Ob.Gyn. News

Most of the United States will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children’s Hospital of Philadelphia.

Courtesy NIAID-RML

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

“Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation’s pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays,” the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the United States but remain below levels seen during the summer and last winter’s surges, according to the New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in the coming weeks.

During the past week, the United States has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the United States in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country’s highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan’s top public health officials described the surge as a “critical” and “deeply concerning” situation on Dec. 10, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Dec. 12.

“If you want to be optimally protected, absolutely get a booster,” he said on ABC’s “This Week.”

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect Dec. 13. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.

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

Most of the United States will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children’s Hospital of Philadelphia.

Courtesy NIAID-RML

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

“Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation’s pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays,” the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the United States but remain below levels seen during the summer and last winter’s surges, according to the New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in the coming weeks.

During the past week, the United States has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the United States in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country’s highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan’s top public health officials described the surge as a “critical” and “deeply concerning” situation on Dec. 10, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Dec. 12.

“If you want to be optimally protected, absolutely get a booster,” he said on ABC’s “This Week.”

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect Dec. 13. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.

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

Most of the United States will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children’s Hospital of Philadelphia.

Courtesy NIAID-RML

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

“Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation’s pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays,” the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the United States but remain below levels seen during the summer and last winter’s surges, according to the New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in the coming weeks.

During the past week, the United States has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the United States in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country’s highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan’s top public health officials described the surge as a “critical” and “deeply concerning” situation on Dec. 10, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Dec. 12.

“If you want to be optimally protected, absolutely get a booster,” he said on ABC’s “This Week.”

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect Dec. 13. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.

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

SAN ANTONIO – A small study suggests the frequent use of antibiotics among women with triple-negative breast cancer, may have an impact on overall and breast cancer–specific mortality.

The study was recently presented at the San Antonio Breast Cancer Symposium by Julia D. Ransohoff, MD, of Stanford (Calif.) University.

Gut-associated lymphoid tissues are the largest component of the immune system. They influence both local and systemic immune responses, but the use of antimicrobials can decrease circulating and tumor-infiltrating lymphocytes that effect the immune repertoire and in turn, the survival of women with triple-negative breast cancer.

Dr. Ransohoff and colleagues hypothesized that increasing antimicrobial exposure in the presence of time-varying absolute lymphocyte counts may lead to higher overall and breast cancer–specific mortality. Their analysis is based on data from the population-based Surveillance, Epidemiology, and End Results registry and electronic medical records from Stanford University and Sutter Health. It included 772 women who were treated for triple-negative breast cancer between 2000 and 2014. The women were followed for an average of 104 months.

In an earlier analysis of this same group, Dr. Ransohoff found that higher minimum absolute lymphocyte counts were associated with lower overall mortality (hazard ratio, 0.23; 95% confidence interval, 0.16-0.35) and breast cancer mortality (HR, 0.19; 95% CI, 0.11-0.34) The association between higher peripheral lymphocyte counts and tumor-infiltrating lymphocytes was significant.

In the analysis of relationships between antibiotic use and mortality, 85% of women (n = 654) were prescribed antibiotics after having been diagnosed with triple-negative breast cancer. The death rate among patients who were prescribed antibiotics was 23% (153/654), compared with 20% (24/118) among the patients who were not treated with antibiotics (which accounts for 15% of the entire group).

For total antibiotic exposure, the HR for overall mortality was 1.06 (95% CI, 1.03-1.09; P < .001) and 1.07 for breast cancer–specific mortality (95% CI, 1.04-1.10; P < .001). For unique antibiotic exposure (not counting repeat prescriptions of the same antibiotic), the HR for overall mortality was 1.17 (95% CI, 1.12-1.22; P < .001) and 1.18 for breast cancer–specific mortality (95% CI, 1.12-1.24; P < .001). 

“These were all statistically significant associations derived from a statistical model that takes into account baseline patient characteristics, so the reported hazard ratios, to the best of our ability, represent the risk of death associated with antibiotic use adjusted for other baseline covariates. We’ve attempted to account for differences at baseline that may indicate patients are sicker, and so the reported risk represents mortality related with antibiotic exposure,” Dr. Ransohoff said.

Elucidating the role of the microbiome in mediating absolute lymphocyte counts and immune response may inform interventions to reduce triple-negative mortality, she said.

SAN ANTONIO – A small study suggests the frequent use of antibiotics among women with triple-negative breast cancer, may have an impact on overall and breast cancer–specific mortality.

The study was recently presented at the San Antonio Breast Cancer Symposium by Julia D. Ransohoff, MD, of Stanford (Calif.) University.

Gut-associated lymphoid tissues are the largest component of the immune system. They influence both local and systemic immune responses, but the use of antimicrobials can decrease circulating and tumor-infiltrating lymphocytes that effect the immune repertoire and in turn, the survival of women with triple-negative breast cancer.

Dr. Ransohoff and colleagues hypothesized that increasing antimicrobial exposure in the presence of time-varying absolute lymphocyte counts may lead to higher overall and breast cancer–specific mortality. Their analysis is based on data from the population-based Surveillance, Epidemiology, and End Results registry and electronic medical records from Stanford University and Sutter Health. It included 772 women who were treated for triple-negative breast cancer between 2000 and 2014. The women were followed for an average of 104 months.

In an earlier analysis of this same group, Dr. Ransohoff found that higher minimum absolute lymphocyte counts were associated with lower overall mortality (hazard ratio, 0.23; 95% confidence interval, 0.16-0.35) and breast cancer mortality (HR, 0.19; 95% CI, 0.11-0.34) The association between higher peripheral lymphocyte counts and tumor-infiltrating lymphocytes was significant.

In the analysis of relationships between antibiotic use and mortality, 85% of women (n = 654) were prescribed antibiotics after having been diagnosed with triple-negative breast cancer. The death rate among patients who were prescribed antibiotics was 23% (153/654), compared with 20% (24/118) among the patients who were not treated with antibiotics (which accounts for 15% of the entire group).

For total antibiotic exposure, the HR for overall mortality was 1.06 (95% CI, 1.03-1.09; P < .001) and 1.07 for breast cancer–specific mortality (95% CI, 1.04-1.10; P < .001). For unique antibiotic exposure (not counting repeat prescriptions of the same antibiotic), the HR for overall mortality was 1.17 (95% CI, 1.12-1.22; P < .001) and 1.18 for breast cancer–specific mortality (95% CI, 1.12-1.24; P < .001). 

“These were all statistically significant associations derived from a statistical model that takes into account baseline patient characteristics, so the reported hazard ratios, to the best of our ability, represent the risk of death associated with antibiotic use adjusted for other baseline covariates. We’ve attempted to account for differences at baseline that may indicate patients are sicker, and so the reported risk represents mortality related with antibiotic exposure,” Dr. Ransohoff said.

Elucidating the role of the microbiome in mediating absolute lymphocyte counts and immune response may inform interventions to reduce triple-negative mortality, she said.

SAN ANTONIO – A small study suggests the frequent use of antibiotics among women with triple-negative breast cancer, may have an impact on overall and breast cancer–specific mortality.

The study was recently presented at the San Antonio Breast Cancer Symposium by Julia D. Ransohoff, MD, of Stanford (Calif.) University.

Gut-associated lymphoid tissues are the largest component of the immune system. They influence both local and systemic immune responses, but the use of antimicrobials can decrease circulating and tumor-infiltrating lymphocytes that effect the immune repertoire and in turn, the survival of women with triple-negative breast cancer.

Dr. Ransohoff and colleagues hypothesized that increasing antimicrobial exposure in the presence of time-varying absolute lymphocyte counts may lead to higher overall and breast cancer–specific mortality. Their analysis is based on data from the population-based Surveillance, Epidemiology, and End Results registry and electronic medical records from Stanford University and Sutter Health. It included 772 women who were treated for triple-negative breast cancer between 2000 and 2014. The women were followed for an average of 104 months.

In an earlier analysis of this same group, Dr. Ransohoff found that higher minimum absolute lymphocyte counts were associated with lower overall mortality (hazard ratio, 0.23; 95% confidence interval, 0.16-0.35) and breast cancer mortality (HR, 0.19; 95% CI, 0.11-0.34) The association between higher peripheral lymphocyte counts and tumor-infiltrating lymphocytes was significant.

