TOPLINE:

Deprescribing antihypertensive medications is associated with a 12% lower likelihood of cognitive decline in older nursing home residents, a new study suggests. The association was strongest among those with dementia.

METHODOLOGY:

• The cohort study included 12,644 long-term care residents (mean age, 77.7 years; 97% men; 17.5% Black) with stays of at least 12 weeks from 2006 to 2019.
• Residents who experienced either a reduction in the total number of antihypertensive medications or a sustained 30% decrease in dosage for at least 2 weeks were classified as deprescribing users (n = 1290). Those with no medication changes were considered stable users (n = 11,354).
• The primary outcome was cognitive impairment assessed using the four-point Cognitive Function Scale (CFS), with the score proportional to the severity of impairment.
• The median follow-up duration was 23 weeks for the deprescribing users and 21 weeks for the stable users.

TAKEAWAY:

• Deprescribing antihypertensives was associated with a 12% lower likelihood of progressing to a worse CFS score per 12-week period (odds ratio [OR], 0.88; 95% CI, 0.78-0.99), compared with stable users.
• Among residents with dementia, deprescribing was associated with a 16% reduced likelihood of cognitive decline per 12-week period (OR, 0.84; 95% CI, 0.72-0.98).
• At the end of follow-up, 12% of residents had a higher CFS score and 7.7% had a lower CFS score.
• In the intention-to-treat analysis, the association between deprescribing antihypertensive medications and reduced cognitive decline remained consistent (OR, 0.94; 95% CI, 0.90-0.98).

IN PRACTICE:

“This work highlights the need for patient-centered approaches to deprescribing, ensuring that medication regimens for older adults are optimized to preserve cognitive function and minimize potential harms,” the study authors wrote.

SOURCE:

The study was led by Bocheng Jing, MS, Department of Medicine, University of California, San Francisco. It was published online in JAMA Internal Medicine.

LIMITATIONS:

The study population included predominantly men and White individuals, limiting the generalizability of the results to women and other racial and ethnic groups. The findings may not be applicable to patients with heart failure owing to their noninclusion. The specificity of dementia diagnosis was limited, as this study combined various forms of dementia, making it challenging to differentiate the impacts among subgroups.

DISCLOSURES:

This study was supported by the US National Institute on Aging. Two authors reported receiving grants, honoraria, consulting fees, or royalties from various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Deprescribing antihypertensive medications is associated with a 12% lower likelihood of cognitive decline in older nursing home residents, a new study suggests. The association was strongest among those with dementia.

METHODOLOGY:

• The cohort study included 12,644 long-term care residents (mean age, 77.7 years; 97% men; 17.5% Black) with stays of at least 12 weeks from 2006 to 2019.
• Residents who experienced either a reduction in the total number of antihypertensive medications or a sustained 30% decrease in dosage for at least 2 weeks were classified as deprescribing users (n = 1290). Those with no medication changes were considered stable users (n = 11,354).
• The primary outcome was cognitive impairment assessed using the four-point Cognitive Function Scale (CFS), with the score proportional to the severity of impairment.
• The median follow-up duration was 23 weeks for the deprescribing users and 21 weeks for the stable users.

TAKEAWAY:

• Deprescribing antihypertensives was associated with a 12% lower likelihood of progressing to a worse CFS score per 12-week period (odds ratio [OR], 0.88; 95% CI, 0.78-0.99), compared with stable users.
• Among residents with dementia, deprescribing was associated with a 16% reduced likelihood of cognitive decline per 12-week period (OR, 0.84; 95% CI, 0.72-0.98).
• At the end of follow-up, 12% of residents had a higher CFS score and 7.7% had a lower CFS score.
• In the intention-to-treat analysis, the association between deprescribing antihypertensive medications and reduced cognitive decline remained consistent (OR, 0.94; 95% CI, 0.90-0.98).

IN PRACTICE:

“This work highlights the need for patient-centered approaches to deprescribing, ensuring that medication regimens for older adults are optimized to preserve cognitive function and minimize potential harms,” the study authors wrote.

SOURCE:

The study was led by Bocheng Jing, MS, Department of Medicine, University of California, San Francisco. It was published online in JAMA Internal Medicine.

LIMITATIONS:

The study population included predominantly men and White individuals, limiting the generalizability of the results to women and other racial and ethnic groups. The findings may not be applicable to patients with heart failure owing to their noninclusion. The specificity of dementia diagnosis was limited, as this study combined various forms of dementia, making it challenging to differentiate the impacts among subgroups.

DISCLOSURES:

This study was supported by the US National Institute on Aging. Two authors reported receiving grants, honoraria, consulting fees, or royalties from various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Deprescribing antihypertensive medications is associated with a 12% lower likelihood of cognitive decline in older nursing home residents, a new study suggests. The association was strongest among those with dementia.

METHODOLOGY:

• The cohort study included 12,644 long-term care residents (mean age, 77.7 years; 97% men; 17.5% Black) with stays of at least 12 weeks from 2006 to 2019.
• Residents who experienced either a reduction in the total number of antihypertensive medications or a sustained 30% decrease in dosage for at least 2 weeks were classified as deprescribing users (n = 1290). Those with no medication changes were considered stable users (n = 11,354).
• The primary outcome was cognitive impairment assessed using the four-point Cognitive Function Scale (CFS), with the score proportional to the severity of impairment.
• The median follow-up duration was 23 weeks for the deprescribing users and 21 weeks for the stable users.

TAKEAWAY:

• Deprescribing antihypertensives was associated with a 12% lower likelihood of progressing to a worse CFS score per 12-week period (odds ratio [OR], 0.88; 95% CI, 0.78-0.99), compared with stable users.
• Among residents with dementia, deprescribing was associated with a 16% reduced likelihood of cognitive decline per 12-week period (OR, 0.84; 95% CI, 0.72-0.98).
• At the end of follow-up, 12% of residents had a higher CFS score and 7.7% had a lower CFS score.
• In the intention-to-treat analysis, the association between deprescribing antihypertensive medications and reduced cognitive decline remained consistent (OR, 0.94; 95% CI, 0.90-0.98).

IN PRACTICE:

“This work highlights the need for patient-centered approaches to deprescribing, ensuring that medication regimens for older adults are optimized to preserve cognitive function and minimize potential harms,” the study authors wrote.

SOURCE:

The study was led by Bocheng Jing, MS, Department of Medicine, University of California, San Francisco. It was published online in JAMA Internal Medicine.

LIMITATIONS:

The study population included predominantly men and White individuals, limiting the generalizability of the results to women and other racial and ethnic groups. The findings may not be applicable to patients with heart failure owing to their noninclusion. The specificity of dementia diagnosis was limited, as this study combined various forms of dementia, making it challenging to differentiate the impacts among subgroups.

DISCLOSURES:

This study was supported by the US National Institute on Aging. Two authors reported receiving grants, honoraria, consulting fees, or royalties from various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.

However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.

This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.

So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
 

What the Research Shows

Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.

“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.

Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.

“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.

tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.

As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.

Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.

On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.

In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.

Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
 

On-Demand Brain Stim

As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.

Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.

So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.

In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.

Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.

Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”

Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
 

A Quick Fix for a Broken System?

Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.

“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.

There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.

“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.

Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”

“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.

As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.

He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.

In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.

“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.

“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
 

Ethical Considerations

Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.

“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.

In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.

On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.

The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.

“This raises concerns because the way you use the device is important,” he said.

Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.

This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.

“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.

Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.

Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.

Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
 

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

As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.

However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.

This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.

So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
 

What the Research Shows

Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.

“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.

Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.

“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.

tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.

As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.

Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.

On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.

In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.

Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
 

On-Demand Brain Stim

As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.

Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.

So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.

In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.

Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.

Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”

Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
 

A Quick Fix for a Broken System?

Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.

“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.

There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.

“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.

Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”

“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.

As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.

He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.

In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.

“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.

“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
 

Ethical Considerations

Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.

“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.

In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.

On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.

The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.

“This raises concerns because the way you use the device is important,” he said.

Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.

This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.

“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.

Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.

Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.

Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
 

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

As at-home, do-it-yourself (DIY) brain stimulation devices like transcranial direct current stimulation (tDCS) gain popularity for common psychiatric conditions like depression, anxiety, and posttraumatic stress disorder (PTSD), questions arise about their safety and efficacy.

However, the US Food and Drug Administration (FDA) has yet to “fully” clear any of these devices and has only granted breakthrough device designation to a few. In addition, most of the portable products don’t market themselves as medical interventions, putting them into a regulatory “gray area” that has little oversight.

This has led to a free-for-all environment, allowing individuals to purchase these products online and self-administer “treatment” — often without the guidance or even knowledge of their healthcare providers.

So how effective and safe are these noninvasive brain stimulators, and what guidance, if any, should clinicians provide to patients who are or are contemplating using them at home; what does the research show, and what are the ethical considerations?
 

What the Research Shows

Data from studies examining unsupervised at-home and use under medical supervision are mixed. Results from a recent randomized trial of more than 200 participants showed no significant difference in safety or efficacy between adjunctive at-home tDCS and at-home sham tDCS for depressive symptoms.

“To be fair, they did not find any unexpected safety issues. What they did find was that there was no clear signal that it worked,” said Noah S. Philip, MD, professor of psychiatry and human behavior, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

Philip, who is also lead for mental health research at Brown’s Center for Neurorestoration and Neurotechnology, Providence, Rhode Island, and was not involved in the study, noted that while other research papers have shown more promising results for depression and other conditions such as adult attention-deficit/hyperactivity disorder (ADHD) and pain, they often are not placebo controlled or include large numbers of patients.

Still, he added the growing use of these devices reflects the fact that standard treatment often doesn’t meet patients’ needs.

