists are very often found where fellowship programs are located. “Ninety-five percent or greater of pediatric rheumatologists are housed in a pediatric hospital,” Dr. Battafarano said. “There are very few adult rheumatologists who see children, for a variety of reasons.”

Dr. Beth L. Jonas

In a panel discussion and question-and-answer session that took place after Dr. Battafarano outlined concerns with the numbers and distribution of rheumatologists across the United States, committee member Beth Jonas, MD, professor of medicine and chief of the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, noted that the rheumatology specialty match is competitive and typically leaves close to 100 residents who had rheumatology as their first choice without a match because there are not enough fellowship positions for them to fill.

The Workforce Solutions Committee hopes to reduce this “bottleneck,” she said, by identifying institutions that are ripe for opening new fellowship programs or have existing programs that can expand their number of positions, as well as expanding musculoskeletal training among nonrheumatologists, such as primary care physicians, advanced practice providers, and sports medicine physicians.

“I think that we’re going to find ourselves needing to be more creative as we become overcome with events with shortages of physicians,” Dr. Battafarano said. He gave an example of a recent pediatric rheumatology fellow in Seattle who wanted to go back home to Montana to practice. At the same time, the pediatric program wanted her to become a faculty member, so they said they would bridge their program to her, rotating fellows and covering her while on vacation.

“That’s an example of a pediatric program spreading its wings,” he said. “I think that we need to think that way, whether we talk about urban, suburban, rural. It’s how can we stage rheumatologists in areas, how can we embrace our primary care providers, and have rheumatology health care teams so that we have rheumatology expertise located within arm’s length but also within telemedicine length.”
 

 

 

Interventions for 2023

As part of a report on the activities of the Workforce Solutions Committee, Dr. Jonas outlined a number of interventions that the ACR is set to launch in 2023. The committee created five intervention teams to support fellowship positions and training providers, recruitment opportunities, fostering patient-centered communities, virtual training programs, and grants for research and training. The ACR’s initial pilot interventions are focused on, but not limited to, the Northwest, Southwest, and South Central regions.

The committee identified 10 potential partner institutions to develop new fellowship programs in the Northwest, Southwest, and South Central regions: University of Nevada, Las Vegas; Texas Tech University Permian Basin Program; Baylor Scott and White Medical Center Round Rock (Tex.) Program; Texas Tech University Health Science Center El Paso Program; University of Texas at Austin Dell Medical School Program; Abrazo Health Network Program in Arizona; University of Arizona Phoenix Program; University of Arkansas (pediatric program); Oklahoma State University; and University of Texas, San Antonio (pediatric program).

Dr. Jonas explained that opening new programs in these underserved areas should help establish new rheumatologists in these areas, because studies have shown that fellows tend to stay within 100-200 miles of where they trained.

In addition to starting new programs, “if you want to grow your program, if you want to add another fellow, we can support that,” Dr. Jonas said.



To help convince institutions of the value of rheumatology care, a position paper will soon be released by the ACR that outlines the benefits of the specialty to a health care system. The paper will describe an annual preventive cost savings of $2,762 per patient who is in the care of a rheumatologist and an annual direct or downstream income of $3.5 million per rheumatologist in a community, committee members said.

To help with recruitment and retention efforts, the ACR will revise its CareerConnection website to make it more useful.

To help in developing patient-centered communities of care, there will be a discussion series with payers on topics such as access, care delivery, and financing, in which 12 payers (including Blue Cross Blue Shield, Aetna, UnitedHealthcare, and Kaiser) will discuss patient access, cost, and quality measures. An in-person payer summit is also scheduled for 2023.

Interventions to enhance rheumatology care will also keep an ongoing focus on virtual training programs for primary care physicians and advanced practice providers, including a Project ECHO (Extension for Community Healthcare Outcomes) virtual lecture and case-based training and mentoring series for nonrheumatologists, an online library of searchable topics targeted to nonrheumatologists, as well as a grand rounds podcast series on certain rheumatic diseases for residents in family medicine, internal medicine, and pediatric programs. For rheumatology educators in 2023, there also will be an online portal curated by the ACR and other sources to use as a resource for developing curriculum.

Dr. Janet Poole

A newly revised Fundamentals of Rheumatology course started in June 2022, which can help many medical students, residents, primary care physicians, and students in rehabilitation professions to learn about rheumatologic diseases, said committee member Janet Poole, PhD, division chief, professor, and director of the occupational therapy graduate program at the University of New Mexico, Albuquerque. Grants from the Rheumatology Research Foundation are available to offset the costs of the course for attendees.

An “onboarding toolkit” for nurse practitioners and physician assistants is now available to provide advice to practices for hiring, mentoring, and conducting performance evaluations in rheumatology care teams, Dr. Poole said. And fact sheets about the roles of interprofessional team members are being revised to give nonspecialty providers a sense of what other disciplines are available to care for patients with rheumatic and musculoskeletal disorders. The Advanced Rheumatology course is also being revised and will be available in summer 2023.

Other planned interventions aim to optimize telemedicine for the rheumatology community with a telehealth curriculum for rheumatology fellows, tools to improve telehealth implementation and delivery, and educational materials for patients to optimize their participation in telehealth visits.

The committee created targeted outreach to promote all grants focused on workforce expansion. As a result, in the last year the committee noted a three- to fourfold rise in the number of grant applications, including people and programs in underserved areas that had not previously applied. The Rheumatology Research Foundation also created a baseline for measuring success of grant funding in underserved areas and earmarked funds to increase awareness of the grants and facilitate applications.

Dr. Rosalind Ramsey-Goldman

Early signs of success are evident in the Rheumatology Access Expansion initiative in the ACR’s Collaborative Initiatives (COIN) department, said committee member Rosalind Ramsey-Goldman, MD, DrPH, professor of medicine/rheumatology at Northwestern University, Chicago. A team of rheumatologists, a pharmacist, and Navajo cultural interpreters developed a 12-week rheumatoid arthritis training program for primary care physicians in the Navajo Nation American Indian reservation, where there’s a high prevalence of RA and a shortage of local rheumatology providers. Results of the pilot study were presented in a plenary session at the meeting.

COIN also worked with the ACR’s Diversity, Equity, and Inclusion task force to sponsor 2022 annual meeting attendance for 11 medical students who identify themselves as underrepresented in medicine to expose them to rheumatology early in their career, said Dr. Ramsey-Goldman. The ACR is starting a program for medical students at historically Black colleges and universities and minority-serving institutions to include mentoring, round tables, and attendance at next year’s annual meeting.

None of the rheumatologists had relevant financial disclosures.

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– New rheumatology fellowships in underserved areas. Rheumatology training for nonspecialists. Telemedicine training, tools, and resources. These are a few of the remedies the American College of Rheumatology’s new Workforce Solutions Committee has concocted to address a shrinking U.S. rheumatology workforce in the face of a rising population of patients with rheumatologic diseases.

In two sessions at the ACR’s annual meeting, committee members provided insights on current workforce projections since the most recent ACR workforce study in 2015. They also outlined the 1-year-old committee’s response to bridge the looming gap in patient care. Some projects are already underway, while others have yet to be implemented and require sustained monetary and project coordination commitments to make their impacts felt across the targeted regions.

Jeff Evans/MDedge News
Dr. Daniel Battafarano

“At the current pace of physician departures from the workforce, even with fellows graduating from adult and pediatric rheumatology training programs, the subspecialty cannot be sustained,” said Daniel Battafarano, DO, chair of the Workforce Solution Committee, professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md., and adjunct professor at the University of Texas Health Science Center, San Antonio.

The Northwest is an example of the problem at hand. “For an adult, there’s 1.65 rheumatologists per 100,000 in 2015. In 2025, there’s going to be 0.5 [adult] rheumatologists per 100,000. That’s a problem. If you look at every region in the United States, every single region is decrementing significantly,” he said.

