Ob.Gyn. News

Women harboring BRCA1/2 gene mutations are at high risk for breast cancer, and thus it’s recommended they undergo annual breast MRI screening in addition to mammogram screening.
 

However, some women are finding that their insurer is refusing to cover the cost of the MRI.

A new study exploring this issue was presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

“Despite guidelines supporting annual breast MRI for screening in patients with gBRCA1/2, insurance denials were present in 11% of patients,” said lead author Sushmita Gordhandas, MD, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “In a high-resource setting, up to 14% of patients who were denied coverage did not undergo recommended MRI screening.”

She also pointed out that the rate of denials was rising. “Compared to 2020, there were significantly more denials, and denials on appeal, in 2021,” Dr. Gordhandas said. “This suggested worsening barriers and added burden on health care systems.”

The addition of MRI to mammography is a standard recommendation for women with BRCA mutations, she pointed out, as it has been shown improve detection of early disease and decrease interval cancer development.

An expert not involved in the study noted that the recommendation for annual MRI screening in women at high risk for breast cancer is “substantiated by many publications, including multiple prospective clinical trials.”

Linda Moy, MD, a radiologist at NYU Langone’s Perlmutter Cancer Center and professor of radiology at NYU Grossman School of Medicine, both in New York, noted that the American Cancer Society’s Guidelines for screening breast MRI recommends annual breast MRI in women with a lifetime risk of greater than 20% – which includes women who are BRCA carriers – and recommends the screening begins at age 30.

“The lifetime breast cancer risk is 72% among BRCA1 and 69% among BRCA2 carriers,” she said, adding that the “American College of Radiology also recommends for BRCA carriers to undergo annual screening MRI at age 30.”

The National Comprehensive Cancer Network recommends that women at high risk for breast cancer undergo a mammogram and breast MRI every year starting at age 25 to 40, depending on the type of gene mutation, noted Dr. Gordhandas. “These guidelines are consistent with those from American College of Obstetricians and Gynecologists, the American Cancer Society, and the American College of Radiology.”
 

Denials increased over time

For the study, Dr. Gordhandas and colleagues looked at the frequency of insurance denials for indicated breast MRI screening in women with germline BRCA1/2 pathogenic variants, and also looked at recent trends in denials over time.

The cohort comprised 682 women with BRCA1/2 gene mutations who were followed in a specialized high-risk breast cancer clinic, and who had breast MRIs ordered from 2020 to 2021. They were then cross-referenced with a database of insurance denials. Radiology records were also accessed to determine if screening breast MRIs had been performed in 2020 and 2021, and rates of MRI denials and results after appeals were determined. The rates between the 2 years were then compared.

The team found that overall, 73 women (11%) had an MRI denied. The median age of women who received a denial was 38 years, whereas those who had it approved was 44 years. “Patients with denials were significantly younger and more likely to be in the Medicaid population,” said Dr. Gordhandas.

In 2020, 29 breast MRIs (5%) were denied, and on appeal, 8 (28%) were denied and 21 (72%) approved. The number of denials rose in 2021 but approvals remained the same; 45 breast MRIs were denied (8%); on appeal, 23 (51%) were denied, and 22 (49%) approved.

Thus, noted the authors, there were significantly more denials in 2021 as compared with 2020 (P = .044), and the denials in 2021 denials were statistically more likely to be denied on appeal (P = .045).

Among the women whose coverage was denied, four (14%) in 2020 and five (11%) in 2021 did not have an MRI screening performed. And within this group, 17 women (2.5%) received a diagnosis of cancer; 12 (1.8%) had invasive carcinoma, and 5 (0.7%) had ductal carcinoma in situ (DCIS). One patient with DCIS had an MRI denial prior to receiving her diagnosis.

“The top reasons given for denials were that they were outside the approved time frame, authorization on file for a similar study, and that the clinician failed to show medical necessity,” she explained.

Additional data are needed to establish a trend. “We are working to increase the approval time frame, which is currently 45 days, and provide resources for the patient to deal with denials,” Dr. Gordhandas added. “We also have to advocate for updates to [U.S. Preventive Services Task Force] screening recommendations in high-risk patients.”

Dr. Gordhandas reported no relevant financial relationships.

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

Women harboring BRCA1/2 gene mutations are at high risk for breast cancer, and thus it’s recommended they undergo annual breast MRI screening in addition to mammogram screening.
 

However, some women are finding that their insurer is refusing to cover the cost of the MRI.

A new study exploring this issue was presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

“Despite guidelines supporting annual breast MRI for screening in patients with gBRCA1/2, insurance denials were present in 11% of patients,” said lead author Sushmita Gordhandas, MD, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “In a high-resource setting, up to 14% of patients who were denied coverage did not undergo recommended MRI screening.”

She also pointed out that the rate of denials was rising. “Compared to 2020, there were significantly more denials, and denials on appeal, in 2021,” Dr. Gordhandas said. “This suggested worsening barriers and added burden on health care systems.”

The addition of MRI to mammography is a standard recommendation for women with BRCA mutations, she pointed out, as it has been shown improve detection of early disease and decrease interval cancer development.

An expert not involved in the study noted that the recommendation for annual MRI screening in women at high risk for breast cancer is “substantiated by many publications, including multiple prospective clinical trials.”

Linda Moy, MD, a radiologist at NYU Langone’s Perlmutter Cancer Center and professor of radiology at NYU Grossman School of Medicine, both in New York, noted that the American Cancer Society’s Guidelines for screening breast MRI recommends annual breast MRI in women with a lifetime risk of greater than 20% – which includes women who are BRCA carriers – and recommends the screening begins at age 30.

“The lifetime breast cancer risk is 72% among BRCA1 and 69% among BRCA2 carriers,” she said, adding that the “American College of Radiology also recommends for BRCA carriers to undergo annual screening MRI at age 30.”

The National Comprehensive Cancer Network recommends that women at high risk for breast cancer undergo a mammogram and breast MRI every year starting at age 25 to 40, depending on the type of gene mutation, noted Dr. Gordhandas. “These guidelines are consistent with those from American College of Obstetricians and Gynecologists, the American Cancer Society, and the American College of Radiology.”
 

Denials increased over time

For the study, Dr. Gordhandas and colleagues looked at the frequency of insurance denials for indicated breast MRI screening in women with germline BRCA1/2 pathogenic variants, and also looked at recent trends in denials over time.

The cohort comprised 682 women with BRCA1/2 gene mutations who were followed in a specialized high-risk breast cancer clinic, and who had breast MRIs ordered from 2020 to 2021. They were then cross-referenced with a database of insurance denials. Radiology records were also accessed to determine if screening breast MRIs had been performed in 2020 and 2021, and rates of MRI denials and results after appeals were determined. The rates between the 2 years were then compared.

The team found that overall, 73 women (11%) had an MRI denied. The median age of women who received a denial was 38 years, whereas those who had it approved was 44 years. “Patients with denials were significantly younger and more likely to be in the Medicaid population,” said Dr. Gordhandas.

In 2020, 29 breast MRIs (5%) were denied, and on appeal, 8 (28%) were denied and 21 (72%) approved. The number of denials rose in 2021 but approvals remained the same; 45 breast MRIs were denied (8%); on appeal, 23 (51%) were denied, and 22 (49%) approved.

Thus, noted the authors, there were significantly more denials in 2021 as compared with 2020 (P = .044), and the denials in 2021 denials were statistically more likely to be denied on appeal (P = .045).

Among the women whose coverage was denied, four (14%) in 2020 and five (11%) in 2021 did not have an MRI screening performed. And within this group, 17 women (2.5%) received a diagnosis of cancer; 12 (1.8%) had invasive carcinoma, and 5 (0.7%) had ductal carcinoma in situ (DCIS). One patient with DCIS had an MRI denial prior to receiving her diagnosis.

“The top reasons given for denials were that they were outside the approved time frame, authorization on file for a similar study, and that the clinician failed to show medical necessity,” she explained.

Additional data are needed to establish a trend. “We are working to increase the approval time frame, which is currently 45 days, and provide resources for the patient to deal with denials,” Dr. Gordhandas added. “We also have to advocate for updates to [U.S. Preventive Services Task Force] screening recommendations in high-risk patients.”

Dr. Gordhandas reported no relevant financial relationships.

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

Women harboring BRCA1/2 gene mutations are at high risk for breast cancer, and thus it’s recommended they undergo annual breast MRI screening in addition to mammogram screening.
 

However, some women are finding that their insurer is refusing to cover the cost of the MRI.

A new study exploring this issue was presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

“Despite guidelines supporting annual breast MRI for screening in patients with gBRCA1/2, insurance denials were present in 11% of patients,” said lead author Sushmita Gordhandas, MD, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “In a high-resource setting, up to 14% of patients who were denied coverage did not undergo recommended MRI screening.”

She also pointed out that the rate of denials was rising. “Compared to 2020, there were significantly more denials, and denials on appeal, in 2021,” Dr. Gordhandas said. “This suggested worsening barriers and added burden on health care systems.”

The addition of MRI to mammography is a standard recommendation for women with BRCA mutations, she pointed out, as it has been shown improve detection of early disease and decrease interval cancer development.

An expert not involved in the study noted that the recommendation for annual MRI screening in women at high risk for breast cancer is “substantiated by many publications, including multiple prospective clinical trials.”

Linda Moy, MD, a radiologist at NYU Langone’s Perlmutter Cancer Center and professor of radiology at NYU Grossman School of Medicine, both in New York, noted that the American Cancer Society’s Guidelines for screening breast MRI recommends annual breast MRI in women with a lifetime risk of greater than 20% – which includes women who are BRCA carriers – and recommends the screening begins at age 30.

“The lifetime breast cancer risk is 72% among BRCA1 and 69% among BRCA2 carriers,” she said, adding that the “American College of Radiology also recommends for BRCA carriers to undergo annual screening MRI at age 30.”

The National Comprehensive Cancer Network recommends that women at high risk for breast cancer undergo a mammogram and breast MRI every year starting at age 25 to 40, depending on the type of gene mutation, noted Dr. Gordhandas. “These guidelines are consistent with those from American College of Obstetricians and Gynecologists, the American Cancer Society, and the American College of Radiology.”
 