“Broadly speaking, part of the hope with brain stimulation is that instead of taking a pill, we’re trying to more directly affect the brain tissues involved — and therefore, avoid the issue of having systemic side effects that you get from the meds. There’s certainly a hunger” for better interventions, Philip said.

tDCS involves a low-intensity electrical current applied through electrodes on the scalp in order to influence brain activity. Generally speaking, it emits less energy than other types of noninvasive brain stimulation, such as transcranial magnetic stimulation. “The trade-off is that’s it also a little harder to find a clear signal about how it works,” Philip said.

As such, he added, it’s important for clinicians to familiarize themselves with these devices, to ask about patient use, and to set up structured assessments of efficacy and adverse events.

Results from a randomized trial published last year in The Lancet showed no significant benefit for in-office use of tDCS plus a selective serotonin reuptake inhibitor vs sham tDCS for major depression.

On the other hand, a randomized trial published earlier this year in Brain Stimulation showed that older adults who received active tDCS had greater reductions in depressive and anxiety symptoms than those in the sham group.

In addition, results from a small study of eight participants published last year in SAGE Open Medicine showed adjuvant tDCS helped patients with refractory PTSD. Finally, a randomized trial of 54 veterans from Philip’s own team showed tDCS plus virtual reality was effective for combat-related PTSD.

Although there have also been several studies showing possible benefit of tDCS for Alzheimer’s disease, Gayatri Devi, MD, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted in a Medscape Neurology Decision Point that “the problem with all these studies is that they’re all very small, and there [are] so many different variables in terms of how you interpret response.”
 

On-Demand Brain Stim

As for at-home use, there’s now a wide offering of these types of devices available online, allowing an individual to apply daily brain stimulation via headsets, dispensing with the need to consult a clinician. Most are battery-powered and emit a low-level current.

Philip noted that there are essentially two ways to obtain such devices. Some are readily available from online stores, while others require a prescription, which typically includes guidelines on how to use the device.

So far, none of these portable products have been fully cleared by the FDA — although the agency did grant Breakthrough Device designation to Sooma Medical for its device to treat depression in 2023 and to Flow Neuroscience in 2022.

In August 2023, Flow announced that its device is now being reviewed for full FDA clearance on the basis of trial results showing at-home tDCS was “twice as effective” as antidepressants. The company received regulatory approval in Europe in 2019.

Other research has shown “encouraging” results for these at-home devices for conditions such as adult ADHD and pain relief with remote supervision.

Philip noted that more high-quality randomized controlled trials are definitely needed, with “a number of companies probably getting close to releasing data sometime soon.”

Is it possible that a placebo effect is at work here? “Yes, partially,” said Philip. Users often become more mindful of managing their depression and other conditions, which leads to behavior change, he said.
 

A Quick Fix for a Broken System?

Joseph J. Fins, MD, The E. William Davis Jr, MD, professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medicine, New York City, also believes there could be a placebo effect at play.

“It’s important that we don’t ascribe efficacy to a device without being aware of the placebo effect,” he said. That’s why more and larger, placebo-controlled trials are needed, he added.

There’s a multitude of reasons why patients may turn to at-home devices on their own, including drug shortages and the inability to see a psychiatrist in a timely manner.

“I think it speaks to the isolation of these folks that leads to them doing this on their own. These devices become a technological quick fix for a system that’s desperately broken. There’s nothing wrong with being a consumer, but at a certain point they need to be a patient, and they need to have a clinician there to help them,” he said.

Fins said that he also worries about regulatory oversight because of the way the devices are classified. He likened them to supplements, which, because they don’t make certain claims, are not regulated with the same stringency as other products and fall into an area “in between regulatory spheres.”

“I think we’re trying to take old regulatory frameworks and jerry-rig it to accommodate new and evolving technologies. And I think we need to have serious study of how we protect patients as they become consumers — to make sure there’s enough safety and enough efficacy and that they don’t get ripped off out of desperation,” Fins said.

As for safety, at-home devices are unlikely to cause physical harm — at least when used as intended. “The riskier situations happen when people build their own, overuse it, or use it in combination with drugs or alcohol or other factors that can produce unpredictable results,” Philip said.

He added that DIY-built products carry a higher risk for burns or excessive energy output. A 2016 “open letter” from a group of neurologists, published in Annals of Neurology, warned about the dangers of DIY tDCS.

In addition, Philip noted that he has seen instances where patients become manic after using at-home tDCS, especially when trying to improve cognition.

“We have seen a number of peculiar side effects emerge in those situations. Typically, it’s anxiety, panic attacks, and sensitivity to bright lights, in addition to the emergence of mania, which would require major psychiatric intervention,” he said.

“So, it’s important that if folks do engage with these sorts of things, it’s with some degree of medical involvement,” Philip added.
 

Ethical Considerations

Roy Hamilton, MD, professor of neurology, psychiatry, and physical medicine & rehabilitation at the University of Pennsylvania, in Philadelphia, said that in the setting of proper training, proper clinician communication, and proper oversight, he doesn’t view at-home tDCS as ethically problematic.

“For individuals who have conditions that are clearly causing them remarkable detriment to quality of life or to their health, it seems like the risk-benefit ratio with respect to the likelihood of harm is quite good,” said Hamilton, who is also the director of the Penn Brain Science, Translation, Innovation, and Modulation Center.

In addition, tDCS and other transcranial electrical stimulation techniques seem to have a better safety profile than “many of the other things we send patients home with to treat their pain,” he said.

On the other hand, this risk calculus changes in a scenario where patients are neurologically intact, he said.

The brain, Hamilton noted, exhibits functional differences based on the region undergoing stimulation. This means users should follow a specific, prescribed method. However, he pointed out that those using commercially available devices often lack clear guidance on where to place the electrodes and what intensity to use.

“This raises concerns because the way you use the device is important,” he said.

Hamilton also highlighted important ethical considerations regarding enhanced cognition through technology or pharmaceutical interventions. The possibility of coercive use raises questions about equity and fairness, particularly if individuals feel pressured to use such devices to remain competitive in academic or professional settings.

This mirrors the current issues surrounding the use of stimulants among students, where those without ADHD may feel compelled to use these drugs to improve performance. In addition, there is the possibility that the capacity to access devices that enhance cognition could exacerbate existing inequalities.

“Any time you introduce a technological intervention, you have to worry about discriminative justice. That’s where only people who can afford such devices or have access to specialists who can give them such devices get to receive improvements in their cognition,” Hamilton said.

Neither the American Academy of Neurology nor the American Psychiatric Association has established practice guidelines for tDCS, either for use in clinical settings or for use at home. Hamilton believes this is due to the current lack of data, noting that organizations likely want to see more approvals and widespread use before creating guidelines.

Fins emphasized the need for organized medicine to sponsor research, noting that the use of these devices is becoming a public health issue. He expressed concern that some devices are marketed as nonmedical interventions, despite involving medical procedures like brain stimulation. He concluded that while scrutiny is necessary, the current landscape should be approached without judgment.

Fins reported no relevant financial relationships. Philip reported serving on a scientific advisory board for Pulvinar Neuro and past involvement in clinical trials related to these devices and their use as home. Hamilton reported he is on the board of trustees for the McKnight Brain Research Foundation, which is dedicated to advancing healthy cognitive aging.
 

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

Metabolic dysfunction–associated steatotic liver disease (MASLD) is expected to bring a wave of added healthcare costs to Canada, with projections indicating an increase of almost C$2 billion (Canadian dollars) by 2050, according to a new study.

The expected surge reflects the growing prevalence of MASLD and its associated conditions, emphasizing the necessity for a comprehensive approach to address this escalating public health issue, reported lead author K. Ally Memedovich, BHSc, of the University of Calgary in Alberta, Canada, and colleagues.

K. Ally Memedovich

“The costs associated with the management of MASLD in Canada remain unknown but have been estimated as being very high,” the investigators wrote in Gastro Hep Advances. “Specifically, in one study from the United States, the healthcare costs and utilization of those with MASLD was nearly double that of patients without MASLD but with similar health status. This difference was largely due to increases in imaging, hospitalization, liver fibrosis assessment, laboratory tests, and outpatient visits.”

Although projections are available to estimate the future prevalence of MASLD in Canada, no models are available to predict the growing national economic burden, prompting the present study.

Memedovich and colleagues analyzed healthcare usage data from 6,358 patients diagnosed with MASLD disease in Calgary from 2018 to 2020. Using provincial administrative data, they calculated both liver-specific and total healthcare costs associated with different stages of liver fibrosis, ranging from F0/F1 (minimal fibrosis) to F4 (advanced fibrosis or cirrhosis).

The patients’ liver fibrosis stages were determined using liver stiffness measurements obtained through shear wave elastography. Average annual cost per patient was then calculated for each fibrosis stage by analyzing hospitalizations, ambulatory care, and physician claims data.

The annual average liver-specific cost per patient increased with severity of liver fibrosis; costs for patients with fibrosis stages F0/F1, F2, F3, and F4 were C$7.02, C$35.30, C$60.46, and C$72.55, respectively. By 2050, liver-specific healthcare costs are projected to increase by C$51 million, reaching C$136 million Canada-wide.

Total healthcare costs were markedly higher; annual costs for patients with fibrosis stages F0/F1, F2, F3, and F4 were C$397.90, C$781.53, C$2,881.84, and C$1,598.82, respectively. As a result, total healthcare costs are expected to rise by nearly C$2 billion, contributing to a Canadian healthcare burden of C$5.81 billion annually by 2050.

The study revealed that over 90% of the healthcare costs for MASLD patients were attributed not to liver disease itself but to the management of associated comorbidities such as diabetes, hypertension, mental illness, and obesity. For instance, diabetes was the most common reason for physician visits among MASLD patients, accounting for 65.2% of cases. One study limitation was exclusion of decompensated cirrhosis, liver cancer, or a liver transplant recipient because of low prevalence in this cohort, potentially contributing to low liver specific healthcare costs.

