Ob.Gyn. News

The evidence is clear: Alcohol can cause cancer.

Earlier this month, US surgeon general Vivek Murthy, MD, issued an advisory, calling for alcoholic beverages to carry a warning label about cancer risk. The advisory flagged alcohol as the third leading preventable cause of cancer in the United States, after tobacco and obesity, and highlighted people’s limited awareness about the relationship between alcohol and cancer risk.

But, when it comes to cancer risk, are all types of alcohol created equal?

For many years, red wine seemed to be an outlier, with studies indicating that, in moderation, it might even be good for you. Red wine has anti-inflammatory and antioxidant properties — most notably, it contains the antioxidant resveratrol. Starting in the 1990s, research began to hint that the compound might protect against heart disease, aging, and cancer, though much of this work was done in animals or test tubes.

The idea that red wine carries health benefits, however, has been called into question more recently. A recent meta-analysis, for instance, suggests that many previous studies touting the health benefits of more moderate drinking were likely biased, potentially leading to “misleading positive health associations.” And one recent study found that alcohol consumption, largely red wine and beer, at all levels was linked to an increased risk for cardiovascular disease.

Although wine’s health halo is dwindling, there might be an exception: Cancer risk.

Overall, research shows that even light to moderate drinking increases the risk for at least seven types of cancer, but when focusing on red wine, in particular, that risk calculus can look different.

“It’s very complicated and nuanced,” said Timothy Rebbeck, PhD, professor of cancer prevention, Harvard T.H. Chan School of Public Health, Boston. “And ‘complicated and nuanced’ doesn’t work very well in public health messages.”

The Knowns About Alcohol and Cancer Risk

Some things about the relationship between alcohol and cancer risk are crystal clear. “There’s no question that alcohol is a group 1 carcinogen,” Rebbeck said. “Alcohol can cause cancer.”

Groups including the International Agency for Research on Cancer (IARC) and American Cancer Society agree that alcohol use is an established cause of seven types of cancer: Those of the oral cavity, larynx, pharynx, esophagus (squamous cell carcinoma), liver (hepatocellular carcinoma), breast, and colon/rectum. Heavy drinking — at least 8 standard drinks a week for women and 15 for men — and binge drinking — 4 or more drinks in 2 hours for women and 5 or more for men — only amplify that risk. (A “standard” drink has 14 g of alcohol, which translates to a 5-oz glass of wine.)

“We’re most concerned about high-risk drinking — more than 2 drinks a day — and/or binge drinking,” said Noelle LoConte, MD, of the Division of Hematology, Medical Oncology and Palliative Care, University of Wisconsin School of Medicine and Public Health, Madison, who authored a 2018 statement on alcohol and cancer risk from the American Society of Clinical Oncology (ASCO).

Compared with not drinking, heavy drinking is linked with a roughly fivefold increase in the risk for oral cavity, pharyngeal, and esophageal cancers, and a 61% increase in the risk for breast cancer, according to LoConte and colleagues.

Things get murkier when it comes to moderate drinking — defined as up to 1 standard drink per day for women and 2 per day for men. There is evidence, LoConte said, that moderate drinking is associated with increased cancer risks, though the magnitude is generally much less than heavier drinking.

Cancer type also matters. One analysis found that the risk for breast cancer increased with even light to moderate alcohol consumption. Compared with no drinking, light to moderate drinking has also been linked to increased risks for oral cavity, pharynx, larynx, and esophageal cancers.

As for whether the type of alcoholic beverage matters, LoConte said, there’s no clear physiological reason that wine would be less risky than beer or liquor. Research indicates that ethanol is the problematic ingredient: Once ingested, it’s metabolized into acetaldehyde, a DNA-damaging substance that’s considered a probable human carcinogen. Ethanol can also alter circulating levels of estrogens and androgens, LoConte said, which is thought to drive its association with breast cancer risk.

“It likely doesn’t matter how you choose to get your ethanol,” she said. “It’s a question of volume.”

Hints That Wine Is an Outlier

Still, some studies suggest that how people ingest ethanol could make a difference.

A study published in August in JAMA Network Open is a case in point. The study found that, among older adults, light to heavy drinkers had an increased risk of dying from cancer, compared with occasional drinkers (though the increased risk among light to moderate drinkers occurred only among people who also had chronic health conditions, such as diabetes or high blood pressure, or were of lower socioeconomic status).

Wine drinkers fared differently. Most notably, drinkers who “preferred” wine — consuming over 80% of total ethanol from wine — or those who drank only with meals showed a small reduction in their risk for cancer mortality and all-cause mortality (hazard ratio [HR], 0.94 for both). The small protective association was somewhat stronger among people who reported both patterns (HR, 0.88), especially if they were of lower socioeconomic status (HR, 0.79).

The findings are in line with other research suggesting that wine drinkers may be outliers when it comes to cancer risk. A 2023 meta-analysis of 26 observational studies, for instance, found no association between wine consumption and any cancer type, with the caveat that there was «substantial» heterogeneity among the studies.

This heterogeneity caveat speaks to the inherent limitations of observational research, said Tim Stockwell, PhD, of the Canadian Institute for Substance Use Research, University of Victoria in British Columbia, Canada.

“Individual studies of alcohol and cancer risk do find differences by type of drink, or patterns of drinking,” Stockwell said. “But it’s so hard to unpack the confounding that goes along with the type of person who’s a wine drinker or a beer drinker or a spirit drinker. The beverage of choice seems to come with a lot of baggage.”

Compared with people who favor beer or liquor, he noted, wine aficionados are typically higher-income, exercise more often, smoke less, and have different diets, for example. The “best” studies, Rebbeck said, try to adjust for those differences, but it’s challenging.

The authors of the 2023 meta-analysis noted that “many components in wine could have anticarcinogenic effects” that theoretically could counter the ill effects of ethanol. Besides resveratrol, which is mainly found in red wine, the list includes anthocyanins, quercetin, and tannins. However, the authors also acknowledged that they couldn’t account for whether other lifestyle habits might explain why wine drinkers, overall, showed no increased cancer risks and sometimes lower risks.

Still, groups such as the IARC and ASCO hold that there is no known “safe” level, or type, of alcohol when it comes to cancer.

In the latest Canadian guidelines on alcohol use, the scientific panel calculated that people who have 6 drinks a week throughout adulthood (whatever the source of the alcohol) could shave 11 weeks from their life expectancy, on average, said Stockwell, who was on the guideline panel. Compare that with heavy drinking, where 4 drinks a day could rob the average person of 2 or 3 years. “If you’re drinking a lot, you could get huge benefits from cutting down,” Stockwell explained. “If you’re a moderate drinker, the benefits would obviously be less.”

Stockwell said that choices around drinking and breast cancer risk, specifically, can be “tough.” Unlike many of the other alcohol-associated cancers, he noted, breast cancer is common — so even small relative risk increases may be concerning. Based on a 2020 meta-analysis of 22 cohort studies, the risk for breast cancer rises by about 10%, on average, for every 10 g of alcohol a woman drinks per day. This study also found no evidence that wine is any different from other types of alcohol.

In real life, the calculus around wine consumption and cancer risk will probably vary widely from person to person, Rebbeck said. One woman with a family history of breast cancer might decide that having wine with dinner isn’t worth it. Another with the same family history might see that glass of wine as a stress reliever and opt to focus on other ways to reduce her breast cancer risk — by exercising and maintaining a healthy weight, for example.

“The bottom line is, in human studies, the data on light to moderate drinking and cancer are limited and messy, and you can’t draw firm conclusions from them,” Rebbeck said. “It probably raises risk in some people, but we don’t know who those people are. And the risk increases are relatively small.”

A Conversation Few Are Having

Even with many studies highlighting the connection between alcohol consumption and cancer risk, most people remain unaware about this risk.

A 2023 study by the National Cancer Institute found that only a minority of US adults knew that drinking alcohol is linked to increased cancer risk, and they were much less likely to say that was true of wine: Only 20% did, vs 31% who said that liquor can boost cancer risk. Meanwhile, 10% believed that wine helps prevent cancer. Other studies show that even among cancer survivors and patients undergoing active cancer treatment, many drink — often heavily.

“What we know right now is, physicians almost never talk about this,” LoConte said.

That could be due to time constraints, according to Rebbeck, or clinicians’ perceptions that the subject is too complicated and/or their own confusion about the data. There could also be some “cognitive dissonance” at play, LoConte noted, because many doctors drink alcohol.

It’s critical, she said, that conversations about drinking habits become “normalized,” and that should include informing patients that alcohol use is associated with certain cancers. Again, LoConte said, it’s high-risk drinking that’s most concerning and where reducing intake could have the biggest impact on cancer risk and other health outcomes.

“From a cancer prevention standpoint, it’s probably best not to drink,” she said. “But people don’t make choices based solely on cancer risk. We don’t want to come out with recommendations saying no one should drink. I don’t think the data support that, and people would buck against that advice.”

Rebbeck made a similar point. Even if there’s uncertainty about the risks for a daily glass of wine, he said, people can use that information to make decisions. “Everybody’s preferences and choices are going to be different,” Rebbeck said. “And that’s all we can really do.”

A version of this article appeared on Medscape.com.

The evidence is clear: Alcohol can cause cancer.

Earlier this month, US surgeon general Vivek Murthy, MD, issued an advisory, calling for alcoholic beverages to carry a warning label about cancer risk. The advisory flagged alcohol as the third leading preventable cause of cancer in the United States, after tobacco and obesity, and highlighted people’s limited awareness about the relationship between alcohol and cancer risk.

But, when it comes to cancer risk, are all types of alcohol created equal?

For many years, red wine seemed to be an outlier, with studies indicating that, in moderation, it might even be good for you. Red wine has anti-inflammatory and antioxidant properties — most notably, it contains the antioxidant resveratrol. Starting in the 1990s, research began to hint that the compound might protect against heart disease, aging, and cancer, though much of this work was done in animals or test tubes.

