The number of children in the United States who unintentionally ingested melatonin supplements over the past 10 years has skyrocketed to the point where, as of 2021, melatonin ingestions by children accounted for almost 5% of all poisonings reported to poison control centers in the United States, data from the National Poison Data System (NPDS) indicate.

This compared with only 0.6% of melatonin ingestions reported to poison control centers in 2012, the authors added.

“Basically the number of pediatric melatonin ingestions increased 530% from 8,337 in 2012 to 52,563 in 2021 so it’s a 6.3-fold increase from the beginning of the study until the end,” Michael Toce, MD, one of the study authors and attending, pediatric emergency medicine/medical toxicology, Boston Children’s Hospital, said in an interview.

“And I think the biggest driver of this increase is simply that sales of melatonin have increased astronomically so there is just more melatonin at home and studies have shown there is a correlation between the amount of an individual medication in the home and the risk of pediatric exposure – so simply put: The more of a single substance in a home, the greater the chance that a child is going to get into it,” he underscored.

The study was published in the Morbidity and Mortality Weekly Report .

Melatonin ingestions

All cases of single substance melatonin ingestions involving children and adolescents between Jan. 1, 2012, and Dec. 31, 2021, were included in the analysis. During the 10-year study interval, 260,435 pediatric melatonin ingestions were reported to the NPDS. Over 94% of the reported ingestions were unintentional and 99% occurred in the home.

Over 88% of them were managed on-site; most involved young male children aged 5 years and under, and almost 83% of children who ingested melatonin supplements remained asymptomatic. On the other hand, 27,795 patients sought care at a health care facility and close to 15% of them were hospitalized. Among all melatonin ingestions, 1.6% resulted in more serious outcomes; more serious outcomes being defined as a moderate or major effects or death. Five children required mechanical ventilation in order to treat their symptoms and 2 patients died.

The largest number of patients who were hospitalized were adolescents who took melatonin intentionally but the largest increase in the rate of exposure was in young, unintentional patients, as Dr. Toce observed. Interestingly, the largest yearly increase in pediatric melatonin ingestions – almost 38% – coincided with the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” the authors speculate. Moreover, sleep disturbances were common during the pandemic, leading to a greater likelihood that parents were buying melatonin and thus exposing children to more melatonin at home.

Taken appropriately and at normal does, melatonin in itself is quite safe, as Dr. Toce stressed. However, “for any substance, the dose makes the poison, so taken in any significant quantity, anything is going to be dangerous.” Moreover, it’s important to appreciate that melatonin, at least in the United States, is regulated as a dietary supplement, not as a pharmaceutical.

“Thus, it doesn’t get the same rigorous testing that something like acetaminophen does by the FDA and that means two things,” Dr. Toce noted. First, if the product says that each gummy contains 3 mg of melatonin, no independent body is verifying whether or not that statement is true so there could be 3 mg of melatonin in each gummy or there could be 10 mg,.

Secondly, because there is no impartial oversight for dietary supplements, there may in fact be no melatonin at all in the product or something else may be added to it that might be harmful. “Just because something is sold over-the-counter does not necessarily mean that it’s safe,” Dr. Toce stressed. To keep children safe from pharmaceuticals and supplements, he recommended several generic poison prevention tips. This advice could be passed on to patients who are parents.

• Keep all pharmaceuticals and supplements preferably locked away so there is less risk of children and adolescents taking products either unintentionally or intentionally
• If parents have no place to lock their products up, put them out of reach, high-up so children cannot easily access them
• Keep the product in the original child-resistant packaging as opposed to taking the pills out of the packaging and putting it in a plastic bag bag. “Certainly we’ve seen that when medications are moved into a non–child-resistant container, ingestions go up,” Dr. Toce warned
• Don’t refer to any medicine or supplement a child might take as “candy.” “A lot of children have difficulty taking medications so some families will say: ‘It’s time for your candy,’ ” Dr. Toce explained. Then, if a child does discover the “candy” on a table where they have access to it, they will not recognize it as medication and they’re likely to pop it into their mouth, thinking it is candy.

Lastly, and most importantly, parents who are considering trying a melatonin supplement to help a child sleep better should first establish a stable sleep routine for their child. “They also need to limit caffeinated beverages before bed as well as screen time,” Dr. Toce added.

And they should talk with their primary care provider as to whether or not initiation of a melatonin supplement is appropriate for their child – “and not just jump right into giving them melatonin without first discussing whether it is appropriate to do so,” Dr. Toce stressed.

Remarkable rise

In a comment on his own experience with melatonin poisoning over recent years, toxicology expert Kevin Osterhoudt, MD, of the University of Pennsylvania, Philadelphia and the Children’s Hospital of Philadelphia, noted that it has been their experience that there has been a remarkable rise in poison center reports of children ingesting melatonin in the recent past. For example, the Poison Control Center at CHOP received nearly 4,000 calls involving melatonin ingestion by children 5 years old or younger in the 5 years between 2017 and 2021 with increasing numbers every year.

