MDedge ObGyn

A study of elderly patients with HER2-positive/HR-negative metastatic breast cancer finds a significantly shorter median overall survival in actual clinical practice than younger counterparts.

After 46 months of treatment, the survival rate was only 25%, according to a study presented in June at the annual meeting of the American Society of Clinical Oncology. The finding suggests that older age is an important prognostic factor for breast cancer survival, said study author Zhonghui Jenny Ou, a doctoral candidate at the Massachusetts College of Pharmacy and Health Sciences in Boston.

For comparison, Ms. Ou cited the CLEOPATRA trial which showed a median overall survival of 57.1 months for patients who were treated with pertuzumab, docetaxel and trastuzumab versus 40.8 months for placebo with docetaxel plus trastuzumab.

The Ou study is based on an analysis of data between 2012 and 2016 from the SEER-Medicare database. The final analysis included 73 women (average age 75 years at diagnosis) with early-stage HER2-positive/HR-negative metastatic breast cancer. Fifty-six women were treated with trastuzumab with pertuzumab and chemotherapy as first-line treatment, and 17 were treated with chemotherapy only. The longest length of treatment with trastuzumab was over 44 months. And, the median follow-up for overall survival was 13 months (95% confidence interval, 12.7-18.7).

Between 2012 and 2016, five patients died from other causes, including lung cancer, cerebrovascular diseases, aortic aneurysm and dissection, pneumonia and influenza, and heart disease.

“While there are many clinical trials about HER2-positive metastatic breast cancer, these trials were all performed in younger and relatively healthier patients. Few studies included elderly patients 65 years or older,” Ms. Ou said.

According to the American Cancer Society, 31% of all newly diagnosed breast cancer cases are in women who are 70 years old or older, yet 47% of all breast cancer deaths each year are in women in this age group.

Undertreatment and lower treatment intensity have been cited by other studies as possible contributing factors to lower overall survival rates, but breast cancer in elderly women is a complex and understudied subject. Why the mortality rates for elderly women are disproportionately higher than those of younger women is attributable to a number of reasons, write the authors of one of the most recent studies on the subject.

“It is well established that receipt of adjuvant chemotherapy, trastuzumab, and hormonal therapy reduces risk of recurrence and death across all age groups, yet multiple studies document suboptimal systemic treatment and adherence for older patients, including omission of efficacious treatments, receipt of lower intensity and/or nonguideline treatment, or poor adherence to hormonal therapy,” Freedman et al. wrote in the May 15, 2018, issue of the journal Cancer.

While the Ou study sample size was small, the study’s real-world analysis is telling, Ms. Ou said.

“The major limitation of this study is that it has – after applying all the eligibility criteria to the 170,516 breast cancer patients from the SEER-Medicare database between 2012 and 2016 – a study population of just 73 patients. The number is sufficient to do survival analysis,” she said.

A study of elderly patients with HER2-positive/HR-negative metastatic breast cancer finds a significantly shorter median overall survival in actual clinical practice than younger counterparts.

After 46 months of treatment, the survival rate was only 25%, according to a study presented in June at the annual meeting of the American Society of Clinical Oncology. The finding suggests that older age is an important prognostic factor for breast cancer survival, said study author Zhonghui Jenny Ou, a doctoral candidate at the Massachusetts College of Pharmacy and Health Sciences in Boston.

For comparison, Ms. Ou cited the CLEOPATRA trial which showed a median overall survival of 57.1 months for patients who were treated with pertuzumab, docetaxel and trastuzumab versus 40.8 months for placebo with docetaxel plus trastuzumab.

The Ou study is based on an analysis of data between 2012 and 2016 from the SEER-Medicare database. The final analysis included 73 women (average age 75 years at diagnosis) with early-stage HER2-positive/HR-negative metastatic breast cancer. Fifty-six women were treated with trastuzumab with pertuzumab and chemotherapy as first-line treatment, and 17 were treated with chemotherapy only. The longest length of treatment with trastuzumab was over 44 months. And, the median follow-up for overall survival was 13 months (95% confidence interval, 12.7-18.7).

Between 2012 and 2016, five patients died from other causes, including lung cancer, cerebrovascular diseases, aortic aneurysm and dissection, pneumonia and influenza, and heart disease.

“While there are many clinical trials about HER2-positive metastatic breast cancer, these trials were all performed in younger and relatively healthier patients. Few studies included elderly patients 65 years or older,” Ms. Ou said.

According to the American Cancer Society, 31% of all newly diagnosed breast cancer cases are in women who are 70 years old or older, yet 47% of all breast cancer deaths each year are in women in this age group.

Undertreatment and lower treatment intensity have been cited by other studies as possible contributing factors to lower overall survival rates, but breast cancer in elderly women is a complex and understudied subject. Why the mortality rates for elderly women are disproportionately higher than those of younger women is attributable to a number of reasons, write the authors of one of the most recent studies on the subject.

“It is well established that receipt of adjuvant chemotherapy, trastuzumab, and hormonal therapy reduces risk of recurrence and death across all age groups, yet multiple studies document suboptimal systemic treatment and adherence for older patients, including omission of efficacious treatments, receipt of lower intensity and/or nonguideline treatment, or poor adherence to hormonal therapy,” Freedman et al. wrote in the May 15, 2018, issue of the journal Cancer.

While the Ou study sample size was small, the study’s real-world analysis is telling, Ms. Ou said.

“The major limitation of this study is that it has – after applying all the eligibility criteria to the 170,516 breast cancer patients from the SEER-Medicare database between 2012 and 2016 – a study population of just 73 patients. The number is sufficient to do survival analysis,” she said.

A study of elderly patients with HER2-positive/HR-negative metastatic breast cancer finds a significantly shorter median overall survival in actual clinical practice than younger counterparts.

After 46 months of treatment, the survival rate was only 25%, according to a study presented in June at the annual meeting of the American Society of Clinical Oncology. The finding suggests that older age is an important prognostic factor for breast cancer survival, said study author Zhonghui Jenny Ou, a doctoral candidate at the Massachusetts College of Pharmacy and Health Sciences in Boston.

For comparison, Ms. Ou cited the CLEOPATRA trial which showed a median overall survival of 57.1 months for patients who were treated with pertuzumab, docetaxel and trastuzumab versus 40.8 months for placebo with docetaxel plus trastuzumab.

The Ou study is based on an analysis of data between 2012 and 2016 from the SEER-Medicare database. The final analysis included 73 women (average age 75 years at diagnosis) with early-stage HER2-positive/HR-negative metastatic breast cancer. Fifty-six women were treated with trastuzumab with pertuzumab and chemotherapy as first-line treatment, and 17 were treated with chemotherapy only. The longest length of treatment with trastuzumab was over 44 months. And, the median follow-up for overall survival was 13 months (95% confidence interval, 12.7-18.7).

Between 2012 and 2016, five patients died from other causes, including lung cancer, cerebrovascular diseases, aortic aneurysm and dissection, pneumonia and influenza, and heart disease.

“While there are many clinical trials about HER2-positive metastatic breast cancer, these trials were all performed in younger and relatively healthier patients. Few studies included elderly patients 65 years or older,” Ms. Ou said.

According to the American Cancer Society, 31% of all newly diagnosed breast cancer cases are in women who are 70 years old or older, yet 47% of all breast cancer deaths each year are in women in this age group.

Undertreatment and lower treatment intensity have been cited by other studies as possible contributing factors to lower overall survival rates, but breast cancer in elderly women is a complex and understudied subject. Why the mortality rates for elderly women are disproportionately higher than those of younger women is attributable to a number of reasons, write the authors of one of the most recent studies on the subject.

“It is well established that receipt of adjuvant chemotherapy, trastuzumab, and hormonal therapy reduces risk of recurrence and death across all age groups, yet multiple studies document suboptimal systemic treatment and adherence for older patients, including omission of efficacious treatments, receipt of lower intensity and/or nonguideline treatment, or poor adherence to hormonal therapy,” Freedman et al. wrote in the May 15, 2018, issue of the journal Cancer.

While the Ou study sample size was small, the study’s real-world analysis is telling, Ms. Ou said.

“The major limitation of this study is that it has – after applying all the eligibility criteria to the 170,516 breast cancer patients from the SEER-Medicare database between 2012 and 2016 – a study population of just 73 patients. The number is sufficient to do survival analysis,” she said.

Eight-year follow-up of the ASTRRA trial confirmed and extended support for adding 2 years of ovarian function suppression with goserelin to tamoxifen, compared with tamoxifen alone.

“Adding ovarian suppression to tamoxifen should be considered for this population of women,” said senior author Hee Jeong Kim, MD, a breast cancer surgeon with the Asan Medical Center, Seoul, South Korea. Dr. Kim presented the data earlier this month at the annual meeting of the American Society of Clinical Oncology.

The median disease-free survival rate of 85.4% for tamoxifen plus ovarian function suppression versus 80.2% for tamoxifen alone (HR, 0.67; 95% confidence interval, 0.514-0.869; P = .0027) was consistent with recent findings from SOFT (Suppression of Ovarian Function Trial), which also showed a clear survival benefit in breast cancer events with the addition of ovarian function suppression to tamoxifen for women who remain premenopausal after chemotherapy. SOFT trial analyses of disease-free survival at 5 and 8 years demonstrated hazard ratios of 0.82 and 0.76 respectively.

Dr. Kim’s study is a post-trial follow-up of the ASTRRA trial, or the Addition of Ovarian Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain Premenopausal or Regain Vaginal Bleeding After Chemotherapy, which randomly assigned 1,298 patients with breast cancer in a one-to-one ratio to receive tamoxifen only (n = 647) or tamoxifen plus ovarian function suppression (n = 635). The primary endpoint was disease-free survival and the secondary endpoint was overall survival.

Earlier ASTRRA analysis at 5-year follow-up had shown disease-free survival rates of 89.9% for tamoxifen plus ovarian function suppression versus 87.2% for tamoxifen alone in women with hormone-sensitive breast cancer who remained premenopausal or had premenopausal status restored after chemotherapy. Overall survival, a secondary endpoint, also favored adding ovarian function suppression (HR, 0.31; 95% CI, 0.10-0.94; P = .029). The absolute difference for disease-free survival adding ovarian function suppression at the later median follow-up of 106.4 months was 5.2%. The difference at 5 years had been 2.7%, Dr. Kim pointed out. Also, these findings were calculated from time of enrollment. When calculated from time of randomization, the disease-free survival rates were 84.1% and 78.1%, respectively, for tamoxifen plus ovarian function suppression and tamoxifen alone, with a 6.0% absolute difference (HR, 0.67; 95% CI, 0.516-0.872); P = .0025).

The benefit of adding ovarian function suppression to tamoxifen for the secondary endpoint of overall survival at 8 years (96.5% versus 95.3%) did not achieve statistical significance (HR, 0.78; 95% CI, 0.486-1.253); P = .3). “Although it’s not statistically significant, there are absolute differences between the two groups favoring tamoxifen plus ovarian function suppression,” Dr. Kim said in an interview. She pointed out also that for distant metastasis-free survival the hazard ratio was 0.71, significantly favoring tamoxifen plus ovarian function suppression. “More than 95% were still surviving at 8 years with tamoxifen plus ovarian function suppression. So, we need more events to fully evaluate the overall survival benefit.”

A study limitation, Dr. Kim acknowledged in the interview, is that safety and adverse event data were not collected. “As ovarian function suppression has been widely used in clinical practice for decades, and the side effects of its relatively short-term use were considered to be well-understood in previous studies, we focused on the oncologic efficacy of ovarian function suppression in this study,” she said.

Eight-year follow-up of the ASTRRA trial confirmed and extended support for adding 2 years of ovarian function suppression with goserelin to tamoxifen, compared with tamoxifen alone.

“Adding ovarian suppression to tamoxifen should be considered for this population of women,” said senior author Hee Jeong Kim, MD, a breast cancer surgeon with the Asan Medical Center, Seoul, South Korea. Dr. Kim presented the data earlier this month at the annual meeting of the American Society of Clinical Oncology.

The median disease-free survival rate of 85.4% for tamoxifen plus ovarian function suppression versus 80.2% for tamoxifen alone (HR, 0.67; 95% confidence interval, 0.514-0.869; P = .0027) was consistent with recent findings from SOFT (Suppression of Ovarian Function Trial), which also showed a clear survival benefit in breast cancer events with the addition of ovarian function suppression to tamoxifen for women who remain premenopausal after chemotherapy. SOFT trial analyses of disease-free survival at 5 and 8 years demonstrated hazard ratios of 0.82 and 0.76 respectively.

Dr. Kim’s study is a post-trial follow-up of the ASTRRA trial, or the Addition of Ovarian Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain Premenopausal or Regain Vaginal Bleeding After Chemotherapy, which randomly assigned 1,298 patients with breast cancer in a one-to-one ratio to receive tamoxifen only (n = 647) or tamoxifen plus ovarian function suppression (n = 635). The primary endpoint was disease-free survival and the secondary endpoint was overall survival.

Earlier ASTRRA analysis at 5-year follow-up had shown disease-free survival rates of 89.9% for tamoxifen plus ovarian function suppression versus 87.2% for tamoxifen alone in women with hormone-sensitive breast cancer who remained premenopausal or had premenopausal status restored after chemotherapy. Overall survival, a secondary endpoint, also favored adding ovarian function suppression (HR, 0.31; 95% CI, 0.10-0.94; P = .029). The absolute difference for disease-free survival adding ovarian function suppression at the later median follow-up of 106.4 months was 5.2%. The difference at 5 years had been 2.7%, Dr. Kim pointed out. Also, these findings were calculated from time of enrollment. When calculated from time of randomization, the disease-free survival rates were 84.1% and 78.1%, respectively, for tamoxifen plus ovarian function suppression and tamoxifen alone, with a 6.0% absolute difference (HR, 0.67; 95% CI, 0.516-0.872); P = .0025).

The benefit of adding ovarian function suppression to tamoxifen for the secondary endpoint of overall survival at 8 years (96.5% versus 95.3%) did not achieve statistical significance (HR, 0.78; 95% CI, 0.486-1.253); P = .3). “Although it’s not statistically significant, there are absolute differences between the two groups favoring tamoxifen plus ovarian function suppression,” Dr. Kim said in an interview. She pointed out also that for distant metastasis-free survival the hazard ratio was 0.71, significantly favoring tamoxifen plus ovarian function suppression. “More than 95% were still surviving at 8 years with tamoxifen plus ovarian function suppression. So, we need more events to fully evaluate the overall survival benefit.”

