MDedge Pediatrics

It’s time to renew two of my three narcotic prescribing licenses. For the first time in my career, I’ve waffled on whether the financial outlay to the US Drug Enforcement Agency (DEA) is worth it. 

At $888 each, I’ve considered letting two licenses lapse because I only work part-time in Montana. But several friends advised me to keep a “spare” in case I transfer to a new location. 

I thought about just paying the fees until I could do a little more research, but there is no mechanism for a refund unless I die within the first year of the 3-year cycle, provide incorrect credit card digits, or accidentally duplicate payments.

The renewal fee is just part of the issue.
 

Mandatory 8-Hour Training

I also received an alert about the requirement for more “narcotics prescribing education” thanks to the Medication Access and Training Expansion Act (MATE). 

The requirement seems counterintuitive because opioid prescribing has decreased for the 10th consecutive year, according to the AMA Overdose Epidemic Report. The continuing rise in overdose deaths is largely due to illegitimate manufacturing of synthetic opioids. 

I’ve written zero outpatient narcotics prescriptions in the past 6 years, and I’ve written very few in my 33 years of practice. My use is limited to intravenous morphine for flash pulmonary edema or refractory angina, but unless you graduated from a training program within 5 years of the June 2023 mandate or are boarded in addiction medicine, there is no way to escape the 8-hour education requirement.

The problem is that these courses are never just 8 hours in duration. After signing up for one such CME course that cost $150, I was still dying of boredom and at risk for DVT 4 days later. That’s how long it took to sit through.

Instead of the 30 seconds it should have taken to review the simple instructions to deliver Narcan, there were scores of screens followed by juvenile quizlets and cartoons. All but about 2 hours out of the 4 days is now relegated to that category of “hours of my life that I can never get back.” Additionally, none of that mandatory “education” will change my prescribing habits one whit. 

And beware the penalty. 

Changes Needed

The only good thing that came of those 4 long days of opioid education was a motivation to drive change in our current licensing and educational experience. Why not use this opportunity to reform the DEA-physician/prescriber relationship? 

The educational requirements should be curtailed for those of us who do not provide outpatient narcotic prescriptions even if we use inpatient opioids. Meds with low abuse potential should be rescheduled to minimize who gets caught in the broad net of the education requirement. 

We should reduce overregulation of the legitimate prescribers by lowering, instead of increasing, licensing fees. We should change to a single license number that covers every state. In this digital age, there is no legitimate excuse to prevent this from happening. 

After all, the settlements from opioid manufacturers and distributors will in time total $50 billion. It seems that at least some of the responsibilities of the DEA could shift to states, cities, and towns. 

My friend Siamak Karimian, MD, who provides locum services in multiple states, pays for seven active DEA licenses every 3 years. He pointed out the hypocrisy in the current regulatory system: “It’s funny that you can have only one DEA or state license and work for the government in all other states or territories with no limits, including the VA, Indian healthcare systems, or prison systems.”

All other prescribers require a separate DEA number for every state. Ultimately, you’d think tracking prescriptions for a single DEA number should be far simpler than tracking someone with seven. 

Competent physicians not guilty of criminal overprescribing seem to be the last to be considered in nearly every healthcare endeavor these days. It would be refreshing if they would reduce our fees and prevent this waste of our time. 

And while we are at it, perhaps a more fitting punishment is due for Richard Sackler and all the Purdue Pharma–affiliated family members. The Sacklers will pay out $6 billion in exchange for immunity against civil litigation. That doesn’t seem like much when they are worth $11 billion. 

Perhaps they should be made to take an 8-hour course on opioid prescribing, annually and in perpetuity. Let’s see them complete a few quizlets and sit through screens of instruction on how to administer Naloxone. Of course, that would be a mild punishment for those who manufactured a drug that killed hundreds of thousands. But it would be a start. 
 

Dr. Walton-Shirley, a clinical cardiologist in Nashville, Tennessee, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

It’s time to renew two of my three narcotic prescribing licenses. For the first time in my career, I’ve waffled on whether the financial outlay to the US Drug Enforcement Agency (DEA) is worth it. 

At $888 each, I’ve considered letting two licenses lapse because I only work part-time in Montana. But several friends advised me to keep a “spare” in case I transfer to a new location. 

I thought about just paying the fees until I could do a little more research, but there is no mechanism for a refund unless I die within the first year of the 3-year cycle, provide incorrect credit card digits, or accidentally duplicate payments.

The renewal fee is just part of the issue.
 

Mandatory 8-Hour Training

I also received an alert about the requirement for more “narcotics prescribing education” thanks to the Medication Access and Training Expansion Act (MATE). 

The requirement seems counterintuitive because opioid prescribing has decreased for the 10th consecutive year, according to the AMA Overdose Epidemic Report. The continuing rise in overdose deaths is largely due to illegitimate manufacturing of synthetic opioids. 

I’ve written zero outpatient narcotics prescriptions in the past 6 years, and I’ve written very few in my 33 years of practice. My use is limited to intravenous morphine for flash pulmonary edema or refractory angina, but unless you graduated from a training program within 5 years of the June 2023 mandate or are boarded in addiction medicine, there is no way to escape the 8-hour education requirement.

The problem is that these courses are never just 8 hours in duration. After signing up for one such CME course that cost $150, I was still dying of boredom and at risk for DVT 4 days later. That’s how long it took to sit through.

Instead of the 30 seconds it should have taken to review the simple instructions to deliver Narcan, there were scores of screens followed by juvenile quizlets and cartoons. All but about 2 hours out of the 4 days is now relegated to that category of “hours of my life that I can never get back.” Additionally, none of that mandatory “education” will change my prescribing habits one whit. 

And beware the penalty. 

Changes Needed

The only good thing that came of those 4 long days of opioid education was a motivation to drive change in our current licensing and educational experience. Why not use this opportunity to reform the DEA-physician/prescriber relationship? 

The educational requirements should be curtailed for those of us who do not provide outpatient narcotic prescriptions even if we use inpatient opioids. Meds with low abuse potential should be rescheduled to minimize who gets caught in the broad net of the education requirement. 

We should reduce overregulation of the legitimate prescribers by lowering, instead of increasing, licensing fees. We should change to a single license number that covers every state. In this digital age, there is no legitimate excuse to prevent this from happening. 

After all, the settlements from opioid manufacturers and distributors will in time total $50 billion. It seems that at least some of the responsibilities of the DEA could shift to states, cities, and towns. 

My friend Siamak Karimian, MD, who provides locum services in multiple states, pays for seven active DEA licenses every 3 years. He pointed out the hypocrisy in the current regulatory system: “It’s funny that you can have only one DEA or state license and work for the government in all other states or territories with no limits, including the VA, Indian healthcare systems, or prison systems.”

All other prescribers require a separate DEA number for every state. Ultimately, you’d think tracking prescriptions for a single DEA number should be far simpler than tracking someone with seven. 

Competent physicians not guilty of criminal overprescribing seem to be the last to be considered in nearly every healthcare endeavor these days. It would be refreshing if they would reduce our fees and prevent this waste of our time. 

And while we are at it, perhaps a more fitting punishment is due for Richard Sackler and all the Purdue Pharma–affiliated family members. The Sacklers will pay out $6 billion in exchange for immunity against civil litigation. That doesn’t seem like much when they are worth $11 billion. 

Perhaps they should be made to take an 8-hour course on opioid prescribing, annually and in perpetuity. Let’s see them complete a few quizlets and sit through screens of instruction on how to administer Naloxone. Of course, that would be a mild punishment for those who manufactured a drug that killed hundreds of thousands. But it would be a start. 
 

Dr. Walton-Shirley, a clinical cardiologist in Nashville, Tennessee, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

It’s time to renew two of my three narcotic prescribing licenses. For the first time in my career, I’ve waffled on whether the financial outlay to the US Drug Enforcement Agency (DEA) is worth it. 

At $888 each, I’ve considered letting two licenses lapse because I only work part-time in Montana. But several friends advised me to keep a “spare” in case I transfer to a new location. 

I thought about just paying the fees until I could do a little more research, but there is no mechanism for a refund unless I die within the first year of the 3-year cycle, provide incorrect credit card digits, or accidentally duplicate payments.

The renewal fee is just part of the issue.
 

Mandatory 8-Hour Training

I also received an alert about the requirement for more “narcotics prescribing education” thanks to the Medication Access and Training Expansion Act (MATE). 

The requirement seems counterintuitive because opioid prescribing has decreased for the 10th consecutive year, according to the AMA Overdose Epidemic Report. The continuing rise in overdose deaths is largely due to illegitimate manufacturing of synthetic opioids. 

I’ve written zero outpatient narcotics prescriptions in the past 6 years, and I’ve written very few in my 33 years of practice. My use is limited to intravenous morphine for flash pulmonary edema or refractory angina, but unless you graduated from a training program within 5 years of the June 2023 mandate or are boarded in addiction medicine, there is no way to escape the 8-hour education requirement.

The problem is that these courses are never just 8 hours in duration. After signing up for one such CME course that cost $150, I was still dying of boredom and at risk for DVT 4 days later. That’s how long it took to sit through.

Instead of the 30 seconds it should have taken to review the simple instructions to deliver Narcan, there were scores of screens followed by juvenile quizlets and cartoons. All but about 2 hours out of the 4 days is now relegated to that category of “hours of my life that I can never get back.” Additionally, none of that mandatory “education” will change my prescribing habits one whit. 

And beware the penalty. 

Changes Needed

The only good thing that came of those 4 long days of opioid education was a motivation to drive change in our current licensing and educational experience. Why not use this opportunity to reform the DEA-physician/prescriber relationship? 

The educational requirements should be curtailed for those of us who do not provide outpatient narcotic prescriptions even if we use inpatient opioids. Meds with low abuse potential should be rescheduled to minimize who gets caught in the broad net of the education requirement. 

We should reduce overregulation of the legitimate prescribers by lowering, instead of increasing, licensing fees. We should change to a single license number that covers every state. In this digital age, there is no legitimate excuse to prevent this from happening. 

After all, the settlements from opioid manufacturers and distributors will in time total $50 billion. It seems that at least some of the responsibilities of the DEA could shift to states, cities, and towns. 

My friend Siamak Karimian, MD, who provides locum services in multiple states, pays for seven active DEA licenses every 3 years. He pointed out the hypocrisy in the current regulatory system: “It’s funny that you can have only one DEA or state license and work for the government in all other states or territories with no limits, including the VA, Indian healthcare systems, or prison systems.”

All other prescribers require a separate DEA number for every state. Ultimately, you’d think tracking prescriptions for a single DEA number should be far simpler than tracking someone with seven. 

Competent physicians not guilty of criminal overprescribing seem to be the last to be considered in nearly every healthcare endeavor these days. It would be refreshing if they would reduce our fees and prevent this waste of our time. 

And while we are at it, perhaps a more fitting punishment is due for Richard Sackler and all the Purdue Pharma–affiliated family members. The Sacklers will pay out $6 billion in exchange for immunity against civil litigation. That doesn’t seem like much when they are worth $11 billion. 

Perhaps they should be made to take an 8-hour course on opioid prescribing, annually and in perpetuity. Let’s see them complete a few quizlets and sit through screens of instruction on how to administer Naloxone. Of course, that would be a mild punishment for those who manufactured a drug that killed hundreds of thousands. But it would be a start. 
 

Dr. Walton-Shirley, a clinical cardiologist in Nashville, Tennessee, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The largest US physician organization wrestled with the professional risks and rewards of artificial intelligence (AI) at its annual meeting, delaying action even as it adopted new policies on prior authorization and other concerns for clinicians and patients.

Physicians and medical students at the annual meeting of the American Medical Association (AMA) House of Delegates in Chicago intensely debated a report and two key resolutions on AI but could not reach consensus, pushing off decision-making until a future meeting in November.

One resolution would establish “augmented intelligence” as the preferred term for AI, reflecting the desired role of these tools in supporting — not making — physicians’ decisions. The other resolution focused on insurers’ use of AI in determining medical necessity.

(See specific policies adopted at the meeting, held June 8-12, below.)

A comprehensive AMA trustees’ report on AI considered additional issues including requirements for disclosing AI use, liability for harms due to flawed application of AI, data privacy, and cybersecurity.

The AMA intends to “continue to methodically assess these issues and make informed recommendations in proposing new policy,” said Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, who became the AMA’s new president-elect.

AMA members at the meeting largely applauded the aim of these AI proposals, but some objected to parts of the trustees’ report.

They raised questions about what, exactly, constitutes an AI-powered service and whether all AI tools need the kind of guardrails the AMA may seek. There also were concerns about calls to make AI use more transparent.

While transparency might be an admirable goal, it might prove too hard to achieve given that AI-powered tools and products are already woven into medical practice in ways that physicians may not know or understand, said Christopher Libby, MD, MPH, a clinical informaticist and emergency physician at Cedars Sinai Medical Center in Los Angeles.

“It’s hard for the practicing clinician to know how every piece of technology works in order to describe it to the patient,” Dr. Libby said at the meeting. “How many people here can identify when algorithms are used in their EHR today?”

He suggested asking for more transparency from the companies that make and sell AI-powered software and tools to insurers and healthcare systems.

Steven H. Kroft, MD, the editor of the American Journal of Clinical Pathology, raised concerns about the unintended harm that unchecked use of AI may pose to scientific research.

He asked the AMA to address “a significant omission in an otherwise comprehensive report” — the need to protect the integrity of study results that can direct patient care.

“While sham science is not a new issue, large language models make it far easier for authors to generate fake papers and far harder for editors, reviewers, and publishers to identify them,” Dr. Kroft said. “This is a rapidly growing phenomenon that is threatening the integrity of the literature. These papers become embedded in the evidence bases that drive clinical decision-making.”

AMA has been working with specialty societies and outside AI experts to refine an effective set of recommendations. The new policies, once finalized, are intended to build on steps AMA already has taken, including last year releasing principles for AI development, deployment, and use.
 

Congress Mulling

The AMA delegates are far from alone in facing AI policy challenges.

Leaders in Congress also are examining AI guardrails, with influential panels such as the Senate Finance and House Energy and Commerce committees holding hearings.

A key congressional AI effort to watch is the expected implementation of a bipartisan Senate “road map,” which Senate Majority Leader Chuck Schumer (D-NY) and colleagues released in May, said Miranda A. Franco, a senior policy advisor at the law firm Holland & Knight.

The product of many months of deliberation, this Senate road map identifies priorities for future legislation, including:

• Creating appropriate guardrails and safety measures to protect patients.
• Making healthcare and biomedical data available for machine learning and data science research while carefully addressing privacy issues.
• Providing transparency for clinicians and the public about the use of AI in medical products and clinical support services, including the data used to train models.
• Examining the Centers for Medicare & Medicaid Services’ reimbursement mechanisms as well as guardrails to ensure accountability, appropriate use, and broad application of AI across all populations.

Congress likely will address issues of AI in healthcare in piecemeal fashion, taking on different aspects of these challenges at different times, Ms. Franco said. The Senate road map gives the key committees directions on where to proceed in their efforts to develop new laws.

“I think this is all going to be slow and rolling, not big and sweeping,” Ms. Franco told this news organization. “I don’t think we’re going to see an encompassing AI bill.”
 

AMA Policies Adopted on Other Issues

At the June meeting, AMA delegates adopted the following policies aiming to:

• Increase oversight and accountability of health insurers’ use of prior authorization controls on patient access to care.
• Encourage policy changes allowing physicians to receive loan forgiveness when they practice in an Indian Health Service, Tribal, or Urban Indian Health Program, similar to physicians practicing in a Veterans Administration facility.
• Advocate for federal policy that limits a patient’s out-of-pocket cost to be the same or less than the amount that a patient with traditional Medicare plus a Medigap plan would pay.
• Oppose state or national legislation that could criminalize in vitro fertilization.
• Limit what the AMA calls the “expensive” cost for Medicare Advantage enrollees who need physician-administered drugs or biologics.
• Help physicians address the handling of de-identified patient data in a rapidly changing digital health ecosystem.
• Support efforts to decriminalize the possession of non-prescribed buprenorphine for personal use by individuals who lack access to a physician for the treatment of opioid use disorder.
• Expand access to hearing, vision, and dental care. The new AMA policy advocates working with state medical associations to support coverage of hearing exams, hearing aids, cochlear implants, and vision exams and aids. The revised AMA policy also supports working with the American Dental Association and other national organizations to improve access to dental care for people enrolled in Medicare, Medicaid, and CHIP programs.
• Increase enrollment of more women and sexual and gender minority populations in clinical trials.

