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Gene therapy is bad business, and hugging chickens is just … bad
Look ma, I’m writing with no hands
Imagine being able to type every thought you had without using your hands, the words just magically appearing on the screen as fast as you can think of writing them down. Well, with the help of a new brain-computer interface (BCI), you can.
In a recent paper published in Nature, a team of researchers described how they developed a whole new way of communicating that blows previous BCIs, which used a method of pointing and clicking on letters, out of the water as far as accuracy and speed are concerned.
Developed for individuals with medical conditions or other disabilities that prevent them from communicating verbally or manually, the technology involves placing tiny sensors on the brain in the areas that control hand and arm movements. All the individual has to do is think of the process of writing and the system does the rest.
Even better, with continual use, the program’s algorithm comes to recognize the patterns of each letter, speeding up the number of words written. The previous record held for a BCI was about 40 characters per minute, but this new program enables users to type 90 characters per minute.
Think of how many emails you could reply to with just a thought. Or the LOTMEs we could write … or think? … Or think about writing?
Chicken noodle salmonella
Chickens and ducks sure are cute, especially babies, but humans should be extra careful around these animals for risk of salmonella. This isn’t a new thing to loyal readers of Livin’ on the MDedge.
As more people keep such creatures at home – Emily Shoop of Penn State University told the N.Y. Times that raising poultry was “the fastest-growing animal-related hobby in the United States” – the ducks and chickens are being treated more like house pets, which is sweet but not safe.
In the latest outbreak, more than 160 people, mostly children under 5 years old, have fallen ill from salmonella poisoning and more than 30 have been hospitalized across 43 states, and the Centers for Disease Control and Prevention suspects the numbers could be higher because many did not get tested and recovered on their own.
People should refrain from kissing these animals and should wash their hands for at least 20 seconds after handling them, their products, or their manure. If they do happen to kiss and cuddle these animals, they should wash their face and brush their teeth.
It’s not that ducks and chickens are dirty creatures, but they naturally carry bacteria. Some can get salmonella from contaminated food, or even contract it from their mothers before birth.
We can’t speak for everyone, but we would find it hard to connect with an animal that’s going to end up on our dinner plate.
This kidney research rocks!
When kids pick teams on the playground, someone is going to get their feelings hurt by being chosen last. There’s no way around it. Someone has to be last.
It’s the same way with research teams. When scientists are trying to cure diseases or pioneer new surgical techniques, they get a team together. And who always gets picked last? That’s right, the geologist, because who needs a geologist when you’re studying brain-computer interfaces?
Turns out, though, that there was a research team that needed a geologist: The one studying kidney stones.
Illinois geology professor Bruce Fouke explains: “The process of kidney stone formation is part of the natural process of the stone formation seen throughout nature. We are bringing together geology, biology, and medicine to map the entire process of kidney stone formation, step by step.”
In its latest work, the team found that kidney stones develop as tiny bits of mineral called microspherules, which can then come together to form larger crystals if they are not flushed out of the kidney tissue. Some eventually become large enough to cause excruciating pain.
Their transdisciplinary approach, known as GeoBioMed, has produced a device the team calls the GeoBioCell, which is “a microfluidic cartridge designed to mimic the intricate internal structures of the kidney,” they said.
Great stuff, no doubt, but we’re thinking the geologists haven’t quite gotten over the whole last-picked-for-the-team business, or maybe they’re just really into Batman. They’ve named the GeoBioCell after themselves, and he had the Batmobile and the Bat-tweezers. Also the Bat-funnel. And the Bat-scilloscope.
Gene therapy: What is it good for? Absolutely nothing!
Gene therapy has the potential to permanently cure all sorts of terrible diseases, and one would assume that this would be something we all could agree on. Yes, no more cancer or diabetes or anything like that, no sane person could possibly be against this, right?
Oh, you poor naive fool.
To be fair, the report written by Goldman Sachs does lay out many potential applications for gene therapy, and all the markets it can expand into. But then the writers ask the question that they’re not supposed to say out loud: Is curing patients a sustainable business model?
They go on to say that, while it would obviously be of enormous benefit to patients and society to give a one-shot cure rather than forcing a long, drawn-out series of treatments, current therapies for chronic disease represent a major source of money that would be cut off if a permanent treatment were found. They specifically mentioned hepatitis C, which has achieved a cure rate of over 90% in the past few years. In 2015, Gilead – the maker of these treatments – brought in sales of over $12 billion from its hepatitis C cure, but the report estimated that in 2021 they would bring in only $4 billion.
The authors of the report suggested that developers focus on “large markets,” such as hemophilia; diseases with high incidence like spinal muscular atrophy; and on diseases such as the various inherited retinal disorders, where there’s plenty of room to constantly bring out new and exciting treatments without sabotaging the all-important money flow.
While we can accept that Goldman Sachs may be technically correct in their assertion that curing disease is bad for business, that’s about as far as our sympathy goes, unless the big biotech companies of the world would like a sad song played on the world’s smallest violin.
Look ma, I’m writing with no hands
Imagine being able to type every thought you had without using your hands, the words just magically appearing on the screen as fast as you can think of writing them down. Well, with the help of a new brain-computer interface (BCI), you can.
In a recent paper published in Nature, a team of researchers described how they developed a whole new way of communicating that blows previous BCIs, which used a method of pointing and clicking on letters, out of the water as far as accuracy and speed are concerned.
Developed for individuals with medical conditions or other disabilities that prevent them from communicating verbally or manually, the technology involves placing tiny sensors on the brain in the areas that control hand and arm movements. All the individual has to do is think of the process of writing and the system does the rest.
Even better, with continual use, the program’s algorithm comes to recognize the patterns of each letter, speeding up the number of words written. The previous record held for a BCI was about 40 characters per minute, but this new program enables users to type 90 characters per minute.
Think of how many emails you could reply to with just a thought. Or the LOTMEs we could write … or think? … Or think about writing?
Chicken noodle salmonella
Chickens and ducks sure are cute, especially babies, but humans should be extra careful around these animals for risk of salmonella. This isn’t a new thing to loyal readers of Livin’ on the MDedge.
As more people keep such creatures at home – Emily Shoop of Penn State University told the N.Y. Times that raising poultry was “the fastest-growing animal-related hobby in the United States” – the ducks and chickens are being treated more like house pets, which is sweet but not safe.
In the latest outbreak, more than 160 people, mostly children under 5 years old, have fallen ill from salmonella poisoning and more than 30 have been hospitalized across 43 states, and the Centers for Disease Control and Prevention suspects the numbers could be higher because many did not get tested and recovered on their own.
People should refrain from kissing these animals and should wash their hands for at least 20 seconds after handling them, their products, or their manure. If they do happen to kiss and cuddle these animals, they should wash their face and brush their teeth.
It’s not that ducks and chickens are dirty creatures, but they naturally carry bacteria. Some can get salmonella from contaminated food, or even contract it from their mothers before birth.
We can’t speak for everyone, but we would find it hard to connect with an animal that’s going to end up on our dinner plate.
This kidney research rocks!
When kids pick teams on the playground, someone is going to get their feelings hurt by being chosen last. There’s no way around it. Someone has to be last.
It’s the same way with research teams. When scientists are trying to cure diseases or pioneer new surgical techniques, they get a team together. And who always gets picked last? That’s right, the geologist, because who needs a geologist when you’re studying brain-computer interfaces?
Turns out, though, that there was a research team that needed a geologist: The one studying kidney stones.
Illinois geology professor Bruce Fouke explains: “The process of kidney stone formation is part of the natural process of the stone formation seen throughout nature. We are bringing together geology, biology, and medicine to map the entire process of kidney stone formation, step by step.”
In its latest work, the team found that kidney stones develop as tiny bits of mineral called microspherules, which can then come together to form larger crystals if they are not flushed out of the kidney tissue. Some eventually become large enough to cause excruciating pain.
Their transdisciplinary approach, known as GeoBioMed, has produced a device the team calls the GeoBioCell, which is “a microfluidic cartridge designed to mimic the intricate internal structures of the kidney,” they said.
Great stuff, no doubt, but we’re thinking the geologists haven’t quite gotten over the whole last-picked-for-the-team business, or maybe they’re just really into Batman. They’ve named the GeoBioCell after themselves, and he had the Batmobile and the Bat-tweezers. Also the Bat-funnel. And the Bat-scilloscope.
Gene therapy: What is it good for? Absolutely nothing!
Gene therapy has the potential to permanently cure all sorts of terrible diseases, and one would assume that this would be something we all could agree on. Yes, no more cancer or diabetes or anything like that, no sane person could possibly be against this, right?
Oh, you poor naive fool.
To be fair, the report written by Goldman Sachs does lay out many potential applications for gene therapy, and all the markets it can expand into. But then the writers ask the question that they’re not supposed to say out loud: Is curing patients a sustainable business model?
They go on to say that, while it would obviously be of enormous benefit to patients and society to give a one-shot cure rather than forcing a long, drawn-out series of treatments, current therapies for chronic disease represent a major source of money that would be cut off if a permanent treatment were found. They specifically mentioned hepatitis C, which has achieved a cure rate of over 90% in the past few years. In 2015, Gilead – the maker of these treatments – brought in sales of over $12 billion from its hepatitis C cure, but the report estimated that in 2021 they would bring in only $4 billion.
The authors of the report suggested that developers focus on “large markets,” such as hemophilia; diseases with high incidence like spinal muscular atrophy; and on diseases such as the various inherited retinal disorders, where there’s plenty of room to constantly bring out new and exciting treatments without sabotaging the all-important money flow.
While we can accept that Goldman Sachs may be technically correct in their assertion that curing disease is bad for business, that’s about as far as our sympathy goes, unless the big biotech companies of the world would like a sad song played on the world’s smallest violin.
Look ma, I’m writing with no hands
Imagine being able to type every thought you had without using your hands, the words just magically appearing on the screen as fast as you can think of writing them down. Well, with the help of a new brain-computer interface (BCI), you can.
In a recent paper published in Nature, a team of researchers described how they developed a whole new way of communicating that blows previous BCIs, which used a method of pointing and clicking on letters, out of the water as far as accuracy and speed are concerned.
Developed for individuals with medical conditions or other disabilities that prevent them from communicating verbally or manually, the technology involves placing tiny sensors on the brain in the areas that control hand and arm movements. All the individual has to do is think of the process of writing and the system does the rest.
Even better, with continual use, the program’s algorithm comes to recognize the patterns of each letter, speeding up the number of words written. The previous record held for a BCI was about 40 characters per minute, but this new program enables users to type 90 characters per minute.
Think of how many emails you could reply to with just a thought. Or the LOTMEs we could write … or think? … Or think about writing?
Chicken noodle salmonella
Chickens and ducks sure are cute, especially babies, but humans should be extra careful around these animals for risk of salmonella. This isn’t a new thing to loyal readers of Livin’ on the MDedge.
As more people keep such creatures at home – Emily Shoop of Penn State University told the N.Y. Times that raising poultry was “the fastest-growing animal-related hobby in the United States” – the ducks and chickens are being treated more like house pets, which is sweet but not safe.
In the latest outbreak, more than 160 people, mostly children under 5 years old, have fallen ill from salmonella poisoning and more than 30 have been hospitalized across 43 states, and the Centers for Disease Control and Prevention suspects the numbers could be higher because many did not get tested and recovered on their own.
People should refrain from kissing these animals and should wash their hands for at least 20 seconds after handling them, their products, or their manure. If they do happen to kiss and cuddle these animals, they should wash their face and brush their teeth.
It’s not that ducks and chickens are dirty creatures, but they naturally carry bacteria. Some can get salmonella from contaminated food, or even contract it from their mothers before birth.
We can’t speak for everyone, but we would find it hard to connect with an animal that’s going to end up on our dinner plate.
This kidney research rocks!
When kids pick teams on the playground, someone is going to get their feelings hurt by being chosen last. There’s no way around it. Someone has to be last.
It’s the same way with research teams. When scientists are trying to cure diseases or pioneer new surgical techniques, they get a team together. And who always gets picked last? That’s right, the geologist, because who needs a geologist when you’re studying brain-computer interfaces?
Turns out, though, that there was a research team that needed a geologist: The one studying kidney stones.
Illinois geology professor Bruce Fouke explains: “The process of kidney stone formation is part of the natural process of the stone formation seen throughout nature. We are bringing together geology, biology, and medicine to map the entire process of kidney stone formation, step by step.”
In its latest work, the team found that kidney stones develop as tiny bits of mineral called microspherules, which can then come together to form larger crystals if they are not flushed out of the kidney tissue. Some eventually become large enough to cause excruciating pain.
Their transdisciplinary approach, known as GeoBioMed, has produced a device the team calls the GeoBioCell, which is “a microfluidic cartridge designed to mimic the intricate internal structures of the kidney,” they said.
Great stuff, no doubt, but we’re thinking the geologists haven’t quite gotten over the whole last-picked-for-the-team business, or maybe they’re just really into Batman. They’ve named the GeoBioCell after themselves, and he had the Batmobile and the Bat-tweezers. Also the Bat-funnel. And the Bat-scilloscope.
Gene therapy: What is it good for? Absolutely nothing!
Gene therapy has the potential to permanently cure all sorts of terrible diseases, and one would assume that this would be something we all could agree on. Yes, no more cancer or diabetes or anything like that, no sane person could possibly be against this, right?
Oh, you poor naive fool.
To be fair, the report written by Goldman Sachs does lay out many potential applications for gene therapy, and all the markets it can expand into. But then the writers ask the question that they’re not supposed to say out loud: Is curing patients a sustainable business model?
They go on to say that, while it would obviously be of enormous benefit to patients and society to give a one-shot cure rather than forcing a long, drawn-out series of treatments, current therapies for chronic disease represent a major source of money that would be cut off if a permanent treatment were found. They specifically mentioned hepatitis C, which has achieved a cure rate of over 90% in the past few years. In 2015, Gilead – the maker of these treatments – brought in sales of over $12 billion from its hepatitis C cure, but the report estimated that in 2021 they would bring in only $4 billion.
The authors of the report suggested that developers focus on “large markets,” such as hemophilia; diseases with high incidence like spinal muscular atrophy; and on diseases such as the various inherited retinal disorders, where there’s plenty of room to constantly bring out new and exciting treatments without sabotaging the all-important money flow.
While we can accept that Goldman Sachs may be technically correct in their assertion that curing disease is bad for business, that’s about as far as our sympathy goes, unless the big biotech companies of the world would like a sad song played on the world’s smallest violin.
‘Overbasalization’ common in type 2 diabetes management
that impedes achievement of optimal glycemic control, new research suggests.
Such ‘overbasalization,’ defined as a hemoglobin A1c of greater than 8% despite use of more than 0.5 units/kg per day of basal insulin, was identified in about 40% of patients seen in a Florida primary care clinic during 2015-2018. The findings were published in the April 2021 issue of Clinical Diabetes by Kevin Cowart, PharmD, a diabetes care and education specialist at the University of South Florida, Tampa, and colleagues.
The literature suggests that once people with type 2 diabetes start basal insulin, the chance that they’ll achieve a given hemoglobin A1c target, i.e., less than 7%, diminishes significantly if that goal isn’t achieved within the first year of starting insulin, Dr. Cowart said in an interview.
“Our analysis suggests that overbasalization plays a role in patients with type 2 diabetes on basal insulin not achieving optimal glycemic control. Basal insulin is not designed to address postprandial hyperglycemia. I think there’s a clear need to address hesitancy in therapeutic progression beyond basal insulin. A lot of factors underlie the delays, with therapeutic inertia being one of them. It’s complex,” he said.
Overbasalization seen in large proportion of patients
The study comprised 655 adults diagnosed with type 2 diabetes for at least a year who received a prescription for a basal insulin (glargine U-100, glargine U-300, detemir, degludec U-100, degludec U-200, regular U-500, or NPH insulin).
The patients had a mean hemoglobin A1c of 8.4% and a mean basal insulin dose 0.4 units/kg per day. The prevalence of overbasalization was 38.1% for those with hemoglobin A1c above 8%, 42.7% for those with A1c of 9% or above, and 42% with A1c of 10% or greater.
Patient characteristics independently associated with overbasalization were age 35-54 years (odds ratio 1.89), age 65-80 years (0.44), A1c 9% or greater (13.97), and A1c 10% or greater (6.04). Having a prescription for insulin glargine U-100 was associated with a lower overbasalization risk (0.62). In multivariate analysis, only an A1c of 9% or greater remained significant.
Rozalina G. McCoy, MD, an endocrinologist and primary care clinician at the Mayo Clinic, Rochester, Minn., said in an interview that she sees [overbasalization] frequently in patients who are referred to her. “It’s kind of that wall that patients with type 2 diabetes hit because their A1c is high but their fasting blood sugars are normal. Sometimes it’s assumed that there’s a discrepancy, because people don’t always think about postprandial hyperglycemia.”
She also noted that there has been a push in recent years to simplify regimens, particularly in older patients.