The idea that red wine carries health benefits, however, has been called into question more recently. A recent meta-analysis, for instance, suggests that many previous studies touting the health benefits of more moderate drinking were likely biased, potentially leading to “misleading positive health associations.” And one recent study found that alcohol consumption, largely red wine and beer, at all levels was linked to an increased risk for cardiovascular disease.

Although wine’s health halo is dwindling, there might be an exception: Cancer risk.

Overall, research shows that even light to moderate drinking increases the risk for at least seven types of cancer, but when focusing on red wine, in particular, that risk calculus can look different.

“It’s very complicated and nuanced,” said Timothy Rebbeck, PhD, professor of cancer prevention, Harvard T.H. Chan School of Public Health, Boston. “And ‘complicated and nuanced’ doesn’t work very well in public health messages.”

The Knowns About Alcohol and Cancer Risk

Some things about the relationship between alcohol and cancer risk are crystal clear. “There’s no question that alcohol is a group 1 carcinogen,” Rebbeck said. “Alcohol can cause cancer.”

Groups including the International Agency for Research on Cancer (IARC) and American Cancer Society agree that alcohol use is an established cause of seven types of cancer: Those of the oral cavity, larynx, pharynx, esophagus (squamous cell carcinoma), liver (hepatocellular carcinoma), breast, and colon/rectum. Heavy drinking — at least 8 standard drinks a week for women and 15 for men — and binge drinking — 4 or more drinks in 2 hours for women and 5 or more for men — only amplify that risk. (A “standard” drink has 14 g of alcohol, which translates to a 5-oz glass of wine.)

“We’re most concerned about high-risk drinking — more than 2 drinks a day — and/or binge drinking,” said Noelle LoConte, MD, of the Division of Hematology, Medical Oncology and Palliative Care, University of Wisconsin School of Medicine and Public Health, Madison, who authored a 2018 statement on alcohol and cancer risk from the American Society of Clinical Oncology (ASCO).

Compared with not drinking, heavy drinking is linked with a roughly fivefold increase in the risk for oral cavity, pharyngeal, and esophageal cancers, and a 61% increase in the risk for breast cancer, according to LoConte and colleagues.

Things get murkier when it comes to moderate drinking — defined as up to 1 standard drink per day for women and 2 per day for men. There is evidence, LoConte said, that moderate drinking is associated with increased cancer risks, though the magnitude is generally much less than heavier drinking.

Cancer type also matters. One analysis found that the risk for breast cancer increased with even light to moderate alcohol consumption. Compared with no drinking, light to moderate drinking has also been linked to increased risks for oral cavity, pharynx, larynx, and esophageal cancers.

As for whether the type of alcoholic beverage matters, LoConte said, there’s no clear physiological reason that wine would be less risky than beer or liquor. Research indicates that ethanol is the problematic ingredient: Once ingested, it’s metabolized into acetaldehyde, a DNA-damaging substance that’s considered a probable human carcinogen. Ethanol can also alter circulating levels of estrogens and androgens, LoConte said, which is thought to drive its association with breast cancer risk.

“It likely doesn’t matter how you choose to get your ethanol,” she said. “It’s a question of volume.”

Hints That Wine Is an Outlier

Still, some studies suggest that how people ingest ethanol could make a difference.

A study published in August in JAMA Network Open is a case in point. The study found that, among older adults, light to heavy drinkers had an increased risk of dying from cancer, compared with occasional drinkers (though the increased risk among light to moderate drinkers occurred only among people who also had chronic health conditions, such as diabetes or high blood pressure, or were of lower socioeconomic status).

Wine drinkers fared differently. Most notably, drinkers who “preferred” wine — consuming over 80% of total ethanol from wine — or those who drank only with meals showed a small reduction in their risk for cancer mortality and all-cause mortality (hazard ratio [HR], 0.94 for both). The small protective association was somewhat stronger among people who reported both patterns (HR, 0.88), especially if they were of lower socioeconomic status (HR, 0.79).

The findings are in line with other research suggesting that wine drinkers may be outliers when it comes to cancer risk. A 2023 meta-analysis of 26 observational studies, for instance, found no association between wine consumption and any cancer type, with the caveat that there was «substantial» heterogeneity among the studies.

This heterogeneity caveat speaks to the inherent limitations of observational research, said Tim Stockwell, PhD, of the Canadian Institute for Substance Use Research, University of Victoria in British Columbia, Canada.

“Individual studies of alcohol and cancer risk do find differences by type of drink, or patterns of drinking,” Stockwell said. “But it’s so hard to unpack the confounding that goes along with the type of person who’s a wine drinker or a beer drinker or a spirit drinker. The beverage of choice seems to come with a lot of baggage.”

Compared with people who favor beer or liquor, he noted, wine aficionados are typically higher-income, exercise more often, smoke less, and have different diets, for example. The “best” studies, Rebbeck said, try to adjust for those differences, but it’s challenging.

The authors of the 2023 meta-analysis noted that “many components in wine could have anticarcinogenic effects” that theoretically could counter the ill effects of ethanol. Besides resveratrol, which is mainly found in red wine, the list includes anthocyanins, quercetin, and tannins. However, the authors also acknowledged that they couldn’t account for whether other lifestyle habits might explain why wine drinkers, overall, showed no increased cancer risks and sometimes lower risks.

Still, groups such as the IARC and ASCO hold that there is no known “safe” level, or type, of alcohol when it comes to cancer.

In the latest Canadian guidelines on alcohol use, the scientific panel calculated that people who have 6 drinks a week throughout adulthood (whatever the source of the alcohol) could shave 11 weeks from their life expectancy, on average, said Stockwell, who was on the guideline panel. Compare that with heavy drinking, where 4 drinks a day could rob the average person of 2 or 3 years. “If you’re drinking a lot, you could get huge benefits from cutting down,” Stockwell explained. “If you’re a moderate drinker, the benefits would obviously be less.”

Stockwell said that choices around drinking and breast cancer risk, specifically, can be “tough.” Unlike many of the other alcohol-associated cancers, he noted, breast cancer is common — so even small relative risk increases may be concerning. Based on a 2020 meta-analysis of 22 cohort studies, the risk for breast cancer rises by about 10%, on average, for every 10 g of alcohol a woman drinks per day. This study also found no evidence that wine is any different from other types of alcohol.

In real life, the calculus around wine consumption and cancer risk will probably vary widely from person to person, Rebbeck said. One woman with a family history of breast cancer might decide that having wine with dinner isn’t worth it. Another with the same family history might see that glass of wine as a stress reliever and opt to focus on other ways to reduce her breast cancer risk — by exercising and maintaining a healthy weight, for example.

“The bottom line is, in human studies, the data on light to moderate drinking and cancer are limited and messy, and you can’t draw firm conclusions from them,” Rebbeck said. “It probably raises risk in some people, but we don’t know who those people are. And the risk increases are relatively small.”

A Conversation Few Are Having

Even with many studies highlighting the connection between alcohol consumption and cancer risk, most people remain unaware about this risk.

A 2023 study by the National Cancer Institute found that only a minority of US adults knew that drinking alcohol is linked to increased cancer risk, and they were much less likely to say that was true of wine: Only 20% did, vs 31% who said that liquor can boost cancer risk. Meanwhile, 10% believed that wine helps prevent cancer. Other studies show that even among cancer survivors and patients undergoing active cancer treatment, many drink — often heavily.

“What we know right now is, physicians almost never talk about this,” LoConte said.

That could be due to time constraints, according to Rebbeck, or clinicians’ perceptions that the subject is too complicated and/or their own confusion about the data. There could also be some “cognitive dissonance” at play, LoConte noted, because many doctors drink alcohol.

It’s critical, she said, that conversations about drinking habits become “normalized,” and that should include informing patients that alcohol use is associated with certain cancers. Again, LoConte said, it’s high-risk drinking that’s most concerning and where reducing intake could have the biggest impact on cancer risk and other health outcomes.

“From a cancer prevention standpoint, it’s probably best not to drink,” she said. “But people don’t make choices based solely on cancer risk. We don’t want to come out with recommendations saying no one should drink. I don’t think the data support that, and people would buck against that advice.”

Rebbeck made a similar point. Even if there’s uncertainty about the risks for a daily glass of wine, he said, people can use that information to make decisions. “Everybody’s preferences and choices are going to be different,” Rebbeck said. “And that’s all we can really do.”

A version of this article appeared on Medscape.com.

The evidence is clear: Alcohol can cause cancer.

Earlier this month, US surgeon general Vivek Murthy, MD, issued an advisory, calling for alcoholic beverages to carry a warning label about cancer risk. The advisory flagged alcohol as the third leading preventable cause of cancer in the United States, after tobacco and obesity, and highlighted people’s limited awareness about the relationship between alcohol and cancer risk.

But, when it comes to cancer risk, are all types of alcohol created equal?

For many years, red wine seemed to be an outlier, with studies indicating that, in moderation, it might even be good for you. Red wine has anti-inflammatory and antioxidant properties — most notably, it contains the antioxidant resveratrol. Starting in the 1990s, research began to hint that the compound might protect against heart disease, aging, and cancer, though much of this work was done in animals or test tubes.

The idea that red wine carries health benefits, however, has been called into question more recently. A recent meta-analysis, for instance, suggests that many previous studies touting the health benefits of more moderate drinking were likely biased, potentially leading to “misleading positive health associations.” And one recent study found that alcohol consumption, largely red wine and beer, at all levels was linked to an increased risk for cardiovascular disease.

Although wine’s health halo is dwindling, there might be an exception: Cancer risk.

Overall, research shows that even light to moderate drinking increases the risk for at least seven types of cancer, but when focusing on red wine, in particular, that risk calculus can look different.

“It’s very complicated and nuanced,” said Timothy Rebbeck, PhD, professor of cancer prevention, Harvard T.H. Chan School of Public Health, Boston. “And ‘complicated and nuanced’ doesn’t work very well in public health messages.”