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

The largest US physician organization wrestled with the professional risks and rewards of artificial intelligence (AI) at its annual meeting, delaying action even as it adopted new policies on prior authorization and other concerns for clinicians and patients.

Physicians and medical students at the annual meeting of the American Medical Association (AMA) House of Delegates in Chicago intensely debated a report and two key resolutions on AI but could not reach consensus, pushing off decision-making until a future meeting in November.

One resolution would establish “augmented intelligence” as the preferred term for AI, reflecting the desired role of these tools in supporting — not making — physicians’ decisions. The other resolution focused on insurers’ use of AI in determining medical necessity.

(See specific policies adopted at the meeting, held June 8-12, below.)

A comprehensive AMA trustees’ report on AI considered additional issues including requirements for disclosing AI use, liability for harms due to flawed application of AI, data privacy, and cybersecurity.

The AMA intends to “continue to methodically assess these issues and make informed recommendations in proposing new policy,” said Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, who became the AMA’s new president-elect.

AMA members at the meeting largely applauded the aim of these AI proposals, but some objected to parts of the trustees’ report.

They raised questions about what, exactly, constitutes an AI-powered service and whether all AI tools need the kind of guardrails the AMA may seek. There also were concerns about calls to make AI use more transparent.

While transparency might be an admirable goal, it might prove too hard to achieve given that AI-powered tools and products are already woven into medical practice in ways that physicians may not know or understand, said Christopher Libby, MD, MPH, a clinical informaticist and emergency physician at Cedars Sinai Medical Center in Los Angeles.

“It’s hard for the practicing clinician to know how every piece of technology works in order to describe it to the patient,” Dr. Libby said at the meeting. “How many people here can identify when algorithms are used in their EHR today?”

He suggested asking for more transparency from the companies that make and sell AI-powered software and tools to insurers and healthcare systems.

Steven H. Kroft, MD, the editor of the American Journal of Clinical Pathology, raised concerns about the unintended harm that unchecked use of AI may pose to scientific research.

He asked the AMA to address “a significant omission in an otherwise comprehensive report” — the need to protect the integrity of study results that can direct patient care.

“While sham science is not a new issue, large language models make it far easier for authors to generate fake papers and far harder for editors, reviewers, and publishers to identify them,” Dr. Kroft said. “This is a rapidly growing phenomenon that is threatening the integrity of the literature. These papers become embedded in the evidence bases that drive clinical decision-making.”

AMA has been working with specialty societies and outside AI experts to refine an effective set of recommendations. The new policies, once finalized, are intended to build on steps AMA already has taken, including last year releasing principles for AI development, deployment, and use.
 

Congress Mulling

The AMA delegates are far from alone in facing AI policy challenges.

Leaders in Congress also are examining AI guardrails, with influential panels such as the Senate Finance and House Energy and Commerce committees holding hearings.

A key congressional AI effort to watch is the expected implementation of a bipartisan Senate “road map,” which Senate Majority Leader Chuck Schumer (D-NY) and colleagues released in May, said Miranda A. Franco, a senior policy advisor at the law firm Holland & Knight.

The product of many months of deliberation, this Senate road map identifies priorities for future legislation, including:

• Creating appropriate guardrails and safety measures to protect patients.
• Making healthcare and biomedical data available for machine learning and data science research while carefully addressing privacy issues.
• Providing transparency for clinicians and the public about the use of AI in medical products and clinical support services, including the data used to train models.
• Examining the Centers for Medicare & Medicaid Services’ reimbursement mechanisms as well as guardrails to ensure accountability, appropriate use, and broad application of AI across all populations.

Congress likely will address issues of AI in healthcare in piecemeal fashion, taking on different aspects of these challenges at different times, Ms. Franco said. The Senate road map gives the key committees directions on where to proceed in their efforts to develop new laws.

“I think this is all going to be slow and rolling, not big and sweeping,” Ms. Franco told this news organization. “I don’t think we’re going to see an encompassing AI bill.”
 

AMA Policies Adopted on Other Issues

At the June meeting, AMA delegates adopted the following policies aiming to:

• Increase oversight and accountability of health insurers’ use of prior authorization controls on patient access to care.
• Encourage policy changes allowing physicians to receive loan forgiveness when they practice in an Indian Health Service, Tribal, or Urban Indian Health Program, similar to physicians practicing in a Veterans Administration facility.
• Advocate for federal policy that limits a patient’s out-of-pocket cost to be the same or less than the amount that a patient with traditional Medicare plus a Medigap plan would pay.
• Oppose state or national legislation that could criminalize in vitro fertilization.
• Limit what the AMA calls the “expensive” cost for Medicare Advantage enrollees who need physician-administered drugs or biologics.
• Help physicians address the handling of de-identified patient data in a rapidly changing digital health ecosystem.
• Support efforts to decriminalize the possession of non-prescribed buprenorphine for personal use by individuals who lack access to a physician for the treatment of opioid use disorder.
• Expand access to hearing, vision, and dental care. The new AMA policy advocates working with state medical associations to support coverage of hearing exams, hearing aids, cochlear implants, and vision exams and aids. The revised AMA policy also supports working with the American Dental Association and other national organizations to improve access to dental care for people enrolled in Medicare, Medicaid, and CHIP programs.
• Increase enrollment of more women and sexual and gender minority populations in clinical trials.

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

The largest US physician organization wrestled with the professional risks and rewards of artificial intelligence (AI) at its annual meeting, delaying action even as it adopted new policies on prior authorization and other concerns for clinicians and patients.

Physicians and medical students at the annual meeting of the American Medical Association (AMA) House of Delegates in Chicago intensely debated a report and two key resolutions on AI but could not reach consensus, pushing off decision-making until a future meeting in November.

One resolution would establish “augmented intelligence” as the preferred term for AI, reflecting the desired role of these tools in supporting — not making — physicians’ decisions. The other resolution focused on insurers’ use of AI in determining medical necessity.

(See specific policies adopted at the meeting, held June 8-12, below.)

A comprehensive AMA trustees’ report on AI considered additional issues including requirements for disclosing AI use, liability for harms due to flawed application of AI, data privacy, and cybersecurity.

The AMA intends to “continue to methodically assess these issues and make informed recommendations in proposing new policy,” said Bobby Mukkamala, MD, an otolaryngologist from Flint, Michigan, who became the AMA’s new president-elect.

AMA members at the meeting largely applauded the aim of these AI proposals, but some objected to parts of the trustees’ report.

They raised questions about what, exactly, constitutes an AI-powered service and whether all AI tools need the kind of guardrails the AMA may seek. There also were concerns about calls to make AI use more transparent.

While transparency might be an admirable goal, it might prove too hard to achieve given that AI-powered tools and products are already woven into medical practice in ways that physicians may not know or understand, said Christopher Libby, MD, MPH, a clinical informaticist and emergency physician at Cedars Sinai Medical Center in Los Angeles.

“It’s hard for the practicing clinician to know how every piece of technology works in order to describe it to the patient,” Dr. Libby said at the meeting. “How many people here can identify when algorithms are used in their EHR today?”

He suggested asking for more transparency from the companies that make and sell AI-powered software and tools to insurers and healthcare systems.

Steven H. Kroft, MD, the editor of the American Journal of Clinical Pathology, raised concerns about the unintended harm that unchecked use of AI may pose to scientific research.

He asked the AMA to address “a significant omission in an otherwise comprehensive report” — the need to protect the integrity of study results that can direct patient care.

“While sham science is not a new issue, large language models make it far easier for authors to generate fake papers and far harder for editors, reviewers, and publishers to identify them,” Dr. Kroft said. “This is a rapidly growing phenomenon that is threatening the integrity of the literature. These papers become embedded in the evidence bases that drive clinical decision-making.”

AMA has been working with specialty societies and outside AI experts to refine an effective set of recommendations. The new policies, once finalized, are intended to build on steps AMA already has taken, including last year releasing principles for AI development, deployment, and use.
 

Congress Mulling

The AMA delegates are far from alone in facing AI policy challenges.

Leaders in Congress also are examining AI guardrails, with influential panels such as the Senate Finance and House Energy and Commerce committees holding hearings.

A key congressional AI effort to watch is the expected implementation of a bipartisan Senate “road map,” which Senate Majority Leader Chuck Schumer (D-NY) and colleagues released in May, said Miranda A. Franco, a senior policy advisor at the law firm Holland & Knight.

The product of many months of deliberation, this Senate road map identifies priorities for future legislation, including:

• Creating appropriate guardrails and safety measures to protect patients.
• Making healthcare and biomedical data available for machine learning and data science research while carefully addressing privacy issues.
• Providing transparency for clinicians and the public about the use of AI in medical products and clinical support services, including the data used to train models.
• Examining the Centers for Medicare & Medicaid Services’ reimbursement mechanisms as well as guardrails to ensure accountability, appropriate use, and broad application of AI across all populations.

Congress likely will address issues of AI in healthcare in piecemeal fashion, taking on different aspects of these challenges at different times, Ms. Franco said. The Senate road map gives the key committees directions on where to proceed in their efforts to develop new laws.

“I think this is all going to be slow and rolling, not big and sweeping,” Ms. Franco told this news organization. “I don’t think we’re going to see an encompassing AI bill.”
 

AMA Policies Adopted on Other Issues

At the June meeting, AMA delegates adopted the following policies aiming to:

• Increase oversight and accountability of health insurers’ use of prior authorization controls on patient access to care.
• Encourage policy changes allowing physicians to receive loan forgiveness when they practice in an Indian Health Service, Tribal, or Urban Indian Health Program, similar to physicians practicing in a Veterans Administration facility.
• Advocate for federal policy that limits a patient’s out-of-pocket cost to be the same or less than the amount that a patient with traditional Medicare plus a Medigap plan would pay.
• Oppose state or national legislation that could criminalize in vitro fertilization.
• Limit what the AMA calls the “expensive” cost for Medicare Advantage enrollees who need physician-administered drugs or biologics.
• Help physicians address the handling of de-identified patient data in a rapidly changing digital health ecosystem.
• Support efforts to decriminalize the possession of non-prescribed buprenorphine for personal use by individuals who lack access to a physician for the treatment of opioid use disorder.
• Expand access to hearing, vision, and dental care. The new AMA policy advocates working with state medical associations to support coverage of hearing exams, hearing aids, cochlear implants, and vision exams and aids. The revised AMA policy also supports working with the American Dental Association and other national organizations to improve access to dental care for people enrolled in Medicare, Medicaid, and CHIP programs.
• Increase enrollment of more women and sexual and gender minority populations in clinical trials.

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

In this column, I recently discussed the impact of the microbiome on childhood vaccine responses. My group has been expanding our research on the topic of childhood vaccine response and its relationship to infection proneness. Therefore, I want to share new research findings.

Immune responsiveness to vaccines varies among children, leaving some susceptible to infections. We also have evidence that the immune deficiencies that contribute to poor vaccine responsiveness also manifest in children as respiratory infection proneness.
 

Predicting Vaccine Response in the Neonatal Period

The first 100 days of life is an amazing transition time in early life. During that time, the immune system is highly influenced by environmental factors that generate epigenetic changes affecting vaccine responsiveness. Some publications have used the term “window of opportunity,” because it is thought that interventions to change a negative trajectory to a positive one for vaccine responsiveness have a better potential to be effective. Predicting which children will be poorly responsive to vaccines would be desirable, so those children could be specifically identified for intervention. Doing so in the neonatal age time frame using easy-to-obtain clinical samples would be a bonus.

In our most recent study, we sought to identify cytokine biosignatures in the neonatal period, measured in convenient nasopharyngeal secretions, that predict vaccine responses, measured as antibody levels to various vaccines at 1 year of life. Secondly, we assessed the effect of antibiotic exposures on vaccine responses in the study cohort. Third, we tested for induction of CD4+ T-cell vaccine-specific immune memory at infant age 1 year. Fourth, we studied antigen presenting cells (APCs) at rest and in response to an adjuvant called R848, known to stimulate toll-like receptor (TLR) 7/8 agonist, to assess its effects on the immune cells of low vaccine responder children, compared with other children.¹

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (New York) General Hospital. He has no conflicts of interest to declare.

References

1. Pichichero ME et al. Variability of Vaccine Responsiveness in Young Children. J Infect Dis. 2023 Nov 22:jiad524. doi: 10.1093/infdis/jiad524.

2. Pichichero ME et al. Functional Immune Cell Differences Associated with Low Vaccine Responses in Infants. J Infect Dis. 2016 Jun 15;213(12):2014-2019. doi: 10.1093/infdis/jiw053.

In this column, I recently discussed the impact of the microbiome on childhood vaccine responses. My group has been expanding our research on the topic of childhood vaccine response and its relationship to infection proneness. Therefore, I want to share new research findings.

Immune responsiveness to vaccines varies among children, leaving some susceptible to infections. We also have evidence that the immune deficiencies that contribute to poor vaccine responsiveness also manifest in children as respiratory infection proneness.
 

Predicting Vaccine Response in the Neonatal Period

The first 100 days of life is an amazing transition time in early life. During that time, the immune system is highly influenced by environmental factors that generate epigenetic changes affecting vaccine responsiveness. Some publications have used the term “window of opportunity,” because it is thought that interventions to change a negative trajectory to a positive one for vaccine responsiveness have a better potential to be effective. Predicting which children will be poorly responsive to vaccines would be desirable, so those children could be specifically identified for intervention. Doing so in the neonatal age time frame using easy-to-obtain clinical samples would be a bonus.

In our most recent study, we sought to identify cytokine biosignatures in the neonatal period, measured in convenient nasopharyngeal secretions, that predict vaccine responses, measured as antibody levels to various vaccines at 1 year of life. Secondly, we assessed the effect of antibiotic exposures on vaccine responses in the study cohort. Third, we tested for induction of CD4+ T-cell vaccine-specific immune memory at infant age 1 year. Fourth, we studied antigen presenting cells (APCs) at rest and in response to an adjuvant called R848, known to stimulate toll-like receptor (TLR) 7/8 agonist, to assess its effects on the immune cells of low vaccine responder children, compared with other children.¹

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (New York) General Hospital. He has no conflicts of interest to declare.

References

1. Pichichero ME et al. Variability of Vaccine Responsiveness in Young Children. J Infect Dis. 2023 Nov 22:jiad524. doi: 10.1093/infdis/jiad524.

2. Pichichero ME et al. Functional Immune Cell Differences Associated with Low Vaccine Responses in Infants. J Infect Dis. 2016 Jun 15;213(12):2014-2019. doi: 10.1093/infdis/jiw053.

In this column, I recently discussed the impact of the microbiome on childhood vaccine responses. My group has been expanding our research on the topic of childhood vaccine response and its relationship to infection proneness. Therefore, I want to share new research findings.

Immune responsiveness to vaccines varies among children, leaving some susceptible to infections. We also have evidence that the immune deficiencies that contribute to poor vaccine responsiveness also manifest in children as respiratory infection proneness.
 

Predicting Vaccine Response in the Neonatal Period

The first 100 days of life is an amazing transition time in early life. During that time, the immune system is highly influenced by environmental factors that generate epigenetic changes affecting vaccine responsiveness. Some publications have used the term “window of opportunity,” because it is thought that interventions to change a negative trajectory to a positive one for vaccine responsiveness have a better potential to be effective. Predicting which children will be poorly responsive to vaccines would be desirable, so those children could be specifically identified for intervention. Doing so in the neonatal age time frame using easy-to-obtain clinical samples would be a bonus.

In our most recent study, we sought to identify cytokine biosignatures in the neonatal period, measured in convenient nasopharyngeal secretions, that predict vaccine responses, measured as antibody levels to various vaccines at 1 year of life. Secondly, we assessed the effect of antibiotic exposures on vaccine responses in the study cohort. Third, we tested for induction of CD4+ T-cell vaccine-specific immune memory at infant age 1 year. Fourth, we studied antigen presenting cells (APCs) at rest and in response to an adjuvant called R848, known to stimulate toll-like receptor (TLR) 7/8 agonist, to assess its effects on the immune cells of low vaccine responder children, compared with other children.¹

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (New York) General Hospital. He has no conflicts of interest to declare.