“The [current study] supports that our regional observation that this has been a national trend,” Dr. Osterhoudt said. Dr. Osterhoudt agreed with Dr. Toce that good sleep is healthy, and it is very important to develop good sleep habits and a regular bedtime routine in order to do so. “In some situations, melatonin may be useful as a short-term sleep aid and that’s a good discussion to have with your child’s health care provider.”

If parents do decide to give their child a melatonin supplement, they need to keep in mind that melatonin may alter how the body handles other drugs such as those used to treat epilepsy or blood clotting. They also need to know experts are still uncertain about how melatonin affects the body over the long term and whether it is safe for mothers to take during pregnancy.

Dr. Osterhoudt offered his own recommendations for safe melatonin use in the home:

• Discuss planned melatonin use with your health care provider.
• Buy only high-quality supplements by looking for the “USP Verified” mark.
• Insist that manufacturers sell products in child-resistant bottles.
• Periodically inspect the medications in your home and dispose of medications that are no longer being used.
• Program the phone number of your regional poison control center into your phone; poison center experts are available 24/7 to answer questions and concerns about ingestions of melatonin (in the United States the number is 1-800-222-1222).

The study authors and neither Dr. Toce nor Dr. Osterhoudt had any relevant conflicts of interest to declare.

The number of children in the United States who unintentionally ingested melatonin supplements over the past 10 years has skyrocketed to the point where, as of 2021, melatonin ingestions by children accounted for almost 5% of all poisonings reported to poison control centers in the United States, data from the National Poison Data System (NPDS) indicate.

This compared with only 0.6% of melatonin ingestions reported to poison control centers in 2012, the authors added.

“Basically the number of pediatric melatonin ingestions increased 530% from 8,337 in 2012 to 52,563 in 2021 so it’s a 6.3-fold increase from the beginning of the study until the end,” Michael Toce, MD, one of the study authors and attending, pediatric emergency medicine/medical toxicology, Boston Children’s Hospital, said in an interview.

“And I think the biggest driver of this increase is simply that sales of melatonin have increased astronomically so there is just more melatonin at home and studies have shown there is a correlation between the amount of an individual medication in the home and the risk of pediatric exposure – so simply put: The more of a single substance in a home, the greater the chance that a child is going to get into it,” he underscored.

The study was published in the Morbidity and Mortality Weekly Report .

Melatonin ingestions

All cases of single substance melatonin ingestions involving children and adolescents between Jan. 1, 2012, and Dec. 31, 2021, were included in the analysis. During the 10-year study interval, 260,435 pediatric melatonin ingestions were reported to the NPDS. Over 94% of the reported ingestions were unintentional and 99% occurred in the home.

Over 88% of them were managed on-site; most involved young male children aged 5 years and under, and almost 83% of children who ingested melatonin supplements remained asymptomatic. On the other hand, 27,795 patients sought care at a health care facility and close to 15% of them were hospitalized. Among all melatonin ingestions, 1.6% resulted in more serious outcomes; more serious outcomes being defined as a moderate or major effects or death. Five children required mechanical ventilation in order to treat their symptoms and 2 patients died.

The largest number of patients who were hospitalized were adolescents who took melatonin intentionally but the largest increase in the rate of exposure was in young, unintentional patients, as Dr. Toce observed. Interestingly, the largest yearly increase in pediatric melatonin ingestions – almost 38% – coincided with the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” the authors speculate. Moreover, sleep disturbances were common during the pandemic, leading to a greater likelihood that parents were buying melatonin and thus exposing children to more melatonin at home.

Taken appropriately and at normal does, melatonin in itself is quite safe, as Dr. Toce stressed. However, “for any substance, the dose makes the poison, so taken in any significant quantity, anything is going to be dangerous.” Moreover, it’s important to appreciate that melatonin, at least in the United States, is regulated as a dietary supplement, not as a pharmaceutical.

“Thus, it doesn’t get the same rigorous testing that something like acetaminophen does by the FDA and that means two things,” Dr. Toce noted. First, if the product says that each gummy contains 3 mg of melatonin, no independent body is verifying whether or not that statement is true so there could be 3 mg of melatonin in each gummy or there could be 10 mg,.

Secondly, because there is no impartial oversight for dietary supplements, there may in fact be no melatonin at all in the product or something else may be added to it that might be harmful. “Just because something is sold over-the-counter does not necessarily mean that it’s safe,” Dr. Toce stressed. To keep children safe from pharmaceuticals and supplements, he recommended several generic poison prevention tips. This advice could be passed on to patients who are parents.