The Knowns About Alcohol and Cancer Risk

Some things about the relationship between alcohol and cancer risk are crystal clear. “There’s no question that alcohol is a group 1 carcinogen,” Rebbeck said. “Alcohol can cause cancer.”

Groups including the International Agency for Research on Cancer (IARC) and American Cancer Society agree that alcohol use is an established cause of seven types of cancer: Those of the oral cavity, larynx, pharynx, esophagus (squamous cell carcinoma), liver (hepatocellular carcinoma), breast, and colon/rectum. Heavy drinking — at least 8 standard drinks a week for women and 15 for men — and binge drinking — 4 or more drinks in 2 hours for women and 5 or more for men — only amplify that risk. (A “standard” drink has 14 g of alcohol, which translates to a 5-oz glass of wine.)

“We’re most concerned about high-risk drinking — more than 2 drinks a day — and/or binge drinking,” said Noelle LoConte, MD, of the Division of Hematology, Medical Oncology and Palliative Care, University of Wisconsin School of Medicine and Public Health, Madison, who authored a 2018 statement on alcohol and cancer risk from the American Society of Clinical Oncology (ASCO).

Compared with not drinking, heavy drinking is linked with a roughly fivefold increase in the risk for oral cavity, pharyngeal, and esophageal cancers, and a 61% increase in the risk for breast cancer, according to LoConte and colleagues.

Things get murkier when it comes to moderate drinking — defined as up to 1 standard drink per day for women and 2 per day for men. There is evidence, LoConte said, that moderate drinking is associated with increased cancer risks, though the magnitude is generally much less than heavier drinking.

Cancer type also matters. One analysis found that the risk for breast cancer increased with even light to moderate alcohol consumption. Compared with no drinking, light to moderate drinking has also been linked to increased risks for oral cavity, pharynx, larynx, and esophageal cancers.

As for whether the type of alcoholic beverage matters, LoConte said, there’s no clear physiological reason that wine would be less risky than beer or liquor. Research indicates that ethanol is the problematic ingredient: Once ingested, it’s metabolized into acetaldehyde, a DNA-damaging substance that’s considered a probable human carcinogen. Ethanol can also alter circulating levels of estrogens and androgens, LoConte said, which is thought to drive its association with breast cancer risk.

“It likely doesn’t matter how you choose to get your ethanol,” she said. “It’s a question of volume.”

Hints That Wine Is an Outlier

Still, some studies suggest that how people ingest ethanol could make a difference.

A study published in August in JAMA Network Open is a case in point. The study found that, among older adults, light to heavy drinkers had an increased risk of dying from cancer, compared with occasional drinkers (though the increased risk among light to moderate drinkers occurred only among people who also had chronic health conditions, such as diabetes or high blood pressure, or were of lower socioeconomic status).

Wine drinkers fared differently. Most notably, drinkers who “preferred” wine — consuming over 80% of total ethanol from wine — or those who drank only with meals showed a small reduction in their risk for cancer mortality and all-cause mortality (hazard ratio [HR], 0.94 for both). The small protective association was somewhat stronger among people who reported both patterns (HR, 0.88), especially if they were of lower socioeconomic status (HR, 0.79).

The findings are in line with other research suggesting that wine drinkers may be outliers when it comes to cancer risk. A 2023 meta-analysis of 26 observational studies, for instance, found no association between wine consumption and any cancer type, with the caveat that there was «substantial» heterogeneity among the studies.

This heterogeneity caveat speaks to the inherent limitations of observational research, said Tim Stockwell, PhD, of the Canadian Institute for Substance Use Research, University of Victoria in British Columbia, Canada.

“Individual studies of alcohol and cancer risk do find differences by type of drink, or patterns of drinking,” Stockwell said. “But it’s so hard to unpack the confounding that goes along with the type of person who’s a wine drinker or a beer drinker or a spirit drinker. The beverage of choice seems to come with a lot of baggage.”

Compared with people who favor beer or liquor, he noted, wine aficionados are typically higher-income, exercise more often, smoke less, and have different diets, for example. The “best” studies, Rebbeck said, try to adjust for those differences, but it’s challenging.

The authors of the 2023 meta-analysis noted that “many components in wine could have anticarcinogenic effects” that theoretically could counter the ill effects of ethanol. Besides resveratrol, which is mainly found in red wine, the list includes anthocyanins, quercetin, and tannins. However, the authors also acknowledged that they couldn’t account for whether other lifestyle habits might explain why wine drinkers, overall, showed no increased cancer risks and sometimes lower risks.

Still, groups such as the IARC and ASCO hold that there is no known “safe” level, or type, of alcohol when it comes to cancer.

In the latest Canadian guidelines on alcohol use, the scientific panel calculated that people who have 6 drinks a week throughout adulthood (whatever the source of the alcohol) could shave 11 weeks from their life expectancy, on average, said Stockwell, who was on the guideline panel. Compare that with heavy drinking, where 4 drinks a day could rob the average person of 2 or 3 years. “If you’re drinking a lot, you could get huge benefits from cutting down,” Stockwell explained. “If you’re a moderate drinker, the benefits would obviously be less.”

Stockwell said that choices around drinking and breast cancer risk, specifically, can be “tough.” Unlike many of the other alcohol-associated cancers, he noted, breast cancer is common — so even small relative risk increases may be concerning. Based on a 2020 meta-analysis of 22 cohort studies, the risk for breast cancer rises by about 10%, on average, for every 10 g of alcohol a woman drinks per day. This study also found no evidence that wine is any different from other types of alcohol.

In real life, the calculus around wine consumption and cancer risk will probably vary widely from person to person, Rebbeck said. One woman with a family history of breast cancer might decide that having wine with dinner isn’t worth it. Another with the same family history might see that glass of wine as a stress reliever and opt to focus on other ways to reduce her breast cancer risk — by exercising and maintaining a healthy weight, for example.

“The bottom line is, in human studies, the data on light to moderate drinking and cancer are limited and messy, and you can’t draw firm conclusions from them,” Rebbeck said. “It probably raises risk in some people, but we don’t know who those people are. And the risk increases are relatively small.”

A Conversation Few Are Having

Even with many studies highlighting the connection between alcohol consumption and cancer risk, most people remain unaware about this risk.

A 2023 study by the National Cancer Institute found that only a minority of US adults knew that drinking alcohol is linked to increased cancer risk, and they were much less likely to say that was true of wine: Only 20% did, vs 31% who said that liquor can boost cancer risk. Meanwhile, 10% believed that wine helps prevent cancer. Other studies show that even among cancer survivors and patients undergoing active cancer treatment, many drink — often heavily.

“What we know right now is, physicians almost never talk about this,” LoConte said.

That could be due to time constraints, according to Rebbeck, or clinicians’ perceptions that the subject is too complicated and/or their own confusion about the data. There could also be some “cognitive dissonance” at play, LoConte noted, because many doctors drink alcohol.

It’s critical, she said, that conversations about drinking habits become “normalized,” and that should include informing patients that alcohol use is associated with certain cancers. Again, LoConte said, it’s high-risk drinking that’s most concerning and where reducing intake could have the biggest impact on cancer risk and other health outcomes.

“From a cancer prevention standpoint, it’s probably best not to drink,” she said. “But people don’t make choices based solely on cancer risk. We don’t want to come out with recommendations saying no one should drink. I don’t think the data support that, and people would buck against that advice.”

Rebbeck made a similar point. Even if there’s uncertainty about the risks for a daily glass of wine, he said, people can use that information to make decisions. “Everybody’s preferences and choices are going to be different,” Rebbeck said. “And that’s all we can really do.”

A version of this article appeared on Medscape.com.

New data link higher county-level radon exposure to gestational diabetes (GD) in women who haven’t previously given birth, emphasizing the need to consider environmental risks in maternal and fetal healthcare.

Yijia Zhang, PhD, with the Department of Obstetrics and Gynecology, Vagelos College of Physicians and Surgeons at Columbia University Irving Medical Center in New York, and colleagues found in a study of 9107 nulliparous pregnant women that those living in US counties with higher radon levels (2 picocuries [pCi]/L) had higher odds of developing GD than those in counties with lower (< 1 pCi/L) radon levels (odds ratio [OR], 1.37; 95% CI, 1.02-1.84.) The researchers used three radon categories, and the middle level was 1 to < 2 pCi/L.

Findings were published online on January 10 in JAMA Network Open. The researchers used data from The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), a multicenter, prospective cohort study that examines factors associated with pregnancy-related outcomes.

“To our knowledge, this is the first study to examine the association between radon exposure and the risk of GD,” the authors wrote.

The researchers also found higher odds of GD in women who had ever smoked who lived in counties with a higher (2 pCi/L) radon level (OR, 2.09; 95% CI, 1.41-3.11) and women living in counties with both higher radon and fine particulate matter air pollutants (PM2.5) levels (OR, 1.93; 95% CI, 1.31-2.83), though no statistically significant interactions were observed. 

 

GD Affects 10% of Pregnancies

GD affects about 10% of pregnancies every year in the United States, according to the Centers for Disease Control and Prevention, and can affect women and offspring long term as it raises mothers’ risk of type 2 diabetes and cardiovascular disease and raises the risk for childhood obesity. Radon exposure’s link with lung cancer risk has been well established, but its link to other health risks is uncertain, the authors note.

The authors said their findings are hypothesis-generating and said, “It is vital to conduct studies that incorporate individual-level indoor radon exposure data,” to get closer to understanding the underlying mechanisms.

 

Individual-Level Exposure Measures Needed

They note that the average radon level in a county might not reflect an individual’s exposure and individual-level residential factors involved with radon exposure, such as household mitigation, and whether a dwelling has a basement, for instance, “are crucial for enhancing the precision of exposure assessment.”

In an invited commentary, Alberto Ruano-Ravina, PhD, and Lucía Martín-Gisbert, MSc, both with the Department of Preventive Medicine and Public Health at the University of Santiago de Compostela in Galicia, Spain, also urged that individual-level studies be conducted to further investigate radon’s link to health risks, noting that “[r]adon is possibly the most prevalent indoor carcinogen to which human beings are exposed.”