References

1. Pichichero ME et al. Variability of Vaccine Responsiveness in Young Children. J Infect Dis. 2023 Nov 22:jiad524. doi: 10.1093/infdis/jiad524.

2. Pichichero ME et al. Functional Immune Cell Differences Associated with Low Vaccine Responses in Infants. J Infect Dis. 2016 Jun 15;213(12):2014-2019. doi: 10.1093/infdis/jiw053.

Diagnosis

During the visit, skin scrapings were performed, revealing several Demodex mites, confirming the diagnosis of demodicosis.

Demodicosis refers to an infestation and sensitivity to Demodex spp. mites, usually in older adults or immunocompromised individuals. Demodex folliculorum and Demodex brevis are the two common species implicated. The life cycle of Demodex spp. occurs in the sebaceous glands, leading to mechanical and chemical irritation of the skin.

Dr. Catalina Matiz

Various immune responses are also triggered, such as a keratinocyte response via Toll-like receptor 2. Patients usually present with non-specific symptoms such as skin erythema, irritation, peeling, and dryness on the cheeks, eyelids, and paranasal areas. Patients may develop a maculopapular or rosacea-like rash.

Diagnosis is often made through microscopic examination of a skin sample in KOH solution. In rare occasions, a skin surface standardization biopsy method may be used, which determines the density of mites per 1 cm². Dermoscopy may identify spiky white structures. Molecular methods such as PCR can be used but are not standard.

The differential diagnosis may include acne, rosacea, folliculitis, and Candida infection. Demodicosis can be differentiated by history and further studies including dermoscopy.

Acne vulgaris is an inflammatory disease of the skin’s pilosebaceous unit, primarily involving the face and trunk. It can present with comedones, papules, pustules, and nodules. Secondary signs suggestive of acne vulgaris include scars, erythema, and hyperpigmentation. All forms of acne share a common pathogenesis resulting in the formation of microcomedones, precursors for all clinical acne lesions. In this patient, the absence of microcomedones and the presence of primary inflammatory papules localized to the nose and cheeks suggested an alternative diagnosis.

Rosacea was also considered in the differential diagnosis. Rosacea is an inflammatory dermatosis characterized by erythema, telangiectasia, recurrent flushing, and inflammatory lesions including papulopustules and swelling, primarily affecting the face. The pathogenesis of rosacea is not fully understood but is suggested to involve immune-mediated responses. Vascular dysregulation and reactive oxygen species damage keratinocytes, fibroblasts, and endothelial cells. A higher incidence of rosacea in those with a family history and UV exposure is a known trigger. Demodex folliculorum and Helicobacter pylori are also implicated. Occasionally, Demodex infestation and rosacea may co-occur, and treatment with topical metronidazole can be helpful.

Folliculitis is an infection and inflammation of the hair follicles, forming pustules or erythematous papules over hair-covered skin. It is commonly caused by bacterial infection but can also be due to fungi, viruses, and noninfectious causes such as eosinophilic folliculitis. Diagnosis is clinical, based on physical exam and history, such as recent increased sweating or scratching. KOH prep can be used for Malassezia folliculitis and skin biopsy for eosinophilic folliculitis. Treatment targets the underlying cause. Most bacterial folliculitis cases resolve without treatment, but topical antibiotics may be used. Fungal folliculitis requires oral antifungals, and herpes simplex folliculitis can be treated with antiviral medications.

Cutaneous candidiasis is an infection of the skin by various Candida species, commonly C. albicans. Superficial infections of the skin and mucous membranes, such as intertrigo, are common types. Risk factors include immunosuppression, endocrine disorders, or compromised blood flow. Increased humidity, occlusion, broken skin barriers, and altered skin microbial flora contribute to Candida infection. Diagnosis is clinical but can be confirmed by KOH prep, microscopy, and culture. Treatment involves anti-inflammatory, antibacterial, and antifungal medications. Topical clotrimazole, nystatin, and miconazole are commonly used. Recurrence is prevented by keeping the affected area dry with barrier creams.

Therapeutic goals include arresting mite reproduction, elimination, and preventing recurrent infestations. Treatment may last several months, and the choice of drug depends on patient factors. There have been no standardized treatment studies or long-term effectiveness analyses. Antibiotics such as tetracycline, metronidazole, doxycycline, and ivermectin may be used to prevent proliferation. Permethrin, benzyl benzoate, crotamiton, lindane, and sulfur have also been used. Metronidazole is a common treatment for demodicosis, as was used in our patient for several weeks until the lesions cleared. Systemic metronidazole therapy may be indicated for reducing Demodex spp. density. Severe cases, particularly in immunocompromised individuals, may require oral ivermectin. Appropriate hygiene is important for prevention, such as washing the face with non-oily cleansers and laundering linens regularly.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Mr. Lee is a medical student at the University of California San Diego.

Suggested Reading

Chudzicka-Strugała I et al. Demodicosis in different age groups and alternative treatment options—A review. J Clin Med. 2023 Feb 19;12(4):1649. doi: 10.3390/jcm12041649.

Eichenfield DZ et al. Management of acne vulgaris: A review. JAMA. 2021 Nov 23;326(20):2055-2067. doi: 10.1001/jama.2021.17633.

Sharma A et al. Rosacea management: A comprehensive review. J Cosmet Dermatol. 2022 May;21(5):1895-1904. doi: 10.1111/jocd.14816.

Taudorf EH et al. Cutaneous candidiasis — an evidence-based review of topical and systemic treatments to inform clinical practice. J Eur Acad Dermatol Venereol. 2019 Oct;33(10):1863-1873. doi: 10.1111/jdv.15782.

Winters RD, Mitchell M. Folliculitis. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547754/
 

Diagnosis

During the visit, skin scrapings were performed, revealing several Demodex mites, confirming the diagnosis of demodicosis.

Demodicosis refers to an infestation and sensitivity to Demodex spp. mites, usually in older adults or immunocompromised individuals. Demodex folliculorum and Demodex brevis are the two common species implicated. The life cycle of Demodex spp. occurs in the sebaceous glands, leading to mechanical and chemical irritation of the skin.

Dr. Catalina Matiz

Various immune responses are also triggered, such as a keratinocyte response via Toll-like receptor 2. Patients usually present with non-specific symptoms such as skin erythema, irritation, peeling, and dryness on the cheeks, eyelids, and paranasal areas. Patients may develop a maculopapular or rosacea-like rash.

Diagnosis is often made through microscopic examination of a skin sample in KOH solution. In rare occasions, a skin surface standardization biopsy method may be used, which determines the density of mites per 1 cm². Dermoscopy may identify spiky white structures. Molecular methods such as PCR can be used but are not standard.

The differential diagnosis may include acne, rosacea, folliculitis, and Candida infection. Demodicosis can be differentiated by history and further studies including dermoscopy.

Acne vulgaris is an inflammatory disease of the skin’s pilosebaceous unit, primarily involving the face and trunk. It can present with comedones, papules, pustules, and nodules. Secondary signs suggestive of acne vulgaris include scars, erythema, and hyperpigmentation. All forms of acne share a common pathogenesis resulting in the formation of microcomedones, precursors for all clinical acne lesions. In this patient, the absence of microcomedones and the presence of primary inflammatory papules localized to the nose and cheeks suggested an alternative diagnosis.

Rosacea was also considered in the differential diagnosis. Rosacea is an inflammatory dermatosis characterized by erythema, telangiectasia, recurrent flushing, and inflammatory lesions including papulopustules and swelling, primarily affecting the face. The pathogenesis of rosacea is not fully understood but is suggested to involve immune-mediated responses. Vascular dysregulation and reactive oxygen species damage keratinocytes, fibroblasts, and endothelial cells. A higher incidence of rosacea in those with a family history and UV exposure is a known trigger. Demodex folliculorum and Helicobacter pylori are also implicated. Occasionally, Demodex infestation and rosacea may co-occur, and treatment with topical metronidazole can be helpful.

Folliculitis is an infection and inflammation of the hair follicles, forming pustules or erythematous papules over hair-covered skin. It is commonly caused by bacterial infection but can also be due to fungi, viruses, and noninfectious causes such as eosinophilic folliculitis. Diagnosis is clinical, based on physical exam and history, such as recent increased sweating or scratching. KOH prep can be used for Malassezia folliculitis and skin biopsy for eosinophilic folliculitis. Treatment targets the underlying cause. Most bacterial folliculitis cases resolve without treatment, but topical antibiotics may be used. Fungal folliculitis requires oral antifungals, and herpes simplex folliculitis can be treated with antiviral medications.

Cutaneous candidiasis is an infection of the skin by various Candida species, commonly C. albicans. Superficial infections of the skin and mucous membranes, such as intertrigo, are common types. Risk factors include immunosuppression, endocrine disorders, or compromised blood flow. Increased humidity, occlusion, broken skin barriers, and altered skin microbial flora contribute to Candida infection. Diagnosis is clinical but can be confirmed by KOH prep, microscopy, and culture. Treatment involves anti-inflammatory, antibacterial, and antifungal medications. Topical clotrimazole, nystatin, and miconazole are commonly used. Recurrence is prevented by keeping the affected area dry with barrier creams.

Therapeutic goals include arresting mite reproduction, elimination, and preventing recurrent infestations. Treatment may last several months, and the choice of drug depends on patient factors. There have been no standardized treatment studies or long-term effectiveness analyses. Antibiotics such as tetracycline, metronidazole, doxycycline, and ivermectin may be used to prevent proliferation. Permethrin, benzyl benzoate, crotamiton, lindane, and sulfur have also been used. Metronidazole is a common treatment for demodicosis, as was used in our patient for several weeks until the lesions cleared. Systemic metronidazole therapy may be indicated for reducing Demodex spp. density. Severe cases, particularly in immunocompromised individuals, may require oral ivermectin. Appropriate hygiene is important for prevention, such as washing the face with non-oily cleansers and laundering linens regularly.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Mr. Lee is a medical student at the University of California San Diego.

Suggested Reading

Chudzicka-Strugała I et al. Demodicosis in different age groups and alternative treatment options—A review. J Clin Med. 2023 Feb 19;12(4):1649. doi: 10.3390/jcm12041649.

Eichenfield DZ et al. Management of acne vulgaris: A review. JAMA. 2021 Nov 23;326(20):2055-2067. doi: 10.1001/jama.2021.17633.

Sharma A et al. Rosacea management: A comprehensive review. J Cosmet Dermatol. 2022 May;21(5):1895-1904. doi: 10.1111/jocd.14816.

Taudorf EH et al. Cutaneous candidiasis — an evidence-based review of topical and systemic treatments to inform clinical practice. J Eur Acad Dermatol Venereol. 2019 Oct;33(10):1863-1873. doi: 10.1111/jdv.15782.

Winters RD, Mitchell M. Folliculitis. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547754/
 

Diagnosis

During the visit, skin scrapings were performed, revealing several Demodex mites, confirming the diagnosis of demodicosis.

Demodicosis refers to an infestation and sensitivity to Demodex spp. mites, usually in older adults or immunocompromised individuals. Demodex folliculorum and Demodex brevis are the two common species implicated. The life cycle of Demodex spp. occurs in the sebaceous glands, leading to mechanical and chemical irritation of the skin.

Dr. Catalina Matiz

Various immune responses are also triggered, such as a keratinocyte response via Toll-like receptor 2. Patients usually present with non-specific symptoms such as skin erythema, irritation, peeling, and dryness on the cheeks, eyelids, and paranasal areas. Patients may develop a maculopapular or rosacea-like rash.

Diagnosis is often made through microscopic examination of a skin sample in KOH solution. In rare occasions, a skin surface standardization biopsy method may be used, which determines the density of mites per 1 cm². Dermoscopy may identify spiky white structures. Molecular methods such as PCR can be used but are not standard.

The differential diagnosis may include acne, rosacea, folliculitis, and Candida infection. Demodicosis can be differentiated by history and further studies including dermoscopy.

Acne vulgaris is an inflammatory disease of the skin’s pilosebaceous unit, primarily involving the face and trunk. It can present with comedones, papules, pustules, and nodules. Secondary signs suggestive of acne vulgaris include scars, erythema, and hyperpigmentation. All forms of acne share a common pathogenesis resulting in the formation of microcomedones, precursors for all clinical acne lesions. In this patient, the absence of microcomedones and the presence of primary inflammatory papules localized to the nose and cheeks suggested an alternative diagnosis.

Rosacea was also considered in the differential diagnosis. Rosacea is an inflammatory dermatosis characterized by erythema, telangiectasia, recurrent flushing, and inflammatory lesions including papulopustules and swelling, primarily affecting the face. The pathogenesis of rosacea is not fully understood but is suggested to involve immune-mediated responses. Vascular dysregulation and reactive oxygen species damage keratinocytes, fibroblasts, and endothelial cells. A higher incidence of rosacea in those with a family history and UV exposure is a known trigger. Demodex folliculorum and Helicobacter pylori are also implicated. Occasionally, Demodex infestation and rosacea may co-occur, and treatment with topical metronidazole can be helpful.

Folliculitis is an infection and inflammation of the hair follicles, forming pustules or erythematous papules over hair-covered skin. It is commonly caused by bacterial infection but can also be due to fungi, viruses, and noninfectious causes such as eosinophilic folliculitis. Diagnosis is clinical, based on physical exam and history, such as recent increased sweating or scratching. KOH prep can be used for Malassezia folliculitis and skin biopsy for eosinophilic folliculitis. Treatment targets the underlying cause. Most bacterial folliculitis cases resolve without treatment, but topical antibiotics may be used. Fungal folliculitis requires oral antifungals, and herpes simplex folliculitis can be treated with antiviral medications.

Cutaneous candidiasis is an infection of the skin by various Candida species, commonly C. albicans. Superficial infections of the skin and mucous membranes, such as intertrigo, are common types. Risk factors include immunosuppression, endocrine disorders, or compromised blood flow. Increased humidity, occlusion, broken skin barriers, and altered skin microbial flora contribute to Candida infection. Diagnosis is clinical but can be confirmed by KOH prep, microscopy, and culture. Treatment involves anti-inflammatory, antibacterial, and antifungal medications. Topical clotrimazole, nystatin, and miconazole are commonly used. Recurrence is prevented by keeping the affected area dry with barrier creams.

Therapeutic goals include arresting mite reproduction, elimination, and preventing recurrent infestations. Treatment may last several months, and the choice of drug depends on patient factors. There have been no standardized treatment studies or long-term effectiveness analyses. Antibiotics such as tetracycline, metronidazole, doxycycline, and ivermectin may be used to prevent proliferation. Permethrin, benzyl benzoate, crotamiton, lindane, and sulfur have also been used. Metronidazole is a common treatment for demodicosis, as was used in our patient for several weeks until the lesions cleared. Systemic metronidazole therapy may be indicated for reducing Demodex spp. density. Severe cases, particularly in immunocompromised individuals, may require oral ivermectin. Appropriate hygiene is important for prevention, such as washing the face with non-oily cleansers and laundering linens regularly.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Mr. Lee is a medical student at the University of California San Diego.

Suggested Reading

Chudzicka-Strugała I et al. Demodicosis in different age groups and alternative treatment options—A review. J Clin Med. 2023 Feb 19;12(4):1649. doi: 10.3390/jcm12041649.

Eichenfield DZ et al. Management of acne vulgaris: A review. JAMA. 2021 Nov 23;326(20):2055-2067. doi: 10.1001/jama.2021.17633.

Sharma A et al. Rosacea management: A comprehensive review. J Cosmet Dermatol. 2022 May;21(5):1895-1904. doi: 10.1111/jocd.14816.

Taudorf EH et al. Cutaneous candidiasis — an evidence-based review of topical and systemic treatments to inform clinical practice. J Eur Acad Dermatol Venereol. 2019 Oct;33(10):1863-1873. doi: 10.1111/jdv.15782.

Winters RD, Mitchell M. Folliculitis. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547754/
 

Women who had overweight or obesity as teens or young adults had more than a twofold increased risk for stroke before age 55, new research suggested.