In the analysis of relationships between antibiotic use and mortality, 85% of women (n = 654) were prescribed antibiotics after having been diagnosed with triple-negative breast cancer. The death rate among patients who were prescribed antibiotics was 23% (153/654), compared with 20% (24/118) among the patients who were not treated with antibiotics (which accounts for 15% of the entire group).

For total antibiotic exposure, the HR for overall mortality was 1.06 (95% CI, 1.03-1.09; P < .001) and 1.07 for breast cancer–specific mortality (95% CI, 1.04-1.10; P < .001). For unique antibiotic exposure (not counting repeat prescriptions of the same antibiotic), the HR for overall mortality was 1.17 (95% CI, 1.12-1.22; P < .001) and 1.18 for breast cancer–specific mortality (95% CI, 1.12-1.24; P < .001). 

“These were all statistically significant associations derived from a statistical model that takes into account baseline patient characteristics, so the reported hazard ratios, to the best of our ability, represent the risk of death associated with antibiotic use adjusted for other baseline covariates. We’ve attempted to account for differences at baseline that may indicate patients are sicker, and so the reported risk represents mortality related with antibiotic exposure,” Dr. Ransohoff said.

Elucidating the role of the microbiome in mediating absolute lymphocyte counts and immune response may inform interventions to reduce triple-negative mortality, she said.

Supplementation with omega-3 polyunsaturated fatty acids (PUFA) leads to gut microbial changes that may protect against inflammation, according to a new analysis of obese and overweight, postmenopausal women who participated in a weight loss trial.

The study was presented by Katherine Cook, PhD, during a poster session at the San Antonio Breast Cancer Symposium. Dr. Cook is a researcher at Wake Forest University, Winston-Salem, N.C.

Obesity increases risk of breast cancer, but it also alters the composition of the gut microbiome. Obesity is associated with a greater frequency of Firmicute bacteria phyla, compared with Bacteroidetes phyla, while abnormally low ratios are associated with inflammatory bowel disease.

In mice, the researchers previously showed that diet can lead to changes in the microbiome of both the gut and the breast. They conducted fecal transplants between mice who were fed normal or high-fat diets (HFD), and then used a chemical carcinogenesis model to investigate the impact on tumor outcomes. They observed changes in the microbiota populations in both the gut and the mammary glands when mice fed a normal diet received fecal transplants from HFD mice. On the other hand, when HFD mice received fecal transplants from mice with normal diets, the transplants countered the increase in serum lipopolysaccharide levels associated with HFD. In vitro models showed that microbiota from HFD mice also altered the epithelial permeability of breast tissue, and infection of breast cancer cells with HFD microbiota led to greater proliferation.

The researchers also examined breast cancer tissue from women who received omega-3 PUFA supplements or placebo before undergoing primary tumor resection, and found that there were differences in the proportional abundance of specific microbes between tumor and adjacent normal tissue, with the former having excess of Lachnospiraceae and Ruminococcus. The finding suggests that these bacteria may grow better in a tumor microenvironment, and could play a role in breast cancer cell signaling. The supplements altered the microbiota of both normal and breast cancer tissue.

In the study presented at SABCS, the researchers analyzed fecal samples from 34 obese and overweight postmenopausal women involved in a weight-loss trial, who received 3.25 g/day of omega-3 PUFA supplements or placebo combined with calorie restriction and exercise. They performed metagenomic sequencing from the fecal samples at baseline and 6 months to determine microbiome populations.

Women who experienced weight loss, with or without omega-3 PUFA supplementation, had a decline in the abundance of Firmicutes phyla – a group linked to inflammation risk – as a percentage of overall bacterial phyla. The researchers found a similar trend among women who received omega-3 PUFA, regardless of how much weight they lost. At the species level, those who received supplements had higher proportional abundance of Phocaeicola massiliensis and reduced proportions of Faecalibacterium prausnitzii, R. lactaris, Blautia obeum, and Dorea formicigenerans (P < .05).

Weight loss combined with supplementation also seemed to affect gut microbiota, with subjects who lost more than 10% of their body weight and received omega-3 PUFA supplements having elevated Bacteriodetes and reduced Firmicutes, compared with all other groups (P < .05).

At 6 months, the researchers grouped women by mean body fat composition, and found both positive and negative correlations among different bacterial species. Finally, the researchers looked at serum levels of the inflammatory cytokines interleukin-6, monocyte chemoattractant protein-1 (MCP-1), and tumor necrosis factor–alpha at 6 months. Women with elevated levels of at least two cytokines had higher levels of two species of mucin-degrading bacteria. Levels of MCP-1 alone also correlated with greater proportions of mucin-degrading bacteria (P < .05).

The authors concluded that increasing omega-3 PUFA uptake to about 2% of total daily calorie intake could push the gut microbiome in a direction that improves intestinal permeability parameters and reduces chronic inflammation. These changes could lead to a reduction in the risk for postmenopausal breast cancer.

The study was funded by the Breast Cancer Research Foundation.

Supplementation with omega-3 polyunsaturated fatty acids (PUFA) leads to gut microbial changes that may protect against inflammation, according to a new analysis of obese and overweight, postmenopausal women who participated in a weight loss trial.

The study was presented by Katherine Cook, PhD, during a poster session at the San Antonio Breast Cancer Symposium. Dr. Cook is a researcher at Wake Forest University, Winston-Salem, N.C.

Obesity increases risk of breast cancer, but it also alters the composition of the gut microbiome. Obesity is associated with a greater frequency of Firmicute bacteria phyla, compared with Bacteroidetes phyla, while abnormally low ratios are associated with inflammatory bowel disease.

In mice, the researchers previously showed that diet can lead to changes in the microbiome of both the gut and the breast. They conducted fecal transplants between mice who were fed normal or high-fat diets (HFD), and then used a chemical carcinogenesis model to investigate the impact on tumor outcomes. They observed changes in the microbiota populations in both the gut and the mammary glands when mice fed a normal diet received fecal transplants from HFD mice. On the other hand, when HFD mice received fecal transplants from mice with normal diets, the transplants countered the increase in serum lipopolysaccharide levels associated with HFD. In vitro models showed that microbiota from HFD mice also altered the epithelial permeability of breast tissue, and infection of breast cancer cells with HFD microbiota led to greater proliferation.

The researchers also examined breast cancer tissue from women who received omega-3 PUFA supplements or placebo before undergoing primary tumor resection, and found that there were differences in the proportional abundance of specific microbes between tumor and adjacent normal tissue, with the former having excess of Lachnospiraceae and Ruminococcus. The finding suggests that these bacteria may grow better in a tumor microenvironment, and could play a role in breast cancer cell signaling. The supplements altered the microbiota of both normal and breast cancer tissue.

In the study presented at SABCS, the researchers analyzed fecal samples from 34 obese and overweight postmenopausal women involved in a weight-loss trial, who received 3.25 g/day of omega-3 PUFA supplements or placebo combined with calorie restriction and exercise. They performed metagenomic sequencing from the fecal samples at baseline and 6 months to determine microbiome populations.

Women who experienced weight loss, with or without omega-3 PUFA supplementation, had a decline in the abundance of Firmicutes phyla – a group linked to inflammation risk – as a percentage of overall bacterial phyla. The researchers found a similar trend among women who received omega-3 PUFA, regardless of how much weight they lost. At the species level, those who received supplements had higher proportional abundance of Phocaeicola massiliensis and reduced proportions of Faecalibacterium prausnitzii, R. lactaris, Blautia obeum, and Dorea formicigenerans (P < .05).

Weight loss combined with supplementation also seemed to affect gut microbiota, with subjects who lost more than 10% of their body weight and received omega-3 PUFA supplements having elevated Bacteriodetes and reduced Firmicutes, compared with all other groups (P < .05).

At 6 months, the researchers grouped women by mean body fat composition, and found both positive and negative correlations among different bacterial species. Finally, the researchers looked at serum levels of the inflammatory cytokines interleukin-6, monocyte chemoattractant protein-1 (MCP-1), and tumor necrosis factor–alpha at 6 months. Women with elevated levels of at least two cytokines had higher levels of two species of mucin-degrading bacteria. Levels of MCP-1 alone also correlated with greater proportions of mucin-degrading bacteria (P < .05).