Denials increased over time

For the study, Dr. Gordhandas and colleagues looked at the frequency of insurance denials for indicated breast MRI screening in women with germline BRCA1/2 pathogenic variants, and also looked at recent trends in denials over time.

The cohort comprised 682 women with BRCA1/2 gene mutations who were followed in a specialized high-risk breast cancer clinic, and who had breast MRIs ordered from 2020 to 2021. They were then cross-referenced with a database of insurance denials. Radiology records were also accessed to determine if screening breast MRIs had been performed in 2020 and 2021, and rates of MRI denials and results after appeals were determined. The rates between the 2 years were then compared.

The team found that overall, 73 women (11%) had an MRI denied. The median age of women who received a denial was 38 years, whereas those who had it approved was 44 years. “Patients with denials were significantly younger and more likely to be in the Medicaid population,” said Dr. Gordhandas.

In 2020, 29 breast MRIs (5%) were denied, and on appeal, 8 (28%) were denied and 21 (72%) approved. The number of denials rose in 2021 but approvals remained the same; 45 breast MRIs were denied (8%); on appeal, 23 (51%) were denied, and 22 (49%) approved.

Thus, noted the authors, there were significantly more denials in 2021 as compared with 2020 (P = .044), and the denials in 2021 denials were statistically more likely to be denied on appeal (P = .045).

Among the women whose coverage was denied, four (14%) in 2020 and five (11%) in 2021 did not have an MRI screening performed. And within this group, 17 women (2.5%) received a diagnosis of cancer; 12 (1.8%) had invasive carcinoma, and 5 (0.7%) had ductal carcinoma in situ (DCIS). One patient with DCIS had an MRI denial prior to receiving her diagnosis.

“The top reasons given for denials were that they were outside the approved time frame, authorization on file for a similar study, and that the clinician failed to show medical necessity,” she explained.

Additional data are needed to establish a trend. “We are working to increase the approval time frame, which is currently 45 days, and provide resources for the patient to deal with denials,” Dr. Gordhandas added. “We also have to advocate for updates to [U.S. Preventive Services Task Force] screening recommendations in high-risk patients.”

Dr. Gordhandas reported no relevant financial relationships.

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

With a federal judge’s recent ruling clouding the future availability of mifepristone for terminating pregnancies, attention has shifted to the efficacy of another abortion drug, misoprostol.

Experts said a misoprostol-only regimen for medical abortions is as safe as but not as effective as the combination of mifepristone and misoprostol. A misoprostol-only approach also comes with more pronounced side effects.

“Misoprostol only is a good alternative; it’s not the best alternative,” Beverly Gray, MD, associate professor in the department of obstetrics and Gynecology at Duke University, Durham, N.C., said during a video conference on April 12. “The best medication would be to use mifepristone and misoprostol together because they’re efficacious with fewer side effects.”

To medically terminate a pregnancy using the two-drug regimen, patients first take the progesterone blocker mifepristone, which ends the pregnancy. That is followed 24-48 hours later with misoprostol, which causes the uterus to expel the pregnancy tissue. Used in combination, the two drugs have an efficacy rate of 98% in terminating a pregnancy.

An alternative approach is a misoprostol-only regimen. Patients take multiple doses of the drug over the course of hours until the pregnancy passes. This method is considered effective and safe, although patients may experience more nausea, vomiting, diarrhea, bleeding, and cramping.

“It’s effective, but not as effective as the combination treatment,” said Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California, Davis. “It also requires much higher doses. To get misoprostol by itself to have relatively high efficacy, you have to use multiple doses. It causes significantly more side effects, and it’s less effective.”

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

Contrary to popular belief, an infant’s gut microbiome is not primarily shaped by the mother’s vaginal microbiome, results of a new study indicate. The findings suggest that practices such as vaginal seeding are ineffective.

A longitudinal, prospective cohort study of more than 600 pregnant Canadian women and their newborns showed significant differences in an infant’s stool composition by delivery mode at 10 days post partum, but the differences could not be explained by the mother’s vaginal microbiome, and they effectively disappeared by 3 months.

Henry Wells

The findings were surprising, Scott Dos Santos, a PhD candidate at the University of Saskatchewan in Saskatoon, told this news organization. “The bacteria living in the maternal vagina are the first microbes that vaginally delivered infants are exposed to. … so it sounds intuitive that different kinds of vaginal microbiomes could end up influencing the development of a baby’s gut microbiome in different ways. But the maternal vaginal microbiome didn’t seem to have any role in predicting what the infant stool microbiome looked like.”

Therefore, women should not be concerned about cesarean delivery having an adverse effect on their baby’s gut microbiome, said Mr. Dos Santos. Moreover, “vaginal seeding is not safe or advised. Professional bodies, including the Society of Obstetricians and Gynecologists of Canada and the American College of Obstetricians and Gynecologists, strongly advise against this practice.”

The study was published online in Frontiers in Cellular and Infection Microbiology.
 

Independent communities

The investigators analyzed vaginal and stool microbiome profiles from 442 mother-infant dyads. The mothers were healthy, low-risk women who delivered at term. They were recruited into the Maternal Microbiome LEGACY Project from three hospitals in British Columbia.

The mean age of the mothers at delivery was 34.6 years, which is typical of the study hospitals’ delivery populations. Participants identified themselves as White (54.7%), Asian (21.2%), South Asian (8.3%), and of other ethnicities.

A nurse, midwife, or clinician collected maternal vaginal swabs of the posterior fornix and lateral vaginal wall at first presentation to the labor and delivery area. Neonatal meconium, which was defined as the first stool specimen collected within 72 hours of birth, and two infant stool samples were collected at follow-up visits at 10 days and 3 months post partum.

A principal component analysis of infant stool microbiomes showed no significant clustering of microbiome profiles at 10 days or 3 months by maternal community state types (that is, microbial species).

Correspondence analyses also showed no coclustering of maternal and infant clusters at either time. In addition, there were no differences in the distribution of maternal vaginal microbiome clusters among infant stool microbiome clusters, regardless of delivery mode.

Vaginal microbiome clusters were distributed across infant stool clusters in proportion to their frequency in the overall maternal population, indicating that the two communities were independent of each other.

Intrapartum antibiotic administration was identified as a confounder of infant stool microbiome differences and was associated with lower abundances of Escherichia coli, Bacteroides vulgatus, Bifidobacterium longum, and Parabacteroides distasonis.

“Our findings demonstrate that maternal vaginal microbiome composition at delivery does not affect infant stool microbiome composition and development, suggesting that practices to amend infant stool microbiome composition focus on factors other than maternal vaginal microbes,” the authors conclude.
 

More evidence needed

Commenting on the study, Emily H. Adhikari, MD, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, and medical director of perinatal infectious diseases for the Parkland Health and Hospital System, said, “These findings contribute significantly more data to an understudied area of research into factors that affect the infant gut microbiome from the earliest hours of life. Prior studies have been small and often conflicting, and the authors reference recent larger studies, which corroborate their findings.”

UT Southwestern Medical Center

The data regarding whether delivery mode or antibiotic-associated differences in infant microbiomes persist remain controversial, said Dr. Adhikari. “More evidence is needed involving a more ethnically diverse sampling of patients.” In addition, prospectively evaluating vaginal seeding in a rigorously designed clinical trial setting is “imperative to understand any potential benefit and certainly to understand the potential harms of the practice. To date, this does not exist.”

The study was funded by a Canadian Institutes of Health Research grant. Mr. Dos Santos and Dr. Adhikari have disclosed no relevant financial relationships.

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

Contrary to popular belief, an infant’s gut microbiome is not primarily shaped by the mother’s vaginal microbiome, results of a new study indicate. The findings suggest that practices such as vaginal seeding are ineffective.

A longitudinal, prospective cohort study of more than 600 pregnant Canadian women and their newborns showed significant differences in an infant’s stool composition by delivery mode at 10 days post partum, but the differences could not be explained by the mother’s vaginal microbiome, and they effectively disappeared by 3 months.

Henry Wells

The findings were surprising, Scott Dos Santos, a PhD candidate at the University of Saskatchewan in Saskatoon, told this news organization. “The bacteria living in the maternal vagina are the first microbes that vaginally delivered infants are exposed to. … so it sounds intuitive that different kinds of vaginal microbiomes could end up influencing the development of a baby’s gut microbiome in different ways. But the maternal vaginal microbiome didn’t seem to have any role in predicting what the infant stool microbiome looked like.”

Therefore, women should not be concerned about cesarean delivery having an adverse effect on their baby’s gut microbiome, said Mr. Dos Santos. Moreover, “vaginal seeding is not safe or advised. Professional bodies, including the Society of Obstetricians and Gynecologists of Canada and the American College of Obstetricians and Gynecologists, strongly advise against this practice.”

The study was published online in Frontiers in Cellular and Infection Microbiology.
 

Independent communities

The investigators analyzed vaginal and stool microbiome profiles from 442 mother-infant dyads. The mothers were healthy, low-risk women who delivered at term. They were recruited into the Maternal Microbiome LEGACY Project from three hospitals in British Columbia.

The mean age of the mothers at delivery was 34.6 years, which is typical of the study hospitals’ delivery populations. Participants identified themselves as White (54.7%), Asian (21.2%), South Asian (8.3%), and of other ethnicities.

A nurse, midwife, or clinician collected maternal vaginal swabs of the posterior fornix and lateral vaginal wall at first presentation to the labor and delivery area. Neonatal meconium, which was defined as the first stool specimen collected within 72 hours of birth, and two infant stool samples were collected at follow-up visits at 10 days and 3 months post partum.

A principal component analysis of infant stool microbiomes showed no significant clustering of microbiome profiles at 10 days or 3 months by maternal community state types (that is, microbial species).

Correspondence analyses also showed no coclustering of maternal and infant clusters at either time. In addition, there were no differences in the distribution of maternal vaginal microbiome clusters among infant stool microbiome clusters, regardless of delivery mode.