Memedovich and colleagues noted that chronic diseases account for approximately C$68 billion annually in direct healthcare costs in Canada, representing around 58% of total healthcare expenditures. Estimates suggest that 1% annual reduction in chronic disease prevalence could save C$107 billion over the course of 20 years.

“Therefore, an approach that focuses on preventing and managing chronic diseases overall is needed to reduce the burden of MASLD on the healthcare system,” they wrote. This study was funded by LiveRx via an Alberta Innovates grant. The investigators disclosed relationships with Gilead, Abbott, GSK, and others.

Metabolic dysfunction–associated steatotic liver disease (MASLD) is expected to bring a wave of added healthcare costs to Canada, with projections indicating an increase of almost C$2 billion (Canadian dollars) by 2050, according to a new study.

The expected surge reflects the growing prevalence of MASLD and its associated conditions, emphasizing the necessity for a comprehensive approach to address this escalating public health issue, reported lead author K. Ally Memedovich, BHSc, of the University of Calgary in Alberta, Canada, and colleagues.

K. Ally Memedovich

“The costs associated with the management of MASLD in Canada remain unknown but have been estimated as being very high,” the investigators wrote in Gastro Hep Advances. “Specifically, in one study from the United States, the healthcare costs and utilization of those with MASLD was nearly double that of patients without MASLD but with similar health status. This difference was largely due to increases in imaging, hospitalization, liver fibrosis assessment, laboratory tests, and outpatient visits.”

Although projections are available to estimate the future prevalence of MASLD in Canada, no models are available to predict the growing national economic burden, prompting the present study.

Memedovich and colleagues analyzed healthcare usage data from 6,358 patients diagnosed with MASLD disease in Calgary from 2018 to 2020. Using provincial administrative data, they calculated both liver-specific and total healthcare costs associated with different stages of liver fibrosis, ranging from F0/F1 (minimal fibrosis) to F4 (advanced fibrosis or cirrhosis).

The patients’ liver fibrosis stages were determined using liver stiffness measurements obtained through shear wave elastography. Average annual cost per patient was then calculated for each fibrosis stage by analyzing hospitalizations, ambulatory care, and physician claims data.

The annual average liver-specific cost per patient increased with severity of liver fibrosis; costs for patients with fibrosis stages F0/F1, F2, F3, and F4 were C$7.02, C$35.30, C$60.46, and C$72.55, respectively. By 2050, liver-specific healthcare costs are projected to increase by C$51 million, reaching C$136 million Canada-wide.

Total healthcare costs were markedly higher; annual costs for patients with fibrosis stages F0/F1, F2, F3, and F4 were C$397.90, C$781.53, C$2,881.84, and C$1,598.82, respectively. As a result, total healthcare costs are expected to rise by nearly C$2 billion, contributing to a Canadian healthcare burden of C$5.81 billion annually by 2050.

The study revealed that over 90% of the healthcare costs for MASLD patients were attributed not to liver disease itself but to the management of associated comorbidities such as diabetes, hypertension, mental illness, and obesity. For instance, diabetes was the most common reason for physician visits among MASLD patients, accounting for 65.2% of cases. One study limitation was exclusion of decompensated cirrhosis, liver cancer, or a liver transplant recipient because of low prevalence in this cohort, potentially contributing to low liver specific healthcare costs.

Memedovich and colleagues noted that chronic diseases account for approximately C$68 billion annually in direct healthcare costs in Canada, representing around 58% of total healthcare expenditures. Estimates suggest that 1% annual reduction in chronic disease prevalence could save C$107 billion over the course of 20 years.

“Therefore, an approach that focuses on preventing and managing chronic diseases overall is needed to reduce the burden of MASLD on the healthcare system,” they wrote. This study was funded by LiveRx via an Alberta Innovates grant. The investigators disclosed relationships with Gilead, Abbott, GSK, and others.

Metabolic dysfunction–associated steatotic liver disease (MASLD) is expected to bring a wave of added healthcare costs to Canada, with projections indicating an increase of almost C$2 billion (Canadian dollars) by 2050, according to a new study.

The expected surge reflects the growing prevalence of MASLD and its associated conditions, emphasizing the necessity for a comprehensive approach to address this escalating public health issue, reported lead author K. Ally Memedovich, BHSc, of the University of Calgary in Alberta, Canada, and colleagues.

K. Ally Memedovich

“The costs associated with the management of MASLD in Canada remain unknown but have been estimated as being very high,” the investigators wrote in Gastro Hep Advances. “Specifically, in one study from the United States, the healthcare costs and utilization of those with MASLD was nearly double that of patients without MASLD but with similar health status. This difference was largely due to increases in imaging, hospitalization, liver fibrosis assessment, laboratory tests, and outpatient visits.”

Although projections are available to estimate the future prevalence of MASLD in Canada, no models are available to predict the growing national economic burden, prompting the present study.

Memedovich and colleagues analyzed healthcare usage data from 6,358 patients diagnosed with MASLD disease in Calgary from 2018 to 2020. Using provincial administrative data, they calculated both liver-specific and total healthcare costs associated with different stages of liver fibrosis, ranging from F0/F1 (minimal fibrosis) to F4 (advanced fibrosis or cirrhosis).

The patients’ liver fibrosis stages were determined using liver stiffness measurements obtained through shear wave elastography. Average annual cost per patient was then calculated for each fibrosis stage by analyzing hospitalizations, ambulatory care, and physician claims data.

The annual average liver-specific cost per patient increased with severity of liver fibrosis; costs for patients with fibrosis stages F0/F1, F2, F3, and F4 were C$7.02, C$35.30, C$60.46, and C$72.55, respectively. By 2050, liver-specific healthcare costs are projected to increase by C$51 million, reaching C$136 million Canada-wide.

Total healthcare costs were markedly higher; annual costs for patients with fibrosis stages F0/F1, F2, F3, and F4 were C$397.90, C$781.53, C$2,881.84, and C$1,598.82, respectively. As a result, total healthcare costs are expected to rise by nearly C$2 billion, contributing to a Canadian healthcare burden of C$5.81 billion annually by 2050.

The study revealed that over 90% of the healthcare costs for MASLD patients were attributed not to liver disease itself but to the management of associated comorbidities such as diabetes, hypertension, mental illness, and obesity. For instance, diabetes was the most common reason for physician visits among MASLD patients, accounting for 65.2% of cases. One study limitation was exclusion of decompensated cirrhosis, liver cancer, or a liver transplant recipient because of low prevalence in this cohort, potentially contributing to low liver specific healthcare costs.

Memedovich and colleagues noted that chronic diseases account for approximately C$68 billion annually in direct healthcare costs in Canada, representing around 58% of total healthcare expenditures. Estimates suggest that 1% annual reduction in chronic disease prevalence could save C$107 billion over the course of 20 years.

“Therefore, an approach that focuses on preventing and managing chronic diseases overall is needed to reduce the burden of MASLD on the healthcare system,” they wrote. This study was funded by LiveRx via an Alberta Innovates grant. The investigators disclosed relationships with Gilead, Abbott, GSK, and others.

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

“Death cafes” — where people gather to discuss death and dying over tea and cookies — have gained momentum in recent years offering a unique way for people to come together and discuss a topic that is often shrouded in discomfort and avoidance.

It’s estimated that there are now about 18,900 death cafes in 90 countries, with the United States hosting more than 9300 on a regular basis. This trend reflects a growing desire to break the taboo surrounding discussions of death and dying.

But these casual get-togethers may not be for everyone, and their potential benefits and harms may depend on who attends and who facilitates the discussion.

Death cafes are informal meetups where people openly discuss death and mortality in a relaxed setting. They are hosted by a facilitator, like Nancy Macke, certified end-of-life doula based in the greater Cincinnati, Ohio, area and owner of Compassionate Transitions.

“These gatherings provide a supportive environment for a wide range of people, including those with terminal diagnoses, chronic illnesses, curiosity seekers, and individuals grieving the loss of loved ones,” Macke said in an interview.
 

How Do They Work?

These free events are typically advertised on community bulletin boards and held in public spaces. Libraries are a great spot to gather because they typically allow the host to bring in snacks and beverages, Macke noted. 

She tries to host a death cafe once a month and said attendance can vary widely; some gatherings will see as few as two participants, while others draw larger groups, reflecting the varied interest levels in different times and locations, Macke said. 

When hosting a death cafe, Macke said she typically introduces herself, and then asks people to introduce themselves and share what prompted them to attend, which usually triggers a discussion.

Death cafe conversations are largely participant driven, with no set agenda, allowing people to share personal stories, beliefs, and feelings related to death, often resulting in a sense of relief or community connection. “They are not therapy sessions,” Macke said. 

In her experience, Macke has found that many people report feeling less anxious and fearful of death after attending a death cafe and express gratitude for the opportunity to talk about death and dying in a relaxed atmosphere.

Macke said death cafes may serve as a valuable adjunct to end-of-life care, helping patients and families process the emotional and psychological aspects of dying. Holding these discussions in nonclinical settings may help normalize these conversations outside of a medical context.
 

Potential Risks?

Normalizing the conversation around grief is crucial, regardless of where it takes place, Kara Rauscher, LCSW, trauma services coordinator with Nashville Cares in Tennessee, said in an interview.

“Many of the clients I’ve seen for grief counseling feel incredibly isolated in their grief. As a society, we are uncomfortable with grief and don’t always know how to hold space for people who are grieving. It is not uncommon to hear phrases like ‘move on’ or ‘just let go of it’ — but that’s just not how grief works,” Rauscher said. 

“Death cafes could be very helpful for some people but may not be helpful for others and should not be viewed as a substitute for counseling or therapy with a trained mental health provider,” Rauscher cautioned. 

Therese Rando, PhD, clinical psychologist and clinical director of The Institute for the Study & Treatment of Loss, Warwick, Rhode Island, also cautioned that death cafes have the potential to be helpful or harmful.