• Keep all pharmaceuticals and supplements preferably locked away so there is less risk of children and adolescents taking products either unintentionally or intentionally
• If parents have no place to lock their products up, put them out of reach, high-up so children cannot easily access them
• Keep the product in the original child-resistant packaging as opposed to taking the pills out of the packaging and putting it in a plastic bag bag. “Certainly we’ve seen that when medications are moved into a non–child-resistant container, ingestions go up,” Dr. Toce warned
• Don’t refer to any medicine or supplement a child might take as “candy.” “A lot of children have difficulty taking medications so some families will say: ‘It’s time for your candy,’ ” Dr. Toce explained. Then, if a child does discover the “candy” on a table where they have access to it, they will not recognize it as medication and they’re likely to pop it into their mouth, thinking it is candy.

Lastly, and most importantly, parents who are considering trying a melatonin supplement to help a child sleep better should first establish a stable sleep routine for their child. “They also need to limit caffeinated beverages before bed as well as screen time,” Dr. Toce added.

And they should talk with their primary care provider as to whether or not initiation of a melatonin supplement is appropriate for their child – “and not just jump right into giving them melatonin without first discussing whether it is appropriate to do so,” Dr. Toce stressed.

Remarkable rise

In a comment on his own experience with melatonin poisoning over recent years, toxicology expert Kevin Osterhoudt, MD, of the University of Pennsylvania, Philadelphia and the Children’s Hospital of Philadelphia, noted that it has been their experience that there has been a remarkable rise in poison center reports of children ingesting melatonin in the recent past. For example, the Poison Control Center at CHOP received nearly 4,000 calls involving melatonin ingestion by children 5 years old or younger in the 5 years between 2017 and 2021 with increasing numbers every year.

“The [current study] supports that our regional observation that this has been a national trend,” Dr. Osterhoudt said. Dr. Osterhoudt agreed with Dr. Toce that good sleep is healthy, and it is very important to develop good sleep habits and a regular bedtime routine in order to do so. “In some situations, melatonin may be useful as a short-term sleep aid and that’s a good discussion to have with your child’s health care provider.”

If parents do decide to give their child a melatonin supplement, they need to keep in mind that melatonin may alter how the body handles other drugs such as those used to treat epilepsy or blood clotting. They also need to know experts are still uncertain about how melatonin affects the body over the long term and whether it is safe for mothers to take during pregnancy.

Dr. Osterhoudt offered his own recommendations for safe melatonin use in the home:

• Discuss planned melatonin use with your health care provider.
• Buy only high-quality supplements by looking for the “USP Verified” mark.
• Insist that manufacturers sell products in child-resistant bottles.
• Periodically inspect the medications in your home and dispose of medications that are no longer being used.
• Program the phone number of your regional poison control center into your phone; poison center experts are available 24/7 to answer questions and concerns about ingestions of melatonin (in the United States the number is 1-800-222-1222).

The study authors and neither Dr. Toce nor Dr. Osterhoudt had any relevant conflicts of interest to declare.

The number of children in the United States who unintentionally ingested melatonin supplements over the past 10 years has skyrocketed to the point where, as of 2021, melatonin ingestions by children accounted for almost 5% of all poisonings reported to poison control centers in the United States, data from the National Poison Data System (NPDS) indicate.

This compared with only 0.6% of melatonin ingestions reported to poison control centers in 2012, the authors added.

“Basically the number of pediatric melatonin ingestions increased 530% from 8,337 in 2012 to 52,563 in 2021 so it’s a 6.3-fold increase from the beginning of the study until the end,” Michael Toce, MD, one of the study authors and attending, pediatric emergency medicine/medical toxicology, Boston Children’s Hospital, said in an interview.

“And I think the biggest driver of this increase is simply that sales of melatonin have increased astronomically so there is just more melatonin at home and studies have shown there is a correlation between the amount of an individual medication in the home and the risk of pediatric exposure – so simply put: The more of a single substance in a home, the greater the chance that a child is going to get into it,” he underscored.

The study was published in the Morbidity and Mortality Weekly Report .

Melatonin ingestions

All cases of single substance melatonin ingestions involving children and adolescents between Jan. 1, 2012, and Dec. 31, 2021, were included in the analysis. During the 10-year study interval, 260,435 pediatric melatonin ingestions were reported to the NPDS. Over 94% of the reported ingestions were unintentional and 99% occurred in the home.

Over 88% of them were managed on-site; most involved young male children aged 5 years and under, and almost 83% of children who ingested melatonin supplements remained asymptomatic. On the other hand, 27,795 patients sought care at a health care facility and close to 15% of them were hospitalized. Among all melatonin ingestions, 1.6% resulted in more serious outcomes; more serious outcomes being defined as a moderate or major effects or death. Five children required mechanical ventilation in order to treat their symptoms and 2 patients died.

The largest number of patients who were hospitalized were adolescents who took melatonin intentionally but the largest increase in the rate of exposure was in young, unintentional patients, as Dr. Toce observed. Interestingly, the largest yearly increase in pediatric melatonin ingestions – almost 38% – coincided with the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” the authors speculate. Moreover, sleep disturbances were common during the pandemic, leading to a greater likelihood that parents were buying melatonin and thus exposing children to more melatonin at home.