Vaginal microbiome clusters were distributed across infant stool clusters in proportion to their frequency in the overall maternal population, indicating that the two communities were independent of each other.

Intrapartum antibiotic administration was identified as a confounder of infant stool microbiome differences and was associated with lower abundances of Escherichia coli, Bacteroides vulgatus, Bifidobacterium longum, and Parabacteroides distasonis.

“Our findings demonstrate that maternal vaginal microbiome composition at delivery does not affect infant stool microbiome composition and development, suggesting that practices to amend infant stool microbiome composition focus on factors other than maternal vaginal microbes,” the authors conclude.
 

More evidence needed

Commenting on the study, Emily H. Adhikari, MD, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, and medical director of perinatal infectious diseases for the Parkland Health and Hospital System, said, “These findings contribute significantly more data to an understudied area of research into factors that affect the infant gut microbiome from the earliest hours of life. Prior studies have been small and often conflicting, and the authors reference recent larger studies, which corroborate their findings.”

UT Southwestern Medical Center

The data regarding whether delivery mode or antibiotic-associated differences in infant microbiomes persist remain controversial, said Dr. Adhikari. “More evidence is needed involving a more ethnically diverse sampling of patients.” In addition, prospectively evaluating vaginal seeding in a rigorously designed clinical trial setting is “imperative to understand any potential benefit and certainly to understand the potential harms of the practice. To date, this does not exist.”

The study was funded by a Canadian Institutes of Health Research grant. Mr. Dos Santos and Dr. Adhikari have disclosed no relevant financial relationships.

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

Contrary to popular belief, an infant’s gut microbiome is not primarily shaped by the mother’s vaginal microbiome, results of a new study indicate. The findings suggest that practices such as vaginal seeding are ineffective.

A longitudinal, prospective cohort study of more than 600 pregnant Canadian women and their newborns showed significant differences in an infant’s stool composition by delivery mode at 10 days post partum, but the differences could not be explained by the mother’s vaginal microbiome, and they effectively disappeared by 3 months.

Henry Wells

The findings were surprising, Scott Dos Santos, a PhD candidate at the University of Saskatchewan in Saskatoon, told this news organization. “The bacteria living in the maternal vagina are the first microbes that vaginally delivered infants are exposed to. … so it sounds intuitive that different kinds of vaginal microbiomes could end up influencing the development of a baby’s gut microbiome in different ways. But the maternal vaginal microbiome didn’t seem to have any role in predicting what the infant stool microbiome looked like.”

Therefore, women should not be concerned about cesarean delivery having an adverse effect on their baby’s gut microbiome, said Mr. Dos Santos. Moreover, “vaginal seeding is not safe or advised. Professional bodies, including the Society of Obstetricians and Gynecologists of Canada and the American College of Obstetricians and Gynecologists, strongly advise against this practice.”

The study was published online in Frontiers in Cellular and Infection Microbiology.
 

Independent communities

The investigators analyzed vaginal and stool microbiome profiles from 442 mother-infant dyads. The mothers were healthy, low-risk women who delivered at term. They were recruited into the Maternal Microbiome LEGACY Project from three hospitals in British Columbia.

The mean age of the mothers at delivery was 34.6 years, which is typical of the study hospitals’ delivery populations. Participants identified themselves as White (54.7%), Asian (21.2%), South Asian (8.3%), and of other ethnicities.

A nurse, midwife, or clinician collected maternal vaginal swabs of the posterior fornix and lateral vaginal wall at first presentation to the labor and delivery area. Neonatal meconium, which was defined as the first stool specimen collected within 72 hours of birth, and two infant stool samples were collected at follow-up visits at 10 days and 3 months post partum.

A principal component analysis of infant stool microbiomes showed no significant clustering of microbiome profiles at 10 days or 3 months by maternal community state types (that is, microbial species).

Correspondence analyses also showed no coclustering of maternal and infant clusters at either time. In addition, there were no differences in the distribution of maternal vaginal microbiome clusters among infant stool microbiome clusters, regardless of delivery mode.

Vaginal microbiome clusters were distributed across infant stool clusters in proportion to their frequency in the overall maternal population, indicating that the two communities were independent of each other.

Intrapartum antibiotic administration was identified as a confounder of infant stool microbiome differences and was associated with lower abundances of Escherichia coli, Bacteroides vulgatus, Bifidobacterium longum, and Parabacteroides distasonis.

“Our findings demonstrate that maternal vaginal microbiome composition at delivery does not affect infant stool microbiome composition and development, suggesting that practices to amend infant stool microbiome composition focus on factors other than maternal vaginal microbes,” the authors conclude.
 

More evidence needed

Commenting on the study, Emily H. Adhikari, MD, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, and medical director of perinatal infectious diseases for the Parkland Health and Hospital System, said, “These findings contribute significantly more data to an understudied area of research into factors that affect the infant gut microbiome from the earliest hours of life. Prior studies have been small and often conflicting, and the authors reference recent larger studies, which corroborate their findings.”

UT Southwestern Medical Center

The data regarding whether delivery mode or antibiotic-associated differences in infant microbiomes persist remain controversial, said Dr. Adhikari. “More evidence is needed involving a more ethnically diverse sampling of patients.” In addition, prospectively evaluating vaginal seeding in a rigorously designed clinical trial setting is “imperative to understand any potential benefit and certainly to understand the potential harms of the practice. To date, this does not exist.”

The study was funded by a Canadian Institutes of Health Research grant. Mr. Dos Santos and Dr. Adhikari have disclosed no relevant financial relationships.

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

In my most recent column, “ ‘They All Laughed When I Spoke of Greedy Doctors,’ ” I attempted to provide a global understanding of some of the economic forces that have made American medicine what it is, how that happened, and why it is still happening.

I did not propose a fix. I have been proposing fixes for more than 30 years, on the pages of JAMA until 1999 and then for this news organization, most recently in 2019 with “Healthcare for All in a Land of Special Interests.”

Where you stand depends a lot on where you sit.

Is this good news or bad news? When William Hubbard was the dean of the University of Michigan School of Medicine in 1969, he said that “an academic medical center is the most efficient energy and resource trapping device that has ever been created” (personal communication, 1969).

To me as a faculty member of an academic medical center for many years, that was great news. We could grow faculty, erect buildings, take the best care of sick people, churn out research papers, mint new physicians and specialists, and get paid well in the process for doing “the Lord’s work.” What’s not to like? At that time, the proportion of the country’s gross national product expended for medical and health care was about 7%. And the predicted life span of an American at birth was 70.5 years.

Is this good news or bad news? In 2021, the proportion of our annual gross domestic product (GDP) consumed by health care was 18.3%, totaling $4.3 trillion, or $12,914 per person. For perspective, in 2021, the median income per capita was $37,638. Because quite a few Americans have very high incomes, the mean income per capita is much higher: $63,444. Predicted life span in 2021 was 76.4 years.

Thus, in a span of 53 years (1969-2022), only 5.9 years of life were gained per person born, for how many trillions of dollars expended? To me as a tax-paying citizen and payer of medical insurance premiums, that is bad news.

Is this good news or bad news? If we compare developed societies globally, our medical system does a whole lot of things very well indeed. But we spend a great deal more than any other country for health care and objectively achieve poorer outcomes. Thus, we are neither efficient nor effective. We keep a lot of workers very busy doing stuff, and they are generally well paid. As a worker, that’s good news; as a manager who values efficiency, it’s bad news indeed.

Is this good news or bad news? We’re the leader at finding money to pay people to do “health care work.” More Americans work in health care than any other field. In 2019, the United States employed some 21,000,000 people doing “health care and social assistance.” Among others, these occupations include physicians, dentists, dental hygienists and assistants, pharmacists, registered nurses, LVNs/LPNs, nursing aides, technologists and technicians, home health aides, respiratory therapists, occupational and speech therapists, social workers, childcare workers, and personal and home care aides. For a patient, parent, grandparent, and great-grandparent, it is good news to have all those folks available to take care of us when we need it.

So, while I have cringed at the frequent exposés from Roy Poses of what seem to me to be massive societal betrayals by American health care industry giants, it doesn’t have to be that way. Might it still be possible to do well while doing good?
 

A jobs program

Consider such common medical procedures as coronary artery stents or bypass grafts for stable angina (when optimal medical therapy is as good, or better than, and much less expensive); PSAs on asymptomatic men followed by unnecessary surgery for localized cancer; excess surgery for low back pain; and the jobs created by managing the people caught up in medical complications of the obesity epidemic.

Don’t forget the number of people employed simply to “follow the money” within our byzantine cockamamie medical billing system. In 2009, this prompted me to describe the bloated system as a “health care bubble” not unlike Enron, the submarket real estate financing debacle, or the dot-com boom and bust. I warned of the downside of bursting that bubble, particularly lost jobs.

The Affordable Care Act (ACA) provided health insurance to some 35 million Americans who had been uninsured. It retarded health care inflation. But it did nothing to trim administrative costs or very high pay for nonclinical executives, or shareholder profits in those companies that were for-profit, or drug and device prices. Without the support of all those groups, the ACA would never have passed Congress. The ACA has clearly been a mixed blessing.

If any large American constituency were ever serious about reducing the percentage of our GDP expended on health care, we have excellent ways to do that while improving the health and well-being of the American people. But remember, one person’s liability (unnecessary work) is another person’s asset (needed job).
 

The MBAization of medicine

Meanwhile, back at Dean Hubbard’s voracious academic medical center, the high intellect and driven nature of those who are attracted to medicine as a career has had other effects. The resulting organizations reflect not only the glorious calling of caring for the sick and the availability of lots of money to recruit and compensate leaders, but also the necessity to develop strong executive types who won’t be “eaten alive” by the high-powered workforce of demanding physicians and the surrounding environment.

Thus, it came as no great surprise that in its 2021 determination of America’s top 25 Best Large Employers, Forbes included five health care organizations and seven universities. Beating out such giants as NASA, Cisco, Microsoft, Netflix, and Google, the University of Alabama Birmingham Hospital was ranked first. Mayo Clinic and Yale University came in third and fifth, respectively, and at the other end of the list were Duke (23), MIT (24), and MD Anderson (25).