Even the Northeast, which boasted 3.07 adult rheumatologists per 100,000 in 2015, will drop to 1.61 in 2025. Other regions are much worse off. The Southwest will drop from 1.28 to 0.64, and North Central will drop from 1.64 to 0.69, projections show.

The situation for pediatrics “has been in a crisis since 2015,” Dr. Battafarano said. It is much worse off than the situation for adult rheumatology, with 2015 figures going from 0.17 to 0.20 in the Southwest and from 0.03 to 0.04 in the South Central region by 2025, and in the Northwest from 0.67 to 0.13 and Northeast from 0.83 to 0.16.

“The ill effects of the pandemic are immeasurable to this point, but anecdotally we know we lost colleagues to part-time employment, we saw early retirements, and that happened across the full spectrum of the United States,” he said. It’s possible that up to 10% of full-time equivalents of physicians left practice in the United States since the pandemic began.

Rheumatologists largely practice in the 392 U.S. metropolitan statistical areas (MSAs), which are defined as a “core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.” The smallest MSA has nearly 59,000 people. This distribution leaves many people in the Northwest, Southwest, South Central, and North Central regions with few rheumatologists. Over 86% of locations where rheumatologists train and work are in MSAs.

“By definition, if you get into a region where there’s 60,000 people or less, you can’t support a rheumatologist,” Dr. Battafarano said. He also noted that all pediatric hospitals tend to be in dense MSAs where rheumatologists might be.
 

 

 

South Central region serves as an example

People in certain MSAs of the South Central region (Oklahoma, Texas, Arkansas) such as Laredo, Tex., population 281,805 – where there is no adult rheumatologist – have to drive nearly 2.5 hours to the nearest well-served MSA (San Antonio) where there is a rheumatology fellowship program and medical school.

“Texas may have rheumatologists, but it depends on where you live,” Dr. Battafarano said. “The same applies to Waco, Texas; Texarkana, Arkansas; Lawton, Oklahoma; Pine Bluff, Arkansas; and Enid, Oklahoma, and you can see the range of traveling is between 45 minutes and 2.5 hours. That’s adult rheumatology.”

People in Laredo have an even longer drive to find a pediatric rheumatologist. In pediatrics, he said, “we don’t even look at towns, we look at pediatrics by state. You can see there’s a pediatric fellowship program in Dallas, and there’s one in Houston. There’s one or two [pediatric] rheumatologists in Austin. It just depends on how quickly they burn out and how long they stay. I’m in San Antonio. We don’t have a pediatric rheumatologist in San Antonio, the seventh-largest city in the United States.”

Pediatric rheumatologists are very often found where fellowship programs are located. “Ninety-five percent or greater of pediatric rheumatologists are housed in a pediatric hospital,” Dr. Battafarano said. “There are very few adult rheumatologists who see children, for a variety of reasons.”

Dr. Beth L. Jonas

In a panel discussion and question-and-answer session that took place after Dr. Battafarano outlined concerns with the numbers and distribution of rheumatologists across the United States, committee member Beth Jonas, MD, professor of medicine and chief of the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, noted that the rheumatology specialty match is competitive and typically leaves close to 100 residents who had rheumatology as their first choice without a match because there are not enough fellowship positions for them to fill.

The Workforce Solutions Committee hopes to reduce this “bottleneck,” she said, by identifying institutions that are ripe for opening new fellowship programs or have existing programs that can expand their number of positions, as well as expanding musculoskeletal training among nonrheumatologists, such as primary care physicians, advanced practice providers, and sports medicine physicians.

“I think that we’re going to find ourselves needing to be more creative as we become overcome with events with shortages of physicians,” Dr. Battafarano said. He gave an example of a recent pediatric rheumatology fellow in Seattle who wanted to go back home to Montana to practice. At the same time, the pediatric program wanted her to become a faculty member, so they said they would bridge their program to her, rotating fellows and covering her while on vacation.

“That’s an example of a pediatric program spreading its wings,” he said. “I think that we need to think that way, whether we talk about urban, suburban, rural. It’s how can we stage rheumatologists in areas, how can we embrace our primary care providers, and have rheumatology health care teams so that we have rheumatology expertise located within arm’s length but also within telemedicine length.”
 

 

 

Interventions for 2023

As part of a report on the activities of the Workforce Solutions Committee, Dr. Jonas outlined a number of interventions that the ACR is set to launch in 2023. The committee created five intervention teams to support fellowship positions and training providers, recruitment opportunities, fostering patient-centered communities, virtual training programs, and grants for research and training. The ACR’s initial pilot interventions are focused on, but not limited to, the Northwest, Southwest, and South Central regions.

The committee identified 10 potential partner institutions to develop new fellowship programs in the Northwest, Southwest, and South Central regions: University of Nevada, Las Vegas; Texas Tech University Permian Basin Program; Baylor Scott and White Medical Center Round Rock (Tex.) Program; Texas Tech University Health Science Center El Paso Program; University of Texas at Austin Dell Medical School Program; Abrazo Health Network Program in Arizona; University of Arizona Phoenix Program; University of Arkansas (pediatric program); Oklahoma State University; and University of Texas, San Antonio (pediatric program).

Dr. Jonas explained that opening new programs in these underserved areas should help establish new rheumatologists in these areas, because studies have shown that fellows tend to stay within 100-200 miles of where they trained.

In addition to starting new programs, “if you want to grow your program, if you want to add another fellow, we can support that,” Dr. Jonas said.



To help convince institutions of the value of rheumatology care, a position paper will soon be released by the ACR that outlines the benefits of the specialty to a health care system. The paper will describe an annual preventive cost savings of $2,762 per patient who is in the care of a rheumatologist and an annual direct or downstream income of $3.5 million per rheumatologist in a community, committee members said.

To help with recruitment and retention efforts, the ACR will revise its CareerConnection website to make it more useful.

To help in developing patient-centered communities of care, there will be a discussion series with payers on topics such as access, care delivery, and financing, in which 12 payers (including Blue Cross Blue Shield, Aetna, UnitedHealthcare, and Kaiser) will discuss patient access, cost, and quality measures. An in-person payer summit is also scheduled for 2023.

Interventions to enhance rheumatology care will also keep an ongoing focus on virtual training programs for primary care physicians and advanced practice providers, including a Project ECHO (Extension for Community Healthcare Outcomes) virtual lecture and case-based training and mentoring series for nonrheumatologists, an online library of searchable topics targeted to nonrheumatologists, as well as a grand rounds podcast series on certain rheumatic diseases for residents in family medicine, internal medicine, and pediatric programs. For rheumatology educators in 2023, there also will be an online portal curated by the ACR and other sources to use as a resource for developing curriculum.

Dr. Janet Poole

A newly revised Fundamentals of Rheumatology course started in June 2022, which can help many medical students, residents, primary care physicians, and students in rehabilitation professions to learn about rheumatologic diseases, said committee member Janet Poole, PhD, division chief, professor, and director of the occupational therapy graduate program at the University of New Mexico, Albuquerque. Grants from the Rheumatology Research Foundation are available to offset the costs of the course for attendees.

An “onboarding toolkit” for nurse practitioners and physician assistants is now available to provide advice to practices for hiring, mentoring, and conducting performance evaluations in rheumatology care teams, Dr. Poole said. And fact sheets about the roles of interprofessional team members are being revised to give nonspecialty providers a sense of what other disciplines are available to care for patients with rheumatic and musculoskeletal disorders. The Advanced Rheumatology course is also being revised and will be available in summer 2023.

Other planned interventions aim to optimize telemedicine for the rheumatology community with a telehealth curriculum for rheumatology fellows, tools to improve telehealth implementation and delivery, and educational materials for patients to optimize their participation in telehealth visits.

The committee created targeted outreach to promote all grants focused on workforce expansion. As a result, in the last year the committee noted a three- to fourfold rise in the number of grant applications, including people and programs in underserved areas that had not previously applied. The Rheumatology Research Foundation also created a baseline for measuring success of grant funding in underserved areas and earmarked funds to increase awareness of the grants and facilitate applications.