An analysis of more than five decades of health data on 10,000 adults revealed that close to 5% experienced a stroke during the follow-up period, with the risk for ischemic stroke being more than twice as high in women who had obesity as teens or young adults. The risk was even higher for hemorrhagic stroke in both men and women with a history of obesity in youth.

“Our findings suggest that being overweight may have long-term health effects, even if the excess weight is temporary,” lead author Ursula Mikkola, BM, an investigator in the Research Unit of Population Health at the University of Oulu, Oulu, Finland, said in a news release.

Gender Differences

Childhood obesity has been associated with a heightened risk for cerebrovascular disease later in life, but most studies have focused on body mass index (BMI) at a single time point without considering its fluctuations throughout life, the investigators noted.

For the study, investigators used data from the Northern Finland Birth Cohort 1966, a prospective, general population-based birth cohort that followed 10,491 individuals (5185 women) until 2020 or the first stroke, death, or moving abroad, whichever came first.

Mean (SD) follow-up for each participant was 39 years from age 14 onward and 23 years from age 31 onward. The analysis was conducted between 1980 and 2020.

BMI data were collected from participants at the age of 14 and 31 years. Age 14 covariates included smoking, parental socioeconomic status, and age at menarche (for girls). Age 31 covariates included smoking and participants’ educational level.

During the follow-up period, 4.7% of participants experienced stroke. Of these events, 31% were ischemic strokes and 40% were transient ischemic attacks. The remainder were hemorrhagic or other cerebrovascular events.

Using normal weight as a reference, researchers found that the risk for ischemic stroke was over twice as high for women who had been overweight at ages 14 (hazard ratio [HR], 2.49; 95% confidence interval [CI], 1.44-4.31) and 31 (HR, 2.13; 95% CI, 1.14-3.97) years. The risk was also considerably higher for women who had obesity at ages 14 (HR, 1.87; 95% CI, 0.76-4.58) and 31 (HR, 2.67; 95% CI, 1.26-5.65) years.

The risk for hemorrhagic stroke was even higher, both among women (HR, 3.49; 95% CI, 1.13-10.7) and men (HR, 5.75; 95% CI, 1.43-23.1) who had obesity at age 31.

No similar associations were found among men, and the findings were independent of earlier or later BMI.

The risk for any cerebrovascular disease related to overweight at age 14 was twice as high among girls vs boys (HR, 2.09; 95% CI, 1.06-4.15), and the risk for ischemic stroke related to obesity at age 31 was nearly seven times higher among women vs men (HR, 6.96; 95% CI, 1.36-35.7).

“Stroke at a young age is rare, so the difference of just a few strokes could have an outsized impact on the risk estimates,” the study authors said. “Also, BMI relies solely on a person’s height and weight; therefore, a high BMI may be a misleading way to define obesity, especially in muscular people who may carry little fat even while weighing more.”
 

Caveats

In an accompanying editorial, Larry Goldstein, MD, chair of the Department of Neurology, University of Kentucky, Lexington, Kentucky, and codirector of the Kentucky Neuroscience Institute, said the study “provides additional evidence of an association between overweight/obesity and stroke in young adults.”

However, Dr. Goldstein added that “while it is tempting to assume that reductions in overweight/obesity in younger populations would translate to lower stroke rates in young adults, this remains to be proven.”

Moreover, it is “always important to acknowledge that associations found in observational studies may not reflect causality.”

This study was supported by Orion Research Foundation, Päivikki and Sakari Sohlberg Foundation, and Paulo Foundation. Dr. Mikkola reported no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Goldstein reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Women who had overweight or obesity as teens or young adults had more than a twofold increased risk for stroke before age 55, new research suggested.

An analysis of more than five decades of health data on 10,000 adults revealed that close to 5% experienced a stroke during the follow-up period, with the risk for ischemic stroke being more than twice as high in women who had obesity as teens or young adults. The risk was even higher for hemorrhagic stroke in both men and women with a history of obesity in youth.

“Our findings suggest that being overweight may have long-term health effects, even if the excess weight is temporary,” lead author Ursula Mikkola, BM, an investigator in the Research Unit of Population Health at the University of Oulu, Oulu, Finland, said in a news release.

Gender Differences

Childhood obesity has been associated with a heightened risk for cerebrovascular disease later in life, but most studies have focused on body mass index (BMI) at a single time point without considering its fluctuations throughout life, the investigators noted.

For the study, investigators used data from the Northern Finland Birth Cohort 1966, a prospective, general population-based birth cohort that followed 10,491 individuals (5185 women) until 2020 or the first stroke, death, or moving abroad, whichever came first.

Mean (SD) follow-up for each participant was 39 years from age 14 onward and 23 years from age 31 onward. The analysis was conducted between 1980 and 2020.

BMI data were collected from participants at the age of 14 and 31 years. Age 14 covariates included smoking, parental socioeconomic status, and age at menarche (for girls). Age 31 covariates included smoking and participants’ educational level.

During the follow-up period, 4.7% of participants experienced stroke. Of these events, 31% were ischemic strokes and 40% were transient ischemic attacks. The remainder were hemorrhagic or other cerebrovascular events.

Using normal weight as a reference, researchers found that the risk for ischemic stroke was over twice as high for women who had been overweight at ages 14 (hazard ratio [HR], 2.49; 95% confidence interval [CI], 1.44-4.31) and 31 (HR, 2.13; 95% CI, 1.14-3.97) years. The risk was also considerably higher for women who had obesity at ages 14 (HR, 1.87; 95% CI, 0.76-4.58) and 31 (HR, 2.67; 95% CI, 1.26-5.65) years.

The risk for hemorrhagic stroke was even higher, both among women (HR, 3.49; 95% CI, 1.13-10.7) and men (HR, 5.75; 95% CI, 1.43-23.1) who had obesity at age 31.

No similar associations were found among men, and the findings were independent of earlier or later BMI.

The risk for any cerebrovascular disease related to overweight at age 14 was twice as high among girls vs boys (HR, 2.09; 95% CI, 1.06-4.15), and the risk for ischemic stroke related to obesity at age 31 was nearly seven times higher among women vs men (HR, 6.96; 95% CI, 1.36-35.7).

“Stroke at a young age is rare, so the difference of just a few strokes could have an outsized impact on the risk estimates,” the study authors said. “Also, BMI relies solely on a person’s height and weight; therefore, a high BMI may be a misleading way to define obesity, especially in muscular people who may carry little fat even while weighing more.”
 

Caveats

In an accompanying editorial, Larry Goldstein, MD, chair of the Department of Neurology, University of Kentucky, Lexington, Kentucky, and codirector of the Kentucky Neuroscience Institute, said the study “provides additional evidence of an association between overweight/obesity and stroke in young adults.”

However, Dr. Goldstein added that “while it is tempting to assume that reductions in overweight/obesity in younger populations would translate to lower stroke rates in young adults, this remains to be proven.”

Moreover, it is “always important to acknowledge that associations found in observational studies may not reflect causality.”

This study was supported by Orion Research Foundation, Päivikki and Sakari Sohlberg Foundation, and Paulo Foundation. Dr. Mikkola reported no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Goldstein reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Women who had overweight or obesity as teens or young adults had more than a twofold increased risk for stroke before age 55, new research suggested.

An analysis of more than five decades of health data on 10,000 adults revealed that close to 5% experienced a stroke during the follow-up period, with the risk for ischemic stroke being more than twice as high in women who had obesity as teens or young adults. The risk was even higher for hemorrhagic stroke in both men and women with a history of obesity in youth.

“Our findings suggest that being overweight may have long-term health effects, even if the excess weight is temporary,” lead author Ursula Mikkola, BM, an investigator in the Research Unit of Population Health at the University of Oulu, Oulu, Finland, said in a news release.

Gender Differences

Childhood obesity has been associated with a heightened risk for cerebrovascular disease later in life, but most studies have focused on body mass index (BMI) at a single time point without considering its fluctuations throughout life, the investigators noted.

For the study, investigators used data from the Northern Finland Birth Cohort 1966, a prospective, general population-based birth cohort that followed 10,491 individuals (5185 women) until 2020 or the first stroke, death, or moving abroad, whichever came first.

Mean (SD) follow-up for each participant was 39 years from age 14 onward and 23 years from age 31 onward. The analysis was conducted between 1980 and 2020.

BMI data were collected from participants at the age of 14 and 31 years. Age 14 covariates included smoking, parental socioeconomic status, and age at menarche (for girls). Age 31 covariates included smoking and participants’ educational level.

During the follow-up period, 4.7% of participants experienced stroke. Of these events, 31% were ischemic strokes and 40% were transient ischemic attacks. The remainder were hemorrhagic or other cerebrovascular events.

Using normal weight as a reference, researchers found that the risk for ischemic stroke was over twice as high for women who had been overweight at ages 14 (hazard ratio [HR], 2.49; 95% confidence interval [CI], 1.44-4.31) and 31 (HR, 2.13; 95% CI, 1.14-3.97) years. The risk was also considerably higher for women who had obesity at ages 14 (HR, 1.87; 95% CI, 0.76-4.58) and 31 (HR, 2.67; 95% CI, 1.26-5.65) years.

The risk for hemorrhagic stroke was even higher, both among women (HR, 3.49; 95% CI, 1.13-10.7) and men (HR, 5.75; 95% CI, 1.43-23.1) who had obesity at age 31.

No similar associations were found among men, and the findings were independent of earlier or later BMI.

The risk for any cerebrovascular disease related to overweight at age 14 was twice as high among girls vs boys (HR, 2.09; 95% CI, 1.06-4.15), and the risk for ischemic stroke related to obesity at age 31 was nearly seven times higher among women vs men (HR, 6.96; 95% CI, 1.36-35.7).

“Stroke at a young age is rare, so the difference of just a few strokes could have an outsized impact on the risk estimates,” the study authors said. “Also, BMI relies solely on a person’s height and weight; therefore, a high BMI may be a misleading way to define obesity, especially in muscular people who may carry little fat even while weighing more.”
 

Caveats

In an accompanying editorial, Larry Goldstein, MD, chair of the Department of Neurology, University of Kentucky, Lexington, Kentucky, and codirector of the Kentucky Neuroscience Institute, said the study “provides additional evidence of an association between overweight/obesity and stroke in young adults.”

However, Dr. Goldstein added that “while it is tempting to assume that reductions in overweight/obesity in younger populations would translate to lower stroke rates in young adults, this remains to be proven.”

Moreover, it is “always important to acknowledge that associations found in observational studies may not reflect causality.”

This study was supported by Orion Research Foundation, Päivikki and Sakari Sohlberg Foundation, and Paulo Foundation. Dr. Mikkola reported no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Goldstein reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

A new analysis of a national dataset of children in the United States shows that there were roughly one million more children with attention-deficit/hyperactivity disorder (ADHD) in 2022 than in 2016.

METHODOLOGY:

• Researchers used 2022 data from the National Survey of Children’s Health to estimate the prevalence of ever-diagnosed and current ADHD among US children between the ages of 3 and 18 years.
• They also estimated, among children with current ADHD, the severity of the condition and the presence of current co-occurring disorders and the receipt of medication and behavioral treatments.
• The researchers calculated overall weighted estimates as well as estimates for specific demographic and clinical subgroups (n = 45,169).

TAKEAWAY:

• The number of children who had ever received an ADHD diagnosis increased from 6.1 million in 2016 to 7.1 million in 2022, and the number with current ADHD increased from 5.4 million to 6.5 million.
• Of those with current ADHD in 2022, 58.1% had moderate or severe ADHD, and 77.9% had at least one co-occurring disorder.
• A total of 53.6% had received ADHD medication, 44.4% had received behavioral treatment in the past year, and 30.1% had received no ADHD-specific treatment.
• A similar percentage of children with ADHD were receiving behavioral treatment in 2022 as in 2016 (44.4% vs 46.7%, respectively), but treatment with ADHD medication was lower in 2022 than in 2016 (53.6% vs 62.0%, respectively).

IN PRACTICE:

The estimates “can be used by clinicians to understand current ADHD diagnosis and treatment utilization patterns to inform clinical practice, such as accounting for the frequency and management of co-occurring conditions and considering the notable percentage of children with ADHD not currently receiving ADHD treatment,” and can be used by policymakers, practitioners, and others “to plan for the needs of children with ADHD, such as by ensuring access to care and services for ADHD,” investigators wrote.

SOURCE:

Melissa L. Danielson, of the National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, led the study, which was published online in the Journal of Clinical Child & Adolescent Psychology.

LIMITATIONS:

Indicators reported in the analysis were on the basis of the parent report, which may be limited by recall and reporting decisions and were not validated against medical records or clinical judgment. Moreover, details about the types of treatment were not included.

DISCLOSURES:

The work was authorized as part of the contributor’s official duties as an employee of the US Government, and therefore is a work of the US Government. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

A new analysis of a national dataset of children in the United States shows that there were roughly one million more children with attention-deficit/hyperactivity disorder (ADHD) in 2022 than in 2016.

METHODOLOGY:

• Researchers used 2022 data from the National Survey of Children’s Health to estimate the prevalence of ever-diagnosed and current ADHD among US children between the ages of 3 and 18 years.
• They also estimated, among children with current ADHD, the severity of the condition and the presence of current co-occurring disorders and the receipt of medication and behavioral treatments.
• The researchers calculated overall weighted estimates as well as estimates for specific demographic and clinical subgroups (n = 45,169).

TAKEAWAY:

• The number of children who had ever received an ADHD diagnosis increased from 6.1 million in 2016 to 7.1 million in 2022, and the number with current ADHD increased from 5.4 million to 6.5 million.
• Of those with current ADHD in 2022, 58.1% had moderate or severe ADHD, and 77.9% had at least one co-occurring disorder.
• A total of 53.6% had received ADHD medication, 44.4% had received behavioral treatment in the past year, and 30.1% had received no ADHD-specific treatment.
• A similar percentage of children with ADHD were receiving behavioral treatment in 2022 as in 2016 (44.4% vs 46.7%, respectively), but treatment with ADHD medication was lower in 2022 than in 2016 (53.6% vs 62.0%, respectively).

IN PRACTICE:

The estimates “can be used by clinicians to understand current ADHD diagnosis and treatment utilization patterns to inform clinical practice, such as accounting for the frequency and management of co-occurring conditions and considering the notable percentage of children with ADHD not currently receiving ADHD treatment,” and can be used by policymakers, practitioners, and others “to plan for the needs of children with ADHD, such as by ensuring access to care and services for ADHD,” investigators wrote.

SOURCE:

Melissa L. Danielson, of the National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, led the study, which was published online in the Journal of Clinical Child & Adolescent Psychology.

LIMITATIONS:

Indicators reported in the analysis were on the basis of the parent report, which may be limited by recall and reporting decisions and were not validated against medical records or clinical judgment. Moreover, details about the types of treatment were not included.

DISCLOSURES:

The work was authorized as part of the contributor’s official duties as an employee of the US Government, and therefore is a work of the US Government. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

A new analysis of a national dataset of children in the United States shows that there were roughly one million more children with attention-deficit/hyperactivity disorder (ADHD) in 2022 than in 2016.

METHODOLOGY:

• Researchers used 2022 data from the National Survey of Children’s Health to estimate the prevalence of ever-diagnosed and current ADHD among US children between the ages of 3 and 18 years.
• They also estimated, among children with current ADHD, the severity of the condition and the presence of current co-occurring disorders and the receipt of medication and behavioral treatments.
• The researchers calculated overall weighted estimates as well as estimates for specific demographic and clinical subgroups (n = 45,169).

TAKEAWAY:

• The number of children who had ever received an ADHD diagnosis increased from 6.1 million in 2016 to 7.1 million in 2022, and the number with current ADHD increased from 5.4 million to 6.5 million.
• Of those with current ADHD in 2022, 58.1% had moderate or severe ADHD, and 77.9% had at least one co-occurring disorder.
• A total of 53.6% had received ADHD medication, 44.4% had received behavioral treatment in the past year, and 30.1% had received no ADHD-specific treatment.
• A similar percentage of children with ADHD were receiving behavioral treatment in 2022 as in 2016 (44.4% vs 46.7%, respectively), but treatment with ADHD medication was lower in 2022 than in 2016 (53.6% vs 62.0%, respectively).