My goodness! Well done.

Yet, as a country attempting to be balanced, Warren Buffett’s descriptive entreaty on the 2021 failure of Haven, the Amazon-Chase-Berkshire Hathaway joint initiative, remains troubling. Calling upon Haven to change the U.S. health care system, Buffet said, “We learned a lot about the difficulty of changing around an industry that’s 17% of the GDP. We were fighting a tapeworm in the American economy, and the tapeworm won.” They had failed to tame the American health care cost beast.

I am on record as despising the “MBAization” of American medicine. Unfairly, I blamed a professional and technical discipline for what I considered misuse. I hereby repent and renounce my earlier condemnations.
 

Take it all over?

Here’s an idea: If you can’t beat them, join them.

Medical care is important, especially for acute illnesses and injuries, early cancer therapy, and many chronic conditions. But the real determinants of health writ large are social: wealth, education, housing, nutritious food, childcare, climate, clean air and water, meaningful employment, safety from violence, exercise schemes, vaccinations, and so on.

Why doesn’t the American medical-industrial complex simply bestow the label of “health care” on all health-related social determinants? Take it all over. Good “health care” jobs for everyone. Medical professionals will still be blamed for the low health quality and poor outcome scores, the main social determinants of health over which we have no control or influence.

Let that tapeworm grow to encompass all social determinants of health, and measure results by length and quality of life, national human happiness, and, of course, jobs. We can do it. Let that bubble glow. Party time.

And that’s the way it is. That’s my opinion.

George Lundberg, MD, is editor-in-chief at Cancer Commons, president of the Lundberg Institute, executive advisor at Cureus, and a clinical professor of pathology at Northwestern University. Previously, he served as editor-in-chief of JAMA (including 10 specialty journals), American Medical News, and Medscape.

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

In my most recent column, “ ‘They All Laughed When I Spoke of Greedy Doctors,’ ” I attempted to provide a global understanding of some of the economic forces that have made American medicine what it is, how that happened, and why it is still happening.

I did not propose a fix. I have been proposing fixes for more than 30 years, on the pages of JAMA until 1999 and then for this news organization, most recently in 2019 with “Healthcare for All in a Land of Special Interests.”

Where you stand depends a lot on where you sit.

Is this good news or bad news? When William Hubbard was the dean of the University of Michigan School of Medicine in 1969, he said that “an academic medical center is the most efficient energy and resource trapping device that has ever been created” (personal communication, 1969).

To me as a faculty member of an academic medical center for many years, that was great news. We could grow faculty, erect buildings, take the best care of sick people, churn out research papers, mint new physicians and specialists, and get paid well in the process for doing “the Lord’s work.” What’s not to like? At that time, the proportion of the country’s gross national product expended for medical and health care was about 7%. And the predicted life span of an American at birth was 70.5 years.

Is this good news or bad news? In 2021, the proportion of our annual gross domestic product (GDP) consumed by health care was 18.3%, totaling $4.3 trillion, or $12,914 per person. For perspective, in 2021, the median income per capita was $37,638. Because quite a few Americans have very high incomes, the mean income per capita is much higher: $63,444. Predicted life span in 2021 was 76.4 years.

Thus, in a span of 53 years (1969-2022), only 5.9 years of life were gained per person born, for how many trillions of dollars expended? To me as a tax-paying citizen and payer of medical insurance premiums, that is bad news.

Is this good news or bad news? If we compare developed societies globally, our medical system does a whole lot of things very well indeed. But we spend a great deal more than any other country for health care and objectively achieve poorer outcomes. Thus, we are neither efficient nor effective. We keep a lot of workers very busy doing stuff, and they are generally well paid. As a worker, that’s good news; as a manager who values efficiency, it’s bad news indeed.

Is this good news or bad news? We’re the leader at finding money to pay people to do “health care work.” More Americans work in health care than any other field. In 2019, the United States employed some 21,000,000 people doing “health care and social assistance.” Among others, these occupations include physicians, dentists, dental hygienists and assistants, pharmacists, registered nurses, LVNs/LPNs, nursing aides, technologists and technicians, home health aides, respiratory therapists, occupational and speech therapists, social workers, childcare workers, and personal and home care aides. For a patient, parent, grandparent, and great-grandparent, it is good news to have all those folks available to take care of us when we need it.

So, while I have cringed at the frequent exposés from Roy Poses of what seem to me to be massive societal betrayals by American health care industry giants, it doesn’t have to be that way. Might it still be possible to do well while doing good?
 

A jobs program

Consider such common medical procedures as coronary artery stents or bypass grafts for stable angina (when optimal medical therapy is as good, or better than, and much less expensive); PSAs on asymptomatic men followed by unnecessary surgery for localized cancer; excess surgery for low back pain; and the jobs created by managing the people caught up in medical complications of the obesity epidemic.

Don’t forget the number of people employed simply to “follow the money” within our byzantine cockamamie medical billing system. In 2009, this prompted me to describe the bloated system as a “health care bubble” not unlike Enron, the submarket real estate financing debacle, or the dot-com boom and bust. I warned of the downside of bursting that bubble, particularly lost jobs.

The Affordable Care Act (ACA) provided health insurance to some 35 million Americans who had been uninsured. It retarded health care inflation. But it did nothing to trim administrative costs or very high pay for nonclinical executives, or shareholder profits in those companies that were for-profit, or drug and device prices. Without the support of all those groups, the ACA would never have passed Congress. The ACA has clearly been a mixed blessing.

If any large American constituency were ever serious about reducing the percentage of our GDP expended on health care, we have excellent ways to do that while improving the health and well-being of the American people. But remember, one person’s liability (unnecessary work) is another person’s asset (needed job).
 

The MBAization of medicine

Meanwhile, back at Dean Hubbard’s voracious academic medical center, the high intellect and driven nature of those who are attracted to medicine as a career has had other effects. The resulting organizations reflect not only the glorious calling of caring for the sick and the availability of lots of money to recruit and compensate leaders, but also the necessity to develop strong executive types who won’t be “eaten alive” by the high-powered workforce of demanding physicians and the surrounding environment.

Thus, it came as no great surprise that in its 2021 determination of America’s top 25 Best Large Employers, Forbes included five health care organizations and seven universities. Beating out such giants as NASA, Cisco, Microsoft, Netflix, and Google, the University of Alabama Birmingham Hospital was ranked first. Mayo Clinic and Yale University came in third and fifth, respectively, and at the other end of the list were Duke (23), MIT (24), and MD Anderson (25).

My goodness! Well done.

Yet, as a country attempting to be balanced, Warren Buffett’s descriptive entreaty on the 2021 failure of Haven, the Amazon-Chase-Berkshire Hathaway joint initiative, remains troubling. Calling upon Haven to change the U.S. health care system, Buffet said, “We learned a lot about the difficulty of changing around an industry that’s 17% of the GDP. We were fighting a tapeworm in the American economy, and the tapeworm won.” They had failed to tame the American health care cost beast.

I am on record as despising the “MBAization” of American medicine. Unfairly, I blamed a professional and technical discipline for what I considered misuse. I hereby repent and renounce my earlier condemnations.
 

Take it all over?

Here’s an idea: If you can’t beat them, join them.

Medical care is important, especially for acute illnesses and injuries, early cancer therapy, and many chronic conditions. But the real determinants of health writ large are social: wealth, education, housing, nutritious food, childcare, climate, clean air and water, meaningful employment, safety from violence, exercise schemes, vaccinations, and so on.

Why doesn’t the American medical-industrial complex simply bestow the label of “health care” on all health-related social determinants? Take it all over. Good “health care” jobs for everyone. Medical professionals will still be blamed for the low health quality and poor outcome scores, the main social determinants of health over which we have no control or influence.

Let that tapeworm grow to encompass all social determinants of health, and measure results by length and quality of life, national human happiness, and, of course, jobs. We can do it. Let that bubble glow. Party time.

And that’s the way it is. That’s my opinion.

George Lundberg, MD, is editor-in-chief at Cancer Commons, president of the Lundberg Institute, executive advisor at Cureus, and a clinical professor of pathology at Northwestern University. Previously, he served as editor-in-chief of JAMA (including 10 specialty journals), American Medical News, and Medscape.

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

In my most recent column, “ ‘They All Laughed When I Spoke of Greedy Doctors,’ ” I attempted to provide a global understanding of some of the economic forces that have made American medicine what it is, how that happened, and why it is still happening.

I did not propose a fix. I have been proposing fixes for more than 30 years, on the pages of JAMA until 1999 and then for this news organization, most recently in 2019 with “Healthcare for All in a Land of Special Interests.”

Where you stand depends a lot on where you sit.

Is this good news or bad news? When William Hubbard was the dean of the University of Michigan School of Medicine in 1969, he said that “an academic medical center is the most efficient energy and resource trapping device that has ever been created” (personal communication, 1969).

To me as a faculty member of an academic medical center for many years, that was great news. We could grow faculty, erect buildings, take the best care of sick people, churn out research papers, mint new physicians and specialists, and get paid well in the process for doing “the Lord’s work.” What’s not to like? At that time, the proportion of the country’s gross national product expended for medical and health care was about 7%. And the predicted life span of an American at birth was 70.5 years.

Is this good news or bad news? In 2021, the proportion of our annual gross domestic product (GDP) consumed by health care was 18.3%, totaling $4.3 trillion, or $12,914 per person. For perspective, in 2021, the median income per capita was $37,638. Because quite a few Americans have very high incomes, the mean income per capita is much higher: $63,444. Predicted life span in 2021 was 76.4 years.

Thus, in a span of 53 years (1969-2022), only 5.9 years of life were gained per person born, for how many trillions of dollars expended? To me as a tax-paying citizen and payer of medical insurance premiums, that is bad news.

Is this good news or bad news? If we compare developed societies globally, our medical system does a whole lot of things very well indeed. But we spend a great deal more than any other country for health care and objectively achieve poorer outcomes. Thus, we are neither efficient nor effective. We keep a lot of workers very busy doing stuff, and they are generally well paid. As a worker, that’s good news; as a manager who values efficiency, it’s bad news indeed.