The authors concluded that increasing omega-3 PUFA uptake to about 2% of total daily calorie intake could push the gut microbiome in a direction that improves intestinal permeability parameters and reduces chronic inflammation. These changes could lead to a reduction in the risk for postmenopausal breast cancer.

The study was funded by the Breast Cancer Research Foundation.

Supplementation with omega-3 polyunsaturated fatty acids (PUFA) leads to gut microbial changes that may protect against inflammation, according to a new analysis of obese and overweight, postmenopausal women who participated in a weight loss trial.

The study was presented by Katherine Cook, PhD, during a poster session at the San Antonio Breast Cancer Symposium. Dr. Cook is a researcher at Wake Forest University, Winston-Salem, N.C.

Obesity increases risk of breast cancer, but it also alters the composition of the gut microbiome. Obesity is associated with a greater frequency of Firmicute bacteria phyla, compared with Bacteroidetes phyla, while abnormally low ratios are associated with inflammatory bowel disease.

In mice, the researchers previously showed that diet can lead to changes in the microbiome of both the gut and the breast. They conducted fecal transplants between mice who were fed normal or high-fat diets (HFD), and then used a chemical carcinogenesis model to investigate the impact on tumor outcomes. They observed changes in the microbiota populations in both the gut and the mammary glands when mice fed a normal diet received fecal transplants from HFD mice. On the other hand, when HFD mice received fecal transplants from mice with normal diets, the transplants countered the increase in serum lipopolysaccharide levels associated with HFD. In vitro models showed that microbiota from HFD mice also altered the epithelial permeability of breast tissue, and infection of breast cancer cells with HFD microbiota led to greater proliferation.

The researchers also examined breast cancer tissue from women who received omega-3 PUFA supplements or placebo before undergoing primary tumor resection, and found that there were differences in the proportional abundance of specific microbes between tumor and adjacent normal tissue, with the former having excess of Lachnospiraceae and Ruminococcus. The finding suggests that these bacteria may grow better in a tumor microenvironment, and could play a role in breast cancer cell signaling. The supplements altered the microbiota of both normal and breast cancer tissue.

In the study presented at SABCS, the researchers analyzed fecal samples from 34 obese and overweight postmenopausal women involved in a weight-loss trial, who received 3.25 g/day of omega-3 PUFA supplements or placebo combined with calorie restriction and exercise. They performed metagenomic sequencing from the fecal samples at baseline and 6 months to determine microbiome populations.

Women who experienced weight loss, with or without omega-3 PUFA supplementation, had a decline in the abundance of Firmicutes phyla – a group linked to inflammation risk – as a percentage of overall bacterial phyla. The researchers found a similar trend among women who received omega-3 PUFA, regardless of how much weight they lost. At the species level, those who received supplements had higher proportional abundance of Phocaeicola massiliensis and reduced proportions of Faecalibacterium prausnitzii, R. lactaris, Blautia obeum, and Dorea formicigenerans (P < .05).

Weight loss combined with supplementation also seemed to affect gut microbiota, with subjects who lost more than 10% of their body weight and received omega-3 PUFA supplements having elevated Bacteriodetes and reduced Firmicutes, compared with all other groups (P < .05).

At 6 months, the researchers grouped women by mean body fat composition, and found both positive and negative correlations among different bacterial species. Finally, the researchers looked at serum levels of the inflammatory cytokines interleukin-6, monocyte chemoattractant protein-1 (MCP-1), and tumor necrosis factor–alpha at 6 months. Women with elevated levels of at least two cytokines had higher levels of two species of mucin-degrading bacteria. Levels of MCP-1 alone also correlated with greater proportions of mucin-degrading bacteria (P < .05).

The authors concluded that increasing omega-3 PUFA uptake to about 2% of total daily calorie intake could push the gut microbiome in a direction that improves intestinal permeability parameters and reduces chronic inflammation. These changes could lead to a reduction in the risk for postmenopausal breast cancer.

The study was funded by the Breast Cancer Research Foundation.

SAN ANTONIO – Sedative-hypnotic medications, such as benzodiazepines and nonbenzodiazepine sedative-hypnotics commonly used to treat chemotherapy-related nausea, anxiety, and insomnia in women being treated for breast cancer, put women at high risk of dependency after chemotherapy treatment, shows a new study.

While benzodiazepines and nonbenzodiazepine sedative-hypnotics are effective for these indications, misuse and increased health care utilization can ensue from their prolonged use, said Jacob C. Cogan, MD, a fellow in oncology/hematology at the Herbert Irving Comprehensive Cancer Center, Columbia University, New York. Dr. Cogan recently presented the results of the study at the San Antonio Breast Cancer Symposium.

The study included patients with breast cancer who received adjuvant chemotherapy between 2008 and 2017. Prescriptions for sedatives were divided into three periods: 365 days prior to chemotherapy to the start of chemotherapy (period one); start of chemotherapy to 90 days after the end of chemotherapy (period two); and 90-365 days after chemotherapy (period three). Patients who filled at least one benzodiazepine prescription in period two and patients who filled at least two benzodiazepine in period three were classified as new persistent benzodiazepine users. The same definitions were then used for nonbenzodiazepine sedative-hypnotics.

Among 17,532 benzodiazepine-naive patients (mean age, 57 years) and 21,863 nonbenzodiazepine sedative-hypnotic drug–naive patients (mean age, 56 years) who received adjuvant chemotherapy for breast cancer, lumpectomies were performed for a small majority (56.6% benzodiazepine naive, 55.1% nonbenzodiazepine sedative-hypnotics naive) versus mastectomy, and about half of patients received less than 4 months of chemotherapy (48.0% benzodiazepine naive, 48.6% nonbenzodiazepine sedative-hypnotics naive). Among benzodiazepine-naive patients, 4,447 (25.4%) filled at least one benzodiazepine prescription during chemotherapy, and 2,160 (9.9%) filled at least one nonbenzodiazepine sedative-hypnotic prescription during chemotherapy. The rate of new persistent benzodiazepine use after initial exposure during chemotherapy was 26.8% (n = 1,192). Similarly, 33.8% (n = 730) of nonbenzodiazepine sedative-hypnotics users became new persistent users. In addition, 115 patients became new persistent users of both types of sedative-hypnotics.

New persistent benzodiazepine use was associated with several characteristics: age 50-65 (odds ratio, 1.23; P = .01) and age greater than 65 (OR, 1.38, P = .005) relative to age less than 49; as well as Medicaid insurance, relative to commercial and Medicare insurance (OR, 1.68; P < .0001). Both new persistent benzodiazepine and nonbenzodiazepine sedative-hypnotics use was associated with chemotherapy duration of less than 4 months relative to 4 or more months of chemotherapy (OR, 1.17; P = .03 for benzodiazepines; OR, 1.58; P < .0001 for nonbenzodiazepine sedative-hypnotics).

It is not clear why shorter chemotherapy duration is associated with more new persistent use, Dr. Cogan said. “It may be that, paradoxically, a shorter duration of treatment could lead to more anxiety about recurrence. These patients may need closer monitoring of mental health symptoms and earlier referral for psychological services.”

Dr. Cogan said that providers should take steps to ensure that benzodiazepines and nonbenzodiazepine sedatives are used appropriately, which includes tapering dosages and, when appropriate, encouraging nonpharmacologic strategies.

There were no funding or other conflicts of interest associated with this study.

SAN ANTONIO – Sedative-hypnotic medications, such as benzodiazepines and nonbenzodiazepine sedative-hypnotics commonly used to treat chemotherapy-related nausea, anxiety, and insomnia in women being treated for breast cancer, put women at high risk of dependency after chemotherapy treatment, shows a new study.

While benzodiazepines and nonbenzodiazepine sedative-hypnotics are effective for these indications, misuse and increased health care utilization can ensue from their prolonged use, said Jacob C. Cogan, MD, a fellow in oncology/hematology at the Herbert Irving Comprehensive Cancer Center, Columbia University, New York. Dr. Cogan recently presented the results of the study at the San Antonio Breast Cancer Symposium.