“We really want to avoid rapid-acting insulin in older patients because we’re afraid of hypoglycemia, so we start them on basal and keep the noninsulins like metformin and sulfonylureas around. Initially those control the postprandial blood sugar but over time they’re no longer enough.”
Options exist for addressing postmeal blood sugar highs while minimizing lows
While in the past adding premeal insulin was the only option, today there are alternatives for addressing postmeal hyperglycemia, at least in the short term.
Dr. Cowart advised that the first step is to have patients self-monitor their blood glucose and titrate their basal insulin to address fasting hyperglycemia first. Once that appropriate dose is reached, if the patient’s hemoglobin A1c is still above target, the next step is to evaluate the need for postmeal control.
For patients who are at high cardiovascular risk, the next step might involve adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) instead of premeal insulin. But for patients in whom overbasalization is the main concern, a GLP-1RA might be the better choice since it will have a greater impact on postprandial glucose levels, while an SGLT2i will have more effect on fasting blood sugar, he said.
Another option is to use a fixed-dose combination of basal insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA), provided there aren’t cost or formulary barriers. “We want to use the right combination of drugs and not use too much of one to lead to hypoglycemia,” Dr. Cowart said.
Dr. McCoy doesn’t use fixed-dose combinations because they don’t allow as much flexibility in dosing. To correct overbasalization, she also recommends adding either a GLP-1RA or SGLT2i instead of premeal insulin. However, she cautions, “you still have to monitor those patients because after a few years it still won’t be enough and you’ll have to add mealtime insulin.”
If cost or lack of coverage prevents a patient’s use of SLGT2i/GLP-1RAs, Dr. McCoy said that adding just one premeal injection of rapid-acting insulin before the largest meal of the day is one option. Another is to use twice-daily NPH insulin instead of analog basal insulin, since that does offer some postprandial coverage.
Dr. Cowart said his approach in cost barrier situations is to try to use patient assistance programs and to look into the patient’s formulary to see if there is step therapy or tier considerations, and maybe have a discussion with the insurance company. “We often have to navigate that, and it does take a significant amount of time and could potentially delay patients getting the right therapy when it’s warranted. That is an area where there is a particular role for pharmacists in helping to overcome that and get patients on the right drugs,” he explained.
Problem may be even more common; testing is key
Dr. McCoy said that the A1c cutoff of 8% used to define overbasalization in the study probably resulted in an underestimation of the problem, since many patients are experiencing nighttime hypoglycemia from the basal insulin. The lows bring down their A1c level, but they’re still experiencing postmeal highs.
“I think they’re missing a lot of people, to be honest. I see a lot of patients with A1cs that aren’t that bad, say 7.5%, and their fasting blood sugars are okay, but if you were to put a [continuous glucose monitor] on those patients, invariably there’s hypoglycemia at night that no one knew about.”
Of course, for insurance reasons, most people with type 2 diabetes don’t currently have access to continuous glucose monitors. And often those who are not taking multiple daily injections are limited to one fingerstick test strip a day.
Dr. McCoy says that if hypoglycemia is a concern she will write a prior authorization justifying more test strips.
“I state explicitly in my notes why I recommend frequent monitoring. If they’re on a sulfonylurea, they should be able to check more frequently because they can have hypoglycemia. Same thing with basal insulin.”
Dr. McCoy advises that patients test their blood sugar 2 hours after the largest meal on one day, and at other times on different days. “Blood glucose after a meal shouldn’t be more than 200 [mg/dL]. If it is, that’s not a failure of basal insulin. It’s doing its job. You just need a different agent.”
Dr. Cowart has no disclosures. Dr. McCoy receives funding from the National Institutes of Health.
that impedes achievement of optimal glycemic control, new research suggests.
Such ‘overbasalization,’ defined as a hemoglobin A1c of greater than 8% despite use of more than 0.5 units/kg per day of basal insulin, was identified in about 40% of patients seen in a Florida primary care clinic during 2015-2018. The findings were published in the April 2021 issue of Clinical Diabetes by Kevin Cowart, PharmD, a diabetes care and education specialist at the University of South Florida, Tampa, and colleagues.
The literature suggests that once people with type 2 diabetes start basal insulin, the chance that they’ll achieve a given hemoglobin A1c target, i.e., less than 7%, diminishes significantly if that goal isn’t achieved within the first year of starting insulin, Dr. Cowart said in an interview.
“Our analysis suggests that overbasalization plays a role in patients with type 2 diabetes on basal insulin not achieving optimal glycemic control. Basal insulin is not designed to address postprandial hyperglycemia. I think there’s a clear need to address hesitancy in therapeutic progression beyond basal insulin. A lot of factors underlie the delays, with therapeutic inertia being one of them. It’s complex,” he said.
Overbasalization seen in large proportion of patients
The study comprised 655 adults diagnosed with type 2 diabetes for at least a year who received a prescription for a basal insulin (glargine U-100, glargine U-300, detemir, degludec U-100, degludec U-200, regular U-500, or NPH insulin).
The patients had a mean hemoglobin A1c of 8.4% and a mean basal insulin dose 0.4 units/kg per day. The prevalence of overbasalization was 38.1% for those with hemoglobin A1c above 8%, 42.7% for those with A1c of 9% or above, and 42% with A1c of 10% or greater.
Patient characteristics independently associated with overbasalization were age 35-54 years (odds ratio 1.89), age 65-80 years (0.44), A1c 9% or greater (13.97), and A1c 10% or greater (6.04). Having a prescription for insulin glargine U-100 was associated with a lower overbasalization risk (0.62). In multivariate analysis, only an A1c of 9% or greater remained significant.
Rozalina G. McCoy, MD, an endocrinologist and primary care clinician at the Mayo Clinic, Rochester, Minn., said in an interview that she sees [overbasalization] frequently in patients who are referred to her. “It’s kind of that wall that patients with type 2 diabetes hit because their A1c is high but their fasting blood sugars are normal. Sometimes it’s assumed that there’s a discrepancy, because people don’t always think about postprandial hyperglycemia.”
She also noted that there has been a push in recent years to simplify regimens, particularly in older patients.
“We really want to avoid rapid-acting insulin in older patients because we’re afraid of hypoglycemia, so we start them on basal and keep the noninsulins like metformin and sulfonylureas around. Initially those control the postprandial blood sugar but over time they’re no longer enough.”
Options exist for addressing postmeal blood sugar highs while minimizing lows
While in the past adding premeal insulin was the only option, today there are alternatives for addressing postmeal hyperglycemia, at least in the short term.
Dr. Cowart advised that the first step is to have patients self-monitor their blood glucose and titrate their basal insulin to address fasting hyperglycemia first. Once that appropriate dose is reached, if the patient’s hemoglobin A1c is still above target, the next step is to evaluate the need for postmeal control.
For patients who are at high cardiovascular risk, the next step might involve adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) instead of premeal insulin. But for patients in whom overbasalization is the main concern, a GLP-1RA might be the better choice since it will have a greater impact on postprandial glucose levels, while an SGLT2i will have more effect on fasting blood sugar, he said.
Another option is to use a fixed-dose combination of basal insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA), provided there aren’t cost or formulary barriers. “We want to use the right combination of drugs and not use too much of one to lead to hypoglycemia,” Dr. Cowart said.
Dr. McCoy doesn’t use fixed-dose combinations because they don’t allow as much flexibility in dosing. To correct overbasalization, she also recommends adding either a GLP-1RA or SGLT2i instead of premeal insulin. However, she cautions, “you still have to monitor those patients because after a few years it still won’t be enough and you’ll have to add mealtime insulin.”
If cost or lack of coverage prevents a patient’s use of SLGT2i/GLP-1RAs, Dr. McCoy said that adding just one premeal injection of rapid-acting insulin before the largest meal of the day is one option. Another is to use twice-daily NPH insulin instead of analog basal insulin, since that does offer some postprandial coverage.
Dr. Cowart said his approach in cost barrier situations is to try to use patient assistance programs and to look into the patient’s formulary to see if there is step therapy or tier considerations, and maybe have a discussion with the insurance company. “We often have to navigate that, and it does take a significant amount of time and could potentially delay patients getting the right therapy when it’s warranted. That is an area where there is a particular role for pharmacists in helping to overcome that and get patients on the right drugs,” he explained.
Problem may be even more common; testing is key
Dr. McCoy said that the A1c cutoff of 8% used to define overbasalization in the study probably resulted in an underestimation of the problem, since many patients are experiencing nighttime hypoglycemia from the basal insulin. The lows bring down their A1c level, but they’re still experiencing postmeal highs.
“I think they’re missing a lot of people, to be honest. I see a lot of patients with A1cs that aren’t that bad, say 7.5%, and their fasting blood sugars are okay, but if you were to put a [continuous glucose monitor] on those patients, invariably there’s hypoglycemia at night that no one knew about.”
Of course, for insurance reasons, most people with type 2 diabetes don’t currently have access to continuous glucose monitors. And often those who are not taking multiple daily injections are limited to one fingerstick test strip a day.
Dr. McCoy says that if hypoglycemia is a concern she will write a prior authorization justifying more test strips.
“I state explicitly in my notes why I recommend frequent monitoring. If they’re on a sulfonylurea, they should be able to check more frequently because they can have hypoglycemia. Same thing with basal insulin.”
Dr. McCoy advises that patients test their blood sugar 2 hours after the largest meal on one day, and at other times on different days. “Blood glucose after a meal shouldn’t be more than 200 [mg/dL]. If it is, that’s not a failure of basal insulin. It’s doing its job. You just need a different agent.”
Dr. Cowart has no disclosures. Dr. McCoy receives funding from the National Institutes of Health.
that impedes achievement of optimal glycemic control, new research suggests.
Such ‘overbasalization,’ defined as a hemoglobin A1c of greater than 8% despite use of more than 0.5 units/kg per day of basal insulin, was identified in about 40% of patients seen in a Florida primary care clinic during 2015-2018. The findings were published in the April 2021 issue of Clinical Diabetes by Kevin Cowart, PharmD, a diabetes care and education specialist at the University of South Florida, Tampa, and colleagues.
The literature suggests that once people with type 2 diabetes start basal insulin, the chance that they’ll achieve a given hemoglobin A1c target, i.e., less than 7%, diminishes significantly if that goal isn’t achieved within the first year of starting insulin, Dr. Cowart said in an interview.
“Our analysis suggests that overbasalization plays a role in patients with type 2 diabetes on basal insulin not achieving optimal glycemic control. Basal insulin is not designed to address postprandial hyperglycemia. I think there’s a clear need to address hesitancy in therapeutic progression beyond basal insulin. A lot of factors underlie the delays, with therapeutic inertia being one of them. It’s complex,” he said.
Overbasalization seen in large proportion of patients
The study comprised 655 adults diagnosed with type 2 diabetes for at least a year who received a prescription for a basal insulin (glargine U-100, glargine U-300, detemir, degludec U-100, degludec U-200, regular U-500, or NPH insulin).
The patients had a mean hemoglobin A1c of 8.4% and a mean basal insulin dose 0.4 units/kg per day. The prevalence of overbasalization was 38.1% for those with hemoglobin A1c above 8%, 42.7% for those with A1c of 9% or above, and 42% with A1c of 10% or greater.
Patient characteristics independently associated with overbasalization were age 35-54 years (odds ratio 1.89), age 65-80 years (0.44), A1c 9% or greater (13.97), and A1c 10% or greater (6.04). Having a prescription for insulin glargine U-100 was associated with a lower overbasalization risk (0.62). In multivariate analysis, only an A1c of 9% or greater remained significant.
Rozalina G. McCoy, MD, an endocrinologist and primary care clinician at the Mayo Clinic, Rochester, Minn., said in an interview that she sees [overbasalization] frequently in patients who are referred to her. “It’s kind of that wall that patients with type 2 diabetes hit because their A1c is high but their fasting blood sugars are normal. Sometimes it’s assumed that there’s a discrepancy, because people don’t always think about postprandial hyperglycemia.”
She also noted that there has been a push in recent years to simplify regimens, particularly in older patients.
“We really want to avoid rapid-acting insulin in older patients because we’re afraid of hypoglycemia, so we start them on basal and keep the noninsulins like metformin and sulfonylureas around. Initially those control the postprandial blood sugar but over time they’re no longer enough.”
Options exist for addressing postmeal blood sugar highs while minimizing lows
While in the past adding premeal insulin was the only option, today there are alternatives for addressing postmeal hyperglycemia, at least in the short term.
Dr. Cowart advised that the first step is to have patients self-monitor their blood glucose and titrate their basal insulin to address fasting hyperglycemia first. Once that appropriate dose is reached, if the patient’s hemoglobin A1c is still above target, the next step is to evaluate the need for postmeal control.
For patients who are at high cardiovascular risk, the next step might involve adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) instead of premeal insulin. But for patients in whom overbasalization is the main concern, a GLP-1RA might be the better choice since it will have a greater impact on postprandial glucose levels, while an SGLT2i will have more effect on fasting blood sugar, he said.
Another option is to use a fixed-dose combination of basal insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA), provided there aren’t cost or formulary barriers. “We want to use the right combination of drugs and not use too much of one to lead to hypoglycemia,” Dr. Cowart said.
Dr. McCoy doesn’t use fixed-dose combinations because they don’t allow as much flexibility in dosing. To correct overbasalization, she also recommends adding either a GLP-1RA or SGLT2i instead of premeal insulin. However, she cautions, “you still have to monitor those patients because after a few years it still won’t be enough and you’ll have to add mealtime insulin.”
If cost or lack of coverage prevents a patient’s use of SLGT2i/GLP-1RAs, Dr. McCoy said that adding just one premeal injection of rapid-acting insulin before the largest meal of the day is one option. Another is to use twice-daily NPH insulin instead of analog basal insulin, since that does offer some postprandial coverage.
Dr. Cowart said his approach in cost barrier situations is to try to use patient assistance programs and to look into the patient’s formulary to see if there is step therapy or tier considerations, and maybe have a discussion with the insurance company. “We often have to navigate that, and it does take a significant amount of time and could potentially delay patients getting the right therapy when it’s warranted. That is an area where there is a particular role for pharmacists in helping to overcome that and get patients on the right drugs,” he explained.
Problem may be even more common; testing is key
Dr. McCoy said that the A1c cutoff of 8% used to define overbasalization in the study probably resulted in an underestimation of the problem, since many patients are experiencing nighttime hypoglycemia from the basal insulin. The lows bring down their A1c level, but they’re still experiencing postmeal highs.
“I think they’re missing a lot of people, to be honest. I see a lot of patients with A1cs that aren’t that bad, say 7.5%, and their fasting blood sugars are okay, but if you were to put a [continuous glucose monitor] on those patients, invariably there’s hypoglycemia at night that no one knew about.”
Of course, for insurance reasons, most people with type 2 diabetes don’t currently have access to continuous glucose monitors. And often those who are not taking multiple daily injections are limited to one fingerstick test strip a day.
Dr. McCoy says that if hypoglycemia is a concern she will write a prior authorization justifying more test strips.
“I state explicitly in my notes why I recommend frequent monitoring. If they’re on a sulfonylurea, they should be able to check more frequently because they can have hypoglycemia. Same thing with basal insulin.”
Dr. McCoy advises that patients test their blood sugar 2 hours after the largest meal on one day, and at other times on different days. “Blood glucose after a meal shouldn’t be more than 200 [mg/dL]. If it is, that’s not a failure of basal insulin. It’s doing its job. You just need a different agent.”
Dr. Cowart has no disclosures. Dr. McCoy receives funding from the National Institutes of Health.
FROM CLINICAL DIABETES
New allergy guidelines call for end to food bans in schools
Children with food allergies often require diligent monitoring and a restricted diet to reduce allergic attacks, but there is little evidence available to support so-called “food bans” at schools and childcare centers.
Instead, a new practice guideline published earlier this month in the Journal of Allergy and Clinical Immunology calls for better allergy management training for staff, as well as increased epinephrine availability in educational environments. The guidelines were developed by an international panel of clinicians, school personnel, and parents.
The guidance at a glance
Rather than creating site-wide food prohibitions on nuts, dairy, and other allergenic foods, the practice guidance recommends centers and schools use “common-sense approaches” to reduce allergic reaction risk among school-aged children. According to the guideline authors, these strategies could include promoting handwashing, providing adult supervision during snacks and meals, and cleaning surfaces where food is either eaten or prepared.
Additionally, the new evidence-based guidance calls for schools and childcare centers to teach school personnel to recognize, prevent, and respond appropriately to food-related allergic reactions when they do occur.
The guidance also recommends that educational institutions require an up-to-date allergy ‘action plan’ from parents, designed for their children with allergies. These action plans can be integrated into the training of teachers and nurses to help manage potential allergic reactions.
Moreover, the guidance suggests schools should keep unassigned epinephrine autoinjectors in stock, both on site and even when traveling, where laws permit, rather than requiring students with allergies to bring in their own autoinjectors. Ultimately, this represents a more proactive approach to treating anaphylaxis, particularly in settings where treatment is urgently needed, such as when students are away from campus and participating in a school-designated trip or event.