Taken appropriately and at normal does, melatonin in itself is quite safe, as Dr. Toce stressed. However, “for any substance, the dose makes the poison, so taken in any significant quantity, anything is going to be dangerous.” Moreover, it’s important to appreciate that melatonin, at least in the United States, is regulated as a dietary supplement, not as a pharmaceutical.

“Thus, it doesn’t get the same rigorous testing that something like acetaminophen does by the FDA and that means two things,” Dr. Toce noted. First, if the product says that each gummy contains 3 mg of melatonin, no independent body is verifying whether or not that statement is true so there could be 3 mg of melatonin in each gummy or there could be 10 mg,.

Secondly, because there is no impartial oversight for dietary supplements, there may in fact be no melatonin at all in the product or something else may be added to it that might be harmful. “Just because something is sold over-the-counter does not necessarily mean that it’s safe,” Dr. Toce stressed. To keep children safe from pharmaceuticals and supplements, he recommended several generic poison prevention tips. This advice could be passed on to patients who are parents.

• Keep all pharmaceuticals and supplements preferably locked away so there is less risk of children and adolescents taking products either unintentionally or intentionally
• If parents have no place to lock their products up, put them out of reach, high-up so children cannot easily access them
• Keep the product in the original child-resistant packaging as opposed to taking the pills out of the packaging and putting it in a plastic bag bag. “Certainly we’ve seen that when medications are moved into a non–child-resistant container, ingestions go up,” Dr. Toce warned
• Don’t refer to any medicine or supplement a child might take as “candy.” “A lot of children have difficulty taking medications so some families will say: ‘It’s time for your candy,’ ” Dr. Toce explained. Then, if a child does discover the “candy” on a table where they have access to it, they will not recognize it as medication and they’re likely to pop it into their mouth, thinking it is candy.

Lastly, and most importantly, parents who are considering trying a melatonin supplement to help a child sleep better should first establish a stable sleep routine for their child. “They also need to limit caffeinated beverages before bed as well as screen time,” Dr. Toce added.

And they should talk with their primary care provider as to whether or not initiation of a melatonin supplement is appropriate for their child – “and not just jump right into giving them melatonin without first discussing whether it is appropriate to do so,” Dr. Toce stressed.

Remarkable rise

In a comment on his own experience with melatonin poisoning over recent years, toxicology expert Kevin Osterhoudt, MD, of the University of Pennsylvania, Philadelphia and the Children’s Hospital of Philadelphia, noted that it has been their experience that there has been a remarkable rise in poison center reports of children ingesting melatonin in the recent past. For example, the Poison Control Center at CHOP received nearly 4,000 calls involving melatonin ingestion by children 5 years old or younger in the 5 years between 2017 and 2021 with increasing numbers every year.

“The [current study] supports that our regional observation that this has been a national trend,” Dr. Osterhoudt said. Dr. Osterhoudt agreed with Dr. Toce that good sleep is healthy, and it is very important to develop good sleep habits and a regular bedtime routine in order to do so. “In some situations, melatonin may be useful as a short-term sleep aid and that’s a good discussion to have with your child’s health care provider.”

If parents do decide to give their child a melatonin supplement, they need to keep in mind that melatonin may alter how the body handles other drugs such as those used to treat epilepsy or blood clotting. They also need to know experts are still uncertain about how melatonin affects the body over the long term and whether it is safe for mothers to take during pregnancy.

Dr. Osterhoudt offered his own recommendations for safe melatonin use in the home:

• Discuss planned melatonin use with your health care provider.
• Buy only high-quality supplements by looking for the “USP Verified” mark.
• Insist that manufacturers sell products in child-resistant bottles.
• Periodically inspect the medications in your home and dispose of medications that are no longer being used.
• Program the phone number of your regional poison control center into your phone; poison center experts are available 24/7 to answer questions and concerns about ingestions of melatonin (in the United States the number is 1-800-222-1222).

The study authors and neither Dr. Toce nor Dr. Osterhoudt had any relevant conflicts of interest to declare.

The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.

The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.

Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.

copyright joloei/Thinkstock

Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.

“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.

This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.

Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.

Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
 

Results from US and clinically detected tophi

Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).

After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.

Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).

Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.

“I wouldn’t expect them to be specific to the Chinese population,” he said.

Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.

Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.

“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.

Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.

“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”

Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.

He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.

“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”

This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.

The authors of the study and Dr. Gaffo report no relevant financial relationships.

The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.

The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.

Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.

copyright joloei/Thinkstock

Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.

“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.

This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.

Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.

Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
 

Results from US and clinically detected tophi

Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).

After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.

Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).

Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.

“I wouldn’t expect them to be specific to the Chinese population,” he said.

Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.

Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.

“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.

Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.

“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”

Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.

He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.

“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”

This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.

The authors of the study and Dr. Gaffo report no relevant financial relationships.

The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.

The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.

Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.

copyright joloei/Thinkstock

Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.

“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.

This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.

Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.

Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
 

Results from US and clinically detected tophi

Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).

After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.

Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).

Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.

“I wouldn’t expect them to be specific to the Chinese population,” he said.

Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.

Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.

“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.

Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.

“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”

Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.

He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.

“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”

This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.

The authors of the study and Dr. Gaffo report no relevant financial relationships.

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the Food and Drug Administration website.

“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA said.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.

Medtronic reports one death associated with this recall and two complaints in the affected lot.

Back in April, as reported by this news organization, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.

The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.

On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.

It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected].

Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.

Earlier in June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the Food and Drug Administration website.

“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA said.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.

Medtronic reports one death associated with this recall and two complaints in the affected lot.

Back in April, as reported by this news organization, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.

The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.

On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.

It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected].

Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.

Earlier in June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the Food and Drug Administration website.

“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA said.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.

Medtronic reports one death associated with this recall and two complaints in the affected lot.

Back in April, as reported by this news organization, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.

The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.

On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.

It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected].

Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.

Earlier in June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images

• 1.31 (95% CI, 1.30-1.33) for heart failure
• 1.40 (95% CI, 1.37-1.43) for stroke
• 1.59 (95% CI, 1.43-1.75) for systemic embolism
• 1.14 (95% CI, 1.13-1.16) for major bleeding  
• 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

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

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images

• 1.31 (95% CI, 1.30-1.33) for heart failure
• 1.40 (95% CI, 1.37-1.43) for stroke
• 1.59 (95% CI, 1.43-1.75) for systemic embolism
• 1.14 (95% CI, 1.13-1.16) for major bleeding  
• 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

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

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images

• 1.31 (95% CI, 1.30-1.33) for heart failure
• 1.40 (95% CI, 1.37-1.43) for stroke
• 1.59 (95% CI, 1.43-1.75) for systemic embolism
• 1.14 (95% CI, 1.13-1.16) for major bleeding  
• 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

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

The Food and Drug Administration has changed the warning about the Volara system to a Class I recall, the most severe level of recall, which is reserved for products that may cause injury or death. At the time of the warning, one injury had been associated with the product; as of June 23, there have been two deaths and one complaint, according to the FDA’s release.

Normally, the Volara system is used for breathing treatments that are administered at home. The medical device company that manufactures it, Baxter International, says the product is designed to help expand the airways and clear mucus for patients who use it. But because of recent product malfunctions, patients are at risk of choking on mucus, developing an infection in their lungs that cuts off their ability to take in oxygen, or in the worst cases, developing brain injury and death.

The risk is especially high because Volara is designed to be used in outpatient settings, not in the hospital under the supervision of a health care professional. It’s supposed to require less supervision than other ventilators. But if there is a problem with the device, or if it’s not connected properly, or if no one is available to assist, people are more likely to be harmed.

People who use the Volara ventilator system at home or people who assist in the use of it should be on alert for these problems. But the FDA advises that patients continue using the therapy if the device has been recommended by a doctor. The device should be used with extra precaution, and patients should be monitored for signs of distress, the release says. Problems while using the device should be reported to the FDA’s Medwatch database.

In addition to these reports, Baxter and its subsidiary company Hillrom say they will update the instructions for the device and will dispatch trainers to make home visits for users. The contact information for the company, as well as additional resources, are listed at the bottom of the release.

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

The Food and Drug Administration has changed the warning about the Volara system to a Class I recall, the most severe level of recall, which is reserved for products that may cause injury or death. At the time of the warning, one injury had been associated with the product; as of June 23, there have been two deaths and one complaint, according to the FDA’s release.

Normally, the Volara system is used for breathing treatments that are administered at home. The medical device company that manufactures it, Baxter International, says the product is designed to help expand the airways and clear mucus for patients who use it. But because of recent product malfunctions, patients are at risk of choking on mucus, developing an infection in their lungs that cuts off their ability to take in oxygen, or in the worst cases, developing brain injury and death.

The risk is especially high because Volara is designed to be used in outpatient settings, not in the hospital under the supervision of a health care professional. It’s supposed to require less supervision than other ventilators. But if there is a problem with the device, or if it’s not connected properly, or if no one is available to assist, people are more likely to be harmed.

People who use the Volara ventilator system at home or people who assist in the use of it should be on alert for these problems. But the FDA advises that patients continue using the therapy if the device has been recommended by a doctor. The device should be used with extra precaution, and patients should be monitored for signs of distress, the release says. Problems while using the device should be reported to the FDA’s Medwatch database.

In addition to these reports, Baxter and its subsidiary company Hillrom say they will update the instructions for the device and will dispatch trainers to make home visits for users. The contact information for the company, as well as additional resources, are listed at the bottom of the release.

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

The Food and Drug Administration has changed the warning about the Volara system to a Class I recall, the most severe level of recall, which is reserved for products that may cause injury or death. At the time of the warning, one injury had been associated with the product; as of June 23, there have been two deaths and one complaint, according to the FDA’s release.