The study included patients with breast cancer who received adjuvant chemotherapy between 2008 and 2017. Prescriptions for sedatives were divided into three periods: 365 days prior to chemotherapy to the start of chemotherapy (period one); start of chemotherapy to 90 days after the end of chemotherapy (period two); and 90-365 days after chemotherapy (period three). Patients who filled at least one benzodiazepine prescription in period two and patients who filled at least two benzodiazepine in period three were classified as new persistent benzodiazepine users. The same definitions were then used for nonbenzodiazepine sedative-hypnotics.

Among 17,532 benzodiazepine-naive patients (mean age, 57 years) and 21,863 nonbenzodiazepine sedative-hypnotic drug–naive patients (mean age, 56 years) who received adjuvant chemotherapy for breast cancer, lumpectomies were performed for a small majority (56.6% benzodiazepine naive, 55.1% nonbenzodiazepine sedative-hypnotics naive) versus mastectomy, and about half of patients received less than 4 months of chemotherapy (48.0% benzodiazepine naive, 48.6% nonbenzodiazepine sedative-hypnotics naive). Among benzodiazepine-naive patients, 4,447 (25.4%) filled at least one benzodiazepine prescription during chemotherapy, and 2,160 (9.9%) filled at least one nonbenzodiazepine sedative-hypnotic prescription during chemotherapy. The rate of new persistent benzodiazepine use after initial exposure during chemotherapy was 26.8% (n = 1,192). Similarly, 33.8% (n = 730) of nonbenzodiazepine sedative-hypnotics users became new persistent users. In addition, 115 patients became new persistent users of both types of sedative-hypnotics.

New persistent benzodiazepine use was associated with several characteristics: age 50-65 (odds ratio, 1.23; P = .01) and age greater than 65 (OR, 1.38, P = .005) relative to age less than 49; as well as Medicaid insurance, relative to commercial and Medicare insurance (OR, 1.68; P < .0001). Both new persistent benzodiazepine and nonbenzodiazepine sedative-hypnotics use was associated with chemotherapy duration of less than 4 months relative to 4 or more months of chemotherapy (OR, 1.17; P = .03 for benzodiazepines; OR, 1.58; P < .0001 for nonbenzodiazepine sedative-hypnotics).

It is not clear why shorter chemotherapy duration is associated with more new persistent use, Dr. Cogan said. “It may be that, paradoxically, a shorter duration of treatment could lead to more anxiety about recurrence. These patients may need closer monitoring of mental health symptoms and earlier referral for psychological services.”

Dr. Cogan said that providers should take steps to ensure that benzodiazepines and nonbenzodiazepine sedatives are used appropriately, which includes tapering dosages and, when appropriate, encouraging nonpharmacologic strategies.

There were no funding or other conflicts of interest associated with this study.

SAN ANTONIO – Sedative-hypnotic medications, such as benzodiazepines and nonbenzodiazepine sedative-hypnotics commonly used to treat chemotherapy-related nausea, anxiety, and insomnia in women being treated for breast cancer, put women at high risk of dependency after chemotherapy treatment, shows a new study.

While benzodiazepines and nonbenzodiazepine sedative-hypnotics are effective for these indications, misuse and increased health care utilization can ensue from their prolonged use, said Jacob C. Cogan, MD, a fellow in oncology/hematology at the Herbert Irving Comprehensive Cancer Center, Columbia University, New York. Dr. Cogan recently presented the results of the study at the San Antonio Breast Cancer Symposium.

The study included patients with breast cancer who received adjuvant chemotherapy between 2008 and 2017. Prescriptions for sedatives were divided into three periods: 365 days prior to chemotherapy to the start of chemotherapy (period one); start of chemotherapy to 90 days after the end of chemotherapy (period two); and 90-365 days after chemotherapy (period three). Patients who filled at least one benzodiazepine prescription in period two and patients who filled at least two benzodiazepine in period three were classified as new persistent benzodiazepine users. The same definitions were then used for nonbenzodiazepine sedative-hypnotics.

Among 17,532 benzodiazepine-naive patients (mean age, 57 years) and 21,863 nonbenzodiazepine sedative-hypnotic drug–naive patients (mean age, 56 years) who received adjuvant chemotherapy for breast cancer, lumpectomies were performed for a small majority (56.6% benzodiazepine naive, 55.1% nonbenzodiazepine sedative-hypnotics naive) versus mastectomy, and about half of patients received less than 4 months of chemotherapy (48.0% benzodiazepine naive, 48.6% nonbenzodiazepine sedative-hypnotics naive). Among benzodiazepine-naive patients, 4,447 (25.4%) filled at least one benzodiazepine prescription during chemotherapy, and 2,160 (9.9%) filled at least one nonbenzodiazepine sedative-hypnotic prescription during chemotherapy. The rate of new persistent benzodiazepine use after initial exposure during chemotherapy was 26.8% (n = 1,192). Similarly, 33.8% (n = 730) of nonbenzodiazepine sedative-hypnotics users became new persistent users. In addition, 115 patients became new persistent users of both types of sedative-hypnotics.

New persistent benzodiazepine use was associated with several characteristics: age 50-65 (odds ratio, 1.23; P = .01) and age greater than 65 (OR, 1.38, P = .005) relative to age less than 49; as well as Medicaid insurance, relative to commercial and Medicare insurance (OR, 1.68; P < .0001). Both new persistent benzodiazepine and nonbenzodiazepine sedative-hypnotics use was associated with chemotherapy duration of less than 4 months relative to 4 or more months of chemotherapy (OR, 1.17; P = .03 for benzodiazepines; OR, 1.58; P < .0001 for nonbenzodiazepine sedative-hypnotics).

It is not clear why shorter chemotherapy duration is associated with more new persistent use, Dr. Cogan said. “It may be that, paradoxically, a shorter duration of treatment could lead to more anxiety about recurrence. These patients may need closer monitoring of mental health symptoms and earlier referral for psychological services.”

Dr. Cogan said that providers should take steps to ensure that benzodiazepines and nonbenzodiazepine sedatives are used appropriately, which includes tapering dosages and, when appropriate, encouraging nonpharmacologic strategies.

There were no funding or other conflicts of interest associated with this study.

Among women with breast cancer being treated with aromatase inhibitors (AI), supplementation with vitamin D and calcium protected against bone loss after 5 years, according to results from a prospective cohort study in Brazil. The study found no difference in bone mineral density outcomes at 5 years between women with hormone receptor–positive cancers treated with aromatase inhibitors (AIG) and triple negative or HER-2 positive patients who were treated with another therapy (CG).

Courtesy Renata Flores

About two-thirds of women with breast cancer have tumors that are positive for hormone receptors, and so are often treated with endocrine therapy such as selective estrogen receptor modulators or AI. However, there are concerns that AI treatment may lead to a loss of bone mineral density and impacts on quality of life. This loss is influenced by a range of factors, including body weight, physical activity, smoking, alcohol consumption, corticosteroid use, calcium in the diet, and circulating levels of vitamin D.

Vitamin D helps to regulate absorption of calcium and phosphorus, ensuring that their plasma concentrations are high enough for adequate bone health. But vitamin D deficiency is a common problem, even in tropical areas such as Brazil. “It is high in the general population and especially in postmenopausal breast cancer patients. Thus, vitamin D and calcium supplementation has an impact on these women’s lives,” said lead author Marcelo Antonini, MD, who presented the study (abstract P1-13-04) at the San Antonio Breast Cancer Symposium. He is a researcher at Hospital Servidor Publico Estadual in São Paulo, Brazil.

Although the findings are encouraging, more work needs to be done before it leads to a change in practice. “Larger studies must be carried out to prove this theory; however, in noncancer patients we have already well established the benefits of vitamin D and calcium supplementation,” Dr. Antonini said in an interview

The researchers examined women before the start of treatment, at 6 months, and at 5 years. Those with vitamin D levels below 30 ng/mL received 7,000 IU/day for 8 weeks, followed by a 1,000 IU/day maintenance dose. Subjects with osteopenia received a calcium supplement (500 mg calcium carbonate), and those with osteoporosis received 4 mg zoledronic acid (Zometa, Novartis).

There were 140 patients in both the AIG and CG groups. The average age was 65 years. Sixty-four percent of the AIG group and 71% of the CG group were vitamin D deficient at baseline. At 5 years, the frequencies were 17% and 16%, respectively. Both groups showed significant declines in bone mineral density in the femoral neck and femur at both 6 months and 5 years, but there was no significant difference between them. There was no significant difference between the two groups with respect to bone density loss in the spine.

