Clinical Psychiatry News

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

TOPLINE:

A single dose of psilocybin administered in a group setting with one-on-one psychological support was associated with a significant and lasting reduction in depression severity among adults with cancer and major depressive disorder, a small study shows.

METHODOLOGY:

• Depression remains common in patients with cancer, and common treatment approaches — antidepressants and psychotherapy — have demonstrated limited success.
• Researchers explored the safety, feasibility, and efficacy of psilocybin-assisted group therapy in 30 patients with major depressive disorder and cancer — about half with earlier-stage disease and half with metastatic disease.
• In this single-center, open-label, phase 2 study, participants received one-on-one and group therapy sessions before, during, and after receiving a single 25-mg psilocybin dose.
• Alongside individual therapy sessions, each cohort of three to four participants received group sessions guided by a therapist who provided educational material and worked to foster trust among participants.

TAKEAWAY:

• Participants experienced a significant reduction in depression severity, demonstrating a 19.1-point reduction in Montgomery-Asberg Depression Rating Scale scores from baseline to follow-up at week 8.
• Overall, 80% of patients showed a lasting response to psilocybin treatment and 50% showed full remission of depressive symptoms by week 1, which persisted for at least 8 weeks.
• The approach was effective for patients with curable and noncurable cancer — with almost 80% in the curable group and 62% in the noncurable group showing clinically meaningful declines in depressive symptoms. The researchers also noted improvements in patients’ anxiety, pain, demoralization, disability, and spiritual well-being.
• No suicidality or other serious treatment-related adverse events occurred; treatment-related nausea and headache were generally mild and expected.

IN PRACTICE:

“Beyond tolerability, psilocybin therapy led to clinically meaningful reductions in depressive symptoms,” the authors concluded. “To our knowledge, this is the first study to show the feasibility of a group-therapy approach for psilocybin‐assisted treatment in patients with cancer. This innovative framework offers increased scalability and dissemination of psilocybin treatment in real‐world settings.”

Among the 28 participants available for exit interviews, the authors reported that, overall, “participants described that the group/simultaneous model fostered a sense of connectedness, meaning, and transcendence through the shared psilocybin experience and group integration.”

SOURCE:

The study, led by Manish Agrawal, MD, Sunstone Therapies, Rockville, Maryland, was published online on December 21, 2023, in Cancer, along with an editorial and related article on patient acceptability of psilocybin-assisted group therapy.

LIMITATIONS:

The study lacked a control group, and the sample size was small and lacked diversity. The study was also not powered to statistically adjust efficacy measures on a possible group effect.

DISCLOSURES:

The study was funded in part by Compass Pathways. Some authors reported various relationships with Compass Pathways and Sunstone Therapies.

A version of this article appeared on Medscape.com.

TOPLINE:

A single dose of psilocybin administered in a group setting with one-on-one psychological support was associated with a significant and lasting reduction in depression severity among adults with cancer and major depressive disorder, a small study shows.

METHODOLOGY:

• Depression remains common in patients with cancer, and common treatment approaches — antidepressants and psychotherapy — have demonstrated limited success.
• Researchers explored the safety, feasibility, and efficacy of psilocybin-assisted group therapy in 30 patients with major depressive disorder and cancer — about half with earlier-stage disease and half with metastatic disease.
• In this single-center, open-label, phase 2 study, participants received one-on-one and group therapy sessions before, during, and after receiving a single 25-mg psilocybin dose.
• Alongside individual therapy sessions, each cohort of three to four participants received group sessions guided by a therapist who provided educational material and worked to foster trust among participants.

TAKEAWAY:

• Participants experienced a significant reduction in depression severity, demonstrating a 19.1-point reduction in Montgomery-Asberg Depression Rating Scale scores from baseline to follow-up at week 8.
• Overall, 80% of patients showed a lasting response to psilocybin treatment and 50% showed full remission of depressive symptoms by week 1, which persisted for at least 8 weeks.
• The approach was effective for patients with curable and noncurable cancer — with almost 80% in the curable group and 62% in the noncurable group showing clinically meaningful declines in depressive symptoms. The researchers also noted improvements in patients’ anxiety, pain, demoralization, disability, and spiritual well-being.
• No suicidality or other serious treatment-related adverse events occurred; treatment-related nausea and headache were generally mild and expected.

IN PRACTICE:

“Beyond tolerability, psilocybin therapy led to clinically meaningful reductions in depressive symptoms,” the authors concluded. “To our knowledge, this is the first study to show the feasibility of a group-therapy approach for psilocybin‐assisted treatment in patients with cancer. This innovative framework offers increased scalability and dissemination of psilocybin treatment in real‐world settings.”

Among the 28 participants available for exit interviews, the authors reported that, overall, “participants described that the group/simultaneous model fostered a sense of connectedness, meaning, and transcendence through the shared psilocybin experience and group integration.”

SOURCE:

The study, led by Manish Agrawal, MD, Sunstone Therapies, Rockville, Maryland, was published online on December 21, 2023, in Cancer, along with an editorial and related article on patient acceptability of psilocybin-assisted group therapy.

LIMITATIONS:

The study lacked a control group, and the sample size was small and lacked diversity. The study was also not powered to statistically adjust efficacy measures on a possible group effect.

DISCLOSURES:

The study was funded in part by Compass Pathways. Some authors reported various relationships with Compass Pathways and Sunstone Therapies.

A version of this article appeared on Medscape.com.

TOPLINE:

A single dose of psilocybin administered in a group setting with one-on-one psychological support was associated with a significant and lasting reduction in depression severity among adults with cancer and major depressive disorder, a small study shows.

METHODOLOGY:

• Depression remains common in patients with cancer, and common treatment approaches — antidepressants and psychotherapy — have demonstrated limited success.
• Researchers explored the safety, feasibility, and efficacy of psilocybin-assisted group therapy in 30 patients with major depressive disorder and cancer — about half with earlier-stage disease and half with metastatic disease.
• In this single-center, open-label, phase 2 study, participants received one-on-one and group therapy sessions before, during, and after receiving a single 25-mg psilocybin dose.
• Alongside individual therapy sessions, each cohort of three to four participants received group sessions guided by a therapist who provided educational material and worked to foster trust among participants.

TAKEAWAY:

• Participants experienced a significant reduction in depression severity, demonstrating a 19.1-point reduction in Montgomery-Asberg Depression Rating Scale scores from baseline to follow-up at week 8.
• Overall, 80% of patients showed a lasting response to psilocybin treatment and 50% showed full remission of depressive symptoms by week 1, which persisted for at least 8 weeks.
• The approach was effective for patients with curable and noncurable cancer — with almost 80% in the curable group and 62% in the noncurable group showing clinically meaningful declines in depressive symptoms. The researchers also noted improvements in patients’ anxiety, pain, demoralization, disability, and spiritual well-being.
• No suicidality or other serious treatment-related adverse events occurred; treatment-related nausea and headache were generally mild and expected.

IN PRACTICE:

“Beyond tolerability, psilocybin therapy led to clinically meaningful reductions in depressive symptoms,” the authors concluded. “To our knowledge, this is the first study to show the feasibility of a group-therapy approach for psilocybin‐assisted treatment in patients with cancer. This innovative framework offers increased scalability and dissemination of psilocybin treatment in real‐world settings.”

Among the 28 participants available for exit interviews, the authors reported that, overall, “participants described that the group/simultaneous model fostered a sense of connectedness, meaning, and transcendence through the shared psilocybin experience and group integration.”

SOURCE:

The study, led by Manish Agrawal, MD, Sunstone Therapies, Rockville, Maryland, was published online on December 21, 2023, in Cancer, along with an editorial and related article on patient acceptability of psilocybin-assisted group therapy.

LIMITATIONS:

The study lacked a control group, and the sample size was small and lacked diversity. The study was also not powered to statistically adjust efficacy measures on a possible group effect.

DISCLOSURES:

The study was funded in part by Compass Pathways. Some authors reported various relationships with Compass Pathways and Sunstone Therapies.

A version of this article appeared on Medscape.com.

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Investigators from the French Health and Medical Research Institute (INSERM), University of Bordeaux, and Charles Perrens Hospital, alongside their Canadian, British, and Swedish counterparts, have shown that attention-deficit/hyperactivity disorder (ADHD) or attention-deficit disorder without hyperactivity is linked with physical health problems. Cédric Galéra, MD, PhD, child and adolescent psychiatrist and epidemiologist at the Bordeaux Population Health Research Center (INSERM/University of Bordeaux) and the Charles Perrens Hospital, explained these findings to this news organization.
 