Normally, the Volara system is used for breathing treatments that are administered at home. The medical device company that manufactures it, Baxter International, says the product is designed to help expand the airways and clear mucus for patients who use it. But because of recent product malfunctions, patients are at risk of choking on mucus, developing an infection in their lungs that cuts off their ability to take in oxygen, or in the worst cases, developing brain injury and death.

The risk is especially high because Volara is designed to be used in outpatient settings, not in the hospital under the supervision of a health care professional. It’s supposed to require less supervision than other ventilators. But if there is a problem with the device, or if it’s not connected properly, or if no one is available to assist, people are more likely to be harmed.

People who use the Volara ventilator system at home or people who assist in the use of it should be on alert for these problems. But the FDA advises that patients continue using the therapy if the device has been recommended by a doctor. The device should be used with extra precaution, and patients should be monitored for signs of distress, the release says. Problems while using the device should be reported to the FDA’s Medwatch database.

In addition to these reports, Baxter and its subsidiary company Hillrom say they will update the instructions for the device and will dispatch trainers to make home visits for users. The contact information for the company, as well as additional resources, are listed at the bottom of the release.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

Pain is common in patients with cirrhosis, and its management presents significant challenges to health care providers, such as worries about GI bleeding, renal injury, falls, and hepatic encephalopathy.

To address those issues, researchers at the University of Michigan, Ann Arbor, authored a review, published in Hepatology, that describes the pain syndromes experienced by patients, as well as pharmaceutical and nonpharmaceutical treatment options.

“I think it’s a very pragmatic approach to a very common problem. Health care providers are concerned about prescribing analgesia for people with cirrhosis for a number of different reasons. One of them is acetaminophen can be toxic to the liver, but generally only in pretty large doses. It’s actually a pretty good option in a dose of less than about 2 g/day because it doesn’t have some of the side effects that other painkillers such as the NSAIDs have. It doesn’t irritate the stomach, and it doesn’t affect kidney function,” said Paul Martin, MD, who was asked to comment on the review. He is chief of digestive health and liver diseases at the University of Miami.

He appreciated the discussion of both pharmacologic and nonpharmacologic interventions, including diet and psychological interventions. “And I think it provides a useful overview of the pharmacological agents we can use in patients with cirrhosis, so I think it’s a very useful contribution to the literature,” said Dr. Martin.

An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of life. The authors noted that, although recent practice guidance had recommended involving palliative care providers, psychiatry, and physical therapy in for patients with decompensated cirrhosis, this is not always feasible. The authors also pointed out that there are different pain phenotypes in cirrhosis, and these require different management strategies.

They described three mechanistic categories of chronic pain: Nociceptive pain involves tissue damage and inflammation; neuropathic pain results from nerve damage; and nociplastic pain describes situations in which there is no evidence of tissue or nerve damage, but clinical or psychophysical signs suggest changes to nociception.

The different pain types are best assessed using different tools: The 2016 Fibromyalgia Survey Criteria is useful for nociplastic pain, the Neuropathic Pain Questionnaire and painDETECT can be useful for neuropathic pain, and a physical examination can pinpoint nociceptive pain.

When managing chronic pain, the initial patient workup should include a complete evaluation of the location, quality, and severity of pain, along with any functional interference or associated symptoms like fatigue, mood disturbance, or sensory sensitivity. One option is to use a body map to assess how widespread the pain is. Multisite pain is often a signal that it could be nociplastic. Any comorbid psychiatric disorders should be identified and treated.

The first treatment option for any pain should be self-directed, nonpharmacologic interventions. This is because most analgesics are only modestly effective in the treatment of chronic pain, leading to improvement in only about one in three cases, the authors noted. Opioids have poor efficacy against chronic pain, particularly nociplastic pain, which may even be worsened by opioid use.

Mladen Zivkovic/iStock/Getty Images

Although there is evidence that patients are motivated to seek out nonpharmacologic pain treatment, they have reported frustration by a dearth of simple, evidence-based therapies. The authors noted that digital self-management tools for pain have been developed, including their own PainGuide, which focuses on exercise and behavioral interventions for chronic pain. Other nonpharmacologic approaches include diet modification and sleep hygiene. Patients should be allowed to choose the approach that interests them most, with the physician emphasizing the importance of self-directed management.

Pharmacologic therapy may be added to these approaches, but they have limited utility and are associated with adverse effects. For nociceptive pain, topical NSAIDs like diclofenac gel can be used, as can acetaminophen (500 mg every 6 hours, maximum dose of 2 g/day). Opioids can be employed for short-term treatment of acute pain (for example: hydromorphone 1 mg every 6 hours as needed, oxycodone 2.5 mg by mouth every 6-8 hours as needed, or fentanyl patch in select patients). Tricyclic antidepressants may be used for multiple symptoms or neuropathic pain, but with caution. Neuropathic pain, as well as associated depression or fatigue, can be treated with low-dose serotonin and norepinephrine reuptake inhibitors, though there is a small risk of hepatotoxicity. Neuropathic pain, sleep difficulties, or anxiety can be treated with gabapentin at low starting doses (for example, 300 mg/day) or pregabalin (for example, 50 mg twice a day). Lidocaine patches are an option for peripheral neuropathic pain or postherpetic neuralgia, and topical capsaicin may be used for peripheral neuropathic pain.