The study is limited by the fact that it was conducted at a single center and had a small population size.

Another prospective observational study, published earlier this year, looked at vitamin D supplementation in 741 patients (mean age 61.9 years) being treated with aromatase inhibitors, whose baseline vitamin D levels were less 30 ng/mL. They received 16,000 IU dose of oral calcifediol every 2 weeks. At 3 months, individuals who achieved vitamin D levels of 40 ng/mL or higher were less likely to have joint pain (P < .05). At 12 months, data from 473 patients showed that for every 10-ng/mL increase in serum vitamin D at 3 months, there was a reduction in loss of bone marrow density in the lumbar spine (adjusted beta = +0.177%, P < .05), though there were no associations between vitamin D levels and BMD of the femur or total hip.

“Our results suggest that optimal levels of vitamin D are associated with a reduced risk of joint pain related to AI treatment. A target threshold (of vitamin D) levels was set at 40 ng/mL to significantly reduce the increase in joint pain. The authors noted that this threshold is well above the goal of 20 ng/mL recommended by the 2010 Institute of Medicine report.

The study did not receive external funding. Dr. Antonini has no relevant financial disclosures.

Among women with breast cancer being treated with aromatase inhibitors (AI), supplementation with vitamin D and calcium protected against bone loss after 5 years, according to results from a prospective cohort study in Brazil. The study found no difference in bone mineral density outcomes at 5 years between women with hormone receptor–positive cancers treated with aromatase inhibitors (AIG) and triple negative or HER-2 positive patients who were treated with another therapy (CG).

Courtesy Renata Flores

About two-thirds of women with breast cancer have tumors that are positive for hormone receptors, and so are often treated with endocrine therapy such as selective estrogen receptor modulators or AI. However, there are concerns that AI treatment may lead to a loss of bone mineral density and impacts on quality of life. This loss is influenced by a range of factors, including body weight, physical activity, smoking, alcohol consumption, corticosteroid use, calcium in the diet, and circulating levels of vitamin D.

Vitamin D helps to regulate absorption of calcium and phosphorus, ensuring that their plasma concentrations are high enough for adequate bone health. But vitamin D deficiency is a common problem, even in tropical areas such as Brazil. “It is high in the general population and especially in postmenopausal breast cancer patients. Thus, vitamin D and calcium supplementation has an impact on these women’s lives,” said lead author Marcelo Antonini, MD, who presented the study (abstract P1-13-04) at the San Antonio Breast Cancer Symposium. He is a researcher at Hospital Servidor Publico Estadual in São Paulo, Brazil.

Although the findings are encouraging, more work needs to be done before it leads to a change in practice. “Larger studies must be carried out to prove this theory; however, in noncancer patients we have already well established the benefits of vitamin D and calcium supplementation,” Dr. Antonini said in an interview

The researchers examined women before the start of treatment, at 6 months, and at 5 years. Those with vitamin D levels below 30 ng/mL received 7,000 IU/day for 8 weeks, followed by a 1,000 IU/day maintenance dose. Subjects with osteopenia received a calcium supplement (500 mg calcium carbonate), and those with osteoporosis received 4 mg zoledronic acid (Zometa, Novartis).

There were 140 patients in both the AIG and CG groups. The average age was 65 years. Sixty-four percent of the AIG group and 71% of the CG group were vitamin D deficient at baseline. At 5 years, the frequencies were 17% and 16%, respectively. Both groups showed significant declines in bone mineral density in the femoral neck and femur at both 6 months and 5 years, but there was no significant difference between them. There was no significant difference between the two groups with respect to bone density loss in the spine.

The study is limited by the fact that it was conducted at a single center and had a small population size.

Another prospective observational study, published earlier this year, looked at vitamin D supplementation in 741 patients (mean age 61.9 years) being treated with aromatase inhibitors, whose baseline vitamin D levels were less 30 ng/mL. They received 16,000 IU dose of oral calcifediol every 2 weeks. At 3 months, individuals who achieved vitamin D levels of 40 ng/mL or higher were less likely to have joint pain (P < .05). At 12 months, data from 473 patients showed that for every 10-ng/mL increase in serum vitamin D at 3 months, there was a reduction in loss of bone marrow density in the lumbar spine (adjusted beta = +0.177%, P < .05), though there were no associations between vitamin D levels and BMD of the femur or total hip.

“Our results suggest that optimal levels of vitamin D are associated with a reduced risk of joint pain related to AI treatment. A target threshold (of vitamin D) levels was set at 40 ng/mL to significantly reduce the increase in joint pain. The authors noted that this threshold is well above the goal of 20 ng/mL recommended by the 2010 Institute of Medicine report.

The study did not receive external funding. Dr. Antonini has no relevant financial disclosures.

Among women with breast cancer being treated with aromatase inhibitors (AI), supplementation with vitamin D and calcium protected against bone loss after 5 years, according to results from a prospective cohort study in Brazil. The study found no difference in bone mineral density outcomes at 5 years between women with hormone receptor–positive cancers treated with aromatase inhibitors (AIG) and triple negative or HER-2 positive patients who were treated with another therapy (CG).

Courtesy Renata Flores

About two-thirds of women with breast cancer have tumors that are positive for hormone receptors, and so are often treated with endocrine therapy such as selective estrogen receptor modulators or AI. However, there are concerns that AI treatment may lead to a loss of bone mineral density and impacts on quality of life. This loss is influenced by a range of factors, including body weight, physical activity, smoking, alcohol consumption, corticosteroid use, calcium in the diet, and circulating levels of vitamin D.

Vitamin D helps to regulate absorption of calcium and phosphorus, ensuring that their plasma concentrations are high enough for adequate bone health. But vitamin D deficiency is a common problem, even in tropical areas such as Brazil. “It is high in the general population and especially in postmenopausal breast cancer patients. Thus, vitamin D and calcium supplementation has an impact on these women’s lives,” said lead author Marcelo Antonini, MD, who presented the study (abstract P1-13-04) at the San Antonio Breast Cancer Symposium. He is a researcher at Hospital Servidor Publico Estadual in São Paulo, Brazil.

Although the findings are encouraging, more work needs to be done before it leads to a change in practice. “Larger studies must be carried out to prove this theory; however, in noncancer patients we have already well established the benefits of vitamin D and calcium supplementation,” Dr. Antonini said in an interview

The researchers examined women before the start of treatment, at 6 months, and at 5 years. Those with vitamin D levels below 30 ng/mL received 7,000 IU/day for 8 weeks, followed by a 1,000 IU/day maintenance dose. Subjects with osteopenia received a calcium supplement (500 mg calcium carbonate), and those with osteoporosis received 4 mg zoledronic acid (Zometa, Novartis).

There were 140 patients in both the AIG and CG groups. The average age was 65 years. Sixty-four percent of the AIG group and 71% of the CG group were vitamin D deficient at baseline. At 5 years, the frequencies were 17% and 16%, respectively. Both groups showed significant declines in bone mineral density in the femoral neck and femur at both 6 months and 5 years, but there was no significant difference between them. There was no significant difference between the two groups with respect to bone density loss in the spine.

The study is limited by the fact that it was conducted at a single center and had a small population size.

Another prospective observational study, published earlier this year, looked at vitamin D supplementation in 741 patients (mean age 61.9 years) being treated with aromatase inhibitors, whose baseline vitamin D levels were less 30 ng/mL. They received 16,000 IU dose of oral calcifediol every 2 weeks. At 3 months, individuals who achieved vitamin D levels of 40 ng/mL or higher were less likely to have joint pain (P < .05). At 12 months, data from 473 patients showed that for every 10-ng/mL increase in serum vitamin D at 3 months, there was a reduction in loss of bone marrow density in the lumbar spine (adjusted beta = +0.177%, P < .05), though there were no associations between vitamin D levels and BMD of the femur or total hip.

“Our results suggest that optimal levels of vitamin D are associated with a reduced risk of joint pain related to AI treatment. A target threshold (of vitamin D) levels was set at 40 ng/mL to significantly reduce the increase in joint pain. The authors noted that this threshold is well above the goal of 20 ng/mL recommended by the 2010 Institute of Medicine report.