Dr. Rosalind Ramsey-Goldman

Early signs of success are evident in the Rheumatology Access Expansion initiative in the ACR’s Collaborative Initiatives (COIN) department, said committee member Rosalind Ramsey-Goldman, MD, DrPH, professor of medicine/rheumatology at Northwestern University, Chicago. A team of rheumatologists, a pharmacist, and Navajo cultural interpreters developed a 12-week rheumatoid arthritis training program for primary care physicians in the Navajo Nation American Indian reservation, where there’s a high prevalence of RA and a shortage of local rheumatology providers. Results of the pilot study were presented in a plenary session at the meeting.

COIN also worked with the ACR’s Diversity, Equity, and Inclusion task force to sponsor 2022 annual meeting attendance for 11 medical students who identify themselves as underrepresented in medicine to expose them to rheumatology early in their career, said Dr. Ramsey-Goldman. The ACR is starting a program for medical students at historically Black colleges and universities and minority-serving institutions to include mentoring, round tables, and attendance at next year’s annual meeting.

None of the rheumatologists had relevant financial disclosures.

– New rheumatology fellowships in underserved areas. Rheumatology training for nonspecialists. Telemedicine training, tools, and resources. These are a few of the remedies the American College of Rheumatology’s new Workforce Solutions Committee has concocted to address a shrinking U.S. rheumatology workforce in the face of a rising population of patients with rheumatologic diseases.

In two sessions at the ACR’s annual meeting, committee members provided insights on current workforce projections since the most recent ACR workforce study in 2015. They also outlined the 1-year-old committee’s response to bridge the looming gap in patient care. Some projects are already underway, while others have yet to be implemented and require sustained monetary and project coordination commitments to make their impacts felt across the targeted regions.

Jeff Evans/MDedge News
Dr. Daniel Battafarano

“At the current pace of physician departures from the workforce, even with fellows graduating from adult and pediatric rheumatology training programs, the subspecialty cannot be sustained,” said Daniel Battafarano, DO, chair of the Workforce Solution Committee, professor of medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md., and adjunct professor at the University of Texas Health Science Center, San Antonio.

The Northwest is an example of the problem at hand. “For an adult, there’s 1.65 rheumatologists per 100,000 in 2015. In 2025, there’s going to be 0.5 [adult] rheumatologists per 100,000. That’s a problem. If you look at every region in the United States, every single region is decrementing significantly,” he said.

Even the Northeast, which boasted 3.07 adult rheumatologists per 100,000 in 2015, will drop to 1.61 in 2025. Other regions are much worse off. The Southwest will drop from 1.28 to 0.64, and North Central will drop from 1.64 to 0.69, projections show.

The situation for pediatrics “has been in a crisis since 2015,” Dr. Battafarano said. It is much worse off than the situation for adult rheumatology, with 2015 figures going from 0.17 to 0.20 in the Southwest and from 0.03 to 0.04 in the South Central region by 2025, and in the Northwest from 0.67 to 0.13 and Northeast from 0.83 to 0.16.

“The ill effects of the pandemic are immeasurable to this point, but anecdotally we know we lost colleagues to part-time employment, we saw early retirements, and that happened across the full spectrum of the United States,” he said. It’s possible that up to 10% of full-time equivalents of physicians left practice in the United States since the pandemic began.

Rheumatologists largely practice in the 392 U.S. metropolitan statistical areas (MSAs), which are defined as a “core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core.” The smallest MSA has nearly 59,000 people. This distribution leaves many people in the Northwest, Southwest, South Central, and North Central regions with few rheumatologists. Over 86% of locations where rheumatologists train and work are in MSAs.

“By definition, if you get into a region where there’s 60,000 people or less, you can’t support a rheumatologist,” Dr. Battafarano said. He also noted that all pediatric hospitals tend to be in dense MSAs where rheumatologists might be.
 

 

 

South Central region serves as an example

People in certain MSAs of the South Central region (Oklahoma, Texas, Arkansas) such as Laredo, Tex., population 281,805 – where there is no adult rheumatologist – have to drive nearly 2.5 hours to the nearest well-served MSA (San Antonio) where there is a rheumatology fellowship program and medical school.

“Texas may have rheumatologists, but it depends on where you live,” Dr. Battafarano said. “The same applies to Waco, Texas; Texarkana, Arkansas; Lawton, Oklahoma; Pine Bluff, Arkansas; and Enid, Oklahoma, and you can see the range of traveling is between 45 minutes and 2.5 hours. That’s adult rheumatology.”

People in Laredo have an even longer drive to find a pediatric rheumatologist. In pediatrics, he said, “we don’t even look at towns, we look at pediatrics by state. You can see there’s a pediatric fellowship program in Dallas, and there’s one in Houston. There’s one or two [pediatric] rheumatologists in Austin. It just depends on how quickly they burn out and how long they stay. I’m in San Antonio. We don’t have a pediatric rheumatologist in San Antonio, the seventh-largest city in the United States.”

Pediatric rheumatologists are very often found where fellowship programs are located. “Ninety-five percent or greater of pediatric rheumatologists are housed in a pediatric hospital,” Dr. Battafarano said. “There are very few adult rheumatologists who see children, for a variety of reasons.”

Dr. Beth L. Jonas

In a panel discussion and question-and-answer session that took place after Dr. Battafarano outlined concerns with the numbers and distribution of rheumatologists across the United States, committee member Beth Jonas, MD, professor of medicine and chief of the division of rheumatology, allergy, and immunology at the University of North Carolina at Chapel Hill, noted that the rheumatology specialty match is competitive and typically leaves close to 100 residents who had rheumatology as their first choice without a match because there are not enough fellowship positions for them to fill.

The Workforce Solutions Committee hopes to reduce this “bottleneck,” she said, by identifying institutions that are ripe for opening new fellowship programs or have existing programs that can expand their number of positions, as well as expanding musculoskeletal training among nonrheumatologists, such as primary care physicians, advanced practice providers, and sports medicine physicians.

“I think that we’re going to find ourselves needing to be more creative as we become overcome with events with shortages of physicians,” Dr. Battafarano said. He gave an example of a recent pediatric rheumatology fellow in Seattle who wanted to go back home to Montana to practice. At the same time, the pediatric program wanted her to become a faculty member, so they said they would bridge their program to her, rotating fellows and covering her while on vacation.

“That’s an example of a pediatric program spreading its wings,” he said. “I think that we need to think that way, whether we talk about urban, suburban, rural. It’s how can we stage rheumatologists in areas, how can we embrace our primary care providers, and have rheumatology health care teams so that we have rheumatology expertise located within arm’s length but also within telemedicine length.”
 

 

 

Interventions for 2023

As part of a report on the activities of the Workforce Solutions Committee, Dr. Jonas outlined a number of interventions that the ACR is set to launch in 2023. The committee created five intervention teams to support fellowship positions and training providers, recruitment opportunities, fostering patient-centered communities, virtual training programs, and grants for research and training. The ACR’s initial pilot interventions are focused on, but not limited to, the Northwest, Southwest, and South Central regions.

The committee identified 10 potential partner institutions to develop new fellowship programs in the Northwest, Southwest, and South Central regions: University of Nevada, Las Vegas; Texas Tech University Permian Basin Program; Baylor Scott and White Medical Center Round Rock (Tex.) Program; Texas Tech University Health Science Center El Paso Program; University of Texas at Austin Dell Medical School Program; Abrazo Health Network Program in Arizona; University of Arizona Phoenix Program; University of Arkansas (pediatric program); Oklahoma State University; and University of Texas, San Antonio (pediatric program).

Dr. Jonas explained that opening new programs in these underserved areas should help establish new rheumatologists in these areas, because studies have shown that fellows tend to stay within 100-200 miles of where they trained.

In addition to starting new programs, “if you want to grow your program, if you want to add another fellow, we can support that,” Dr. Jonas said.