“There is no reason for not having these studies once we have some evidence of an association from ecological studies,” they wrote. They point out that reliable radon assessments are easy and inexpensive.

“The potential association of radon exposure with gestational diabetes or any other disease should be better analyzed using exclusively radon-prone areas. An observance of a dose-response effect may be indicative of a causal relationship, and it could be easily evidenced in radon-prone areas should such a relationship exist,” the commenters wrote.

Such areas have low, medium, high, and extremely high concentration levels, the commenters wrote. Zhang’s team, they point out, had to use only three exposure levels because the number of residents in high-exposure areas (exceeding 3 pCi/L) was too small.

“It is time now to move forward and really understand the full implications of radon exposure for health,” they concluded.

One coauthor reported serving on the board of directors for Merck for Mothers and as a board member for March for Moms outside the submitted work. One coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Institutes of Health (NIH) during the conduct of the study. Four coauthors reported grants from the NIH during the conduct of the study. One coauthor reported grants from the NIH during the conduct of the study and being a cofounder of Naima Health and receiving personal fees from Organon outside the submitted work. Both commenters reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

New data link higher county-level radon exposure to gestational diabetes (GD) in women who haven’t previously given birth, emphasizing the need to consider environmental risks in maternal and fetal healthcare.

Yijia Zhang, PhD, with the Department of Obstetrics and Gynecology, Vagelos College of Physicians and Surgeons at Columbia University Irving Medical Center in New York, and colleagues found in a study of 9107 nulliparous pregnant women that those living in US counties with higher radon levels (2 picocuries [pCi]/L) had higher odds of developing GD than those in counties with lower (< 1 pCi/L) radon levels (odds ratio [OR], 1.37; 95% CI, 1.02-1.84.) The researchers used three radon categories, and the middle level was 1 to < 2 pCi/L.

Findings were published online on January 10 in JAMA Network Open. The researchers used data from The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), a multicenter, prospective cohort study that examines factors associated with pregnancy-related outcomes.

“To our knowledge, this is the first study to examine the association between radon exposure and the risk of GD,” the authors wrote.

The researchers also found higher odds of GD in women who had ever smoked who lived in counties with a higher (2 pCi/L) radon level (OR, 2.09; 95% CI, 1.41-3.11) and women living in counties with both higher radon and fine particulate matter air pollutants (PM2.5) levels (OR, 1.93; 95% CI, 1.31-2.83), though no statistically significant interactions were observed. 

 

GD Affects 10% of Pregnancies

GD affects about 10% of pregnancies every year in the United States, according to the Centers for Disease Control and Prevention, and can affect women and offspring long term as it raises mothers’ risk of type 2 diabetes and cardiovascular disease and raises the risk for childhood obesity. Radon exposure’s link with lung cancer risk has been well established, but its link to other health risks is uncertain, the authors note.

The authors said their findings are hypothesis-generating and said, “It is vital to conduct studies that incorporate individual-level indoor radon exposure data,” to get closer to understanding the underlying mechanisms.

 

Individual-Level Exposure Measures Needed

They note that the average radon level in a county might not reflect an individual’s exposure and individual-level residential factors involved with radon exposure, such as household mitigation, and whether a dwelling has a basement, for instance, “are crucial for enhancing the precision of exposure assessment.”

In an invited commentary, Alberto Ruano-Ravina, PhD, and Lucía Martín-Gisbert, MSc, both with the Department of Preventive Medicine and Public Health at the University of Santiago de Compostela in Galicia, Spain, also urged that individual-level studies be conducted to further investigate radon’s link to health risks, noting that “[r]adon is possibly the most prevalent indoor carcinogen to which human beings are exposed.”

“There is no reason for not having these studies once we have some evidence of an association from ecological studies,” they wrote. They point out that reliable radon assessments are easy and inexpensive.

“The potential association of radon exposure with gestational diabetes or any other disease should be better analyzed using exclusively radon-prone areas. An observance of a dose-response effect may be indicative of a causal relationship, and it could be easily evidenced in radon-prone areas should such a relationship exist,” the commenters wrote.

Such areas have low, medium, high, and extremely high concentration levels, the commenters wrote. Zhang’s team, they point out, had to use only three exposure levels because the number of residents in high-exposure areas (exceeding 3 pCi/L) was too small.

“It is time now to move forward and really understand the full implications of radon exposure for health,” they concluded.

One coauthor reported serving on the board of directors for Merck for Mothers and as a board member for March for Moms outside the submitted work. One coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Institutes of Health (NIH) during the conduct of the study. Four coauthors reported grants from the NIH during the conduct of the study. One coauthor reported grants from the NIH during the conduct of the study and being a cofounder of Naima Health and receiving personal fees from Organon outside the submitted work. Both commenters reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

New data link higher county-level radon exposure to gestational diabetes (GD) in women who haven’t previously given birth, emphasizing the need to consider environmental risks in maternal and fetal healthcare.

Yijia Zhang, PhD, with the Department of Obstetrics and Gynecology, Vagelos College of Physicians and Surgeons at Columbia University Irving Medical Center in New York, and colleagues found in a study of 9107 nulliparous pregnant women that those living in US counties with higher radon levels (2 picocuries [pCi]/L) had higher odds of developing GD than those in counties with lower (< 1 pCi/L) radon levels (odds ratio [OR], 1.37; 95% CI, 1.02-1.84.) The researchers used three radon categories, and the middle level was 1 to < 2 pCi/L.

Findings were published online on January 10 in JAMA Network Open. The researchers used data from The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), a multicenter, prospective cohort study that examines factors associated with pregnancy-related outcomes.

“To our knowledge, this is the first study to examine the association between radon exposure and the risk of GD,” the authors wrote.

The researchers also found higher odds of GD in women who had ever smoked who lived in counties with a higher (2 pCi/L) radon level (OR, 2.09; 95% CI, 1.41-3.11) and women living in counties with both higher radon and fine particulate matter air pollutants (PM2.5) levels (OR, 1.93; 95% CI, 1.31-2.83), though no statistically significant interactions were observed. 

 

GD Affects 10% of Pregnancies

GD affects about 10% of pregnancies every year in the United States, according to the Centers for Disease Control and Prevention, and can affect women and offspring long term as it raises mothers’ risk of type 2 diabetes and cardiovascular disease and raises the risk for childhood obesity. Radon exposure’s link with lung cancer risk has been well established, but its link to other health risks is uncertain, the authors note.

The authors said their findings are hypothesis-generating and said, “It is vital to conduct studies that incorporate individual-level indoor radon exposure data,” to get closer to understanding the underlying mechanisms.

 

Individual-Level Exposure Measures Needed

They note that the average radon level in a county might not reflect an individual’s exposure and individual-level residential factors involved with radon exposure, such as household mitigation, and whether a dwelling has a basement, for instance, “are crucial for enhancing the precision of exposure assessment.”

In an invited commentary, Alberto Ruano-Ravina, PhD, and Lucía Martín-Gisbert, MSc, both with the Department of Preventive Medicine and Public Health at the University of Santiago de Compostela in Galicia, Spain, also urged that individual-level studies be conducted to further investigate radon’s link to health risks, noting that “[r]adon is possibly the most prevalent indoor carcinogen to which human beings are exposed.”

“There is no reason for not having these studies once we have some evidence of an association from ecological studies,” they wrote. They point out that reliable radon assessments are easy and inexpensive.

“The potential association of radon exposure with gestational diabetes or any other disease should be better analyzed using exclusively radon-prone areas. An observance of a dose-response effect may be indicative of a causal relationship, and it could be easily evidenced in radon-prone areas should such a relationship exist,” the commenters wrote.

Such areas have low, medium, high, and extremely high concentration levels, the commenters wrote. Zhang’s team, they point out, had to use only three exposure levels because the number of residents in high-exposure areas (exceeding 3 pCi/L) was too small.

“It is time now to move forward and really understand the full implications of radon exposure for health,” they concluded.

One coauthor reported serving on the board of directors for Merck for Mothers and as a board member for March for Moms outside the submitted work. One coauthor reported grants from the National Heart, Lung, and Blood Institute and the National Institutes of Health (NIH) during the conduct of the study. Four coauthors reported grants from the NIH during the conduct of the study. One coauthor reported grants from the NIH during the conduct of the study and being a cofounder of Naima Health and receiving personal fees from Organon outside the submitted work. Both commenters reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

I want to talk about something that’s extremely controversial, but something that needs public discussion, in my view, as sometimes it doesn’t get the attention it deserves. That is: Are you ever too old to become a parent? 

In my experience, this topic comes up when women — often, single women — decide that they haven’t had a child and they consider pursuing fertility services using in vitro fertilization, donor sperm, a younger woman’s egg, or an egg they’ve preserved, and they say they’d like to have a child. 

I don’t have any huge objection to a younger woman with good health and energy trying to pursue parenting, but we’ve seen women try to do this in their 60s. It does seem to me, biologically, that is a high risk for anyone to undertake a pregnancy at that age. I think there’s agreement from obstetricians that they’re high risk. 

I think it’s dangerous, if you’re going to be the single parent at that age, that you may wind up entering a nursing home by the time your child enters, say, high school. In thinking about parenting, sure, we want to think about our own values and what we want, and normally, people don’t tell us what to do. I’m not calling for any legislation here. I’m calling for an ethical discussion about the rights and wrongs of parenting at older age. 

In response to the case I made against single women over age 60 trying to have children, it’s often brought up to me that men do it. Recently, there was a story about Al Pacino, who had a kid — I think he’s now 84, so he must have had the child at 83.

In an interview with Newsweek, he said he had this child with his ex, who was 30, a woman named Noor Alfallah. He also said he doesn’t see the child very much. He communicates mainly with that child as a co-parent through digital texting and internet contact. He said he uses video basically as a parent.