Is this good news or bad news? We’re the leader at finding money to pay people to do “health care work.” More Americans work in health care than any other field. In 2019, the United States employed some 21,000,000 people doing “health care and social assistance.” Among others, these occupations include physicians, dentists, dental hygienists and assistants, pharmacists, registered nurses, LVNs/LPNs, nursing aides, technologists and technicians, home health aides, respiratory therapists, occupational and speech therapists, social workers, childcare workers, and personal and home care aides. For a patient, parent, grandparent, and great-grandparent, it is good news to have all those folks available to take care of us when we need it.

So, while I have cringed at the frequent exposés from Roy Poses of what seem to me to be massive societal betrayals by American health care industry giants, it doesn’t have to be that way. Might it still be possible to do well while doing good?
 

A jobs program

Consider such common medical procedures as coronary artery stents or bypass grafts for stable angina (when optimal medical therapy is as good, or better than, and much less expensive); PSAs on asymptomatic men followed by unnecessary surgery for localized cancer; excess surgery for low back pain; and the jobs created by managing the people caught up in medical complications of the obesity epidemic.

Don’t forget the number of people employed simply to “follow the money” within our byzantine cockamamie medical billing system. In 2009, this prompted me to describe the bloated system as a “health care bubble” not unlike Enron, the submarket real estate financing debacle, or the dot-com boom and bust. I warned of the downside of bursting that bubble, particularly lost jobs.

The Affordable Care Act (ACA) provided health insurance to some 35 million Americans who had been uninsured. It retarded health care inflation. But it did nothing to trim administrative costs or very high pay for nonclinical executives, or shareholder profits in those companies that were for-profit, or drug and device prices. Without the support of all those groups, the ACA would never have passed Congress. The ACA has clearly been a mixed blessing.

If any large American constituency were ever serious about reducing the percentage of our GDP expended on health care, we have excellent ways to do that while improving the health and well-being of the American people. But remember, one person’s liability (unnecessary work) is another person’s asset (needed job).
 

The MBAization of medicine

Meanwhile, back at Dean Hubbard’s voracious academic medical center, the high intellect and driven nature of those who are attracted to medicine as a career has had other effects. The resulting organizations reflect not only the glorious calling of caring for the sick and the availability of lots of money to recruit and compensate leaders, but also the necessity to develop strong executive types who won’t be “eaten alive” by the high-powered workforce of demanding physicians and the surrounding environment.

Thus, it came as no great surprise that in its 2021 determination of America’s top 25 Best Large Employers, Forbes included five health care organizations and seven universities. Beating out such giants as NASA, Cisco, Microsoft, Netflix, and Google, the University of Alabama Birmingham Hospital was ranked first. Mayo Clinic and Yale University came in third and fifth, respectively, and at the other end of the list were Duke (23), MIT (24), and MD Anderson (25).

My goodness! Well done.

Yet, as a country attempting to be balanced, Warren Buffett’s descriptive entreaty on the 2021 failure of Haven, the Amazon-Chase-Berkshire Hathaway joint initiative, remains troubling. Calling upon Haven to change the U.S. health care system, Buffet said, “We learned a lot about the difficulty of changing around an industry that’s 17% of the GDP. We were fighting a tapeworm in the American economy, and the tapeworm won.” They had failed to tame the American health care cost beast.

I am on record as despising the “MBAization” of American medicine. Unfairly, I blamed a professional and technical discipline for what I considered misuse. I hereby repent and renounce my earlier condemnations.
 

Take it all over?

Here’s an idea: If you can’t beat them, join them.

Medical care is important, especially for acute illnesses and injuries, early cancer therapy, and many chronic conditions. But the real determinants of health writ large are social: wealth, education, housing, nutritious food, childcare, climate, clean air and water, meaningful employment, safety from violence, exercise schemes, vaccinations, and so on.

Why doesn’t the American medical-industrial complex simply bestow the label of “health care” on all health-related social determinants? Take it all over. Good “health care” jobs for everyone. Medical professionals will still be blamed for the low health quality and poor outcome scores, the main social determinants of health over which we have no control or influence.

Let that tapeworm grow to encompass all social determinants of health, and measure results by length and quality of life, national human happiness, and, of course, jobs. We can do it. Let that bubble glow. Party time.

And that’s the way it is. That’s my opinion.

George Lundberg, MD, is editor-in-chief at Cancer Commons, president of the Lundberg Institute, executive advisor at Cureus, and a clinical professor of pathology at Northwestern University. Previously, he served as editor-in-chief of JAMA (including 10 specialty journals), American Medical News, and Medscape.

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

You and me and baby makes 10,003

If you were a virus hunter, looking for your next big virus discovery, where would you go? The wholesale seafood market in Wuhan? A gathering of unmasked anti-vaxxers in the heartland of America? The frozen snot fields of northwest Siberia?

Comstock/Thinkstock

How about babies? Well, it’s too late now, because that’s what Dennis Sandris Nielsen, PhD, of the University of Copenhagen, and his associates did, and they hit the mother lode. Actually, it was more like the infant load, if we’re being honest here.

“We found an exceptional number of unknown viruses in the faeces of these babies,” Dr. Nielsen said in a written statement from the university. (The study was published in Nature Microbiology, so we get the English spelling of feces.)

The investigators mapped the gut “viromes” of 647 healthy Danish 1-year-old children over the course of 5 years and found 10,000 species of viruses distributed across 248 different viral families, of which only 16 were already known. Incredible stuff, but then things took a turn for the cute. “The researchers named the remaining 232 unknown viral families after the children whose diapers made the study possible. As a result, new viral families include names like Sylvesterviridae, Rigmorviridae and Tristanviridae,” the university said.

About 90% of the viruses found in the feces are bacterial viruses, aka bacteriophages, which have bacteria as their hosts and don’t attack the children’s cells, so they don’t cause disease. The other 10%, however, are eukaryotic: They use human cells as hosts, so they can be either friend or foe. “It is thought-provoking that all children run around with 10-20 of these virus types that infect human cells. So, there is a constant viral infection taking place, which apparently doesn’t make them sick,” Dr. Nielsen said.

Doesn’t make them sick? Riiiight. The thought that this gives rise to now? People love babies. Everyone wants to pick up the baby. Now we know why. Because the viruses want us to! Well, those cute little faces aren’t fooling us anymore. No more babies for us. Everyone should stay away from babies and their evil little eukaryotic viruses. STOP THE BABIES!

[Editor’s note: After a short timeout, we explained to the staff that the human species actually needs babies for its survival. They calmed down, picked up their crayons, and quietly went back to work.]

Fooled them. _{Stop the babies!}

At least someone out there appreciates hospital food

Life in Alaska is not for the meek. It’s dark half the year. Summer is 3 weeks in July. And somehow, there’s a moose in line ahead of you at the doctor’s office. To make matters worse, it’s arguing about insurance. “What do you mean, you’ve heard the Moo Cross Moo Shield joke before?”

Jean Beaufort/PublicDomainPictures.net

One might expect that Providence Alaska Health Park, located near downtown Anchorage, the largest city in Alaska by a massive margin, might be safe from ungulate invasion. Nope. In recent days, a young moose has taken to hanging around Providence campus, and it just could not find anything to eat. Remember, it may be early April, but this is Alaska. It’s still winter there. The ground’s still covered in snow.

Eventually, the gears in our young moose friend’s mind turned and it settled on a course of action: “Hey, those are some nice-looking plants behind that door over there. …” And that’s how Providence Alaska Health ended up with a moose munching on decorative potted plants in the hospital lobby.

Funnily enough, the moose didn’t even make a big scene. It just walked through the automatic doors and started chowing down. Security only found out because a tenant called them. Naturally though, once security made the announcement that a massive wild animal had been spotted in the building, the lobby was evacuated. … What do you mean, half the hospital came around to see it? Apparently, even though Alaskans have to fight moose herds on their daily commute, a lot of people wanted to see our moose friend do its thing.

“That’s crazy,” a woman in scrubs said in a video as she snapped a photo with her phone.

“This is the best. Like, what’s the code for this?” asked another bystander.

Despite security’s best efforts to shoo the moose out with barricades and offers of tasty branches, our furry friend left of its own volition, presumably irritated that his breakfast had become a spectator sport. But it didn’t go far. It hung around the front drive for a while, then went around the back of the building for a nap. What has four hooves and still doesn’t give a crap? Bob Moose-o! How you doing?
 

That click sounded stressed

How can people tell that you’re stressed? Maybe you get irritable and a little snappy. Some people have an inability to concentrate or focus. Eating that muffin when you weren’t really hungry could be a sign you’re not relaxed.

Georgijevic/E+/Getty Images

Did you know that your computer can be an indicator of your stress levels?

We tend to be working when we’re using computers, right? That can be a stressor in itself. Well, some researchers at ETH Zürich decided to have a look at the situation. Surprisingly, at least to us, one in three Swiss employees experience workplace stress, which makes us wonder what the percentage is in this country.

The Swiss researchers developed a model that tells how stressed someone is just by the way they use their computer mouse or type. The results of their study showed that those who were stressed clicked and tapped differently than participants who were more relaxed.

Stressed people click “more often and less precisely and cover longer distances on the screen,” while the relaxed take “shorter, more direct routes to reach their destination and take more time doing so,” study author Mara Nägelin explained in a written statement from ETH (Eidgenössische Technische Hochschule, or Swiss Federal Institute of Technology) Zürich.

Ever find when you’re frustrated and in a rush you end up making more mistakes? Same deal. Coauthor Jasmine Kerr noted that “increased levels of stress negatively impact our brain’s ability to process information.” Which totally is going to affect how we move.

Hopefully, these results can give insight to companies on how stressed their employees are and the effect it has on their work performance, eventually leading to, guess what, more research on how to alleviate workplace stress in general, which can benefit us all.

So if you find yourself in the office working on your computer like it’s a game of Perfection and time is running out, take a beat. Maybe try a stress-relieving breathing technique. Nonstressed people, according to the study, take fewer and longer pauses on their computers. Perfection on the job may mean relaxing first.