To help convince institutions of the value of rheumatology care, a position paper will soon be released by the ACR that outlines the benefits of the specialty to a health care system. The paper will describe an annual preventive cost savings of $2,762 per patient who is in the care of a rheumatologist and an annual direct or downstream income of $3.5 million per rheumatologist in a community, committee members said.

To help with recruitment and retention efforts, the ACR will revise its CareerConnection website to make it more useful.

To help in developing patient-centered communities of care, there will be a discussion series with payers on topics such as access, care delivery, and financing, in which 12 payers (including Blue Cross Blue Shield, Aetna, UnitedHealthcare, and Kaiser) will discuss patient access, cost, and quality measures. An in-person payer summit is also scheduled for 2023.

Interventions to enhance rheumatology care will also keep an ongoing focus on virtual training programs for primary care physicians and advanced practice providers, including a Project ECHO (Extension for Community Healthcare Outcomes) virtual lecture and case-based training and mentoring series for nonrheumatologists, an online library of searchable topics targeted to nonrheumatologists, as well as a grand rounds podcast series on certain rheumatic diseases for residents in family medicine, internal medicine, and pediatric programs. For rheumatology educators in 2023, there also will be an online portal curated by the ACR and other sources to use as a resource for developing curriculum.

Dr. Janet Poole

A newly revised Fundamentals of Rheumatology course started in June 2022, which can help many medical students, residents, primary care physicians, and students in rehabilitation professions to learn about rheumatologic diseases, said committee member Janet Poole, PhD, division chief, professor, and director of the occupational therapy graduate program at the University of New Mexico, Albuquerque. Grants from the Rheumatology Research Foundation are available to offset the costs of the course for attendees.

An “onboarding toolkit” for nurse practitioners and physician assistants is now available to provide advice to practices for hiring, mentoring, and conducting performance evaluations in rheumatology care teams, Dr. Poole said. And fact sheets about the roles of interprofessional team members are being revised to give nonspecialty providers a sense of what other disciplines are available to care for patients with rheumatic and musculoskeletal disorders. The Advanced Rheumatology course is also being revised and will be available in summer 2023.

Other planned interventions aim to optimize telemedicine for the rheumatology community with a telehealth curriculum for rheumatology fellows, tools to improve telehealth implementation and delivery, and educational materials for patients to optimize their participation in telehealth visits.

The committee created targeted outreach to promote all grants focused on workforce expansion. As a result, in the last year the committee noted a three- to fourfold rise in the number of grant applications, including people and programs in underserved areas that had not previously applied. The Rheumatology Research Foundation also created a baseline for measuring success of grant funding in underserved areas and earmarked funds to increase awareness of the grants and facilitate applications.

Dr. Rosalind Ramsey-Goldman

Early signs of success are evident in the Rheumatology Access Expansion initiative in the ACR’s Collaborative Initiatives (COIN) department, said committee member Rosalind Ramsey-Goldman, MD, DrPH, professor of medicine/rheumatology at Northwestern University, Chicago. A team of rheumatologists, a pharmacist, and Navajo cultural interpreters developed a 12-week rheumatoid arthritis training program for primary care physicians in the Navajo Nation American Indian reservation, where there’s a high prevalence of RA and a shortage of local rheumatology providers. Results of the pilot study were presented in a plenary session at the meeting.

COIN also worked with the ACR’s Diversity, Equity, and Inclusion task force to sponsor 2022 annual meeting attendance for 11 medical students who identify themselves as underrepresented in medicine to expose them to rheumatology early in their career, said Dr. Ramsey-Goldman. The ACR is starting a program for medical students at historically Black colleges and universities and minority-serving institutions to include mentoring, round tables, and attendance at next year’s annual meeting.

None of the rheumatologists had relevant financial disclosures.

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Overturning Roe: Exacerbating inequities in abortion care and ObGyn training

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Overturning Roe: Exacerbating inequities in abortion care and ObGyn training

 

On a recent overnight shift, our ObGyn on-call team was urgently paged to the emergency room for a patient who was brought in hemorrhaging after having passed out mid-flight from Texas to Boston. She was 12-weeks pregnant. We rushed her to the operating room for surgical removal of the pregnancy by dilation and curettage to stop her bleeding. Landing in Massachusetts had saved her life.

The significance of this patient’s case was not lost on the multidisciplinary teams caring for her, as the—at the time—impending Roe v Wade decision weighed heavily on our minds. One of many, her story foreshadows the harrowing experiences that we anticipate in the coming months and highlights the danger that the Supreme Court has inflicted on pregnant people nationally.

The Supreme Court decision on Dobbs v Jackson condemns us as a nation in which abortion rights are no longer federally protected under Roe v Wade.1 Twenty-six states have been poised to ban abortion, and in at least 12 states, abortion is now illegal.2,3 Political decision making will soon deny pregnant people the right to bodily autonomy, and the United States will lag behind other nations in abortion access.4 As ObGyn resident physicians who practice in tertiary referral hospitals in Massachusetts, where the ROE Act protects abortion beyond 24 weeks’ gestational age, we affirm abortion as essential health care that saves lives.5

Collectively as physician residents, we have provided an abortion for the patient at 22 weeks with a desired pregnancy who would have otherwise died from high blood pressures, the patient who ended her pregnancy to expedite breast cancer treatment, and the 16-year-old who feared for her life after suffering an assault by her partner for disclosing her pregnancy. With the overturn of Roe v Wade, patients like these will suffer dramatically divergent fates as race, class, and, now more than ever, geography will impact who is able to access abortion care.

Ramifications of the overturn of Roe

History foreshadows the grim impact of repealing Roe. Ohio’s 2011 law that requires the use of the restrictive protocol approved by the US Food and Drug Administration for mifepristone administration deepened existing inequities in abortion access.6 Patients with private insurance, higher income, higher level of education, and those who were White were more likely to obtain abortion care.7 In Texas, after the implementation of SB8 and other restrictive laws, Hispanic women whose travel distance increased more than 100 miles had the greatest reduction in abortion rates.8,9 A recent study regarding banning abortion in the United States estimated a 7% increase in pregnancy-related deaths in 1 year, with a 21% increase in subsequent years.10

Inequities in abortion access subsequently will disparately increase deaths of pregnant individuals in certain populations.11,12 Communities with the highest rates of unintended pregnancy, medical comorbidities, and lack of access to abortion, as well as historically marginalized populations—including non-Hispanic Black people, LGBTQIA people, those with limited English proficiency, and undocumented persons—will experience the greatest increase in pregnancy-related deaths due to a total abortion ban.13-15

The US maternal mortality rate is already the highest among developed nations, and it will only climb if ObGyns are not appropriately trained to operate within our full scope of practice and, thus, are unable to provide the highest quality of care.16,17

Continue: Abortion is a medical treatment that requires resident training...

 

 

Abortion is a medical treatment that requires resident training

Abortion care must be protected. Uterine evacuation by medical management, suction curettage, or dilation and evacuation is indicated for undesired pregnancy, regardless of reasoning or life circumstance. Pregnancy carries inherent risks that can at times be deadly.18 Abortion serves as first-line treatment for certain life-threatening pregnancy risks, including septic miscarriage, maternal hemorrhage, early-onset severe preeclampsia, and certain health conditions.19 Surgical skills and medical management of abortion are therefore fundamental components of ObGyn care and residency training.20

In choosing to become ObGyns,and particularly in selecting our training program, the ability to provide safe abortion care was a calculated priority. A recent study on the implications of overturning Roe predicted that nearly half of ObGyn residents will likely or certainly lose access to in-state abortion training.21 As demonstrated already in states with restrictive abortion laws, we will lose an entire generation of medical professionals skilled in performing this lifesaving procedure.9,22 While privileged patients may travel across state borders to access care, ObGyn and other medical trainees who are contract bound to residency programs do not have such flexibility to seek out abortion training. Although we hope the reversal of Roe will be fleeting, the consequences of this lost generation are irreparable.23,24 For physicians like ourselves, who fortunately are trained in surgical abortions and safe management of medical terminations, the discrepancy between evidence-based guidelines and impending political restrictions is distressing. We are forced to imagine refusing patients necessary health care—or face incarceration to save their lives.