A Bilateral Association 

ADHD is a neurodevelopmental condition that develops in childhood and is characterized by high levels of inattention or agitation and impulsiveness. Some studies have revealed a link between ADHD and medical comorbidities, but these studies were carried out on small patient samples and were cross-sectional.

A new longitudinal study published in Lancet Child and Adolescent Health has shown a reciprocal link between ADHD and physical health problems. The researchers conducted statistical analyses to measure the links between ADHD symptoms and subsequent development of certain physical conditions and, conversely, between physical problems during childhood and subsequent development of ADHD symptoms.
 

Children From Quebec

The study was conducted by a team headed by Dr. Galéra in collaboration with teams from Britain, Sweden, and Canada. “We studied a Quebec-based cohort of 2000 children aged between 5 months and 17 years,” said Dr. Galéra.

“The researchers in Quebec sent interviewers to question parents at home. And once the children were able to answer for themselves, from adolescence, they were asked to answer the questions directly,” he added.

The children were assessed on the severity of their ADHD symptoms as well as their physical condition (general well-being, any conditions diagnosed, etc.).
 

Dental Caries, Excess Weight

“We were able to show links between ADHD in childhood and physical health problems in adolescence. There is a greater risk for dental caries, infections, injuries, wounds, sleep disorders, and excess weight.

“Accounting for socioeconomic status and mental health problems such as anxiety and depression or medical treatments, we observed that dental caries, wounds, excess weight, and restless legs syndrome were the conditions that cropped up time and time again,” said Dr. Galéra.

On the other hand, the researchers noted that certain physical health issues in childhood were linked with the onset of ADHD at a later stage. “We discovered that asthma in early childhood, injuries, sleep disturbances, epilepsy, and excess weight were associated with ADHD. Taking all above-referenced features into account, we were left with just wounds and injuries as well as restless legs syndrome as being linked to ADHD,” Dr. Galéra concluded.

For Dr. Galéra, the study illustrates the direction and timing of the links between physical problems and ADHD. “This reflects the link between physical and mental health. It’s important that all healthcare professionals be alert to this. Psychiatrists and mental health professionals must be vigilant about the physical health risks, and pediatricians and family physicians must be aware of the fact that children can present with physical conditions that will later be linked with ADHD. Each of them must be able to refer their young patients to their medical colleagues to ensure that these people receive the best care,” he emphasized.

The team will continue to study this cohort to see which problems emerge in adulthood. They also wish to study the Elfe cohort, a French longitudinal study of children.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Investigators from the French Health and Medical Research Institute (INSERM), University of Bordeaux, and Charles Perrens Hospital, alongside their Canadian, British, and Swedish counterparts, have shown that attention-deficit/hyperactivity disorder (ADHD) or attention-deficit disorder without hyperactivity is linked with physical health problems. Cédric Galéra, MD, PhD, child and adolescent psychiatrist and epidemiologist at the Bordeaux Population Health Research Center (INSERM/University of Bordeaux) and the Charles Perrens Hospital, explained these findings to this news organization.
 

A Bilateral Association 

ADHD is a neurodevelopmental condition that develops in childhood and is characterized by high levels of inattention or agitation and impulsiveness. Some studies have revealed a link between ADHD and medical comorbidities, but these studies were carried out on small patient samples and were cross-sectional.

A new longitudinal study published in Lancet Child and Adolescent Health has shown a reciprocal link between ADHD and physical health problems. The researchers conducted statistical analyses to measure the links between ADHD symptoms and subsequent development of certain physical conditions and, conversely, between physical problems during childhood and subsequent development of ADHD symptoms.
 

Children From Quebec

The study was conducted by a team headed by Dr. Galéra in collaboration with teams from Britain, Sweden, and Canada. “We studied a Quebec-based cohort of 2000 children aged between 5 months and 17 years,” said Dr. Galéra.

“The researchers in Quebec sent interviewers to question parents at home. And once the children were able to answer for themselves, from adolescence, they were asked to answer the questions directly,” he added.

The children were assessed on the severity of their ADHD symptoms as well as their physical condition (general well-being, any conditions diagnosed, etc.).
 

Dental Caries, Excess Weight

“We were able to show links between ADHD in childhood and physical health problems in adolescence. There is a greater risk for dental caries, infections, injuries, wounds, sleep disorders, and excess weight.

“Accounting for socioeconomic status and mental health problems such as anxiety and depression or medical treatments, we observed that dental caries, wounds, excess weight, and restless legs syndrome were the conditions that cropped up time and time again,” said Dr. Galéra.

On the other hand, the researchers noted that certain physical health issues in childhood were linked with the onset of ADHD at a later stage. “We discovered that asthma in early childhood, injuries, sleep disturbances, epilepsy, and excess weight were associated with ADHD. Taking all above-referenced features into account, we were left with just wounds and injuries as well as restless legs syndrome as being linked to ADHD,” Dr. Galéra concluded.

For Dr. Galéra, the study illustrates the direction and timing of the links between physical problems and ADHD. “This reflects the link between physical and mental health. It’s important that all healthcare professionals be alert to this. Psychiatrists and mental health professionals must be vigilant about the physical health risks, and pediatricians and family physicians must be aware of the fact that children can present with physical conditions that will later be linked with ADHD. Each of them must be able to refer their young patients to their medical colleagues to ensure that these people receive the best care,” he emphasized.

The team will continue to study this cohort to see which problems emerge in adulthood. They also wish to study the Elfe cohort, a French longitudinal study of children.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Investigators from the French Health and Medical Research Institute (INSERM), University of Bordeaux, and Charles Perrens Hospital, alongside their Canadian, British, and Swedish counterparts, have shown that attention-deficit/hyperactivity disorder (ADHD) or attention-deficit disorder without hyperactivity is linked with physical health problems. Cédric Galéra, MD, PhD, child and adolescent psychiatrist and epidemiologist at the Bordeaux Population Health Research Center (INSERM/University of Bordeaux) and the Charles Perrens Hospital, explained these findings to this news organization.
 

A Bilateral Association 

ADHD is a neurodevelopmental condition that develops in childhood and is characterized by high levels of inattention or agitation and impulsiveness. Some studies have revealed a link between ADHD and medical comorbidities, but these studies were carried out on small patient samples and were cross-sectional.

A new longitudinal study published in Lancet Child and Adolescent Health has shown a reciprocal link between ADHD and physical health problems. The researchers conducted statistical analyses to measure the links between ADHD symptoms and subsequent development of certain physical conditions and, conversely, between physical problems during childhood and subsequent development of ADHD symptoms.
 

Children From Quebec

The study was conducted by a team headed by Dr. Galéra in collaboration with teams from Britain, Sweden, and Canada. “We studied a Quebec-based cohort of 2000 children aged between 5 months and 17 years,” said Dr. Galéra.

“The researchers in Quebec sent interviewers to question parents at home. And once the children were able to answer for themselves, from adolescence, they were asked to answer the questions directly,” he added.

The children were assessed on the severity of their ADHD symptoms as well as their physical condition (general well-being, any conditions diagnosed, etc.).
 

Dental Caries, Excess Weight

“We were able to show links between ADHD in childhood and physical health problems in adolescence. There is a greater risk for dental caries, infections, injuries, wounds, sleep disorders, and excess weight.

“Accounting for socioeconomic status and mental health problems such as anxiety and depression or medical treatments, we observed that dental caries, wounds, excess weight, and restless legs syndrome were the conditions that cropped up time and time again,” said Dr. Galéra.

On the other hand, the researchers noted that certain physical health issues in childhood were linked with the onset of ADHD at a later stage. “We discovered that asthma in early childhood, injuries, sleep disturbances, epilepsy, and excess weight were associated with ADHD. Taking all above-referenced features into account, we were left with just wounds and injuries as well as restless legs syndrome as being linked to ADHD,” Dr. Galéra concluded.

For Dr. Galéra, the study illustrates the direction and timing of the links between physical problems and ADHD. “This reflects the link between physical and mental health. It’s important that all healthcare professionals be alert to this. Psychiatrists and mental health professionals must be vigilant about the physical health risks, and pediatricians and family physicians must be aware of the fact that children can present with physical conditions that will later be linked with ADHD. Each of them must be able to refer their young patients to their medical colleagues to ensure that these people receive the best care,” he emphasized.

The team will continue to study this cohort to see which problems emerge in adulthood. They also wish to study the Elfe cohort, a French longitudinal study of children.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) have overlapping neurologic symptoms — particularly profound fatigue. The similarity between these two conditions has led to the question of whether they are indeed distinct central nervous system (CNS) entities, or whether they exist along a spectrum and are actually two different manifestations of the same disease process.