A study limitation, Dr. Kim acknowledged in the interview, is that safety and adverse event data were not collected. “As ovarian function suppression has been widely used in clinical practice for decades, and the side effects of its relatively short-term use were considered to be well-understood in previous studies, we focused on the oncologic efficacy of ovarian function suppression in this study,” she said.

Eight-year follow-up of the ASTRRA trial confirmed and extended support for adding 2 years of ovarian function suppression with goserelin to tamoxifen, compared with tamoxifen alone.

“Adding ovarian suppression to tamoxifen should be considered for this population of women,” said senior author Hee Jeong Kim, MD, a breast cancer surgeon with the Asan Medical Center, Seoul, South Korea. Dr. Kim presented the data earlier this month at the annual meeting of the American Society of Clinical Oncology.

The median disease-free survival rate of 85.4% for tamoxifen plus ovarian function suppression versus 80.2% for tamoxifen alone (HR, 0.67; 95% confidence interval, 0.514-0.869; P = .0027) was consistent with recent findings from SOFT (Suppression of Ovarian Function Trial), which also showed a clear survival benefit in breast cancer events with the addition of ovarian function suppression to tamoxifen for women who remain premenopausal after chemotherapy. SOFT trial analyses of disease-free survival at 5 and 8 years demonstrated hazard ratios of 0.82 and 0.76 respectively.

Dr. Kim’s study is a post-trial follow-up of the ASTRRA trial, or the Addition of Ovarian Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain Premenopausal or Regain Vaginal Bleeding After Chemotherapy, which randomly assigned 1,298 patients with breast cancer in a one-to-one ratio to receive tamoxifen only (n = 647) or tamoxifen plus ovarian function suppression (n = 635). The primary endpoint was disease-free survival and the secondary endpoint was overall survival.

Earlier ASTRRA analysis at 5-year follow-up had shown disease-free survival rates of 89.9% for tamoxifen plus ovarian function suppression versus 87.2% for tamoxifen alone in women with hormone-sensitive breast cancer who remained premenopausal or had premenopausal status restored after chemotherapy. Overall survival, a secondary endpoint, also favored adding ovarian function suppression (HR, 0.31; 95% CI, 0.10-0.94; P = .029). The absolute difference for disease-free survival adding ovarian function suppression at the later median follow-up of 106.4 months was 5.2%. The difference at 5 years had been 2.7%, Dr. Kim pointed out. Also, these findings were calculated from time of enrollment. When calculated from time of randomization, the disease-free survival rates were 84.1% and 78.1%, respectively, for tamoxifen plus ovarian function suppression and tamoxifen alone, with a 6.0% absolute difference (HR, 0.67; 95% CI, 0.516-0.872); P = .0025).

The benefit of adding ovarian function suppression to tamoxifen for the secondary endpoint of overall survival at 8 years (96.5% versus 95.3%) did not achieve statistical significance (HR, 0.78; 95% CI, 0.486-1.253); P = .3). “Although it’s not statistically significant, there are absolute differences between the two groups favoring tamoxifen plus ovarian function suppression,” Dr. Kim said in an interview. She pointed out also that for distant metastasis-free survival the hazard ratio was 0.71, significantly favoring tamoxifen plus ovarian function suppression. “More than 95% were still surviving at 8 years with tamoxifen plus ovarian function suppression. So, we need more events to fully evaluate the overall survival benefit.”

A study limitation, Dr. Kim acknowledged in the interview, is that safety and adverse event data were not collected. “As ovarian function suppression has been widely used in clinical practice for decades, and the side effects of its relatively short-term use were considered to be well-understood in previous studies, we focused on the oncologic efficacy of ovarian function suppression in this study,” she said.

A neighborhood analysis of socioeconomic status conducted in the Pittsburgh area found worse metastatic breast cancer survival outcomes among patients of low socioeconomic status. The findings suggest that race is not a relevant factor in outcomes.

“This study demonstrates that metastatic breast cancer patients of low socioeconomic status have worse outcomes than those with higher socioeconomic status at our center. It also underscores the idea that race is not so much a biological construct but more a consequence of socioeconomic issues. The effect of race is likely mediated by lower socioeconomic status,” said Susrutha Puthanmadhom Narayanan, MD, who presented the results of her study earlier this month in Chicago at the annual meeting of the American Society of Clinical Oncology.

“The current study should make clinicians cognizant of the potential for biases in the management of metastatic breast cancer in terms of socioeconomic status and race. One should think of socioeconomic status as a predictor of bad outcomes, almost like a comorbidity, and think of [associations between race and outcomes], as a consequence of socioeconomic inequality,” said Dr. Puthanmadhom Narayanan, who is an internal medicine resident at University of Pittsburgh Medical Center.

She and her colleagues intend to dig deeper into the relationships. “We are interested in looking at utilization of different treatment options for metastatic breast cancer between the socioeconomic status groups. In the preliminary analysis, we saw that ER-positive metastatic breast cancer patients with lower socioeconomic status get treated with tamoxifen more often than aromatase inhibitors and newer agents. And, we have plans to study stress signaling and inflammation as mediators of bad outcomes in the low socioeconomic status population,” Dr. Puthanmadhom Narayanan said.

In fact, that tendency for lower socioeconomic status patients to receive older treatments should be a call to action for physicians. “This study should make clinicians cognizant of the potential for biases in management of metastatic breast cancer in terms of socioeconomic status and race,” she said.

The study is based on an analysis of data from the Neighborhood Atlas in which a Neighborhood Deprivation Index (NDI) score was calculated. An NDI score in the bottom tertile meant that patients were better off than patients with mid to high range NDI scores. In this study, socioeconomic status was described as “low deprivation” or “high depreviation.” Higher deprivation correlated with lower overall survival. And, there were more Black patients in the higher deprivation group (10.5%), compared with the low deprivation group (3.7%). In multivariate Cox proportional hazard model, socioeconomic status, but not race, had a significant effect on overall survival (HR for high deprivation was 1.19 [95% confidence interval; 1.04-1.37], P = 0.01).

It included 1,246 patients who were treated at the University of Pittsburgh Medical Center between 2000 and 2017. Of 1,246 patients, 414 patients considered in the bottom tertile of NDI as having low deprivation, while 832 patients in the middle or top tertiles were classified as having high deprivation.

The two socioeconomic status groups were similar in baseline characteristics, with the exception of race: 10.5% of the high deprivation group were African American, compared with 3.7% of the low deprivation group (P =.000093).

Univariate analyses showed worse survival in both Black women and women in the lower socioeconomic status group, but a multivariate analysis found only socioeconomic status was associated with overall survival (hazard ratio for lower socioeconomic status, 1.19; P = .01).

The study had several strengths, according to Rachel Freedman, MD, MPH, who served as a discussant for the abstract. “It included both de novo and recurrent metastatic breast cancer, unlike previous studies based on the Surveillance, Epidemiology, and End Results (SEER) database that only included de novo cases. It also employed a novel tool to define socioeconomic status in the form of the Neighborhood Atlas. The study “adds more evidence that socioeconomic status likely mediates much of what we see when it comes to racial disparities,” said Dr. Freedman, who is a senior physician at Dana Farber Cancer Institute.

Nevertheless, more work needs to be done. Dr. Freedman pointed out that the current study did not include information on treatment.

The findings underscore the failure to date to address disparities in breast cancer treatment, an effort that is hampered by difficulty in teasing out complex factors that may impact survival. “We need to standardize the way that we collect social determinants of health and act upon findings, and we need to standardize patient navigation, and we need to commit as a community to diverse clinical trial populations,” Dr. Freedman said.

Dr. Narayanan has no relevant financial disclosures. Dr. Freedman is an employee and stockholder of Firefly Health.

A neighborhood analysis of socioeconomic status conducted in the Pittsburgh area found worse metastatic breast cancer survival outcomes among patients of low socioeconomic status. The findings suggest that race is not a relevant factor in outcomes.

“This study demonstrates that metastatic breast cancer patients of low socioeconomic status have worse outcomes than those with higher socioeconomic status at our center. It also underscores the idea that race is not so much a biological construct but more a consequence of socioeconomic issues. The effect of race is likely mediated by lower socioeconomic status,” said Susrutha Puthanmadhom Narayanan, MD, who presented the results of her study earlier this month in Chicago at the annual meeting of the American Society of Clinical Oncology.

“The current study should make clinicians cognizant of the potential for biases in the management of metastatic breast cancer in terms of socioeconomic status and race. One should think of socioeconomic status as a predictor of bad outcomes, almost like a comorbidity, and think of [associations between race and outcomes], as a consequence of socioeconomic inequality,” said Dr. Puthanmadhom Narayanan, who is an internal medicine resident at University of Pittsburgh Medical Center.

She and her colleagues intend to dig deeper into the relationships. “We are interested in looking at utilization of different treatment options for metastatic breast cancer between the socioeconomic status groups. In the preliminary analysis, we saw that ER-positive metastatic breast cancer patients with lower socioeconomic status get treated with tamoxifen more often than aromatase inhibitors and newer agents. And, we have plans to study stress signaling and inflammation as mediators of bad outcomes in the low socioeconomic status population,” Dr. Puthanmadhom Narayanan said.

In fact, that tendency for lower socioeconomic status patients to receive older treatments should be a call to action for physicians. “This study should make clinicians cognizant of the potential for biases in management of metastatic breast cancer in terms of socioeconomic status and race,” she said.

The study is based on an analysis of data from the Neighborhood Atlas in which a Neighborhood Deprivation Index (NDI) score was calculated. An NDI score in the bottom tertile meant that patients were better off than patients with mid to high range NDI scores. In this study, socioeconomic status was described as “low deprivation” or “high depreviation.” Higher deprivation correlated with lower overall survival. And, there were more Black patients in the higher deprivation group (10.5%), compared with the low deprivation group (3.7%). In multivariate Cox proportional hazard model, socioeconomic status, but not race, had a significant effect on overall survival (HR for high deprivation was 1.19 [95% confidence interval; 1.04-1.37], P = 0.01).

It included 1,246 patients who were treated at the University of Pittsburgh Medical Center between 2000 and 2017. Of 1,246 patients, 414 patients considered in the bottom tertile of NDI as having low deprivation, while 832 patients in the middle or top tertiles were classified as having high deprivation.

The two socioeconomic status groups were similar in baseline characteristics, with the exception of race: 10.5% of the high deprivation group were African American, compared with 3.7% of the low deprivation group (P =.000093).

Univariate analyses showed worse survival in both Black women and women in the lower socioeconomic status group, but a multivariate analysis found only socioeconomic status was associated with overall survival (hazard ratio for lower socioeconomic status, 1.19; P = .01).

The study had several strengths, according to Rachel Freedman, MD, MPH, who served as a discussant for the abstract. “It included both de novo and recurrent metastatic breast cancer, unlike previous studies based on the Surveillance, Epidemiology, and End Results (SEER) database that only included de novo cases. It also employed a novel tool to define socioeconomic status in the form of the Neighborhood Atlas. The study “adds more evidence that socioeconomic status likely mediates much of what we see when it comes to racial disparities,” said Dr. Freedman, who is a senior physician at Dana Farber Cancer Institute.

Nevertheless, more work needs to be done. Dr. Freedman pointed out that the current study did not include information on treatment.

The findings underscore the failure to date to address disparities in breast cancer treatment, an effort that is hampered by difficulty in teasing out complex factors that may impact survival. “We need to standardize the way that we collect social determinants of health and act upon findings, and we need to standardize patient navigation, and we need to commit as a community to diverse clinical trial populations,” Dr. Freedman said.

Dr. Narayanan has no relevant financial disclosures. Dr. Freedman is an employee and stockholder of Firefly Health.

A neighborhood analysis of socioeconomic status conducted in the Pittsburgh area found worse metastatic breast cancer survival outcomes among patients of low socioeconomic status. The findings suggest that race is not a relevant factor in outcomes.

“This study demonstrates that metastatic breast cancer patients of low socioeconomic status have worse outcomes than those with higher socioeconomic status at our center. It also underscores the idea that race is not so much a biological construct but more a consequence of socioeconomic issues. The effect of race is likely mediated by lower socioeconomic status,” said Susrutha Puthanmadhom Narayanan, MD, who presented the results of her study earlier this month in Chicago at the annual meeting of the American Society of Clinical Oncology.

“The current study should make clinicians cognizant of the potential for biases in the management of metastatic breast cancer in terms of socioeconomic status and race. One should think of socioeconomic status as a predictor of bad outcomes, almost like a comorbidity, and think of [associations between race and outcomes], as a consequence of socioeconomic inequality,” said Dr. Puthanmadhom Narayanan, who is an internal medicine resident at University of Pittsburgh Medical Center.

She and her colleagues intend to dig deeper into the relationships. “We are interested in looking at utilization of different treatment options for metastatic breast cancer between the socioeconomic status groups. In the preliminary analysis, we saw that ER-positive metastatic breast cancer patients with lower socioeconomic status get treated with tamoxifen more often than aromatase inhibitors and newer agents. And, we have plans to study stress signaling and inflammation as mediators of bad outcomes in the low socioeconomic status population,” Dr. Puthanmadhom Narayanan said.

In fact, that tendency for lower socioeconomic status patients to receive older treatments should be a call to action for physicians. “This study should make clinicians cognizant of the potential for biases in management of metastatic breast cancer in terms of socioeconomic status and race,” she said.

The study is based on an analysis of data from the Neighborhood Atlas in which a Neighborhood Deprivation Index (NDI) score was calculated. An NDI score in the bottom tertile meant that patients were better off than patients with mid to high range NDI scores. In this study, socioeconomic status was described as “low deprivation” or “high depreviation.” Higher deprivation correlated with lower overall survival. And, there were more Black patients in the higher deprivation group (10.5%), compared with the low deprivation group (3.7%). In multivariate Cox proportional hazard model, socioeconomic status, but not race, had a significant effect on overall survival (HR for high deprivation was 1.19 [95% confidence interval; 1.04-1.37], P = 0.01).

It included 1,246 patients who were treated at the University of Pittsburgh Medical Center between 2000 and 2017. Of 1,246 patients, 414 patients considered in the bottom tertile of NDI as having low deprivation, while 832 patients in the middle or top tertiles were classified as having high deprivation.

The two socioeconomic status groups were similar in baseline characteristics, with the exception of race: 10.5% of the high deprivation group were African American, compared with 3.7% of the low deprivation group (P =.000093).