The idea of watching a patient die, whether by hemorrhage, sepsis, or suicide, while armed with the tools of safe abortion technique is horrific. As authors with roots in Texas, Michigan, and Georgia, where abortion has or will almost certainly become illegal now that Roe v Wade is overturned, this scene is personal. It affects our future patients, our families, our colleagues, and our ability to return to our home states to live and practice.

Political organizing is critical to protect and restore abortion rights and defend against conservative coercive politics.25 Nearly half of pregnancies in the United States are unintended, and more than half of these end in abortion.26,27 Threats to abortion access require action from every one of the 59% of Americans who believe abortion should remain legal.28 This is especially important from a social and racial justice perspective as abortion bans will disproportionately affect marginalized groups and further exacerbate inequities in maternal mortality.13

Call to action

Now is the time for community action for reproductive justice and human rights. We urge everyone to donate to abortion funds, vote for leaders who support reproductive justice, and petition your state legislators to codify Roe into law. Now is the time to expand legislation to protect abortion providers and our patients. To ObGyns, family medicine physicians, internists, and other reproductive health clinicians, now is the time to maximize your abortion training. Now is the time to act; otherwise, pregnant individuals will die and future generations of physicians will not have the training to save their lives. ●

References

 

  1. de Vogue A, Sneed T, Duster C, et al. Supreme Court overturns Roe v Wade. CNN Politics. June 24, 2022. Accessed July 19, 2022. https://www.cnn.com/2022/06/24/politics/dobbs-missis sippi-supreme-court-abortion-roe-wade/index.html
  2. Nash E, Cross L. 26 States are certain or likely to ban abortion without Roe: here’s which ones and why. Guttmacher Institute. October 28, 2021. Updated April 19, 2022. Accessed July 19, 2022. https://www.guttmacher.org/article/2021/10/26-states-are-certain-or-likely-ban-abortion-without-roe-heres-which-ones-and-why
  3. Messerly M. Abortion laws by state: where abortions are illegal after Roe v Wade overturned. Politico. June 24, 2022. Accessed July 19, 2022. https://www.politico.com/news/2022/06/24/abortion-laws-by-state-roe-v-wade-00037695
  4. Archie A. US would lag behind global abortion access if Roe v Wade is undone, advocates say. NPR. May 5, 2022. Accessed July 19, 2022. https://www.npr.org/2022/05/05/1096805490/abortion-access-supreme-court-roe-v-wade-united-nations
  5. Romo V. Massachusetts senate overrides veto, passes law expanding abortion access. NPR. December 29, 2020. Accessed July 19, 2022. https://www.npr.org/2020/12/29/951259506/massachusetts-senate-overrides-veto-passes-law-expanding-abortion-access
  6. Upadhyay UD, Johns NE, Combellick SL, et al. Comparison of outcomes before and after Ohio’s law mandating use of the FDA-approved protocol for medication abortion: a retrospective cohort study. PLoS Med. 2016;13:e1002110.
  7. Upadhyay UD, Johns NE, Cartwright AF, et al. Sociodemographic characteristics of women able to obtain medication abortion before and after Ohio’s law requiring use of the Food and Drug Administration protocol. Health Equity. 2018;2:122-130.
  8. Goyal V, Brooks IHM, Powers DA. Differences in abortion rates by race-ethnicity after implementation of a restrictive Texas law. Contraception. 2020;102:109-114.
  9. Noyes E Holder BH, Evans ML. Texas SB8 and the future of abortion care. OBG Manag. 2021;33. doi:12788/obgm.0151.
  10. Vilda D, Wallace ME, Daniel C, et al. State abortion policies and maternal death in the United States, 2015‒2018. Am J Public Health. 2021;111:1696-1704.
  11. The Lancet. Why Roe v Wade must be defended. Lancet. 2022;399:1845.
  12. Nambiar A, Patel S, Santiago-Munoz P, et al. Maternal morbidity and fetal outcomes among pregnant women at 22 weeks’ gestation or less with complications in two Texas hospitals after legislation on abortion. Am J Obstet Gynecol. 2022;227:648-650.e1.
  13. Stevenson AJ. The pregnancy-related mortality impact of a total abortion ban in the United States: a research note on increased deaths due to remaining pregnant. Demography. 2021;58:20192028.
  14. Medley S. Gutting abortion rights would be devastating for LGBTQ+ people. Them. September 17, 2021. Accessed July 20, 2022. https://www.them.us/story/gutting-abortion-rights-devastating-lgbtq-people
  15. Holter L. Detained immigrant women are facing a grueling abortion struggle. National Latina Institute for Reproductive Justice. May 10, 2017. Accessed July 20, 2022. https://www.latinainsti tute.org/es/node/4620
  16. Haddad LB, Nour NM. Unsafe abortion: unnecessary maternal mortality. Rev Obstet Gynecol. 2009;2:122-126.
  17. Tikkanen R, Gunja MZ, FitzGerald M, et al. Maternal mortality and maternity care in the United States compared to 10 other developed countries. The Commonwealth Fund. November 18, 2020. Accessed November 17, 2022. https://www .commonwealthfund.org/publications/issue -briefs/2020/nov/maternal-mortality-maternity -care-us-compared-10-countries
  18. Collier A-RY, Molina RL. Maternal mortality in the United States: updates on trends, causes, and solutions. Neoreviews. 2019;20:e561-e574.
  19. ACOG practice bulletin no. 135: Second-trimester abortion. Obstet Gynecol. 2013;121:1394-1406.
  20. Committee on Health Care for Underserved Women. ACOG Committee opinion no. 612: Abortion training and education. Obstet Gynecol. 2014;124:1055-1059.
  21. Vinekar K, Karlapudi A, Nathan L, et al. Projected implications of overturning Roe v Wade on abortion training in US obstetrics and gynecology residency programs. Obstet Gynecol. 2022;140:146-149.
  22. Horvath S, Turk J, Steinauer J, et al. Increase in obstetrics and gynecology resident self-assessed competence in early pregnancy loss management with routine abortion care training. Obstet Gynecol. 2022;139:116-119.
  23. Anderson N. The fall of Roe scrambles abortion training in university hospitals. The Washington Post. June 30, 2022. Accessed July 20, 2022. https://www.washingtonpost.com/educa tion/2022/06/30/abortion-training-upheaval-dobbs/
  24. Weiner S. How the repeal of Roe v Wade will affect training in abortion and reproductive health. AAMC. June 24, 2022. Accessed July 20, 2022. https://www.aamc.org/news-insights/how-repeal-roe-v-wade-will-affect-training-abortion-and-reproductive-health
  25. Dreweke J. Coercion is at the heart of social conservatives’ reproductive health agenda. Guttmacher Institute. February 7, 2018. Accessed July 20, 2022. https://www.guttmacher.org/gpr/2018/02/coercion-heart-social-conservatives-reproduc tive-health-agenda
  26. Unintended pregnancy and abortion worldwide. Guttmacher Institute. March 2022. Accessed July 20, 2022. https://www.guttmacher.org/fact-sheet/induced-abortion-worldwide
  27. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374:843-852.
  28. Hartig H. About six-in-ten Americans say abortion should be legal in all or most cases. Pew Research Center. June 13, 2022. Accessed July 20, 2022. https://www.pewresearch.org/fact-tank/2022/06/13/about-six-in-ten-americans-say-abortion-should-be-legal-in-all-or-most-cases-2/
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Emily R. Burdette, MD, MPH

Dr. Burdette is Resident, Obstetrics and Gynecology, Brigham and Women’s Hospital and Massachusetts General Hospital, Boston.