A new study utilized a novel methodology — unbiased quantitative mass spectrometry-based proteomics — to investigate this question by analyzing cerebrospinal fluid (CSF) in a group of patients with ME/CFS and another group of patients diagnosed with both ME/CFS and FM.

Close to 2,100 proteins were identified, of which nearly 1,800 were common to both conditions.

“ME/CFS and fibromyalgia do not appear to be distinct entities, with respect to their cerebrospinal fluid proteins,” lead author Steven Schutzer, MD, professor of medicine, Rutgers New Jersey School of Medicine, told this news organization.

“Work is underway to solve the multiple mysteries of ME/CFS, fibromyalgia, and other neurologic-associated diseases,” he continued. “We have further affirmed that we have a precise objective discovery tool in our hands. Collectively studying multiple diseases brings clarity to each individual disease.”

The study was published in the December 2023 issue of Annals of Medicine.
 

Cutting-Edge Technology

“ME/CFS is characterized by disabling fatigue, and FM is an illness characterized by body-wide pain,” Dr. Schutzer said. These “medically unexplained” illnesses often coexist by current definitions, and the overlap between them has suggested that they may be part of the “same illness spectrum.”

But co-investigator Benjamin Natelson, MD, professor of neurology and director of the Pain and Fatigue Study Center, Mount Sinai, New York, and others found in previous research that there are distinct differences between the conditions, raising the possibility that there may be different pathophysiological processes.

“The physicians and scientists on our team have had longstanding interest in studying neurologic diseases with cutting-edge tools such as mass spectrometry applied to CSF,” Dr. Schutzer said. “We have had success using this message to distinguish diseases such as ME/CFS from post-treatment Lyme disease, multiple sclerosis, and healthy normal people.”

Dr. Schutzer explained that Dr. Natelson had acquired CSF samples from “well-characterized [ME/CFS] patients and controls.”

Since the cause of ME/CFS is “unknown,” it seemed “ripe to investigate it further with the discovery tool of mass spectrometry” by harnessing the “most advanced equipment in the country at the pacific Northwest National Laboratory, which is part of the US Department of Energy.”

Dr. Schutzer noted that it was the “merger of different clinical and laboratory expertise” that enabled them to address whether ME/CFS and FM are two distinct disease processes.

The choice of analyzing CSF is that it’s the fluid closest to the brain, he added. “A lot of people have studied ME/CFS peripherally because they don’t have access to spinal fluid or it’s easier to look peripherally in the blood, but that doesn’t mean that the blood is where the real ‘action’ is occurring.”

The researchers compared the CSF of 15 patients with ME/CFS only to 15 patients with ME/CFS+FM using mass spectrometry-based proteomics, which they had employed in previous research to see whether ME/CFS was distinct from persistent neurologic Lyme disease syndrome.

This technology has become the “method of choice and discovery tool to rapidly uncover protein biomarkers that can distinguish one disease from another,” the authors stated.

In particular, in unbiased quantitative mass spectrometry-based proteomics, the researchers do not have to know in advance what’s in a sample before studying it, Dr. Schutzer explained.
 

Shared Pathophysiology?

Both groups of patients were of similar age (41.3 ± 9.4 years and 40.1 ± 11.0 years, respectively), with no differences in gender or rates of current comorbid psychiatric diagnoses between the groups.

The researchers quantified a total of 2,083 proteins, including 1,789 that were specifically quantified in all of the CSF samples, regardless of the presence or absence of FM.

Several analyses (including an ANOVA analysis with adjusted P values, a Random Forest machine learning approach that looked at relative protein abundance changes between those with ME/CFS and ME/CFS+FM, and unsupervised hierarchical clustering analyses) did not find distinguishing differences between the groups.

“The sum of these results does not support the hypothesis that ME/CFS and ME/CFS+FM are distinct entities, as currently defined,” the authors stated.

They noted that both conditions are “medically unexplained,” with core symptoms of pain, fatigue, sleep problems, and cognitive difficulty. The fact that these two syndromes coexist so often has led to the assumption that the “similarities between them outweigh the differences,” they wrote.

They pointed to some differences between the conditions, including an increase in substance P in the CSF of FM patients, but not in ME/CFS patients reported by others. There are also some immunological, physiological and genetic differences.

But if the conclusion that the two illnesses may share a similar pathophysiological basis is supported by other research that includes FM-only patients as comparators to those with ME/CFS, “this would support the notion that the two illnesses fall along a common illness spectrum and may be approached as a single entity — with implications for both diagnosis and the development of new treatment approaches,” they concluded.
 

‘Noncontributory’ Findings

Commenting on the research, Robert G. Lahita, MD, PhD, director of the Institute for Autoimmune and Rheumatic Diseases, St. Joseph Health, Wayne, New Jersey, stated that he does not regard these diseases as neurologic but rather as rheumatologic.

“Most neurologists don’t see these diseases, but as a rheumatologist, I see them every day,” said Dr. Lahita, professor of medicine at Hackensack (New Jersey) Meridian School of Medicine and a clinical professor of medicine at Rutgers New Jersey Medical School, New Brunswick. “ME/CFS isn’t as common in my practice, but we do deal with many post-COVID patients who are afflicted mostly with ME/CFS.”

He noted that an important reason for fatigue in FM is that patients generally don’t sleep, or their sleep is disrupted. This is different from the cause of fatigue in ME/CFS.

In addition, the small sample size and the lack of difference between males and females were both limitations of the current study, said Dr. Lahita, who was not involved in this research. “We know that FM disproportionately affects women — in my practice, for example, over 95% of the patients with FM are female — while ME/CFS affects both genders similarly.”

Using proteomics as a biomarker was also problematic, according to Dr. Lahita. “It would have been more valuable to investigate differences in cytokines, for example,” he suggested.

Ultimately, Dr. Lahita thinks that the study is “non-contributory to the field and, as complex as the analysis was, it does nothing to shed differentiate the two conditions or explain the syndromes themselves.”

He added that it would have been more valuable to compare ME/CFS not only to ME/CFS plus FM but also with FM without ME/CFS and to healthy controls, and perhaps to a group with an autoimmune condition, such as lupus or Hashimoto’s thyroiditis.

Dr. Schutzer acknowledged that a limitation of the current study is that his team was unable analyze the CSF of patients with only FM. He and his colleagues “combed the world’s labs” for existing CSF samples of patients with FM alone but were unable to obtain any. “We see this study as a ‘stepping stone’ and hope that future studies will include patients with FM who are willing to donate CSF samples that we can use for comparison,” he said.

The authors received support from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Neurological Disorders and Stroke. Dr. Schutzer, coauthors, and Dr. Lahita reported no relevant financial relationships.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) have overlapping neurologic symptoms — particularly profound fatigue. The similarity between these two conditions has led to the question of whether they are indeed distinct central nervous system (CNS) entities, or whether they exist along a spectrum and are actually two different manifestations of the same disease process.

A new study utilized a novel methodology — unbiased quantitative mass spectrometry-based proteomics — to investigate this question by analyzing cerebrospinal fluid (CSF) in a group of patients with ME/CFS and another group of patients diagnosed with both ME/CFS and FM.

Close to 2,100 proteins were identified, of which nearly 1,800 were common to both conditions.

“ME/CFS and fibromyalgia do not appear to be distinct entities, with respect to their cerebrospinal fluid proteins,” lead author Steven Schutzer, MD, professor of medicine, Rutgers New Jersey School of Medicine, told this news organization.

“Work is underway to solve the multiple mysteries of ME/CFS, fibromyalgia, and other neurologic-associated diseases,” he continued. “We have further affirmed that we have a precise objective discovery tool in our hands. Collectively studying multiple diseases brings clarity to each individual disease.”

The study was published in the December 2023 issue of Annals of Medicine.
 

Cutting-Edge Technology

“ME/CFS is characterized by disabling fatigue, and FM is an illness characterized by body-wide pain,” Dr. Schutzer said. These “medically unexplained” illnesses often coexist by current definitions, and the overlap between them has suggested that they may be part of the “same illness spectrum.”

But co-investigator Benjamin Natelson, MD, professor of neurology and director of the Pain and Fatigue Study Center, Mount Sinai, New York, and others found in previous research that there are distinct differences between the conditions, raising the possibility that there may be different pathophysiological processes.