Univariate analyses showed worse survival in both Black women and women in the lower socioeconomic status group, but a multivariate analysis found only socioeconomic status was associated with overall survival (hazard ratio for lower socioeconomic status, 1.19; P = .01).

The study had several strengths, according to Rachel Freedman, MD, MPH, who served as a discussant for the abstract. “It included both de novo and recurrent metastatic breast cancer, unlike previous studies based on the Surveillance, Epidemiology, and End Results (SEER) database that only included de novo cases. It also employed a novel tool to define socioeconomic status in the form of the Neighborhood Atlas. The study “adds more evidence that socioeconomic status likely mediates much of what we see when it comes to racial disparities,” said Dr. Freedman, who is a senior physician at Dana Farber Cancer Institute.

Nevertheless, more work needs to be done. Dr. Freedman pointed out that the current study did not include information on treatment.

The findings underscore the failure to date to address disparities in breast cancer treatment, an effort that is hampered by difficulty in teasing out complex factors that may impact survival. “We need to standardize the way that we collect social determinants of health and act upon findings, and we need to standardize patient navigation, and we need to commit as a community to diverse clinical trial populations,” Dr. Freedman said.

Dr. Narayanan has no relevant financial disclosures. Dr. Freedman is an employee and stockholder of Firefly Health.

“My soul is in deep anguish. How long, Lord, how long?” – Psalm 6

Lament is making a comeback. A once-common word in the 1800s, it fell steeply in popularity in the 20th century. Lately, I see it everywhere. It’s a beautiful word, capturing not only sorrow, but also weariness. It is also audacious, facing injustice and acknowledging that it ought not be this way, and communal, bearing witness to the shared hardship of being human. The Hebrew scriptures captured the experience of lament in the form of psalms, from the Greek, psalmoi or “words to accompany the music.” A few thousand years later, the words still resonate, especially in times of grief. “I am weary with my groaning; all the night make I my bed to swim; I water my couch with my tears.”

“Hair loss” is not the chief complaint you want to see when running behind in clinic – it’s never a 15-minute visit. A woman in her late 30s with wavy, light-brown hair that grew to her waistline was seated on the exam chair. When I sat across from her, I couldn’t see her scalp. No erythema or scale. No frontal band of hair loss. Just a bit thin everywhere. Perhaps another post-COVID telogen? This might be easy. I blew right by her mother, who was sitting in the corner of the room. Her black and white horizontal striped shirt seemed to match her gray and white hair. She looked worried.

Having perused my patient’s labs and done an exam, I announced that the diagnosis was telogen effluvium. “There are many possible causes, stress is a common one. Have you been under a lot of stress lately?” (The answer is always yes, thus providing a good foothold to climb out of a hair-loss visit). “Yes. My 1-year-old daughter died last year. She had choked on a cashew from a granola bar given by her sister.” I gasped and turned from her green eyes to her mom’s. Without saying a word, mom pleaded with me to help. “I don’t know what to say,” I said, “I’m so sorry.” Neither replied.

On the commute home that day I listened to a live recording of the U2 song, “40.” I had recently read about it in a touching essay about lament by Enuma Okoro of the Financial Times. I thought about my patient’s suffering and the brutal injustice of fate. It feels like it’s everywhere lately. Reporting from the events in Ukraine, Buffalo, Uvalde, Tulsa has put agonized faces like hers in the public square for us all to gape at and quietly mourn.

Even from a secular lens, it can be seen that a beauty of psalms is how they move from despair to hope. Prayers will be answered. Things will get better. Turn up the volume and feel the urgency and pathos Bono injects into your soul as he sings the refrain; “How long, how long? How long to sing this song?” In the live version we the audience take over for him. The words accompanying the music swell over the crowd. How much longer? How much more suffering? My patient’s hair will grow back. It will take years. All we can do is lament with her.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

“My soul is in deep anguish. How long, Lord, how long?” – Psalm 6

Lament is making a comeback. A once-common word in the 1800s, it fell steeply in popularity in the 20th century. Lately, I see it everywhere. It’s a beautiful word, capturing not only sorrow, but also weariness. It is also audacious, facing injustice and acknowledging that it ought not be this way, and communal, bearing witness to the shared hardship of being human. The Hebrew scriptures captured the experience of lament in the form of psalms, from the Greek, psalmoi or “words to accompany the music.” A few thousand years later, the words still resonate, especially in times of grief. “I am weary with my groaning; all the night make I my bed to swim; I water my couch with my tears.”

“Hair loss” is not the chief complaint you want to see when running behind in clinic – it’s never a 15-minute visit. A woman in her late 30s with wavy, light-brown hair that grew to her waistline was seated on the exam chair. When I sat across from her, I couldn’t see her scalp. No erythema or scale. No frontal band of hair loss. Just a bit thin everywhere. Perhaps another post-COVID telogen? This might be easy. I blew right by her mother, who was sitting in the corner of the room. Her black and white horizontal striped shirt seemed to match her gray and white hair. She looked worried.

Having perused my patient’s labs and done an exam, I announced that the diagnosis was telogen effluvium. “There are many possible causes, stress is a common one. Have you been under a lot of stress lately?” (The answer is always yes, thus providing a good foothold to climb out of a hair-loss visit). “Yes. My 1-year-old daughter died last year. She had choked on a cashew from a granola bar given by her sister.” I gasped and turned from her green eyes to her mom’s. Without saying a word, mom pleaded with me to help. “I don’t know what to say,” I said, “I’m so sorry.” Neither replied.

On the commute home that day I listened to a live recording of the U2 song, “40.” I had recently read about it in a touching essay about lament by Enuma Okoro of the Financial Times. I thought about my patient’s suffering and the brutal injustice of fate. It feels like it’s everywhere lately. Reporting from the events in Ukraine, Buffalo, Uvalde, Tulsa has put agonized faces like hers in the public square for us all to gape at and quietly mourn.

Even from a secular lens, it can be seen that a beauty of psalms is how they move from despair to hope. Prayers will be answered. Things will get better. Turn up the volume and feel the urgency and pathos Bono injects into your soul as he sings the refrain; “How long, how long? How long to sing this song?” In the live version we the audience take over for him. The words accompanying the music swell over the crowd. How much longer? How much more suffering? My patient’s hair will grow back. It will take years. All we can do is lament with her.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

“My soul is in deep anguish. How long, Lord, how long?” – Psalm 6

Lament is making a comeback. A once-common word in the 1800s, it fell steeply in popularity in the 20th century. Lately, I see it everywhere. It’s a beautiful word, capturing not only sorrow, but also weariness. It is also audacious, facing injustice and acknowledging that it ought not be this way, and communal, bearing witness to the shared hardship of being human. The Hebrew scriptures captured the experience of lament in the form of psalms, from the Greek, psalmoi or “words to accompany the music.” A few thousand years later, the words still resonate, especially in times of grief. “I am weary with my groaning; all the night make I my bed to swim; I water my couch with my tears.”

“Hair loss” is not the chief complaint you want to see when running behind in clinic – it’s never a 15-minute visit. A woman in her late 30s with wavy, light-brown hair that grew to her waistline was seated on the exam chair. When I sat across from her, I couldn’t see her scalp. No erythema or scale. No frontal band of hair loss. Just a bit thin everywhere. Perhaps another post-COVID telogen? This might be easy. I blew right by her mother, who was sitting in the corner of the room. Her black and white horizontal striped shirt seemed to match her gray and white hair. She looked worried.

Having perused my patient’s labs and done an exam, I announced that the diagnosis was telogen effluvium. “There are many possible causes, stress is a common one. Have you been under a lot of stress lately?” (The answer is always yes, thus providing a good foothold to climb out of a hair-loss visit). “Yes. My 1-year-old daughter died last year. She had choked on a cashew from a granola bar given by her sister.” I gasped and turned from her green eyes to her mom’s. Without saying a word, mom pleaded with me to help. “I don’t know what to say,” I said, “I’m so sorry.” Neither replied.

On the commute home that day I listened to a live recording of the U2 song, “40.” I had recently read about it in a touching essay about lament by Enuma Okoro of the Financial Times. I thought about my patient’s suffering and the brutal injustice of fate. It feels like it’s everywhere lately. Reporting from the events in Ukraine, Buffalo, Uvalde, Tulsa has put agonized faces like hers in the public square for us all to gape at and quietly mourn.

Even from a secular lens, it can be seen that a beauty of psalms is how they move from despair to hope. Prayers will be answered. Things will get better. Turn up the volume and feel the urgency and pathos Bono injects into your soul as he sings the refrain; “How long, how long? How long to sing this song?” In the live version we the audience take over for him. The words accompanying the music swell over the crowd. How much longer? How much more suffering? My patient’s hair will grow back. It will take years. All we can do is lament with her.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

When 29-year-old Sakeenah Fowler was pregnant with her first child, doctors kept a close watch. Ms. Fowler has lupus, high blood pressure, a history of blood clotting, and kidney problems that all could have endangered her or the health of her unborn baby.

She saw maternal-fetal specialists who could keep watch of her high-risk pregnancy, and she collected urine samples every 24 hours to make sure her kidneys were functioning properly from her home in Roebuck, S.C.

But the pregnancy ultimately proved uneventful; even her kidneys remained stable. So Ms. Fowler said she was shocked when her doctors ordered an emergency cesarean delivery after she had gone into active labor.

“I was already dilated all the way to 6 cm,” but the baby’s heart rate had decreased by a small amount, she says. “They thought it was best to just go ahead with a C-section.”

Ms. Fowler, who is Black, said she believes the surgical intervention was unnecessary and that she wasn’t given a chance to discuss her options for a vaginal childbirth.  

“They already had it in their minds that I wasn’t going to make it through the pregnancy without any issues; then when I did, it was like they wanted to find something that made me have to have a C-section,” Ms. Fowler said. “It was close to the holidays; everybody was ready to go home. It was just like I was pushed to do what they wanted me to do.”

Ms. Fowler’s sense of a lack of choice is important beyond the measure of patient experience. While cesarean deliveries can be a lifeline for mother and baby, they can put up massive roadblocks to maternal and infant health when not necessary.

“The risk of hemorrhage, infection – on average, all of these go up when you have surgery instead of a vaginal delivery,” says Kimberly B. Glazer, PhD, a perinatal epidemiologist at the Icahn School of Medicine at Mount Sinai, New York.

“Birth is one of the most salient experiences you can have. People want to feel like their values and preferences – whatever they may be – were honored and respected. Even if the delivery goes a different way than you wanted, feeling like your values were taken into account is very important.”

More than 1 million women undergo cesarean deliveries in the United States every year, composing over 31% of all births in 2020, according to the Centers for Disease Control and Prevention.

The World Health Organization, meanwhile, recommends a rate of cesarean delivery of no more than 15% per region. Whether or not all the U.S. procedures were medically warranted is unclear, however.

Black women have higher odds of undergoing a cesarean: 36% undergo surgical deliveries annually, compared with about 30% of White women. Black women are also about three times more likely to die of pregnancy-related causes than White women.
 

Risk becomes reality

Ms. Fowler eventually developed an infection in her cesarean surgical wound, but her doctors initially insisted her alternating chills and fever were merely postpartum hormonal swings, she says.

“I thought something had to be wrong, but they just kept saying nothing was wrong,” she says.

By the time her doctors caught the infection, Ms. Fowler was readmitted to the hospital for several days of IV antibiotic therapy. The infection “almost got into my bloodstream and could have killed me,” she says.  

While cesarean deliveries are associated with decreases in maternal, neonatal, and infant mortality, the benefits are only seen up to a certain threshold. The WHO, for instance, has reported that over the 15% threshold, that lower mortality benefit disappears.

“When medically necessary, cesarean delivery can improve outcomes for mother and baby. But the fact that cesarean section rates have increased in recent years without a corresponding improvement in health outcomes indicates overreliance on the procedure,” Dr. Glazer says.
 

Clinical discretion leads to biased judgment calls

Rates of cesarean deliveries are even higher among low-risk pregnancies in women of color than in White women. Between 2016 and 2019, the overall rate of cesarean deliveries for low-risk births was 23%, according to a recent analysis. But the rate was almost 18% higher among Black women than among White women (27% vs. 22%).

“When you see data about these subjective indications varying by race and ethnicity, I think that’s pointing us toward some answers,” Dr. Glazer says. “Once you adjust for all these measures, prepregnancy characteristics, and risk factors, the research identifies variation in quality and outcomes that is rooted in structural and systemic racism in health care, implicit bias from clinicians.”

Researchers investigating cesarean deliveries have found that Black women are more likely to undergo the surgery for reasons that are highly subjective, such as fetal distress.

“There is a huge range of how concerning a fetal heart rate can be, and some health providers might perform a C-section for only minor changes in the fetal heart rate, while others might wait until it is much worse,” said Rebecca Hamm, MD, an assistant professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania.

At least some of the differences in care can be explained by where women deliver their babies, studies have shown. Women of color disproportionately deliver at hospitals with poorer quality outcomes for moms and babies.
 

Dealing with the aftermath

There can be costs that reverberate throughout the life of a mother, child, and their family as the result of surgical delivery.

“Cesarean sections cost a lot more,” says Jamila Taylor, PhD, director of health care reform and a senior fellow with The Century Foundation, a progressive policy think tank in Washington, D.C. The cost of a cesarean delivery averages about $17,000, compared with about $12,200 for a vaginal birth; for uninsured patients, surgical deliveries cost about $9,000 more than vaginal deliveries.

Dr. Taylor, who has studied the historical mistreatment of Black women in obstetrics, noted that this cost includes not just the bill for surgery but also a prolonged recovery time that is often spent in a hospital bed.

Beyond the detrimental effect that a large hospital bill for delivery and aftercare can have on families, other costs can crop up later. Infants delivered by cesarean surgery are more likely to develop an infection, breathing problems, and to spend time in the neonatal intensive care unit than babies born vaginally. Although studies suggest these outcomes may result from a medically necessary health concern that spurred the cesarean surgery, they often stem from the delivery itself.  

Babies born surgically also miss out on the benefits of passing through the birth canal, such as supporting a newborn’s immune system and preparing their lungs to breathe oxygen after birth.

Most of the efforts to reduce inequities in maternal care are happening at the clinical level, aimed at both patients and providers, Dr. Taylor says.

“As advocates, we’re talking about how we can help Black women be advocates for themselves in the health care system – if the physician suggests a C-section, getting a second opinion, or walking through what a [surgical delivery] will mean and what their recovery will look like,” she says.