Ellen C. Murphy, MD

Dr. Murphy is Resident, Obstetrics and Gynecology, Brigham and Women’s Hospital and Massachusetts General Hospital, Boston.

 

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Ellen C. Murphy, MD

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Emily R. Burdette, MD, MPH

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Ellen C. Murphy, MD

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On a recent overnight shift, our ObGyn on-call team was urgently paged to the emergency room for a patient who was brought in hemorrhaging after having passed out mid-flight from Texas to Boston. She was 12-weeks pregnant. We rushed her to the operating room for surgical removal of the pregnancy by dilation and curettage to stop her bleeding. Landing in Massachusetts had saved her life.

The significance of this patient’s case was not lost on the multidisciplinary teams caring for her, as the—at the time—impending Roe v Wade decision weighed heavily on our minds. One of many, her story foreshadows the harrowing experiences that we anticipate in the coming months and highlights the danger that the Supreme Court has inflicted on pregnant people nationally.

The Supreme Court decision on Dobbs v Jackson condemns us as a nation in which abortion rights are no longer federally protected under Roe v Wade.1 Twenty-six states have been poised to ban abortion, and in at least 12 states, abortion is now illegal.2,3 Political decision making will soon deny pregnant people the right to bodily autonomy, and the United States will lag behind other nations in abortion access.4 As ObGyn resident physicians who practice in tertiary referral hospitals in Massachusetts, where the ROE Act protects abortion beyond 24 weeks’ gestational age, we affirm abortion as essential health care that saves lives.5

Collectively as physician residents, we have provided an abortion for the patient at 22 weeks with a desired pregnancy who would have otherwise died from high blood pressures, the patient who ended her pregnancy to expedite breast cancer treatment, and the 16-year-old who feared for her life after suffering an assault by her partner for disclosing her pregnancy. With the overturn of Roe v Wade, patients like these will suffer dramatically divergent fates as race, class, and, now more than ever, geography will impact who is able to access abortion care.

Ramifications of the overturn of Roe

History foreshadows the grim impact of repealing Roe. Ohio’s 2011 law that requires the use of the restrictive protocol approved by the US Food and Drug Administration for mifepristone administration deepened existing inequities in abortion access.6 Patients with private insurance, higher income, higher level of education, and those who were White were more likely to obtain abortion care.7 In Texas, after the implementation of SB8 and other restrictive laws, Hispanic women whose travel distance increased more than 100 miles had the greatest reduction in abortion rates.8,9 A recent study regarding banning abortion in the United States estimated a 7% increase in pregnancy-related deaths in 1 year, with a 21% increase in subsequent years.10

Inequities in abortion access subsequently will disparately increase deaths of pregnant individuals in certain populations.11,12 Communities with the highest rates of unintended pregnancy, medical comorbidities, and lack of access to abortion, as well as historically marginalized populations—including non-Hispanic Black people, LGBTQIA people, those with limited English proficiency, and undocumented persons—will experience the greatest increase in pregnancy-related deaths due to a total abortion ban.13-15

The US maternal mortality rate is already the highest among developed nations, and it will only climb if ObGyns are not appropriately trained to operate within our full scope of practice and, thus, are unable to provide the highest quality of care.16,17

Continue: Abortion is a medical treatment that requires resident training...

 

 

Abortion is a medical treatment that requires resident training

Abortion care must be protected. Uterine evacuation by medical management, suction curettage, or dilation and evacuation is indicated for undesired pregnancy, regardless of reasoning or life circumstance. Pregnancy carries inherent risks that can at times be deadly.18 Abortion serves as first-line treatment for certain life-threatening pregnancy risks, including septic miscarriage, maternal hemorrhage, early-onset severe preeclampsia, and certain health conditions.19 Surgical skills and medical management of abortion are therefore fundamental components of ObGyn care and residency training.20

In choosing to become ObGyns,and particularly in selecting our training program, the ability to provide safe abortion care was a calculated priority. A recent study on the implications of overturning Roe predicted that nearly half of ObGyn residents will likely or certainly lose access to in-state abortion training.21 As demonstrated already in states with restrictive abortion laws, we will lose an entire generation of medical professionals skilled in performing this lifesaving procedure.9,22 While privileged patients may travel across state borders to access care, ObGyn and other medical trainees who are contract bound to residency programs do not have such flexibility to seek out abortion training. Although we hope the reversal of Roe will be fleeting, the consequences of this lost generation are irreparable.23,24 For physicians like ourselves, who fortunately are trained in surgical abortions and safe management of medical terminations, the discrepancy between evidence-based guidelines and impending political restrictions is distressing. We are forced to imagine refusing patients necessary health care—or face incarceration to save their lives.

The idea of watching a patient die, whether by hemorrhage, sepsis, or suicide, while armed with the tools of safe abortion technique is horrific. As authors with roots in Texas, Michigan, and Georgia, where abortion has or will almost certainly become illegal now that Roe v Wade is overturned, this scene is personal. It affects our future patients, our families, our colleagues, and our ability to return to our home states to live and practice.

Political organizing is critical to protect and restore abortion rights and defend against conservative coercive politics.25 Nearly half of pregnancies in the United States are unintended, and more than half of these end in abortion.26,27 Threats to abortion access require action from every one of the 59% of Americans who believe abortion should remain legal.28 This is especially important from a social and racial justice perspective as abortion bans will disproportionately affect marginalized groups and further exacerbate inequities in maternal mortality.13

Call to action

Now is the time for community action for reproductive justice and human rights. We urge everyone to donate to abortion funds, vote for leaders who support reproductive justice, and petition your state legislators to codify Roe into law. Now is the time to expand legislation to protect abortion providers and our patients. To ObGyns, family medicine physicians, internists, and other reproductive health clinicians, now is the time to maximize your abortion training. Now is the time to act; otherwise, pregnant individuals will die and future generations of physicians will not have the training to save their lives. ●

 

On a recent overnight shift, our ObGyn on-call team was urgently paged to the emergency room for a patient who was brought in hemorrhaging after having passed out mid-flight from Texas to Boston. She was 12-weeks pregnant. We rushed her to the operating room for surgical removal of the pregnancy by dilation and curettage to stop her bleeding. Landing in Massachusetts had saved her life.

The significance of this patient’s case was not lost on the multidisciplinary teams caring for her, as the—at the time—impending Roe v Wade decision weighed heavily on our minds. One of many, her story foreshadows the harrowing experiences that we anticipate in the coming months and highlights the danger that the Supreme Court has inflicted on pregnant people nationally.

The Supreme Court decision on Dobbs v Jackson condemns us as a nation in which abortion rights are no longer federally protected under Roe v Wade.1 Twenty-six states have been poised to ban abortion, and in at least 12 states, abortion is now illegal.2,3 Political decision making will soon deny pregnant people the right to bodily autonomy, and the United States will lag behind other nations in abortion access.4 As ObGyn resident physicians who practice in tertiary referral hospitals in Massachusetts, where the ROE Act protects abortion beyond 24 weeks’ gestational age, we affirm abortion as essential health care that saves lives.5

Collectively as physician residents, we have provided an abortion for the patient at 22 weeks with a desired pregnancy who would have otherwise died from high blood pressures, the patient who ended her pregnancy to expedite breast cancer treatment, and the 16-year-old who feared for her life after suffering an assault by her partner for disclosing her pregnancy. With the overturn of Roe v Wade, patients like these will suffer dramatically divergent fates as race, class, and, now more than ever, geography will impact who is able to access abortion care.