“The physicians and scientists on our team have had longstanding interest in studying neurologic diseases with cutting-edge tools such as mass spectrometry applied to CSF,” Dr. Schutzer said. “We have had success using this message to distinguish diseases such as ME/CFS from post-treatment Lyme disease, multiple sclerosis, and healthy normal people.”

Dr. Schutzer explained that Dr. Natelson had acquired CSF samples from “well-characterized [ME/CFS] patients and controls.”

Since the cause of ME/CFS is “unknown,” it seemed “ripe to investigate it further with the discovery tool of mass spectrometry” by harnessing the “most advanced equipment in the country at the pacific Northwest National Laboratory, which is part of the US Department of Energy.”

Dr. Schutzer noted that it was the “merger of different clinical and laboratory expertise” that enabled them to address whether ME/CFS and FM are two distinct disease processes.

The choice of analyzing CSF is that it’s the fluid closest to the brain, he added. “A lot of people have studied ME/CFS peripherally because they don’t have access to spinal fluid or it’s easier to look peripherally in the blood, but that doesn’t mean that the blood is where the real ‘action’ is occurring.”

The researchers compared the CSF of 15 patients with ME/CFS only to 15 patients with ME/CFS+FM using mass spectrometry-based proteomics, which they had employed in previous research to see whether ME/CFS was distinct from persistent neurologic Lyme disease syndrome.

This technology has become the “method of choice and discovery tool to rapidly uncover protein biomarkers that can distinguish one disease from another,” the authors stated.

In particular, in unbiased quantitative mass spectrometry-based proteomics, the researchers do not have to know in advance what’s in a sample before studying it, Dr. Schutzer explained.
 

Shared Pathophysiology?

Both groups of patients were of similar age (41.3 ± 9.4 years and 40.1 ± 11.0 years, respectively), with no differences in gender or rates of current comorbid psychiatric diagnoses between the groups.

The researchers quantified a total of 2,083 proteins, including 1,789 that were specifically quantified in all of the CSF samples, regardless of the presence or absence of FM.

Several analyses (including an ANOVA analysis with adjusted P values, a Random Forest machine learning approach that looked at relative protein abundance changes between those with ME/CFS and ME/CFS+FM, and unsupervised hierarchical clustering analyses) did not find distinguishing differences between the groups.

“The sum of these results does not support the hypothesis that ME/CFS and ME/CFS+FM are distinct entities, as currently defined,” the authors stated.

They noted that both conditions are “medically unexplained,” with core symptoms of pain, fatigue, sleep problems, and cognitive difficulty. The fact that these two syndromes coexist so often has led to the assumption that the “similarities between them outweigh the differences,” they wrote.

They pointed to some differences between the conditions, including an increase in substance P in the CSF of FM patients, but not in ME/CFS patients reported by others. There are also some immunological, physiological and genetic differences.

But if the conclusion that the two illnesses may share a similar pathophysiological basis is supported by other research that includes FM-only patients as comparators to those with ME/CFS, “this would support the notion that the two illnesses fall along a common illness spectrum and may be approached as a single entity — with implications for both diagnosis and the development of new treatment approaches,” they concluded.
 

‘Noncontributory’ Findings

Commenting on the research, Robert G. Lahita, MD, PhD, director of the Institute for Autoimmune and Rheumatic Diseases, St. Joseph Health, Wayne, New Jersey, stated that he does not regard these diseases as neurologic but rather as rheumatologic.

“Most neurologists don’t see these diseases, but as a rheumatologist, I see them every day,” said Dr. Lahita, professor of medicine at Hackensack (New Jersey) Meridian School of Medicine and a clinical professor of medicine at Rutgers New Jersey Medical School, New Brunswick. “ME/CFS isn’t as common in my practice, but we do deal with many post-COVID patients who are afflicted mostly with ME/CFS.”

He noted that an important reason for fatigue in FM is that patients generally don’t sleep, or their sleep is disrupted. This is different from the cause of fatigue in ME/CFS.

In addition, the small sample size and the lack of difference between males and females were both limitations of the current study, said Dr. Lahita, who was not involved in this research. “We know that FM disproportionately affects women — in my practice, for example, over 95% of the patients with FM are female — while ME/CFS affects both genders similarly.”

Using proteomics as a biomarker was also problematic, according to Dr. Lahita. “It would have been more valuable to investigate differences in cytokines, for example,” he suggested.

Ultimately, Dr. Lahita thinks that the study is “non-contributory to the field and, as complex as the analysis was, it does nothing to shed differentiate the two conditions or explain the syndromes themselves.”

He added that it would have been more valuable to compare ME/CFS not only to ME/CFS plus FM but also with FM without ME/CFS and to healthy controls, and perhaps to a group with an autoimmune condition, such as lupus or Hashimoto’s thyroiditis.

Dr. Schutzer acknowledged that a limitation of the current study is that his team was unable analyze the CSF of patients with only FM. He and his colleagues “combed the world’s labs” for existing CSF samples of patients with FM alone but were unable to obtain any. “We see this study as a ‘stepping stone’ and hope that future studies will include patients with FM who are willing to donate CSF samples that we can use for comparison,” he said.

The authors received support from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Neurological Disorders and Stroke. Dr. Schutzer, coauthors, and Dr. Lahita reported no relevant financial relationships.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM) have overlapping neurologic symptoms — particularly profound fatigue. The similarity between these two conditions has led to the question of whether they are indeed distinct central nervous system (CNS) entities, or whether they exist along a spectrum and are actually two different manifestations of the same disease process.

A new study utilized a novel methodology — unbiased quantitative mass spectrometry-based proteomics — to investigate this question by analyzing cerebrospinal fluid (CSF) in a group of patients with ME/CFS and another group of patients diagnosed with both ME/CFS and FM.

Close to 2,100 proteins were identified, of which nearly 1,800 were common to both conditions.

“ME/CFS and fibromyalgia do not appear to be distinct entities, with respect to their cerebrospinal fluid proteins,” lead author Steven Schutzer, MD, professor of medicine, Rutgers New Jersey School of Medicine, told this news organization.

“Work is underway to solve the multiple mysteries of ME/CFS, fibromyalgia, and other neurologic-associated diseases,” he continued. “We have further affirmed that we have a precise objective discovery tool in our hands. Collectively studying multiple diseases brings clarity to each individual disease.”

The study was published in the December 2023 issue of Annals of Medicine.
 

Cutting-Edge Technology

“ME/CFS is characterized by disabling fatigue, and FM is an illness characterized by body-wide pain,” Dr. Schutzer said. These “medically unexplained” illnesses often coexist by current definitions, and the overlap between them has suggested that they may be part of the “same illness spectrum.”

But co-investigator Benjamin Natelson, MD, professor of neurology and director of the Pain and Fatigue Study Center, Mount Sinai, New York, and others found in previous research that there are distinct differences between the conditions, raising the possibility that there may be different pathophysiological processes.

“The physicians and scientists on our team have had longstanding interest in studying neurologic diseases with cutting-edge tools such as mass spectrometry applied to CSF,” Dr. Schutzer said. “We have had success using this message to distinguish diseases such as ME/CFS from post-treatment Lyme disease, multiple sclerosis, and healthy normal people.”

Dr. Schutzer explained that Dr. Natelson had acquired CSF samples from “well-characterized [ME/CFS] patients and controls.”

Since the cause of ME/CFS is “unknown,” it seemed “ripe to investigate it further with the discovery tool of mass spectrometry” by harnessing the “most advanced equipment in the country at the pacific Northwest National Laboratory, which is part of the US Department of Energy.”

Dr. Schutzer noted that it was the “merger of different clinical and laboratory expertise” that enabled them to address whether ME/CFS and FM are two distinct disease processes.

The choice of analyzing CSF is that it’s the fluid closest to the brain, he added. “A lot of people have studied ME/CFS peripherally because they don’t have access to spinal fluid or it’s easier to look peripherally in the blood, but that doesn’t mean that the blood is where the real ‘action’ is occurring.”

The researchers compared the CSF of 15 patients with ME/CFS only to 15 patients with ME/CFS+FM using mass spectrometry-based proteomics, which they had employed in previous research to see whether ME/CFS was distinct from persistent neurologic Lyme disease syndrome.

This technology has become the “method of choice and discovery tool to rapidly uncover protein biomarkers that can distinguish one disease from another,” the authors stated.

In particular, in unbiased quantitative mass spectrometry-based proteomics, the researchers do not have to know in advance what’s in a sample before studying it, Dr. Schutzer explained.
 

Shared Pathophysiology?

Both groups of patients were of similar age (41.3 ± 9.4 years and 40.1 ± 11.0 years, respectively), with no differences in gender or rates of current comorbid psychiatric diagnoses between the groups.