Expert perspectives
Jennifer A. Dantzer, MD, MHS, allergist-immunologist and assistant professor of pediatrics at Johns Hopkins University, Baltimore, told this news organization via email that the practice guidelines offer an important starting point for ensuring quality of life of students, parents, and other school personnel.
While the Centers for Disease Control and Prevention published voluntary guidance for managing food allergies in schools back in 2013, there has since “been a lack of universal policies and procedures to manage the risk of allergic reactions in schools,” explained Dr. Dantzer. “The new guidelines are a good first step of using available evidence and all the key stakeholders, clinicians, school personnel, and families to figure out the best way to keep children with food allergies safe at school.”
Dr. Dantzer wasn’t involved in the creation of the new practice guidelines, but she shared how her clinical experience reinforces the need for the evidence-based recommendations. “Every single week we talk with families, both in clinic and in our research studies, about living with food allergies, and we recognize that every child is different,” she said. “We constantly work to advocate for each individual child with food allergies.”
Pediatric allergist Malika Gupta, MBBS, MD, said in an interview via email that the guidelines could assist in the creation of new nationwide policies for food allergy management at schools. “Also, the guidelines are labeled ‘conditional,’ which gives policymakers the ability to adapt to their specific circumstances and individuals, as well as make modifications according to regional trends,” she added.
Dr. Gupta, a clinical assistant professor in the Division of Allergy and Clinical Immunology at the University of Michigan, Ann Arbor, echoed the guideline panel’s sentiments regarding food bans, explaining that prohibiting certain foods could lend a “false sense of security” and could also “promote bullying and a sense of isolation for the food-allergic child.” In spite of the lack of evidence supporting food bans, Dr. Gupta noted that these bans can give families a sense of control and security. Ideally, more research should be performed to determine whether food bans actually work, she added.
In addition to promoting the new guidelines, allergists and pediatricians can also implement proactive allergy reaction mitigation strategies that work with school systems, according to Dr. Gupta. “In-clinic, we ensure all families have food allergy action plans for school and current epinephrine auto-injectors,” she said. “We also often have our food allergy nurses educate schools when food allergy awareness is a concern.”
Many of the 25 authors of the food allergy guidelines disclosed relevant financial relationships. The full list is with the original article. According to a footnote within the guidelines, “Panel members who were deemed to have a real, perceived, or potential conflict of interest were asked to abstain from voting on recommendations related to that interest.”
A version of this article first appeared on Medscape.com.
Children with food allergies often require diligent monitoring and a restricted diet to reduce allergic attacks, but there is little evidence available to support so-called “food bans” at schools and childcare centers.
Instead, a new practice guideline published earlier this month in the Journal of Allergy and Clinical Immunology calls for better allergy management training for staff, as well as increased epinephrine availability in educational environments. The guidelines were developed by an international panel of clinicians, school personnel, and parents.
The guidance at a glance
Rather than creating site-wide food prohibitions on nuts, dairy, and other allergenic foods, the practice guidance recommends centers and schools use “common-sense approaches” to reduce allergic reaction risk among school-aged children. According to the guideline authors, these strategies could include promoting handwashing, providing adult supervision during snacks and meals, and cleaning surfaces where food is either eaten or prepared.
Additionally, the new evidence-based guidance calls for schools and childcare centers to teach school personnel to recognize, prevent, and respond appropriately to food-related allergic reactions when they do occur.
The guidance also recommends that educational institutions require an up-to-date allergy ‘action plan’ from parents, designed for their children with allergies. These action plans can be integrated into the training of teachers and nurses to help manage potential allergic reactions.
Moreover, the guidance suggests schools should keep unassigned epinephrine autoinjectors in stock, both on site and even when traveling, where laws permit, rather than requiring students with allergies to bring in their own autoinjectors. Ultimately, this represents a more proactive approach to treating anaphylaxis, particularly in settings where treatment is urgently needed, such as when students are away from campus and participating in a school-designated trip or event.
Expert perspectives
Jennifer A. Dantzer, MD, MHS, allergist-immunologist and assistant professor of pediatrics at Johns Hopkins University, Baltimore, told this news organization via email that the practice guidelines offer an important starting point for ensuring quality of life of students, parents, and other school personnel.
While the Centers for Disease Control and Prevention published voluntary guidance for managing food allergies in schools back in 2013, there has since “been a lack of universal policies and procedures to manage the risk of allergic reactions in schools,” explained Dr. Dantzer. “The new guidelines are a good first step of using available evidence and all the key stakeholders, clinicians, school personnel, and families to figure out the best way to keep children with food allergies safe at school.”
Dr. Dantzer wasn’t involved in the creation of the new practice guidelines, but she shared how her clinical experience reinforces the need for the evidence-based recommendations. “Every single week we talk with families, both in clinic and in our research studies, about living with food allergies, and we recognize that every child is different,” she said. “We constantly work to advocate for each individual child with food allergies.”
Pediatric allergist Malika Gupta, MBBS, MD, said in an interview via email that the guidelines could assist in the creation of new nationwide policies for food allergy management at schools. “Also, the guidelines are labeled ‘conditional,’ which gives policymakers the ability to adapt to their specific circumstances and individuals, as well as make modifications according to regional trends,” she added.
Dr. Gupta, a clinical assistant professor in the Division of Allergy and Clinical Immunology at the University of Michigan, Ann Arbor, echoed the guideline panel’s sentiments regarding food bans, explaining that prohibiting certain foods could lend a “false sense of security” and could also “promote bullying and a sense of isolation for the food-allergic child.” In spite of the lack of evidence supporting food bans, Dr. Gupta noted that these bans can give families a sense of control and security. Ideally, more research should be performed to determine whether food bans actually work, she added.
In addition to promoting the new guidelines, allergists and pediatricians can also implement proactive allergy reaction mitigation strategies that work with school systems, according to Dr. Gupta. “In-clinic, we ensure all families have food allergy action plans for school and current epinephrine auto-injectors,” she said. “We also often have our food allergy nurses educate schools when food allergy awareness is a concern.”
Many of the 25 authors of the food allergy guidelines disclosed relevant financial relationships. The full list is with the original article. According to a footnote within the guidelines, “Panel members who were deemed to have a real, perceived, or potential conflict of interest were asked to abstain from voting on recommendations related to that interest.”
A version of this article first appeared on Medscape.com.
Children with food allergies often require diligent monitoring and a restricted diet to reduce allergic attacks, but there is little evidence available to support so-called “food bans” at schools and childcare centers.
Instead, a new practice guideline published earlier this month in the Journal of Allergy and Clinical Immunology calls for better allergy management training for staff, as well as increased epinephrine availability in educational environments. The guidelines were developed by an international panel of clinicians, school personnel, and parents.
The guidance at a glance
Rather than creating site-wide food prohibitions on nuts, dairy, and other allergenic foods, the practice guidance recommends centers and schools use “common-sense approaches” to reduce allergic reaction risk among school-aged children. According to the guideline authors, these strategies could include promoting handwashing, providing adult supervision during snacks and meals, and cleaning surfaces where food is either eaten or prepared.
Additionally, the new evidence-based guidance calls for schools and childcare centers to teach school personnel to recognize, prevent, and respond appropriately to food-related allergic reactions when they do occur.
The guidance also recommends that educational institutions require an up-to-date allergy ‘action plan’ from parents, designed for their children with allergies. These action plans can be integrated into the training of teachers and nurses to help manage potential allergic reactions.
Moreover, the guidance suggests schools should keep unassigned epinephrine autoinjectors in stock, both on site and even when traveling, where laws permit, rather than requiring students with allergies to bring in their own autoinjectors. Ultimately, this represents a more proactive approach to treating anaphylaxis, particularly in settings where treatment is urgently needed, such as when students are away from campus and participating in a school-designated trip or event.
Expert perspectives
Jennifer A. Dantzer, MD, MHS, allergist-immunologist and assistant professor of pediatrics at Johns Hopkins University, Baltimore, told this news organization via email that the practice guidelines offer an important starting point for ensuring quality of life of students, parents, and other school personnel.
While the Centers for Disease Control and Prevention published voluntary guidance for managing food allergies in schools back in 2013, there has since “been a lack of universal policies and procedures to manage the risk of allergic reactions in schools,” explained Dr. Dantzer. “The new guidelines are a good first step of using available evidence and all the key stakeholders, clinicians, school personnel, and families to figure out the best way to keep children with food allergies safe at school.”
Dr. Dantzer wasn’t involved in the creation of the new practice guidelines, but she shared how her clinical experience reinforces the need for the evidence-based recommendations. “Every single week we talk with families, both in clinic and in our research studies, about living with food allergies, and we recognize that every child is different,” she said. “We constantly work to advocate for each individual child with food allergies.”
Pediatric allergist Malika Gupta, MBBS, MD, said in an interview via email that the guidelines could assist in the creation of new nationwide policies for food allergy management at schools. “Also, the guidelines are labeled ‘conditional,’ which gives policymakers the ability to adapt to their specific circumstances and individuals, as well as make modifications according to regional trends,” she added.
Dr. Gupta, a clinical assistant professor in the Division of Allergy and Clinical Immunology at the University of Michigan, Ann Arbor, echoed the guideline panel’s sentiments regarding food bans, explaining that prohibiting certain foods could lend a “false sense of security” and could also “promote bullying and a sense of isolation for the food-allergic child.” In spite of the lack of evidence supporting food bans, Dr. Gupta noted that these bans can give families a sense of control and security. Ideally, more research should be performed to determine whether food bans actually work, she added.
In addition to promoting the new guidelines, allergists and pediatricians can also implement proactive allergy reaction mitigation strategies that work with school systems, according to Dr. Gupta. “In-clinic, we ensure all families have food allergy action plans for school and current epinephrine auto-injectors,” she said. “We also often have our food allergy nurses educate schools when food allergy awareness is a concern.”
Many of the 25 authors of the food allergy guidelines disclosed relevant financial relationships. The full list is with the original article. According to a footnote within the guidelines, “Panel members who were deemed to have a real, perceived, or potential conflict of interest were asked to abstain from voting on recommendations related to that interest.”
A version of this article first appeared on Medscape.com.
COVID-19 vaccination rate rising quickly among adolescents
With nearly half of all Americans having received at least one dose of a COVID-19 vaccine, the youngest eligible group is beginning to overcome its late start, according to data from the Centers for Disease Control and Prevention.
As of May 24, 49.4% of the U.S. population – that’s almost 164 million people – has received at least one dose of vaccine. The corresponding figure for children aged 12-15 years is 14.4%, but that’s up from only 0.6% just 3 weeks before. Among children aged 16-17, who’ve been getting vaccinated since early April in some states, the proportion receiving at least one dose went from 24.9% to 33.9% over those same 3 weeks, the CDC said on its COVID Data Tracker site.
The comparatively rapid increase among the younger group of eligible children can be seen over the last 14 days. To put that into perspective, only those aged 25-39 years were higher at 21.9%, while 18-24 (12.1%), 40-49 (13.4%), 50-64 (18.2%), 65-74 (5.3%), and ≥75 (2.9%) were all lower.
The 12- to 15-year-olds are further behind when it comes to full vaccination status, however, with just 0.6% having received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 21.6% for those aged 16-17 years. Children aged 12-15 make up 5% of the total U.S. population but just 0.1% of all those who have been fully vaccinated versus 2.5% and 1.4%, respectively, for those aged 16-17, the CDC reported.
With nearly half of all Americans having received at least one dose of a COVID-19 vaccine, the youngest eligible group is beginning to overcome its late start, according to data from the Centers for Disease Control and Prevention.
As of May 24, 49.4% of the U.S. population – that’s almost 164 million people – has received at least one dose of vaccine. The corresponding figure for children aged 12-15 years is 14.4%, but that’s up from only 0.6% just 3 weeks before. Among children aged 16-17, who’ve been getting vaccinated since early April in some states, the proportion receiving at least one dose went from 24.9% to 33.9% over those same 3 weeks, the CDC said on its COVID Data Tracker site.
The comparatively rapid increase among the younger group of eligible children can be seen over the last 14 days. To put that into perspective, only those aged 25-39 years were higher at 21.9%, while 18-24 (12.1%), 40-49 (13.4%), 50-64 (18.2%), 65-74 (5.3%), and ≥75 (2.9%) were all lower.
The 12- to 15-year-olds are further behind when it comes to full vaccination status, however, with just 0.6% having received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 21.6% for those aged 16-17 years. Children aged 12-15 make up 5% of the total U.S. population but just 0.1% of all those who have been fully vaccinated versus 2.5% and 1.4%, respectively, for those aged 16-17, the CDC reported.
With nearly half of all Americans having received at least one dose of a COVID-19 vaccine, the youngest eligible group is beginning to overcome its late start, according to data from the Centers for Disease Control and Prevention.
As of May 24, 49.4% of the U.S. population – that’s almost 164 million people – has received at least one dose of vaccine. The corresponding figure for children aged 12-15 years is 14.4%, but that’s up from only 0.6% just 3 weeks before. Among children aged 16-17, who’ve been getting vaccinated since early April in some states, the proportion receiving at least one dose went from 24.9% to 33.9% over those same 3 weeks, the CDC said on its COVID Data Tracker site.
The comparatively rapid increase among the younger group of eligible children can be seen over the last 14 days. To put that into perspective, only those aged 25-39 years were higher at 21.9%, while 18-24 (12.1%), 40-49 (13.4%), 50-64 (18.2%), 65-74 (5.3%), and ≥75 (2.9%) were all lower.
The 12- to 15-year-olds are further behind when it comes to full vaccination status, however, with just 0.6% having received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 21.6% for those aged 16-17 years. Children aged 12-15 make up 5% of the total U.S. population but just 0.1% of all those who have been fully vaccinated versus 2.5% and 1.4%, respectively, for those aged 16-17, the CDC reported.
Tezepelumab reduces serious exacerbations in severe asthma
Results from the NAVIGATOR study of tezepelumab showed that treatment of adults and adolescents with severe, uncontrolled asthma with the new biologic led to a large reduction in exacerbations requiring hospital stays and ED visits.
Tezepelumab, codeveloped by Amgen and AstraZeneca, has a novel mechanism of action. It blocks thymic stromal lymphopoietin (TSLP), which is a cytokine produced by epithelial cells. TSLP levels correlate with airway obstruction, severity of disease, and glucocorticoid resistance. TSLP is involved in T2 inflammation within the airway, but also plays a role in the interactions between airway cells and immune cells, which doesn’t rely only solely on T2 inflammation. That broad mechanism of action distinguishes tezepelumab from most other biologics for the treatment of asthma, which are more targeted.
“By working at the top of the cascade, tezepelumab helps stop inflammation at a key source. Clinical trials with tezepelumab showed a clinical benefit in patients irrespective of their baseline biomarker level, including patients with low eosinophil levels at baseline,” said Jean-Pierre Llanos-Ackert, MD, who is executive medical director and global medical affairs lead for tezepelumab at Amgen.
The primary endpoint data look robust, according to Praveen Akuthota, MD, who is an associate professor of medicine at the University of California, San Diego, and comoderated the session at the American Thoracic Society’s virtual international conference, where the research was presented. The study was also published on May 13, 2021, in the New England Journal of Medicine. The conference session included updated results.
The drug holds promise, but more study is needed. “The question really will be, how is this drug different from the existing biologics? How much better is this drug in patients who have borderline T2 biomarkers, or even low T2. The study does show some efficacy in patients whose T2 signals may not be as robust. We’ll have to see with ongoing longitudinal data, how this drug positions, compared to the other agents. It’s obviously exciting, though, to have another option, given that we know what our current armamentarium of agents there are still nonresponders,” said Dr. Akuthota in an interview.
The other comoderator in the session, Laura Crotty Alexander, MD, commented: “It seems like it might work possibly even better than some that are directly covering one pathway only. Hopefully, this agent will be efficacious in a broader population than some of the more targeted biologics.” Dr. Alexander is an associate professor of medicine at the University of California, San Diego, and section chief of pulmonary critical care at the Veterans Affairs San Diego Healthcare System.
She pointed out that physicians often think of asthma patients in broad brush terms, as high or low T2, or T2 high and Th1 or neutrophilic or obese, but many patients present a more complicated picture. “There is some overlap across those phenotypes, such that an agent that works really well for one group doesn’t mean that it won’t have an impact, especially clinically, on some of these other phenotypes,” said Dr. Alexander.
Dr. Akuthota agreed. “Having options for patients whose biomarkers are not maybe as clear is, I think, important.”
Promising results
The study included 1,059 patients aged 12-80 who received 210 mg tezepelumab or placebo. Over 52 weeks, the treatment group had a 79% reduction in exacerbations requiring hospitalization or an ED visit, compared with placebo (rate ratio, 0.21; 95% confidence interval, 0.12-0.37), and an 85% reduction in exacerbations requiring hospitalization (RR, 0.15; 95% CI, 0.07-0.33). The drug increased the time to first exacerbation requiring hospitalization that required hospitalization or an ED visit, reducing risk by 65% (hazard ratio, 0.35; 95% CI, 0.22-0.56).