“Exposing ourselves to healthy death conversations and realizing that death is an inevitable part of life can help a person lead a more fulfilling life, prioritize things that are important to them, and recognize that there is not a limitless supply of tomorrows, so they need to make good choices,” Rando said in an interview.

But the benefits or harms that are realized depend on who is attending and who is facilitating these death cafes, she noted.

“It’s fine to have a group of people coming at it from an intellectual point of view, or even if they have had a loss, they might be able to address some of their existential or philosophical questions. But you could get somebody who’s really raw or on the edge or who has psychological issues, and a death cafe may not be suitable for them at that point,” said Rando, author of the book How to Go on Living When Someone You Love Dies.

“It must be recognized that for some people, casual discussions about death and dying could — although not necessarily will — exacerbate anxiety, if they are not facilitated by trained individuals,” Rando added.

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

“Death cafes” — where people gather to discuss death and dying over tea and cookies — have gained momentum in recent years offering a unique way for people to come together and discuss a topic that is often shrouded in discomfort and avoidance.

It’s estimated that there are now about 18,900 death cafes in 90 countries, with the United States hosting more than 9300 on a regular basis. This trend reflects a growing desire to break the taboo surrounding discussions of death and dying.

But these casual get-togethers may not be for everyone, and their potential benefits and harms may depend on who attends and who facilitates the discussion.

Death cafes are informal meetups where people openly discuss death and mortality in a relaxed setting. They are hosted by a facilitator, like Nancy Macke, certified end-of-life doula based in the greater Cincinnati, Ohio, area and owner of Compassionate Transitions.

“These gatherings provide a supportive environment for a wide range of people, including those with terminal diagnoses, chronic illnesses, curiosity seekers, and individuals grieving the loss of loved ones,” Macke said in an interview.
 

How Do They Work?

These free events are typically advertised on community bulletin boards and held in public spaces. Libraries are a great spot to gather because they typically allow the host to bring in snacks and beverages, Macke noted. 

She tries to host a death cafe once a month and said attendance can vary widely; some gatherings will see as few as two participants, while others draw larger groups, reflecting the varied interest levels in different times and locations, Macke said. 

When hosting a death cafe, Macke said she typically introduces herself, and then asks people to introduce themselves and share what prompted them to attend, which usually triggers a discussion.

Death cafe conversations are largely participant driven, with no set agenda, allowing people to share personal stories, beliefs, and feelings related to death, often resulting in a sense of relief or community connection. “They are not therapy sessions,” Macke said. 

In her experience, Macke has found that many people report feeling less anxious and fearful of death after attending a death cafe and express gratitude for the opportunity to talk about death and dying in a relaxed atmosphere.

Macke said death cafes may serve as a valuable adjunct to end-of-life care, helping patients and families process the emotional and psychological aspects of dying. Holding these discussions in nonclinical settings may help normalize these conversations outside of a medical context.
 

Potential Risks?

Normalizing the conversation around grief is crucial, regardless of where it takes place, Kara Rauscher, LCSW, trauma services coordinator with Nashville Cares in Tennessee, said in an interview.

“Many of the clients I’ve seen for grief counseling feel incredibly isolated in their grief. As a society, we are uncomfortable with grief and don’t always know how to hold space for people who are grieving. It is not uncommon to hear phrases like ‘move on’ or ‘just let go of it’ — but that’s just not how grief works,” Rauscher said. 

“Death cafes could be very helpful for some people but may not be helpful for others and should not be viewed as a substitute for counseling or therapy with a trained mental health provider,” Rauscher cautioned. 

Therese Rando, PhD, clinical psychologist and clinical director of The Institute for the Study & Treatment of Loss, Warwick, Rhode Island, also cautioned that death cafes have the potential to be helpful or harmful.

“Exposing ourselves to healthy death conversations and realizing that death is an inevitable part of life can help a person lead a more fulfilling life, prioritize things that are important to them, and recognize that there is not a limitless supply of tomorrows, so they need to make good choices,” Rando said in an interview.

But the benefits or harms that are realized depend on who is attending and who is facilitating these death cafes, she noted.

“It’s fine to have a group of people coming at it from an intellectual point of view, or even if they have had a loss, they might be able to address some of their existential or philosophical questions. But you could get somebody who’s really raw or on the edge or who has psychological issues, and a death cafe may not be suitable for them at that point,” said Rando, author of the book How to Go on Living When Someone You Love Dies.

“It must be recognized that for some people, casual discussions about death and dying could — although not necessarily will — exacerbate anxiety, if they are not facilitated by trained individuals,” Rando added.

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

“Death cafes” — where people gather to discuss death and dying over tea and cookies — have gained momentum in recent years offering a unique way for people to come together and discuss a topic that is often shrouded in discomfort and avoidance.

It’s estimated that there are now about 18,900 death cafes in 90 countries, with the United States hosting more than 9300 on a regular basis. This trend reflects a growing desire to break the taboo surrounding discussions of death and dying.

But these casual get-togethers may not be for everyone, and their potential benefits and harms may depend on who attends and who facilitates the discussion.

Death cafes are informal meetups where people openly discuss death and mortality in a relaxed setting. They are hosted by a facilitator, like Nancy Macke, certified end-of-life doula based in the greater Cincinnati, Ohio, area and owner of Compassionate Transitions.

“These gatherings provide a supportive environment for a wide range of people, including those with terminal diagnoses, chronic illnesses, curiosity seekers, and individuals grieving the loss of loved ones,” Macke said in an interview.
 

How Do They Work?

These free events are typically advertised on community bulletin boards and held in public spaces. Libraries are a great spot to gather because they typically allow the host to bring in snacks and beverages, Macke noted. 

She tries to host a death cafe once a month and said attendance can vary widely; some gatherings will see as few as two participants, while others draw larger groups, reflecting the varied interest levels in different times and locations, Macke said. 

When hosting a death cafe, Macke said she typically introduces herself, and then asks people to introduce themselves and share what prompted them to attend, which usually triggers a discussion.

Death cafe conversations are largely participant driven, with no set agenda, allowing people to share personal stories, beliefs, and feelings related to death, often resulting in a sense of relief or community connection. “They are not therapy sessions,” Macke said. 

In her experience, Macke has found that many people report feeling less anxious and fearful of death after attending a death cafe and express gratitude for the opportunity to talk about death and dying in a relaxed atmosphere.

Macke said death cafes may serve as a valuable adjunct to end-of-life care, helping patients and families process the emotional and psychological aspects of dying. Holding these discussions in nonclinical settings may help normalize these conversations outside of a medical context.
 

Potential Risks?

Normalizing the conversation around grief is crucial, regardless of where it takes place, Kara Rauscher, LCSW, trauma services coordinator with Nashville Cares in Tennessee, said in an interview.

“Many of the clients I’ve seen for grief counseling feel incredibly isolated in their grief. As a society, we are uncomfortable with grief and don’t always know how to hold space for people who are grieving. It is not uncommon to hear phrases like ‘move on’ or ‘just let go of it’ — but that’s just not how grief works,” Rauscher said. 

“Death cafes could be very helpful for some people but may not be helpful for others and should not be viewed as a substitute for counseling or therapy with a trained mental health provider,” Rauscher cautioned. 

Therese Rando, PhD, clinical psychologist and clinical director of The Institute for the Study & Treatment of Loss, Warwick, Rhode Island, also cautioned that death cafes have the potential to be helpful or harmful.

“Exposing ourselves to healthy death conversations and realizing that death is an inevitable part of life can help a person lead a more fulfilling life, prioritize things that are important to them, and recognize that there is not a limitless supply of tomorrows, so they need to make good choices,” Rando said in an interview.

But the benefits or harms that are realized depend on who is attending and who is facilitating these death cafes, she noted.

“It’s fine to have a group of people coming at it from an intellectual point of view, or even if they have had a loss, they might be able to address some of their existential or philosophical questions. But you could get somebody who’s really raw or on the edge or who has psychological issues, and a death cafe may not be suitable for them at that point,” said Rando, author of the book How to Go on Living When Someone You Love Dies.

“It must be recognized that for some people, casual discussions about death and dying could — although not necessarily will — exacerbate anxiety, if they are not facilitated by trained individuals,” Rando added.

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

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

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

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

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

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

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

Papillary thyroid cancer is widely known as the “good cancer.” This term has been around for years and is used ubiquitously. Some think it’s “appropriate” because the cancer is highly treatable and has good survival rates. Yet, recent research, provider experiences, and patient feedback suggest the term should no longer be used.

Papillary is the most common type of thyroid cancer, comprising about 70%-80% of all thyroid cancers. It tends to grow slowly and “has a generally excellent outlook, even if there is spread to the lymph nodes,” according to the American Thyroid Association.

This “excellent outlook” can prompt a physician to call it a “good” cancer.

“There is often a perception that a patient is diagnosed, treated, and then once treatment is complete, gets to go back to their ‘normal’ lives,” said Fiona Schulte, PhD, RPsych, of the University of Calgary, Alberta, Canada.

“The surgery and other treatments thyroid patients may require are not benign and leave patients with many long-term challenging consequences,” she said in an interview. “For many, treatment is just the beginning of a long journey of dealing with multiple late effects.”
 

Misguided ‘Support’

“I do believe the doctor’s intention is to bring comfort to the patient by saying they have a very curable disease,” Miranda Fidler-Benaoudia, MD, of the University of Calgary, said in an interview. Fidler-Benaoudia is the principal author of a recent survey/interview study of early-onset thyroid cancer survivors, titled “No such thing as a good cancer.” Despite the doctor’s intention, her team found that “for the majority of individuals interviewed, the response was actually quite negative.” 

“Specifically,” she said, “thyroid cancer patients felt that the use of the term ‘good cancer’ minimized their diagnosis and experience, often making them feel like their struggles with the diagnosis and its treatment were not justified. While they were indeed cancer patients, they did not feel they could claim to be one because their prognosis was very positive or they didn’t have more intensive therapies like radiotherapy or chemotherapy.”