“Since all pain types can co-occur, interventions to address nociplastic pain may be broadly therapeutic,” the authors concluded. “The treatment of nociplastic pain emphasizes nonpharmacologic management, including self-management techniques addressing mood, cognitions, behaviors, sleep, and environment. Future research should continue to explore methods of pain phenotyping, as well as self-management therapies, including implementation tools.”

The authors and Dr. Martin reported no relevant conflicts of interest.

Pain is common in patients with cirrhosis, and its management presents significant challenges to health care providers, such as worries about GI bleeding, renal injury, falls, and hepatic encephalopathy.

To address those issues, researchers at the University of Michigan, Ann Arbor, authored a review, published in Hepatology, that describes the pain syndromes experienced by patients, as well as pharmaceutical and nonpharmaceutical treatment options.

“I think it’s a very pragmatic approach to a very common problem. Health care providers are concerned about prescribing analgesia for people with cirrhosis for a number of different reasons. One of them is acetaminophen can be toxic to the liver, but generally only in pretty large doses. It’s actually a pretty good option in a dose of less than about 2 g/day because it doesn’t have some of the side effects that other painkillers such as the NSAIDs have. It doesn’t irritate the stomach, and it doesn’t affect kidney function,” said Paul Martin, MD, who was asked to comment on the review. He is chief of digestive health and liver diseases at the University of Miami.

He appreciated the discussion of both pharmacologic and nonpharmacologic interventions, including diet and psychological interventions. “And I think it provides a useful overview of the pharmacological agents we can use in patients with cirrhosis, so I think it’s a very useful contribution to the literature,” said Dr. Martin.

An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of life. The authors noted that, although recent practice guidance had recommended involving palliative care providers, psychiatry, and physical therapy in for patients with decompensated cirrhosis, this is not always feasible. The authors also pointed out that there are different pain phenotypes in cirrhosis, and these require different management strategies.

They described three mechanistic categories of chronic pain: Nociceptive pain involves tissue damage and inflammation; neuropathic pain results from nerve damage; and nociplastic pain describes situations in which there is no evidence of tissue or nerve damage, but clinical or psychophysical signs suggest changes to nociception.

The different pain types are best assessed using different tools: The 2016 Fibromyalgia Survey Criteria is useful for nociplastic pain, the Neuropathic Pain Questionnaire and painDETECT can be useful for neuropathic pain, and a physical examination can pinpoint nociceptive pain.

When managing chronic pain, the initial patient workup should include a complete evaluation of the location, quality, and severity of pain, along with any functional interference or associated symptoms like fatigue, mood disturbance, or sensory sensitivity. One option is to use a body map to assess how widespread the pain is. Multisite pain is often a signal that it could be nociplastic. Any comorbid psychiatric disorders should be identified and treated.

The first treatment option for any pain should be self-directed, nonpharmacologic interventions. This is because most analgesics are only modestly effective in the treatment of chronic pain, leading to improvement in only about one in three cases, the authors noted. Opioids have poor efficacy against chronic pain, particularly nociplastic pain, which may even be worsened by opioid use.

Mladen Zivkovic/iStock/Getty Images

Although there is evidence that patients are motivated to seek out nonpharmacologic pain treatment, they have reported frustration by a dearth of simple, evidence-based therapies. The authors noted that digital self-management tools for pain have been developed, including their own PainGuide, which focuses on exercise and behavioral interventions for chronic pain. Other nonpharmacologic approaches include diet modification and sleep hygiene. Patients should be allowed to choose the approach that interests them most, with the physician emphasizing the importance of self-directed management.

Pharmacologic therapy may be added to these approaches, but they have limited utility and are associated with adverse effects. For nociceptive pain, topical NSAIDs like diclofenac gel can be used, as can acetaminophen (500 mg every 6 hours, maximum dose of 2 g/day). Opioids can be employed for short-term treatment of acute pain (for example: hydromorphone 1 mg every 6 hours as needed, oxycodone 2.5 mg by mouth every 6-8 hours as needed, or fentanyl patch in select patients). Tricyclic antidepressants may be used for multiple symptoms or neuropathic pain, but with caution. Neuropathic pain, as well as associated depression or fatigue, can be treated with low-dose serotonin and norepinephrine reuptake inhibitors, though there is a small risk of hepatotoxicity. Neuropathic pain, sleep difficulties, or anxiety can be treated with gabapentin at low starting doses (for example, 300 mg/day) or pregabalin (for example, 50 mg twice a day). Lidocaine patches are an option for peripheral neuropathic pain or postherpetic neuralgia, and topical capsaicin may be used for peripheral neuropathic pain.