Fewer patients in the treatment group than placebo used asthma-related health care resources, including: ED visits (32 vs. 94), unscheduled visit to a specialist (285 vs. 406), telephone calls to a health care provider (234 vs. 599), ambulance transport (5 vs. 22), and home visits from a health care provider (18 vs. 22). Fewer patients in the tezepelumab group had hospital stays (3.2% vs. 7.0%), and they had a lower total number of hospital days (108 vs. 497) and days in the ICU (0 vs. 31).
The study was funded by Amgen and AstraZeneca. Dr. Llanos-Ackert is an employee of Amgen. Dr. Alexander has no relevant financial disclosures. Dr. Akuthota has consulted for AstraZeneca and participated in their clinical trials.
Results from the NAVIGATOR study of tezepelumab showed that treatment of adults and adolescents with severe, uncontrolled asthma with the new biologic led to a large reduction in exacerbations requiring hospital stays and ED visits.
Tezepelumab, codeveloped by Amgen and AstraZeneca, has a novel mechanism of action. It blocks thymic stromal lymphopoietin (TSLP), which is a cytokine produced by epithelial cells. TSLP levels correlate with airway obstruction, severity of disease, and glucocorticoid resistance. TSLP is involved in T2 inflammation within the airway, but also plays a role in the interactions between airway cells and immune cells, which doesn’t rely only solely on T2 inflammation. That broad mechanism of action distinguishes tezepelumab from most other biologics for the treatment of asthma, which are more targeted.
“By working at the top of the cascade, tezepelumab helps stop inflammation at a key source. Clinical trials with tezepelumab showed a clinical benefit in patients irrespective of their baseline biomarker level, including patients with low eosinophil levels at baseline,” said Jean-Pierre Llanos-Ackert, MD, who is executive medical director and global medical affairs lead for tezepelumab at Amgen.
The primary endpoint data look robust, according to Praveen Akuthota, MD, who is an associate professor of medicine at the University of California, San Diego, and comoderated the session at the American Thoracic Society’s virtual international conference, where the research was presented. The study was also published on May 13, 2021, in the New England Journal of Medicine. The conference session included updated results.
The drug holds promise, but more study is needed. “The question really will be, how is this drug different from the existing biologics? How much better is this drug in patients who have borderline T2 biomarkers, or even low T2. The study does show some efficacy in patients whose T2 signals may not be as robust. We’ll have to see with ongoing longitudinal data, how this drug positions, compared to the other agents. It’s obviously exciting, though, to have another option, given that we know what our current armamentarium of agents there are still nonresponders,” said Dr. Akuthota in an interview.
The other comoderator in the session, Laura Crotty Alexander, MD, commented: “It seems like it might work possibly even better than some that are directly covering one pathway only. Hopefully, this agent will be efficacious in a broader population than some of the more targeted biologics.” Dr. Alexander is an associate professor of medicine at the University of California, San Diego, and section chief of pulmonary critical care at the Veterans Affairs San Diego Healthcare System.
She pointed out that physicians often think of asthma patients in broad brush terms, as high or low T2, or T2 high and Th1 or neutrophilic or obese, but many patients present a more complicated picture. “There is some overlap across those phenotypes, such that an agent that works really well for one group doesn’t mean that it won’t have an impact, especially clinically, on some of these other phenotypes,” said Dr. Alexander.
Dr. Akuthota agreed. “Having options for patients whose biomarkers are not maybe as clear is, I think, important.”
Promising results
The study included 1,059 patients aged 12-80 who received 210 mg tezepelumab or placebo. Over 52 weeks, the treatment group had a 79% reduction in exacerbations requiring hospitalization or an ED visit, compared with placebo (rate ratio, 0.21; 95% confidence interval, 0.12-0.37), and an 85% reduction in exacerbations requiring hospitalization (RR, 0.15; 95% CI, 0.07-0.33). The drug increased the time to first exacerbation requiring hospitalization that required hospitalization or an ED visit, reducing risk by 65% (hazard ratio, 0.35; 95% CI, 0.22-0.56).
Fewer patients in the treatment group than placebo used asthma-related health care resources, including: ED visits (32 vs. 94), unscheduled visit to a specialist (285 vs. 406), telephone calls to a health care provider (234 vs. 599), ambulance transport (5 vs. 22), and home visits from a health care provider (18 vs. 22). Fewer patients in the tezepelumab group had hospital stays (3.2% vs. 7.0%), and they had a lower total number of hospital days (108 vs. 497) and days in the ICU (0 vs. 31).
The study was funded by Amgen and AstraZeneca. Dr. Llanos-Ackert is an employee of Amgen. Dr. Alexander has no relevant financial disclosures. Dr. Akuthota has consulted for AstraZeneca and participated in their clinical trials.
Results from the NAVIGATOR study of tezepelumab showed that treatment of adults and adolescents with severe, uncontrolled asthma with the new biologic led to a large reduction in exacerbations requiring hospital stays and ED visits.
Tezepelumab, codeveloped by Amgen and AstraZeneca, has a novel mechanism of action. It blocks thymic stromal lymphopoietin (TSLP), which is a cytokine produced by epithelial cells. TSLP levels correlate with airway obstruction, severity of disease, and glucocorticoid resistance. TSLP is involved in T2 inflammation within the airway, but also plays a role in the interactions between airway cells and immune cells, which doesn’t rely only solely on T2 inflammation. That broad mechanism of action distinguishes tezepelumab from most other biologics for the treatment of asthma, which are more targeted.
“By working at the top of the cascade, tezepelumab helps stop inflammation at a key source. Clinical trials with tezepelumab showed a clinical benefit in patients irrespective of their baseline biomarker level, including patients with low eosinophil levels at baseline,” said Jean-Pierre Llanos-Ackert, MD, who is executive medical director and global medical affairs lead for tezepelumab at Amgen.
The primary endpoint data look robust, according to Praveen Akuthota, MD, who is an associate professor of medicine at the University of California, San Diego, and comoderated the session at the American Thoracic Society’s virtual international conference, where the research was presented. The study was also published on May 13, 2021, in the New England Journal of Medicine. The conference session included updated results.
The drug holds promise, but more study is needed. “The question really will be, how is this drug different from the existing biologics? How much better is this drug in patients who have borderline T2 biomarkers, or even low T2. The study does show some efficacy in patients whose T2 signals may not be as robust. We’ll have to see with ongoing longitudinal data, how this drug positions, compared to the other agents. It’s obviously exciting, though, to have another option, given that we know what our current armamentarium of agents there are still nonresponders,” said Dr. Akuthota in an interview.
The other comoderator in the session, Laura Crotty Alexander, MD, commented: “It seems like it might work possibly even better than some that are directly covering one pathway only. Hopefully, this agent will be efficacious in a broader population than some of the more targeted biologics.” Dr. Alexander is an associate professor of medicine at the University of California, San Diego, and section chief of pulmonary critical care at the Veterans Affairs San Diego Healthcare System.
She pointed out that physicians often think of asthma patients in broad brush terms, as high or low T2, or T2 high and Th1 or neutrophilic or obese, but many patients present a more complicated picture. “There is some overlap across those phenotypes, such that an agent that works really well for one group doesn’t mean that it won’t have an impact, especially clinically, on some of these other phenotypes,” said Dr. Alexander.
Dr. Akuthota agreed. “Having options for patients whose biomarkers are not maybe as clear is, I think, important.”
Promising results
The study included 1,059 patients aged 12-80 who received 210 mg tezepelumab or placebo. Over 52 weeks, the treatment group had a 79% reduction in exacerbations requiring hospitalization or an ED visit, compared with placebo (rate ratio, 0.21; 95% confidence interval, 0.12-0.37), and an 85% reduction in exacerbations requiring hospitalization (RR, 0.15; 95% CI, 0.07-0.33). The drug increased the time to first exacerbation requiring hospitalization that required hospitalization or an ED visit, reducing risk by 65% (hazard ratio, 0.35; 95% CI, 0.22-0.56).
Fewer patients in the treatment group than placebo used asthma-related health care resources, including: ED visits (32 vs. 94), unscheduled visit to a specialist (285 vs. 406), telephone calls to a health care provider (234 vs. 599), ambulance transport (5 vs. 22), and home visits from a health care provider (18 vs. 22). Fewer patients in the tezepelumab group had hospital stays (3.2% vs. 7.0%), and they had a lower total number of hospital days (108 vs. 497) and days in the ICU (0 vs. 31).
The study was funded by Amgen and AstraZeneca. Dr. Llanos-Ackert is an employee of Amgen. Dr. Alexander has no relevant financial disclosures. Dr. Akuthota has consulted for AstraZeneca and participated in their clinical trials.
FROM ATS 2021
Skip routine probiotics for preemies, AAP says
The American Academy of Pediatrics now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1,000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis.
Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the Food and Drug Administration.
Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center’s flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety.
The AAP’s clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country.
Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. “Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing,” wrote Brenda Poindexter, MD, FAAP, chief of neonatology at Children’s Healthcare of Atlanta, and members of the AAP’s Committee on Fetus and Newborn.
Analyses of U.S. collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions.
“NEC is a devastating morbidity of prematurity, and it’s multifactorial. Some babies only given mother’s milk still get NEC, and the decision to use these products is a very nuanced one,” Dr. Poindexter said in an interview. “I suspect some people will disagree with the report, and we tried to give folks some wiggle room.”
Evidence from other countries suggests that probiotics can be protective against NEC, she added, “so not to have a reliable product in this country is very frustrating.”
Dr. Poindexter and colleagues pointed to a 2015 study that found that only 1 of 16 commercial products tested contained the exact organisms listed on their labels. One product contained none of the species listed on the label.
In light of increasing use, the AAP emphasizes the need for development of pharmaceutical-grade probiotics that would be rigorously evaluated for safety and efficacy.
The infant microbiome
Over the past decade, the gut microbiome has been increasingly recognized as a factor relevant to health and disease in preterm infants, the authors noted. Differences in the intestinal microbiota between full-term and preterm infants are substantial. The microbiome of preterm infants tends to include fewer bacterial species and greater proportions of potentially pathogenic strains.
Evidence of benefit from probiotics has been mixed. Some studies and pooled systematic analyses suggest a significant benefit. However, Dr. Poindexter and colleagues noted that some researchers express concerns about the study methods used, such as pooling results from trials that tested different probiotic strains or that had few infants in the highest risk category.
Whereas the potential for probiotic-related infection appears low, there does seem to be some risk for sepsis associated with colonization by a strain in a given product or from contamination with a pathogen during manufacturing, the report explains.
At least one trial found that a third of infants randomly assigned to receive placebo showed evidence of the probiotic strain.
“However, it may be difficult to distinguish the change in the infant from the change in the resident flora of the NICU,” the AAP panel wrote.
In addition, there have recently been several recalls of dietary supplement–grade probiotics for contamination, which have raised concerns. Pathogens include Salmonella, Rhizopus, and Penicillium species. Fatal gastrointestinal mucormycosis has also been reported in a preterm infant who received ABC Dophilus powder that was contaminated with the microfungus Rhizopus oryzae.
Other safety considerations, according to the authors, are the unknown longer-term effect of probiotics on preterm infants and the unknown impact of microorganisms on the microbiome over time.
Last year, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition published a position paper with a conditional recommendation for selected probiotics to reduce NEC rates. “These guidelines would be applicable in the U.S. if we had products manufactured in a way that could guarantee that what’s on the label is in the bottle,” Dr. Poindexter said.
Asked for her perspective on the AAP clinical report, Erica Wymore, MD, assistant professor of neonatal and perinatal medicine at the University of Colorado at Denver, Aurora, called it “an excellent review of the current literature” that shows the inadequacy of data on the composition, dosage, timing, duration, and use of single-strain vs. multiple-strain probiotics to reduce NEC. Her clinical center, Children’s Hospital Colorado, does not administer probiotics to preterm babies.
Although guidelines can improve outcomes, said Dr. Wymore, who was not involved in the AAP report, improvement observed with probiotics results from more stringent care in centers that experience high NEC rates. “It’s hard to know if it’s due to the probiotics if they already have a high rate of NEC,” Dr. Wymore said.
She echoed the AAP’s position and stressed the need for extreme caution in giving these products to vulnerable infants with immature immune systems. Before that can be safely done, she said, “we need more FDA oversight of product composition [and] pharmaceutical-grade products, and more studies to determine efficacy.”
Added Dr. Poindexter: “Hopefully, this report will inform clinicians of the risks of using non–pharmaceutical-grade products and encourage industry to actually develop probiotics for neonates that we can feel comfortable using.”
The report received no external funding. Dr. Poindexter and Dr. Wymore have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The American Academy of Pediatrics now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1,000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis.
Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the Food and Drug Administration.
Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center’s flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety.
The AAP’s clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country.
Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. “Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing,” wrote Brenda Poindexter, MD, FAAP, chief of neonatology at Children’s Healthcare of Atlanta, and members of the AAP’s Committee on Fetus and Newborn.
Analyses of U.S. collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions.
“NEC is a devastating morbidity of prematurity, and it’s multifactorial. Some babies only given mother’s milk still get NEC, and the decision to use these products is a very nuanced one,” Dr. Poindexter said in an interview. “I suspect some people will disagree with the report, and we tried to give folks some wiggle room.”
Evidence from other countries suggests that probiotics can be protective against NEC, she added, “so not to have a reliable product in this country is very frustrating.”
Dr. Poindexter and colleagues pointed to a 2015 study that found that only 1 of 16 commercial products tested contained the exact organisms listed on their labels. One product contained none of the species listed on the label.
In light of increasing use, the AAP emphasizes the need for development of pharmaceutical-grade probiotics that would be rigorously evaluated for safety and efficacy.
The infant microbiome
Over the past decade, the gut microbiome has been increasingly recognized as a factor relevant to health and disease in preterm infants, the authors noted. Differences in the intestinal microbiota between full-term and preterm infants are substantial. The microbiome of preterm infants tends to include fewer bacterial species and greater proportions of potentially pathogenic strains.
Evidence of benefit from probiotics has been mixed. Some studies and pooled systematic analyses suggest a significant benefit. However, Dr. Poindexter and colleagues noted that some researchers express concerns about the study methods used, such as pooling results from trials that tested different probiotic strains or that had few infants in the highest risk category.
Whereas the potential for probiotic-related infection appears low, there does seem to be some risk for sepsis associated with colonization by a strain in a given product or from contamination with a pathogen during manufacturing, the report explains.
At least one trial found that a third of infants randomly assigned to receive placebo showed evidence of the probiotic strain.
“However, it may be difficult to distinguish the change in the infant from the change in the resident flora of the NICU,” the AAP panel wrote.
In addition, there have recently been several recalls of dietary supplement–grade probiotics for contamination, which have raised concerns. Pathogens include Salmonella, Rhizopus, and Penicillium species. Fatal gastrointestinal mucormycosis has also been reported in a preterm infant who received ABC Dophilus powder that was contaminated with the microfungus Rhizopus oryzae.
Other safety considerations, according to the authors, are the unknown longer-term effect of probiotics on preterm infants and the unknown impact of microorganisms on the microbiome over time.
Last year, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition published a position paper with a conditional recommendation for selected probiotics to reduce NEC rates. “These guidelines would be applicable in the U.S. if we had products manufactured in a way that could guarantee that what’s on the label is in the bottle,” Dr. Poindexter said.
Asked for her perspective on the AAP clinical report, Erica Wymore, MD, assistant professor of neonatal and perinatal medicine at the University of Colorado at Denver, Aurora, called it “an excellent review of the current literature” that shows the inadequacy of data on the composition, dosage, timing, duration, and use of single-strain vs. multiple-strain probiotics to reduce NEC. Her clinical center, Children’s Hospital Colorado, does not administer probiotics to preterm babies.
Although guidelines can improve outcomes, said Dr. Wymore, who was not involved in the AAP report, improvement observed with probiotics results from more stringent care in centers that experience high NEC rates. “It’s hard to know if it’s due to the probiotics if they already have a high rate of NEC,” Dr. Wymore said.
She echoed the AAP’s position and stressed the need for extreme caution in giving these products to vulnerable infants with immature immune systems. Before that can be safely done, she said, “we need more FDA oversight of product composition [and] pharmaceutical-grade products, and more studies to determine efficacy.”
Added Dr. Poindexter: “Hopefully, this report will inform clinicians of the risks of using non–pharmaceutical-grade products and encourage industry to actually develop probiotics for neonates that we can feel comfortable using.”
The report received no external funding. Dr. Poindexter and Dr. Wymore have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The American Academy of Pediatrics now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1,000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis.
Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the Food and Drug Administration.
Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center’s flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety.
The AAP’s clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country.
Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. “Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing,” wrote Brenda Poindexter, MD, FAAP, chief of neonatology at Children’s Healthcare of Atlanta, and members of the AAP’s Committee on Fetus and Newborn.
Analyses of U.S. collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions.