You and me and baby makes 10,003

If you were a virus hunter, looking for your next big virus discovery, where would you go? The wholesale seafood market in Wuhan? A gathering of unmasked anti-vaxxers in the heartland of America? The frozen snot fields of northwest Siberia?

Comstock/Thinkstock

How about babies? Well, it’s too late now, because that’s what Dennis Sandris Nielsen, PhD, of the University of Copenhagen, and his associates did, and they hit the mother lode. Actually, it was more like the infant load, if we’re being honest here.

“We found an exceptional number of unknown viruses in the faeces of these babies,” Dr. Nielsen said in a written statement from the university. (The study was published in Nature Microbiology, so we get the English spelling of feces.)

The investigators mapped the gut “viromes” of 647 healthy Danish 1-year-old children over the course of 5 years and found 10,000 species of viruses distributed across 248 different viral families, of which only 16 were already known. Incredible stuff, but then things took a turn for the cute. “The researchers named the remaining 232 unknown viral families after the children whose diapers made the study possible. As a result, new viral families include names like Sylvesterviridae, Rigmorviridae and Tristanviridae,” the university said.

About 90% of the viruses found in the feces are bacterial viruses, aka bacteriophages, which have bacteria as their hosts and don’t attack the children’s cells, so they don’t cause disease. The other 10%, however, are eukaryotic: They use human cells as hosts, so they can be either friend or foe. “It is thought-provoking that all children run around with 10-20 of these virus types that infect human cells. So, there is a constant viral infection taking place, which apparently doesn’t make them sick,” Dr. Nielsen said.

Doesn’t make them sick? Riiiight. The thought that this gives rise to now? People love babies. Everyone wants to pick up the baby. Now we know why. Because the viruses want us to! Well, those cute little faces aren’t fooling us anymore. No more babies for us. Everyone should stay away from babies and their evil little eukaryotic viruses. STOP THE BABIES!

[Editor’s note: After a short timeout, we explained to the staff that the human species actually needs babies for its survival. They calmed down, picked up their crayons, and quietly went back to work.]

Fooled them. _{Stop the babies!}

At least someone out there appreciates hospital food

Life in Alaska is not for the meek. It’s dark half the year. Summer is 3 weeks in July. And somehow, there’s a moose in line ahead of you at the doctor’s office. To make matters worse, it’s arguing about insurance. “What do you mean, you’ve heard the Moo Cross Moo Shield joke before?”

Jean Beaufort/PublicDomainPictures.net

One might expect that Providence Alaska Health Park, located near downtown Anchorage, the largest city in Alaska by a massive margin, might be safe from ungulate invasion. Nope. In recent days, a young moose has taken to hanging around Providence campus, and it just could not find anything to eat. Remember, it may be early April, but this is Alaska. It’s still winter there. The ground’s still covered in snow.

Eventually, the gears in our young moose friend’s mind turned and it settled on a course of action: “Hey, those are some nice-looking plants behind that door over there. …” And that’s how Providence Alaska Health ended up with a moose munching on decorative potted plants in the hospital lobby.

Funnily enough, the moose didn’t even make a big scene. It just walked through the automatic doors and started chowing down. Security only found out because a tenant called them. Naturally though, once security made the announcement that a massive wild animal had been spotted in the building, the lobby was evacuated. … What do you mean, half the hospital came around to see it? Apparently, even though Alaskans have to fight moose herds on their daily commute, a lot of people wanted to see our moose friend do its thing.

“That’s crazy,” a woman in scrubs said in a video as she snapped a photo with her phone.

“This is the best. Like, what’s the code for this?” asked another bystander.

Despite security’s best efforts to shoo the moose out with barricades and offers of tasty branches, our furry friend left of its own volition, presumably irritated that his breakfast had become a spectator sport. But it didn’t go far. It hung around the front drive for a while, then went around the back of the building for a nap. What has four hooves and still doesn’t give a crap? Bob Moose-o! How you doing?
 

That click sounded stressed

How can people tell that you’re stressed? Maybe you get irritable and a little snappy. Some people have an inability to concentrate or focus. Eating that muffin when you weren’t really hungry could be a sign you’re not relaxed.

Georgijevic/E+/Getty Images

Did you know that your computer can be an indicator of your stress levels?

We tend to be working when we’re using computers, right? That can be a stressor in itself. Well, some researchers at ETH Zürich decided to have a look at the situation. Surprisingly, at least to us, one in three Swiss employees experience workplace stress, which makes us wonder what the percentage is in this country.

The Swiss researchers developed a model that tells how stressed someone is just by the way they use their computer mouse or type. The results of their study showed that those who were stressed clicked and tapped differently than participants who were more relaxed.

Stressed people click “more often and less precisely and cover longer distances on the screen,” while the relaxed take “shorter, more direct routes to reach their destination and take more time doing so,” study author Mara Nägelin explained in a written statement from ETH (Eidgenössische Technische Hochschule, or Swiss Federal Institute of Technology) Zürich.

Ever find when you’re frustrated and in a rush you end up making more mistakes? Same deal. Coauthor Jasmine Kerr noted that “increased levels of stress negatively impact our brain’s ability to process information.” Which totally is going to affect how we move.

Hopefully, these results can give insight to companies on how stressed their employees are and the effect it has on their work performance, eventually leading to, guess what, more research on how to alleviate workplace stress in general, which can benefit us all.

So if you find yourself in the office working on your computer like it’s a game of Perfection and time is running out, take a beat. Maybe try a stress-relieving breathing technique. Nonstressed people, according to the study, take fewer and longer pauses on their computers. Perfection on the job may mean relaxing first.

You and me and baby makes 10,003

If you were a virus hunter, looking for your next big virus discovery, where would you go? The wholesale seafood market in Wuhan? A gathering of unmasked anti-vaxxers in the heartland of America? The frozen snot fields of northwest Siberia?

Comstock/Thinkstock

How about babies? Well, it’s too late now, because that’s what Dennis Sandris Nielsen, PhD, of the University of Copenhagen, and his associates did, and they hit the mother lode. Actually, it was more like the infant load, if we’re being honest here.

“We found an exceptional number of unknown viruses in the faeces of these babies,” Dr. Nielsen said in a written statement from the university. (The study was published in Nature Microbiology, so we get the English spelling of feces.)

The investigators mapped the gut “viromes” of 647 healthy Danish 1-year-old children over the course of 5 years and found 10,000 species of viruses distributed across 248 different viral families, of which only 16 were already known. Incredible stuff, but then things took a turn for the cute. “The researchers named the remaining 232 unknown viral families after the children whose diapers made the study possible. As a result, new viral families include names like Sylvesterviridae, Rigmorviridae and Tristanviridae,” the university said.

About 90% of the viruses found in the feces are bacterial viruses, aka bacteriophages, which have bacteria as their hosts and don’t attack the children’s cells, so they don’t cause disease. The other 10%, however, are eukaryotic: They use human cells as hosts, so they can be either friend or foe. “It is thought-provoking that all children run around with 10-20 of these virus types that infect human cells. So, there is a constant viral infection taking place, which apparently doesn’t make them sick,” Dr. Nielsen said.

Doesn’t make them sick? Riiiight. The thought that this gives rise to now? People love babies. Everyone wants to pick up the baby. Now we know why. Because the viruses want us to! Well, those cute little faces aren’t fooling us anymore. No more babies for us. Everyone should stay away from babies and their evil little eukaryotic viruses. STOP THE BABIES!

[Editor’s note: After a short timeout, we explained to the staff that the human species actually needs babies for its survival. They calmed down, picked up their crayons, and quietly went back to work.]

Fooled them. _{Stop the babies!}

At least someone out there appreciates hospital food

Life in Alaska is not for the meek. It’s dark half the year. Summer is 3 weeks in July. And somehow, there’s a moose in line ahead of you at the doctor’s office. To make matters worse, it’s arguing about insurance. “What do you mean, you’ve heard the Moo Cross Moo Shield joke before?”

Jean Beaufort/PublicDomainPictures.net

One might expect that Providence Alaska Health Park, located near downtown Anchorage, the largest city in Alaska by a massive margin, might be safe from ungulate invasion. Nope. In recent days, a young moose has taken to hanging around Providence campus, and it just could not find anything to eat. Remember, it may be early April, but this is Alaska. It’s still winter there. The ground’s still covered in snow.

Eventually, the gears in our young moose friend’s mind turned and it settled on a course of action: “Hey, those are some nice-looking plants behind that door over there. …” And that’s how Providence Alaska Health ended up with a moose munching on decorative potted plants in the hospital lobby.

Funnily enough, the moose didn’t even make a big scene. It just walked through the automatic doors and started chowing down. Security only found out because a tenant called them. Naturally though, once security made the announcement that a massive wild animal had been spotted in the building, the lobby was evacuated. … What do you mean, half the hospital came around to see it? Apparently, even though Alaskans have to fight moose herds on their daily commute, a lot of people wanted to see our moose friend do its thing.

“That’s crazy,” a woman in scrubs said in a video as she snapped a photo with her phone.

“This is the best. Like, what’s the code for this?” asked another bystander.

Despite security’s best efforts to shoo the moose out with barricades and offers of tasty branches, our furry friend left of its own volition, presumably irritated that his breakfast had become a spectator sport. But it didn’t go far. It hung around the front drive for a while, then went around the back of the building for a nap. What has four hooves and still doesn’t give a crap? Bob Moose-o! How you doing?
 

That click sounded stressed

How can people tell that you’re stressed? Maybe you get irritable and a little snappy. Some people have an inability to concentrate or focus. Eating that muffin when you weren’t really hungry could be a sign you’re not relaxed.

Georgijevic/E+/Getty Images

Did you know that your computer can be an indicator of your stress levels?

We tend to be working when we’re using computers, right? That can be a stressor in itself. Well, some researchers at ETH Zürich decided to have a look at the situation. Surprisingly, at least to us, one in three Swiss employees experience workplace stress, which makes us wonder what the percentage is in this country.