Women are also increasingly choosing non-hospital settings to deliver when possible, Dr. Taylor says. Including doulas or midwife practitioners in the maternal care team can reduce unnecessary cesarean deliveries among Black women, according to Camille Clare, MD, chair of the New York chapter of the American College of Obstetricians and Gynecologists.

Also, last year, race was removed from the vaginal birth after C-section (VBAC) calculator, which is used to gauge the safety of vaginal delivery in women with a history of surgical birth. The original calculator included race-based correction factors for Black women and Hispanic women. It predicted a lower likelihood of successful vaginal deliveries for women who already had a C-section and who identify as Black or Hispanic than for White women with otherwise identical characteristics, such as age, weight, and a history of cesarean delivery.

“Those are things that over time should reduce the high rates of cesarean section for Black women in particular,” Dr. Clare says.

In addition to embracing the updated calculator and including nurse-midwives and doulas in their obstetrics services, Penn Medicine, Philadelphia received a federal grant to study the impact of creating a standard plan for deliveries. This includes standardizing the induction of labor and any effect that might have on reducing C-section rates.

“This idea that biases lead to difference in decisionmaking, and that by standardizing practices we could address these differences – people were somewhat resistant at first,” Dr. Hamm says. “They didn’t believe there were differences in their practices.”

People struggle to recognize those differences, she says, and “it takes active participation in reducing disparities to make that happen.”

At the community level, Synergistic Sisters in Science (SIS), a group of maternal health experts and health equity advocates, is working on a project called PM3, to reduce maternal mortality through mobile technology.

The smartphone app will provide information for new moms to empower them to start conversations with health care providers. It also connects users to social support and resources. SIS is especially hoping to engage Black women living in rural areas.

“There is so much mistrust due to things like unnecessary C-sections and the fact that Black women feel they aren’t heard,” said Natalie Hernandez, PhD, executive director of the Center for Maternal Health Equity at Morehouse School of Medicine, Atlanta. “Here is a tool that gives a woman information that’s culturally centered, looks like her, and was informed by her voice.”

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

When 29-year-old Sakeenah Fowler was pregnant with her first child, doctors kept a close watch. Ms. Fowler has lupus, high blood pressure, a history of blood clotting, and kidney problems that all could have endangered her or the health of her unborn baby.

She saw maternal-fetal specialists who could keep watch of her high-risk pregnancy, and she collected urine samples every 24 hours to make sure her kidneys were functioning properly from her home in Roebuck, S.C.

But the pregnancy ultimately proved uneventful; even her kidneys remained stable. So Ms. Fowler said she was shocked when her doctors ordered an emergency cesarean delivery after she had gone into active labor.

“I was already dilated all the way to 6 cm,” but the baby’s heart rate had decreased by a small amount, she says. “They thought it was best to just go ahead with a C-section.”

Ms. Fowler, who is Black, said she believes the surgical intervention was unnecessary and that she wasn’t given a chance to discuss her options for a vaginal childbirth.  

“They already had it in their minds that I wasn’t going to make it through the pregnancy without any issues; then when I did, it was like they wanted to find something that made me have to have a C-section,” Ms. Fowler said. “It was close to the holidays; everybody was ready to go home. It was just like I was pushed to do what they wanted me to do.”

Ms. Fowler’s sense of a lack of choice is important beyond the measure of patient experience. While cesarean deliveries can be a lifeline for mother and baby, they can put up massive roadblocks to maternal and infant health when not necessary.

“The risk of hemorrhage, infection – on average, all of these go up when you have surgery instead of a vaginal delivery,” says Kimberly B. Glazer, PhD, a perinatal epidemiologist at the Icahn School of Medicine at Mount Sinai, New York.

“Birth is one of the most salient experiences you can have. People want to feel like their values and preferences – whatever they may be – were honored and respected. Even if the delivery goes a different way than you wanted, feeling like your values were taken into account is very important.”

More than 1 million women undergo cesarean deliveries in the United States every year, composing over 31% of all births in 2020, according to the Centers for Disease Control and Prevention.

The World Health Organization, meanwhile, recommends a rate of cesarean delivery of no more than 15% per region. Whether or not all the U.S. procedures were medically warranted is unclear, however.

Black women have higher odds of undergoing a cesarean: 36% undergo surgical deliveries annually, compared with about 30% of White women. Black women are also about three times more likely to die of pregnancy-related causes than White women.
 

Risk becomes reality

Ms. Fowler eventually developed an infection in her cesarean surgical wound, but her doctors initially insisted her alternating chills and fever were merely postpartum hormonal swings, she says.

“I thought something had to be wrong, but they just kept saying nothing was wrong,” she says.

By the time her doctors caught the infection, Ms. Fowler was readmitted to the hospital for several days of IV antibiotic therapy. The infection “almost got into my bloodstream and could have killed me,” she says.  

While cesarean deliveries are associated with decreases in maternal, neonatal, and infant mortality, the benefits are only seen up to a certain threshold. The WHO, for instance, has reported that over the 15% threshold, that lower mortality benefit disappears.

“When medically necessary, cesarean delivery can improve outcomes for mother and baby. But the fact that cesarean section rates have increased in recent years without a corresponding improvement in health outcomes indicates overreliance on the procedure,” Dr. Glazer says.
 

Clinical discretion leads to biased judgment calls

Rates of cesarean deliveries are even higher among low-risk pregnancies in women of color than in White women. Between 2016 and 2019, the overall rate of cesarean deliveries for low-risk births was 23%, according to a recent analysis. But the rate was almost 18% higher among Black women than among White women (27% vs. 22%).

“When you see data about these subjective indications varying by race and ethnicity, I think that’s pointing us toward some answers,” Dr. Glazer says. “Once you adjust for all these measures, prepregnancy characteristics, and risk factors, the research identifies variation in quality and outcomes that is rooted in structural and systemic racism in health care, implicit bias from clinicians.”

Researchers investigating cesarean deliveries have found that Black women are more likely to undergo the surgery for reasons that are highly subjective, such as fetal distress.

“There is a huge range of how concerning a fetal heart rate can be, and some health providers might perform a C-section for only minor changes in the fetal heart rate, while others might wait until it is much worse,” said Rebecca Hamm, MD, an assistant professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania.

At least some of the differences in care can be explained by where women deliver their babies, studies have shown. Women of color disproportionately deliver at hospitals with poorer quality outcomes for moms and babies.
 

Dealing with the aftermath

There can be costs that reverberate throughout the life of a mother, child, and their family as the result of surgical delivery.

“Cesarean sections cost a lot more,” says Jamila Taylor, PhD, director of health care reform and a senior fellow with The Century Foundation, a progressive policy think tank in Washington, D.C. The cost of a cesarean delivery averages about $17,000, compared with about $12,200 for a vaginal birth; for uninsured patients, surgical deliveries cost about $9,000 more than vaginal deliveries.

Dr. Taylor, who has studied the historical mistreatment of Black women in obstetrics, noted that this cost includes not just the bill for surgery but also a prolonged recovery time that is often spent in a hospital bed.

Beyond the detrimental effect that a large hospital bill for delivery and aftercare can have on families, other costs can crop up later. Infants delivered by cesarean surgery are more likely to develop an infection, breathing problems, and to spend time in the neonatal intensive care unit than babies born vaginally. Although studies suggest these outcomes may result from a medically necessary health concern that spurred the cesarean surgery, they often stem from the delivery itself.  

Babies born surgically also miss out on the benefits of passing through the birth canal, such as supporting a newborn’s immune system and preparing their lungs to breathe oxygen after birth.

Most of the efforts to reduce inequities in maternal care are happening at the clinical level, aimed at both patients and providers, Dr. Taylor says.

“As advocates, we’re talking about how we can help Black women be advocates for themselves in the health care system – if the physician suggests a C-section, getting a second opinion, or walking through what a [surgical delivery] will mean and what their recovery will look like,” she says.

Women are also increasingly choosing non-hospital settings to deliver when possible, Dr. Taylor says. Including doulas or midwife practitioners in the maternal care team can reduce unnecessary cesarean deliveries among Black women, according to Camille Clare, MD, chair of the New York chapter of the American College of Obstetricians and Gynecologists.

Also, last year, race was removed from the vaginal birth after C-section (VBAC) calculator, which is used to gauge the safety of vaginal delivery in women with a history of surgical birth. The original calculator included race-based correction factors for Black women and Hispanic women. It predicted a lower likelihood of successful vaginal deliveries for women who already had a C-section and who identify as Black or Hispanic than for White women with otherwise identical characteristics, such as age, weight, and a history of cesarean delivery.

“Those are things that over time should reduce the high rates of cesarean section for Black women in particular,” Dr. Clare says.

In addition to embracing the updated calculator and including nurse-midwives and doulas in their obstetrics services, Penn Medicine, Philadelphia received a federal grant to study the impact of creating a standard plan for deliveries. This includes standardizing the induction of labor and any effect that might have on reducing C-section rates.

“This idea that biases lead to difference in decisionmaking, and that by standardizing practices we could address these differences – people were somewhat resistant at first,” Dr. Hamm says. “They didn’t believe there were differences in their practices.”

People struggle to recognize those differences, she says, and “it takes active participation in reducing disparities to make that happen.”

At the community level, Synergistic Sisters in Science (SIS), a group of maternal health experts and health equity advocates, is working on a project called PM3, to reduce maternal mortality through mobile technology.

The smartphone app will provide information for new moms to empower them to start conversations with health care providers. It also connects users to social support and resources. SIS is especially hoping to engage Black women living in rural areas.

“There is so much mistrust due to things like unnecessary C-sections and the fact that Black women feel they aren’t heard,” said Natalie Hernandez, PhD, executive director of the Center for Maternal Health Equity at Morehouse School of Medicine, Atlanta. “Here is a tool that gives a woman information that’s culturally centered, looks like her, and was informed by her voice.”

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

When 29-year-old Sakeenah Fowler was pregnant with her first child, doctors kept a close watch. Ms. Fowler has lupus, high blood pressure, a history of blood clotting, and kidney problems that all could have endangered her or the health of her unborn baby.

She saw maternal-fetal specialists who could keep watch of her high-risk pregnancy, and she collected urine samples every 24 hours to make sure her kidneys were functioning properly from her home in Roebuck, S.C.

But the pregnancy ultimately proved uneventful; even her kidneys remained stable. So Ms. Fowler said she was shocked when her doctors ordered an emergency cesarean delivery after she had gone into active labor.

“I was already dilated all the way to 6 cm,” but the baby’s heart rate had decreased by a small amount, she says. “They thought it was best to just go ahead with a C-section.”

Ms. Fowler, who is Black, said she believes the surgical intervention was unnecessary and that she wasn’t given a chance to discuss her options for a vaginal childbirth.  

“They already had it in their minds that I wasn’t going to make it through the pregnancy without any issues; then when I did, it was like they wanted to find something that made me have to have a C-section,” Ms. Fowler said. “It was close to the holidays; everybody was ready to go home. It was just like I was pushed to do what they wanted me to do.”

Ms. Fowler’s sense of a lack of choice is important beyond the measure of patient experience. While cesarean deliveries can be a lifeline for mother and baby, they can put up massive roadblocks to maternal and infant health when not necessary.

“The risk of hemorrhage, infection – on average, all of these go up when you have surgery instead of a vaginal delivery,” says Kimberly B. Glazer, PhD, a perinatal epidemiologist at the Icahn School of Medicine at Mount Sinai, New York.

“Birth is one of the most salient experiences you can have. People want to feel like their values and preferences – whatever they may be – were honored and respected. Even if the delivery goes a different way than you wanted, feeling like your values were taken into account is very important.”

More than 1 million women undergo cesarean deliveries in the United States every year, composing over 31% of all births in 2020, according to the Centers for Disease Control and Prevention.

The World Health Organization, meanwhile, recommends a rate of cesarean delivery of no more than 15% per region. Whether or not all the U.S. procedures were medically warranted is unclear, however.

Black women have higher odds of undergoing a cesarean: 36% undergo surgical deliveries annually, compared with about 30% of White women. Black women are also about three times more likely to die of pregnancy-related causes than White women.
 

Risk becomes reality

Ms. Fowler eventually developed an infection in her cesarean surgical wound, but her doctors initially insisted her alternating chills and fever were merely postpartum hormonal swings, she says.

“I thought something had to be wrong, but they just kept saying nothing was wrong,” she says.

By the time her doctors caught the infection, Ms. Fowler was readmitted to the hospital for several days of IV antibiotic therapy. The infection “almost got into my bloodstream and could have killed me,” she says.  

While cesarean deliveries are associated with decreases in maternal, neonatal, and infant mortality, the benefits are only seen up to a certain threshold. The WHO, for instance, has reported that over the 15% threshold, that lower mortality benefit disappears.

“When medically necessary, cesarean delivery can improve outcomes for mother and baby. But the fact that cesarean section rates have increased in recent years without a corresponding improvement in health outcomes indicates overreliance on the procedure,” Dr. Glazer says.
 

Clinical discretion leads to biased judgment calls

Rates of cesarean deliveries are even higher among low-risk pregnancies in women of color than in White women. Between 2016 and 2019, the overall rate of cesarean deliveries for low-risk births was 23%, according to a recent analysis. But the rate was almost 18% higher among Black women than among White women (27% vs. 22%).

“When you see data about these subjective indications varying by race and ethnicity, I think that’s pointing us toward some answers,” Dr. Glazer says. “Once you adjust for all these measures, prepregnancy characteristics, and risk factors, the research identifies variation in quality and outcomes that is rooted in structural and systemic racism in health care, implicit bias from clinicians.”

Researchers investigating cesarean deliveries have found that Black women are more likely to undergo the surgery for reasons that are highly subjective, such as fetal distress.

“There is a huge range of how concerning a fetal heart rate can be, and some health providers might perform a C-section for only minor changes in the fetal heart rate, while others might wait until it is much worse,” said Rebecca Hamm, MD, an assistant professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania.

At least some of the differences in care can be explained by where women deliver their babies, studies have shown. Women of color disproportionately deliver at hospitals with poorer quality outcomes for moms and babies.
 

Dealing with the aftermath

There can be costs that reverberate throughout the life of a mother, child, and their family as the result of surgical delivery.

“Cesarean sections cost a lot more,” says Jamila Taylor, PhD, director of health care reform and a senior fellow with The Century Foundation, a progressive policy think tank in Washington, D.C. The cost of a cesarean delivery averages about $17,000, compared with about $12,200 for a vaginal birth; for uninsured patients, surgical deliveries cost about $9,000 more than vaginal deliveries.