“NEC is a devastating morbidity of prematurity, and it’s multifactorial. Some babies only given mother’s milk still get NEC, and the decision to use these products is a very nuanced one,” Dr. Poindexter said in an interview. “I suspect some people will disagree with the report, and we tried to give folks some wiggle room.”
Evidence from other countries suggests that probiotics can be protective against NEC, she added, “so not to have a reliable product in this country is very frustrating.”
Dr. Poindexter and colleagues pointed to a 2015 study that found that only 1 of 16 commercial products tested contained the exact organisms listed on their labels. One product contained none of the species listed on the label.
In light of increasing use, the AAP emphasizes the need for development of pharmaceutical-grade probiotics that would be rigorously evaluated for safety and efficacy.
The infant microbiome
Over the past decade, the gut microbiome has been increasingly recognized as a factor relevant to health and disease in preterm infants, the authors noted. Differences in the intestinal microbiota between full-term and preterm infants are substantial. The microbiome of preterm infants tends to include fewer bacterial species and greater proportions of potentially pathogenic strains.
Evidence of benefit from probiotics has been mixed. Some studies and pooled systematic analyses suggest a significant benefit. However, Dr. Poindexter and colleagues noted that some researchers express concerns about the study methods used, such as pooling results from trials that tested different probiotic strains or that had few infants in the highest risk category.
Whereas the potential for probiotic-related infection appears low, there does seem to be some risk for sepsis associated with colonization by a strain in a given product or from contamination with a pathogen during manufacturing, the report explains.
At least one trial found that a third of infants randomly assigned to receive placebo showed evidence of the probiotic strain.
“However, it may be difficult to distinguish the change in the infant from the change in the resident flora of the NICU,” the AAP panel wrote.
In addition, there have recently been several recalls of dietary supplement–grade probiotics for contamination, which have raised concerns. Pathogens include Salmonella, Rhizopus, and Penicillium species. Fatal gastrointestinal mucormycosis has also been reported in a preterm infant who received ABC Dophilus powder that was contaminated with the microfungus Rhizopus oryzae.
Other safety considerations, according to the authors, are the unknown longer-term effect of probiotics on preterm infants and the unknown impact of microorganisms on the microbiome over time.
Last year, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition published a position paper with a conditional recommendation for selected probiotics to reduce NEC rates. “These guidelines would be applicable in the U.S. if we had products manufactured in a way that could guarantee that what’s on the label is in the bottle,” Dr. Poindexter said.
Asked for her perspective on the AAP clinical report, Erica Wymore, MD, assistant professor of neonatal and perinatal medicine at the University of Colorado at Denver, Aurora, called it “an excellent review of the current literature” that shows the inadequacy of data on the composition, dosage, timing, duration, and use of single-strain vs. multiple-strain probiotics to reduce NEC. Her clinical center, Children’s Hospital Colorado, does not administer probiotics to preterm babies.
Although guidelines can improve outcomes, said Dr. Wymore, who was not involved in the AAP report, improvement observed with probiotics results from more stringent care in centers that experience high NEC rates. “It’s hard to know if it’s due to the probiotics if they already have a high rate of NEC,” Dr. Wymore said.
She echoed the AAP’s position and stressed the need for extreme caution in giving these products to vulnerable infants with immature immune systems. Before that can be safely done, she said, “we need more FDA oversight of product composition [and] pharmaceutical-grade products, and more studies to determine efficacy.”
Added Dr. Poindexter: “Hopefully, this report will inform clinicians of the risks of using non–pharmaceutical-grade products and encourage industry to actually develop probiotics for neonates that we can feel comfortable using.”
The report received no external funding. Dr. Poindexter and Dr. Wymore have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adversity accelerates aging at early ages, now measurable in real-time
Adversity in early life – whether preterm birth or socioeconomic disadvantage in childhood – accelerates aging, according to two recent studies, but underlying mechanisms remain unclear, and methods of investigation continue to evolve.
While one study used an established epigenetic clock to measure biological age among adults with extremely low birth weight, the other showcased a relatively new tool to measure pace of biological aging in disadvantaged children, suggesting that the metric may one day serve as a real-time measure of interventional efficacy.
These findings build upon previous studies that have demonstrated a correlation between biological age, also known as methylation age, and an increased risk of health problems later in life, according to Daniel A. Notterman, MD, professor of molecular biology at Princeton (N.J.) University.
“Finding that a person’s methylation age is greater than their chronological age has been taken as evidence of increased ‘biological age’ and perhaps a tendency to greater future morbidity,” Dr. Notterman wrote in a Pediatrics editorial. “Indeed, methylation age is advanced in association with a number of childhood and midlife adversities as well as morbidities such as atherosclerosis, cancer, and obesity.”
Extremely low birth weight associated with faster aging in men
For some individuals, accelerated biological aging begins at birth, or even in utero, according to Ryan J. Van Lieshout, MD, PhD, Canada Research Chair in the Perinatal Programming of Mental Disorders and the Albert Einstein/Irving Zucker Chair in Neuroscience at McMaster University, Hamilton, Ont., and colleagues.
The investigators conducted a study involving 45 extremely low birth weight (ELBW) survivors and 49 individuals born at normal birth weight. All participants were drawn from a longitudinal study conducted between 1977 and 1982 that assessed advances in neonatal intensive care. Controls were recruited at 8 years of age and matched with ELBW survivors based on family socioeconomic status, sex, and age. Follow-up continued through adulthood, allowing for the present trial to compare data from ages 8, 30, and 35.
Using samples of buccal epithelial cells, the investigators measured biological age with the Horvath epigenetic clock, the most commonly used tool of its kind, which measures cytosine-5 methylation at 353 cytosine-phosphate-guanine sites. Results were adjusted for a variety of covariates, such as smoking status, body mass index, number of chronic health conditions, and others.
Between groups, ELBW survivors trended toward older biological age, compared with adults born at normal birth weight (29.0 vs. 27.9 years), a difference that was not statistically significant. Further analysis, however, showed a significant sex-based difference between groups: Male survivors of ELBW, in adulthood, were almost 5 years biologically older than men born at normal birth weight (31.4 vs. 26.9 years; P = .01).
“[W]e provide preliminary evidence of a new link between ELBW and accelerated biological aging among men,” the investigators concluded.
In an accompanying editorial, Pam Factor-Litvak, PhD, vice chair of epidemiology at Columbia University, New York, wrote, “The findings are intriguing and open many questions for further study.”
Dr. Factor-Litvak noted that it remains unclear whether differences in biological aging were present at birth.
“[D]ifferences would provide evidence that accelerated aging begins during the in utero period, perhaps because of maternal undernutrition, stress, or another exposure,” Dr. Factor-Litvak wrote. “[R]eductions in chronic stress levels, which may begin for neonates with ELBW in utero and in the first hours of life, may provide an opportunity for interventions,” she added.
According to Calvin J. Hobel, MD, professor of pediatrics at Cedars-Sinai and professor of obstetrics and gynecology at University of California, Los Angeles, who has been studying preterm birth for more than 40 years, interventions may need to begin even earlier.
“The only way to prevent preterm birth is to do it before women get pregnant,” Dr. Hobel said in an interview. “The reason for preterm birth and poor fetal growth is the fact that the mother has early cardiovascular disease – unrecognized.”
Compared with women who give birth to full-term infants, women who give birth to preterm infants typically have increased blood pressure, Dr. Hobel said. Although these elevations in blood pressure are generally asymptomatic and not high enough to be classified as hypertensive, they impact umbilical artery vascular resistance starting at 28 weeks of gestation.
“In utero, [preterm infants] are programmed for increased vascular resistance and increased risk of cardiovascular disease,” Dr. Hobel said.
Regarding the effects of ELBW in men versus women, Dr. Hobel suggested that dissimilar neuroendocrine systems between sexes may protect females from adverse outcomes, although exact mechanisms remain elusive.
Measuring the impact of socioeconomic status on biological aging, now in real-time
A second study, by Laurel Raffington, PhD, of the University of Texas at Austin, and colleagues, evaluated the relationship between socioeconomic disadvantage in childhood and pace of biological aging.
To do so, they used the DunedinPoAm DNA methylation algorithm, a relatively new tool that was developed by analyzing changes in organ system integrity over time among adults with the same chronological age.
“Whereas epigenetic clocks quantify the amount of aging that has already occurred up to the time of measurement, DunedinPoAm quantifies how fast an individual is aging,” Dr. Raffington and colleagues wrote. “In other words, whereas epigenetic clocks tell you what time it is, pace-of-aging measures tell you how fast the clock is ticking.”
The investigators measured pace of aging in 600 children and adolescents (8-18 years of age) from the Texas Twin Project, “an ongoing longitudinal study that includes the collection of salivary samples.” The final dataset included 457 participants who identified as White, 77 who identified as Latinx, and 61 who identified as both White and Latinx.
The investigators evaluated pace of aging compared with family-level and neighborhood-level socioeconomic status, and tested for confounding by tobacco exposure, BMI, and pubertal development.
This analysis revealed that children experiencing socioeconomic disadvantage were aging more quickly than their peers, in terms of both family-level and neighborhood-level inequity (both levels, r = 0.18; P = .001).
Children who identified as Latinx aged faster than did those who identified as White only or White and Latinx, “consistent with higher levels of disadvantage in this group,” the investigators wrote. “Thus, our findings are consistent with observations that racial and/or ethnic socioeconomic disparities are an important contributor to racial and/or ethnic disparities in health.”
Higher BMI, greater tobacco exposure, and more advanced pubertal development were also associated with more rapid aging. After adjustment for these covariates, however, the significant correlation between socioeconomic disadvantage and rapid aging remained, the investigators noted.
“Our results suggest that salivary DNA methylation measures of pace of aging may provide a surrogate or intermediate endpoint for understanding the health impacts of [childhood] interventions,” the investigators concluded. “Such applications may prove particularly useful for evaluating the effectiveness of health-promoting interventions in at-risk groups.”
Still, more work is needed to understand exactly how socioeconomic disadvantage is associated with accelerated aging.
“Ultimately, not only longitudinal repeated-measures studies but also natural experiment studies and randomized controlled trials of social programs are needed to establish causal effects of social disadvantage on DunedinPoAm-measured pace of aging and to establish DunedinPoAm as a mediator of the process through which childhood disadvantage leads to aging-related health conditions,” the investigators wrote.
In his editorial, Dr. Notterman emphasized this point.
“[I]t is worth remembering that associations with either methylation age or pace of aging and health or longevity may represent the effect of an exposure on both the measure and the outcome of interest rather than a causal pathway that runs from the exposure (low socioeconomic status, adversity) to health outcome (i.e., cancer, vascular disease),” he wrote.
Paul Chung, MD, professor and chair of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., and adjunct professor at the University of California, Los Angeles, called the findings “preliminary,” but noted that confirmation through further research could “fill in some really important gaps.
“Right now, to some degree, we’re at a little bit of an impasse,” Dr. Chung said.
Adverse childhood experiences are “associated very strongly” with mental and physical health issues, Dr. Chung said, “but we don’t know exactly why, and because of that, it’s really hard to come up with social policy solutions that aren’t anything but extremely sort of blunt-ended. We just say, ‘Well, I guess you gotta fix everything.’ And it’s a hard place to be, I think, in the field.”
Although the present study doesn’t resolve this issue, Dr. Chung suggested that the findings “really open the door to a lot of really exciting research that could have a lot of impacts on practice and policy.”
“Sometimes the only way to get people to pay attention enough to generate the level of excitement that would allow you to even do these sorts of studies ... is to generate some initial exploratory data that makes people perk up their ears, and makes people go, ‘Hey, wow, maybe we should be looking into this.’ ”
The study by Dr. Raffington and colleagues was funded by the National Institutes of Health and the Jacobs Foundation, with additional support from the German Research Foundation, Russell Sage Foundation Biology and Social Science Grant, the Canadian Institute for Advanced Research Child and Brain Development Network, and others. The study by Dr. Lieshout and colleagues was supported by Canadian Institutes of Health Research. Dr. Factor-Litvak and Dr. Notterman reported funding from the National Institutes of Health. All of the investigators and interviewees reported no conflicts of interest.
Adversity in early life – whether preterm birth or socioeconomic disadvantage in childhood – accelerates aging, according to two recent studies, but underlying mechanisms remain unclear, and methods of investigation continue to evolve.
While one study used an established epigenetic clock to measure biological age among adults with extremely low birth weight, the other showcased a relatively new tool to measure pace of biological aging in disadvantaged children, suggesting that the metric may one day serve as a real-time measure of interventional efficacy.
These findings build upon previous studies that have demonstrated a correlation between biological age, also known as methylation age, and an increased risk of health problems later in life, according to Daniel A. Notterman, MD, professor of molecular biology at Princeton (N.J.) University.
“Finding that a person’s methylation age is greater than their chronological age has been taken as evidence of increased ‘biological age’ and perhaps a tendency to greater future morbidity,” Dr. Notterman wrote in a Pediatrics editorial. “Indeed, methylation age is advanced in association with a number of childhood and midlife adversities as well as morbidities such as atherosclerosis, cancer, and obesity.”
Extremely low birth weight associated with faster aging in men
For some individuals, accelerated biological aging begins at birth, or even in utero, according to Ryan J. Van Lieshout, MD, PhD, Canada Research Chair in the Perinatal Programming of Mental Disorders and the Albert Einstein/Irving Zucker Chair in Neuroscience at McMaster University, Hamilton, Ont., and colleagues.
The investigators conducted a study involving 45 extremely low birth weight (ELBW) survivors and 49 individuals born at normal birth weight. All participants were drawn from a longitudinal study conducted between 1977 and 1982 that assessed advances in neonatal intensive care. Controls were recruited at 8 years of age and matched with ELBW survivors based on family socioeconomic status, sex, and age. Follow-up continued through adulthood, allowing for the present trial to compare data from ages 8, 30, and 35.
Using samples of buccal epithelial cells, the investigators measured biological age with the Horvath epigenetic clock, the most commonly used tool of its kind, which measures cytosine-5 methylation at 353 cytosine-phosphate-guanine sites. Results were adjusted for a variety of covariates, such as smoking status, body mass index, number of chronic health conditions, and others.
Between groups, ELBW survivors trended toward older biological age, compared with adults born at normal birth weight (29.0 vs. 27.9 years), a difference that was not statistically significant. Further analysis, however, showed a significant sex-based difference between groups: Male survivors of ELBW, in adulthood, were almost 5 years biologically older than men born at normal birth weight (31.4 vs. 26.9 years; P = .01).
“[W]e provide preliminary evidence of a new link between ELBW and accelerated biological aging among men,” the investigators concluded.
In an accompanying editorial, Pam Factor-Litvak, PhD, vice chair of epidemiology at Columbia University, New York, wrote, “The findings are intriguing and open many questions for further study.”
Dr. Factor-Litvak noted that it remains unclear whether differences in biological aging were present at birth.
“[D]ifferences would provide evidence that accelerated aging begins during the in utero period, perhaps because of maternal undernutrition, stress, or another exposure,” Dr. Factor-Litvak wrote. “[R]eductions in chronic stress levels, which may begin for neonates with ELBW in utero and in the first hours of life, may provide an opportunity for interventions,” she added.
According to Calvin J. Hobel, MD, professor of pediatrics at Cedars-Sinai and professor of obstetrics and gynecology at University of California, Los Angeles, who has been studying preterm birth for more than 40 years, interventions may need to begin even earlier.
“The only way to prevent preterm birth is to do it before women get pregnant,” Dr. Hobel said in an interview. “The reason for preterm birth and poor fetal growth is the fact that the mother has early cardiovascular disease – unrecognized.”
Compared with women who give birth to full-term infants, women who give birth to preterm infants typically have increased blood pressure, Dr. Hobel said. Although these elevations in blood pressure are generally asymptomatic and not high enough to be classified as hypertensive, they impact umbilical artery vascular resistance starting at 28 weeks of gestation.
“In utero, [preterm infants] are programmed for increased vascular resistance and increased risk of cardiovascular disease,” Dr. Hobel said.
Regarding the effects of ELBW in men versus women, Dr. Hobel suggested that dissimilar neuroendocrine systems between sexes may protect females from adverse outcomes, although exact mechanisms remain elusive.
Measuring the impact of socioeconomic status on biological aging, now in real-time
A second study, by Laurel Raffington, PhD, of the University of Texas at Austin, and colleagues, evaluated the relationship between socioeconomic disadvantage in childhood and pace of biological aging.
To do so, they used the DunedinPoAm DNA methylation algorithm, a relatively new tool that was developed by analyzing changes in organ system integrity over time among adults with the same chronological age.
“Whereas epigenetic clocks quantify the amount of aging that has already occurred up to the time of measurement, DunedinPoAm quantifies how fast an individual is aging,” Dr. Raffington and colleagues wrote. “In other words, whereas epigenetic clocks tell you what time it is, pace-of-aging measures tell you how fast the clock is ticking.”