Why that is, I’m not sure. Did he have a falling out with his ex and has he been excluded? Is he in poor health such that he can’t really do parenting anymore? 

I cite his case, and there are many other celebrities that we’ve heard about over the years who’ve had kids in their 80s, such as the former talk show host Larry King and, I believe, Clint Eastwood. There are cases that hit the news all the time about older men.

I think the same question should apply ethically. Again, I’m not saying we’re going to ban it or outlaw it, but it’s something we have to discuss and think through. I think doctors involved in helping a very old parent should raise the questions so that people can at least discuss them.

If you’re going to have a kid at 84, it means you’re not going to be around in any competent way by the time the kid hits high school. I’m not sure that’s in the child’s best interest. Certainly, there is the case that a younger woman could adequately raise the kid, but if something happens to her, you’re not going to be around in that age category to parent at all. 

It’s also the case that older parents, if you’re using your sperm, may have the same issues as women, whose eggs age in their late 30s into their 40s; you’re more likely to transmit a genetic disease. We don’t talk about it often, but it is a fact that someone who’s thinking about parenting either naturally or using infertility techniques really should be responsible and think about it.

Bottom line: Am I going to say we should let Congress or a state legislature step in and say, you’re going to go to jail if you have a kid at age X? No. Ethics is there for a reason; it’s trying to make sure that you don’t do things that harm or hurt the interests of a kid. 

If two older people have a child and they’re not likely to be there for a crucial period — say, the teenage years — and they haven’t made provisions for the care of the child, if both die, that’s a problem. 

If one person who’s very old tries to do it, they’re not likely to be alive and/or in good health when the kid enters puberty or into the teenage years; that’s something that you have to think about. Am I doing this because I’m just going to do what I want to do, or am I going to really look out for the best interests of any child I might create? 

This is food for thought about the question of when anyone is too old to parent. I know that’s partly determined by partner, resources, and many other variables, but I don’t believe that we should ignore the discussion of the ethics of the decision just out of respect for the idea that we’re not going to legislate.

Dr. Caplan is with the Division of Medical Ethics at New York University’s Grossman School of Medicine. He has disclosed relevant financial relationships with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and Medscape.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

I want to talk about something that’s extremely controversial, but something that needs public discussion, in my view, as sometimes it doesn’t get the attention it deserves. That is: Are you ever too old to become a parent? 

In my experience, this topic comes up when women — often, single women — decide that they haven’t had a child and they consider pursuing fertility services using in vitro fertilization, donor sperm, a younger woman’s egg, or an egg they’ve preserved, and they say they’d like to have a child. 

I don’t have any huge objection to a younger woman with good health and energy trying to pursue parenting, but we’ve seen women try to do this in their 60s. It does seem to me, biologically, that is a high risk for anyone to undertake a pregnancy at that age. I think there’s agreement from obstetricians that they’re high risk. 

I think it’s dangerous, if you’re going to be the single parent at that age, that you may wind up entering a nursing home by the time your child enters, say, high school. In thinking about parenting, sure, we want to think about our own values and what we want, and normally, people don’t tell us what to do. I’m not calling for any legislation here. I’m calling for an ethical discussion about the rights and wrongs of parenting at older age. 

In response to the case I made against single women over age 60 trying to have children, it’s often brought up to me that men do it. Recently, there was a story about Al Pacino, who had a kid — I think he’s now 84, so he must have had the child at 83.

In an interview with Newsweek, he said he had this child with his ex, who was 30, a woman named Noor Alfallah. He also said he doesn’t see the child very much. He communicates mainly with that child as a co-parent through digital texting and internet contact. He said he uses video basically as a parent.

Why that is, I’m not sure. Did he have a falling out with his ex and has he been excluded? Is he in poor health such that he can’t really do parenting anymore? 

I cite his case, and there are many other celebrities that we’ve heard about over the years who’ve had kids in their 80s, such as the former talk show host Larry King and, I believe, Clint Eastwood. There are cases that hit the news all the time about older men.

I think the same question should apply ethically. Again, I’m not saying we’re going to ban it or outlaw it, but it’s something we have to discuss and think through. I think doctors involved in helping a very old parent should raise the questions so that people can at least discuss them.

If you’re going to have a kid at 84, it means you’re not going to be around in any competent way by the time the kid hits high school. I’m not sure that’s in the child’s best interest. Certainly, there is the case that a younger woman could adequately raise the kid, but if something happens to her, you’re not going to be around in that age category to parent at all. 

It’s also the case that older parents, if you’re using your sperm, may have the same issues as women, whose eggs age in their late 30s into their 40s; you’re more likely to transmit a genetic disease. We don’t talk about it often, but it is a fact that someone who’s thinking about parenting either naturally or using infertility techniques really should be responsible and think about it.

Bottom line: Am I going to say we should let Congress or a state legislature step in and say, you’re going to go to jail if you have a kid at age X? No. Ethics is there for a reason; it’s trying to make sure that you don’t do things that harm or hurt the interests of a kid. 

If two older people have a child and they’re not likely to be there for a crucial period — say, the teenage years — and they haven’t made provisions for the care of the child, if both die, that’s a problem. 

If one person who’s very old tries to do it, they’re not likely to be alive and/or in good health when the kid enters puberty or into the teenage years; that’s something that you have to think about. Am I doing this because I’m just going to do what I want to do, or am I going to really look out for the best interests of any child I might create? 

This is food for thought about the question of when anyone is too old to parent. I know that’s partly determined by partner, resources, and many other variables, but I don’t believe that we should ignore the discussion of the ethics of the decision just out of respect for the idea that we’re not going to legislate.

Dr. Caplan is with the Division of Medical Ethics at New York University’s Grossman School of Medicine. He has disclosed relevant financial relationships with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and Medscape.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

I want to talk about something that’s extremely controversial, but something that needs public discussion, in my view, as sometimes it doesn’t get the attention it deserves. That is: Are you ever too old to become a parent? 

In my experience, this topic comes up when women — often, single women — decide that they haven’t had a child and they consider pursuing fertility services using in vitro fertilization, donor sperm, a younger woman’s egg, or an egg they’ve preserved, and they say they’d like to have a child. 

I don’t have any huge objection to a younger woman with good health and energy trying to pursue parenting, but we’ve seen women try to do this in their 60s. It does seem to me, biologically, that is a high risk for anyone to undertake a pregnancy at that age. I think there’s agreement from obstetricians that they’re high risk. 

I think it’s dangerous, if you’re going to be the single parent at that age, that you may wind up entering a nursing home by the time your child enters, say, high school. In thinking about parenting, sure, we want to think about our own values and what we want, and normally, people don’t tell us what to do. I’m not calling for any legislation here. I’m calling for an ethical discussion about the rights and wrongs of parenting at older age. 

In response to the case I made against single women over age 60 trying to have children, it’s often brought up to me that men do it. Recently, there was a story about Al Pacino, who had a kid — I think he’s now 84, so he must have had the child at 83.

In an interview with Newsweek, he said he had this child with his ex, who was 30, a woman named Noor Alfallah. He also said he doesn’t see the child very much. He communicates mainly with that child as a co-parent through digital texting and internet contact. He said he uses video basically as a parent.

Why that is, I’m not sure. Did he have a falling out with his ex and has he been excluded? Is he in poor health such that he can’t really do parenting anymore? 

I cite his case, and there are many other celebrities that we’ve heard about over the years who’ve had kids in their 80s, such as the former talk show host Larry King and, I believe, Clint Eastwood. There are cases that hit the news all the time about older men.

I think the same question should apply ethically. Again, I’m not saying we’re going to ban it or outlaw it, but it’s something we have to discuss and think through. I think doctors involved in helping a very old parent should raise the questions so that people can at least discuss them.

If you’re going to have a kid at 84, it means you’re not going to be around in any competent way by the time the kid hits high school. I’m not sure that’s in the child’s best interest. Certainly, there is the case that a younger woman could adequately raise the kid, but if something happens to her, you’re not going to be around in that age category to parent at all. 

It’s also the case that older parents, if you’re using your sperm, may have the same issues as women, whose eggs age in their late 30s into their 40s; you’re more likely to transmit a genetic disease. We don’t talk about it often, but it is a fact that someone who’s thinking about parenting either naturally or using infertility techniques really should be responsible and think about it.

Bottom line: Am I going to say we should let Congress or a state legislature step in and say, you’re going to go to jail if you have a kid at age X? No. Ethics is there for a reason; it’s trying to make sure that you don’t do things that harm or hurt the interests of a kid. 

If two older people have a child and they’re not likely to be there for a crucial period — say, the teenage years — and they haven’t made provisions for the care of the child, if both die, that’s a problem. 

If one person who’s very old tries to do it, they’re not likely to be alive and/or in good health when the kid enters puberty or into the teenage years; that’s something that you have to think about. Am I doing this because I’m just going to do what I want to do, or am I going to really look out for the best interests of any child I might create? 

This is food for thought about the question of when anyone is too old to parent. I know that’s partly determined by partner, resources, and many other variables, but I don’t believe that we should ignore the discussion of the ethics of the decision just out of respect for the idea that we’re not going to legislate.

Dr. Caplan is with the Division of Medical Ethics at New York University’s Grossman School of Medicine. He has disclosed relevant financial relationships with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and Medscape.

A version of this article appeared on Medscape.com.

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

Is there a connection between antibiotics taken before conception and adverse outcomes, such as reduced fertility, miscarriages, and congenital malformations?

A meta-analysis published in the journal eClinicalMedicine suggests a potential link between antibiotics taken before conception and negative outcomes, such as reduced fertility, miscarriages, and congenital malformations. However, a German expert in reproductive toxicology warned against drawing false conclusions.

“It would be fatal if women who want to have children refused necessary antibiotic treatment because they are afraid of infertility, miscarriages, and malformations,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Hospital in Ulm, Germany. In an interview, the expert criticized not only the authors’ conclusions but also the selection of studies included in the meta-analysis.