IN PRACTICE:

The estimates “can be used by clinicians to understand current ADHD diagnosis and treatment utilization patterns to inform clinical practice, such as accounting for the frequency and management of co-occurring conditions and considering the notable percentage of children with ADHD not currently receiving ADHD treatment,” and can be used by policymakers, practitioners, and others “to plan for the needs of children with ADHD, such as by ensuring access to care and services for ADHD,” investigators wrote.

SOURCE:

Melissa L. Danielson, of the National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, led the study, which was published online in the Journal of Clinical Child & Adolescent Psychology.

LIMITATIONS:

Indicators reported in the analysis were on the basis of the parent report, which may be limited by recall and reporting decisions and were not validated against medical records or clinical judgment. Moreover, details about the types of treatment were not included.

DISCLOSURES:

The work was authorized as part of the contributor’s official duties as an employee of the US Government, and therefore is a work of the US Government. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

Fundamentally, an immigrant parent’s traditional role as teacher of culture and social systems to their children is undermined by immigration. In their native country, they learned throughout their life cultural norms and systems that defined their environment. When these parents immigrate to a new country, their different set of knowledge may not be applicable in many ways to their new environment.

The Disruption of Social Roles

Culturally, language is one of the most important types of knowledge parents pass to their children. Nearly half of adult immigrants in the United States have limited English proficiency. ¹

Their children often learn the language faster, often placing these children in the position of interpreters for their parents. These parents can become dependent on their children to negotiate social structures instead of vice versa, potentially undermining the social hierarchy and role of parenting. ² Both Mr. Contreras and Dr. Nguyen recall that as children of immigrant parents — from Mexico and Vietnam, respectively — they commanded English better than their parents, which often made them take on more “adult roles.” For example, Dr. Nguyen recalls that his mother would solicit his help in grocery shopping because she could neither navigate the aisles effectively nor ask for help. Mr. Contreras commonly found himself acting as an impromptu medical translator for his mother on several occasions. This dependence of immigrant parents on their children for guidance in their host country can be pervasive in other social structures such as legal and academic.

Impact on School

Potentially, an immigrant parent’s lack of knowledge of the language and systems of their host country can make them ineffective advocates for their children at school. Mr. Contreras’s intervention for his patient as a medical student demonstrates this in the arena of school.

Mr. Contreras was rotating at a hospital burn unit in 2023 when R, a young middle school student, and his mother arrived in the emergency department. An incident had occurred at his school. R had been the victim of aggravated battery and assault, sustaining a 3x2 cm burn on his forearm from students placing hot glue onto a piece of cardboard then immediately onto his skin and silencing him by covering his mouth. For months the older students had been bullying R. R’s mother made multiple attempts with both the school’s front desk and counselors to address the issue, but to no avail. R himself, though encouraged to speak up, did not out of fear. As Mr. Contreras realized the situation and the impasse, he used his fluency in Spanish and English to facilitate a joint call with the school district. Within 10 minutes, they were able to connect with a student safety specialist and launch a full investigation. A language barrier and the lack of knowledge of their rights and school system had prevented R’s mother from effectively advocating for her child’s safety.

In Dr. Nguyen’s experience as a teacher, even in classrooms dominated by minority students, the advocacy for students struggling in classes was disproportionate. It favored White parents, but also generally more educated families. This is further supported by a study of 225 schools across six states of kindergarten children showing similar trends, that African American, Latino, and less-educated parents were less involved in their children’s education as reported by teachers.³ It is important to note that in this study teachers were 80% White, 9% Latino, 7% African American, 3% multiracial, and 1% Asian American, suggesting that cultural discrepancy between teachers and parents could be an important factor affecting parent-teacher communication. Dr. Nguyen also recalled trying to discipline several students who were disruptive in his class by telling them he would speak to their parents. Several times, these students would counter defiantly, “Well, good luck, they can’t speak English.” The parents’ dependency on their children to communicate with teachers undermined the abilities of both adults to manage their behaviors and promote learning.
 

The Mental Health of Immigrant Parents  

Migrants often have greater incidence of mental health problems, including depression, PTSD, and anxiety, from a combination of peri-migrational experiences. ⁴ Immigrant mothers are known to have higher rates of post-natal depression, which cause problems later with child development. ⁵ Though she warns larger studies are needed, Dr. Fazel’s review of Croatian refugees suggests that displacement from one’s native country is a risk factor for poorer mental health, namely due to difficulty in psychosocial adaptation. ⁶ The likely mechanism is that lack of access to one’s language and culture, or a language and culture that one can navigate effectively, exacerbates, even engenders mental health sequelae. Because of this, first-generation immigrant children often face harsher and more violent parenting. ^7,8 Immigrant parents also may have less access to mental health resources since they often resort to their own cultural practices. Both Mr. Contreras’s and Dr. Nguyen’s following narratives of their mothers’ struggle with mental health illustrate the causes and consequences.

Mr. Contreras, who grew up in a Mexican immigrant household in Los Angeles, saw firsthand how his mother, who faced language barriers and a distrust of Western medicine, turned to traditional healers and herbal remedies for her health needs. Accompanying her to doctor appointments as her translator, he often felt the disconnect between her cultural background and the Western medical system. For her, seeking help from traditional healers was not just about addressing physical ailments but also about finding comfort and familiarity in practices rooted in her cultural beliefs. This preference for cultural or religious methods for mental health support is not uncommon among Mexican immigrant families.

Dr. Nguyen, whose mother was a refugee from Vietnam, recalls her constant depressed mood and suicidal thoughts in the immediate years after she resettled in San Diego. This was caused mostly by the missing of her social supports in Vietnam, her difficulty adjusting to American culture and language, and her difficulty finding work. Often her depression and stress took a darker turn in terms of more violent parenting. Of course, the cause of her poor mental health is hard to parse from the traumas and violence she had faced as a refugee, but in subsequent years, her many brothers and sisters who immigrated through a more orderly process also displayed similar mental health vulnerabilities.

   

The Mental Health of Children of Immigrant Parents  

The relationship between an immigrant parent’s poor mental health and their children is difficult to parse from what we know about native parents and their children. But the primary differences appear to be a great disruption of social roles, the effects of migration itself, and the oftentimes more strict and disciplinarian parenting style as discussed above. Given this, one would expect immigrant children to suffer greater mental health difficulties. However, a recent study of almost 500,000 children in Canada revealed decreased prevalence of conduct disorder, ADHD, and mood and anxiety disorders in immigrant youth, both first- and second-generation, as compared to non-immigrants. ⁹ This perhaps surprising result highlights how much more we need to understand about the effects of culture on the mental health diagnosis of immigrant youth. It suggests differences in mental health access and use from the cultural factors we mentioned above, to problems with using Western-based mental criteria and symptomatology for diagnosing non-Western children. It can even suggest the underestimation of the protective effects of native culture such as strong ethnic identity and cultural support systems, thereby challenging a purely deficit mental health model of the immigrant experience.

Summary

Dr. Duy Nguyen and Mr. Andrew Contreras are both children of immigrant parents from Vietnam and Mexico, respectively. Dr. Nguyen spent 15 years as an English teacher at San Leandro High School, whose student body was roughly 50% Hispanic and 25% Asian, making immigrant parents a huge swath of his educational partners. Mr. Contreras founded a high school outreach program where he interacted with K-12 children of immigrant youth. In addition, he partners with Fresno’s Economic Opportunity Commission to educate immigrant Hispanic parents and their teens on having difficult conversations with their teenage children on topics such as mental and reproductive health. Dr. Duy Nguyen and Mr. Andrew Contreras will explore the differences in immigrant parent-child relationships, compared with native ones, as they relate to mental health ramifications for the child and parent. They reveal immigrant mental health disruptions regarding culture and language, familial hierarchies, parenting styles, as well as parental mental health sequelae brought about by immigration using research and their own personal experiences.

Dr. Nguyen is a second-year resident at the University of California, San Francisco, Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously. Mr. Contreras is currently a 4th-year medical student at University of California, San Francisco, and applying to Psychiatry for the 2025 match.

References  

1. Rao A et al. Five Key Facts About Immigrants With Limited English Proficiency. KFF. 2024 March 14. https://www.kff.org/racial-equity-and-health-policy/issue-brief-five-key-facts-about-immigrants-with-limited-english-proficiency .

2. Raffaetà R. Migration and Parenting: Reviewing the Debate and Calling for Future Research. International Journal of Migration, Health and Social Care. 2016;12(1):38-50. doi: 10.1108/IJMHSC-12-2014-0052/full/html .

3. Nzinga‐Johnson S et al. Teacher‐Parent Relationships and School Involvement Among Racially and Educationally Diverse Parents of Kindergartners. Elementary School Journal. 2009 Sept. doi: 10.1086/598844 .

4. Close C et al. The Mental Health and Wellbeing of First Generation Migrants: A Systematic-Narrative Review of Reviews. Global Health. 2016 Aug 25;12(1):47. doi: 10.1186/s12992-016-0187-3.

5. Collins CH et al. Refugee, Asylum Seeker, Immigrant Women and Postnatal Depression: Rates and Risk Factors. Arch Womens Ment Health. 2011 Feb;14(1):3-11. doi: 10.1007/s00737-010-0198-7 .

6. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5 .

7. Pottie K et al. Do First Generation Immigrant Adolescents Face Higher Rates of Bullying, Violence and Suicidal Behaviours Than Do Third Generation and Native Born? J Immigr Minor Health. 2015 Oct;17(5):1557-1566. doi: 10.1007/s10903-014-0108-6.

8. Smokowski PR, Bacallao ML. Acculturation and Aggression in Latino Adolescents: A Structural Model Focusing on Cultural Risk Factors and Assets. J Abnorm Child Psychol. 2006 Oct;34(5):659-673. doi: 10.1007/s10802-006-9049-4 .

9. Gadermann AM et al. Prevalence of Mental Health Disorders Among Immigrant, Refugee, and Nonimmigrant Children and Youth in British Columbia, Canada. JAMA Netw Open. 2022;5(2):e2144934. doi: 10.1001/jamanetworkopen.2021.44934 .

Fundamentally, an immigrant parent’s traditional role as teacher of culture and social systems to their children is undermined by immigration. In their native country, they learned throughout their life cultural norms and systems that defined their environment. When these parents immigrate to a new country, their different set of knowledge may not be applicable in many ways to their new environment.

The Disruption of Social Roles

Culturally, language is one of the most important types of knowledge parents pass to their children. Nearly half of adult immigrants in the United States have limited English proficiency. ¹

Their children often learn the language faster, often placing these children in the position of interpreters for their parents. These parents can become dependent on their children to negotiate social structures instead of vice versa, potentially undermining the social hierarchy and role of parenting. ² Both Mr. Contreras and Dr. Nguyen recall that as children of immigrant parents — from Mexico and Vietnam, respectively — they commanded English better than their parents, which often made them take on more “adult roles.” For example, Dr. Nguyen recalls that his mother would solicit his help in grocery shopping because she could neither navigate the aisles effectively nor ask for help. Mr. Contreras commonly found himself acting as an impromptu medical translator for his mother on several occasions. This dependence of immigrant parents on their children for guidance in their host country can be pervasive in other social structures such as legal and academic.

Impact on School

Potentially, an immigrant parent’s lack of knowledge of the language and systems of their host country can make them ineffective advocates for their children at school. Mr. Contreras’s intervention for his patient as a medical student demonstrates this in the arena of school.

Mr. Contreras was rotating at a hospital burn unit in 2023 when R, a young middle school student, and his mother arrived in the emergency department. An incident had occurred at his school. R had been the victim of aggravated battery and assault, sustaining a 3x2 cm burn on his forearm from students placing hot glue onto a piece of cardboard then immediately onto his skin and silencing him by covering his mouth. For months the older students had been bullying R. R’s mother made multiple attempts with both the school’s front desk and counselors to address the issue, but to no avail. R himself, though encouraged to speak up, did not out of fear. As Mr. Contreras realized the situation and the impasse, he used his fluency in Spanish and English to facilitate a joint call with the school district. Within 10 minutes, they were able to connect with a student safety specialist and launch a full investigation. A language barrier and the lack of knowledge of their rights and school system had prevented R’s mother from effectively advocating for her child’s safety.

In Dr. Nguyen’s experience as a teacher, even in classrooms dominated by minority students, the advocacy for students struggling in classes was disproportionate. It favored White parents, but also generally more educated families. This is further supported by a study of 225 schools across six states of kindergarten children showing similar trends, that African American, Latino, and less-educated parents were less involved in their children’s education as reported by teachers.³ It is important to note that in this study teachers were 80% White, 9% Latino, 7% African American, 3% multiracial, and 1% Asian American, suggesting that cultural discrepancy between teachers and parents could be an important factor affecting parent-teacher communication. Dr. Nguyen also recalled trying to discipline several students who were disruptive in his class by telling them he would speak to their parents. Several times, these students would counter defiantly, “Well, good luck, they can’t speak English.” The parents’ dependency on their children to communicate with teachers undermined the abilities of both adults to manage their behaviors and promote learning.
 

The Mental Health of Immigrant Parents  

Migrants often have greater incidence of mental health problems, including depression, PTSD, and anxiety, from a combination of peri-migrational experiences. ⁴ Immigrant mothers are known to have higher rates of post-natal depression, which cause problems later with child development. ⁵ Though she warns larger studies are needed, Dr. Fazel’s review of Croatian refugees suggests that displacement from one’s native country is a risk factor for poorer mental health, namely due to difficulty in psychosocial adaptation. ⁶ The likely mechanism is that lack of access to one’s language and culture, or a language and culture that one can navigate effectively, exacerbates, even engenders mental health sequelae. Because of this, first-generation immigrant children often face harsher and more violent parenting. ^7,8 Immigrant parents also may have less access to mental health resources since they often resort to their own cultural practices. Both Mr. Contreras’s and Dr. Nguyen’s following narratives of their mothers’ struggle with mental health illustrate the causes and consequences.

Mr. Contreras, who grew up in a Mexican immigrant household in Los Angeles, saw firsthand how his mother, who faced language barriers and a distrust of Western medicine, turned to traditional healers and herbal remedies for her health needs. Accompanying her to doctor appointments as her translator, he often felt the disconnect between her cultural background and the Western medical system. For her, seeking help from traditional healers was not just about addressing physical ailments but also about finding comfort and familiarity in practices rooted in her cultural beliefs. This preference for cultural or religious methods for mental health support is not uncommon among Mexican immigrant families.

Dr. Nguyen, whose mother was a refugee from Vietnam, recalls her constant depressed mood and suicidal thoughts in the immediate years after she resettled in San Diego. This was caused mostly by the missing of her social supports in Vietnam, her difficulty adjusting to American culture and language, and her difficulty finding work. Often her depression and stress took a darker turn in terms of more violent parenting. Of course, the cause of her poor mental health is hard to parse from the traumas and violence she had faced as a refugee, but in subsequent years, her many brothers and sisters who immigrated through a more orderly process also displayed similar mental health vulnerabilities.

   

The Mental Health of Children of Immigrant Parents  

The relationship between an immigrant parent’s poor mental health and their children is difficult to parse from what we know about native parents and their children. But the primary differences appear to be a great disruption of social roles, the effects of migration itself, and the oftentimes more strict and disciplinarian parenting style as discussed above. Given this, one would expect immigrant children to suffer greater mental health difficulties. However, a recent study of almost 500,000 children in Canada revealed decreased prevalence of conduct disorder, ADHD, and mood and anxiety disorders in immigrant youth, both first- and second-generation, as compared to non-immigrants. ⁹ This perhaps surprising result highlights how much more we need to understand about the effects of culture on the mental health diagnosis of immigrant youth. It suggests differences in mental health access and use from the cultural factors we mentioned above, to problems with using Western-based mental criteria and symptomatology for diagnosing non-Western children. It can even suggest the underestimation of the protective effects of native culture such as strong ethnic identity and cultural support systems, thereby challenging a purely deficit mental health model of the immigrant experience.

Summary

Dr. Duy Nguyen and Mr. Andrew Contreras are both children of immigrant parents from Vietnam and Mexico, respectively. Dr. Nguyen spent 15 years as an English teacher at San Leandro High School, whose student body was roughly 50% Hispanic and 25% Asian, making immigrant parents a huge swath of his educational partners. Mr. Contreras founded a high school outreach program where he interacted with K-12 children of immigrant youth. In addition, he partners with Fresno’s Economic Opportunity Commission to educate immigrant Hispanic parents and their teens on having difficult conversations with their teenage children on topics such as mental and reproductive health. Dr. Duy Nguyen and Mr. Andrew Contreras will explore the differences in immigrant parent-child relationships, compared with native ones, as they relate to mental health ramifications for the child and parent. They reveal immigrant mental health disruptions regarding culture and language, familial hierarchies, parenting styles, as well as parental mental health sequelae brought about by immigration using research and their own personal experiences.