Dr. Taylor, who has studied the historical mistreatment of Black women in obstetrics, noted that this cost includes not just the bill for surgery but also a prolonged recovery time that is often spent in a hospital bed.

Beyond the detrimental effect that a large hospital bill for delivery and aftercare can have on families, other costs can crop up later. Infants delivered by cesarean surgery are more likely to develop an infection, breathing problems, and to spend time in the neonatal intensive care unit than babies born vaginally. Although studies suggest these outcomes may result from a medically necessary health concern that spurred the cesarean surgery, they often stem from the delivery itself.  

Babies born surgically also miss out on the benefits of passing through the birth canal, such as supporting a newborn’s immune system and preparing their lungs to breathe oxygen after birth.

Most of the efforts to reduce inequities in maternal care are happening at the clinical level, aimed at both patients and providers, Dr. Taylor says.

“As advocates, we’re talking about how we can help Black women be advocates for themselves in the health care system – if the physician suggests a C-section, getting a second opinion, or walking through what a [surgical delivery] will mean and what their recovery will look like,” she says.

Women are also increasingly choosing non-hospital settings to deliver when possible, Dr. Taylor says. Including doulas or midwife practitioners in the maternal care team can reduce unnecessary cesarean deliveries among Black women, according to Camille Clare, MD, chair of the New York chapter of the American College of Obstetricians and Gynecologists.

Also, last year, race was removed from the vaginal birth after C-section (VBAC) calculator, which is used to gauge the safety of vaginal delivery in women with a history of surgical birth. The original calculator included race-based correction factors for Black women and Hispanic women. It predicted a lower likelihood of successful vaginal deliveries for women who already had a C-section and who identify as Black or Hispanic than for White women with otherwise identical characteristics, such as age, weight, and a history of cesarean delivery.

“Those are things that over time should reduce the high rates of cesarean section for Black women in particular,” Dr. Clare says.

In addition to embracing the updated calculator and including nurse-midwives and doulas in their obstetrics services, Penn Medicine, Philadelphia received a federal grant to study the impact of creating a standard plan for deliveries. This includes standardizing the induction of labor and any effect that might have on reducing C-section rates.

“This idea that biases lead to difference in decisionmaking, and that by standardizing practices we could address these differences – people were somewhat resistant at first,” Dr. Hamm says. “They didn’t believe there were differences in their practices.”

People struggle to recognize those differences, she says, and “it takes active participation in reducing disparities to make that happen.”

At the community level, Synergistic Sisters in Science (SIS), a group of maternal health experts and health equity advocates, is working on a project called PM3, to reduce maternal mortality through mobile technology.

The smartphone app will provide information for new moms to empower them to start conversations with health care providers. It also connects users to social support and resources. SIS is especially hoping to engage Black women living in rural areas.

“There is so much mistrust due to things like unnecessary C-sections and the fact that Black women feel they aren’t heard,” said Natalie Hernandez, PhD, executive director of the Center for Maternal Health Equity at Morehouse School of Medicine, Atlanta. “Here is a tool that gives a woman information that’s culturally centered, looks like her, and was informed by her voice.”

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

MADRID – During the International Scientific Symposium “New Frontiers in Scientific Research” that recently took place in Barcelona, specialists analyzed the role of the very-low-calorie ketogenic diet. This analysis was in relation to three comorbidities that have a higher incidence among overweight and obese patients: polycystic ovary syndrome, nonalcoholic fatty liver disease, and type 2 diabetes. The experts’ aim? To analyze and update the latest evidence on the benefits of this dietary choice.

Polycystic ovary syndrome

Alessandra Gambineri, MD, PhD, associate professor at the department of medicine and surgery (DIMEC) at the University of Bologna, Italy, addressed the link between obesity and polycystic ovary syndrome, which she described as a chronic disease that affects about 10% of women of childbearing age and that presents diverse phenotypes with different characteristics.

“The pathophysiology of this syndrome is characterized by the interaction of three factors: androgen excess, adipose tissue dysfunction, and insulin resistance. These factors interact with each other and are expressed differently in each phenotype,” said Dr. Gambineri.

She indicated that adipose tissue dysfunction is central to this pathology. This centrality results from its association with secretions, such as free fatty acids, proinflammatory cytokines, certain adipokines that promote insulin resistance, glucocorticosteroids, androgens, and oxidative stress.

“Similarly, the oxidative stress that characterizes this syndrome is increasingly present in obese individuals,” said Dr. Gambineri. “This oxidative stress also produces ovary hypotoxicity that aggravates ovulatory function. In this context, the very-low-calorie ketogenic diet can be useful in several ways: weight reduction; promoting the loss of mainly visceral/abdominal fat; decreasing lipotoxicity; and improving inflammation, hyperinsulinemia, and insulin resistance.”

This was the path followed to carry out a study that aimed to analyze the effects of the very-low-calorie ketogenic diet on manifestations of polycystic ovary syndrome in the obesity phenotype. Dr. Gambineri presented its results.

“The objective was to compare the effects of a very-low-calorie ketogenic diet and the standard low-calorie (hypocaloric) diet as a control group,” she said. “The effects studied include body weight, insulin resistance, menstrual cycle, ovulation, ovarian morphology, and hyperandrogenism in a population of 30 obese women with polycystic ovary syndrome and insulin resistance.”

Study participants had a diagnosis of polycystic ovary syndrome as defined by the National Institutes of Health criteria and were aged 18-45 years. These women were randomly assigned to two groups of equal size: experimental (very-low-calorie ketogenic diet) and control (hypocaloric diet). “The women assigned to the experimental group followed the ketogenic stage for eight weeks and then moved to the second, low-calorie diet phase for an additional eight weeks, while those in the control group (hypocaloric diet) followed the low-calorie diet for all 16 weeks.”

The primary outcomes were changes in weight and body composition, specifically fat mass and lean mass, measured by bioimpedance. “The changes observed in the following aspects were considered secondary outcomes: abdominal fat distribution, metabolic parameters, ovulation, ovarian morphology, hirsutism, hyperandrogenism, psychological well-being, and psychological distress,” said Dr. Gambineri. “Any reduction in the ovarian stroma, the area where androgens are synthesized, was also analyzed.”

The study authors found that although BMI decreased in both groups, this reduction was greater in the group that followed the very-low-calorie ketogenic diet. Significant weight loss was observed in both groups, 12.4 kg versus 4.7 kg. Significant differences were also observed in waist circumference (−8.1% in the experimental group vs. −2.2% in the control group), fat mass (−15.1% vs. −8.5%), and free testosterone (−30.3% vs. +10.6%). Only the experimental group saw a reduction in insulin.

“A key point regarding hyperandrogenism, especially regarding what’s referred to as free testosterone, there was only a significant reduction in the very-low-calorie ketogenic diet group,” said Dr. Gambineri. “This reduction was especially evident in the first part of the study, coinciding with the ketogenic period. The reason for this effect lies in the significant increase in the concentration of sex hormone-binding globulins, SHB6. Said globulins bind to the testosterone present in female blood, producing a reduction in free testosterone, a very important effect considering that this syndrome is an androgenic disorder. Furthermore, current treatments for polycystic ovary syndrome do not reduce free testosterone as much as this dietary approach does.”

For the specialist, among all these positive effects in these patients, perhaps most important is the notable improvement that occurs in ovulation. “At the beginning of the study, only 38.5% of the participants in the experimental group and 14.3% of those in the control group had ovulatory cycles. After the intervention, 84.6% managed to ovulate, compared to 35.7% who achieved this goal in the other group.”

Dr. Gambineri suggested that this method is “valid for reducing fat mass and rapidly improving hyperandrogenism and ovulatory dysfunction in women with obesity and polycystic ovary syndrome.”
 

Reversing type 2 diabetes?

Daniela Sofrà, MD, an endocrinologist specializing in diabetology at La Source Clinic, Lausanne, Switzerland, reviewed the current evidence on the role of the very-low-calorie ketogenic diet in the management of type 2 diabetes.

“It’s time to rethink diabetes treatment and focus efforts on managing obesity as an associated factor,” she said. “One of the hypotheses being examined in this regard is the twin cycle, which postulates that type 2 diabetes is the result of excess fat in the liver. This in turn is associated with insulin resistance with pancreas dysfunction.”

Dr. Sofrà added that there is a study documenting for the first time the reversibility of the morphology of the diabetic pancreas after caloric restriction with the very-low-calorie ketogenic diet. “The reason for this effect is the use of visceral and intrahepatic fat, which can lead to the remission of the clinical manifestation of type 2 diabetes, understanding as such the definition made by the American Diabetes Association: glycosylated hemoglobin < 6.5% without pharmacological therapy.”

Specifically, the results of this research showed that after following the very-low-calorie ketogenic diet and achieving a 15% weight loss (mean weight loss of the participants), liver glucose levels returned to normal levels within 7 days. Beta cell function returned to near normal within 8 weeks.

“Subsequent studies have shown the durability of remission of type 2 diabetes, thanks to the reactivation of the insulin-secreting function of beta cells that had become dedifferentiated in the face of chronic nutrient excess. Specifically, 6 out of 10 patients maintained glycosylated hemoglobin < 6% after 6 months without the need for pharmacological therapy,” Dr. Sofrà added.

Likewise, she highlighted that the probability of achieving remission is mainly determined by the duration of the disease. “The years with diabetes are one of the main predictors of the response that the patient will have with this dietary intervention. Studies have shown that remission is possible in patients with diabetes for less than 6 years, although there are other projects that indicate that it can be achieved with up to 10 years’ duration.”

Based on these data, Dr. Sofrà emphasized the pleiotropic effects of the very-low-calorie ketogenic diet on glycemic control, favoring the possible remission of diabetes or the reduction of drugs, as well as the reduction of the HOMA-IR index (insulin resistance) and waist circumference in people with type 2 diabetes.
 

Nonalcoholic fatty liver disease

The third comorbidity of obesity that may benefit from the very-low-calorie ketogenic diet is hepatic steatosis, or nonalcoholic fatty liver disease, said Hardy Walle, MD, an internal medicine specialist and director/founder of the Bodymed center, Kirkel, Germany, and one of the authors of this research.

“Recent research shows that ectopic fat and nonalcoholic fatty liver disease could be considered a cause, or at least one of the causes, of most of the diseases that affect the population as a consequence of overweight and obesity,” said Dr. Walle. “Some authors have stated that without fatty liver, there is no type 2 diabetes.”

Dr. Walle pointed out that between 30% and 40% of the adult population has nonalcoholic fatty liver disease, a percentage that increases considerably in people with obesity, reaching 70% prevalence and increasing, in the case of type 2 diabetes, to almost 90%. “Even normal weight does not rule out fatty liver; in fact, about 15% of people with nonalcoholic fatty liver disease are not overweight.”

In a setting where there are no approved drugs for the treatment of fatty liver (the current standard approach focuses on lifestyle interventions), a short-term hypocaloric diet (or liver fasting) is considered an effective method for management of this pathology. This principle was demonstrated by a study by the Saarland University, Saarbrücken, Germany, that Dr. Walle used to illustrate this statement.

“The participants (60 patients with hepatic steatosis) followed a hypocaloric diet (less than 1,000 kcal/day) for 14 days with a formula rich in protein and fiber specially developed for the treatment of nonalcoholic fatty liver disease. A fibroscan was then performed with controlled attenuation parameter measurement to quantify fatty liver disease. The results showed not only a significant improvement in nonalcoholic fatty liver disease parameters but also a marked improvement in all relevant metabolic parameters (serum lipids, liver enzymes),” explained Dr. Walle.

“This evidence leads us to affirm that the concept of hepatic fasting (by means of a hypocaloric diet) marks a point of reference for a future treatment approach for nonalcoholic fatty liver disease,” he concluded.

The study that Dr. Gambineri presented was carried out with the collaboration of the Pronokal Group (Nestlé Health Science). Dr. Gambineri, Dr. Sofrà, and Dr. Walle disclosed no relevant financial relationships.

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

MADRID – During the International Scientific Symposium “New Frontiers in Scientific Research” that recently took place in Barcelona, specialists analyzed the role of the very-low-calorie ketogenic diet. This analysis was in relation to three comorbidities that have a higher incidence among overweight and obese patients: polycystic ovary syndrome, nonalcoholic fatty liver disease, and type 2 diabetes. The experts’ aim? To analyze and update the latest evidence on the benefits of this dietary choice.

Polycystic ovary syndrome

Alessandra Gambineri, MD, PhD, associate professor at the department of medicine and surgery (DIMEC) at the University of Bologna, Italy, addressed the link between obesity and polycystic ovary syndrome, which she described as a chronic disease that affects about 10% of women of childbearing age and that presents diverse phenotypes with different characteristics.

“The pathophysiology of this syndrome is characterized by the interaction of three factors: androgen excess, adipose tissue dysfunction, and insulin resistance. These factors interact with each other and are expressed differently in each phenotype,” said Dr. Gambineri.

She indicated that adipose tissue dysfunction is central to this pathology. This centrality results from its association with secretions, such as free fatty acids, proinflammatory cytokines, certain adipokines that promote insulin resistance, glucocorticosteroids, androgens, and oxidative stress.

“Similarly, the oxidative stress that characterizes this syndrome is increasingly present in obese individuals,” said Dr. Gambineri. “This oxidative stress also produces ovary hypotoxicity that aggravates ovulatory function. In this context, the very-low-calorie ketogenic diet can be useful in several ways: weight reduction; promoting the loss of mainly visceral/abdominal fat; decreasing lipotoxicity; and improving inflammation, hyperinsulinemia, and insulin resistance.”

This was the path followed to carry out a study that aimed to analyze the effects of the very-low-calorie ketogenic diet on manifestations of polycystic ovary syndrome in the obesity phenotype. Dr. Gambineri presented its results.

“The objective was to compare the effects of a very-low-calorie ketogenic diet and the standard low-calorie (hypocaloric) diet as a control group,” she said. “The effects studied include body weight, insulin resistance, menstrual cycle, ovulation, ovarian morphology, and hyperandrogenism in a population of 30 obese women with polycystic ovary syndrome and insulin resistance.”

Study participants had a diagnosis of polycystic ovary syndrome as defined by the National Institutes of Health criteria and were aged 18-45 years. These women were randomly assigned to two groups of equal size: experimental (very-low-calorie ketogenic diet) and control (hypocaloric diet). “The women assigned to the experimental group followed the ketogenic stage for eight weeks and then moved to the second, low-calorie diet phase for an additional eight weeks, while those in the control group (hypocaloric diet) followed the low-calorie diet for all 16 weeks.”