The researchers quantified a total of 2,083 proteins, including 1,789 that were specifically quantified in all of the CSF samples, regardless of the presence or absence of FM.

Several analyses (including an ANOVA analysis with adjusted P values, a Random Forest machine learning approach that looked at relative protein abundance changes between those with ME/CFS and ME/CFS+FM, and unsupervised hierarchical clustering analyses) did not find distinguishing differences between the groups.

“The sum of these results does not support the hypothesis that ME/CFS and ME/CFS+FM are distinct entities, as currently defined,” the authors stated.

They noted that both conditions are “medically unexplained,” with core symptoms of pain, fatigue, sleep problems, and cognitive difficulty. The fact that these two syndromes coexist so often has led to the assumption that the “similarities between them outweigh the differences,” they wrote.

They pointed to some differences between the conditions, including an increase in substance P in the CSF of FM patients, but not in ME/CFS patients reported by others. There are also some immunological, physiological and genetic differences.

But if the conclusion that the two illnesses may share a similar pathophysiological basis is supported by other research that includes FM-only patients as comparators to those with ME/CFS, “this would support the notion that the two illnesses fall along a common illness spectrum and may be approached as a single entity — with implications for both diagnosis and the development of new treatment approaches,” they concluded.
 

‘Noncontributory’ Findings

Commenting on the research, Robert G. Lahita, MD, PhD, director of the Institute for Autoimmune and Rheumatic Diseases, St. Joseph Health, Wayne, New Jersey, stated that he does not regard these diseases as neurologic but rather as rheumatologic.

“Most neurologists don’t see these diseases, but as a rheumatologist, I see them every day,” said Dr. Lahita, professor of medicine at Hackensack (New Jersey) Meridian School of Medicine and a clinical professor of medicine at Rutgers New Jersey Medical School, New Brunswick. “ME/CFS isn’t as common in my practice, but we do deal with many post-COVID patients who are afflicted mostly with ME/CFS.”

He noted that an important reason for fatigue in FM is that patients generally don’t sleep, or their sleep is disrupted. This is different from the cause of fatigue in ME/CFS.

In addition, the small sample size and the lack of difference between males and females were both limitations of the current study, said Dr. Lahita, who was not involved in this research. “We know that FM disproportionately affects women — in my practice, for example, over 95% of the patients with FM are female — while ME/CFS affects both genders similarly.”

Using proteomics as a biomarker was also problematic, according to Dr. Lahita. “It would have been more valuable to investigate differences in cytokines, for example,” he suggested.

Ultimately, Dr. Lahita thinks that the study is “non-contributory to the field and, as complex as the analysis was, it does nothing to shed differentiate the two conditions or explain the syndromes themselves.”

He added that it would have been more valuable to compare ME/CFS not only to ME/CFS plus FM but also with FM without ME/CFS and to healthy controls, and perhaps to a group with an autoimmune condition, such as lupus or Hashimoto’s thyroiditis.

Dr. Schutzer acknowledged that a limitation of the current study is that his team was unable analyze the CSF of patients with only FM. He and his colleagues “combed the world’s labs” for existing CSF samples of patients with FM alone but were unable to obtain any. “We see this study as a ‘stepping stone’ and hope that future studies will include patients with FM who are willing to donate CSF samples that we can use for comparison,” he said.

The authors received support from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and National Institute of Neurological Disorders and Stroke. Dr. Schutzer, coauthors, and Dr. Lahita reported no relevant financial relationships.

Women with autoimmune disease are more likely to have perinatal depression (PND), according to findings from a new study that also suggested the reverse relationship is true: Women with a history of PND have a higher risk of developing autoimmune disease.

The research, published online on January 9, 2024, in Molecular Psychiatry, was led by Emma Bränn, PhD, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.

The researchers used data from the Swedish Medical Birth Register and identified all women who had given birth in Sweden between 2001 and 2013. Out of the group of approximately 815,000 women and 1.3 million pregnancies, just more than 55,000 women had been diagnosed with depression during their pregnancy or within a year after delivery.

The researchers then compared the incidence of 41 autoimmune diseases in women who had and did not have PND. They controlled for factors including genetic makeup and childhood environment.

Results indicated that women with autoimmune disease were 30% more likely to have PND (odds ratio, 1.30; 95% CI, 1.25-1.35). Conversely, women with PND were 30% more likely than women with no PND to develop an autoimmune disease (hazard ratio, 1.30; 95% CI, 1.25-1.36).

A sibling comparison helped confirm the results by controlling for some shared genetic and early life environmental factors related to the household in which sisters grew up.
 

Potential Shared Biological Mechanisms

The association was independent of psychiatric comorbidities, suggesting there may be shared biological mechanisms.

Dr. Bränn told this news organization that the research team wanted to do the study because previous research has shown involvement of the immune system in depression, with similarities in both the symptoms of immune system–activated diseases and depression and the molecular pathways activated by the immune system.

“Adding on top of the tremendous changes in the immune system that we see in the body of the woman during the perinatal period, we hypothesized that autoimmune diseases could be associated to perinatal depression,” she said. “This had also been shown in some previous literature but not to the extent as what we have investigated in this paper.”

She said their results help make a case for counseling women at several points in healthcare interactions — before and after conception and childbirth — and in rheumatology visits to inform women with autoimmune diseases who are contemplating motherhood of the association with developing PND. The results may also demonstrate a need for monitoring women in these groups for depression or autoimmune disease.

Fred Miller, MD, PhD, retired Scientist Emeritus of the Environmental Autoimmunity Group at the National Institute of Environmental Health Sciences, who was not part of the study, said the results seem plausible as they build on early work that demonstrated selected associations between autoimmune conditions and mental illness.

“These associations may be the result of shared genetic and environmental risk factors, including stress, hormonal changes, medications, and the proinflammatory states that can lead to both,” he said.

The novelty, he said, is in the relatively strong associations of PND with autoimmune disease overall and with specific autoimmune diseases.
 

Strong Link Found With Multiple Sclerosis (MS)

According to the paper, a significant positive bidirectional link was found for autoimmune thyroid disease, psoriasis, MS, ulcerative colitis, and celiac disease.

Researchers found a particularly strong association — double the risk in both directions — between PND and MS.

Dr. Miller said though it is unclear from this study why the association of PND with MS was stronger than with other autoimmune diseases, people with MS are known to be at a high risk for depression in general. That may come from greater shared genetic and environmental risk factors, he added.

Additionally, MS is one of the more common autoimmune diseases, he noted, so the population is larger for study.

He said he was surprised the researchers didn’t investigate medication use because medications used in depression have immunologic effects and medications used in autoimmune diseases could have effects on mental conditions.

The study has implications for clinicians in a wide variety of specialties, Dr. Miller noted.

“It suggests that caregivers be more alert to the signs of developing autoimmune disease in women with perinatal depression and to the signs of developing perinatal depression in those with autoimmune disease,” Dr. Miller said, “so that appropriate screening, diagnostics, and interventions may be undertaken.”

The researchers say they will continue to examine the long-term effects of depression during pregnancy and in the year after childbirth.

“Depression during this sensitive period can have serious consequences for both the mother and the baby,” Dr. Bränn said. “We hope that our results will help decision-makers to steer funding toward maternal healthcare so that more women can get help and support in time.”

The study was financed by Karolinska Institute, Forte (the Swedish Research Council for Health, Working Life and Welfare), the Swedish Research Council, and the Icelandic Research Fund.

The researchers and Dr. Miller reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Women with autoimmune disease are more likely to have perinatal depression (PND), according to findings from a new study that also suggested the reverse relationship is true: Women with a history of PND have a higher risk of developing autoimmune disease.

The research, published online on January 9, 2024, in Molecular Psychiatry, was led by Emma Bränn, PhD, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.

The researchers used data from the Swedish Medical Birth Register and identified all women who had given birth in Sweden between 2001 and 2013. Out of the group of approximately 815,000 women and 1.3 million pregnancies, just more than 55,000 women had been diagnosed with depression during their pregnancy or within a year after delivery.

The researchers then compared the incidence of 41 autoimmune diseases in women who had and did not have PND. They controlled for factors including genetic makeup and childhood environment.

Results indicated that women with autoimmune disease were 30% more likely to have PND (odds ratio, 1.30; 95% CI, 1.25-1.35). Conversely, women with PND were 30% more likely than women with no PND to develop an autoimmune disease (hazard ratio, 1.30; 95% CI, 1.25-1.36).