 

Confusion Over Use and Exposure

The meta-analysis, conducted by Bekalu Kassie Alemu, PhD, and colleagues from the Department of Obstetrics and Gynecology at The Chinese University of Hong Kong included 15 studies involving over 1.2 million women to examine how preconception antibiotic use affects fertility and pregnancy outcomes. In most studies (n = 11) that were included in the meta-analysis, fertility was examined as an endpoint, primarily in infertile women. One study involved Danish pharmacy employees who handled antibiotics at work.

“Not only was the therapeutic use of antibiotics not examined in this study, but the biological plausibility is completely lacking in this context,” Paulus noted.

The possible effects of preconception antibiotics on miscarriages were investigated in four studies, while two studies focused on congenital malformations as an endpoint.

 

Mixed Findings on Infertility

Regarding infertility, the authors reported abnormalities in macrolides and sulfonamides. Women who had received macrolide antibiotics, such as azithromycin, before conception showed a 35% reduction in fertility rates.

However, Paulus questioned whether this was solely because of macrolides. “Macrolide antibiotics are typically used for chlamydia, and chlamydia infection is a significant factor in women with unmet fertility desires,” he explained. Often, the chlamydia has already caused damage, such as inflammatory processes in the fallopian tubes, contributing to infertility that cannot be resolved by administering antibiotics.

The meta-analysis also showed that women who received sulfonamide before conception had a 2.35-fold increased likelihood of infertility. However, this association is not always one-sided. The results for tetracyclines were heterogeneous; while chlortetracycline appeared to increase the risk for infertility, exposure to oxytetracycline appeared to decrease it.

Treatment with oxytetracycline and beta-lactam antibiotics (except penicillin G) was associated with a 64% lower likelihood of infertility. The authors also found that fluoroquinolone antibiotics were associated with a 13% lower likelihood of infertility.

 

Miscarriage and Malformation Risks

Alemu and colleagues found a significant association between the use of antibiotics before conception and adverse pregnancy outcomes, showing a 34% increased risk for miscarriages and an 85% higher risk for congenital malformations with the use of trimethoprim during preconception. These findings highlight the need for caution regarding antibiotic use in women who are planning to conceive.

“Most antibiotics have half-lives of only a few hours. Therefore, antibiotics administered before conception can hardly have a direct effect on embryonic development,” Paulus noted. He pointed out that extensive data exist on most antibiotic classes included in this meta-analysis regarding childhood anomalies when used during the sensitive phase of organ development. These data do not indicate an increased risk for malformation. Therefore, the increased risk for malformations due to exposure before conception seems less plausible.

Alemu and colleagues assumed that antibiotics might negatively affect female reproductive health by disrupting the gut microbiome. The reasons for the reduced risk for infertility associated with beta-lactams and fluoroquinolones require further investigation. They reach a significant conclusion: “Preconception antibiotics exposure in females increases the risk of infertility, miscarriage, and congenital anomalies.” However, differences exist between the antibiotic classes. While the risk for infertility, spontaneous miscarriages, and congenital malformations increases with the use of macrolide antibiotics, sulfonamides, and trimethoprim, it decreases with the use of beta-lactams and fluoroquinolone antibiotics.

 

Expert Disagreement

“It is conceivable that the use of antibiotics damages the physiological environment, such as in the vaginal area. This may allow unwanted microbes to establish themselves, leading to more adverse outcomes such as infertility and miscarriages,” Paulus acknowledged.

Disruption of the microbiome due to antibiotic therapy could also result in a deficiency in relevant vitamins and trace elements (eg, folic acid), which could contribute to organogenesis disorders. Therefore, it may be beneficial to stabilize the gut and vaginal flora using probiotics after antibiotic treatment.

However, Paulus disagrees with the study conclusions. First, the studies included in the meta-analysis, which were largely observational, did not allow for the direct effect of antibiotics on the examined outcomes. Second, “quinolone antibiotics are highlighted as positive here, as if they were less problematic for patients trying to have children.”

Quinolone antibiotics are generally “frowned upon,” regardless of whether the patient wants to have children, as they can cause damage to the tendons, muscles, joints, and nervous system. They are currently used only as reserve medications.

“Quinolone antibiotics should not be administered during pregnancy, as they have already caused problems in animal studies, and they should not be used before pregnancy because of their side-effect profile,” Paulus stressed.

 

Serious Consequences

Paulus clarified: “The message must not be that women trying to conceive should avoid antibiotics. This applies to treating bacterial infections regardless of fertility desires, as well as for women trying to conceive who have problematic pathogens found in vaginal swabs.”

In these cases, antibiotic treatment is appropriate, and there should be no fear of adverse effects on fertility or pregnancy outcomes. “If antibiotics are not given and the infection worsens, the patient will be even less likely to conceive successfully.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Is there a connection between antibiotics taken before conception and adverse outcomes, such as reduced fertility, miscarriages, and congenital malformations?

A meta-analysis published in the journal eClinicalMedicine suggests a potential link between antibiotics taken before conception and negative outcomes, such as reduced fertility, miscarriages, and congenital malformations. However, a German expert in reproductive toxicology warned against drawing false conclusions.

“It would be fatal if women who want to have children refused necessary antibiotic treatment because they are afraid of infertility, miscarriages, and malformations,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Hospital in Ulm, Germany. In an interview, the expert criticized not only the authors’ conclusions but also the selection of studies included in the meta-analysis.

 

Confusion Over Use and Exposure

The meta-analysis, conducted by Bekalu Kassie Alemu, PhD, and colleagues from the Department of Obstetrics and Gynecology at The Chinese University of Hong Kong included 15 studies involving over 1.2 million women to examine how preconception antibiotic use affects fertility and pregnancy outcomes. In most studies (n = 11) that were included in the meta-analysis, fertility was examined as an endpoint, primarily in infertile women. One study involved Danish pharmacy employees who handled antibiotics at work.

“Not only was the therapeutic use of antibiotics not examined in this study, but the biological plausibility is completely lacking in this context,” Paulus noted.

The possible effects of preconception antibiotics on miscarriages were investigated in four studies, while two studies focused on congenital malformations as an endpoint.

 

Mixed Findings on Infertility

Regarding infertility, the authors reported abnormalities in macrolides and sulfonamides. Women who had received macrolide antibiotics, such as azithromycin, before conception showed a 35% reduction in fertility rates.

However, Paulus questioned whether this was solely because of macrolides. “Macrolide antibiotics are typically used for chlamydia, and chlamydia infection is a significant factor in women with unmet fertility desires,” he explained. Often, the chlamydia has already caused damage, such as inflammatory processes in the fallopian tubes, contributing to infertility that cannot be resolved by administering antibiotics.

The meta-analysis also showed that women who received sulfonamide before conception had a 2.35-fold increased likelihood of infertility. However, this association is not always one-sided. The results for tetracyclines were heterogeneous; while chlortetracycline appeared to increase the risk for infertility, exposure to oxytetracycline appeared to decrease it.

Treatment with oxytetracycline and beta-lactam antibiotics (except penicillin G) was associated with a 64% lower likelihood of infertility. The authors also found that fluoroquinolone antibiotics were associated with a 13% lower likelihood of infertility.

 

Miscarriage and Malformation Risks

Alemu and colleagues found a significant association between the use of antibiotics before conception and adverse pregnancy outcomes, showing a 34% increased risk for miscarriages and an 85% higher risk for congenital malformations with the use of trimethoprim during preconception. These findings highlight the need for caution regarding antibiotic use in women who are planning to conceive.

“Most antibiotics have half-lives of only a few hours. Therefore, antibiotics administered before conception can hardly have a direct effect on embryonic development,” Paulus noted. He pointed out that extensive data exist on most antibiotic classes included in this meta-analysis regarding childhood anomalies when used during the sensitive phase of organ development. These data do not indicate an increased risk for malformation. Therefore, the increased risk for malformations due to exposure before conception seems less plausible.

Alemu and colleagues assumed that antibiotics might negatively affect female reproductive health by disrupting the gut microbiome. The reasons for the reduced risk for infertility associated with beta-lactams and fluoroquinolones require further investigation. They reach a significant conclusion: “Preconception antibiotics exposure in females increases the risk of infertility, miscarriage, and congenital anomalies.” However, differences exist between the antibiotic classes. While the risk for infertility, spontaneous miscarriages, and congenital malformations increases with the use of macrolide antibiotics, sulfonamides, and trimethoprim, it decreases with the use of beta-lactams and fluoroquinolone antibiotics.

 

Expert Disagreement

“It is conceivable that the use of antibiotics damages the physiological environment, such as in the vaginal area. This may allow unwanted microbes to establish themselves, leading to more adverse outcomes such as infertility and miscarriages,” Paulus acknowledged.

Disruption of the microbiome due to antibiotic therapy could also result in a deficiency in relevant vitamins and trace elements (eg, folic acid), which could contribute to organogenesis disorders. Therefore, it may be beneficial to stabilize the gut and vaginal flora using probiotics after antibiotic treatment.

However, Paulus disagrees with the study conclusions. First, the studies included in the meta-analysis, which were largely observational, did not allow for the direct effect of antibiotics on the examined outcomes. Second, “quinolone antibiotics are highlighted as positive here, as if they were less problematic for patients trying to have children.”

Quinolone antibiotics are generally “frowned upon,” regardless of whether the patient wants to have children, as they can cause damage to the tendons, muscles, joints, and nervous system. They are currently used only as reserve medications.

“Quinolone antibiotics should not be administered during pregnancy, as they have already caused problems in animal studies, and they should not be used before pregnancy because of their side-effect profile,” Paulus stressed.

 

Serious Consequences

Paulus clarified: “The message must not be that women trying to conceive should avoid antibiotics. This applies to treating bacterial infections regardless of fertility desires, as well as for women trying to conceive who have problematic pathogens found in vaginal swabs.”