The primary outcomes were changes in weight and body composition, specifically fat mass and lean mass, measured by bioimpedance. “The changes observed in the following aspects were considered secondary outcomes: abdominal fat distribution, metabolic parameters, ovulation, ovarian morphology, hirsutism, hyperandrogenism, psychological well-being, and psychological distress,” said Dr. Gambineri. “Any reduction in the ovarian stroma, the area where androgens are synthesized, was also analyzed.”

The study authors found that although BMI decreased in both groups, this reduction was greater in the group that followed the very-low-calorie ketogenic diet. Significant weight loss was observed in both groups, 12.4 kg versus 4.7 kg. Significant differences were also observed in waist circumference (−8.1% in the experimental group vs. −2.2% in the control group), fat mass (−15.1% vs. −8.5%), and free testosterone (−30.3% vs. +10.6%). Only the experimental group saw a reduction in insulin.

“A key point regarding hyperandrogenism, especially regarding what’s referred to as free testosterone, there was only a significant reduction in the very-low-calorie ketogenic diet group,” said Dr. Gambineri. “This reduction was especially evident in the first part of the study, coinciding with the ketogenic period. The reason for this effect lies in the significant increase in the concentration of sex hormone-binding globulins, SHB6. Said globulins bind to the testosterone present in female blood, producing a reduction in free testosterone, a very important effect considering that this syndrome is an androgenic disorder. Furthermore, current treatments for polycystic ovary syndrome do not reduce free testosterone as much as this dietary approach does.”

For the specialist, among all these positive effects in these patients, perhaps most important is the notable improvement that occurs in ovulation. “At the beginning of the study, only 38.5% of the participants in the experimental group and 14.3% of those in the control group had ovulatory cycles. After the intervention, 84.6% managed to ovulate, compared to 35.7% who achieved this goal in the other group.”

Dr. Gambineri suggested that this method is “valid for reducing fat mass and rapidly improving hyperandrogenism and ovulatory dysfunction in women with obesity and polycystic ovary syndrome.”
 

Reversing type 2 diabetes?

Daniela Sofrà, MD, an endocrinologist specializing in diabetology at La Source Clinic, Lausanne, Switzerland, reviewed the current evidence on the role of the very-low-calorie ketogenic diet in the management of type 2 diabetes.

“It’s time to rethink diabetes treatment and focus efforts on managing obesity as an associated factor,” she said. “One of the hypotheses being examined in this regard is the twin cycle, which postulates that type 2 diabetes is the result of excess fat in the liver. This in turn is associated with insulin resistance with pancreas dysfunction.”

Dr. Sofrà added that there is a study documenting for the first time the reversibility of the morphology of the diabetic pancreas after caloric restriction with the very-low-calorie ketogenic diet. “The reason for this effect is the use of visceral and intrahepatic fat, which can lead to the remission of the clinical manifestation of type 2 diabetes, understanding as such the definition made by the American Diabetes Association: glycosylated hemoglobin < 6.5% without pharmacological therapy.”

Specifically, the results of this research showed that after following the very-low-calorie ketogenic diet and achieving a 15% weight loss (mean weight loss of the participants), liver glucose levels returned to normal levels within 7 days. Beta cell function returned to near normal within 8 weeks.

“Subsequent studies have shown the durability of remission of type 2 diabetes, thanks to the reactivation of the insulin-secreting function of beta cells that had become dedifferentiated in the face of chronic nutrient excess. Specifically, 6 out of 10 patients maintained glycosylated hemoglobin < 6% after 6 months without the need for pharmacological therapy,” Dr. Sofrà added.

Likewise, she highlighted that the probability of achieving remission is mainly determined by the duration of the disease. “The years with diabetes are one of the main predictors of the response that the patient will have with this dietary intervention. Studies have shown that remission is possible in patients with diabetes for less than 6 years, although there are other projects that indicate that it can be achieved with up to 10 years’ duration.”

Based on these data, Dr. Sofrà emphasized the pleiotropic effects of the very-low-calorie ketogenic diet on glycemic control, favoring the possible remission of diabetes or the reduction of drugs, as well as the reduction of the HOMA-IR index (insulin resistance) and waist circumference in people with type 2 diabetes.
 

Nonalcoholic fatty liver disease

The third comorbidity of obesity that may benefit from the very-low-calorie ketogenic diet is hepatic steatosis, or nonalcoholic fatty liver disease, said Hardy Walle, MD, an internal medicine specialist and director/founder of the Bodymed center, Kirkel, Germany, and one of the authors of this research.

“Recent research shows that ectopic fat and nonalcoholic fatty liver disease could be considered a cause, or at least one of the causes, of most of the diseases that affect the population as a consequence of overweight and obesity,” said Dr. Walle. “Some authors have stated that without fatty liver, there is no type 2 diabetes.”

Dr. Walle pointed out that between 30% and 40% of the adult population has nonalcoholic fatty liver disease, a percentage that increases considerably in people with obesity, reaching 70% prevalence and increasing, in the case of type 2 diabetes, to almost 90%. “Even normal weight does not rule out fatty liver; in fact, about 15% of people with nonalcoholic fatty liver disease are not overweight.”

In a setting where there are no approved drugs for the treatment of fatty liver (the current standard approach focuses on lifestyle interventions), a short-term hypocaloric diet (or liver fasting) is considered an effective method for management of this pathology. This principle was demonstrated by a study by the Saarland University, Saarbrücken, Germany, that Dr. Walle used to illustrate this statement.

“The participants (60 patients with hepatic steatosis) followed a hypocaloric diet (less than 1,000 kcal/day) for 14 days with a formula rich in protein and fiber specially developed for the treatment of nonalcoholic fatty liver disease. A fibroscan was then performed with controlled attenuation parameter measurement to quantify fatty liver disease. The results showed not only a significant improvement in nonalcoholic fatty liver disease parameters but also a marked improvement in all relevant metabolic parameters (serum lipids, liver enzymes),” explained Dr. Walle.

“This evidence leads us to affirm that the concept of hepatic fasting (by means of a hypocaloric diet) marks a point of reference for a future treatment approach for nonalcoholic fatty liver disease,” he concluded.

The study that Dr. Gambineri presented was carried out with the collaboration of the Pronokal Group (Nestlé Health Science). Dr. Gambineri, Dr. Sofrà, and Dr. Walle disclosed no relevant financial relationships.

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

MADRID – During the International Scientific Symposium “New Frontiers in Scientific Research” that recently took place in Barcelona, specialists analyzed the role of the very-low-calorie ketogenic diet. This analysis was in relation to three comorbidities that have a higher incidence among overweight and obese patients: polycystic ovary syndrome, nonalcoholic fatty liver disease, and type 2 diabetes. The experts’ aim? To analyze and update the latest evidence on the benefits of this dietary choice.

Polycystic ovary syndrome

Alessandra Gambineri, MD, PhD, associate professor at the department of medicine and surgery (DIMEC) at the University of Bologna, Italy, addressed the link between obesity and polycystic ovary syndrome, which she described as a chronic disease that affects about 10% of women of childbearing age and that presents diverse phenotypes with different characteristics.

“The pathophysiology of this syndrome is characterized by the interaction of three factors: androgen excess, adipose tissue dysfunction, and insulin resistance. These factors interact with each other and are expressed differently in each phenotype,” said Dr. Gambineri.

She indicated that adipose tissue dysfunction is central to this pathology. This centrality results from its association with secretions, such as free fatty acids, proinflammatory cytokines, certain adipokines that promote insulin resistance, glucocorticosteroids, androgens, and oxidative stress.

“Similarly, the oxidative stress that characterizes this syndrome is increasingly present in obese individuals,” said Dr. Gambineri. “This oxidative stress also produces ovary hypotoxicity that aggravates ovulatory function. In this context, the very-low-calorie ketogenic diet can be useful in several ways: weight reduction; promoting the loss of mainly visceral/abdominal fat; decreasing lipotoxicity; and improving inflammation, hyperinsulinemia, and insulin resistance.”

This was the path followed to carry out a study that aimed to analyze the effects of the very-low-calorie ketogenic diet on manifestations of polycystic ovary syndrome in the obesity phenotype. Dr. Gambineri presented its results.

“The objective was to compare the effects of a very-low-calorie ketogenic diet and the standard low-calorie (hypocaloric) diet as a control group,” she said. “The effects studied include body weight, insulin resistance, menstrual cycle, ovulation, ovarian morphology, and hyperandrogenism in a population of 30 obese women with polycystic ovary syndrome and insulin resistance.”

Study participants had a diagnosis of polycystic ovary syndrome as defined by the National Institutes of Health criteria and were aged 18-45 years. These women were randomly assigned to two groups of equal size: experimental (very-low-calorie ketogenic diet) and control (hypocaloric diet). “The women assigned to the experimental group followed the ketogenic stage for eight weeks and then moved to the second, low-calorie diet phase for an additional eight weeks, while those in the control group (hypocaloric diet) followed the low-calorie diet for all 16 weeks.”

The primary outcomes were changes in weight and body composition, specifically fat mass and lean mass, measured by bioimpedance. “The changes observed in the following aspects were considered secondary outcomes: abdominal fat distribution, metabolic parameters, ovulation, ovarian morphology, hirsutism, hyperandrogenism, psychological well-being, and psychological distress,” said Dr. Gambineri. “Any reduction in the ovarian stroma, the area where androgens are synthesized, was also analyzed.”

The study authors found that although BMI decreased in both groups, this reduction was greater in the group that followed the very-low-calorie ketogenic diet. Significant weight loss was observed in both groups, 12.4 kg versus 4.7 kg. Significant differences were also observed in waist circumference (−8.1% in the experimental group vs. −2.2% in the control group), fat mass (−15.1% vs. −8.5%), and free testosterone (−30.3% vs. +10.6%). Only the experimental group saw a reduction in insulin.

“A key point regarding hyperandrogenism, especially regarding what’s referred to as free testosterone, there was only a significant reduction in the very-low-calorie ketogenic diet group,” said Dr. Gambineri. “This reduction was especially evident in the first part of the study, coinciding with the ketogenic period. The reason for this effect lies in the significant increase in the concentration of sex hormone-binding globulins, SHB6. Said globulins bind to the testosterone present in female blood, producing a reduction in free testosterone, a very important effect considering that this syndrome is an androgenic disorder. Furthermore, current treatments for polycystic ovary syndrome do not reduce free testosterone as much as this dietary approach does.”

For the specialist, among all these positive effects in these patients, perhaps most important is the notable improvement that occurs in ovulation. “At the beginning of the study, only 38.5% of the participants in the experimental group and 14.3% of those in the control group had ovulatory cycles. After the intervention, 84.6% managed to ovulate, compared to 35.7% who achieved this goal in the other group.”

Dr. Gambineri suggested that this method is “valid for reducing fat mass and rapidly improving hyperandrogenism and ovulatory dysfunction in women with obesity and polycystic ovary syndrome.”
 

Reversing type 2 diabetes?

Daniela Sofrà, MD, an endocrinologist specializing in diabetology at La Source Clinic, Lausanne, Switzerland, reviewed the current evidence on the role of the very-low-calorie ketogenic diet in the management of type 2 diabetes.

“It’s time to rethink diabetes treatment and focus efforts on managing obesity as an associated factor,” she said. “One of the hypotheses being examined in this regard is the twin cycle, which postulates that type 2 diabetes is the result of excess fat in the liver. This in turn is associated with insulin resistance with pancreas dysfunction.”

Dr. Sofrà added that there is a study documenting for the first time the reversibility of the morphology of the diabetic pancreas after caloric restriction with the very-low-calorie ketogenic diet. “The reason for this effect is the use of visceral and intrahepatic fat, which can lead to the remission of the clinical manifestation of type 2 diabetes, understanding as such the definition made by the American Diabetes Association: glycosylated hemoglobin < 6.5% without pharmacological therapy.”

Specifically, the results of this research showed that after following the very-low-calorie ketogenic diet and achieving a 15% weight loss (mean weight loss of the participants), liver glucose levels returned to normal levels within 7 days. Beta cell function returned to near normal within 8 weeks.

“Subsequent studies have shown the durability of remission of type 2 diabetes, thanks to the reactivation of the insulin-secreting function of beta cells that had become dedifferentiated in the face of chronic nutrient excess. Specifically, 6 out of 10 patients maintained glycosylated hemoglobin < 6% after 6 months without the need for pharmacological therapy,” Dr. Sofrà added.

Likewise, she highlighted that the probability of achieving remission is mainly determined by the duration of the disease. “The years with diabetes are one of the main predictors of the response that the patient will have with this dietary intervention. Studies have shown that remission is possible in patients with diabetes for less than 6 years, although there are other projects that indicate that it can be achieved with up to 10 years’ duration.”

Based on these data, Dr. Sofrà emphasized the pleiotropic effects of the very-low-calorie ketogenic diet on glycemic control, favoring the possible remission of diabetes or the reduction of drugs, as well as the reduction of the HOMA-IR index (insulin resistance) and waist circumference in people with type 2 diabetes.
 

Nonalcoholic fatty liver disease

The third comorbidity of obesity that may benefit from the very-low-calorie ketogenic diet is hepatic steatosis, or nonalcoholic fatty liver disease, said Hardy Walle, MD, an internal medicine specialist and director/founder of the Bodymed center, Kirkel, Germany, and one of the authors of this research.

“Recent research shows that ectopic fat and nonalcoholic fatty liver disease could be considered a cause, or at least one of the causes, of most of the diseases that affect the population as a consequence of overweight and obesity,” said Dr. Walle. “Some authors have stated that without fatty liver, there is no type 2 diabetes.”

Dr. Walle pointed out that between 30% and 40% of the adult population has nonalcoholic fatty liver disease, a percentage that increases considerably in people with obesity, reaching 70% prevalence and increasing, in the case of type 2 diabetes, to almost 90%. “Even normal weight does not rule out fatty liver; in fact, about 15% of people with nonalcoholic fatty liver disease are not overweight.”

In a setting where there are no approved drugs for the treatment of fatty liver (the current standard approach focuses on lifestyle interventions), a short-term hypocaloric diet (or liver fasting) is considered an effective method for management of this pathology. This principle was demonstrated by a study by the Saarland University, Saarbrücken, Germany, that Dr. Walle used to illustrate this statement.