The study did not receive external funding. Dr. Antonini has no relevant financial disclosures.

Adjuvant treatment with metformin did not improve outcomes in most patients with early breast cancer, according to new findings from a randomized controlled trial.

In the primary analysis, the addition of metformin to standard therapy in moderate/high-risk hormone receptor positive or negative breast cancer did not improve invasive disease–free survival (IDFS), overall survival, or other breast outcomes, explained lead author Pamela J. Goodwin, MD, FRCPC, professor of medicine at the University of Toronto. “Metformin should not be used as breast cancer treatment in this population.”

However, an exploratory analysis suggested that metformin may have a beneficial effect in women with HER2-positive breast cancer, Dr. Goodwin noted.

In this subset, IDFS was improved in patients who received metformin (hazard ratio, 0.64; P = .03), as was overall survival (HR, 0.53; P = .04).

The findings were presented at the San Antonio Breast Cancer Symposium.

“This trial arose from the observation that obesity is associated with poor breast cancer outcomes, and insulin levels are higher in obesity and may be more strongly associated with breast cancer outcomes than obesity,” said Dr. Goodwin.

Metformin was used because of its ability to promote modest weight loss and lower insulin by about 15%-20% in nondiabetic breast cancer survivors. It has also shown anticancer effects in preclinical studies. “In some window of opportunity neoadjuvant studies, it has been shown to reduce Ki67 in breast cancer cells,” she said. “And in preclinical in vitro and in vivo research, it slows growth of breast cancer.”

In addition, emerging evidence from observational studies suggests that the use of metformin to treat diabetes in breast cancer patients may be associated with better outcomes, strengthening the rationale for the study.

The negative results in breast cancer follow recent reports of negative findings in lung cancer, when metformin was found to be ineffective when used alongside chemotherapy in locally advanced lung cancer, as reported by this news organization.
 

No benefit seen

Metformin was compared to placebo in the phase 3 CCTG MA.32 trial, conducted in 3,649 patients aged 18-74 years with T1-3 N0-3 M0 breast cancer. All patients were treated with standard therapy and were randomized to receive metformin 850 mg twice daily for 5 years or placebo.

In 2016, “futility was declared in ER/PR-negative patients” after a second interim analysis conducted at 29.6 months’ median follow-up, Dr. Goodwin noted. The intervention was stopped in that group, although blinding and follow-up continued.

After that, the study’s primary analysis focused on the 2,533 ER/PR-positive patients (mean age, 52.7 years; mean body mass index, 28.8; approx. 60% postmenopausal).

Just over half of these patients had T2 tumor stage, and most disease was grade 2 or 3.

In addition, 16.5% (of metformin) and 17.4% (of placebo) patients had HER2-positive disease, with the majority (97%) of all HER2 patients receiving trastuzumab.

There was no difference between the two groups in IDFS events, occurring in 18.5% of patients receiving metformin and 18.3% who received placebo, with most (75.6%) events due to breast cancer (HR, 1.01; P = .92).

There were 131 deaths in the metformin arm and 119 in the placebo arm, with most (75.8%) of the deaths related to breast cancer (HR, 1.10; P = .47).

Other breast cancer outcomes had similar results, including distant disease-free survival (HR, 0.99; P = .94) and breast cancer–free interval (HR, 0.98; P = .87), both of which showed no advantage for metformin.
 

Possible HER2 advantage

However, the exploratory analysis suggested there may be an advantage for patients with HER2-positive disease, but primarily those who had at least one C allele of a prespecified ATM associated rs11212617 SNP. These patients achieved a higher pathologic complete response rate with metformin than that of those without the allele.

There were 620 patients with HER2-positive disease analyzed, with 99.4% receiving chemotherapy and 96.5% receiving trastuzumab. There were 99 IDFS events, and 47 OS events.

In the entire HER2-positive cohort, patients who received metformin had fewer IDFS events (HR, 0.64; P = .026) compared with the placebo arm. Mortality was lower with metformin (HR for overall survival, 0.53; P = .038).

“Subjects with HER2-positive breast cancer, notably those with at least one C allele of the ATM-associated rs11212617 SNP, experienced improved IDFS and overall survival with metformin,” Dr. Goodwin concluded. “However, no P-value ‘spend’ was allocated to this comparison. As a result, it requires replication in a prospective trial focusing on the HER2-positive population.”
 

More research?

Stephanie Bernik, MD, chief of breast surgery, Mount Sinai West, and associate professor of breast surgery, Icahn School of Medicine at Mount Sinai, New York, was approached by this news organization for an independent comment.

“It has long been known that obesity, which often correlates with diabetes, increases a woman’s risk of breast cancer,” she said.

“This study tried to show that using a medication that helps control insulin levels, even in those without diabetes, might decrease one’s risk of breast cancer,” she said. “Unfortunately, using metformin had no effect on outcomes in this study, even though it has shown promise in other studies. Perhaps more research needs to be carried out to try to pinpoint which mechanisms of action, if any, might be helpful to combat cancer in those with and without diabetes.”

The study was funded by the Canadian Cancer Trials Group, Cancer Therapy Evaluation Program, Breast Cancer Researcher Foundation, Susan G. Komen for the Cure, Canadian Cancer Society, Apotex, Swiss Cancer Research, and the Canadian Breast Cancer Foundation. Dr. Goodwin has no disclosures.

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

Adjuvant treatment with metformin did not improve outcomes in most patients with early breast cancer, according to new findings from a randomized controlled trial.

In the primary analysis, the addition of metformin to standard therapy in moderate/high-risk hormone receptor positive or negative breast cancer did not improve invasive disease–free survival (IDFS), overall survival, or other breast outcomes, explained lead author Pamela J. Goodwin, MD, FRCPC, professor of medicine at the University of Toronto. “Metformin should not be used as breast cancer treatment in this population.”

However, an exploratory analysis suggested that metformin may have a beneficial effect in women with HER2-positive breast cancer, Dr. Goodwin noted.

In this subset, IDFS was improved in patients who received metformin (hazard ratio, 0.64; P = .03), as was overall survival (HR, 0.53; P = .04).

The findings were presented at the San Antonio Breast Cancer Symposium.

“This trial arose from the observation that obesity is associated with poor breast cancer outcomes, and insulin levels are higher in obesity and may be more strongly associated with breast cancer outcomes than obesity,” said Dr. Goodwin.

Metformin was used because of its ability to promote modest weight loss and lower insulin by about 15%-20% in nondiabetic breast cancer survivors. It has also shown anticancer effects in preclinical studies. “In some window of opportunity neoadjuvant studies, it has been shown to reduce Ki67 in breast cancer cells,” she said. “And in preclinical in vitro and in vivo research, it slows growth of breast cancer.”

In addition, emerging evidence from observational studies suggests that the use of metformin to treat diabetes in breast cancer patients may be associated with better outcomes, strengthening the rationale for the study.

The negative results in breast cancer follow recent reports of negative findings in lung cancer, when metformin was found to be ineffective when used alongside chemotherapy in locally advanced lung cancer, as reported by this news organization.
 

No benefit seen

Metformin was compared to placebo in the phase 3 CCTG MA.32 trial, conducted in 3,649 patients aged 18-74 years with T1-3 N0-3 M0 breast cancer. All patients were treated with standard therapy and were randomized to receive metformin 850 mg twice daily for 5 years or placebo.

In 2016, “futility was declared in ER/PR-negative patients” after a second interim analysis conducted at 29.6 months’ median follow-up, Dr. Goodwin noted. The intervention was stopped in that group, although blinding and follow-up continued.

After that, the study’s primary analysis focused on the 2,533 ER/PR-positive patients (mean age, 52.7 years; mean body mass index, 28.8; approx. 60% postmenopausal).

Just over half of these patients had T2 tumor stage, and most disease was grade 2 or 3.

In addition, 16.5% (of metformin) and 17.4% (of placebo) patients had HER2-positive disease, with the majority (97%) of all HER2 patients receiving trastuzumab.

There was no difference between the two groups in IDFS events, occurring in 18.5% of patients receiving metformin and 18.3% who received placebo, with most (75.6%) events due to breast cancer (HR, 1.01; P = .92).