Dr. Nguyen is a second-year resident at the University of California, San Francisco, Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously. Mr. Contreras is currently a 4th-year medical student at University of California, San Francisco, and applying to Psychiatry for the 2025 match.

References  

1. Rao A et al. Five Key Facts About Immigrants With Limited English Proficiency. KFF. 2024 March 14. https://www.kff.org/racial-equity-and-health-policy/issue-brief-five-key-facts-about-immigrants-with-limited-english-proficiency .

2. Raffaetà R. Migration and Parenting: Reviewing the Debate and Calling for Future Research. International Journal of Migration, Health and Social Care. 2016;12(1):38-50. doi: 10.1108/IJMHSC-12-2014-0052/full/html .

3. Nzinga‐Johnson S et al. Teacher‐Parent Relationships and School Involvement Among Racially and Educationally Diverse Parents of Kindergartners. Elementary School Journal. 2009 Sept. doi: 10.1086/598844 .

4. Close C et al. The Mental Health and Wellbeing of First Generation Migrants: A Systematic-Narrative Review of Reviews. Global Health. 2016 Aug 25;12(1):47. doi: 10.1186/s12992-016-0187-3.

5. Collins CH et al. Refugee, Asylum Seeker, Immigrant Women and Postnatal Depression: Rates and Risk Factors. Arch Womens Ment Health. 2011 Feb;14(1):3-11. doi: 10.1007/s00737-010-0198-7 .

6. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5 .

7. Pottie K et al. Do First Generation Immigrant Adolescents Face Higher Rates of Bullying, Violence and Suicidal Behaviours Than Do Third Generation and Native Born? J Immigr Minor Health. 2015 Oct;17(5):1557-1566. doi: 10.1007/s10903-014-0108-6.

8. Smokowski PR, Bacallao ML. Acculturation and Aggression in Latino Adolescents: A Structural Model Focusing on Cultural Risk Factors and Assets. J Abnorm Child Psychol. 2006 Oct;34(5):659-673. doi: 10.1007/s10802-006-9049-4 .

9. Gadermann AM et al. Prevalence of Mental Health Disorders Among Immigrant, Refugee, and Nonimmigrant Children and Youth in British Columbia, Canada. JAMA Netw Open. 2022;5(2):e2144934. doi: 10.1001/jamanetworkopen.2021.44934 .

Fundamentally, an immigrant parent’s traditional role as teacher of culture and social systems to their children is undermined by immigration. In their native country, they learned throughout their life cultural norms and systems that defined their environment. When these parents immigrate to a new country, their different set of knowledge may not be applicable in many ways to their new environment.

The Disruption of Social Roles

Culturally, language is one of the most important types of knowledge parents pass to their children. Nearly half of adult immigrants in the United States have limited English proficiency. ¹

Their children often learn the language faster, often placing these children in the position of interpreters for their parents. These parents can become dependent on their children to negotiate social structures instead of vice versa, potentially undermining the social hierarchy and role of parenting. ² Both Mr. Contreras and Dr. Nguyen recall that as children of immigrant parents — from Mexico and Vietnam, respectively — they commanded English better than their parents, which often made them take on more “adult roles.” For example, Dr. Nguyen recalls that his mother would solicit his help in grocery shopping because she could neither navigate the aisles effectively nor ask for help. Mr. Contreras commonly found himself acting as an impromptu medical translator for his mother on several occasions. This dependence of immigrant parents on their children for guidance in their host country can be pervasive in other social structures such as legal and academic.

Impact on School

Potentially, an immigrant parent’s lack of knowledge of the language and systems of their host country can make them ineffective advocates for their children at school. Mr. Contreras’s intervention for his patient as a medical student demonstrates this in the arena of school.

Mr. Contreras was rotating at a hospital burn unit in 2023 when R, a young middle school student, and his mother arrived in the emergency department. An incident had occurred at his school. R had been the victim of aggravated battery and assault, sustaining a 3x2 cm burn on his forearm from students placing hot glue onto a piece of cardboard then immediately onto his skin and silencing him by covering his mouth. For months the older students had been bullying R. R’s mother made multiple attempts with both the school’s front desk and counselors to address the issue, but to no avail. R himself, though encouraged to speak up, did not out of fear. As Mr. Contreras realized the situation and the impasse, he used his fluency in Spanish and English to facilitate a joint call with the school district. Within 10 minutes, they were able to connect with a student safety specialist and launch a full investigation. A language barrier and the lack of knowledge of their rights and school system had prevented R’s mother from effectively advocating for her child’s safety.

In Dr. Nguyen’s experience as a teacher, even in classrooms dominated by minority students, the advocacy for students struggling in classes was disproportionate. It favored White parents, but also generally more educated families. This is further supported by a study of 225 schools across six states of kindergarten children showing similar trends, that African American, Latino, and less-educated parents were less involved in their children’s education as reported by teachers.³ It is important to note that in this study teachers were 80% White, 9% Latino, 7% African American, 3% multiracial, and 1% Asian American, suggesting that cultural discrepancy between teachers and parents could be an important factor affecting parent-teacher communication. Dr. Nguyen also recalled trying to discipline several students who were disruptive in his class by telling them he would speak to their parents. Several times, these students would counter defiantly, “Well, good luck, they can’t speak English.” The parents’ dependency on their children to communicate with teachers undermined the abilities of both adults to manage their behaviors and promote learning.
 

The Mental Health of Immigrant Parents  

Migrants often have greater incidence of mental health problems, including depression, PTSD, and anxiety, from a combination of peri-migrational experiences. ⁴ Immigrant mothers are known to have higher rates of post-natal depression, which cause problems later with child development. ⁵ Though she warns larger studies are needed, Dr. Fazel’s review of Croatian refugees suggests that displacement from one’s native country is a risk factor for poorer mental health, namely due to difficulty in psychosocial adaptation. ⁶ The likely mechanism is that lack of access to one’s language and culture, or a language and culture that one can navigate effectively, exacerbates, even engenders mental health sequelae. Because of this, first-generation immigrant children often face harsher and more violent parenting. ^7,8 Immigrant parents also may have less access to mental health resources since they often resort to their own cultural practices. Both Mr. Contreras’s and Dr. Nguyen’s following narratives of their mothers’ struggle with mental health illustrate the causes and consequences.

Mr. Contreras, who grew up in a Mexican immigrant household in Los Angeles, saw firsthand how his mother, who faced language barriers and a distrust of Western medicine, turned to traditional healers and herbal remedies for her health needs. Accompanying her to doctor appointments as her translator, he often felt the disconnect between her cultural background and the Western medical system. For her, seeking help from traditional healers was not just about addressing physical ailments but also about finding comfort and familiarity in practices rooted in her cultural beliefs. This preference for cultural or religious methods for mental health support is not uncommon among Mexican immigrant families.

Dr. Nguyen, whose mother was a refugee from Vietnam, recalls her constant depressed mood and suicidal thoughts in the immediate years after she resettled in San Diego. This was caused mostly by the missing of her social supports in Vietnam, her difficulty adjusting to American culture and language, and her difficulty finding work. Often her depression and stress took a darker turn in terms of more violent parenting. Of course, the cause of her poor mental health is hard to parse from the traumas and violence she had faced as a refugee, but in subsequent years, her many brothers and sisters who immigrated through a more orderly process also displayed similar mental health vulnerabilities.

   

The Mental Health of Children of Immigrant Parents  

The relationship between an immigrant parent’s poor mental health and their children is difficult to parse from what we know about native parents and their children. But the primary differences appear to be a great disruption of social roles, the effects of migration itself, and the oftentimes more strict and disciplinarian parenting style as discussed above. Given this, one would expect immigrant children to suffer greater mental health difficulties. However, a recent study of almost 500,000 children in Canada revealed decreased prevalence of conduct disorder, ADHD, and mood and anxiety disorders in immigrant youth, both first- and second-generation, as compared to non-immigrants. ⁹ This perhaps surprising result highlights how much more we need to understand about the effects of culture on the mental health diagnosis of immigrant youth. It suggests differences in mental health access and use from the cultural factors we mentioned above, to problems with using Western-based mental criteria and symptomatology for diagnosing non-Western children. It can even suggest the underestimation of the protective effects of native culture such as strong ethnic identity and cultural support systems, thereby challenging a purely deficit mental health model of the immigrant experience.

Summary

Dr. Duy Nguyen and Mr. Andrew Contreras are both children of immigrant parents from Vietnam and Mexico, respectively. Dr. Nguyen spent 15 years as an English teacher at San Leandro High School, whose student body was roughly 50% Hispanic and 25% Asian, making immigrant parents a huge swath of his educational partners. Mr. Contreras founded a high school outreach program where he interacted with K-12 children of immigrant youth. In addition, he partners with Fresno’s Economic Opportunity Commission to educate immigrant Hispanic parents and their teens on having difficult conversations with their teenage children on topics such as mental and reproductive health. Dr. Duy Nguyen and Mr. Andrew Contreras will explore the differences in immigrant parent-child relationships, compared with native ones, as they relate to mental health ramifications for the child and parent. They reveal immigrant mental health disruptions regarding culture and language, familial hierarchies, parenting styles, as well as parental mental health sequelae brought about by immigration using research and their own personal experiences.

Dr. Nguyen is a second-year resident at the University of California, San Francisco, Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously. Mr. Contreras is currently a 4th-year medical student at University of California, San Francisco, and applying to Psychiatry for the 2025 match.

References  

1. Rao A et al. Five Key Facts About Immigrants With Limited English Proficiency. KFF. 2024 March 14. https://www.kff.org/racial-equity-and-health-policy/issue-brief-five-key-facts-about-immigrants-with-limited-english-proficiency .

2. Raffaetà R. Migration and Parenting: Reviewing the Debate and Calling for Future Research. International Journal of Migration, Health and Social Care. 2016;12(1):38-50. doi: 10.1108/IJMHSC-12-2014-0052/full/html .

3. Nzinga‐Johnson S et al. Teacher‐Parent Relationships and School Involvement Among Racially and Educationally Diverse Parents of Kindergartners. Elementary School Journal. 2009 Sept. doi: 10.1086/598844 .

4. Close C et al. The Mental Health and Wellbeing of First Generation Migrants: A Systematic-Narrative Review of Reviews. Global Health. 2016 Aug 25;12(1):47. doi: 10.1186/s12992-016-0187-3.

5. Collins CH et al. Refugee, Asylum Seeker, Immigrant Women and Postnatal Depression: Rates and Risk Factors. Arch Womens Ment Health. 2011 Feb;14(1):3-11. doi: 10.1007/s00737-010-0198-7 .

6. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5 .

7. Pottie K et al. Do First Generation Immigrant Adolescents Face Higher Rates of Bullying, Violence and Suicidal Behaviours Than Do Third Generation and Native Born? J Immigr Minor Health. 2015 Oct;17(5):1557-1566. doi: 10.1007/s10903-014-0108-6.

8. Smokowski PR, Bacallao ML. Acculturation and Aggression in Latino Adolescents: A Structural Model Focusing on Cultural Risk Factors and Assets. J Abnorm Child Psychol. 2006 Oct;34(5):659-673. doi: 10.1007/s10802-006-9049-4 .

9. Gadermann AM et al. Prevalence of Mental Health Disorders Among Immigrant, Refugee, and Nonimmigrant Children and Youth in British Columbia, Canada. JAMA Netw Open. 2022;5(2):e2144934. doi: 10.1001/jamanetworkopen.2021.44934 .

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg (139 lb). 

“Polyarticular juvenile idiopathic arthritis (JIA) can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron in a press release. 

It is estimated that nearly 300,000 children in the United States have JIA, and 1 in 4 of them have pJIA, according to the Arthritis Foundation. 

Wikimedia Commons/FitzColinGerald/Creative Commons License

“Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment,” Dr. Yancopoulos continued. “The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.” 

Sarilumab, jointly developed by Sanofi and Regeneron, is an interleukin 6 receptor blocker. It was first approved in 2017 for the treatment of moderate to severely active rheumatoid arthritis (RA) in adults who had inadequate response or intolerance to at least one other disease-modifying antirheumatic drug (DMARD). 

In 2023, the FDA approved sarilumab as the first biologic treatment for polymyalgia rheumatica in adults who had inadequate response to corticosteroids and could not tolerate a corticosteroid taper. 

For pJIA, sarilumab is administered subcutaneously using a 200-mg/1.14-mL prefilled syringe once every 2 weeks. The medication can be used alone or in combination with other conventional DMARDs. 

“Use of KEVZARA in pediatric patients with pJIA is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA,” and pharmacokinetic comparability in 101 pediatric patients aged 2-17 years treated with sarilumab, according to the prescribing information. Sarilumab is not approved for pediatric patients < 63 kg “because of a lack of an appropriate dosage form.” 

The most common reported adverse reactions for sarilumab in pJIA are nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The pJIA trial recorded no new adverse reactions or safety concerns, compared with patients with RA. 
 

A version of this article appeared on Medscape.com.

I am going to guess that if we asked 500,000 adults in this country if they felt that children and adolescents were spending too much time on their smartphones, we would elicit almost uniform agreement that, yes indeed, smartphone use is gobbling up too much time from our young people. And, the adults would volunteer a long laundry list of all the bad consequences this overuse was generating. If you ask this same sample of adults if they too were spending too much time on their smartphones they would answer yes and, again, give you a list of the problems they feel are the result of this overuse.

We might begin to find a scattering of responses if we ask the adults when a child is too young to have his/her own cell phone. But, they would all agree that “young children” weren’t ready to be trusted with a cell phone. The “when” they were ready would be up for discussion. However, I suspect we might see a clustering around age 10 years. The reality is that despite what the majority may believe, a 2022 survey found that 42% of children have a cell phone by age 10, 71% by age 12, and 91% by age 14.

So, it would appear that, while we believe there can be significant downsides to having a cell phone, we are having great difficulty in policing ourselves and creating limits for our children. Does cell phone use qualify as an addiction, or is it just another example of how adults have lost the ability to say “no” to themselves and to their children?

When it comes to cell phones in school, the situation gets increasingly murky. The teachers I speak with are very clear that cell phones are creating problems for both the academic and the social experiences of their students. One teacher referred me to an article from the Norwegian Institute of Public Health, which found that banning cell phones in school decreased the incidence of psychological symptoms and diseases in girls. Bullying decreased in both genders and the girls’ GPA scores improved. In schools with cell phone bans, girls were more likely to choose and attend academic track programs, an effect which was more pronounced in young women with lower socioeconomic backgrounds. But, the if, when, and how to institute smartphone bans in school is complicated.

On one front, the movement toward cell phone bans in school has been given a major boost with the publication and publicity of a new book titled The Anxious Generation by social psychologist Jonathan Haidt, PhD. The New York University professor sees the GenZ’ers as experiencing a tsunami of mental health challenges including anxiety, self-harm, and suicide. And, he lays much of the blame for this situation on cell phone use.

He is optimistic about turning the tide because he claims that everywhere he speaks about the problem he says “I feel that I’m pushing on open doors.” Comparing the phenomenon to the collapse of the Berlin Wall, Dr. Haidt says “When you have a system that everyone hates, and then you have a way to escape it, it can change in a year.”

I wish I could share in his optimism, although I did just encounter a news story in the Portland paper describing a national program called “Wait Until 8th,” which is being considered by a parents’ group here in Maine.

The usual suspects have their own predictable take on the issue. The House and Senate have proposed a study on the use of cell phones in elementary and secondary schools and a pilot program awarding grants to some schools to create mobile device–free environments. Sounds like a momentum killer to me.

Not surprisingly, the issue of cell phone bans in school has taken on a bit of a political odor. The National Parents Union reports in a very small and inadequately described sample that 56% of parents are against total school bans. In the accompanying press release, the organizations offers an extensive list of concerns parents have reported — many cite the need to remain in contact with their children throughout the day. One has to wonder how often these concerns are a reflection of unresolved separation anxiety.