“The participants (60 patients with hepatic steatosis) followed a hypocaloric diet (less than 1,000 kcal/day) for 14 days with a formula rich in protein and fiber specially developed for the treatment of nonalcoholic fatty liver disease. A fibroscan was then performed with controlled attenuation parameter measurement to quantify fatty liver disease. The results showed not only a significant improvement in nonalcoholic fatty liver disease parameters but also a marked improvement in all relevant metabolic parameters (serum lipids, liver enzymes),” explained Dr. Walle.

“This evidence leads us to affirm that the concept of hepatic fasting (by means of a hypocaloric diet) marks a point of reference for a future treatment approach for nonalcoholic fatty liver disease,” he concluded.

The study that Dr. Gambineri presented was carried out with the collaboration of the Pronokal Group (Nestlé Health Science). Dr. Gambineri, Dr. Sofrà, and Dr. Walle disclosed no relevant financial relationships.

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

CHICAGO – Health insurance should cover treatment for infertility caused by gender-affirming medical interventions, the American Medical Association said June 13 at its House of Delegates meeting.

Speaking on behalf of the Medical Student Section, Justin Magrath, of Louisiana, said, “We as a section feel that these interventions should be considered as additional causes of iatrogenic infertility and be covered by insurance.”

Iatrogenic infertility is infertility caused by surgery, radiotherapy, chemotherapy, or other medically necessary treatment. The AMA voted June 13 to support including the phrase, “impaired fertility as a consequence of gender-affirming hormone therapy and gender-affirming surgery,” in that definition.

The AMA also supports access to fertility preservation services for people who undergo those treatments.

“I’ve had many friends who went through transitions and gender-affirming care and had no idea that these options were available and others who did know they were available but they were so expensive that they couldn’t access them,” said emergency medicine resident Sophia Spadafore, MD, delegate for the Resident and Fellow Section. “So while people might be able to access gender-affirming care, sometimes they have to make the decision between future fertility and having children and accessing this kind of lifesaving care that we support.”

The AMA already had policies that support insurance coverage of treatments for gender dysphoria and the right to seek fertility preservation services for people who undergo gender-affirming hormone therapy or surgery, but until this week, it had not addressed insurance coverage for preserving fertility in those cases.

“The transgender population already faces many barriers to care, such as provider discrimination, legal concerns, financial burden, and emotional cost,” Mr. Magrath said during a reference committee hearing on June 11. “We as a section ask our organization to continue to serve as an ally, providing equitable care for diverse populations and expanding coverage for medically necessary treatments.”

“I am a gender surgeon, so this is pretty important to me,” said Sean Figy, MD, of Nebraska, a delegate for the American Society for Reconstructive Microsurgery.

The original resolution included the words “medically necessary” when referring to gender-affirming treatments, and Dr. Figy expressed hesitancy about those words. An amendment removed them.

“I’ve seen that phrase weaponized against gender-nonconforming patients,” he said.

Ophthalmologist Charles Hickey, MD, of the Ohio delegation, spoke in favor of referral or of waiting to adopt the resolution.

“I think the different amendments being discussed here are evidence that this needs a more thorough and careful treatment than we can do at this point right now,” he said.

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

CHICAGO – Health insurance should cover treatment for infertility caused by gender-affirming medical interventions, the American Medical Association said June 13 at its House of Delegates meeting.

Speaking on behalf of the Medical Student Section, Justin Magrath, of Louisiana, said, “We as a section feel that these interventions should be considered as additional causes of iatrogenic infertility and be covered by insurance.”

Iatrogenic infertility is infertility caused by surgery, radiotherapy, chemotherapy, or other medically necessary treatment. The AMA voted June 13 to support including the phrase, “impaired fertility as a consequence of gender-affirming hormone therapy and gender-affirming surgery,” in that definition.

The AMA also supports access to fertility preservation services for people who undergo those treatments.

“I’ve had many friends who went through transitions and gender-affirming care and had no idea that these options were available and others who did know they were available but they were so expensive that they couldn’t access them,” said emergency medicine resident Sophia Spadafore, MD, delegate for the Resident and Fellow Section. “So while people might be able to access gender-affirming care, sometimes they have to make the decision between future fertility and having children and accessing this kind of lifesaving care that we support.”

The AMA already had policies that support insurance coverage of treatments for gender dysphoria and the right to seek fertility preservation services for people who undergo gender-affirming hormone therapy or surgery, but until this week, it had not addressed insurance coverage for preserving fertility in those cases.

“The transgender population already faces many barriers to care, such as provider discrimination, legal concerns, financial burden, and emotional cost,” Mr. Magrath said during a reference committee hearing on June 11. “We as a section ask our organization to continue to serve as an ally, providing equitable care for diverse populations and expanding coverage for medically necessary treatments.”

“I am a gender surgeon, so this is pretty important to me,” said Sean Figy, MD, of Nebraska, a delegate for the American Society for Reconstructive Microsurgery.

The original resolution included the words “medically necessary” when referring to gender-affirming treatments, and Dr. Figy expressed hesitancy about those words. An amendment removed them.

“I’ve seen that phrase weaponized against gender-nonconforming patients,” he said.

Ophthalmologist Charles Hickey, MD, of the Ohio delegation, spoke in favor of referral or of waiting to adopt the resolution.

“I think the different amendments being discussed here are evidence that this needs a more thorough and careful treatment than we can do at this point right now,” he said.

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

CHICAGO – Health insurance should cover treatment for infertility caused by gender-affirming medical interventions, the American Medical Association said June 13 at its House of Delegates meeting.

Speaking on behalf of the Medical Student Section, Justin Magrath, of Louisiana, said, “We as a section feel that these interventions should be considered as additional causes of iatrogenic infertility and be covered by insurance.”

Iatrogenic infertility is infertility caused by surgery, radiotherapy, chemotherapy, or other medically necessary treatment. The AMA voted June 13 to support including the phrase, “impaired fertility as a consequence of gender-affirming hormone therapy and gender-affirming surgery,” in that definition.

The AMA also supports access to fertility preservation services for people who undergo those treatments.

“I’ve had many friends who went through transitions and gender-affirming care and had no idea that these options were available and others who did know they were available but they were so expensive that they couldn’t access them,” said emergency medicine resident Sophia Spadafore, MD, delegate for the Resident and Fellow Section. “So while people might be able to access gender-affirming care, sometimes they have to make the decision between future fertility and having children and accessing this kind of lifesaving care that we support.”

The AMA already had policies that support insurance coverage of treatments for gender dysphoria and the right to seek fertility preservation services for people who undergo gender-affirming hormone therapy or surgery, but until this week, it had not addressed insurance coverage for preserving fertility in those cases.

“The transgender population already faces many barriers to care, such as provider discrimination, legal concerns, financial burden, and emotional cost,” Mr. Magrath said during a reference committee hearing on June 11. “We as a section ask our organization to continue to serve as an ally, providing equitable care for diverse populations and expanding coverage for medically necessary treatments.”

“I am a gender surgeon, so this is pretty important to me,” said Sean Figy, MD, of Nebraska, a delegate for the American Society for Reconstructive Microsurgery.

The original resolution included the words “medically necessary” when referring to gender-affirming treatments, and Dr. Figy expressed hesitancy about those words. An amendment removed them.

“I’ve seen that phrase weaponized against gender-nonconforming patients,” he said.

Ophthalmologist Charles Hickey, MD, of the Ohio delegation, spoke in favor of referral or of waiting to adopt the resolution.

“I think the different amendments being discussed here are evidence that this needs a more thorough and careful treatment than we can do at this point right now,” he said.

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

A recent series of columns on practice merger options generated a multitude of questions regarding merger, employment, and buyout agreements. The most common question was, “Do I really need to go to the trouble and expense of negotiating them?” If you have more than one physician in your group, you absolutely do need written contracts for a variety of reasons, but mostly to avoid conflicts later on. The proverbial “handshake agreement” is worthless in a major business dispute; everyone loses in such situations except the lawyers and accountants.

Mergers and buy-ins were covered at some length in my two previous columns. If the arrangement is to be one of employer and employees rather than a merger of equal partners, you will need an employment agreement to cover duties, requirements, expectations, and benefits. They define how each practitioner/employee will be paid, along with paid time off, health insurance, expense allowances, and malpractice coverage, among other basics. The more that is spelled out in the employment agreement, the fewer disagreements you are likely to have down the road.

Many employment contracts include a “termination without cause” clause, which benefits both the practice and the practitioners. It allows a practice to terminate a new associate if it feels a mistake has been made, even if he or she has done nothing wrong. On the other hand, the newcomer has the option to terminate if a better offer arises, their spouse hates the area, or for any other reason.

Buyouts should be addressed in advance as well. Several recent correspondents told me they didn’t see the necessity of writing a buyout agreement, because they plan to eventually sell their practice, rendering any buyout conditions moot. But what happens if an associate dies, becomes permanently disabled, or abruptly decides to leave the practice? If you haven’t prepared for such eventualities, you could find yourself receiving a demand from your ex-partner (or surviving spouse) for immediate payment of that partner’s portion of the practice’s value. And your valuation of the practice is likely to be severely at odds with the other party’s. Meanwhile, remaining partners must cover all the practice’s expenses and deal with an increased patient load.

A buyout agreement avoids these problems by planning for such eventualities in advance. You must agree on how a buyout amount will be valued. As I’ve said in previous columns, I strongly advise using a formula, not a fixed amount. If a buyout is based on 15- or 20-year-old reimbursements, the buyout will have no relationship to what the partners are currently being paid. Likewise, any buyout calculated at “appraised value” is a problem, because the buyout amount remains a mystery until an appraisal is performed. If the appraised value ends up being too high, the remaining owners may refuse to pay it. Have an actuary create a formula, so that a buyout figure can be calculated at any time. This area, especially, is where you need experienced, competent legal advice.

To avoid surprises, any buyout should require ample notice (6-12 months is common) to allow time to rearrange finances and recruit a new provider. Vesting schedules, similar to those used in retirement plans, are also popular. If a partner leaves before a prescribed time period has elapsed – say, 20 years – the buyout is proportionally reduced.

Buyouts can also be useful when dealing with noncompete agreements, which are notoriously difficult (and expensive) to enforce. One solution is a buyout penalty; a departing partner can compete with his or her former practice, but at the cost of a substantially reduced buyout. This permits competition, but discourages it, and compensates the targeted practice.

Buyouts are also a potential solution to some buy-in issues. A new associate entering an established practice may not be able to contribute assets equal to existing partners’ stakes and may lack the cash necessary to make up the difference. One alternative is to agree that any inequalities will be compensated at the other end in buyout value. Those partners contributing more assets will receive larger buyouts than those contributing less.

As I’ve said many times, these are not negotiations to undertake on your own. Enlist the aid of a consultant or attorney (or both) with ample medical practice experience.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

A recent series of columns on practice merger options generated a multitude of questions regarding merger, employment, and buyout agreements. The most common question was, “Do I really need to go to the trouble and expense of negotiating them?” If you have more than one physician in your group, you absolutely do need written contracts for a variety of reasons, but mostly to avoid conflicts later on. The proverbial “handshake agreement” is worthless in a major business dispute; everyone loses in such situations except the lawyers and accountants.

Mergers and buy-ins were covered at some length in my two previous columns. If the arrangement is to be one of employer and employees rather than a merger of equal partners, you will need an employment agreement to cover duties, requirements, expectations, and benefits. They define how each practitioner/employee will be paid, along with paid time off, health insurance, expense allowances, and malpractice coverage, among other basics. The more that is spelled out in the employment agreement, the fewer disagreements you are likely to have down the road.

Many employment contracts include a “termination without cause” clause, which benefits both the practice and the practitioners. It allows a practice to terminate a new associate if it feels a mistake has been made, even if he or she has done nothing wrong. On the other hand, the newcomer has the option to terminate if a better offer arises, their spouse hates the area, or for any other reason.

Buyouts should be addressed in advance as well. Several recent correspondents told me they didn’t see the necessity of writing a buyout agreement, because they plan to eventually sell their practice, rendering any buyout conditions moot. But what happens if an associate dies, becomes permanently disabled, or abruptly decides to leave the practice? If you haven’t prepared for such eventualities, you could find yourself receiving a demand from your ex-partner (or surviving spouse) for immediate payment of that partner’s portion of the practice’s value. And your valuation of the practice is likely to be severely at odds with the other party’s. Meanwhile, remaining partners must cover all the practice’s expenses and deal with an increased patient load.

A buyout agreement avoids these problems by planning for such eventualities in advance. You must agree on how a buyout amount will be valued. As I’ve said in previous columns, I strongly advise using a formula, not a fixed amount. If a buyout is based on 15- or 20-year-old reimbursements, the buyout will have no relationship to what the partners are currently being paid. Likewise, any buyout calculated at “appraised value” is a problem, because the buyout amount remains a mystery until an appraisal is performed. If the appraised value ends up being too high, the remaining owners may refuse to pay it. Have an actuary create a formula, so that a buyout figure can be calculated at any time. This area, especially, is where you need experienced, competent legal advice.

To avoid surprises, any buyout should require ample notice (6-12 months is common) to allow time to rearrange finances and recruit a new provider. Vesting schedules, similar to those used in retirement plans, are also popular. If a partner leaves before a prescribed time period has elapsed – say, 20 years – the buyout is proportionally reduced.

Buyouts can also be useful when dealing with noncompete agreements, which are notoriously difficult (and expensive) to enforce. One solution is a buyout penalty; a departing partner can compete with his or her former practice, but at the cost of a substantially reduced buyout. This permits competition, but discourages it, and compensates the targeted practice.

Buyouts are also a potential solution to some buy-in issues. A new associate entering an established practice may not be able to contribute assets equal to existing partners’ stakes and may lack the cash necessary to make up the difference. One alternative is to agree that any inequalities will be compensated at the other end in buyout value. Those partners contributing more assets will receive larger buyouts than those contributing less.

As I’ve said many times, these are not negotiations to undertake on your own. Enlist the aid of a consultant or attorney (or both) with ample medical practice experience.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

A recent series of columns on practice merger options generated a multitude of questions regarding merger, employment, and buyout agreements. The most common question was, “Do I really need to go to the trouble and expense of negotiating them?” If you have more than one physician in your group, you absolutely do need written contracts for a variety of reasons, but mostly to avoid conflicts later on. The proverbial “handshake agreement” is worthless in a major business dispute; everyone loses in such situations except the lawyers and accountants.