There were 131 deaths in the metformin arm and 119 in the placebo arm, with most (75.8%) of the deaths related to breast cancer (HR, 1.10; P = .47).

Other breast cancer outcomes had similar results, including distant disease-free survival (HR, 0.99; P = .94) and breast cancer–free interval (HR, 0.98; P = .87), both of which showed no advantage for metformin.
 

Possible HER2 advantage

However, the exploratory analysis suggested there may be an advantage for patients with HER2-positive disease, but primarily those who had at least one C allele of a prespecified ATM associated rs11212617 SNP. These patients achieved a higher pathologic complete response rate with metformin than that of those without the allele.

There were 620 patients with HER2-positive disease analyzed, with 99.4% receiving chemotherapy and 96.5% receiving trastuzumab. There were 99 IDFS events, and 47 OS events.

In the entire HER2-positive cohort, patients who received metformin had fewer IDFS events (HR, 0.64; P = .026) compared with the placebo arm. Mortality was lower with metformin (HR for overall survival, 0.53; P = .038).

“Subjects with HER2-positive breast cancer, notably those with at least one C allele of the ATM-associated rs11212617 SNP, experienced improved IDFS and overall survival with metformin,” Dr. Goodwin concluded. “However, no P-value ‘spend’ was allocated to this comparison. As a result, it requires replication in a prospective trial focusing on the HER2-positive population.”
 

More research?

Stephanie Bernik, MD, chief of breast surgery, Mount Sinai West, and associate professor of breast surgery, Icahn School of Medicine at Mount Sinai, New York, was approached by this news organization for an independent comment.

“It has long been known that obesity, which often correlates with diabetes, increases a woman’s risk of breast cancer,” she said.

“This study tried to show that using a medication that helps control insulin levels, even in those without diabetes, might decrease one’s risk of breast cancer,” she said. “Unfortunately, using metformin had no effect on outcomes in this study, even though it has shown promise in other studies. Perhaps more research needs to be carried out to try to pinpoint which mechanisms of action, if any, might be helpful to combat cancer in those with and without diabetes.”

The study was funded by the Canadian Cancer Trials Group, Cancer Therapy Evaluation Program, Breast Cancer Researcher Foundation, Susan G. Komen for the Cure, Canadian Cancer Society, Apotex, Swiss Cancer Research, and the Canadian Breast Cancer Foundation. Dr. Goodwin has no disclosures.

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

Adjuvant treatment with metformin did not improve outcomes in most patients with early breast cancer, according to new findings from a randomized controlled trial.

In the primary analysis, the addition of metformin to standard therapy in moderate/high-risk hormone receptor positive or negative breast cancer did not improve invasive disease–free survival (IDFS), overall survival, or other breast outcomes, explained lead author Pamela J. Goodwin, MD, FRCPC, professor of medicine at the University of Toronto. “Metformin should not be used as breast cancer treatment in this population.”

However, an exploratory analysis suggested that metformin may have a beneficial effect in women with HER2-positive breast cancer, Dr. Goodwin noted.

In this subset, IDFS was improved in patients who received metformin (hazard ratio, 0.64; P = .03), as was overall survival (HR, 0.53; P = .04).

The findings were presented at the San Antonio Breast Cancer Symposium.

“This trial arose from the observation that obesity is associated with poor breast cancer outcomes, and insulin levels are higher in obesity and may be more strongly associated with breast cancer outcomes than obesity,” said Dr. Goodwin.

Metformin was used because of its ability to promote modest weight loss and lower insulin by about 15%-20% in nondiabetic breast cancer survivors. It has also shown anticancer effects in preclinical studies. “In some window of opportunity neoadjuvant studies, it has been shown to reduce Ki67 in breast cancer cells,” she said. “And in preclinical in vitro and in vivo research, it slows growth of breast cancer.”

In addition, emerging evidence from observational studies suggests that the use of metformin to treat diabetes in breast cancer patients may be associated with better outcomes, strengthening the rationale for the study.

The negative results in breast cancer follow recent reports of negative findings in lung cancer, when metformin was found to be ineffective when used alongside chemotherapy in locally advanced lung cancer, as reported by this news organization.
 

No benefit seen

Metformin was compared to placebo in the phase 3 CCTG MA.32 trial, conducted in 3,649 patients aged 18-74 years with T1-3 N0-3 M0 breast cancer. All patients were treated with standard therapy and were randomized to receive metformin 850 mg twice daily for 5 years or placebo.

In 2016, “futility was declared in ER/PR-negative patients” after a second interim analysis conducted at 29.6 months’ median follow-up, Dr. Goodwin noted. The intervention was stopped in that group, although blinding and follow-up continued.

After that, the study’s primary analysis focused on the 2,533 ER/PR-positive patients (mean age, 52.7 years; mean body mass index, 28.8; approx. 60% postmenopausal).

Just over half of these patients had T2 tumor stage, and most disease was grade 2 or 3.

In addition, 16.5% (of metformin) and 17.4% (of placebo) patients had HER2-positive disease, with the majority (97%) of all HER2 patients receiving trastuzumab.

There was no difference between the two groups in IDFS events, occurring in 18.5% of patients receiving metformin and 18.3% who received placebo, with most (75.6%) events due to breast cancer (HR, 1.01; P = .92).

There were 131 deaths in the metformin arm and 119 in the placebo arm, with most (75.8%) of the deaths related to breast cancer (HR, 1.10; P = .47).

Other breast cancer outcomes had similar results, including distant disease-free survival (HR, 0.99; P = .94) and breast cancer–free interval (HR, 0.98; P = .87), both of which showed no advantage for metformin.
 

Possible HER2 advantage

However, the exploratory analysis suggested there may be an advantage for patients with HER2-positive disease, but primarily those who had at least one C allele of a prespecified ATM associated rs11212617 SNP. These patients achieved a higher pathologic complete response rate with metformin than that of those without the allele.

There were 620 patients with HER2-positive disease analyzed, with 99.4% receiving chemotherapy and 96.5% receiving trastuzumab. There were 99 IDFS events, and 47 OS events.

In the entire HER2-positive cohort, patients who received metformin had fewer IDFS events (HR, 0.64; P = .026) compared with the placebo arm. Mortality was lower with metformin (HR for overall survival, 0.53; P = .038).

“Subjects with HER2-positive breast cancer, notably those with at least one C allele of the ATM-associated rs11212617 SNP, experienced improved IDFS and overall survival with metformin,” Dr. Goodwin concluded. “However, no P-value ‘spend’ was allocated to this comparison. As a result, it requires replication in a prospective trial focusing on the HER2-positive population.”
 

More research?

Stephanie Bernik, MD, chief of breast surgery, Mount Sinai West, and associate professor of breast surgery, Icahn School of Medicine at Mount Sinai, New York, was approached by this news organization for an independent comment.

“It has long been known that obesity, which often correlates with diabetes, increases a woman’s risk of breast cancer,” she said.

“This study tried to show that using a medication that helps control insulin levels, even in those without diabetes, might decrease one’s risk of breast cancer,” she said. “Unfortunately, using metformin had no effect on outcomes in this study, even though it has shown promise in other studies. Perhaps more research needs to be carried out to try to pinpoint which mechanisms of action, if any, might be helpful to combat cancer in those with and without diabetes.”

The study was funded by the Canadian Cancer Trials Group, Cancer Therapy Evaluation Program, Breast Cancer Researcher Foundation, Susan G. Komen for the Cure, Canadian Cancer Society, Apotex, Swiss Cancer Research, and the Canadian Breast Cancer Foundation. Dr. Goodwin has no disclosures.

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

In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.

trekandshoot/thinkstock

As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.

The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.

The court refused efforts on behalf of abortion providers and the federal government to overturn the law, but said lower courts should determine the law’s ultimate fate. The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.

The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.

A timeline on the case

The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.

The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.

A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.

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

In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.

trekandshoot/thinkstock

As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.

The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.

The court refused efforts on behalf of abortion providers and the federal government to overturn the law, but said lower courts should determine the law’s ultimate fate. The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.

The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.

A timeline on the case

The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.

The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.

A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.

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

In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.

trekandshoot/thinkstock

As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.

The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.

The court refused efforts on behalf of abortion providers and the federal government to overturn the law, but said lower courts should determine the law’s ultimate fate. The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.

The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.