The American Academy of Pediatrics has rolled out a “5 Cs” framework that pediatricians can use to discuss media use with families. As usual, the thought is that talking about a problem is going to somehow convince parents to do what they already know is the correct action. And, of course, pediatricians have plenty of time to initiate this discussion of the obvious.

A recent study from the Department of Pediatrics at University of California, San Francisco, has found that parental monitoring, limit setting, and modeling good screen use behavior (my bolding) are the most effective strategies for reducing adolescent screen time. Using screen time allowances as a reward or punishment does not seem to be effective.

So there you have it. It looks like cell phone overuse, particularly in school, is something most of us see as a problem deserving an immediate solution. However, despite Dr. Haidt’s optimism about a seismic turnaround, I suspect it will more likely be guerrilla warfare — one family, one school, or one school district at a time.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I am going to guess that if we asked 500,000 adults in this country if they felt that children and adolescents were spending too much time on their smartphones, we would elicit almost uniform agreement that, yes indeed, smartphone use is gobbling up too much time from our young people. And, the adults would volunteer a long laundry list of all the bad consequences this overuse was generating. If you ask this same sample of adults if they too were spending too much time on their smartphones they would answer yes and, again, give you a list of the problems they feel are the result of this overuse.

We might begin to find a scattering of responses if we ask the adults when a child is too young to have his/her own cell phone. But, they would all agree that “young children” weren’t ready to be trusted with a cell phone. The “when” they were ready would be up for discussion. However, I suspect we might see a clustering around age 10 years. The reality is that despite what the majority may believe, a 2022 survey found that 42% of children have a cell phone by age 10, 71% by age 12, and 91% by age 14.

So, it would appear that, while we believe there can be significant downsides to having a cell phone, we are having great difficulty in policing ourselves and creating limits for our children. Does cell phone use qualify as an addiction, or is it just another example of how adults have lost the ability to say “no” to themselves and to their children?

When it comes to cell phones in school, the situation gets increasingly murky. The teachers I speak with are very clear that cell phones are creating problems for both the academic and the social experiences of their students. One teacher referred me to an article from the Norwegian Institute of Public Health, which found that banning cell phones in school decreased the incidence of psychological symptoms and diseases in girls. Bullying decreased in both genders and the girls’ GPA scores improved. In schools with cell phone bans, girls were more likely to choose and attend academic track programs, an effect which was more pronounced in young women with lower socioeconomic backgrounds. But, the if, when, and how to institute smartphone bans in school is complicated.

On one front, the movement toward cell phone bans in school has been given a major boost with the publication and publicity of a new book titled The Anxious Generation by social psychologist Jonathan Haidt, PhD. The New York University professor sees the GenZ’ers as experiencing a tsunami of mental health challenges including anxiety, self-harm, and suicide. And, he lays much of the blame for this situation on cell phone use.

He is optimistic about turning the tide because he claims that everywhere he speaks about the problem he says “I feel that I’m pushing on open doors.” Comparing the phenomenon to the collapse of the Berlin Wall, Dr. Haidt says “When you have a system that everyone hates, and then you have a way to escape it, it can change in a year.”

I wish I could share in his optimism, although I did just encounter a news story in the Portland paper describing a national program called “Wait Until 8th,” which is being considered by a parents’ group here in Maine.

The usual suspects have their own predictable take on the issue. The House and Senate have proposed a study on the use of cell phones in elementary and secondary schools and a pilot program awarding grants to some schools to create mobile device–free environments. Sounds like a momentum killer to me.

Not surprisingly, the issue of cell phone bans in school has taken on a bit of a political odor. The National Parents Union reports in a very small and inadequately described sample that 56% of parents are against total school bans. In the accompanying press release, the organizations offers an extensive list of concerns parents have reported — many cite the need to remain in contact with their children throughout the day. One has to wonder how often these concerns are a reflection of unresolved separation anxiety.

The American Academy of Pediatrics has rolled out a “5 Cs” framework that pediatricians can use to discuss media use with families. As usual, the thought is that talking about a problem is going to somehow convince parents to do what they already know is the correct action. And, of course, pediatricians have plenty of time to initiate this discussion of the obvious.

A recent study from the Department of Pediatrics at University of California, San Francisco, has found that parental monitoring, limit setting, and modeling good screen use behavior (my bolding) are the most effective strategies for reducing adolescent screen time. Using screen time allowances as a reward or punishment does not seem to be effective.

So there you have it. It looks like cell phone overuse, particularly in school, is something most of us see as a problem deserving an immediate solution. However, despite Dr. Haidt’s optimism about a seismic turnaround, I suspect it will more likely be guerrilla warfare — one family, one school, or one school district at a time.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I am going to guess that if we asked 500,000 adults in this country if they felt that children and adolescents were spending too much time on their smartphones, we would elicit almost uniform agreement that, yes indeed, smartphone use is gobbling up too much time from our young people. And, the adults would volunteer a long laundry list of all the bad consequences this overuse was generating. If you ask this same sample of adults if they too were spending too much time on their smartphones they would answer yes and, again, give you a list of the problems they feel are the result of this overuse.

We might begin to find a scattering of responses if we ask the adults when a child is too young to have his/her own cell phone. But, they would all agree that “young children” weren’t ready to be trusted with a cell phone. The “when” they were ready would be up for discussion. However, I suspect we might see a clustering around age 10 years. The reality is that despite what the majority may believe, a 2022 survey found that 42% of children have a cell phone by age 10, 71% by age 12, and 91% by age 14.

So, it would appear that, while we believe there can be significant downsides to having a cell phone, we are having great difficulty in policing ourselves and creating limits for our children. Does cell phone use qualify as an addiction, or is it just another example of how adults have lost the ability to say “no” to themselves and to their children?

When it comes to cell phones in school, the situation gets increasingly murky. The teachers I speak with are very clear that cell phones are creating problems for both the academic and the social experiences of their students. One teacher referred me to an article from the Norwegian Institute of Public Health, which found that banning cell phones in school decreased the incidence of psychological symptoms and diseases in girls. Bullying decreased in both genders and the girls’ GPA scores improved. In schools with cell phone bans, girls were more likely to choose and attend academic track programs, an effect which was more pronounced in young women with lower socioeconomic backgrounds. But, the if, when, and how to institute smartphone bans in school is complicated.

On one front, the movement toward cell phone bans in school has been given a major boost with the publication and publicity of a new book titled The Anxious Generation by social psychologist Jonathan Haidt, PhD. The New York University professor sees the GenZ’ers as experiencing a tsunami of mental health challenges including anxiety, self-harm, and suicide. And, he lays much of the blame for this situation on cell phone use.

He is optimistic about turning the tide because he claims that everywhere he speaks about the problem he says “I feel that I’m pushing on open doors.” Comparing the phenomenon to the collapse of the Berlin Wall, Dr. Haidt says “When you have a system that everyone hates, and then you have a way to escape it, it can change in a year.”

I wish I could share in his optimism, although I did just encounter a news story in the Portland paper describing a national program called “Wait Until 8th,” which is being considered by a parents’ group here in Maine.

The usual suspects have their own predictable take on the issue. The House and Senate have proposed a study on the use of cell phones in elementary and secondary schools and a pilot program awarding grants to some schools to create mobile device–free environments. Sounds like a momentum killer to me.

Not surprisingly, the issue of cell phone bans in school has taken on a bit of a political odor. The National Parents Union reports in a very small and inadequately described sample that 56% of parents are against total school bans. In the accompanying press release, the organizations offers an extensive list of concerns parents have reported — many cite the need to remain in contact with their children throughout the day. One has to wonder how often these concerns are a reflection of unresolved separation anxiety.

The American Academy of Pediatrics has rolled out a “5 Cs” framework that pediatricians can use to discuss media use with families. As usual, the thought is that talking about a problem is going to somehow convince parents to do what they already know is the correct action. And, of course, pediatricians have plenty of time to initiate this discussion of the obvious.

A recent study from the Department of Pediatrics at University of California, San Francisco, has found that parental monitoring, limit setting, and modeling good screen use behavior (my bolding) are the most effective strategies for reducing adolescent screen time. Using screen time allowances as a reward or punishment does not seem to be effective.

So there you have it. It looks like cell phone overuse, particularly in school, is something most of us see as a problem deserving an immediate solution. However, despite Dr. Haidt’s optimism about a seismic turnaround, I suspect it will more likely be guerrilla warfare — one family, one school, or one school district at a time.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Do drugs work better if taken by the clock?

A new analysis published in The Lancet journal’s eClinicalMedicine suggests: Yes, they do — if you consider the patient’s individual body clock. The study is the first to find that timing blood pressure drugs to a person’s personal “chronotype” — that is, whether they are a night owl or an early bird — may reduce the risk for a heart attack.

The findings represent a significant advance in the field of circadian medicine or “chronotherapy” — timing drug administration to circadian rhythms. A growing stack of research suggests this approach could reduce side effects and improve the effectiveness of a wide range of therapies, including vaccines, cancer treatments, and drugs for depression, glaucoma, pain, seizures, and other conditions. Still, despite decades of research, time of day is rarely considered in writing prescriptions.

“We are really just at the beginning of an exciting new way of looking at patient care,” said Kenneth A. Dyar, PhD, whose lab at Helmholtz Zentrum München’s Institute for Diabetes and Cancer focuses on metabolic physiology. Dr. Dyar is co-lead author of the new blood pressure analysis.

“Chronotherapy is a rapidly growing field,” he said, “and I suspect we are soon going to see more and more studies focused on ‘personalized chronotherapy,’ not only in hypertension but also potentially in other clinical areas.”
 

The ‘Missing Piece’ in Chronotherapy Research

Blood pressure drugs have long been chronotherapy’s battleground. After all, blood pressure follows a circadian rhythm, peaking in the morning and dropping at night.

That healthy overnight dip can disappear in people with diabetes, kidney disease, and obstructive sleep apnea. Some physicians have suggested a bed-time dose to restore that dip. But studies have had mixed results, so “take at bedtime” has become a less common recommendation in recent years.

But the debate continued. After a large 2019 Spanish study found that bedtime doses had benefits so big that the results drew questions, an even larger, 2022 randomized, controlled trial from the University of Dundee in Dundee, Scotland — called the TIME study — aimed to settle the question.

Researchers assigned over 21,000 people to take morning or night hypertension drugs for several years and found no difference in cardiovascular outcomes.

“We did this study thinking nocturnal blood pressure tablets might be better,” said Thomas MacDonald, MD, professor emeritus of clinical pharmacology and pharmacoepidemiology at the University of Dundee and principal investigator for the TIME study and the recent chronotype analysis. “But there was no difference for heart attacks, strokes, or vascular death.”

So, the researchers then looked at participants’ chronotypes, sorting outcomes based on whether the participants were late-to-bed, late-to-rise “night owls” or early-to-bed, early-to-rise “morning larks.”

Their analysis of these 5358 TIME participants found the following results: Risk for hospitalization for a heart attack was at least 34% lower for “owls” who took their drugs at bedtime. By contrast, owls’ heart attack risk was at least 62% higher with morning doses. For “larks,” the opposite was true. Morning doses were associated with an 11% lower heart attack risk and night doses with an 11% higher risk, according to supplemental data.

The personalized approach could explain why some previous chronotherapy studies have failed to show a benefit. Those studies did not individualize drug timing as this one did. But personalization could be key to circadian medicine’s success.

“Our ‘internal personal time’ appears to be an important variable to consider when dosing antihypertensives,” said co-lead author Filippo Pigazzani, MD, PhD, clinical senior lecturer and honorary consultant cardiologist at the University of Dundee School of Medicine. “Chronotherapy research has been going on for decades. We knew there was something important with time of day. But researchers haven’t considered the internal time of individual people. I think that is the missing piece.”

The analysis has several important limitations, the researchers said. A total of 95% of participants were White. And it was an observational study, not a true randomized comparison. “We started it late in the original TIME study,” Dr. MacDonald said. “You could argue we were reporting on those who survived long enough to get into the analysis.” More research is needed, they concluded.
 

Looking Beyond Blood Pressure

What about the rest of the body? “Almost all the cells of our body contain ‘circadian clocks’ that are synchronized by daily environmental cues, including light-dark, activity-rest, and feeding-fasting cycles,” said Dr. Dyar.

An estimated 50% of prescription drugs hit targets in the body that have circadian patterns. So, experts suspect that syncing a drug with a person’s body clock might increase effectiveness of many drugs.

A handful of US Food and Drug Administration–approved drugs already have time-of-day recommendations on the label for effectiveness or to limit side effects, including bedtime or evening for the insomnia drug Ambien, the HIV antiviral Atripla, and cholesterol-lowering Zocor. Others are intended to be taken with or after your last meal of the day, such as the long-acting insulin Levemir and the cardiovascular drug Xarelto. A morning recommendation comes with the proton pump inhibitor Nexium and the attention-deficit/hyperactivity disorder drug Ritalin.

Interest is expanding. About one third of the papers published about chronotherapy in the past 25 years have come out in the past 5 years. The May 2024 meeting of the Society for Research on Biological Rhythms featured a day-long session aimed at bringing clinicians up to speed. An organization called the International Association of Circadian Health Clinics is trying to bring circadian medicine findings to clinicians and their patients and to support research.

Moreover, while recent research suggests minding the clock could have benefits for a wide range of treatments, ignoring it could cause problems.

In a Massachusetts Institute of Technology study published in April in Science Advances, researchers looked at engineered livers made from human donor cells and found more than 300 genes that operate on a circadian schedule, many with roles in drug metabolism. They also found that circadian patterns affected the toxicity of acetaminophen and atorvastatin. Identifying the time of day to take these drugs could maximize effectiveness and minimize adverse effects, the researchers said.
 

Timing and the Immune System

Circadian rhythms are also seen in immune processes. In a 2023 study in The Journal of Clinical Investigation of vaccine data from 1.5 million people in Israel, researchers found that children and older adults who got their second dose of the Pfizer mRNA COVID vaccine earlier in the day were about 36% less likely to be hospitalized with SARS-CoV-2 infection than those who got an evening shot.

“The sweet spot in our data was somewhere around late morning to late afternoon,” said lead researcher Jeffrey Haspel, MD, PhD, associate professor of medicine in the division of pulmonary and critical care medicine at Washington University School of Medicine in St. Louis.

In a multicenter, 2024 analysis of 13 studies of immunotherapy for advanced cancers in 1663 people, researchers found treatment earlier in the day was associated with longer survival time and longer survival without cancer progression.

“Patients with selected metastatic cancers seemed to largely benefit from early [time of day] infusions, which is consistent with circadian mechanisms in immune-cell functions and trafficking,” the researchers noted. But “retrospective randomized trials are needed to establish recommendations for optimal circadian timing.”

Other research suggests or is investigating possible chronotherapy benefits for depression, glaucoma, respiratory diseases, stroke treatment, epilepsy, and sedatives used in surgery. So why aren’t healthcare providers adding time of day to more prescriptions? “What’s missing is more reliable data,” Dr. Dyar said.
 

Should You Use Chronotherapy Now?

Experts emphasize that more research is needed before doctors use chronotherapy and before medical organizations include it in treatment recommendations. But for some patients, circadian dosing may be worth a try:

Night owls whose blood pressure isn’t well controlled. Dr. Dyar and Dr. Pigazzani said night-time blood pressure drugs may be helpful for people with a “late chronotype.” Of course, patients shouldn’t change their medication schedule on their own, they said. And doctors may want to consider other concerns, like more overnight bathroom visits with evening diuretics.

In their study, the researchers determined participants’ chronotype with a few questions from the Munich Chronotype Questionnaire about what time they fell asleep and woke up on workdays and days off and whether they considered themselves “morning types” or “evening types.” (The questions can be found in supplementary data for the study.)

If a physician thinks matching the timing of a dose with chronotype would help, they can consider it, Dr. Pigazzani said. “However, I must add that this was an observational study, so I would advise healthcare practitioners to wait for our data to be confirmed in new RCTs of personalized chronotherapy of hypertension.”

Children and older adults getting vaccines. Timing COVID shots and possibly other vaccines from late morning to mid-afternoon could have a small benefit for individuals and a bigger public-health benefit, Dr. Haspel said. But the most important thing is getting vaccinated. “If you can only get one in the evening, it’s still worthwhile. Timing may add oomph at a public-health level for more vulnerable groups.”
 