The investigators measured pace of aging in 600 children and adolescents (8-18 years of age) from the Texas Twin Project, “an ongoing longitudinal study that includes the collection of salivary samples.” The final dataset included 457 participants who identified as White, 77 who identified as Latinx, and 61 who identified as both White and Latinx.
The investigators evaluated pace of aging compared with family-level and neighborhood-level socioeconomic status, and tested for confounding by tobacco exposure, BMI, and pubertal development.
This analysis revealed that children experiencing socioeconomic disadvantage were aging more quickly than their peers, in terms of both family-level and neighborhood-level inequity (both levels, r = 0.18; P = .001).
Children who identified as Latinx aged faster than did those who identified as White only or White and Latinx, “consistent with higher levels of disadvantage in this group,” the investigators wrote. “Thus, our findings are consistent with observations that racial and/or ethnic socioeconomic disparities are an important contributor to racial and/or ethnic disparities in health.”
Higher BMI, greater tobacco exposure, and more advanced pubertal development were also associated with more rapid aging. After adjustment for these covariates, however, the significant correlation between socioeconomic disadvantage and rapid aging remained, the investigators noted.
“Our results suggest that salivary DNA methylation measures of pace of aging may provide a surrogate or intermediate endpoint for understanding the health impacts of [childhood] interventions,” the investigators concluded. “Such applications may prove particularly useful for evaluating the effectiveness of health-promoting interventions in at-risk groups.”
Still, more work is needed to understand exactly how socioeconomic disadvantage is associated with accelerated aging.
“Ultimately, not only longitudinal repeated-measures studies but also natural experiment studies and randomized controlled trials of social programs are needed to establish causal effects of social disadvantage on DunedinPoAm-measured pace of aging and to establish DunedinPoAm as a mediator of the process through which childhood disadvantage leads to aging-related health conditions,” the investigators wrote.
In his editorial, Dr. Notterman emphasized this point.
“[I]t is worth remembering that associations with either methylation age or pace of aging and health or longevity may represent the effect of an exposure on both the measure and the outcome of interest rather than a causal pathway that runs from the exposure (low socioeconomic status, adversity) to health outcome (i.e., cancer, vascular disease),” he wrote.
Paul Chung, MD, professor and chair of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., and adjunct professor at the University of California, Los Angeles, called the findings “preliminary,” but noted that confirmation through further research could “fill in some really important gaps.
“Right now, to some degree, we’re at a little bit of an impasse,” Dr. Chung said.
Adverse childhood experiences are “associated very strongly” with mental and physical health issues, Dr. Chung said, “but we don’t know exactly why, and because of that, it’s really hard to come up with social policy solutions that aren’t anything but extremely sort of blunt-ended. We just say, ‘Well, I guess you gotta fix everything.’ And it’s a hard place to be, I think, in the field.”
Although the present study doesn’t resolve this issue, Dr. Chung suggested that the findings “really open the door to a lot of really exciting research that could have a lot of impacts on practice and policy.”
“Sometimes the only way to get people to pay attention enough to generate the level of excitement that would allow you to even do these sorts of studies ... is to generate some initial exploratory data that makes people perk up their ears, and makes people go, ‘Hey, wow, maybe we should be looking into this.’ ”
The study by Dr. Raffington and colleagues was funded by the National Institutes of Health and the Jacobs Foundation, with additional support from the German Research Foundation, Russell Sage Foundation Biology and Social Science Grant, the Canadian Institute for Advanced Research Child and Brain Development Network, and others. The study by Dr. Lieshout and colleagues was supported by Canadian Institutes of Health Research. Dr. Factor-Litvak and Dr. Notterman reported funding from the National Institutes of Health. All of the investigators and interviewees reported no conflicts of interest.
Adversity in early life – whether preterm birth or socioeconomic disadvantage in childhood – accelerates aging, according to two recent studies, but underlying mechanisms remain unclear, and methods of investigation continue to evolve.
While one study used an established epigenetic clock to measure biological age among adults with extremely low birth weight, the other showcased a relatively new tool to measure pace of biological aging in disadvantaged children, suggesting that the metric may one day serve as a real-time measure of interventional efficacy.
These findings build upon previous studies that have demonstrated a correlation between biological age, also known as methylation age, and an increased risk of health problems later in life, according to Daniel A. Notterman, MD, professor of molecular biology at Princeton (N.J.) University.
“Finding that a person’s methylation age is greater than their chronological age has been taken as evidence of increased ‘biological age’ and perhaps a tendency to greater future morbidity,” Dr. Notterman wrote in a Pediatrics editorial. “Indeed, methylation age is advanced in association with a number of childhood and midlife adversities as well as morbidities such as atherosclerosis, cancer, and obesity.”
Extremely low birth weight associated with faster aging in men
For some individuals, accelerated biological aging begins at birth, or even in utero, according to Ryan J. Van Lieshout, MD, PhD, Canada Research Chair in the Perinatal Programming of Mental Disorders and the Albert Einstein/Irving Zucker Chair in Neuroscience at McMaster University, Hamilton, Ont., and colleagues.
The investigators conducted a study involving 45 extremely low birth weight (ELBW) survivors and 49 individuals born at normal birth weight. All participants were drawn from a longitudinal study conducted between 1977 and 1982 that assessed advances in neonatal intensive care. Controls were recruited at 8 years of age and matched with ELBW survivors based on family socioeconomic status, sex, and age. Follow-up continued through adulthood, allowing for the present trial to compare data from ages 8, 30, and 35.
Using samples of buccal epithelial cells, the investigators measured biological age with the Horvath epigenetic clock, the most commonly used tool of its kind, which measures cytosine-5 methylation at 353 cytosine-phosphate-guanine sites. Results were adjusted for a variety of covariates, such as smoking status, body mass index, number of chronic health conditions, and others.
Between groups, ELBW survivors trended toward older biological age, compared with adults born at normal birth weight (29.0 vs. 27.9 years), a difference that was not statistically significant. Further analysis, however, showed a significant sex-based difference between groups: Male survivors of ELBW, in adulthood, were almost 5 years biologically older than men born at normal birth weight (31.4 vs. 26.9 years; P = .01).
“[W]e provide preliminary evidence of a new link between ELBW and accelerated biological aging among men,” the investigators concluded.
In an accompanying editorial, Pam Factor-Litvak, PhD, vice chair of epidemiology at Columbia University, New York, wrote, “The findings are intriguing and open many questions for further study.”
Dr. Factor-Litvak noted that it remains unclear whether differences in biological aging were present at birth.
“[D]ifferences would provide evidence that accelerated aging begins during the in utero period, perhaps because of maternal undernutrition, stress, or another exposure,” Dr. Factor-Litvak wrote. “[R]eductions in chronic stress levels, which may begin for neonates with ELBW in utero and in the first hours of life, may provide an opportunity for interventions,” she added.
According to Calvin J. Hobel, MD, professor of pediatrics at Cedars-Sinai and professor of obstetrics and gynecology at University of California, Los Angeles, who has been studying preterm birth for more than 40 years, interventions may need to begin even earlier.
“The only way to prevent preterm birth is to do it before women get pregnant,” Dr. Hobel said in an interview. “The reason for preterm birth and poor fetal growth is the fact that the mother has early cardiovascular disease – unrecognized.”
Compared with women who give birth to full-term infants, women who give birth to preterm infants typically have increased blood pressure, Dr. Hobel said. Although these elevations in blood pressure are generally asymptomatic and not high enough to be classified as hypertensive, they impact umbilical artery vascular resistance starting at 28 weeks of gestation.
“In utero, [preterm infants] are programmed for increased vascular resistance and increased risk of cardiovascular disease,” Dr. Hobel said.
Regarding the effects of ELBW in men versus women, Dr. Hobel suggested that dissimilar neuroendocrine systems between sexes may protect females from adverse outcomes, although exact mechanisms remain elusive.
Measuring the impact of socioeconomic status on biological aging, now in real-time
A second study, by Laurel Raffington, PhD, of the University of Texas at Austin, and colleagues, evaluated the relationship between socioeconomic disadvantage in childhood and pace of biological aging.
To do so, they used the DunedinPoAm DNA methylation algorithm, a relatively new tool that was developed by analyzing changes in organ system integrity over time among adults with the same chronological age.
“Whereas epigenetic clocks quantify the amount of aging that has already occurred up to the time of measurement, DunedinPoAm quantifies how fast an individual is aging,” Dr. Raffington and colleagues wrote. “In other words, whereas epigenetic clocks tell you what time it is, pace-of-aging measures tell you how fast the clock is ticking.”
The investigators measured pace of aging in 600 children and adolescents (8-18 years of age) from the Texas Twin Project, “an ongoing longitudinal study that includes the collection of salivary samples.” The final dataset included 457 participants who identified as White, 77 who identified as Latinx, and 61 who identified as both White and Latinx.
The investigators evaluated pace of aging compared with family-level and neighborhood-level socioeconomic status, and tested for confounding by tobacco exposure, BMI, and pubertal development.
This analysis revealed that children experiencing socioeconomic disadvantage were aging more quickly than their peers, in terms of both family-level and neighborhood-level inequity (both levels, r = 0.18; P = .001).
Children who identified as Latinx aged faster than did those who identified as White only or White and Latinx, “consistent with higher levels of disadvantage in this group,” the investigators wrote. “Thus, our findings are consistent with observations that racial and/or ethnic socioeconomic disparities are an important contributor to racial and/or ethnic disparities in health.”
Higher BMI, greater tobacco exposure, and more advanced pubertal development were also associated with more rapid aging. After adjustment for these covariates, however, the significant correlation between socioeconomic disadvantage and rapid aging remained, the investigators noted.
“Our results suggest that salivary DNA methylation measures of pace of aging may provide a surrogate or intermediate endpoint for understanding the health impacts of [childhood] interventions,” the investigators concluded. “Such applications may prove particularly useful for evaluating the effectiveness of health-promoting interventions in at-risk groups.”
Still, more work is needed to understand exactly how socioeconomic disadvantage is associated with accelerated aging.
“Ultimately, not only longitudinal repeated-measures studies but also natural experiment studies and randomized controlled trials of social programs are needed to establish causal effects of social disadvantage on DunedinPoAm-measured pace of aging and to establish DunedinPoAm as a mediator of the process through which childhood disadvantage leads to aging-related health conditions,” the investigators wrote.
In his editorial, Dr. Notterman emphasized this point.
“[I]t is worth remembering that associations with either methylation age or pace of aging and health or longevity may represent the effect of an exposure on both the measure and the outcome of interest rather than a causal pathway that runs from the exposure (low socioeconomic status, adversity) to health outcome (i.e., cancer, vascular disease),” he wrote.
Paul Chung, MD, professor and chair of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., and adjunct professor at the University of California, Los Angeles, called the findings “preliminary,” but noted that confirmation through further research could “fill in some really important gaps.
“Right now, to some degree, we’re at a little bit of an impasse,” Dr. Chung said.
Adverse childhood experiences are “associated very strongly” with mental and physical health issues, Dr. Chung said, “but we don’t know exactly why, and because of that, it’s really hard to come up with social policy solutions that aren’t anything but extremely sort of blunt-ended. We just say, ‘Well, I guess you gotta fix everything.’ And it’s a hard place to be, I think, in the field.”
Although the present study doesn’t resolve this issue, Dr. Chung suggested that the findings “really open the door to a lot of really exciting research that could have a lot of impacts on practice and policy.”
“Sometimes the only way to get people to pay attention enough to generate the level of excitement that would allow you to even do these sorts of studies ... is to generate some initial exploratory data that makes people perk up their ears, and makes people go, ‘Hey, wow, maybe we should be looking into this.’ ”
The study by Dr. Raffington and colleagues was funded by the National Institutes of Health and the Jacobs Foundation, with additional support from the German Research Foundation, Russell Sage Foundation Biology and Social Science Grant, the Canadian Institute for Advanced Research Child and Brain Development Network, and others. The study by Dr. Lieshout and colleagues was supported by Canadian Institutes of Health Research. Dr. Factor-Litvak and Dr. Notterman reported funding from the National Institutes of Health. All of the investigators and interviewees reported no conflicts of interest.
FROM PEDIATRICS
Physicians’ trust in health care leadership drops in pandemic
according to a survey conducted by NORC at the University of Chicago on behalf of the American Board of Internal Medicine Foundation.
Survey results, released May 21, indicate that 30% of physicians say their trust in the U.S. health care system and health care leadership has decreased during the pandemic. Only 18% reported an increase in trust.
Physicians, however, have great trust in their fellow clinicians.
In the survey of 600 physicians, 94% said they trust doctors within their practice; 85% trusted doctors outside of their practice; and 89% trusted nurses. That trust increased during the pandemic, with 41% saying their trust in fellow physicians rose and 37% saying their trust in nurses did.
In a separate survey, NORC asked patients about their trust in various aspects of health care. Among 2,069 respondents, a wide majority reported that they trust doctors (84%) and nurses (85%), but only 64% trusted the health care system as a whole. One in three consumers (32%) said their trust in the health care system decreased during the pandemic, compared with 11% who said their trust increased.
The ABIM Foundation released the research findings on May 21 as part of Building Trust, a national campaign that aims to boost trust among patients, clinicians, system leaders, researchers, and others.
Richard J. Baron, MD, president and chief executive officer of the ABIM Foundation, said in an interview, “Clearly there’s lower trust in health care organization leaders and executives, and that’s troubling.
“Science by itself is not enough,” he said. “Becoming trustworthy has to be a core project of everybody in health care.”
Deterioration in physicians’ trust during the pandemic comes in part from failed promises of adequate personal protective equipment and some physicians’ loss of income as a result of the crisis, Dr. Baron said.
He added that the vaccine rollout was very uneven and that policies as to which elective procedures could be performed were handled differently in different parts of the country.
He also noted that, early on, transparency was lacking as to how many COVID patients hospitals were treating, which may have contributed to the decrease in trust in the system.
Fear of being known as ‘the COVID hospital’
Hospitals were afraid of being known as “the COVID hospital” and losing patients who were afraid to come there, Dr. Baron said.
He said the COVID-19 epidemic exacerbated problems regarding trust, but that trust has been declining for some time. The Building Trust campaign will focus on solutions in breaches of trust as physicians move increasingly toward being employees of huge systems, according to Dr. Baron.
However, trust works both ways, Dr. Baron notes. Physicians can be champions for their health care system or “throw the system under the bus,” he said.
For example, if a patient complains about the appointment system, clinicians who trust their institutions may say the system usually works and that they will try to make sure the patient has a better experience next time. Clinicians without trust may say they agree that the health care system doesn’t know what it is doing, and patients may further lose confidence when physicians validate their complaint, and patients may then go elsewhere.
78% of patients trust primary care doctor
When asked whether they trust their primary care physician, 78% of patients said yes. However, trust in doctors was higher among people who were older (90%), White (82%), or had high income (89%). Among people reporting lower trust, 25% said their physician spends too little time with them, and 14% said their doctor does not know or listen to them.
The survey shows that government agencies have work to do to earn trust. Responses indicate that 43% of physicians said they have “complete trust” in government health care agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which is substantially higher than other parts of the health care system. However, trust in agencies declined for 43% of physician respondents and increased for 21%.
Dhruv Khullar, MD, MPP, of the department of health policy and economics at Weill Cornell Medical College in New York, told this news organization the survey results match what he sees anecdotally in medicine – that physicians have been losing trust in the system but not in their colleagues.
He said the sample size of 600 is enough to be influential, though he said he would like to know the response rate, which was not calculated for this survey.
He added that, in large part, physicians’ lack of trust in their systems may come from generally being asked to see more patients and to meet more metrics during the same or shorter periods.
Physicians’ lack of trust in the system can have significant consequences, he said. It can lead to burnout, which has been linked with poorer quality of care and physician turnover, he noted.
COVID-19 led some physicians to wonder whether their system had their best interests at heart, insofar as access to adequate medicines and supplies as well as emotional support were inconsistent, Dr. Khullar said.
He said that to regain trust health care systems need to ask themselves questions in three areas. The first is whether their goals are focused on the best interest of the organization or the best interest of the patient.
“Next is competency,” Dr. Khullar said. “Maybe your motives are right, but are you able to deliver? Are you delivering a good product, whether clinical services or something else?”
The third area is transparency, he said. “Are you going to be honest and forthright in what we’re doing and where we’re going?”
Caroline Pearson, senior vice president of health care strategy for NORC, said the emailed survey was conducted between Dec. 29, 2020, and Feb. 5, 2021, with a health care survey partner that maintains a nationwide panel of physicians across specialties.
She said this report is fairly novel insofar as surveys are more typically conducted regarding patients’ trust of their doctors or of the health care system.
Ms. Pearson said because health care is delivered in teams, understanding the level of trust among the entities helps ensure that care will be delivered effectively and seamlessly with high quality.
“We want our patients to trust our doctors, but we really want doctors to trust each other and trust the hospitals and systems in which they’re working,” she said.
Dr. Baron, Ms. Pearson, and Dr. Khullar report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a survey conducted by NORC at the University of Chicago on behalf of the American Board of Internal Medicine Foundation.