These feelings were echoed in a recent Moffitt Center article. When Emma Stevens learned she had thyroid cancer at age 19, she said she heard the same statements repeatedly, including: “At least it’s only thyroid cancer.” “It’s the good cancer, and easy to deal with.”

“These are such weird things to say to me,” said Stevens, now 26. “I know they didn’t have any ill will and they couldn’t see how such statements could be upsetting. It’s been my goal to shed some light on how what they see as encouraging thoughts can upset someone like me.”

In an article on the appropriateness of the term “good cancer,” Reese W. Randle, MD, now at Wake Forest University School of Medicine, Winston-Salem, North Carolina, and colleagues wrote, “Patients with papillary thyroid cancer commonly confront the perception that their malignancy is ‘good,’ but the favorable prognosis and treatability of the disease do not comprehensively represent their cancer fight.”

“The ‘good cancer’ perception is at the root of many mixed and confusing emotions,” they continued. “Clinicians emphasize optimistic outcomes, hoping to comfort, but they might inadvertently invalidate the impact thyroid cancer has on patients’ lives.”
 

Life-Altering

“Having a diagnosis of thyroid cancer, even with usually a very good prognosis, can be life-altering, said Caitlin P. McMullen, MD, a head and neck cancer specialist at Moffitt Cancer Center, Tampa, Florida.

Most papillary thyroid cancers are cured with surgery alone, sometimes followed by radioactive iodine, she said in an interview. “The surgery involves removing half (lobectomy), or sometimes all (total thyroidectomy), of the thyroid gland.” Patients with lymph node involvement have a longer surgery that includes lymph node removal. 

Many patients must also remain on medication permanently to replace their thyroid hormone, she continued. And, after treatment is complete, “patients require regular follow up with bloodwork and imaging for many years to ensure the cancer does not return.” 

“Repeated visits, medications, and testing can also result in financial toxicities and repeated disruptions for patients,” she added. “These downstream effects of a thyroid cancer diagnosis can significantly alter a patient’s life.”

Kaniksha Desai, MD, Endocrinology Quality Director at Stanford University School of Medicine, Palo Alto, California, said in an interview that thyroid cancer treatments carry some risks that shouldn’t be overlooked and may affect recovery for years. These include:

• Recurrent laryngeal nerve damage: Thyroid surgery can lead to vocal cord paralysis, affecting speech and swallowing.
• Hypoparathyroidism: Postsurgical damage to the parathyroid glands can cause long-term calcium regulation problems resulting in pain and emergency department visits as well as lifelong supplementation with calcium and vitamin D.
• Radioactive iodine (RAI) treatment: RAI can have side effects such as dry mouth, tear duct obstruction, salivary gland dysfunction, and an increased risk of secondary cancers.
• Psychosocial Impact: Being told they have cancer can create significant psychological distress for patients, including fear of recurrence, body image concerns, and anxiety, all of which persist even with a “good prognosis.”

Fidler-Benaoudia’s studies focused specifically on the psychosocial impact on younger patients. “Facing a cancer diagnosis at a young age really forces the person to hit the ‘pause button’ – they may need to take a break from school or work, and it may impact their relationships with their family and friends.” 

“Even if their cancer has a very high survival rate, when a young person receives a cancer diagnosis they are often facing their own immortality for the first time, which can be very distressing,” she said. Many of her study participants also struggled to maintain appropriate thyroid hormone levels with medication, which left them feeling tired, losing hair or gaining weight. The surgery itself “can leave a substantial scar on the throat that is visible unless purposefully covered with clothing or accessories,” she noted. “We found that this scar impacted quite a few survivors’ body image.” 
 

Awareness, Education

Two recent studies pointed to the need for clinicians to be aware of their patients’ reactions to a thyroid diagnosis. Susan C. Pitt, MD, associate professor of surgery and director of the endocrine surgery health services research program at the University of Michigan, Ann Arbor, and colleagues reviewed the literature on patient perception of receiving a thyroid diagnosis and found, “Fear and worry about cancer in general and the possibility for recurrence contribute to lasting psychological distress and decreased quality of life. Patients’ perceptions of their diagnosis and resulting emotional reactions influence treatment decision making and have the potential to contribute to decisions that may over-treat a low-risk thyroid cancer.”

In another recent study, Pitt and colleagues assessed fear of thyroid cancer in the general US population and found that close to half of 1136 respondents to an online survey had high levels of thyroid cancer-specific fear, particularly women and those under age 40. “Because disease-specific fear is associated with overtreatment, targeted education about the seriousness, incidence, and risk factors for developing thyroid cancer may decrease public fear and possibly overtreatment related to ‘scared decision-making,’” the authors concluded.

McMullen added, “Taking the time to educate the patient on the diagnosis, prognosis, and treatments can provide reassurance without being dismissive. Most patients are very receptive and understanding once things are explained thoroughly and their questions are answered. We find that factual information can be even more reassuring for patients than saying, ‘This is a good cancer.’”

Desai advised, “Clinicians should acknowledge the spectrum of experiences patients may have.” They should provide empathy and reassurance as well as personalized discussions regarding prognosis and treatment options. In addition, “they should focus on survivorship care by addressing both the long-term and short-term effects on health and lifestyle that can occur post treatment,” as well as the possible need for mental health support.

“I heard many times in residency that, ‘if you had to have cancer, have thyroid cancer,’ ” Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, and vice chair of the American Association of Clinical Endocrinology’s Disease State Networks, said in an interview.

“One should not want any cancer,” she said. “There are some very aggressive tumor markers in differentiated thyroid cancer that can have a worse prognosis. There are many aspects of thyroid cancer treatment that cause anxiety and a stress burden. Recovery varies from person to person.”  

“There needs to be education across all sectors of healthcare, particularly in primary care,” she added. “I personally have medullary thyroid cancer that I found myself while fixing my ultrasound. There are many aspects to survivorship.”

Fidler-Benaoudia, Schulte, McMullen, and Desai declared no competing interests. Gupta is on the speaker bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie.

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

Papillary thyroid cancer is widely known as the “good cancer.” This term has been around for years and is used ubiquitously. Some think it’s “appropriate” because the cancer is highly treatable and has good survival rates. Yet, recent research, provider experiences, and patient feedback suggest the term should no longer be used.

Papillary is the most common type of thyroid cancer, comprising about 70%-80% of all thyroid cancers. It tends to grow slowly and “has a generally excellent outlook, even if there is spread to the lymph nodes,” according to the American Thyroid Association.

This “excellent outlook” can prompt a physician to call it a “good” cancer.

“There is often a perception that a patient is diagnosed, treated, and then once treatment is complete, gets to go back to their ‘normal’ lives,” said Fiona Schulte, PhD, RPsych, of the University of Calgary, Alberta, Canada.

“The surgery and other treatments thyroid patients may require are not benign and leave patients with many long-term challenging consequences,” she said in an interview. “For many, treatment is just the beginning of a long journey of dealing with multiple late effects.”
 

Misguided ‘Support’

“I do believe the doctor’s intention is to bring comfort to the patient by saying they have a very curable disease,” Miranda Fidler-Benaoudia, MD, of the University of Calgary, said in an interview. Fidler-Benaoudia is the principal author of a recent survey/interview study of early-onset thyroid cancer survivors, titled “No such thing as a good cancer.” Despite the doctor’s intention, her team found that “for the majority of individuals interviewed, the response was actually quite negative.” 

“Specifically,” she said, “thyroid cancer patients felt that the use of the term ‘good cancer’ minimized their diagnosis and experience, often making them feel like their struggles with the diagnosis and its treatment were not justified. While they were indeed cancer patients, they did not feel they could claim to be one because their prognosis was very positive or they didn’t have more intensive therapies like radiotherapy or chemotherapy.”

These feelings were echoed in a recent Moffitt Center article. When Emma Stevens learned she had thyroid cancer at age 19, she said she heard the same statements repeatedly, including: “At least it’s only thyroid cancer.” “It’s the good cancer, and easy to deal with.”

“These are such weird things to say to me,” said Stevens, now 26. “I know they didn’t have any ill will and they couldn’t see how such statements could be upsetting. It’s been my goal to shed some light on how what they see as encouraging thoughts can upset someone like me.”

In an article on the appropriateness of the term “good cancer,” Reese W. Randle, MD, now at Wake Forest University School of Medicine, Winston-Salem, North Carolina, and colleagues wrote, “Patients with papillary thyroid cancer commonly confront the perception that their malignancy is ‘good,’ but the favorable prognosis and treatability of the disease do not comprehensively represent their cancer fight.”

“The ‘good cancer’ perception is at the root of many mixed and confusing emotions,” they continued. “Clinicians emphasize optimistic outcomes, hoping to comfort, but they might inadvertently invalidate the impact thyroid cancer has on patients’ lives.”
 

Life-Altering

“Having a diagnosis of thyroid cancer, even with usually a very good prognosis, can be life-altering, said Caitlin P. McMullen, MD, a head and neck cancer specialist at Moffitt Cancer Center, Tampa, Florida.

Most papillary thyroid cancers are cured with surgery alone, sometimes followed by radioactive iodine, she said in an interview. “The surgery involves removing half (lobectomy), or sometimes all (total thyroidectomy), of the thyroid gland.” Patients with lymph node involvement have a longer surgery that includes lymph node removal. 

Many patients must also remain on medication permanently to replace their thyroid hormone, she continued. And, after treatment is complete, “patients require regular follow up with bloodwork and imaging for many years to ensure the cancer does not return.” 

“Repeated visits, medications, and testing can also result in financial toxicities and repeated disruptions for patients,” she added. “These downstream effects of a thyroid cancer diagnosis can significantly alter a patient’s life.”