The Swiss researchers developed a model that tells how stressed someone is just by the way they use their computer mouse or type. The results of their study showed that those who were stressed clicked and tapped differently than participants who were more relaxed.

Stressed people click “more often and less precisely and cover longer distances on the screen,” while the relaxed take “shorter, more direct routes to reach their destination and take more time doing so,” study author Mara Nägelin explained in a written statement from ETH (Eidgenössische Technische Hochschule, or Swiss Federal Institute of Technology) Zürich.

Ever find when you’re frustrated and in a rush you end up making more mistakes? Same deal. Coauthor Jasmine Kerr noted that “increased levels of stress negatively impact our brain’s ability to process information.” Which totally is going to affect how we move.

Hopefully, these results can give insight to companies on how stressed their employees are and the effect it has on their work performance, eventually leading to, guess what, more research on how to alleviate workplace stress in general, which can benefit us all.

So if you find yourself in the office working on your computer like it’s a game of Perfection and time is running out, take a beat. Maybe try a stress-relieving breathing technique. Nonstressed people, according to the study, take fewer and longer pauses on their computers. Perfection on the job may mean relaxing first.

Pregnancies in users of combined oral contraceptives occur more often when more than two pills are missed or when missed-pill protocols are not followed, based on data from nearly 3,000 women.

Combined oral contraceptives (COCs) remain a popular method of pregnancy prevention worldwide, but efficacy and failure rates can be difficult to determine, as real-word use does not always mirror clinical trials, wrote Mitchell D. Creinin, MD, of the University of California, Davis, and colleagues. Clinical trials include perfect use or method-failure rates, but data on pregnancy risk based on reported adherence alone are lacking, they said.

To assess the effects of missed pills on COC efficacy, the researchers reviewed data from a pair of parallel phase 3 trials, focusing only on adherence to the pill dosing regimen. The findings were published in Obstetrics & Gynecology.

The study population included 1,864 individuals from the United States and Canada, and 1,553 from Europe and Russia.

The participants were healthy, sexually active adults aged 16-50 years in monogamous relationships from 2016 through 2018 who agreed to used estetrol 15 mg and drospirenone 3 mg for up to 13 28-day cycles as their only contraceptive method. Condom use was permitted for protection against sexually transmitted infections if needed. The 28-day COCs included 24 hormonal tablets and 4 placebo tablets. Participants received written instructions for what to do it they missed pills.

The primary outcome was the relationship between missed pills and pregnancies.

A total of 31 pregnancies occurred across both studies; none of these occurred during cycles in which other contraception was used. Of 22 pregnancies in participants who reported taking all pills, 21 reported daily pill use during the cycle in which pregnancy occurred. One participant reported not taking one pill and one participant reported not taking two pills; neither correctly followed the instructions for missed pills.

Pregnancies occurred in .09% of cycles in which participants reported taking all pills, and in 0.25%, 0.83%, and 1.6% of cycles in which participants reported missing one pill, two pills, or more than two pills, respectively.

“Pregnancy rates exceeded 1% only in participants who did not correctly follow missed-pill instructions,” the researchers noted.

Pregnancy rates per cycle ranged from 0% to 0.21%, and 48.4% of the pregnancies occurred during the first four cycles of COC use. Approximately one-third (32.3%) of pregnancies occurred within the first week of a new pill pack.

“Fertilization does not appear to be related to the timing of missed pills within the cycle because pregnancy did not occur more frequently earlier in the cycle (after the placebo pills),” the researchers wrote in their discussion. This finding contradicts previous research suggesting that contraceptive failure rates decrease over the first year of use, they said. In addition, the formulation of the pill used may affect pregnancy rates when pills are missed, as some hormones have longer half-lives, they noted.

The study findings were limited by several factors, including the lack of adjustment for outcomes based on reported sexual activity per cycle, and by the reliance on self-reports.

However, the results were strengthened by the use of the clinical outcomes of pregnancy as the primary outcome, rather than characteristics and predictors of participants who missed pills, the researchers said.

The cycle-based methodology used in the current study may provide insight on the relationship between COC adherence and pregnancy risk that can inform future studies, they concluded.
 

Findings highlight the importance of options

“With increasing restrictions on abortion care, offering more contraceptive options for people is critical,” Lauren Owens, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, said in an interview. “That’s not to say that having another pill option makes up for the harm people are experiencing as they navigate abortion bans and legal interference in their health care, but no one pill works for all people, and having more options is helpful,” she said.

Dr. Owens noted that the rates of pregnancy in the current study were lower than she traditionally associates with COCs, “although I usually discuss annual failure rates with patients, not failure rates per cycle, and the latter will clearly be lower.” In the current study, “The authors hypothesize some of this may be due to the longer half-life that estetrol has compared to ethinyl estradiol, the estrogen form more commonly found in oral contraceptive pills,” she said.

From a clinical standpoint, “I appreciated the linkage between number of missed pills and pregnancies occurring,” Dr. Owens said. “This is a good reminder to clinicians to talk to patients ahead of time about what to do when missed pills occur and to provide resources in advance that patients can reference when needed,” she said.

“The authors published other studies on this pill in the last year and it seems to work well and have a reasonable safety profile,” Dr. Owens told this news organization. However, “We still need to broaden the methods available to patients, particularly methods that people producing sperm can use. In the face of ongoing and escalating attacks on access to contraceptive care and abortion care, it’s more important than ever to do what we can to improve options for patients,” she said.

The study was supported by Estetra SRL, an affiliate company of Mithra Pharmaceuticals. Dr. Creinin disclosed relationships with multiple companies including Gedeon Richter, Mayne, and Organon. He disclosed serving on the advisory boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck, OLIC, Organon, and Searchlight, and serving as a consultant for Estetra SRL (including the current study), Libbs, Mayne, and Medicines360; his university department receives contraceptive research funding from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. Dr. Owens had no relevant financial conflicts to disclose.

Pregnancies in users of combined oral contraceptives occur more often when more than two pills are missed or when missed-pill protocols are not followed, based on data from nearly 3,000 women.

Combined oral contraceptives (COCs) remain a popular method of pregnancy prevention worldwide, but efficacy and failure rates can be difficult to determine, as real-word use does not always mirror clinical trials, wrote Mitchell D. Creinin, MD, of the University of California, Davis, and colleagues. Clinical trials include perfect use or method-failure rates, but data on pregnancy risk based on reported adherence alone are lacking, they said.

To assess the effects of missed pills on COC efficacy, the researchers reviewed data from a pair of parallel phase 3 trials, focusing only on adherence to the pill dosing regimen. The findings were published in Obstetrics & Gynecology.

The study population included 1,864 individuals from the United States and Canada, and 1,553 from Europe and Russia.

The participants were healthy, sexually active adults aged 16-50 years in monogamous relationships from 2016 through 2018 who agreed to used estetrol 15 mg and drospirenone 3 mg for up to 13 28-day cycles as their only contraceptive method. Condom use was permitted for protection against sexually transmitted infections if needed. The 28-day COCs included 24 hormonal tablets and 4 placebo tablets. Participants received written instructions for what to do it they missed pills.

The primary outcome was the relationship between missed pills and pregnancies.

A total of 31 pregnancies occurred across both studies; none of these occurred during cycles in which other contraception was used. Of 22 pregnancies in participants who reported taking all pills, 21 reported daily pill use during the cycle in which pregnancy occurred. One participant reported not taking one pill and one participant reported not taking two pills; neither correctly followed the instructions for missed pills.

Pregnancies occurred in .09% of cycles in which participants reported taking all pills, and in 0.25%, 0.83%, and 1.6% of cycles in which participants reported missing one pill, two pills, or more than two pills, respectively.

“Pregnancy rates exceeded 1% only in participants who did not correctly follow missed-pill instructions,” the researchers noted.

Pregnancy rates per cycle ranged from 0% to 0.21%, and 48.4% of the pregnancies occurred during the first four cycles of COC use. Approximately one-third (32.3%) of pregnancies occurred within the first week of a new pill pack.

“Fertilization does not appear to be related to the timing of missed pills within the cycle because pregnancy did not occur more frequently earlier in the cycle (after the placebo pills),” the researchers wrote in their discussion. This finding contradicts previous research suggesting that contraceptive failure rates decrease over the first year of use, they said. In addition, the formulation of the pill used may affect pregnancy rates when pills are missed, as some hormones have longer half-lives, they noted.

The study findings were limited by several factors, including the lack of adjustment for outcomes based on reported sexual activity per cycle, and by the reliance on self-reports.

However, the results were strengthened by the use of the clinical outcomes of pregnancy as the primary outcome, rather than characteristics and predictors of participants who missed pills, the researchers said.

The cycle-based methodology used in the current study may provide insight on the relationship between COC adherence and pregnancy risk that can inform future studies, they concluded.
 

Findings highlight the importance of options

“With increasing restrictions on abortion care, offering more contraceptive options for people is critical,” Lauren Owens, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, said in an interview. “That’s not to say that having another pill option makes up for the harm people are experiencing as they navigate abortion bans and legal interference in their health care, but no one pill works for all people, and having more options is helpful,” she said.

Dr. Owens noted that the rates of pregnancy in the current study were lower than she traditionally associates with COCs, “although I usually discuss annual failure rates with patients, not failure rates per cycle, and the latter will clearly be lower.” In the current study, “The authors hypothesize some of this may be due to the longer half-life that estetrol has compared to ethinyl estradiol, the estrogen form more commonly found in oral contraceptive pills,” she said.

From a clinical standpoint, “I appreciated the linkage between number of missed pills and pregnancies occurring,” Dr. Owens said. “This is a good reminder to clinicians to talk to patients ahead of time about what to do when missed pills occur and to provide resources in advance that patients can reference when needed,” she said.

“The authors published other studies on this pill in the last year and it seems to work well and have a reasonable safety profile,” Dr. Owens told this news organization. However, “We still need to broaden the methods available to patients, particularly methods that people producing sperm can use. In the face of ongoing and escalating attacks on access to contraceptive care and abortion care, it’s more important than ever to do what we can to improve options for patients,” she said.