Survey results, released May 21, indicate that 30% of physicians say their trust in the U.S. health care system and health care leadership has decreased during the pandemic. Only 18% reported an increase in trust.
Physicians, however, have great trust in their fellow clinicians.
In the survey of 600 physicians, 94% said they trust doctors within their practice; 85% trusted doctors outside of their practice; and 89% trusted nurses. That trust increased during the pandemic, with 41% saying their trust in fellow physicians rose and 37% saying their trust in nurses did.
In a separate survey, NORC asked patients about their trust in various aspects of health care. Among 2,069 respondents, a wide majority reported that they trust doctors (84%) and nurses (85%), but only 64% trusted the health care system as a whole. One in three consumers (32%) said their trust in the health care system decreased during the pandemic, compared with 11% who said their trust increased.
The ABIM Foundation released the research findings on May 21 as part of Building Trust, a national campaign that aims to boost trust among patients, clinicians, system leaders, researchers, and others.
Richard J. Baron, MD, president and chief executive officer of the ABIM Foundation, said in an interview, “Clearly there’s lower trust in health care organization leaders and executives, and that’s troubling.
“Science by itself is not enough,” he said. “Becoming trustworthy has to be a core project of everybody in health care.”
Deterioration in physicians’ trust during the pandemic comes in part from failed promises of adequate personal protective equipment and some physicians’ loss of income as a result of the crisis, Dr. Baron said.
He added that the vaccine rollout was very uneven and that policies as to which elective procedures could be performed were handled differently in different parts of the country.
He also noted that, early on, transparency was lacking as to how many COVID patients hospitals were treating, which may have contributed to the decrease in trust in the system.
Fear of being known as ‘the COVID hospital’
Hospitals were afraid of being known as “the COVID hospital” and losing patients who were afraid to come there, Dr. Baron said.
He said the COVID-19 epidemic exacerbated problems regarding trust, but that trust has been declining for some time. The Building Trust campaign will focus on solutions in breaches of trust as physicians move increasingly toward being employees of huge systems, according to Dr. Baron.
However, trust works both ways, Dr. Baron notes. Physicians can be champions for their health care system or “throw the system under the bus,” he said.
For example, if a patient complains about the appointment system, clinicians who trust their institutions may say the system usually works and that they will try to make sure the patient has a better experience next time. Clinicians without trust may say they agree that the health care system doesn’t know what it is doing, and patients may further lose confidence when physicians validate their complaint, and patients may then go elsewhere.
78% of patients trust primary care doctor
When asked whether they trust their primary care physician, 78% of patients said yes. However, trust in doctors was higher among people who were older (90%), White (82%), or had high income (89%). Among people reporting lower trust, 25% said their physician spends too little time with them, and 14% said their doctor does not know or listen to them.
The survey shows that government agencies have work to do to earn trust. Responses indicate that 43% of physicians said they have “complete trust” in government health care agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which is substantially higher than other parts of the health care system. However, trust in agencies declined for 43% of physician respondents and increased for 21%.
Dhruv Khullar, MD, MPP, of the department of health policy and economics at Weill Cornell Medical College in New York, told this news organization the survey results match what he sees anecdotally in medicine – that physicians have been losing trust in the system but not in their colleagues.
He said the sample size of 600 is enough to be influential, though he said he would like to know the response rate, which was not calculated for this survey.
He added that, in large part, physicians’ lack of trust in their systems may come from generally being asked to see more patients and to meet more metrics during the same or shorter periods.
Physicians’ lack of trust in the system can have significant consequences, he said. It can lead to burnout, which has been linked with poorer quality of care and physician turnover, he noted.
COVID-19 led some physicians to wonder whether their system had their best interests at heart, insofar as access to adequate medicines and supplies as well as emotional support were inconsistent, Dr. Khullar said.
He said that to regain trust health care systems need to ask themselves questions in three areas. The first is whether their goals are focused on the best interest of the organization or the best interest of the patient.
“Next is competency,” Dr. Khullar said. “Maybe your motives are right, but are you able to deliver? Are you delivering a good product, whether clinical services or something else?”
The third area is transparency, he said. “Are you going to be honest and forthright in what we’re doing and where we’re going?”
Caroline Pearson, senior vice president of health care strategy for NORC, said the emailed survey was conducted between Dec. 29, 2020, and Feb. 5, 2021, with a health care survey partner that maintains a nationwide panel of physicians across specialties.
She said this report is fairly novel insofar as surveys are more typically conducted regarding patients’ trust of their doctors or of the health care system.
Ms. Pearson said because health care is delivered in teams, understanding the level of trust among the entities helps ensure that care will be delivered effectively and seamlessly with high quality.
“We want our patients to trust our doctors, but we really want doctors to trust each other and trust the hospitals and systems in which they’re working,” she said.
Dr. Baron, Ms. Pearson, and Dr. Khullar report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a survey conducted by NORC at the University of Chicago on behalf of the American Board of Internal Medicine Foundation.
Survey results, released May 21, indicate that 30% of physicians say their trust in the U.S. health care system and health care leadership has decreased during the pandemic. Only 18% reported an increase in trust.
Physicians, however, have great trust in their fellow clinicians.
In the survey of 600 physicians, 94% said they trust doctors within their practice; 85% trusted doctors outside of their practice; and 89% trusted nurses. That trust increased during the pandemic, with 41% saying their trust in fellow physicians rose and 37% saying their trust in nurses did.
In a separate survey, NORC asked patients about their trust in various aspects of health care. Among 2,069 respondents, a wide majority reported that they trust doctors (84%) and nurses (85%), but only 64% trusted the health care system as a whole. One in three consumers (32%) said their trust in the health care system decreased during the pandemic, compared with 11% who said their trust increased.
The ABIM Foundation released the research findings on May 21 as part of Building Trust, a national campaign that aims to boost trust among patients, clinicians, system leaders, researchers, and others.
Richard J. Baron, MD, president and chief executive officer of the ABIM Foundation, said in an interview, “Clearly there’s lower trust in health care organization leaders and executives, and that’s troubling.
“Science by itself is not enough,” he said. “Becoming trustworthy has to be a core project of everybody in health care.”
Deterioration in physicians’ trust during the pandemic comes in part from failed promises of adequate personal protective equipment and some physicians’ loss of income as a result of the crisis, Dr. Baron said.
He added that the vaccine rollout was very uneven and that policies as to which elective procedures could be performed were handled differently in different parts of the country.
He also noted that, early on, transparency was lacking as to how many COVID patients hospitals were treating, which may have contributed to the decrease in trust in the system.
Fear of being known as ‘the COVID hospital’
Hospitals were afraid of being known as “the COVID hospital” and losing patients who were afraid to come there, Dr. Baron said.
He said the COVID-19 epidemic exacerbated problems regarding trust, but that trust has been declining for some time. The Building Trust campaign will focus on solutions in breaches of trust as physicians move increasingly toward being employees of huge systems, according to Dr. Baron.
However, trust works both ways, Dr. Baron notes. Physicians can be champions for their health care system or “throw the system under the bus,” he said.
For example, if a patient complains about the appointment system, clinicians who trust their institutions may say the system usually works and that they will try to make sure the patient has a better experience next time. Clinicians without trust may say they agree that the health care system doesn’t know what it is doing, and patients may further lose confidence when physicians validate their complaint, and patients may then go elsewhere.
78% of patients trust primary care doctor
When asked whether they trust their primary care physician, 78% of patients said yes. However, trust in doctors was higher among people who were older (90%), White (82%), or had high income (89%). Among people reporting lower trust, 25% said their physician spends too little time with them, and 14% said their doctor does not know or listen to them.
The survey shows that government agencies have work to do to earn trust. Responses indicate that 43% of physicians said they have “complete trust” in government health care agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which is substantially higher than other parts of the health care system. However, trust in agencies declined for 43% of physician respondents and increased for 21%.
Dhruv Khullar, MD, MPP, of the department of health policy and economics at Weill Cornell Medical College in New York, told this news organization the survey results match what he sees anecdotally in medicine – that physicians have been losing trust in the system but not in their colleagues.
He said the sample size of 600 is enough to be influential, though he said he would like to know the response rate, which was not calculated for this survey.
He added that, in large part, physicians’ lack of trust in their systems may come from generally being asked to see more patients and to meet more metrics during the same or shorter periods.
Physicians’ lack of trust in the system can have significant consequences, he said. It can lead to burnout, which has been linked with poorer quality of care and physician turnover, he noted.
COVID-19 led some physicians to wonder whether their system had their best interests at heart, insofar as access to adequate medicines and supplies as well as emotional support were inconsistent, Dr. Khullar said.
He said that to regain trust health care systems need to ask themselves questions in three areas. The first is whether their goals are focused on the best interest of the organization or the best interest of the patient.
“Next is competency,” Dr. Khullar said. “Maybe your motives are right, but are you able to deliver? Are you delivering a good product, whether clinical services or something else?”
The third area is transparency, he said. “Are you going to be honest and forthright in what we’re doing and where we’re going?”
Caroline Pearson, senior vice president of health care strategy for NORC, said the emailed survey was conducted between Dec. 29, 2020, and Feb. 5, 2021, with a health care survey partner that maintains a nationwide panel of physicians across specialties.
She said this report is fairly novel insofar as surveys are more typically conducted regarding patients’ trust of their doctors or of the health care system.
Ms. Pearson said because health care is delivered in teams, understanding the level of trust among the entities helps ensure that care will be delivered effectively and seamlessly with high quality.
“We want our patients to trust our doctors, but we really want doctors to trust each other and trust the hospitals and systems in which they’re working,” she said.
Dr. Baron, Ms. Pearson, and Dr. Khullar report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Two key suicide risk factors identified in borderline personality disorder
Feelings of chronic emptiness and self-injury have been identified as two key risk factors for suicide attempts (SAs) in patients with borderline personality disorder (BPD), a new cross-sectional, nationally representative study suggests.
The findings also show lifetime and past-year SAs are common among patients with BPD, even when excluding self-injurious behaviors.
The results suggest that in addition to asking patients about self-harm during suicide risk screenings and assessments, clinicians should query them about “longstanding” feelings of emptiness, study investigator Carlos M. Grilo, PhD, professor of psychiatry and psychology, Yale University, New Haven, Conn., said in an interview.
Although related, chronic emptiness “is distinct and goes beyond feelings of sadness, loneliness, and hopelessness,” explained Dr. Grilo. he said.
The study was published online May 11 in JAMA Network Open.
Filling a research gap
While BPD and other psychiatric disorders are associated with suicide, the authors noted there is a “dearth of epidemiological research” examining the link between BPD and suicide.
Criteria for BPD diagnosis requires any five of the following criteria: relationships, affective instability, abandonment fear, anger, identity disturbance, emptiness, disassociation/paranoia, self-injurious behavior, and impulsivity, along with social-occupation dysfunction.
To determine SA risk with specific BPD diagnostic criteria, the investigators examined data on 36,309 individuals who participated in the third wave of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-III), conducted from 2012 to 2013.
During computer-assisted, face-to-face interviews, study participants answered questions based on the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-5) of the National Institute on Alcohol Abuse and Alcoholism.
This structured interview assesses a range of DSM-5–defined psychiatric disorders and their criteria. In addition to BPD, the AUDADIS-5 generates diagnoses for mood disorders, anxiety disorders, posttraumatic stress disorder, substance use disorders, antisocial personality disorder, schizotypal disorder, and conduct disorder.
During the interviews, respondents were asked if they had ever attempted suicide. For those who had, interviewers recorded the total number of lifetime attempts.
Participants also answered questions about childhood maltreatment including physical neglect, emotional neglect, physical abuse, emotional abuse, and sexual abuse by parents or caregivers and other adverse events occurring before the age of 18.
Childhood trauma common
Patients with BPD frequently report a history of childhood trauma, noted Dr. Grilo, adding that such trauma is associated with self-harm and suicide attempts. Sociodemographic information, including age, sex, and ethnicity/race, education level, and income, was also gathered.
Investigators examined data on suicide attempts using relatively stringent coding that required serious dysfunction in at least five BPD criteria.
Using this definition, investigators found the lifetime SA prevalence in patients with BPD was 30.4%, and 3.2% for past-year SAs. This compared with a rate of 3.7% for lifetime SAs and 0.2% for past-year SAs in those without a BPD diagnosis.
The authors examined SA rates using diagnostic codes in the NESARC-III that required seriously impaired function in only 1 or 2 BPD criteria. Rates were higher using the 5-criteria definition.
When the researchers excluded the BPD criterion of self-injurious behavior, the prevalence was 28.1% for lifetime and 3.0% for past-year SAs among the BPD group, with corresponding rates of 3.8% and 0.2% in those without a BPD diagnosis.
It’s important to look at this, said Dr. Grilo, as some patients with BPD who engage in self-harm have suicidal intent while others don’t.
“We tested whether BPD had heightened risk for suicide attempts if we eliminated the self-injurious criterion and we found that heightened risk was still there,” he explained.
Looking at individual criteria for BPD, a model that adjusted for sociodemographic characteristics, other psychiatric disorders, age at BPD onset, and history of childhood adverse events uncovered two criteria that were significantly associated with increased odds of SAs.
One was emptiness. For lifetime suicide attempts, the adjusted odds ratio (aOR) was 1.58 (95% confidence interval, 1.16-2.14) and for past-year attempts, the aOR was 1.99 (95% CI, 1.08-3.66).
The second was self-injurious behavior. For lifetime attempts, the aOR was 24.28 (95% CI, 16.83-32.03) and for past-year attempts, the aOR was 19.32 (95% CI, 5.22-71.58).
In a model in which all BPD-specific criteria were entered while excluding self-injurious behavior, the aORs for emptiness were 1.66 (95% CI, 1.23-2.24) for lifetime suicide attempts and 2.45 (95% CI, 1.18-5.08) for past year attempts.
Unlike another recent study that included more than 700 treatment-seeking patients with BPD who were followed for 10 years, the current study did not show significant associations with SAs for two other BPD criteria – identity disturbance and frantic attempts to avoid abandonment.
Dr. Grilo explained this might be because the earlier study included treatment-seeking patients instead of community cases, or because of differences in assessment interviews or other factors.
‘Compelling evidence’
“Our epidemiological sample has much broader generalizability and fewer potential confounds than the clinical treatment-seeking sample,” said Dr. Grilo.
However, he noted that the two studies “converge strongly and provide compelling evidence that BPD is associated with substantially heightened risk for suicide attempts over the lifetime.”
The two studies “also converge in finding that the presence of symptoms such as repeated self-harm and feelings of chronic emptiness are also associated with risk for suicide attempts.”
The new findings highlight the need to ask potentially at-risk patients about feelings of emptiness as well as self-injurious behaviors. Clinicians could, for example, ask: “Have you often felt like your life had no purpose or meaning?” or “Have you often felt empty inside?”
Limitations of the study include reliance on retrospective self-reports and use of lay interviewers, although these interviewers were trained and had an average of 5 years of experience conducting health-related surveys.
Although the study included a representative sample of U.S. adults, the sample did not include groups known to have high rates of suicide and self-harm behaviors, such as institutionalized, incarcerated, or homeless individuals.
In addition, the study did not evaluate severity and duration of BPD, although the authors noted they did adjust for age at BPD onset, this did not alter the findings.
Often misdiagnosed
Commenting on the study, John M. Oldham, MD, Distinguished Emeritus Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, and past-president, American Psychiatric Association, and an expert on BPD, had high praise for the research.
BPD is often misdiagnosed, Dr. Oldham said in an interview. Many patients seek help from primary care doctors who may label the symptoms as an anxiety disorder or a mood disorder, he said.
Although medications can help treat some BPD symptoms, “the primary, core evidence-based treatment for BPD is psychotherapy,” said Dr. Oldham, who some years ago helped develop evidence-based practice guidelines for BPD.
“It’s a clear and very well-designed study, and I don’t see any major limitations or problems with it,” he said. “The authors kept their focus rigorously on their goals and they used really careful methodology.”
He noted the “huge” numbers of patients included in the data and the relatively large percentage of men (43.7%).
“There’s a general belief that it’s mostly females who have BPD, but that’s not true; it’s females who come to treatment,” said Dr. Oldham.
Requiring that all five criteria lead to seriously impaired functioning “is a much more rigorous diagnostic methodology” than requiring only one or two criteria to lead to such impairment, said Dr. Oldham. “This is really important” and makes it “a much stronger study.”
The finding that self-harm behavior was linked to suicide attempts isn’t that surprising as this association has been well documented, but the finding that chronic emptiness is also predictive of future suicide attempts “is news,” said Dr. Oldham.
“We have not paid enough attention to this criterion in the clinical world or in the research world.”
Dr. Oldham said one patient with BPD gave him an ideal metaphor for emptiness. “She said it’s like there’s just nobody home. Think of it as an empty house that may look fine on the outside but you go inside and nobody lives there; there’s no furniture; no favorite things; no photos; no possessions.”
The authors have “important messages we need to pay attention to, and the main one is to explore this sense of chronic ‘nobody home’ emptiness,” said Dr. Oldham.