Kaniksha Desai, MD, Endocrinology Quality Director at Stanford University School of Medicine, Palo Alto, California, said in an interview that thyroid cancer treatments carry some risks that shouldn’t be overlooked and may affect recovery for years. These include:

• Recurrent laryngeal nerve damage: Thyroid surgery can lead to vocal cord paralysis, affecting speech and swallowing.
• Hypoparathyroidism: Postsurgical damage to the parathyroid glands can cause long-term calcium regulation problems resulting in pain and emergency department visits as well as lifelong supplementation with calcium and vitamin D.
• Radioactive iodine (RAI) treatment: RAI can have side effects such as dry mouth, tear duct obstruction, salivary gland dysfunction, and an increased risk of secondary cancers.
• Psychosocial Impact: Being told they have cancer can create significant psychological distress for patients, including fear of recurrence, body image concerns, and anxiety, all of which persist even with a “good prognosis.”

Fidler-Benaoudia’s studies focused specifically on the psychosocial impact on younger patients. “Facing a cancer diagnosis at a young age really forces the person to hit the ‘pause button’ – they may need to take a break from school or work, and it may impact their relationships with their family and friends.” 

“Even if their cancer has a very high survival rate, when a young person receives a cancer diagnosis they are often facing their own immortality for the first time, which can be very distressing,” she said. Many of her study participants also struggled to maintain appropriate thyroid hormone levels with medication, which left them feeling tired, losing hair or gaining weight. The surgery itself “can leave a substantial scar on the throat that is visible unless purposefully covered with clothing or accessories,” she noted. “We found that this scar impacted quite a few survivors’ body image.” 
 

Awareness, Education

Two recent studies pointed to the need for clinicians to be aware of their patients’ reactions to a thyroid diagnosis. Susan C. Pitt, MD, associate professor of surgery and director of the endocrine surgery health services research program at the University of Michigan, Ann Arbor, and colleagues reviewed the literature on patient perception of receiving a thyroid diagnosis and found, “Fear and worry about cancer in general and the possibility for recurrence contribute to lasting psychological distress and decreased quality of life. Patients’ perceptions of their diagnosis and resulting emotional reactions influence treatment decision making and have the potential to contribute to decisions that may over-treat a low-risk thyroid cancer.”

In another recent study, Pitt and colleagues assessed fear of thyroid cancer in the general US population and found that close to half of 1136 respondents to an online survey had high levels of thyroid cancer-specific fear, particularly women and those under age 40. “Because disease-specific fear is associated with overtreatment, targeted education about the seriousness, incidence, and risk factors for developing thyroid cancer may decrease public fear and possibly overtreatment related to ‘scared decision-making,’” the authors concluded.

McMullen added, “Taking the time to educate the patient on the diagnosis, prognosis, and treatments can provide reassurance without being dismissive. Most patients are very receptive and understanding once things are explained thoroughly and their questions are answered. We find that factual information can be even more reassuring for patients than saying, ‘This is a good cancer.’”

Desai advised, “Clinicians should acknowledge the spectrum of experiences patients may have.” They should provide empathy and reassurance as well as personalized discussions regarding prognosis and treatment options. In addition, “they should focus on survivorship care by addressing both the long-term and short-term effects on health and lifestyle that can occur post treatment,” as well as the possible need for mental health support.

“I heard many times in residency that, ‘if you had to have cancer, have thyroid cancer,’ ” Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, and vice chair of the American Association of Clinical Endocrinology’s Disease State Networks, said in an interview.

“One should not want any cancer,” she said. “There are some very aggressive tumor markers in differentiated thyroid cancer that can have a worse prognosis. There are many aspects of thyroid cancer treatment that cause anxiety and a stress burden. Recovery varies from person to person.”  

“There needs to be education across all sectors of healthcare, particularly in primary care,” she added. “I personally have medullary thyroid cancer that I found myself while fixing my ultrasound. There are many aspects to survivorship.”

Fidler-Benaoudia, Schulte, McMullen, and Desai declared no competing interests. Gupta is on the speaker bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie.

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

Papillary thyroid cancer is widely known as the “good cancer.” This term has been around for years and is used ubiquitously. Some think it’s “appropriate” because the cancer is highly treatable and has good survival rates. Yet, recent research, provider experiences, and patient feedback suggest the term should no longer be used.

Papillary is the most common type of thyroid cancer, comprising about 70%-80% of all thyroid cancers. It tends to grow slowly and “has a generally excellent outlook, even if there is spread to the lymph nodes,” according to the American Thyroid Association.

This “excellent outlook” can prompt a physician to call it a “good” cancer.

“There is often a perception that a patient is diagnosed, treated, and then once treatment is complete, gets to go back to their ‘normal’ lives,” said Fiona Schulte, PhD, RPsych, of the University of Calgary, Alberta, Canada.

“The surgery and other treatments thyroid patients may require are not benign and leave patients with many long-term challenging consequences,” she said in an interview. “For many, treatment is just the beginning of a long journey of dealing with multiple late effects.”
 

Misguided ‘Support’

“I do believe the doctor’s intention is to bring comfort to the patient by saying they have a very curable disease,” Miranda Fidler-Benaoudia, MD, of the University of Calgary, said in an interview. Fidler-Benaoudia is the principal author of a recent survey/interview study of early-onset thyroid cancer survivors, titled “No such thing as a good cancer.” Despite the doctor’s intention, her team found that “for the majority of individuals interviewed, the response was actually quite negative.” 

“Specifically,” she said, “thyroid cancer patients felt that the use of the term ‘good cancer’ minimized their diagnosis and experience, often making them feel like their struggles with the diagnosis and its treatment were not justified. While they were indeed cancer patients, they did not feel they could claim to be one because their prognosis was very positive or they didn’t have more intensive therapies like radiotherapy or chemotherapy.”

These feelings were echoed in a recent Moffitt Center article. When Emma Stevens learned she had thyroid cancer at age 19, she said she heard the same statements repeatedly, including: “At least it’s only thyroid cancer.” “It’s the good cancer, and easy to deal with.”

“These are such weird things to say to me,” said Stevens, now 26. “I know they didn’t have any ill will and they couldn’t see how such statements could be upsetting. It’s been my goal to shed some light on how what they see as encouraging thoughts can upset someone like me.”

In an article on the appropriateness of the term “good cancer,” Reese W. Randle, MD, now at Wake Forest University School of Medicine, Winston-Salem, North Carolina, and colleagues wrote, “Patients with papillary thyroid cancer commonly confront the perception that their malignancy is ‘good,’ but the favorable prognosis and treatability of the disease do not comprehensively represent their cancer fight.”

“The ‘good cancer’ perception is at the root of many mixed and confusing emotions,” they continued. “Clinicians emphasize optimistic outcomes, hoping to comfort, but they might inadvertently invalidate the impact thyroid cancer has on patients’ lives.”
 

Life-Altering

“Having a diagnosis of thyroid cancer, even with usually a very good prognosis, can be life-altering, said Caitlin P. McMullen, MD, a head and neck cancer specialist at Moffitt Cancer Center, Tampa, Florida.

Most papillary thyroid cancers are cured with surgery alone, sometimes followed by radioactive iodine, she said in an interview. “The surgery involves removing half (lobectomy), or sometimes all (total thyroidectomy), of the thyroid gland.” Patients with lymph node involvement have a longer surgery that includes lymph node removal. 

Many patients must also remain on medication permanently to replace their thyroid hormone, she continued. And, after treatment is complete, “patients require regular follow up with bloodwork and imaging for many years to ensure the cancer does not return.” 

“Repeated visits, medications, and testing can also result in financial toxicities and repeated disruptions for patients,” she added. “These downstream effects of a thyroid cancer diagnosis can significantly alter a patient’s life.”

Kaniksha Desai, MD, Endocrinology Quality Director at Stanford University School of Medicine, Palo Alto, California, said in an interview that thyroid cancer treatments carry some risks that shouldn’t be overlooked and may affect recovery for years. These include:

• Recurrent laryngeal nerve damage: Thyroid surgery can lead to vocal cord paralysis, affecting speech and swallowing.
• Hypoparathyroidism: Postsurgical damage to the parathyroid glands can cause long-term calcium regulation problems resulting in pain and emergency department visits as well as lifelong supplementation with calcium and vitamin D.
• Radioactive iodine (RAI) treatment: RAI can have side effects such as dry mouth, tear duct obstruction, salivary gland dysfunction, and an increased risk of secondary cancers.
• Psychosocial Impact: Being told they have cancer can create significant psychological distress for patients, including fear of recurrence, body image concerns, and anxiety, all of which persist even with a “good prognosis.”

Fidler-Benaoudia’s studies focused specifically on the psychosocial impact on younger patients. “Facing a cancer diagnosis at a young age really forces the person to hit the ‘pause button’ – they may need to take a break from school or work, and it may impact their relationships with their family and friends.” 

“Even if their cancer has a very high survival rate, when a young person receives a cancer diagnosis they are often facing their own immortality for the first time, which can be very distressing,” she said. Many of her study participants also struggled to maintain appropriate thyroid hormone levels with medication, which left them feeling tired, losing hair or gaining weight. The surgery itself “can leave a substantial scar on the throat that is visible unless purposefully covered with clothing or accessories,” she noted. “We found that this scar impacted quite a few survivors’ body image.” 
 

Awareness, Education

Two recent studies pointed to the need for clinicians to be aware of their patients’ reactions to a thyroid diagnosis. Susan C. Pitt, MD, associate professor of surgery and director of the endocrine surgery health services research program at the University of Michigan, Ann Arbor, and colleagues reviewed the literature on patient perception of receiving a thyroid diagnosis and found, “Fear and worry about cancer in general and the possibility for recurrence contribute to lasting psychological distress and decreased quality of life. Patients’ perceptions of their diagnosis and resulting emotional reactions influence treatment decision making and have the potential to contribute to decisions that may over-treat a low-risk thyroid cancer.”