“Since all pain types can co-occur, interventions to address nociplastic pain may be broadly therapeutic,” the authors concluded. “The treatment of nociplastic pain emphasizes nonpharmacologic management, including self-management techniques addressing mood, cognitions, behaviors, sleep, and environment. Future research should continue to explore methods of pain phenotyping, as well as self-management therapies, including implementation tools.”

The authors and Dr. Martin reported no relevant conflicts of interest.

Pain is common in patients with cirrhosis, and its management presents significant challenges to health care providers, such as worries about GI bleeding, renal injury, falls, and hepatic encephalopathy.

To address those issues, researchers at the University of Michigan, Ann Arbor, authored a review, published in Hepatology, that describes the pain syndromes experienced by patients, as well as pharmaceutical and nonpharmaceutical treatment options.

“I think it’s a very pragmatic approach to a very common problem. Health care providers are concerned about prescribing analgesia for people with cirrhosis for a number of different reasons. One of them is acetaminophen can be toxic to the liver, but generally only in pretty large doses. It’s actually a pretty good option in a dose of less than about 2 g/day because it doesn’t have some of the side effects that other painkillers such as the NSAIDs have. It doesn’t irritate the stomach, and it doesn’t affect kidney function,” said Paul Martin, MD, who was asked to comment on the review. He is chief of digestive health and liver diseases at the University of Miami.

He appreciated the discussion of both pharmacologic and nonpharmacologic interventions, including diet and psychological interventions. “And I think it provides a useful overview of the pharmacological agents we can use in patients with cirrhosis, so I think it’s a very useful contribution to the literature,” said Dr. Martin.

An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of life. The authors noted that, although recent practice guidance had recommended involving palliative care providers, psychiatry, and physical therapy in for patients with decompensated cirrhosis, this is not always feasible. The authors also pointed out that there are different pain phenotypes in cirrhosis, and these require different management strategies.

They described three mechanistic categories of chronic pain: Nociceptive pain involves tissue damage and inflammation; neuropathic pain results from nerve damage; and nociplastic pain describes situations in which there is no evidence of tissue or nerve damage, but clinical or psychophysical signs suggest changes to nociception.

The different pain types are best assessed using different tools: The 2016 Fibromyalgia Survey Criteria is useful for nociplastic pain, the Neuropathic Pain Questionnaire and painDETECT can be useful for neuropathic pain, and a physical examination can pinpoint nociceptive pain.

When managing chronic pain, the initial patient workup should include a complete evaluation of the location, quality, and severity of pain, along with any functional interference or associated symptoms like fatigue, mood disturbance, or sensory sensitivity. One option is to use a body map to assess how widespread the pain is. Multisite pain is often a signal that it could be nociplastic. Any comorbid psychiatric disorders should be identified and treated.

The first treatment option for any pain should be self-directed, nonpharmacologic interventions. This is because most analgesics are only modestly effective in the treatment of chronic pain, leading to improvement in only about one in three cases, the authors noted. Opioids have poor efficacy against chronic pain, particularly nociplastic pain, which may even be worsened by opioid use.

Mladen Zivkovic/iStock/Getty Images

Although there is evidence that patients are motivated to seek out nonpharmacologic pain treatment, they have reported frustration by a dearth of simple, evidence-based therapies. The authors noted that digital self-management tools for pain have been developed, including their own PainGuide, which focuses on exercise and behavioral interventions for chronic pain. Other nonpharmacologic approaches include diet modification and sleep hygiene. Patients should be allowed to choose the approach that interests them most, with the physician emphasizing the importance of self-directed management.

Pharmacologic therapy may be added to these approaches, but they have limited utility and are associated with adverse effects. For nociceptive pain, topical NSAIDs like diclofenac gel can be used, as can acetaminophen (500 mg every 6 hours, maximum dose of 2 g/day). Opioids can be employed for short-term treatment of acute pain (for example: hydromorphone 1 mg every 6 hours as needed, oxycodone 2.5 mg by mouth every 6-8 hours as needed, or fentanyl patch in select patients). Tricyclic antidepressants may be used for multiple symptoms or neuropathic pain, but with caution. Neuropathic pain, as well as associated depression or fatigue, can be treated with low-dose serotonin and norepinephrine reuptake inhibitors, though there is a small risk of hepatotoxicity. Neuropathic pain, sleep difficulties, or anxiety can be treated with gabapentin at low starting doses (for example, 300 mg/day) or pregabalin (for example, 50 mg twice a day). Lidocaine patches are an option for peripheral neuropathic pain or postherpetic neuralgia, and topical capsaicin may be used for peripheral neuropathic pain.

“Since all pain types can co-occur, interventions to address nociplastic pain may be broadly therapeutic,” the authors concluded. “The treatment of nociplastic pain emphasizes nonpharmacologic management, including self-management techniques addressing mood, cognitions, behaviors, sleep, and environment. Future research should continue to explore methods of pain phenotyping, as well as self-management therapies, including implementation tools.”

The authors and Dr. Martin reported no relevant conflicts of interest.

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

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

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

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

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

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