In these cases, antibiotic treatment is appropriate, and there should be no fear of adverse effects on fertility or pregnancy outcomes. “If antibiotics are not given and the infection worsens, the patient will be even less likely to conceive successfully.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Is there a connection between antibiotics taken before conception and adverse outcomes, such as reduced fertility, miscarriages, and congenital malformations?

A meta-analysis published in the journal eClinicalMedicine suggests a potential link between antibiotics taken before conception and negative outcomes, such as reduced fertility, miscarriages, and congenital malformations. However, a German expert in reproductive toxicology warned against drawing false conclusions.

“It would be fatal if women who want to have children refused necessary antibiotic treatment because they are afraid of infertility, miscarriages, and malformations,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Hospital in Ulm, Germany. In an interview, the expert criticized not only the authors’ conclusions but also the selection of studies included in the meta-analysis.

 

Confusion Over Use and Exposure

The meta-analysis, conducted by Bekalu Kassie Alemu, PhD, and colleagues from the Department of Obstetrics and Gynecology at The Chinese University of Hong Kong included 15 studies involving over 1.2 million women to examine how preconception antibiotic use affects fertility and pregnancy outcomes. In most studies (n = 11) that were included in the meta-analysis, fertility was examined as an endpoint, primarily in infertile women. One study involved Danish pharmacy employees who handled antibiotics at work.

“Not only was the therapeutic use of antibiotics not examined in this study, but the biological plausibility is completely lacking in this context,” Paulus noted.

The possible effects of preconception antibiotics on miscarriages were investigated in four studies, while two studies focused on congenital malformations as an endpoint.

 

Mixed Findings on Infertility

Regarding infertility, the authors reported abnormalities in macrolides and sulfonamides. Women who had received macrolide antibiotics, such as azithromycin, before conception showed a 35% reduction in fertility rates.

However, Paulus questioned whether this was solely because of macrolides. “Macrolide antibiotics are typically used for chlamydia, and chlamydia infection is a significant factor in women with unmet fertility desires,” he explained. Often, the chlamydia has already caused damage, such as inflammatory processes in the fallopian tubes, contributing to infertility that cannot be resolved by administering antibiotics.

The meta-analysis also showed that women who received sulfonamide before conception had a 2.35-fold increased likelihood of infertility. However, this association is not always one-sided. The results for tetracyclines were heterogeneous; while chlortetracycline appeared to increase the risk for infertility, exposure to oxytetracycline appeared to decrease it.

Treatment with oxytetracycline and beta-lactam antibiotics (except penicillin G) was associated with a 64% lower likelihood of infertility. The authors also found that fluoroquinolone antibiotics were associated with a 13% lower likelihood of infertility.

 

Miscarriage and Malformation Risks

Alemu and colleagues found a significant association between the use of antibiotics before conception and adverse pregnancy outcomes, showing a 34% increased risk for miscarriages and an 85% higher risk for congenital malformations with the use of trimethoprim during preconception. These findings highlight the need for caution regarding antibiotic use in women who are planning to conceive.

“Most antibiotics have half-lives of only a few hours. Therefore, antibiotics administered before conception can hardly have a direct effect on embryonic development,” Paulus noted. He pointed out that extensive data exist on most antibiotic classes included in this meta-analysis regarding childhood anomalies when used during the sensitive phase of organ development. These data do not indicate an increased risk for malformation. Therefore, the increased risk for malformations due to exposure before conception seems less plausible.

Alemu and colleagues assumed that antibiotics might negatively affect female reproductive health by disrupting the gut microbiome. The reasons for the reduced risk for infertility associated with beta-lactams and fluoroquinolones require further investigation. They reach a significant conclusion: “Preconception antibiotics exposure in females increases the risk of infertility, miscarriage, and congenital anomalies.” However, differences exist between the antibiotic classes. While the risk for infertility, spontaneous miscarriages, and congenital malformations increases with the use of macrolide antibiotics, sulfonamides, and trimethoprim, it decreases with the use of beta-lactams and fluoroquinolone antibiotics.

 

Expert Disagreement

“It is conceivable that the use of antibiotics damages the physiological environment, such as in the vaginal area. This may allow unwanted microbes to establish themselves, leading to more adverse outcomes such as infertility and miscarriages,” Paulus acknowledged.

Disruption of the microbiome due to antibiotic therapy could also result in a deficiency in relevant vitamins and trace elements (eg, folic acid), which could contribute to organogenesis disorders. Therefore, it may be beneficial to stabilize the gut and vaginal flora using probiotics after antibiotic treatment.

However, Paulus disagrees with the study conclusions. First, the studies included in the meta-analysis, which were largely observational, did not allow for the direct effect of antibiotics on the examined outcomes. Second, “quinolone antibiotics are highlighted as positive here, as if they were less problematic for patients trying to have children.”

Quinolone antibiotics are generally “frowned upon,” regardless of whether the patient wants to have children, as they can cause damage to the tendons, muscles, joints, and nervous system. They are currently used only as reserve medications.

“Quinolone antibiotics should not be administered during pregnancy, as they have already caused problems in animal studies, and they should not be used before pregnancy because of their side-effect profile,” Paulus stressed.

 

Serious Consequences

Paulus clarified: “The message must not be that women trying to conceive should avoid antibiotics. This applies to treating bacterial infections regardless of fertility desires, as well as for women trying to conceive who have problematic pathogens found in vaginal swabs.”

In these cases, antibiotic treatment is appropriate, and there should be no fear of adverse effects on fertility or pregnancy outcomes. “If antibiotics are not given and the infection worsens, the patient will be even less likely to conceive successfully.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

The quality and credibility of scientific publications have received increasing scrutiny. Findings from studies by Maria Ángeles Oviedo-García, PhD, from the Department of Business and Marketing at the University of Seville in Spain, highlight growing concerns about the integrity of published research. Insights from the journal Science and the US blog Retraction Watch reveal similar concerns regarding research integrity.

Artificial Intelligence (AI) Spurs Low-Quality Submissions

According to a report in Science, journals are inundated with low-quality contributions such as letters and comments generated by AI. Daniel Prevedello, MD, editor in chief of Neurosurgical Review, announced that the journal would temporarily stop accepting these submissions because of their poor quality.

Neurosurgical Review is not the only journal to experience low-quality submissions. In the journal Oral Oncology Reports (Elsevier), comments comprised 70% of the content, whereas in the International Journal of Surgery Open (Wolters Kluwer), they accounted for nearly half. In Neurosurgical Review, letters, comments, and editorials made up 58% of the total content from January to October 2024, compared with only 9% in the previous year.

This trend benefits authors by allowing them to inflate their publication lists with quickly produced contributions that bypass peer review. Publishers may also profit, as many charge fees to publish comments. Additionally, universities and research institutions find this type of content generation useful as more publications can enhance their reputation.

 

Concerns Over Peer Reviews

The troubling behavior described by Oviedo-García in the journal Scientometrics raises further doubts. An analysis of 263 peer reviews from 37 journals revealed that reviewers often used identical or very similar phrases in their evaluations, regardless of the content. In one case, the reviewer used the same wording in 52 reviews. This suggests that some reviewers read the studies that they are supposed to evaluate only superficially. Such practices can lead to valueless reviews and jeopardize the integrity of scientific literature. “Some other researchers will probably base their future research on these fake reports, which is frightening, especially when it comes to health and medicine,” Oviedo-García stated.

She suspects that the reviewers may have relied on templates to produce their reports quickly. This allowed them to list this work on their resumes for potential career advantages. Some reviewers have reportedly even “requested” the authors of the studies they reviewed to cite their own scientific work.

 

AI Complicates Peer Review

The process of research and publication has become increasingly challenging in recent years, and more standard and predatory journals allow anyone to publish their work for a fee. Roger W. Byard, MD, PhD, from the University of Adelaide in Australia, explained this trend in the journal Forensic Science, Medicine and Pathology. AI is increasingly being used to generate articles. At international conferences, experts have highlighted claims that AI can complete papers in just a few weeks and dissertations in less than a year. According to the authors of a letter in Critical Care, generative AI is infiltrating the peer review process.

Moreover, the peer review process can be bypassed by publishing research findings on online platforms (eg, preprint servers). Another issue is that some publications have hundreds of authors who can extend their publication list in this manner, even if their contribution to the publication is ambiguous or not substantial.

In a guest article for the Laborjournal, Ulrich Dirnagl, MD, PhD, from the Charité — Universitätsmedizin Berlin in Germany, emphasized that the scientific papers have become so complex that two or three experts often cannot thoroughly assess everything presented. The review process is time-consuming and can take several days for reviewers. Currently, very few people have time, especially because it is an unpaid and anonymous task. Dirnagl stated, “the self-correction of science no longer works as it claims.”

The old Russian saying ‘Dowjerjaj, no prowjerjaj: Trust, but verify’  remains a timeless recommendation that is likely to stay relevant for years to come.

This story was translated from Univadis Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

The quality and credibility of scientific publications have received increasing scrutiny. Findings from studies by Maria Ángeles Oviedo-García, PhD, from the Department of Business and Marketing at the University of Seville in Spain, highlight growing concerns about the integrity of published research. Insights from the journal Science and the US blog Retraction Watch reveal similar concerns regarding research integrity.

Artificial Intelligence (AI) Spurs Low-Quality Submissions

According to a report in Science, journals are inundated with low-quality contributions such as letters and comments generated by AI. Daniel Prevedello, MD, editor in chief of Neurosurgical Review, announced that the journal would temporarily stop accepting these submissions because of their poor quality.

Neurosurgical Review is not the only journal to experience low-quality submissions. In the journal Oral Oncology Reports (Elsevier), comments comprised 70% of the content, whereas in the International Journal of Surgery Open (Wolters Kluwer), they accounted for nearly half. In Neurosurgical Review, letters, comments, and editorials made up 58% of the total content from January to October 2024, compared with only 9% in the previous year.

This trend benefits authors by allowing them to inflate their publication lists with quickly produced contributions that bypass peer review. Publishers may also profit, as many charge fees to publish comments. Additionally, universities and research institutions find this type of content generation useful as more publications can enhance their reputation.