In another recent study, Pitt and colleagues assessed fear of thyroid cancer in the general US population and found that close to half of 1136 respondents to an online survey had high levels of thyroid cancer-specific fear, particularly women and those under age 40. “Because disease-specific fear is associated with overtreatment, targeted education about the seriousness, incidence, and risk factors for developing thyroid cancer may decrease public fear and possibly overtreatment related to ‘scared decision-making,’” the authors concluded.

McMullen added, “Taking the time to educate the patient on the diagnosis, prognosis, and treatments can provide reassurance without being dismissive. Most patients are very receptive and understanding once things are explained thoroughly and their questions are answered. We find that factual information can be even more reassuring for patients than saying, ‘This is a good cancer.’”

Desai advised, “Clinicians should acknowledge the spectrum of experiences patients may have.” They should provide empathy and reassurance as well as personalized discussions regarding prognosis and treatment options. In addition, “they should focus on survivorship care by addressing both the long-term and short-term effects on health and lifestyle that can occur post treatment,” as well as the possible need for mental health support.

“I heard many times in residency that, ‘if you had to have cancer, have thyroid cancer,’ ” Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, and vice chair of the American Association of Clinical Endocrinology’s Disease State Networks, said in an interview.

“One should not want any cancer,” she said. “There are some very aggressive tumor markers in differentiated thyroid cancer that can have a worse prognosis. There are many aspects of thyroid cancer treatment that cause anxiety and a stress burden. Recovery varies from person to person.”  

“There needs to be education across all sectors of healthcare, particularly in primary care,” she added. “I personally have medullary thyroid cancer that I found myself while fixing my ultrasound. There are many aspects to survivorship.”

Fidler-Benaoudia, Schulte, McMullen, and Desai declared no competing interests. Gupta is on the speaker bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie.

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

TOPLINE:

A study has found that less than half of US veterans on chronic immunosuppressive medications, and a much lower percentage of those younger than 50 years, received at least one dose of the recombinant zoster vaccine (RZV) by mid-2023; the low rate of herpes zoster vaccination in this immunocompromised group, especially among younger individuals, is concerning.

METHODOLOGY:

• In 2021, the Food and Drug Administration authorized the use of RZV for adults aged 18 years or older on chronic immunosuppressive medications because of their high risk for herpes zoster and its related complications, followed by updated guidance from the Centers for Disease Control and Prevention and American College of Rheumatology in 2021 and 2022, respectively.
• This study aimed to assess the receipt of RZV among veterans receiving immunosuppressive medications within the Veterans Health Administration (VHA) healthcare system before and after the expanded indications in February 2022.
• It included 190,162 veterans who were prescribed one or more immunosuppressive medications for at least 90 days at 130 medical facilities between January 1, 2018, and June 30, 2023.
• A total of 23,295 veterans (12.3%) were younger than 50 years by the end of the study period.
• The outcome measured was the percentage of veterans with one or more doses of RZV documented during the study period.

TAKEAWAY:

• Among veterans aged 50 years or older, 36.2% and 49.8% received an RZV before the expanded indication and by mid-2023, respectively. Even though the rate of vaccination is higher than that observed in the 2021 National Health Interview Survey, significant room for improvement remains.
• Among veterans younger than 50 years, very few (2.8%) received an RZV before the expanded indication, and only 13.4% received it by mid-2023.
• Demographic factors associated with lower odds of vaccination included male sex, African American or unknown race, and nonurban residence (P ≤ .004 for all).
• Those who received targeted synthetic disease-modifying antirheumatic drugs (DMARDs) alone or in combination with other drugs or those who received other vaccines were more likely to receive RZV than those who received conventional synthetic DMARD monotherapy (P < .001 for both).

IN PRACTICE:

“Future work to improve RZV vaccination in patients at high risk should focus on creating informatics tools to identify individuals at high risk and standardizing vaccination guidelines across subspecialties,” the authors wrote.

SOURCE:

This study was led by Sharon Abada, MD, University of California, San Francisco. It was published online on October 11, 2024, in JAMA Network Open.

LIMITATIONS:

This study may not be generalizable to nonveteran populations or countries outside the United States. Limitations also included difficulty with capturing vaccinations not administered within the VHA system, which may have resulted in an underestimation of the percentage of patients vaccinated.

DISCLOSURES:

This work was funded by grants from the VA Quality Enhancement Research Initiative and the Agency for Healthcare Research and Quality. Some authors reported receiving grants from institutions and pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A study has found that less than half of US veterans on chronic immunosuppressive medications, and a much lower percentage of those younger than 50 years, received at least one dose of the recombinant zoster vaccine (RZV) by mid-2023; the low rate of herpes zoster vaccination in this immunocompromised group, especially among younger individuals, is concerning.

METHODOLOGY:

• In 2021, the Food and Drug Administration authorized the use of RZV for adults aged 18 years or older on chronic immunosuppressive medications because of their high risk for herpes zoster and its related complications, followed by updated guidance from the Centers for Disease Control and Prevention and American College of Rheumatology in 2021 and 2022, respectively.
• This study aimed to assess the receipt of RZV among veterans receiving immunosuppressive medications within the Veterans Health Administration (VHA) healthcare system before and after the expanded indications in February 2022.
• It included 190,162 veterans who were prescribed one or more immunosuppressive medications for at least 90 days at 130 medical facilities between January 1, 2018, and June 30, 2023.
• A total of 23,295 veterans (12.3%) were younger than 50 years by the end of the study period.
• The outcome measured was the percentage of veterans with one or more doses of RZV documented during the study period.

TAKEAWAY:

• Among veterans aged 50 years or older, 36.2% and 49.8% received an RZV before the expanded indication and by mid-2023, respectively. Even though the rate of vaccination is higher than that observed in the 2021 National Health Interview Survey, significant room for improvement remains.
• Among veterans younger than 50 years, very few (2.8%) received an RZV before the expanded indication, and only 13.4% received it by mid-2023.
• Demographic factors associated with lower odds of vaccination included male sex, African American or unknown race, and nonurban residence (P ≤ .004 for all).
• Those who received targeted synthetic disease-modifying antirheumatic drugs (DMARDs) alone or in combination with other drugs or those who received other vaccines were more likely to receive RZV than those who received conventional synthetic DMARD monotherapy (P < .001 for both).

IN PRACTICE:

“Future work to improve RZV vaccination in patients at high risk should focus on creating informatics tools to identify individuals at high risk and standardizing vaccination guidelines across subspecialties,” the authors wrote.

SOURCE:

This study was led by Sharon Abada, MD, University of California, San Francisco. It was published online on October 11, 2024, in JAMA Network Open.

LIMITATIONS:

This study may not be generalizable to nonveteran populations or countries outside the United States. Limitations also included difficulty with capturing vaccinations not administered within the VHA system, which may have resulted in an underestimation of the percentage of patients vaccinated.

DISCLOSURES:

This work was funded by grants from the VA Quality Enhancement Research Initiative and the Agency for Healthcare Research and Quality. Some authors reported receiving grants from institutions and pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A study has found that less than half of US veterans on chronic immunosuppressive medications, and a much lower percentage of those younger than 50 years, received at least one dose of the recombinant zoster vaccine (RZV) by mid-2023; the low rate of herpes zoster vaccination in this immunocompromised group, especially among younger individuals, is concerning.

METHODOLOGY:

• In 2021, the Food and Drug Administration authorized the use of RZV for adults aged 18 years or older on chronic immunosuppressive medications because of their high risk for herpes zoster and its related complications, followed by updated guidance from the Centers for Disease Control and Prevention and American College of Rheumatology in 2021 and 2022, respectively.
• This study aimed to assess the receipt of RZV among veterans receiving immunosuppressive medications within the Veterans Health Administration (VHA) healthcare system before and after the expanded indications in February 2022.
• It included 190,162 veterans who were prescribed one or more immunosuppressive medications for at least 90 days at 130 medical facilities between January 1, 2018, and June 30, 2023.
• A total of 23,295 veterans (12.3%) were younger than 50 years by the end of the study period.
• The outcome measured was the percentage of veterans with one or more doses of RZV documented during the study period.

TAKEAWAY:

• Among veterans aged 50 years or older, 36.2% and 49.8% received an RZV before the expanded indication and by mid-2023, respectively. Even though the rate of vaccination is higher than that observed in the 2021 National Health Interview Survey, significant room for improvement remains.
• Among veterans younger than 50 years, very few (2.8%) received an RZV before the expanded indication, and only 13.4% received it by mid-2023.
• Demographic factors associated with lower odds of vaccination included male sex, African American or unknown race, and nonurban residence (P ≤ .004 for all).
• Those who received targeted synthetic disease-modifying antirheumatic drugs (DMARDs) alone or in combination with other drugs or those who received other vaccines were more likely to receive RZV than those who received conventional synthetic DMARD monotherapy (P < .001 for both).

IN PRACTICE:

“Future work to improve RZV vaccination in patients at high risk should focus on creating informatics tools to identify individuals at high risk and standardizing vaccination guidelines across subspecialties,” the authors wrote.

SOURCE:

This study was led by Sharon Abada, MD, University of California, San Francisco. It was published online on October 11, 2024, in JAMA Network Open.

LIMITATIONS:

This study may not be generalizable to nonveteran populations or countries outside the United States. Limitations also included difficulty with capturing vaccinations not administered within the VHA system, which may have resulted in an underestimation of the percentage of patients vaccinated.

DISCLOSURES:

This work was funded by grants from the VA Quality Enhancement Research Initiative and the Agency for Healthcare Research and Quality. Some authors reported receiving grants from institutions and pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy.

People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which narcotics such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a September 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost 2 weeks passed before she was allowed to bring her baby home.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The US Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the Food and Drug Administration (FDA) in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI.

The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study coauthored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The US Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two cosponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy.