The study was supported by Estetra SRL, an affiliate company of Mithra Pharmaceuticals. Dr. Creinin disclosed relationships with multiple companies including Gedeon Richter, Mayne, and Organon. He disclosed serving on the advisory boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck, OLIC, Organon, and Searchlight, and serving as a consultant for Estetra SRL (including the current study), Libbs, Mayne, and Medicines360; his university department receives contraceptive research funding from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. Dr. Owens had no relevant financial conflicts to disclose.

Pregnancies in users of combined oral contraceptives occur more often when more than two pills are missed or when missed-pill protocols are not followed, based on data from nearly 3,000 women.

Combined oral contraceptives (COCs) remain a popular method of pregnancy prevention worldwide, but efficacy and failure rates can be difficult to determine, as real-word use does not always mirror clinical trials, wrote Mitchell D. Creinin, MD, of the University of California, Davis, and colleagues. Clinical trials include perfect use or method-failure rates, but data on pregnancy risk based on reported adherence alone are lacking, they said.

To assess the effects of missed pills on COC efficacy, the researchers reviewed data from a pair of parallel phase 3 trials, focusing only on adherence to the pill dosing regimen. The findings were published in Obstetrics & Gynecology.

The study population included 1,864 individuals from the United States and Canada, and 1,553 from Europe and Russia.

The participants were healthy, sexually active adults aged 16-50 years in monogamous relationships from 2016 through 2018 who agreed to used estetrol 15 mg and drospirenone 3 mg for up to 13 28-day cycles as their only contraceptive method. Condom use was permitted for protection against sexually transmitted infections if needed. The 28-day COCs included 24 hormonal tablets and 4 placebo tablets. Participants received written instructions for what to do it they missed pills.

The primary outcome was the relationship between missed pills and pregnancies.

A total of 31 pregnancies occurred across both studies; none of these occurred during cycles in which other contraception was used. Of 22 pregnancies in participants who reported taking all pills, 21 reported daily pill use during the cycle in which pregnancy occurred. One participant reported not taking one pill and one participant reported not taking two pills; neither correctly followed the instructions for missed pills.

Pregnancies occurred in .09% of cycles in which participants reported taking all pills, and in 0.25%, 0.83%, and 1.6% of cycles in which participants reported missing one pill, two pills, or more than two pills, respectively.

“Pregnancy rates exceeded 1% only in participants who did not correctly follow missed-pill instructions,” the researchers noted.

Pregnancy rates per cycle ranged from 0% to 0.21%, and 48.4% of the pregnancies occurred during the first four cycles of COC use. Approximately one-third (32.3%) of pregnancies occurred within the first week of a new pill pack.

“Fertilization does not appear to be related to the timing of missed pills within the cycle because pregnancy did not occur more frequently earlier in the cycle (after the placebo pills),” the researchers wrote in their discussion. This finding contradicts previous research suggesting that contraceptive failure rates decrease over the first year of use, they said. In addition, the formulation of the pill used may affect pregnancy rates when pills are missed, as some hormones have longer half-lives, they noted.

The study findings were limited by several factors, including the lack of adjustment for outcomes based on reported sexual activity per cycle, and by the reliance on self-reports.

However, the results were strengthened by the use of the clinical outcomes of pregnancy as the primary outcome, rather than characteristics and predictors of participants who missed pills, the researchers said.

The cycle-based methodology used in the current study may provide insight on the relationship between COC adherence and pregnancy risk that can inform future studies, they concluded.
 

Findings highlight the importance of options

“With increasing restrictions on abortion care, offering more contraceptive options for people is critical,” Lauren Owens, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, said in an interview. “That’s not to say that having another pill option makes up for the harm people are experiencing as they navigate abortion bans and legal interference in their health care, but no one pill works for all people, and having more options is helpful,” she said.

Dr. Owens noted that the rates of pregnancy in the current study were lower than she traditionally associates with COCs, “although I usually discuss annual failure rates with patients, not failure rates per cycle, and the latter will clearly be lower.” In the current study, “The authors hypothesize some of this may be due to the longer half-life that estetrol has compared to ethinyl estradiol, the estrogen form more commonly found in oral contraceptive pills,” she said.

From a clinical standpoint, “I appreciated the linkage between number of missed pills and pregnancies occurring,” Dr. Owens said. “This is a good reminder to clinicians to talk to patients ahead of time about what to do when missed pills occur and to provide resources in advance that patients can reference when needed,” she said.

“The authors published other studies on this pill in the last year and it seems to work well and have a reasonable safety profile,” Dr. Owens told this news organization. However, “We still need to broaden the methods available to patients, particularly methods that people producing sperm can use. In the face of ongoing and escalating attacks on access to contraceptive care and abortion care, it’s more important than ever to do what we can to improve options for patients,” she said.

The study was supported by Estetra SRL, an affiliate company of Mithra Pharmaceuticals. Dr. Creinin disclosed relationships with multiple companies including Gedeon Richter, Mayne, and Organon. He disclosed serving on the advisory boards for Evofem, Fuji Pharma, Gedeon Richter, GlaxoSmithKline, Mayne, Merck, OLIC, Organon, and Searchlight, and serving as a consultant for Estetra SRL (including the current study), Libbs, Mayne, and Medicines360; his university department receives contraceptive research funding from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, and Sebela. Dr. Owens had no relevant financial conflicts to disclose.

In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
 

CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.

They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.

The scientific statement was published online in Circulation.
 

Look beyond traditional risk factors

“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release. 

“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.

Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.

Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.

The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.

“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.

“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
 

No one-size-fits-all approach

The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.

It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.

“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.

“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.

Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.

They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
 

CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.

They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.

The scientific statement was published online in Circulation.
 

Look beyond traditional risk factors

“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release. 

“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.

Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.

Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.

The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.

“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.

“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
 

No one-size-fits-all approach

The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.

It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.

“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.

“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.

Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.

They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
 

CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.

They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.

The scientific statement was published online in Circulation.
 

Look beyond traditional risk factors

“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release. 

“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.

Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.

Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.

The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.

“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.

“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
 

No one-size-fits-all approach

The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.

It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.

“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.

“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.

Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.

They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

Experts recommend that most adults get 7-9 hours of sleep a night. If your patient is among the roughly one-third of people who sleep less (or more), regular exercise may help them dodge possible long-term health consequences such as heart disease and early death.

Plenty of research points to sleep and physical activity as crucial factors affecting life expectancy. Regular exercise can lengthen life, while too little or too much sleep may cut it short.

But evidence is growing that exercise may counteract the negative effects of poor sleep. A 2022 study found that being physically active for at least 25 minutes a day can erase the risk of early death associated with too much sleep or trouble falling asleep. And a 2021 study found that lower levels of physical activity may exacerbate the impact of poor sleep on early death, heart disease, and cancer.

The latest such study, published in the European Journal of Preventive Cardiology, suggests that higher volumes of exercise can virtually eliminate the risk of early death associated with sleeping too little or too long.

This study is unique, the researchers say, because it used accelerometers (motion-tracking sensors) to quantify sleep and physical activity. Other studies asked participants to report their own data, opening the door to false reports and mistakes.

Some 92,000 participants in the United Kingdom (mean age, 62 years; 56% women) wore the activity trackers for a week to measure how much they moved and slept. In the following 7 years, 3,080 participants died, mostly from cardiovascular disease or cancer.

As one might expect, the participants who were least likely to die also exercised the most and slept the “normal” amount (6-8 hours a night, as defined by the study).

Compared with that group, those who exercised the least and slept less than 6 hours were 2.5 times more likely to die during those 7 years (P < .001). Less active persons who got the recommended sleep were 79% more likely to die (P < .001). The risk was slightly higher than that for those who logged more than 8 hours a night.

But those risks disappeared for short- or long-sleeping participants who logged at least 150 minutes a week of moderate to vigorous activity.

“Exercise fights inflammatory and metabolic dysregulations and abnormal sympathetic nervous system activity,” said study author Jihui Zhang, PhD, of the Affiliated Brain Hospital of Guangzhou (China). Those problems are associated with cardiovascular diseases and other potentially fatal conditions.
 

More objective data – with tech

A study’s findings are only as good as the data it relies on. That’s why obtaining objective data not influenced by individual perception is key.

“Self-report questionnaires are prone to misperception, or recall or response bias,” Dr. Zhang explains.

Take sleep, for example. Research reveals that several factors can affect how we judge our sleep. When people have to sleep at irregular times, they often underestimate how many hours they sleep but overestimate how long they nap, found a study in the Journal of Clinical Sleep Medicine.

Another study showed that when people are under a lot of stress, they’ll report more sleep problems than they actually have, as revealed by an Actiheart monitor.

With exercise, participants often report doing more exercise, and doing it at a higher intensity, than objective measurements show they did. At the same time, self-reports typically don’t account for much of the unplanned, low-effort movement people do throughout the day.
 

Staying active when you’re tired

The study raises a practical question: If you don’t get the proper amount of sleep, how are you supposed to find the time, energy, and motivation to exercise?

The solution is to use one to fix the other.

Exercise and sleep have “a robust directional relationship,” Dr. Zhang said. Exercise improves sleep, while better sleep makes it easier to stick with an exercise program.

Ideally, that program will include a mix of cardio and resistance exercise, said Mitch Duncan, PhD, a professor of public health at the University of Newcastle, Australia.

As Dr. Duncan and his co-authors showed in a recent study, “the largest benefits to health occur when people do a combination of both aerobic and muscle-strengthening activity,” Dr. Duncan said.

“In terms of benefits to sleep, there doesn’t seem to be consistent evidence that favors either as being most effective.”

The timing or intensity of exercise doesn’t seem to matter much, either.

“But there is evidence that a greater duration contributes to larger improvements in sleep,” Dr. Duncan said.

In other words, longer workouts are generally better, but they don’t necessarily have to be super-intense.

The strongest evidence of all, however, shows that recent and regular exercise offer the biggest benefits at bedtime.

Today’s workout will improve tonight’s sleep. And the better you sleep tonight, the more likely you are to stick with the program.

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