A sibling comparison helped confirm the results by controlling for some shared genetic and early life environmental factors related to the household in which sisters grew up.
 

Potential Shared Biological Mechanisms

The association was independent of psychiatric comorbidities, suggesting there may be shared biological mechanisms.

Dr. Bränn told this news organization that the research team wanted to do the study because previous research has shown involvement of the immune system in depression, with similarities in both the symptoms of immune system–activated diseases and depression and the molecular pathways activated by the immune system.

“Adding on top of the tremendous changes in the immune system that we see in the body of the woman during the perinatal period, we hypothesized that autoimmune diseases could be associated to perinatal depression,” she said. “This had also been shown in some previous literature but not to the extent as what we have investigated in this paper.”

She said their results help make a case for counseling women at several points in healthcare interactions — before and after conception and childbirth — and in rheumatology visits to inform women with autoimmune diseases who are contemplating motherhood of the association with developing PND. The results may also demonstrate a need for monitoring women in these groups for depression or autoimmune disease.

Fred Miller, MD, PhD, retired Scientist Emeritus of the Environmental Autoimmunity Group at the National Institute of Environmental Health Sciences, who was not part of the study, said the results seem plausible as they build on early work that demonstrated selected associations between autoimmune conditions and mental illness.

“These associations may be the result of shared genetic and environmental risk factors, including stress, hormonal changes, medications, and the proinflammatory states that can lead to both,” he said.

The novelty, he said, is in the relatively strong associations of PND with autoimmune disease overall and with specific autoimmune diseases.
 

Strong Link Found With Multiple Sclerosis (MS)

According to the paper, a significant positive bidirectional link was found for autoimmune thyroid disease, psoriasis, MS, ulcerative colitis, and celiac disease.

Researchers found a particularly strong association — double the risk in both directions — between PND and MS.

Dr. Miller said though it is unclear from this study why the association of PND with MS was stronger than with other autoimmune diseases, people with MS are known to be at a high risk for depression in general. That may come from greater shared genetic and environmental risk factors, he added.

Additionally, MS is one of the more common autoimmune diseases, he noted, so the population is larger for study.

He said he was surprised the researchers didn’t investigate medication use because medications used in depression have immunologic effects and medications used in autoimmune diseases could have effects on mental conditions.

The study has implications for clinicians in a wide variety of specialties, Dr. Miller noted.

“It suggests that caregivers be more alert to the signs of developing autoimmune disease in women with perinatal depression and to the signs of developing perinatal depression in those with autoimmune disease,” Dr. Miller said, “so that appropriate screening, diagnostics, and interventions may be undertaken.”

The researchers say they will continue to examine the long-term effects of depression during pregnancy and in the year after childbirth.

“Depression during this sensitive period can have serious consequences for both the mother and the baby,” Dr. Bränn said. “We hope that our results will help decision-makers to steer funding toward maternal healthcare so that more women can get help and support in time.”

The study was financed by Karolinska Institute, Forte (the Swedish Research Council for Health, Working Life and Welfare), the Swedish Research Council, and the Icelandic Research Fund.

The researchers and Dr. Miller reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Women with autoimmune disease are more likely to have perinatal depression (PND), according to findings from a new study that also suggested the reverse relationship is true: Women with a history of PND have a higher risk of developing autoimmune disease.

The research, published online on January 9, 2024, in Molecular Psychiatry, was led by Emma Bränn, PhD, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.

The researchers used data from the Swedish Medical Birth Register and identified all women who had given birth in Sweden between 2001 and 2013. Out of the group of approximately 815,000 women and 1.3 million pregnancies, just more than 55,000 women had been diagnosed with depression during their pregnancy or within a year after delivery.

The researchers then compared the incidence of 41 autoimmune diseases in women who had and did not have PND. They controlled for factors including genetic makeup and childhood environment.

Results indicated that women with autoimmune disease were 30% more likely to have PND (odds ratio, 1.30; 95% CI, 1.25-1.35). Conversely, women with PND were 30% more likely than women with no PND to develop an autoimmune disease (hazard ratio, 1.30; 95% CI, 1.25-1.36).

A sibling comparison helped confirm the results by controlling for some shared genetic and early life environmental factors related to the household in which sisters grew up.
 

Potential Shared Biological Mechanisms

The association was independent of psychiatric comorbidities, suggesting there may be shared biological mechanisms.

Dr. Bränn told this news organization that the research team wanted to do the study because previous research has shown involvement of the immune system in depression, with similarities in both the symptoms of immune system–activated diseases and depression and the molecular pathways activated by the immune system.

“Adding on top of the tremendous changes in the immune system that we see in the body of the woman during the perinatal period, we hypothesized that autoimmune diseases could be associated to perinatal depression,” she said. “This had also been shown in some previous literature but not to the extent as what we have investigated in this paper.”

She said their results help make a case for counseling women at several points in healthcare interactions — before and after conception and childbirth — and in rheumatology visits to inform women with autoimmune diseases who are contemplating motherhood of the association with developing PND. The results may also demonstrate a need for monitoring women in these groups for depression or autoimmune disease.

Fred Miller, MD, PhD, retired Scientist Emeritus of the Environmental Autoimmunity Group at the National Institute of Environmental Health Sciences, who was not part of the study, said the results seem plausible as they build on early work that demonstrated selected associations between autoimmune conditions and mental illness.

“These associations may be the result of shared genetic and environmental risk factors, including stress, hormonal changes, medications, and the proinflammatory states that can lead to both,” he said.

The novelty, he said, is in the relatively strong associations of PND with autoimmune disease overall and with specific autoimmune diseases.
 

Strong Link Found With Multiple Sclerosis (MS)

According to the paper, a significant positive bidirectional link was found for autoimmune thyroid disease, psoriasis, MS, ulcerative colitis, and celiac disease.

Researchers found a particularly strong association — double the risk in both directions — between PND and MS.

Dr. Miller said though it is unclear from this study why the association of PND with MS was stronger than with other autoimmune diseases, people with MS are known to be at a high risk for depression in general. That may come from greater shared genetic and environmental risk factors, he added.

Additionally, MS is one of the more common autoimmune diseases, he noted, so the population is larger for study.

He said he was surprised the researchers didn’t investigate medication use because medications used in depression have immunologic effects and medications used in autoimmune diseases could have effects on mental conditions.

The study has implications for clinicians in a wide variety of specialties, Dr. Miller noted.

“It suggests that caregivers be more alert to the signs of developing autoimmune disease in women with perinatal depression and to the signs of developing perinatal depression in those with autoimmune disease,” Dr. Miller said, “so that appropriate screening, diagnostics, and interventions may be undertaken.”

The researchers say they will continue to examine the long-term effects of depression during pregnancy and in the year after childbirth.

“Depression during this sensitive period can have serious consequences for both the mother and the baby,” Dr. Bränn said. “We hope that our results will help decision-makers to steer funding toward maternal healthcare so that more women can get help and support in time.”

The study was financed by Karolinska Institute, Forte (the Swedish Research Council for Health, Working Life and Welfare), the Swedish Research Council, and the Icelandic Research Fund.

The researchers and Dr. Miller reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

It’s an appealing concept: Stop addictive behaviors for a while — think social media, video games, gambling, porn, junk food, drugs, alcohol (dry January, anyone?) — to reset your brain’s reward circuitry, so you can feel great minus the bad habits.

People call it dopamine fasting, abstinence sampling, or dopamine detox. But is shutting off the rush of that feel-good neurotransmitter really the key to kicking addictions?

TikTok influencers and Silicon Valley execs seem to think so. But so do some physicians.

Prominent among the proponents is Anna Lembke, MD, professor of psychiatry at Stanford University School of Medicine and chief of the Stanford Addiction Medicine Dual Diagnosis Clinic. There, the dopamine fast is an early intervention framework for many of her patients.

“What we have seen in those patients is that not only does craving begin to subside in about 4 weeks, but that mood and anxiety and sleep and all these other parameters and markers of good mental health also improve,” Dr. Lembke said.

Any clinician, regardless of background, can adopt this framework, the Dopamine Nation author said during her talk at the American College of Lifestyle Medicine (ACLM) conference last fall. “There is this idea in medicine that we have to leave addiction to the Betty Ford Clinic or to an addiction psychiatrist,” she told the gathering. “But there’s so much that we can do, no matter what our training and no matter our treatment setting.”  

But is dopamine fasting right for your patients? Some experts said it’s an oversimplified or even dangerous approach. Here’s what to know.

Dopamine and the Brain

From the prefrontal cortex — your brain’s control center — to the nucleus accumbens and ventral tegmental area located deep in your limbic system, dopamine bridges gaps between neurons to deliver critical messages about pleasure, reward, and motivation. 