A timeline on the case

The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.

The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.

A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.

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

The new Omicron variant could make it more likely that people will need a fourth coronavirus vaccine earlier than expected, Pfizer officials said on Dec. 8.

The standard two doses may be less effective against the variant, the company announced earlier in the day, and a booster dose increases neutralizing antibodies.

But the timeline might need to be moved up for a fourth dose. Previously, Pfizer CEO Albert Bourla, PhD, said another dose might be needed about a year after a third shot. Now the company’s scientists believe that a fourth shot, which targets the Omicron variant, could be required sooner.

“With Omicron, we need to wait and see because we have very little information. We may need it faster,” Dr. Bourla said on CNBC’s Squawk Box.

“But for right now, the most important thing is that we have winter in front of us,” he said. “From a healthcare perspective, it is important to understand that we need to be well-protected to go through the winter.”

A third dose should provide protection throughout the winter, Dr. Bourla said. That may buy time until the early spring to develop new shots that target Omicron, which Pfizer could have ready by March, according to  Bloomberg News.

As of the afternoon of Dec. 8, 43 people in 19 states had tested positive for the Omicron variant, according to The Associated Press. More than 75% had been vaccinated, and a third had had booster shots. About a third had traveled internationally.

Nearly all of them have had mild symptoms so far, the AP reported, with the most common symptoms being a cough, congestion, and fatigue. One person has been hospitalized, but no deaths have been reported so far.

The CDC is still trying to determine how the Omicron variant may affect the course of the pandemic and whether the strain is more contagious or causes more severe disease.

“What we generally know is the more mutations a variant has, the higher level you need your immunity to be,” Rochelle Walensky, MD, director of the CDC, told the AP.

“We want to make sure we bolster everybody’s immunity,” she said. “And that’s really what motivated the decision to expand our guidance [on boosters for all adults].”

The Omicron variant has been reported in 57 countries so far, World Health Organization officials reported Dec. 8, and they expect that number to continue growing.

“Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know,” Tedros Adhanom Ghebreyesus, PhD, the World Health Organization’s director-general, said during a media briefing.

Several studies suggest that Omicron leads to a rapid increase in transmission, he said, though scientists are still trying to understand whether it can “outcompete Delta.” Data from South Africa also suggests a higher risk of reinfection with Omicron, though it appears to cause milder disease than Delta, he noted.

“Even though we still need answers to some crucial questions, we are not defenseless against Omicron or Delta,” he said. “The steps countries take today, and in the coming days and weeks, will determine how Omicron unfolds.”

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

The new Omicron variant could make it more likely that people will need a fourth coronavirus vaccine earlier than expected, Pfizer officials said on Dec. 8.

The standard two doses may be less effective against the variant, the company announced earlier in the day, and a booster dose increases neutralizing antibodies.

But the timeline might need to be moved up for a fourth dose. Previously, Pfizer CEO Albert Bourla, PhD, said another dose might be needed about a year after a third shot. Now the company’s scientists believe that a fourth shot, which targets the Omicron variant, could be required sooner.

“With Omicron, we need to wait and see because we have very little information. We may need it faster,” Dr. Bourla said on CNBC’s Squawk Box.

“But for right now, the most important thing is that we have winter in front of us,” he said. “From a healthcare perspective, it is important to understand that we need to be well-protected to go through the winter.”

A third dose should provide protection throughout the winter, Dr. Bourla said. That may buy time until the early spring to develop new shots that target Omicron, which Pfizer could have ready by March, according to  Bloomberg News.

As of the afternoon of Dec. 8, 43 people in 19 states had tested positive for the Omicron variant, according to The Associated Press. More than 75% had been vaccinated, and a third had had booster shots. About a third had traveled internationally.

Nearly all of them have had mild symptoms so far, the AP reported, with the most common symptoms being a cough, congestion, and fatigue. One person has been hospitalized, but no deaths have been reported so far.

The CDC is still trying to determine how the Omicron variant may affect the course of the pandemic and whether the strain is more contagious or causes more severe disease.

“What we generally know is the more mutations a variant has, the higher level you need your immunity to be,” Rochelle Walensky, MD, director of the CDC, told the AP.

“We want to make sure we bolster everybody’s immunity,” she said. “And that’s really what motivated the decision to expand our guidance [on boosters for all adults].”

The Omicron variant has been reported in 57 countries so far, World Health Organization officials reported Dec. 8, and they expect that number to continue growing.

“Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know,” Tedros Adhanom Ghebreyesus, PhD, the World Health Organization’s director-general, said during a media briefing.

Several studies suggest that Omicron leads to a rapid increase in transmission, he said, though scientists are still trying to understand whether it can “outcompete Delta.” Data from South Africa also suggests a higher risk of reinfection with Omicron, though it appears to cause milder disease than Delta, he noted.

“Even though we still need answers to some crucial questions, we are not defenseless against Omicron or Delta,” he said. “The steps countries take today, and in the coming days and weeks, will determine how Omicron unfolds.”

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

The new Omicron variant could make it more likely that people will need a fourth coronavirus vaccine earlier than expected, Pfizer officials said on Dec. 8.

The standard two doses may be less effective against the variant, the company announced earlier in the day, and a booster dose increases neutralizing antibodies.

But the timeline might need to be moved up for a fourth dose. Previously, Pfizer CEO Albert Bourla, PhD, said another dose might be needed about a year after a third shot. Now the company’s scientists believe that a fourth shot, which targets the Omicron variant, could be required sooner.

“With Omicron, we need to wait and see because we have very little information. We may need it faster,” Dr. Bourla said on CNBC’s Squawk Box.

“But for right now, the most important thing is that we have winter in front of us,” he said. “From a healthcare perspective, it is important to understand that we need to be well-protected to go through the winter.”

A third dose should provide protection throughout the winter, Dr. Bourla said. That may buy time until the early spring to develop new shots that target Omicron, which Pfizer could have ready by March, according to  Bloomberg News.

As of the afternoon of Dec. 8, 43 people in 19 states had tested positive for the Omicron variant, according to The Associated Press. More than 75% had been vaccinated, and a third had had booster shots. About a third had traveled internationally.

Nearly all of them have had mild symptoms so far, the AP reported, with the most common symptoms being a cough, congestion, and fatigue. One person has been hospitalized, but no deaths have been reported so far.

The CDC is still trying to determine how the Omicron variant may affect the course of the pandemic and whether the strain is more contagious or causes more severe disease.

“What we generally know is the more mutations a variant has, the higher level you need your immunity to be,” Rochelle Walensky, MD, director of the CDC, told the AP.

“We want to make sure we bolster everybody’s immunity,” she said. “And that’s really what motivated the decision to expand our guidance [on boosters for all adults].”

The Omicron variant has been reported in 57 countries so far, World Health Organization officials reported Dec. 8, and they expect that number to continue growing.

“Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know,” Tedros Adhanom Ghebreyesus, PhD, the World Health Organization’s director-general, said during a media briefing.

Several studies suggest that Omicron leads to a rapid increase in transmission, he said, though scientists are still trying to understand whether it can “outcompete Delta.” Data from South Africa also suggests a higher risk of reinfection with Omicron, though it appears to cause milder disease than Delta, he noted.

“Even though we still need answers to some crucial questions, we are not defenseless against Omicron or Delta,” he said. “The steps countries take today, and in the coming days and weeks, will determine how Omicron unfolds.”

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

Under pressure from Republican state lawmakers, the Tennessee Board of Medical Examiners has removed from its website its recent policy statement that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license.

The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.

The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.

Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.

There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.

“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.

Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.

“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”

But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.

Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.

In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.

In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.

Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.

Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.

The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”

But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.

He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.

Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.

“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”

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

Under pressure from Republican state lawmakers, the Tennessee Board of Medical Examiners has removed from its website its recent policy statement that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license.

The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.

The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.

Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.

There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.

“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.

Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.

“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”

But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.

Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.

In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.

In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.

Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.

Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.

The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”

But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.

He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.

Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.

“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”

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

Under pressure from Republican state lawmakers, the Tennessee Board of Medical Examiners has removed from its website its recent policy statement that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license.

The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.

The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.

Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.

There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.

“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.

Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.

“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”

But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.

Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.

In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.

In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.

Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.

Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.

The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”

But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.

He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.

Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.

“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”

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

Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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