Ramifications of the overturn of Roe

History foreshadows the grim impact of repealing Roe. Ohio’s 2011 law that requires the use of the restrictive protocol approved by the US Food and Drug Administration for mifepristone administration deepened existing inequities in abortion access.6 Patients with private insurance, higher income, higher level of education, and those who were White were more likely to obtain abortion care.7 In Texas, after the implementation of SB8 and other restrictive laws, Hispanic women whose travel distance increased more than 100 miles had the greatest reduction in abortion rates.8,9 A recent study regarding banning abortion in the United States estimated a 7% increase in pregnancy-related deaths in 1 year, with a 21% increase in subsequent years.10

Inequities in abortion access subsequently will disparately increase deaths of pregnant individuals in certain populations.11,12 Communities with the highest rates of unintended pregnancy, medical comorbidities, and lack of access to abortion, as well as historically marginalized populations—including non-Hispanic Black people, LGBTQIA people, those with limited English proficiency, and undocumented persons—will experience the greatest increase in pregnancy-related deaths due to a total abortion ban.13-15

The US maternal mortality rate is already the highest among developed nations, and it will only climb if ObGyns are not appropriately trained to operate within our full scope of practice and, thus, are unable to provide the highest quality of care.16,17

Continue: Abortion is a medical treatment that requires resident training...

 

 

Abortion is a medical treatment that requires resident training

Abortion care must be protected. Uterine evacuation by medical management, suction curettage, or dilation and evacuation is indicated for undesired pregnancy, regardless of reasoning or life circumstance. Pregnancy carries inherent risks that can at times be deadly.18 Abortion serves as first-line treatment for certain life-threatening pregnancy risks, including septic miscarriage, maternal hemorrhage, early-onset severe preeclampsia, and certain health conditions.19 Surgical skills and medical management of abortion are therefore fundamental components of ObGyn care and residency training.20

In choosing to become ObGyns,and particularly in selecting our training program, the ability to provide safe abortion care was a calculated priority. A recent study on the implications of overturning Roe predicted that nearly half of ObGyn residents will likely or certainly lose access to in-state abortion training.21 As demonstrated already in states with restrictive abortion laws, we will lose an entire generation of medical professionals skilled in performing this lifesaving procedure.9,22 While privileged patients may travel across state borders to access care, ObGyn and other medical trainees who are contract bound to residency programs do not have such flexibility to seek out abortion training. Although we hope the reversal of Roe will be fleeting, the consequences of this lost generation are irreparable.23,24 For physicians like ourselves, who fortunately are trained in surgical abortions and safe management of medical terminations, the discrepancy between evidence-based guidelines and impending political restrictions is distressing. We are forced to imagine refusing patients necessary health care—or face incarceration to save their lives.

The idea of watching a patient die, whether by hemorrhage, sepsis, or suicide, while armed with the tools of safe abortion technique is horrific. As authors with roots in Texas, Michigan, and Georgia, where abortion has or will almost certainly become illegal now that Roe v Wade is overturned, this scene is personal. It affects our future patients, our families, our colleagues, and our ability to return to our home states to live and practice.

Political organizing is critical to protect and restore abortion rights and defend against conservative coercive politics.25 Nearly half of pregnancies in the United States are unintended, and more than half of these end in abortion.26,27 Threats to abortion access require action from every one of the 59% of Americans who believe abortion should remain legal.28 This is especially important from a social and racial justice perspective as abortion bans will disproportionately affect marginalized groups and further exacerbate inequities in maternal mortality.13

Call to action

Now is the time for community action for reproductive justice and human rights. We urge everyone to donate to abortion funds, vote for leaders who support reproductive justice, and petition your state legislators to codify Roe into law. Now is the time to expand legislation to protect abortion providers and our patients. To ObGyns, family medicine physicians, internists, and other reproductive health clinicians, now is the time to maximize your abortion training. Now is the time to act; otherwise, pregnant individuals will die and future generations of physicians will not have the training to save their lives. ●

References

 

  1. de Vogue A, Sneed T, Duster C, et al. Supreme Court overturns Roe v Wade. CNN Politics. June 24, 2022. Accessed July 19, 2022. https://www.cnn.com/2022/06/24/politics/dobbs-missis sippi-supreme-court-abortion-roe-wade/index.html
  2. Nash E, Cross L. 26 States are certain or likely to ban abortion without Roe: here’s which ones and why. Guttmacher Institute. October 28, 2021. Updated April 19, 2022. Accessed July 19, 2022. https://www.guttmacher.org/article/2021/10/26-states-are-certain-or-likely-ban-abortion-without-roe-heres-which-ones-and-why
  3. Messerly M. Abortion laws by state: where abortions are illegal after Roe v Wade overturned. Politico. June 24, 2022. Accessed July 19, 2022. https://www.politico.com/news/2022/06/24/abortion-laws-by-state-roe-v-wade-00037695
  4. Archie A. US would lag behind global abortion access if Roe v Wade is undone, advocates say. NPR. May 5, 2022. Accessed July 19, 2022. https://www.npr.org/2022/05/05/1096805490/abortion-access-supreme-court-roe-v-wade-united-nations
  5. Romo V. Massachusetts senate overrides veto, passes law expanding abortion access. NPR. December 29, 2020. Accessed July 19, 2022. https://www.npr.org/2020/12/29/951259506/massachusetts-senate-overrides-veto-passes-law-expanding-abortion-access
  6. Upadhyay UD, Johns NE, Combellick SL, et al. Comparison of outcomes before and after Ohio’s law mandating use of the FDA-approved protocol for medication abortion: a retrospective cohort study. PLoS Med. 2016;13:e1002110.
  7. Upadhyay UD, Johns NE, Cartwright AF, et al. Sociodemographic characteristics of women able to obtain medication abortion before and after Ohio’s law requiring use of the Food and Drug Administration protocol. Health Equity. 2018;2:122-130.
  8. Goyal V, Brooks IHM, Powers DA. Differences in abortion rates by race-ethnicity after implementation of a restrictive Texas law. Contraception. 2020;102:109-114.
  9. Noyes E Holder BH, Evans ML. Texas SB8 and the future of abortion care. OBG Manag. 2021;33. doi:12788/obgm.0151.
  10. Vilda D, Wallace ME, Daniel C, et al. State abortion policies and maternal death in the United States, 2015‒2018. Am J Public Health. 2021;111:1696-1704.
  11. The Lancet. Why Roe v Wade must be defended. Lancet. 2022;399:1845.
  12. Nambiar A, Patel S, Santiago-Munoz P, et al. Maternal morbidity and fetal outcomes among pregnant women at 22 weeks’ gestation or less with complications in two Texas hospitals after legislation on abortion. Am J Obstet Gynecol. 2022;227:648-650.e1.
  13. Stevenson AJ. The pregnancy-related mortality impact of a total abortion ban in the United States: a research note on increased deaths due to remaining pregnant. Demography. 2021;58:20192028.
  14. Medley S. Gutting abortion rights would be devastating for LGBTQ+ people. Them. September 17, 2021. Accessed July 20, 2022. https://www.them.us/story/gutting-abortion-rights-devastating-lgbtq-people
  15. Holter L. Detained immigrant women are facing a grueling abortion struggle. National Latina Institute for Reproductive Justice. May 10, 2017. Accessed July 20, 2022. https://www.latinainsti tute.org/es/node/4620
  16. Haddad LB, Nour NM. Unsafe abortion: unnecessary maternal mortality. Rev Obstet Gynecol. 2009;2:122-126.
  17. Tikkanen R, Gunja MZ, FitzGerald M, et al. Maternal mortality and maternity care in the United States compared to 10 other developed countries. The Commonwealth Fund. November 18, 2020. Accessed November 17, 2022. https://www .commonwealthfund.org/publications/issue -briefs/2020/nov/maternal-mortality-maternity -care-us-compared-10-countries
  18. Collier A-RY, Molina RL. Maternal mortality in the United States: updates on trends, causes, and solutions. Neoreviews. 2019;20:e561-e574.
  19. ACOG practice bulletin no. 135: Second-trimester abortion. Obstet Gynecol. 2013;121:1394-1406.
  20. Committee on Health Care for Underserved Women. ACOG Committee opinion no. 612: Abortion training and education. Obstet Gynecol. 2014;124:1055-1059.
  21. Vinekar K, Karlapudi A, Nathan L, et al. Projected implications of overturning Roe v Wade on abortion training in US obstetrics and gynecology residency programs. Obstet Gynecol. 2022;140:146-149.
  22. Horvath S, Turk J, Steinauer J, et al. Increase in obstetrics and gynecology resident self-assessed competence in early pregnancy loss management with routine abortion care training. Obstet Gynecol. 2022;139:116-119.
  23. Anderson N. The fall of Roe scrambles abortion training in university hospitals. The Washington Post. June 30, 2022. Accessed July 20, 2022. https://www.washingtonpost.com/educa tion/2022/06/30/abortion-training-upheaval-dobbs/
  24. Weiner S. How the repeal of Roe v Wade will affect training in abortion and reproductive health. AAMC. June 24, 2022. Accessed July 20, 2022. https://www.aamc.org/news-insights/how-repeal-roe-v-wade-will-affect-training-abortion-and-reproductive-health
  25. Dreweke J. Coercion is at the heart of social conservatives’ reproductive health agenda. Guttmacher Institute. February 7, 2018. Accessed July 20, 2022. https://www.guttmacher.org/gpr/2018/02/coercion-heart-social-conservatives-reproduc tive-health-agenda
  26. Unintended pregnancy and abortion worldwide. Guttmacher Institute. March 2022. Accessed July 20, 2022. https://www.guttmacher.org/fact-sheet/induced-abortion-worldwide
  27. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374:843-852.
  28. Hartig H. About six-in-ten Americans say abortion should be legal in all or most cases. Pew Research Center. June 13, 2022. Accessed July 20, 2022. https://www.pewresearch.org/fact-tank/2022/06/13/about-six-in-ten-americans-say-abortion-should-be-legal-in-all-or-most-cases-2/
References