We all have a baseline level of dopamine. Substances and behaviors we like — everything from chocolate and sex to cocaine and amphetamines — increase dopamine firing. 

“When we seek healthy rewards, like a good meal out in a restaurant or having a nice chat with friends, dopaminergic neurons fire, and dopamine is released,” said Birgitta Dresp, PhD, a cognitive psychologist and research director with the Centre National de la Recherche Scientifique in Paris. “That gives us a good feeling.”

But over time, with chronic exposure to hyperpleasurable stimuli, your brain adapts. Dopamine receptors downregulate and shrink, and your “hedonic setpoint,” or baseline happiness level, drops. You now need more of your favorite stimuli to feel as good as you did before.

This primitive brain wiring served evolutionary purposes, helping our ancestors relentlessly pursue scarce resources like food. But in our modern world full of easily accessible, novel, potent, and stimulating activities, our brains are constantly trying to compensate. Paradoxically, this constant “self-titillation” may be contributing to our national and global mental health crisis, Dr. Lembke suggested.

“Human activity has changed the world we live in,” said Dr. Lembke, “and now this ancient mechanistic structure has become a liability of sorts.”

The Dopamine Fast in Action

To reset this wiring, Dr. Lembke recommended a 4-week fast from a person’s “drug of choice.” But this isn’t the trendy tech-bro quick cure-all where you abstain from everything that brings you joy. It’s a targeted intervention usually aimed at one behavior or substance at a time. The fast allows a person to understand “the nature of the hijacked brain,” and breaking free motivates them to change habits long term, said Dr. Lembke.

Although the first 2 weeks are difficult, she found that many patients feel better and more motivated after 4 weeks.

How do you identify patients who might benefit from a dopamine fast? Start with “how much” and proceed to “why.” Instead of asking how much of a substance or behavior they indulge in per week, which can be inaccurate, Dr. Lembke uses a “timeline follow-back” technique — how much yesterday, the day before that, and so on. This can lead to an “aha” moment when they see the week’s true total, she told the ACLM conference.  

She also explored why they do it. Often patients say they are self-medicating or that the substance helps with their anxiety or depression. When people are compulsively continuing to use despite negative consequences, she might recommend a 4-week reset.

Important exceptions: Dr. Lembke did not recommend dopamine fasting to anyone who has repeatedly and unsuccessfully tried to quit a drug on their own nor anyone for whom withdrawal is life-threatening.

For people who can safely try the dopamine fast, she recommended “self-binding” strategies to help them stay the course. Consider the people, places, and things that encourage you to use, and try to avoid them. For example, delete your social media apps if you’re trying to detox from social media. Put physical distance between you and your phone. For foods and substances, keep them out of the house. 

Dr. Lembke also recommended “hormesis,” painful but productive activities like exercise. Your brain’s system for pleasure and pain are closely related, so these activities affect reward circuitry.

“You’re intentionally doing things that are hard, which doesn’t initially release dopamine, in contrast to intoxicants, but you get a gradual increase that remains elevated even after that activity is stopped, which is a nice way to get dopamine indirectly,” she said.

If patients plan to resume their “drug of choice” after the dopamine fast, Dr. Lembke helps them plan how much they will consume and when. For some, this works. Others, unfortunately, go back to using as much or more than they did before. But in many cases, she said, patients feel better and find that their “drug of choice” wasn’t serving them as well as they thought. 

Critiques of Dopamine Fasting

Dopamine fasting isn’t for everyone, and experts debate its safety and effectiveness. Here are some common concerns: 

It’s too simplistic. Peter Grinspoon, MD, a primary care physician at Massachusetts General Hospital and instructor at Harvard Medical School, said dopamine fasting isn’t really fasting — you don’t have a finite store of dopamine to conserve or deplete in a fixed amount of time. Even if you abstain from certain pleasures, your brain will still produce some dopamine.

What makes more sense, he said, is gradual “dopamine retargeting,” seeking rewards from healthy pleasurable activities.

“Addiction is a disease of isolation, and learning to take pleasure in the healthy things in life, like a nice home-cooked meal or a walk in the woods or a hug or a swim in the ocean, is exactly what addiction recovery is about,” he said. “Because once you learn to do that and to be happy, there’s no longer any room for the drug and you’re not nearly as susceptible to relapse.”

A related concern is that the dopamine system isn’t the only part of your brain that matters in addiction. “There are other bits of the brain which are much more important for controlling temptation,” said Trevor W. Robbins, PhD, professor of cognitive neuroscience and director of research at the Behavioural and Clinical Neuroscience Institute at the University of Cambridge. Dopamine plays an important role in addiction and recovery, “but to call this a dopamine fast, it’s just a trendy saying to make it sound exciting,” he said.

Empirical evidence is lacking. Without clinical trials to back it up, dopamine fasting lacks evidence on safety and effectiveness, said David Tzall, PsyD, a psychologist practicing in Brooklyn. “It sounds kind of fun, right? To think like, oh, I’ll just stop doing this for a while, and my body will correct itself,” said Dr. Tzall. “I think that’s a very dangerous thing because we don’t have enough evidence on it to think of how it can be effective or how it can be dangerous.”

Dr. Lembke “would like to see more evidence, too,” beyond clinical observation and expert consensus. Future research could also reveal who is most likely to benefit and how long the fast should last for maximum benefit.

It’s too much a one-size-fits-all approach. “Stopping a drug of choice is going to look different for a lot of people,” said Dr. Tzall. Some people can quit smoking cold turkey; others need to phase it out. Some need nicotine patches; some don’t. Some can do it alone; others need help. 

The individual’s why behind addiction is also crucial. Without their drug or habit, can they “cope with the stressors of life?” Dr. Tzall asked. They may need new strategies. And if they quit before they are ready and fail, they could end up feeling even worse than they did before.

Experts do agree on one thing: We can do more to help people who are struggling. “It’s very good that people are having discussions around tempering consumption because we clearly have a serious drug and alcohol addiction, obesity, and digital media problem,” said Dr. Lembke.

A version of this article appeared on Medscape.com.

It’s an appealing concept: Stop addictive behaviors for a while — think social media, video games, gambling, porn, junk food, drugs, alcohol (dry January, anyone?) — to reset your brain’s reward circuitry, so you can feel great minus the bad habits.

People call it dopamine fasting, abstinence sampling, or dopamine detox. But is shutting off the rush of that feel-good neurotransmitter really the key to kicking addictions?

TikTok influencers and Silicon Valley execs seem to think so. But so do some physicians.

Prominent among the proponents is Anna Lembke, MD, professor of psychiatry at Stanford University School of Medicine and chief of the Stanford Addiction Medicine Dual Diagnosis Clinic. There, the dopamine fast is an early intervention framework for many of her patients.

“What we have seen in those patients is that not only does craving begin to subside in about 4 weeks, but that mood and anxiety and sleep and all these other parameters and markers of good mental health also improve,” Dr. Lembke said.

Any clinician, regardless of background, can adopt this framework, the Dopamine Nation author said during her talk at the American College of Lifestyle Medicine (ACLM) conference last fall. “There is this idea in medicine that we have to leave addiction to the Betty Ford Clinic or to an addiction psychiatrist,” she told the gathering. “But there’s so much that we can do, no matter what our training and no matter our treatment setting.”  

But is dopamine fasting right for your patients? Some experts said it’s an oversimplified or even dangerous approach. Here’s what to know.

Dopamine and the Brain

From the prefrontal cortex — your brain’s control center — to the nucleus accumbens and ventral tegmental area located deep in your limbic system, dopamine bridges gaps between neurons to deliver critical messages about pleasure, reward, and motivation. 

We all have a baseline level of dopamine. Substances and behaviors we like — everything from chocolate and sex to cocaine and amphetamines — increase dopamine firing. 

“When we seek healthy rewards, like a good meal out in a restaurant or having a nice chat with friends, dopaminergic neurons fire, and dopamine is released,” said Birgitta Dresp, PhD, a cognitive psychologist and research director with the Centre National de la Recherche Scientifique in Paris. “That gives us a good feeling.”

But over time, with chronic exposure to hyperpleasurable stimuli, your brain adapts. Dopamine receptors downregulate and shrink, and your “hedonic setpoint,” or baseline happiness level, drops. You now need more of your favorite stimuli to feel as good as you did before.