People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which narcotics such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a September 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost 2 weeks passed before she was allowed to bring her baby home.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The US Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the Food and Drug Administration (FDA) in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI.

The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study coauthored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The US Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two cosponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy.

People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which narcotics such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a September 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost 2 weeks passed before she was allowed to bring her baby home.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The US Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the Food and Drug Administration (FDA) in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI.

The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study coauthored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The US Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two cosponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

TOPLINE:

Delayed reporting of cancer diagnosis by registries probably led to the weaker-than-expected effects of screening colonoscopy in preventing colorectal cancer (CRC) observed in the NordICC trial, a new analysis found.

METHODOLOGY:

• The NordICC trial randomly assigned 85,179 adults aged 55-64 years in a 1:2 ratio to receive or not receive an invitation for a single screening colonoscopy and determined the risk for CRC diagnosis and death over 10-15 years of follow-up using cancer registries. After randomization, the trial excluded 221 adults who had CRC at baseline but who did not yet appear in a cancer registry at the time of randomization.
• The trial found that CRC risk and associated mortality were lower in adults who had colonoscopy, though only modestly so, which generated considerable controversy.
• Because registration delays are a known concern with population-based cancer registries but the trial did not account for them, researchers on the current study postulated that delays might have led to an underestimation of the impact of colonoscopy on CRC risk.
• They estimated the magnitude of delayed reporting of CRC diagnosis to cancer registries by comparing the 221 exclusions with expected CRC diagnoses per year. They explored the impact that delays may have had on the results of the trial’s intention-to-screen analysis and adjusted per-protocol analysis.

TAKEAWAY:

• The trial’s post hoc exclusion of 221 adults who had CRC at baseline but who did not yet appear in a cancer registry at the time of randomization suggests delays of 2-3 years in registration.
• With no assumed delay in cancer registration, the 10-year reported CRC risk difference was 0.22% in intention-to-screen and 0.38% in adjusted per-protocol analyses. With a mean delay in cancer registration of 2 years, the risk difference rose to 0.44% in the intention-to-screen analysis and 0.76% in the adjusted per-protocol analysis.
• Assuming no delay in cancer registration, the number needed to invite for screening colonoscopy and number needed to undergo the procedure to prevent 1 CRC diagnosis/death were 455 and 263, respectively. These numbers decreased to 227 and 132, respectively, with a 2-year reporting delay.
• Registration delays of 1, 2, or 3 years led to an underestimated risk for CRC by 25%, 50%, and 75%, respectively.

IN PRACTICE:

“Updated analyses ensuring complete 10- and 15-year follow-up will be crucial to derive the true reductions of CRC risk and mortality in the trial’s predefined interim and primary analysis. In the meantime, available estimates are to be interpreted with caution, as they likely severely underestimate true screening colonoscopy effects,” the authors concluded.

The lag in reporting found by the study raises questions about the time interval needed beyond the end of a study to assure its completeness, which varies across registries, wrote Chyke A. Doubeni, MD, MPH, Ohio State University Wexner Medical Center, Columbus, and colleagues in an invited commentary. “Publication guidelines should be strengthened to ensure affirmation of completeness and quality of cancer registries used for outcomes ascertainment to minimize uncertainties.”

SOURCE:

The study, with first author Hermann Brenner, MD, MPH, German Cancer Research Center, Heidelberg, was published online in JAMA Network Open, as was the invited commentary.

LIMITATIONS:

Exact quantification of and correction for registration delays were not possible.

DISCLOSURES:

The study was partially funded by the German Federal Ministry of Education and Research and German Cancer Aid. The authors reported no conflicts of interest.

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

TOPLINE:

Delayed reporting of cancer diagnosis by registries probably led to the weaker-than-expected effects of screening colonoscopy in preventing colorectal cancer (CRC) observed in the NordICC trial, a new analysis found.

METHODOLOGY:

• The NordICC trial randomly assigned 85,179 adults aged 55-64 years in a 1:2 ratio to receive or not receive an invitation for a single screening colonoscopy and determined the risk for CRC diagnosis and death over 10-15 years of follow-up using cancer registries. After randomization, the trial excluded 221 adults who had CRC at baseline but who did not yet appear in a cancer registry at the time of randomization.
• The trial found that CRC risk and associated mortality were lower in adults who had colonoscopy, though only modestly so, which generated considerable controversy.
• Because registration delays are a known concern with population-based cancer registries but the trial did not account for them, researchers on the current study postulated that delays might have led to an underestimation of the impact of colonoscopy on CRC risk.
• They estimated the magnitude of delayed reporting of CRC diagnosis to cancer registries by comparing the 221 exclusions with expected CRC diagnoses per year. They explored the impact that delays may have had on the results of the trial’s intention-to-screen analysis and adjusted per-protocol analysis.

TAKEAWAY:

• The trial’s post hoc exclusion of 221 adults who had CRC at baseline but who did not yet appear in a cancer registry at the time of randomization suggests delays of 2-3 years in registration.
• With no assumed delay in cancer registration, the 10-year reported CRC risk difference was 0.22% in intention-to-screen and 0.38% in adjusted per-protocol analyses. With a mean delay in cancer registration of 2 years, the risk difference rose to 0.44% in the intention-to-screen analysis and 0.76% in the adjusted per-protocol analysis.
• Assuming no delay in cancer registration, the number needed to invite for screening colonoscopy and number needed to undergo the procedure to prevent 1 CRC diagnosis/death were 455 and 263, respectively. These numbers decreased to 227 and 132, respectively, with a 2-year reporting delay.
• Registration delays of 1, 2, or 3 years led to an underestimated risk for CRC by 25%, 50%, and 75%, respectively.

IN PRACTICE:

“Updated analyses ensuring complete 10- and 15-year follow-up will be crucial to derive the true reductions of CRC risk and mortality in the trial’s predefined interim and primary analysis. In the meantime, available estimates are to be interpreted with caution, as they likely severely underestimate true screening colonoscopy effects,” the authors concluded.

The lag in reporting found by the study raises questions about the time interval needed beyond the end of a study to assure its completeness, which varies across registries, wrote Chyke A. Doubeni, MD, MPH, Ohio State University Wexner Medical Center, Columbus, and colleagues in an invited commentary. “Publication guidelines should be strengthened to ensure affirmation of completeness and quality of cancer registries used for outcomes ascertainment to minimize uncertainties.”

SOURCE:

The study, with first author Hermann Brenner, MD, MPH, German Cancer Research Center, Heidelberg, was published online in JAMA Network Open, as was the invited commentary.

LIMITATIONS:

Exact quantification of and correction for registration delays were not possible.

DISCLOSURES:

The study was partially funded by the German Federal Ministry of Education and Research and German Cancer Aid. The authors reported no conflicts of interest.

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

TOPLINE:

Delayed reporting of cancer diagnosis by registries probably led to the weaker-than-expected effects of screening colonoscopy in preventing colorectal cancer (CRC) observed in the NordICC trial, a new analysis found.

METHODOLOGY:

• The NordICC trial randomly assigned 85,179 adults aged 55-64 years in a 1:2 ratio to receive or not receive an invitation for a single screening colonoscopy and determined the risk for CRC diagnosis and death over 10-15 years of follow-up using cancer registries. After randomization, the trial excluded 221 adults who had CRC at baseline but who did not yet appear in a cancer registry at the time of randomization.
• The trial found that CRC risk and associated mortality were lower in adults who had colonoscopy, though only modestly so, which generated considerable controversy.
• Because registration delays are a known concern with population-based cancer registries but the trial did not account for them, researchers on the current study postulated that delays might have led to an underestimation of the impact of colonoscopy on CRC risk.
• They estimated the magnitude of delayed reporting of CRC diagnosis to cancer registries by comparing the 221 exclusions with expected CRC diagnoses per year. They explored the impact that delays may have had on the results of the trial’s intention-to-screen analysis and adjusted per-protocol analysis.

TAKEAWAY:

• The trial’s post hoc exclusion of 221 adults who had CRC at baseline but who did not yet appear in a cancer registry at the time of randomization suggests delays of 2-3 years in registration.
• With no assumed delay in cancer registration, the 10-year reported CRC risk difference was 0.22% in intention-to-screen and 0.38% in adjusted per-protocol analyses. With a mean delay in cancer registration of 2 years, the risk difference rose to 0.44% in the intention-to-screen analysis and 0.76% in the adjusted per-protocol analysis.
• Assuming no delay in cancer registration, the number needed to invite for screening colonoscopy and number needed to undergo the procedure to prevent 1 CRC diagnosis/death were 455 and 263, respectively. These numbers decreased to 227 and 132, respectively, with a 2-year reporting delay.
• Registration delays of 1, 2, or 3 years led to an underestimated risk for CRC by 25%, 50%, and 75%, respectively.

IN PRACTICE:

“Updated analyses ensuring complete 10- and 15-year follow-up will be crucial to derive the true reductions of CRC risk and mortality in the trial’s predefined interim and primary analysis. In the meantime, available estimates are to be interpreted with caution, as they likely severely underestimate true screening colonoscopy effects,” the authors concluded.

The lag in reporting found by the study raises questions about the time interval needed beyond the end of a study to assure its completeness, which varies across registries, wrote Chyke A. Doubeni, MD, MPH, Ohio State University Wexner Medical Center, Columbus, and colleagues in an invited commentary. “Publication guidelines should be strengthened to ensure affirmation of completeness and quality of cancer registries used for outcomes ascertainment to minimize uncertainties.”

SOURCE:

The study, with first author Hermann Brenner, MD, MPH, German Cancer Research Center, Heidelberg, was published online in JAMA Network Open, as was the invited commentary.

LIMITATIONS:

Exact quantification of and correction for registration delays were not possible.

DISCLOSURES:

The study was partially funded by the German Federal Ministry of Education and Research and German Cancer Aid. The authors reported no conflicts of interest.

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