 

  1. de Vogue A, Sneed T, Duster C, et al. Supreme Court overturns Roe v Wade. CNN Politics. June 24, 2022. Accessed July 19, 2022. https://www.cnn.com/2022/06/24/politics/dobbs-missis sippi-supreme-court-abortion-roe-wade/index.html
  2. Nash E, Cross L. 26 States are certain or likely to ban abortion without Roe: here’s which ones and why. Guttmacher Institute. October 28, 2021. Updated April 19, 2022. Accessed July 19, 2022. https://www.guttmacher.org/article/2021/10/26-states-are-certain-or-likely-ban-abortion-without-roe-heres-which-ones-and-why
  3. Messerly M. Abortion laws by state: where abortions are illegal after Roe v Wade overturned. Politico. June 24, 2022. Accessed July 19, 2022. https://www.politico.com/news/2022/06/24/abortion-laws-by-state-roe-v-wade-00037695
  4. Archie A. US would lag behind global abortion access if Roe v Wade is undone, advocates say. NPR. May 5, 2022. Accessed July 19, 2022. https://www.npr.org/2022/05/05/1096805490/abortion-access-supreme-court-roe-v-wade-united-nations
  5. Romo V. Massachusetts senate overrides veto, passes law expanding abortion access. NPR. December 29, 2020. Accessed July 19, 2022. https://www.npr.org/2020/12/29/951259506/massachusetts-senate-overrides-veto-passes-law-expanding-abortion-access
  6. Upadhyay UD, Johns NE, Combellick SL, et al. Comparison of outcomes before and after Ohio’s law mandating use of the FDA-approved protocol for medication abortion: a retrospective cohort study. PLoS Med. 2016;13:e1002110.
  7. Upadhyay UD, Johns NE, Cartwright AF, et al. Sociodemographic characteristics of women able to obtain medication abortion before and after Ohio’s law requiring use of the Food and Drug Administration protocol. Health Equity. 2018;2:122-130.
  8. Goyal V, Brooks IHM, Powers DA. Differences in abortion rates by race-ethnicity after implementation of a restrictive Texas law. Contraception. 2020;102:109-114.
  9. Noyes E Holder BH, Evans ML. Texas SB8 and the future of abortion care. OBG Manag. 2021;33. doi:12788/obgm.0151.
  10. Vilda D, Wallace ME, Daniel C, et al. State abortion policies and maternal death in the United States, 2015‒2018. Am J Public Health. 2021;111:1696-1704.
  11. The Lancet. Why Roe v Wade must be defended. Lancet. 2022;399:1845.
  12. Nambiar A, Patel S, Santiago-Munoz P, et al. Maternal morbidity and fetal outcomes among pregnant women at 22 weeks’ gestation or less with complications in two Texas hospitals after legislation on abortion. Am J Obstet Gynecol. 2022;227:648-650.e1.
  13. Stevenson AJ. The pregnancy-related mortality impact of a total abortion ban in the United States: a research note on increased deaths due to remaining pregnant. Demography. 2021;58:20192028.
  14. Medley S. Gutting abortion rights would be devastating for LGBTQ+ people. Them. September 17, 2021. Accessed July 20, 2022. https://www.them.us/story/gutting-abortion-rights-devastating-lgbtq-people
  15. Holter L. Detained immigrant women are facing a grueling abortion struggle. National Latina Institute for Reproductive Justice. May 10, 2017. Accessed July 20, 2022. https://www.latinainsti tute.org/es/node/4620
  16. Haddad LB, Nour NM. Unsafe abortion: unnecessary maternal mortality. Rev Obstet Gynecol. 2009;2:122-126.
  17. Tikkanen R, Gunja MZ, FitzGerald M, et al. Maternal mortality and maternity care in the United States compared to 10 other developed countries. The Commonwealth Fund. November 18, 2020. Accessed November 17, 2022. https://www .commonwealthfund.org/publications/issue -briefs/2020/nov/maternal-mortality-maternity -care-us-compared-10-countries
  18. Collier A-RY, Molina RL. Maternal mortality in the United States: updates on trends, causes, and solutions. Neoreviews. 2019;20:e561-e574.
  19. ACOG practice bulletin no. 135: Second-trimester abortion. Obstet Gynecol. 2013;121:1394-1406.
  20. Committee on Health Care for Underserved Women. ACOG Committee opinion no. 612: Abortion training and education. Obstet Gynecol. 2014;124:1055-1059.
  21. Vinekar K, Karlapudi A, Nathan L, et al. Projected implications of overturning Roe v Wade on abortion training in US obstetrics and gynecology residency programs. Obstet Gynecol. 2022;140:146-149.
  22. Horvath S, Turk J, Steinauer J, et al. Increase in obstetrics and gynecology resident self-assessed competence in early pregnancy loss management with routine abortion care training. Obstet Gynecol. 2022;139:116-119.
  23. Anderson N. The fall of Roe scrambles abortion training in university hospitals. The Washington Post. June 30, 2022. Accessed July 20, 2022. https://www.washingtonpost.com/educa tion/2022/06/30/abortion-training-upheaval-dobbs/
  24. Weiner S. How the repeal of Roe v Wade will affect training in abortion and reproductive health. AAMC. June 24, 2022. Accessed July 20, 2022. https://www.aamc.org/news-insights/how-repeal-roe-v-wade-will-affect-training-abortion-and-reproductive-health
  25. Dreweke J. Coercion is at the heart of social conservatives’ reproductive health agenda. Guttmacher Institute. February 7, 2018. Accessed July 20, 2022. https://www.guttmacher.org/gpr/2018/02/coercion-heart-social-conservatives-reproduc tive-health-agenda
  26. Unintended pregnancy and abortion worldwide. Guttmacher Institute. March 2022. Accessed July 20, 2022. https://www.guttmacher.org/fact-sheet/induced-abortion-worldwide
  27. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374:843-852.
  28. Hartig H. About six-in-ten Americans say abortion should be legal in all or most cases. Pew Research Center. June 13, 2022. Accessed July 20, 2022. https://www.pewresearch.org/fact-tank/2022/06/13/about-six-in-ten-americans-say-abortion-should-be-legal-in-all-or-most-cases-2/
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