A version of this article appeared on Medscape.com.

Do drugs work better if taken by the clock?

A new analysis published in The Lancet journal’s eClinicalMedicine suggests: Yes, they do — if you consider the patient’s individual body clock. The study is the first to find that timing blood pressure drugs to a person’s personal “chronotype” — that is, whether they are a night owl or an early bird — may reduce the risk for a heart attack.

The findings represent a significant advance in the field of circadian medicine or “chronotherapy” — timing drug administration to circadian rhythms. A growing stack of research suggests this approach could reduce side effects and improve the effectiveness of a wide range of therapies, including vaccines, cancer treatments, and drugs for depression, glaucoma, pain, seizures, and other conditions. Still, despite decades of research, time of day is rarely considered in writing prescriptions.

“We are really just at the beginning of an exciting new way of looking at patient care,” said Kenneth A. Dyar, PhD, whose lab at Helmholtz Zentrum München’s Institute for Diabetes and Cancer focuses on metabolic physiology. Dr. Dyar is co-lead author of the new blood pressure analysis.

“Chronotherapy is a rapidly growing field,” he said, “and I suspect we are soon going to see more and more studies focused on ‘personalized chronotherapy,’ not only in hypertension but also potentially in other clinical areas.”
 

The ‘Missing Piece’ in Chronotherapy Research

Blood pressure drugs have long been chronotherapy’s battleground. After all, blood pressure follows a circadian rhythm, peaking in the morning and dropping at night.

That healthy overnight dip can disappear in people with diabetes, kidney disease, and obstructive sleep apnea. Some physicians have suggested a bed-time dose to restore that dip. But studies have had mixed results, so “take at bedtime” has become a less common recommendation in recent years.

But the debate continued. After a large 2019 Spanish study found that bedtime doses had benefits so big that the results drew questions, an even larger, 2022 randomized, controlled trial from the University of Dundee in Dundee, Scotland — called the TIME study — aimed to settle the question.

Researchers assigned over 21,000 people to take morning or night hypertension drugs for several years and found no difference in cardiovascular outcomes.

“We did this study thinking nocturnal blood pressure tablets might be better,” said Thomas MacDonald, MD, professor emeritus of clinical pharmacology and pharmacoepidemiology at the University of Dundee and principal investigator for the TIME study and the recent chronotype analysis. “But there was no difference for heart attacks, strokes, or vascular death.”

So, the researchers then looked at participants’ chronotypes, sorting outcomes based on whether the participants were late-to-bed, late-to-rise “night owls” or early-to-bed, early-to-rise “morning larks.”

Their analysis of these 5358 TIME participants found the following results: Risk for hospitalization for a heart attack was at least 34% lower for “owls” who took their drugs at bedtime. By contrast, owls’ heart attack risk was at least 62% higher with morning doses. For “larks,” the opposite was true. Morning doses were associated with an 11% lower heart attack risk and night doses with an 11% higher risk, according to supplemental data.

The personalized approach could explain why some previous chronotherapy studies have failed to show a benefit. Those studies did not individualize drug timing as this one did. But personalization could be key to circadian medicine’s success.

“Our ‘internal personal time’ appears to be an important variable to consider when dosing antihypertensives,” said co-lead author Filippo Pigazzani, MD, PhD, clinical senior lecturer and honorary consultant cardiologist at the University of Dundee School of Medicine. “Chronotherapy research has been going on for decades. We knew there was something important with time of day. But researchers haven’t considered the internal time of individual people. I think that is the missing piece.”

The analysis has several important limitations, the researchers said. A total of 95% of participants were White. And it was an observational study, not a true randomized comparison. “We started it late in the original TIME study,” Dr. MacDonald said. “You could argue we were reporting on those who survived long enough to get into the analysis.” More research is needed, they concluded.
 

Looking Beyond Blood Pressure

What about the rest of the body? “Almost all the cells of our body contain ‘circadian clocks’ that are synchronized by daily environmental cues, including light-dark, activity-rest, and feeding-fasting cycles,” said Dr. Dyar.

An estimated 50% of prescription drugs hit targets in the body that have circadian patterns. So, experts suspect that syncing a drug with a person’s body clock might increase effectiveness of many drugs.

A handful of US Food and Drug Administration–approved drugs already have time-of-day recommendations on the label for effectiveness or to limit side effects, including bedtime or evening for the insomnia drug Ambien, the HIV antiviral Atripla, and cholesterol-lowering Zocor. Others are intended to be taken with or after your last meal of the day, such as the long-acting insulin Levemir and the cardiovascular drug Xarelto. A morning recommendation comes with the proton pump inhibitor Nexium and the attention-deficit/hyperactivity disorder drug Ritalin.

Interest is expanding. About one third of the papers published about chronotherapy in the past 25 years have come out in the past 5 years. The May 2024 meeting of the Society for Research on Biological Rhythms featured a day-long session aimed at bringing clinicians up to speed. An organization called the International Association of Circadian Health Clinics is trying to bring circadian medicine findings to clinicians and their patients and to support research.

Moreover, while recent research suggests minding the clock could have benefits for a wide range of treatments, ignoring it could cause problems.

In a Massachusetts Institute of Technology study published in April in Science Advances, researchers looked at engineered livers made from human donor cells and found more than 300 genes that operate on a circadian schedule, many with roles in drug metabolism. They also found that circadian patterns affected the toxicity of acetaminophen and atorvastatin. Identifying the time of day to take these drugs could maximize effectiveness and minimize adverse effects, the researchers said.
 

Timing and the Immune System

Circadian rhythms are also seen in immune processes. In a 2023 study in The Journal of Clinical Investigation of vaccine data from 1.5 million people in Israel, researchers found that children and older adults who got their second dose of the Pfizer mRNA COVID vaccine earlier in the day were about 36% less likely to be hospitalized with SARS-CoV-2 infection than those who got an evening shot.

“The sweet spot in our data was somewhere around late morning to late afternoon,” said lead researcher Jeffrey Haspel, MD, PhD, associate professor of medicine in the division of pulmonary and critical care medicine at Washington University School of Medicine in St. Louis.

In a multicenter, 2024 analysis of 13 studies of immunotherapy for advanced cancers in 1663 people, researchers found treatment earlier in the day was associated with longer survival time and longer survival without cancer progression.

“Patients with selected metastatic cancers seemed to largely benefit from early [time of day] infusions, which is consistent with circadian mechanisms in immune-cell functions and trafficking,” the researchers noted. But “retrospective randomized trials are needed to establish recommendations for optimal circadian timing.”

Other research suggests or is investigating possible chronotherapy benefits for depression, glaucoma, respiratory diseases, stroke treatment, epilepsy, and sedatives used in surgery. So why aren’t healthcare providers adding time of day to more prescriptions? “What’s missing is more reliable data,” Dr. Dyar said.
 

Should You Use Chronotherapy Now?

Experts emphasize that more research is needed before doctors use chronotherapy and before medical organizations include it in treatment recommendations. But for some patients, circadian dosing may be worth a try:

Night owls whose blood pressure isn’t well controlled. Dr. Dyar and Dr. Pigazzani said night-time blood pressure drugs may be helpful for people with a “late chronotype.” Of course, patients shouldn’t change their medication schedule on their own, they said. And doctors may want to consider other concerns, like more overnight bathroom visits with evening diuretics.

In their study, the researchers determined participants’ chronotype with a few questions from the Munich Chronotype Questionnaire about what time they fell asleep and woke up on workdays and days off and whether they considered themselves “morning types” or “evening types.” (The questions can be found in supplementary data for the study.)

If a physician thinks matching the timing of a dose with chronotype would help, they can consider it, Dr. Pigazzani said. “However, I must add that this was an observational study, so I would advise healthcare practitioners to wait for our data to be confirmed in new RCTs of personalized chronotherapy of hypertension.”

Children and older adults getting vaccines. Timing COVID shots and possibly other vaccines from late morning to mid-afternoon could have a small benefit for individuals and a bigger public-health benefit, Dr. Haspel said. But the most important thing is getting vaccinated. “If you can only get one in the evening, it’s still worthwhile. Timing may add oomph at a public-health level for more vulnerable groups.”
 

A version of this article appeared on Medscape.com.

Do drugs work better if taken by the clock?

A new analysis published in The Lancet journal’s eClinicalMedicine suggests: Yes, they do — if you consider the patient’s individual body clock. The study is the first to find that timing blood pressure drugs to a person’s personal “chronotype” — that is, whether they are a night owl or an early bird — may reduce the risk for a heart attack.

The findings represent a significant advance in the field of circadian medicine or “chronotherapy” — timing drug administration to circadian rhythms. A growing stack of research suggests this approach could reduce side effects and improve the effectiveness of a wide range of therapies, including vaccines, cancer treatments, and drugs for depression, glaucoma, pain, seizures, and other conditions. Still, despite decades of research, time of day is rarely considered in writing prescriptions.

“We are really just at the beginning of an exciting new way of looking at patient care,” said Kenneth A. Dyar, PhD, whose lab at Helmholtz Zentrum München’s Institute for Diabetes and Cancer focuses on metabolic physiology. Dr. Dyar is co-lead author of the new blood pressure analysis.

“Chronotherapy is a rapidly growing field,” he said, “and I suspect we are soon going to see more and more studies focused on ‘personalized chronotherapy,’ not only in hypertension but also potentially in other clinical areas.”
 

The ‘Missing Piece’ in Chronotherapy Research

Blood pressure drugs have long been chronotherapy’s battleground. After all, blood pressure follows a circadian rhythm, peaking in the morning and dropping at night.

That healthy overnight dip can disappear in people with diabetes, kidney disease, and obstructive sleep apnea. Some physicians have suggested a bed-time dose to restore that dip. But studies have had mixed results, so “take at bedtime” has become a less common recommendation in recent years.

But the debate continued. After a large 2019 Spanish study found that bedtime doses had benefits so big that the results drew questions, an even larger, 2022 randomized, controlled trial from the University of Dundee in Dundee, Scotland — called the TIME study — aimed to settle the question.

Researchers assigned over 21,000 people to take morning or night hypertension drugs for several years and found no difference in cardiovascular outcomes.

“We did this study thinking nocturnal blood pressure tablets might be better,” said Thomas MacDonald, MD, professor emeritus of clinical pharmacology and pharmacoepidemiology at the University of Dundee and principal investigator for the TIME study and the recent chronotype analysis. “But there was no difference for heart attacks, strokes, or vascular death.”

So, the researchers then looked at participants’ chronotypes, sorting outcomes based on whether the participants were late-to-bed, late-to-rise “night owls” or early-to-bed, early-to-rise “morning larks.”

Their analysis of these 5358 TIME participants found the following results: Risk for hospitalization for a heart attack was at least 34% lower for “owls” who took their drugs at bedtime. By contrast, owls’ heart attack risk was at least 62% higher with morning doses. For “larks,” the opposite was true. Morning doses were associated with an 11% lower heart attack risk and night doses with an 11% higher risk, according to supplemental data.

The personalized approach could explain why some previous chronotherapy studies have failed to show a benefit. Those studies did not individualize drug timing as this one did. But personalization could be key to circadian medicine’s success.

“Our ‘internal personal time’ appears to be an important variable to consider when dosing antihypertensives,” said co-lead author Filippo Pigazzani, MD, PhD, clinical senior lecturer and honorary consultant cardiologist at the University of Dundee School of Medicine. “Chronotherapy research has been going on for decades. We knew there was something important with time of day. But researchers haven’t considered the internal time of individual people. I think that is the missing piece.”

The analysis has several important limitations, the researchers said. A total of 95% of participants were White. And it was an observational study, not a true randomized comparison. “We started it late in the original TIME study,” Dr. MacDonald said. “You could argue we were reporting on those who survived long enough to get into the analysis.” More research is needed, they concluded.
 

Looking Beyond Blood Pressure

What about the rest of the body? “Almost all the cells of our body contain ‘circadian clocks’ that are synchronized by daily environmental cues, including light-dark, activity-rest, and feeding-fasting cycles,” said Dr. Dyar.

An estimated 50% of prescription drugs hit targets in the body that have circadian patterns. So, experts suspect that syncing a drug with a person’s body clock might increase effectiveness of many drugs.

A handful of US Food and Drug Administration–approved drugs already have time-of-day recommendations on the label for effectiveness or to limit side effects, including bedtime or evening for the insomnia drug Ambien, the HIV antiviral Atripla, and cholesterol-lowering Zocor. Others are intended to be taken with or after your last meal of the day, such as the long-acting insulin Levemir and the cardiovascular drug Xarelto. A morning recommendation comes with the proton pump inhibitor Nexium and the attention-deficit/hyperactivity disorder drug Ritalin.

Interest is expanding. About one third of the papers published about chronotherapy in the past 25 years have come out in the past 5 years. The May 2024 meeting of the Society for Research on Biological Rhythms featured a day-long session aimed at bringing clinicians up to speed. An organization called the International Association of Circadian Health Clinics is trying to bring circadian medicine findings to clinicians and their patients and to support research.

Moreover, while recent research suggests minding the clock could have benefits for a wide range of treatments, ignoring it could cause problems.

In a Massachusetts Institute of Technology study published in April in Science Advances, researchers looked at engineered livers made from human donor cells and found more than 300 genes that operate on a circadian schedule, many with roles in drug metabolism. They also found that circadian patterns affected the toxicity of acetaminophen and atorvastatin. Identifying the time of day to take these drugs could maximize effectiveness and minimize adverse effects, the researchers said.
 

Timing and the Immune System

Circadian rhythms are also seen in immune processes. In a 2023 study in The Journal of Clinical Investigation of vaccine data from 1.5 million people in Israel, researchers found that children and older adults who got their second dose of the Pfizer mRNA COVID vaccine earlier in the day were about 36% less likely to be hospitalized with SARS-CoV-2 infection than those who got an evening shot.

“The sweet spot in our data was somewhere around late morning to late afternoon,” said lead researcher Jeffrey Haspel, MD, PhD, associate professor of medicine in the division of pulmonary and critical care medicine at Washington University School of Medicine in St. Louis.

In a multicenter, 2024 analysis of 13 studies of immunotherapy for advanced cancers in 1663 people, researchers found treatment earlier in the day was associated with longer survival time and longer survival without cancer progression.

“Patients with selected metastatic cancers seemed to largely benefit from early [time of day] infusions, which is consistent with circadian mechanisms in immune-cell functions and trafficking,” the researchers noted. But “retrospective randomized trials are needed to establish recommendations for optimal circadian timing.”

Other research suggests or is investigating possible chronotherapy benefits for depression, glaucoma, respiratory diseases, stroke treatment, epilepsy, and sedatives used in surgery. So why aren’t healthcare providers adding time of day to more prescriptions? “What’s missing is more reliable data,” Dr. Dyar said.
 

Should You Use Chronotherapy Now?

Experts emphasize that more research is needed before doctors use chronotherapy and before medical organizations include it in treatment recommendations. But for some patients, circadian dosing may be worth a try:

Night owls whose blood pressure isn’t well controlled. Dr. Dyar and Dr. Pigazzani said night-time blood pressure drugs may be helpful for people with a “late chronotype.” Of course, patients shouldn’t change their medication schedule on their own, they said. And doctors may want to consider other concerns, like more overnight bathroom visits with evening diuretics.

In their study, the researchers determined participants’ chronotype with a few questions from the Munich Chronotype Questionnaire about what time they fell asleep and woke up on workdays and days off and whether they considered themselves “morning types” or “evening types.” (The questions can be found in supplementary data for the study.)

If a physician thinks matching the timing of a dose with chronotype would help, they can consider it, Dr. Pigazzani said. “However, I must add that this was an observational study, so I would advise healthcare practitioners to wait for our data to be confirmed in new RCTs of personalized chronotherapy of hypertension.”

Children and older adults getting vaccines. Timing COVID shots and possibly other vaccines from late morning to mid-afternoon could have a small benefit for individuals and a bigger public-health benefit, Dr. Haspel said. But the most important thing is getting vaccinated. “If you can only get one in the evening, it’s still worthwhile. Timing may add oomph at a public-health level for more vulnerable groups.”
 

A version of this article appeared on Medscape.com.