 

Concerns Over Peer Reviews

The troubling behavior described by Oviedo-García in the journal Scientometrics raises further doubts. An analysis of 263 peer reviews from 37 journals revealed that reviewers often used identical or very similar phrases in their evaluations, regardless of the content. In one case, the reviewer used the same wording in 52 reviews. This suggests that some reviewers read the studies that they are supposed to evaluate only superficially. Such practices can lead to valueless reviews and jeopardize the integrity of scientific literature. “Some other researchers will probably base their future research on these fake reports, which is frightening, especially when it comes to health and medicine,” Oviedo-García stated.

She suspects that the reviewers may have relied on templates to produce their reports quickly. This allowed them to list this work on their resumes for potential career advantages. Some reviewers have reportedly even “requested” the authors of the studies they reviewed to cite their own scientific work.

 

AI Complicates Peer Review

The process of research and publication has become increasingly challenging in recent years, and more standard and predatory journals allow anyone to publish their work for a fee. Roger W. Byard, MD, PhD, from the University of Adelaide in Australia, explained this trend in the journal Forensic Science, Medicine and Pathology. AI is increasingly being used to generate articles. At international conferences, experts have highlighted claims that AI can complete papers in just a few weeks and dissertations in less than a year. According to the authors of a letter in Critical Care, generative AI is infiltrating the peer review process.

Moreover, the peer review process can be bypassed by publishing research findings on online platforms (eg, preprint servers). Another issue is that some publications have hundreds of authors who can extend their publication list in this manner, even if their contribution to the publication is ambiguous or not substantial.

In a guest article for the Laborjournal, Ulrich Dirnagl, MD, PhD, from the Charité — Universitätsmedizin Berlin in Germany, emphasized that the scientific papers have become so complex that two or three experts often cannot thoroughly assess everything presented. The review process is time-consuming and can take several days for reviewers. Currently, very few people have time, especially because it is an unpaid and anonymous task. Dirnagl stated, “the self-correction of science no longer works as it claims.”

The old Russian saying ‘Dowjerjaj, no prowjerjaj: Trust, but verify’  remains a timeless recommendation that is likely to stay relevant for years to come.

This story was translated from Univadis Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

The quality and credibility of scientific publications have received increasing scrutiny. Findings from studies by Maria Ángeles Oviedo-García, PhD, from the Department of Business and Marketing at the University of Seville in Spain, highlight growing concerns about the integrity of published research. Insights from the journal Science and the US blog Retraction Watch reveal similar concerns regarding research integrity.

Artificial Intelligence (AI) Spurs Low-Quality Submissions

According to a report in Science, journals are inundated with low-quality contributions such as letters and comments generated by AI. Daniel Prevedello, MD, editor in chief of Neurosurgical Review, announced that the journal would temporarily stop accepting these submissions because of their poor quality.

Neurosurgical Review is not the only journal to experience low-quality submissions. In the journal Oral Oncology Reports (Elsevier), comments comprised 70% of the content, whereas in the International Journal of Surgery Open (Wolters Kluwer), they accounted for nearly half. In Neurosurgical Review, letters, comments, and editorials made up 58% of the total content from January to October 2024, compared with only 9% in the previous year.

This trend benefits authors by allowing them to inflate their publication lists with quickly produced contributions that bypass peer review. Publishers may also profit, as many charge fees to publish comments. Additionally, universities and research institutions find this type of content generation useful as more publications can enhance their reputation.

 

Concerns Over Peer Reviews

The troubling behavior described by Oviedo-García in the journal Scientometrics raises further doubts. An analysis of 263 peer reviews from 37 journals revealed that reviewers often used identical or very similar phrases in their evaluations, regardless of the content. In one case, the reviewer used the same wording in 52 reviews. This suggests that some reviewers read the studies that they are supposed to evaluate only superficially. Such practices can lead to valueless reviews and jeopardize the integrity of scientific literature. “Some other researchers will probably base their future research on these fake reports, which is frightening, especially when it comes to health and medicine,” Oviedo-García stated.

She suspects that the reviewers may have relied on templates to produce their reports quickly. This allowed them to list this work on their resumes for potential career advantages. Some reviewers have reportedly even “requested” the authors of the studies they reviewed to cite their own scientific work.

 

AI Complicates Peer Review

The process of research and publication has become increasingly challenging in recent years, and more standard and predatory journals allow anyone to publish their work for a fee. Roger W. Byard, MD, PhD, from the University of Adelaide in Australia, explained this trend in the journal Forensic Science, Medicine and Pathology. AI is increasingly being used to generate articles. At international conferences, experts have highlighted claims that AI can complete papers in just a few weeks and dissertations in less than a year. According to the authors of a letter in Critical Care, generative AI is infiltrating the peer review process.

Moreover, the peer review process can be bypassed by publishing research findings on online platforms (eg, preprint servers). Another issue is that some publications have hundreds of authors who can extend their publication list in this manner, even if their contribution to the publication is ambiguous or not substantial.

In a guest article for the Laborjournal, Ulrich Dirnagl, MD, PhD, from the Charité — Universitätsmedizin Berlin in Germany, emphasized that the scientific papers have become so complex that two or three experts often cannot thoroughly assess everything presented. The review process is time-consuming and can take several days for reviewers. Currently, very few people have time, especially because it is an unpaid and anonymous task. Dirnagl stated, “the self-correction of science no longer works as it claims.”

The old Russian saying ‘Dowjerjaj, no prowjerjaj: Trust, but verify’  remains a timeless recommendation that is likely to stay relevant for years to come.

This story was translated from Univadis Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

SAN ANTONIO — Adding the CDK 4/6 blocker palbociclib to standard endocrine and antihuman epidermal growth factor receptor 2 (HER2) therapies in metastatic hormone receptor (HR)–positive, HER2-positive breast cancer extended patients’ median progression-free survival more than a year, according to the results of the phase 3 PATINA study.

This regimen “may represent a new standard of care” for these patients, said principal investigator and presenter Otto Metzger, MD, a medical breast oncologist at the Dana-Farber Cancer Institute in Boston, Massachusetts, who presented the findings at the San Antonio Breast Cancer Symposium (SABCS) 2024.

The open-label PATINA trial, which was conducted in Europe, Australia, New Zealand, and the United States, included a total of 518 patients. Patients received first-line treatment of six to eight cycles of induction chemotherapy plus anti-HER2 therapy. Researchers then randomized patients to either palbociclib plus anti-HER2 and endocrine therapy (n = 261) or to anti-HER2 and endocrine therapy alone (n = 257).

Patients did not progress on induction therapy, which likely would have signaled early resistance to anti-HER2 treatment. For anti-HER2 therapy, 97.3% received a combination of trastuzumab and pertuzumab. For endocrine therapy, 90.9% received an aromatase inhibitor.

Metzger and colleagues found that median progression-free survival was 1.3 years longer in patients receiving palbociclib — 3.7 years in the palbociclib arm vs 2.4 years in the control group (hazard ratio [HR], 0.74; P = .0074).

Although overall survival outcomes are immature, 5-year survival rates were slightly better in the palbociclib arm — 74.3% with palbociclib vs 69.8% without it — but the difference was not statistically significant.

Grade 3 neutropenia was the most frequent adverse event in the palbociclib arm (63.2% vs 2%). Grades 2 and 3 fatigue, stomatitis, and diarrhea were also more common with palbociclib. Grade 4 adverse events occurred in 12.3% of those receiving palbociclib and 8.9% of those who did not. There were no treatment-related deaths.

“We’re very impressed with the results,” said Metzger.

On the basis of previous studies, it’s believed that CDK 4/6 inhibition counteracts the development of resistance to anti-HER2 and endocrine therapies, which likely explains the benefit found in the trial.

But even without CDK 4/6 inhibition, the progression-free survival of 2.4 years in the control arm “far exceed[ed] our expectations,” Metzger reported. This may have occurred because the control arm received endocrine therapy, something previous trials of anti-HER2 therapy have avoided because of tolerability and other concerns.

These findings, however, support “the common use of endocrine therapy,” Metzger said.

 

‘Incredible’ Results

The progression-free survival as well as overall survival results in the trial are “incredible,” said study discussant Sara Hurvitz, MD, a medical breast oncologist at the Fred Hutch Cancer Center in Seattle, Washington. This is “historic and very important data.”

Hurvitz even suggested the results might mean that patients who fit the PATINA criteria can avoid the toxicity of upfront trastuzumab deruxtecan and use the PATINA regimen instead, potentially preserving their quality of life for longer.

Another study discussant, Virginia Kaklamani, MD, a medical breast oncologist at the University of Texas MD Anderson Cancer Center, San Antonio, had a similar thought.

In PATINA, “we’re talking about patients being on a treatment that’s well tolerated, where patients continue to work and continue with their lives despite being on treatment for metastatic breast cancer for 4 years, which is remarkable,” Kaklamani said.

Many of us have dabbled with giving CDK 4/6 inhibitors in triple-positive breast cancer, but “now we have more definitive data,” she said. The approach can help “maintain the quality of life of our patients for a longer period of time” and delay the use of chemotherapy in the second line, she added.

Metzger said Pfizer, the maker of palbociclib, plans to file for a HER2-positive indication with the Food and Drug Administration based on the trial results.

For now, the CDK 4/6 blocker is only indicated in combination with endocrine therapy for HR-positive, HER2-negative metastatic disease.

In response to a question about using the PATINA regimen in patients who don’t get chemotherapy induction, Metzger noted that, “while the study didn’t test this directly, I would argue that this data is quite compelling” for using palbociclib plus anti-HER2 and endocrine therapy, even without chemotherapy induction.

The work was funded by palbociclib maker Pfizer. Metzger had no disclosures. Hurvitz has numerous industry ties, including being a researcher and advisor to Pfizer. Kaklamani also has numerous industry ties, including reporting personal/consulting fees from Pfizer Canada.

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