Dr. Grilo has reported receiving research grants from the National Institutes of Health; serving as a consultant for Sunovion and Weight Watchers; receiving honoraria for lectures, continuing medical education activities, and presentations at scientific conferences; and receiving royalties from Guilford Press and Taylor & Francis, all outside the submitted work.
A version of this article first appeared on Medscape.com.
Feelings of chronic emptiness and self-injury have been identified as two key risk factors for suicide attempts (SAs) in patients with borderline personality disorder (BPD), a new cross-sectional, nationally representative study suggests.
The findings also show lifetime and past-year SAs are common among patients with BPD, even when excluding self-injurious behaviors.
The results suggest that in addition to asking patients about self-harm during suicide risk screenings and assessments, clinicians should query them about “longstanding” feelings of emptiness, study investigator Carlos M. Grilo, PhD, professor of psychiatry and psychology, Yale University, New Haven, Conn., said in an interview.
Although related, chronic emptiness “is distinct and goes beyond feelings of sadness, loneliness, and hopelessness,” explained Dr. Grilo. he said.
The study was published online May 11 in JAMA Network Open.
Filling a research gap
While BPD and other psychiatric disorders are associated with suicide, the authors noted there is a “dearth of epidemiological research” examining the link between BPD and suicide.
Criteria for BPD diagnosis requires any five of the following criteria: relationships, affective instability, abandonment fear, anger, identity disturbance, emptiness, disassociation/paranoia, self-injurious behavior, and impulsivity, along with social-occupation dysfunction.
To determine SA risk with specific BPD diagnostic criteria, the investigators examined data on 36,309 individuals who participated in the third wave of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-III), conducted from 2012 to 2013.
During computer-assisted, face-to-face interviews, study participants answered questions based on the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-5) of the National Institute on Alcohol Abuse and Alcoholism.
This structured interview assesses a range of DSM-5–defined psychiatric disorders and their criteria. In addition to BPD, the AUDADIS-5 generates diagnoses for mood disorders, anxiety disorders, posttraumatic stress disorder, substance use disorders, antisocial personality disorder, schizotypal disorder, and conduct disorder.
During the interviews, respondents were asked if they had ever attempted suicide. For those who had, interviewers recorded the total number of lifetime attempts.
Participants also answered questions about childhood maltreatment including physical neglect, emotional neglect, physical abuse, emotional abuse, and sexual abuse by parents or caregivers and other adverse events occurring before the age of 18.
Childhood trauma common
Patients with BPD frequently report a history of childhood trauma, noted Dr. Grilo, adding that such trauma is associated with self-harm and suicide attempts. Sociodemographic information, including age, sex, and ethnicity/race, education level, and income, was also gathered.
Investigators examined data on suicide attempts using relatively stringent coding that required serious dysfunction in at least five BPD criteria.
Using this definition, investigators found the lifetime SA prevalence in patients with BPD was 30.4%, and 3.2% for past-year SAs. This compared with a rate of 3.7% for lifetime SAs and 0.2% for past-year SAs in those without a BPD diagnosis.
The authors examined SA rates using diagnostic codes in the NESARC-III that required seriously impaired function in only 1 or 2 BPD criteria. Rates were higher using the 5-criteria definition.
When the researchers excluded the BPD criterion of self-injurious behavior, the prevalence was 28.1% for lifetime and 3.0% for past-year SAs among the BPD group, with corresponding rates of 3.8% and 0.2% in those without a BPD diagnosis.
It’s important to look at this, said Dr. Grilo, as some patients with BPD who engage in self-harm have suicidal intent while others don’t.
“We tested whether BPD had heightened risk for suicide attempts if we eliminated the self-injurious criterion and we found that heightened risk was still there,” he explained.
Looking at individual criteria for BPD, a model that adjusted for sociodemographic characteristics, other psychiatric disorders, age at BPD onset, and history of childhood adverse events uncovered two criteria that were significantly associated with increased odds of SAs.
One was emptiness. For lifetime suicide attempts, the adjusted odds ratio (aOR) was 1.58 (95% confidence interval, 1.16-2.14) and for past-year attempts, the aOR was 1.99 (95% CI, 1.08-3.66).
The second was self-injurious behavior. For lifetime attempts, the aOR was 24.28 (95% CI, 16.83-32.03) and for past-year attempts, the aOR was 19.32 (95% CI, 5.22-71.58).
In a model in which all BPD-specific criteria were entered while excluding self-injurious behavior, the aORs for emptiness were 1.66 (95% CI, 1.23-2.24) for lifetime suicide attempts and 2.45 (95% CI, 1.18-5.08) for past year attempts.
Unlike another recent study that included more than 700 treatment-seeking patients with BPD who were followed for 10 years, the current study did not show significant associations with SAs for two other BPD criteria – identity disturbance and frantic attempts to avoid abandonment.
Dr. Grilo explained this might be because the earlier study included treatment-seeking patients instead of community cases, or because of differences in assessment interviews or other factors.
‘Compelling evidence’
“Our epidemiological sample has much broader generalizability and fewer potential confounds than the clinical treatment-seeking sample,” said Dr. Grilo.
However, he noted that the two studies “converge strongly and provide compelling evidence that BPD is associated with substantially heightened risk for suicide attempts over the lifetime.”
The two studies “also converge in finding that the presence of symptoms such as repeated self-harm and feelings of chronic emptiness are also associated with risk for suicide attempts.”
The new findings highlight the need to ask potentially at-risk patients about feelings of emptiness as well as self-injurious behaviors. Clinicians could, for example, ask: “Have you often felt like your life had no purpose or meaning?” or “Have you often felt empty inside?”
Limitations of the study include reliance on retrospective self-reports and use of lay interviewers, although these interviewers were trained and had an average of 5 years of experience conducting health-related surveys.
Although the study included a representative sample of U.S. adults, the sample did not include groups known to have high rates of suicide and self-harm behaviors, such as institutionalized, incarcerated, or homeless individuals.
In addition, the study did not evaluate severity and duration of BPD, although the authors noted they did adjust for age at BPD onset, this did not alter the findings.
Often misdiagnosed
Commenting on the study, John M. Oldham, MD, Distinguished Emeritus Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, and past-president, American Psychiatric Association, and an expert on BPD, had high praise for the research.
BPD is often misdiagnosed, Dr. Oldham said in an interview. Many patients seek help from primary care doctors who may label the symptoms as an anxiety disorder or a mood disorder, he said.
Although medications can help treat some BPD symptoms, “the primary, core evidence-based treatment for BPD is psychotherapy,” said Dr. Oldham, who some years ago helped develop evidence-based practice guidelines for BPD.
“It’s a clear and very well-designed study, and I don’t see any major limitations or problems with it,” he said. “The authors kept their focus rigorously on their goals and they used really careful methodology.”
He noted the “huge” numbers of patients included in the data and the relatively large percentage of men (43.7%).
“There’s a general belief that it’s mostly females who have BPD, but that’s not true; it’s females who come to treatment,” said Dr. Oldham.
Requiring that all five criteria lead to seriously impaired functioning “is a much more rigorous diagnostic methodology” than requiring only one or two criteria to lead to such impairment, said Dr. Oldham. “This is really important” and makes it “a much stronger study.”
The finding that self-harm behavior was linked to suicide attempts isn’t that surprising as this association has been well documented, but the finding that chronic emptiness is also predictive of future suicide attempts “is news,” said Dr. Oldham.
“We have not paid enough attention to this criterion in the clinical world or in the research world.”
Dr. Oldham said one patient with BPD gave him an ideal metaphor for emptiness. “She said it’s like there’s just nobody home. Think of it as an empty house that may look fine on the outside but you go inside and nobody lives there; there’s no furniture; no favorite things; no photos; no possessions.”
The authors have “important messages we need to pay attention to, and the main one is to explore this sense of chronic ‘nobody home’ emptiness,” said Dr. Oldham.
Dr. Grilo has reported receiving research grants from the National Institutes of Health; serving as a consultant for Sunovion and Weight Watchers; receiving honoraria for lectures, continuing medical education activities, and presentations at scientific conferences; and receiving royalties from Guilford Press and Taylor & Francis, all outside the submitted work.
A version of this article first appeared on Medscape.com.
Feelings of chronic emptiness and self-injury have been identified as two key risk factors for suicide attempts (SAs) in patients with borderline personality disorder (BPD), a new cross-sectional, nationally representative study suggests.
The findings also show lifetime and past-year SAs are common among patients with BPD, even when excluding self-injurious behaviors.
The results suggest that in addition to asking patients about self-harm during suicide risk screenings and assessments, clinicians should query them about “longstanding” feelings of emptiness, study investigator Carlos M. Grilo, PhD, professor of psychiatry and psychology, Yale University, New Haven, Conn., said in an interview.
Although related, chronic emptiness “is distinct and goes beyond feelings of sadness, loneliness, and hopelessness,” explained Dr. Grilo. he said.
The study was published online May 11 in JAMA Network Open.
Filling a research gap
While BPD and other psychiatric disorders are associated with suicide, the authors noted there is a “dearth of epidemiological research” examining the link between BPD and suicide.
Criteria for BPD diagnosis requires any five of the following criteria: relationships, affective instability, abandonment fear, anger, identity disturbance, emptiness, disassociation/paranoia, self-injurious behavior, and impulsivity, along with social-occupation dysfunction.
To determine SA risk with specific BPD diagnostic criteria, the investigators examined data on 36,309 individuals who participated in the third wave of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC-III), conducted from 2012 to 2013.
During computer-assisted, face-to-face interviews, study participants answered questions based on the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-5) of the National Institute on Alcohol Abuse and Alcoholism.
This structured interview assesses a range of DSM-5–defined psychiatric disorders and their criteria. In addition to BPD, the AUDADIS-5 generates diagnoses for mood disorders, anxiety disorders, posttraumatic stress disorder, substance use disorders, antisocial personality disorder, schizotypal disorder, and conduct disorder.
During the interviews, respondents were asked if they had ever attempted suicide. For those who had, interviewers recorded the total number of lifetime attempts.
Participants also answered questions about childhood maltreatment including physical neglect, emotional neglect, physical abuse, emotional abuse, and sexual abuse by parents or caregivers and other adverse events occurring before the age of 18.
Childhood trauma common
Patients with BPD frequently report a history of childhood trauma, noted Dr. Grilo, adding that such trauma is associated with self-harm and suicide attempts. Sociodemographic information, including age, sex, and ethnicity/race, education level, and income, was also gathered.
Investigators examined data on suicide attempts using relatively stringent coding that required serious dysfunction in at least five BPD criteria.
Using this definition, investigators found the lifetime SA prevalence in patients with BPD was 30.4%, and 3.2% for past-year SAs. This compared with a rate of 3.7% for lifetime SAs and 0.2% for past-year SAs in those without a BPD diagnosis.
The authors examined SA rates using diagnostic codes in the NESARC-III that required seriously impaired function in only 1 or 2 BPD criteria. Rates were higher using the 5-criteria definition.
When the researchers excluded the BPD criterion of self-injurious behavior, the prevalence was 28.1% for lifetime and 3.0% for past-year SAs among the BPD group, with corresponding rates of 3.8% and 0.2% in those without a BPD diagnosis.
It’s important to look at this, said Dr. Grilo, as some patients with BPD who engage in self-harm have suicidal intent while others don’t.
“We tested whether BPD had heightened risk for suicide attempts if we eliminated the self-injurious criterion and we found that heightened risk was still there,” he explained.
Looking at individual criteria for BPD, a model that adjusted for sociodemographic characteristics, other psychiatric disorders, age at BPD onset, and history of childhood adverse events uncovered two criteria that were significantly associated with increased odds of SAs.
One was emptiness. For lifetime suicide attempts, the adjusted odds ratio (aOR) was 1.58 (95% confidence interval, 1.16-2.14) and for past-year attempts, the aOR was 1.99 (95% CI, 1.08-3.66).
The second was self-injurious behavior. For lifetime attempts, the aOR was 24.28 (95% CI, 16.83-32.03) and for past-year attempts, the aOR was 19.32 (95% CI, 5.22-71.58).
In a model in which all BPD-specific criteria were entered while excluding self-injurious behavior, the aORs for emptiness were 1.66 (95% CI, 1.23-2.24) for lifetime suicide attempts and 2.45 (95% CI, 1.18-5.08) for past year attempts.
Unlike another recent study that included more than 700 treatment-seeking patients with BPD who were followed for 10 years, the current study did not show significant associations with SAs for two other BPD criteria – identity disturbance and frantic attempts to avoid abandonment.
Dr. Grilo explained this might be because the earlier study included treatment-seeking patients instead of community cases, or because of differences in assessment interviews or other factors.
‘Compelling evidence’
“Our epidemiological sample has much broader generalizability and fewer potential confounds than the clinical treatment-seeking sample,” said Dr. Grilo.
However, he noted that the two studies “converge strongly and provide compelling evidence that BPD is associated with substantially heightened risk for suicide attempts over the lifetime.”
The two studies “also converge in finding that the presence of symptoms such as repeated self-harm and feelings of chronic emptiness are also associated with risk for suicide attempts.”
The new findings highlight the need to ask potentially at-risk patients about feelings of emptiness as well as self-injurious behaviors. Clinicians could, for example, ask: “Have you often felt like your life had no purpose or meaning?” or “Have you often felt empty inside?”
Limitations of the study include reliance on retrospective self-reports and use of lay interviewers, although these interviewers were trained and had an average of 5 years of experience conducting health-related surveys.
Although the study included a representative sample of U.S. adults, the sample did not include groups known to have high rates of suicide and self-harm behaviors, such as institutionalized, incarcerated, or homeless individuals.
In addition, the study did not evaluate severity and duration of BPD, although the authors noted they did adjust for age at BPD onset, this did not alter the findings.
Often misdiagnosed
Commenting on the study, John M. Oldham, MD, Distinguished Emeritus Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, and past-president, American Psychiatric Association, and an expert on BPD, had high praise for the research.
BPD is often misdiagnosed, Dr. Oldham said in an interview. Many patients seek help from primary care doctors who may label the symptoms as an anxiety disorder or a mood disorder, he said.
Although medications can help treat some BPD symptoms, “the primary, core evidence-based treatment for BPD is psychotherapy,” said Dr. Oldham, who some years ago helped develop evidence-based practice guidelines for BPD.
“It’s a clear and very well-designed study, and I don’t see any major limitations or problems with it,” he said. “The authors kept their focus rigorously on their goals and they used really careful methodology.”
He noted the “huge” numbers of patients included in the data and the relatively large percentage of men (43.7%).
“There’s a general belief that it’s mostly females who have BPD, but that’s not true; it’s females who come to treatment,” said Dr. Oldham.
Requiring that all five criteria lead to seriously impaired functioning “is a much more rigorous diagnostic methodology” than requiring only one or two criteria to lead to such impairment, said Dr. Oldham. “This is really important” and makes it “a much stronger study.”
The finding that self-harm behavior was linked to suicide attempts isn’t that surprising as this association has been well documented, but the finding that chronic emptiness is also predictive of future suicide attempts “is news,” said Dr. Oldham.
“We have not paid enough attention to this criterion in the clinical world or in the research world.”
Dr. Oldham said one patient with BPD gave him an ideal metaphor for emptiness. “She said it’s like there’s just nobody home. Think of it as an empty house that may look fine on the outside but you go inside and nobody lives there; there’s no furniture; no favorite things; no photos; no possessions.”
The authors have “important messages we need to pay attention to, and the main one is to explore this sense of chronic ‘nobody home’ emptiness,” said Dr. Oldham.
Dr. Grilo has reported receiving research grants from the National Institutes of Health; serving as a consultant for Sunovion and Weight Watchers; receiving honoraria for lectures, continuing medical education activities, and presentations at scientific conferences; and receiving royalties from Guilford Press and Taylor & Francis, all outside the submitted work.
A version of this article first appeared on Medscape.com.
ID experts dole out practical advice to help with mask confusion
The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).
The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.
That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.
Among their practical tips on how to interpret the guidance:
To mask or not?
To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said. And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.
Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.
“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.
If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.
The CDC also continues to recommend masks on mass transit for all.
One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.
“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.
“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.
Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.
Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”
In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
How to protect toddlers and infants
With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”
Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
J & J vaccine recipients
With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly?
“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”
Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).
The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.
That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.
Among their practical tips on how to interpret the guidance:
To mask or not?
To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said. And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.
Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.
“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.
If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.
The CDC also continues to recommend masks on mass transit for all.
One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.
“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.
“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.
Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.
Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”
In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
How to protect toddlers and infants
With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”
Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
J & J vaccine recipients
With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly?
“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”
Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).
The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.
That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.
Among their practical tips on how to interpret the guidance:
To mask or not?
To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said. And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.
Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.
“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.
If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.
The CDC also continues to recommend masks on mass transit for all.
One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.
“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.
“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.
Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.
Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”
In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
How to protect toddlers and infants
With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”
Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
J & J vaccine recipients
With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly?
“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”
Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.
A version of this article first appeared on Medscape.com.