Mergers and buy-ins were covered at some length in my two previous columns. If the arrangement is to be one of employer and employees rather than a merger of equal partners, you will need an employment agreement to cover duties, requirements, expectations, and benefits. They define how each practitioner/employee will be paid, along with paid time off, health insurance, expense allowances, and malpractice coverage, among other basics. The more that is spelled out in the employment agreement, the fewer disagreements you are likely to have down the road.

Many employment contracts include a “termination without cause” clause, which benefits both the practice and the practitioners. It allows a practice to terminate a new associate if it feels a mistake has been made, even if he or she has done nothing wrong. On the other hand, the newcomer has the option to terminate if a better offer arises, their spouse hates the area, or for any other reason.

Buyouts should be addressed in advance as well. Several recent correspondents told me they didn’t see the necessity of writing a buyout agreement, because they plan to eventually sell their practice, rendering any buyout conditions moot. But what happens if an associate dies, becomes permanently disabled, or abruptly decides to leave the practice? If you haven’t prepared for such eventualities, you could find yourself receiving a demand from your ex-partner (or surviving spouse) for immediate payment of that partner’s portion of the practice’s value. And your valuation of the practice is likely to be severely at odds with the other party’s. Meanwhile, remaining partners must cover all the practice’s expenses and deal with an increased patient load.

A buyout agreement avoids these problems by planning for such eventualities in advance. You must agree on how a buyout amount will be valued. As I’ve said in previous columns, I strongly advise using a formula, not a fixed amount. If a buyout is based on 15- or 20-year-old reimbursements, the buyout will have no relationship to what the partners are currently being paid. Likewise, any buyout calculated at “appraised value” is a problem, because the buyout amount remains a mystery until an appraisal is performed. If the appraised value ends up being too high, the remaining owners may refuse to pay it. Have an actuary create a formula, so that a buyout figure can be calculated at any time. This area, especially, is where you need experienced, competent legal advice.

To avoid surprises, any buyout should require ample notice (6-12 months is common) to allow time to rearrange finances and recruit a new provider. Vesting schedules, similar to those used in retirement plans, are also popular. If a partner leaves before a prescribed time period has elapsed – say, 20 years – the buyout is proportionally reduced.

Buyouts can also be useful when dealing with noncompete agreements, which are notoriously difficult (and expensive) to enforce. One solution is a buyout penalty; a departing partner can compete with his or her former practice, but at the cost of a substantially reduced buyout. This permits competition, but discourages it, and compensates the targeted practice.

Buyouts are also a potential solution to some buy-in issues. A new associate entering an established practice may not be able to contribute assets equal to existing partners’ stakes and may lack the cash necessary to make up the difference. One alternative is to agree that any inequalities will be compensated at the other end in buyout value. Those partners contributing more assets will receive larger buyouts than those contributing less.

As I’ve said many times, these are not negotiations to undertake on your own. Enlist the aid of a consultant or attorney (or both) with ample medical practice experience.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Menopause gets a bad rap in medical literature and throughout society, say authors of a new analysis. And they argue that the negativity undermines women’s health outlook in the years that should be a natural life transition.

Menopause has been medicalized over centuries and talked about as if it were a disease, they say, and that may increase women’s anxiety and apprehension about the midlife stage.

It’s time to change the narrative, says Martha Hickey, MD, with the department of obstetrics and gynaecology at the Royal Women’s Hospital in Victoria, Australia, and her coauthors. Their analysis was published online in the BMJ.

“The message that menopause signals decay and decline, which can potentially be delayed or reversed by hormonal treatments, persists and is reinforced by the media, medical literature, and information for women, often driven by marketing interests,” they write.

Such messages may chip away at women’s confidence. Dr. Hickey and colleagues cite surveys in the United States and Ireland that found that most women (65%-77%) feel unprepared for menopause.

“Together with limited public discussion and education and shame attached to ageing in women, this may contribute to embarrassment and negative expectations about menopause,” the authors write.
 

The ‘untold misery of oestrogen-starved women’

These messages have deep roots. Take for instance, gynecologist Robert Wilson’s words in his 1966 book “Feminine Forever.” The authors note he recommended estrogen for all menopausal women “to treat their ‘serious, painful and often crippling disease’ and avoid the ‘untold misery of alcoholism, drug addiction, divorce, and broken

homes caused by these unstable, oestrogen-starved women.’ ”

Women experience menopause in very different ways. Experience with menopause also differs by country, the authors explain. “Women’s experience of menopause is also strongly influenced by social values around reproduction and ageing, with positive or negative ramifications,” they write.

“For example, women tend to have worse experiences of menopause in countries where their value is predicated on youth and reproductive capacity and ageing is associated with decline.”

The authors argue that the medicalization of menopause has condensed the wide range of women’s experiences at a typical age into “a narrowly defined disease requiring treatment.”
 

Promoting exercise, stopping smoking among positive messages

An editorial by Haitham Hamoda, MD, and Sara Moger, with the British Menopause Society, notes that more than 75% of women experiencing menopause report symptoms, and more than 25% describe severe symptoms.

The editorialists point out that the National Institute of Health and Care Excellence and others recommend an individualized approach to addressing menopause that includes a comprehensive approach – advice on exercise, weight management, stopping smoking, and reducing alcohol as well as options such as hormone therapy (HT).

The literature says the main indication for HT is for severe symptoms and not as a preventive measure. “Evidence does not support use of HT to reduce the risk of dementia,” they point out.

While some women may benefit from HT, that should not be explored to the exclusion of other avenues of help, Dr. Hickey and colleagues write. Risks must also be considered.
 

Menopause blamed in a difficult time of life

Jennifer Howell, MD, an obstetrician/gynecologist and certified menopause provider at Duke University in Durham, N.C., told this news organization that menopause is often blamed in a time of life when women naturally are experiencing an array of stressful and emotional changes.

It often coincides with children heading to college, navigating midlife challenges in marriage, helping aging parents, managing demanding careers, and health issues.

People want a reason for changes women experience, and too often the finger gets pointed at menopause, Dr. Howell said.

The message women hear has always been, “It’s got to be your hormones. And people want to hear that there’s a hormonal solution.”

Making menopause the target also has led to nonevidence-based “snake-oil” type remedies sold in unregulated powders, creams, and pellets, Dr. Howell noted.

Dr. Howell has treated thousands of menopausal women in her clinic and she says she spends a good deal of time with them explaining a holistic view of the process, much like what the authors describe, with lifestyle changes and treatment options.

Sometimes HT is the solution, Dr. Howell says, but “it’s become a crutch. Hormones are not a panacea.”

She is frustrated with the amount of disinformation circulating online. Groups like the North American Menopause Society put out reliable evidence-based information, but they compete “with a lot of nonsense,” she says.

The message that women should hear, she says is that “[menopause] is a natural part of aging and there may or may not be symptoms that come along with it. If there are, there are things we can do,” she says.

Menopause gets a bad rap in medical literature and throughout society, say authors of a new analysis. And they argue that the negativity undermines women’s health outlook in the years that should be a natural life transition.

Menopause has been medicalized over centuries and talked about as if it were a disease, they say, and that may increase women’s anxiety and apprehension about the midlife stage.

It’s time to change the narrative, says Martha Hickey, MD, with the department of obstetrics and gynaecology at the Royal Women’s Hospital in Victoria, Australia, and her coauthors. Their analysis was published online in the BMJ.

“The message that menopause signals decay and decline, which can potentially be delayed or reversed by hormonal treatments, persists and is reinforced by the media, medical literature, and information for women, often driven by marketing interests,” they write.

Such messages may chip away at women’s confidence. Dr. Hickey and colleagues cite surveys in the United States and Ireland that found that most women (65%-77%) feel unprepared for menopause.

“Together with limited public discussion and education and shame attached to ageing in women, this may contribute to embarrassment and negative expectations about menopause,” the authors write.
 

The ‘untold misery of oestrogen-starved women’

These messages have deep roots. Take for instance, gynecologist Robert Wilson’s words in his 1966 book “Feminine Forever.” The authors note he recommended estrogen for all menopausal women “to treat their ‘serious, painful and often crippling disease’ and avoid the ‘untold misery of alcoholism, drug addiction, divorce, and broken

homes caused by these unstable, oestrogen-starved women.’ ”

Women experience menopause in very different ways. Experience with menopause also differs by country, the authors explain. “Women’s experience of menopause is also strongly influenced by social values around reproduction and ageing, with positive or negative ramifications,” they write.

“For example, women tend to have worse experiences of menopause in countries where their value is predicated on youth and reproductive capacity and ageing is associated with decline.”

The authors argue that the medicalization of menopause has condensed the wide range of women’s experiences at a typical age into “a narrowly defined disease requiring treatment.”
 

Promoting exercise, stopping smoking among positive messages

An editorial by Haitham Hamoda, MD, and Sara Moger, with the British Menopause Society, notes that more than 75% of women experiencing menopause report symptoms, and more than 25% describe severe symptoms.

The editorialists point out that the National Institute of Health and Care Excellence and others recommend an individualized approach to addressing menopause that includes a comprehensive approach – advice on exercise, weight management, stopping smoking, and reducing alcohol as well as options such as hormone therapy (HT).

The literature says the main indication for HT is for severe symptoms and not as a preventive measure. “Evidence does not support use of HT to reduce the risk of dementia,” they point out.

While some women may benefit from HT, that should not be explored to the exclusion of other avenues of help, Dr. Hickey and colleagues write. Risks must also be considered.
 

Menopause blamed in a difficult time of life

Jennifer Howell, MD, an obstetrician/gynecologist and certified menopause provider at Duke University in Durham, N.C., told this news organization that menopause is often blamed in a time of life when women naturally are experiencing an array of stressful and emotional changes.

It often coincides with children heading to college, navigating midlife challenges in marriage, helping aging parents, managing demanding careers, and health issues.

People want a reason for changes women experience, and too often the finger gets pointed at menopause, Dr. Howell said.

The message women hear has always been, “It’s got to be your hormones. And people want to hear that there’s a hormonal solution.”

Making menopause the target also has led to nonevidence-based “snake-oil” type remedies sold in unregulated powders, creams, and pellets, Dr. Howell noted.

Dr. Howell has treated thousands of menopausal women in her clinic and she says she spends a good deal of time with them explaining a holistic view of the process, much like what the authors describe, with lifestyle changes and treatment options.

Sometimes HT is the solution, Dr. Howell says, but “it’s become a crutch. Hormones are not a panacea.”

She is frustrated with the amount of disinformation circulating online. Groups like the North American Menopause Society put out reliable evidence-based information, but they compete “with a lot of nonsense,” she says.

The message that women should hear, she says is that “[menopause] is a natural part of aging and there may or may not be symptoms that come along with it. If there are, there are things we can do,” she says.

Menopause gets a bad rap in medical literature and throughout society, say authors of a new analysis. And they argue that the negativity undermines women’s health outlook in the years that should be a natural life transition.

Menopause has been medicalized over centuries and talked about as if it were a disease, they say, and that may increase women’s anxiety and apprehension about the midlife stage.

It’s time to change the narrative, says Martha Hickey, MD, with the department of obstetrics and gynaecology at the Royal Women’s Hospital in Victoria, Australia, and her coauthors. Their analysis was published online in the BMJ.

“The message that menopause signals decay and decline, which can potentially be delayed or reversed by hormonal treatments, persists and is reinforced by the media, medical literature, and information for women, often driven by marketing interests,” they write.

Such messages may chip away at women’s confidence. Dr. Hickey and colleagues cite surveys in the United States and Ireland that found that most women (65%-77%) feel unprepared for menopause.

“Together with limited public discussion and education and shame attached to ageing in women, this may contribute to embarrassment and negative expectations about menopause,” the authors write.
 

The ‘untold misery of oestrogen-starved women’

These messages have deep roots. Take for instance, gynecologist Robert Wilson’s words in his 1966 book “Feminine Forever.” The authors note he recommended estrogen for all menopausal women “to treat their ‘serious, painful and often crippling disease’ and avoid the ‘untold misery of alcoholism, drug addiction, divorce, and broken

homes caused by these unstable, oestrogen-starved women.’ ”

Women experience menopause in very different ways. Experience with menopause also differs by country, the authors explain. “Women’s experience of menopause is also strongly influenced by social values around reproduction and ageing, with positive or negative ramifications,” they write.

“For example, women tend to have worse experiences of menopause in countries where their value is predicated on youth and reproductive capacity and ageing is associated with decline.”

The authors argue that the medicalization of menopause has condensed the wide range of women’s experiences at a typical age into “a narrowly defined disease requiring treatment.”
 

Promoting exercise, stopping smoking among positive messages

An editorial by Haitham Hamoda, MD, and Sara Moger, with the British Menopause Society, notes that more than 75% of women experiencing menopause report symptoms, and more than 25% describe severe symptoms.

The editorialists point out that the National Institute of Health and Care Excellence and others recommend an individualized approach to addressing menopause that includes a comprehensive approach – advice on exercise, weight management, stopping smoking, and reducing alcohol as well as options such as hormone therapy (HT).

The literature says the main indication for HT is for severe symptoms and not as a preventive measure. “Evidence does not support use of HT to reduce the risk of dementia,” they point out.

While some women may benefit from HT, that should not be explored to the exclusion of other avenues of help, Dr. Hickey and colleagues write. Risks must also be considered.
 

Menopause blamed in a difficult time of life

Jennifer Howell, MD, an obstetrician/gynecologist and certified menopause provider at Duke University in Durham, N.C., told this news organization that menopause is often blamed in a time of life when women naturally are experiencing an array of stressful and emotional changes.

It often coincides with children heading to college, navigating midlife challenges in marriage, helping aging parents, managing demanding careers, and health issues.

People want a reason for changes women experience, and too often the finger gets pointed at menopause, Dr. Howell said.

The message women hear has always been, “It’s got to be your hormones. And people want to hear that there’s a hormonal solution.”

Making menopause the target also has led to nonevidence-based “snake-oil” type remedies sold in unregulated powders, creams, and pellets, Dr. Howell noted.

Dr. Howell has treated thousands of menopausal women in her clinic and she says she spends a good deal of time with them explaining a holistic view of the process, much like what the authors describe, with lifestyle changes and treatment options.

Sometimes HT is the solution, Dr. Howell says, but “it’s become a crutch. Hormones are not a panacea.”

She is frustrated with the amount of disinformation circulating online. Groups like the North American Menopause Society put out reliable evidence-based information, but they compete “with a lot of nonsense,” she says.

The message that women should hear, she says is that “[menopause] is a natural part of aging and there may or may not be symptoms that come along with it. If there are, there are things we can do,” she says.