This primitive brain wiring served evolutionary purposes, helping our ancestors relentlessly pursue scarce resources like food. But in our modern world full of easily accessible, novel, potent, and stimulating activities, our brains are constantly trying to compensate. Paradoxically, this constant “self-titillation” may be contributing to our national and global mental health crisis, Dr. Lembke suggested.

“Human activity has changed the world we live in,” said Dr. Lembke, “and now this ancient mechanistic structure has become a liability of sorts.”

The Dopamine Fast in Action

To reset this wiring, Dr. Lembke recommended a 4-week fast from a person’s “drug of choice.” But this isn’t the trendy tech-bro quick cure-all where you abstain from everything that brings you joy. It’s a targeted intervention usually aimed at one behavior or substance at a time. The fast allows a person to understand “the nature of the hijacked brain,” and breaking free motivates them to change habits long term, said Dr. Lembke.

Although the first 2 weeks are difficult, she found that many patients feel better and more motivated after 4 weeks.

How do you identify patients who might benefit from a dopamine fast? Start with “how much” and proceed to “why.” Instead of asking how much of a substance or behavior they indulge in per week, which can be inaccurate, Dr. Lembke uses a “timeline follow-back” technique — how much yesterday, the day before that, and so on. This can lead to an “aha” moment when they see the week’s true total, she told the ACLM conference.  

She also explored why they do it. Often patients say they are self-medicating or that the substance helps with their anxiety or depression. When people are compulsively continuing to use despite negative consequences, she might recommend a 4-week reset.

Important exceptions: Dr. Lembke did not recommend dopamine fasting to anyone who has repeatedly and unsuccessfully tried to quit a drug on their own nor anyone for whom withdrawal is life-threatening.

For people who can safely try the dopamine fast, she recommended “self-binding” strategies to help them stay the course. Consider the people, places, and things that encourage you to use, and try to avoid them. For example, delete your social media apps if you’re trying to detox from social media. Put physical distance between you and your phone. For foods and substances, keep them out of the house. 

Dr. Lembke also recommended “hormesis,” painful but productive activities like exercise. Your brain’s system for pleasure and pain are closely related, so these activities affect reward circuitry.

“You’re intentionally doing things that are hard, which doesn’t initially release dopamine, in contrast to intoxicants, but you get a gradual increase that remains elevated even after that activity is stopped, which is a nice way to get dopamine indirectly,” she said.

If patients plan to resume their “drug of choice” after the dopamine fast, Dr. Lembke helps them plan how much they will consume and when. For some, this works. Others, unfortunately, go back to using as much or more than they did before. But in many cases, she said, patients feel better and find that their “drug of choice” wasn’t serving them as well as they thought. 

Critiques of Dopamine Fasting

Dopamine fasting isn’t for everyone, and experts debate its safety and effectiveness. Here are some common concerns: 

It’s too simplistic. Peter Grinspoon, MD, a primary care physician at Massachusetts General Hospital and instructor at Harvard Medical School, said dopamine fasting isn’t really fasting — you don’t have a finite store of dopamine to conserve or deplete in a fixed amount of time. Even if you abstain from certain pleasures, your brain will still produce some dopamine.

What makes more sense, he said, is gradual “dopamine retargeting,” seeking rewards from healthy pleasurable activities.

“Addiction is a disease of isolation, and learning to take pleasure in the healthy things in life, like a nice home-cooked meal or a walk in the woods or a hug or a swim in the ocean, is exactly what addiction recovery is about,” he said. “Because once you learn to do that and to be happy, there’s no longer any room for the drug and you’re not nearly as susceptible to relapse.”

A related concern is that the dopamine system isn’t the only part of your brain that matters in addiction. “There are other bits of the brain which are much more important for controlling temptation,” said Trevor W. Robbins, PhD, professor of cognitive neuroscience and director of research at the Behavioural and Clinical Neuroscience Institute at the University of Cambridge. Dopamine plays an important role in addiction and recovery, “but to call this a dopamine fast, it’s just a trendy saying to make it sound exciting,” he said.

Empirical evidence is lacking. Without clinical trials to back it up, dopamine fasting lacks evidence on safety and effectiveness, said David Tzall, PsyD, a psychologist practicing in Brooklyn. “It sounds kind of fun, right? To think like, oh, I’ll just stop doing this for a while, and my body will correct itself,” said Dr. Tzall. “I think that’s a very dangerous thing because we don’t have enough evidence on it to think of how it can be effective or how it can be dangerous.”

Dr. Lembke “would like to see more evidence, too,” beyond clinical observation and expert consensus. Future research could also reveal who is most likely to benefit and how long the fast should last for maximum benefit.

It’s too much a one-size-fits-all approach. “Stopping a drug of choice is going to look different for a lot of people,” said Dr. Tzall. Some people can quit smoking cold turkey; others need to phase it out. Some need nicotine patches; some don’t. Some can do it alone; others need help. 

The individual’s why behind addiction is also crucial. Without their drug or habit, can they “cope with the stressors of life?” Dr. Tzall asked. They may need new strategies. And if they quit before they are ready and fail, they could end up feeling even worse than they did before.

Experts do agree on one thing: We can do more to help people who are struggling. “It’s very good that people are having discussions around tempering consumption because we clearly have a serious drug and alcohol addiction, obesity, and digital media problem,” said Dr. Lembke.

A version of this article appeared on Medscape.com.

It’s an appealing concept: Stop addictive behaviors for a while — think social media, video games, gambling, porn, junk food, drugs, alcohol (dry January, anyone?) — to reset your brain’s reward circuitry, so you can feel great minus the bad habits.

People call it dopamine fasting, abstinence sampling, or dopamine detox. But is shutting off the rush of that feel-good neurotransmitter really the key to kicking addictions?

TikTok influencers and Silicon Valley execs seem to think so. But so do some physicians.

Prominent among the proponents is Anna Lembke, MD, professor of psychiatry at Stanford University School of Medicine and chief of the Stanford Addiction Medicine Dual Diagnosis Clinic. There, the dopamine fast is an early intervention framework for many of her patients.

“What we have seen in those patients is that not only does craving begin to subside in about 4 weeks, but that mood and anxiety and sleep and all these other parameters and markers of good mental health also improve,” Dr. Lembke said.

Any clinician, regardless of background, can adopt this framework, the Dopamine Nation author said during her talk at the American College of Lifestyle Medicine (ACLM) conference last fall. “There is this idea in medicine that we have to leave addiction to the Betty Ford Clinic or to an addiction psychiatrist,” she told the gathering. “But there’s so much that we can do, no matter what our training and no matter our treatment setting.”  

But is dopamine fasting right for your patients? Some experts said it’s an oversimplified or even dangerous approach. Here’s what to know.

Dopamine and the Brain

From the prefrontal cortex — your brain’s control center — to the nucleus accumbens and ventral tegmental area located deep in your limbic system, dopamine bridges gaps between neurons to deliver critical messages about pleasure, reward, and motivation. 

We all have a baseline level of dopamine. Substances and behaviors we like — everything from chocolate and sex to cocaine and amphetamines — increase dopamine firing. 

“When we seek healthy rewards, like a good meal out in a restaurant or having a nice chat with friends, dopaminergic neurons fire, and dopamine is released,” said Birgitta Dresp, PhD, a cognitive psychologist and research director with the Centre National de la Recherche Scientifique in Paris. “That gives us a good feeling.”

But over time, with chronic exposure to hyperpleasurable stimuli, your brain adapts. Dopamine receptors downregulate and shrink, and your “hedonic setpoint,” or baseline happiness level, drops. You now need more of your favorite stimuli to feel as good as you did before.

This primitive brain wiring served evolutionary purposes, helping our ancestors relentlessly pursue scarce resources like food. But in our modern world full of easily accessible, novel, potent, and stimulating activities, our brains are constantly trying to compensate. Paradoxically, this constant “self-titillation” may be contributing to our national and global mental health crisis, Dr. Lembke suggested.

“Human activity has changed the world we live in,” said Dr. Lembke, “and now this ancient mechanistic structure has become a liability of sorts.”

The Dopamine Fast in Action

To reset this wiring, Dr. Lembke recommended a 4-week fast from a person’s “drug of choice.” But this isn’t the trendy tech-bro quick cure-all where you abstain from everything that brings you joy. It’s a targeted intervention usually aimed at one behavior or substance at a time. The fast allows a person to understand “the nature of the hijacked brain,” and breaking free motivates them to change habits long term, said Dr. Lembke.

Although the first 2 weeks are difficult, she found that many patients feel better and more motivated after 4 weeks.

How do you identify patients who might benefit from a dopamine fast? Start with “how much” and proceed to “why.” Instead of asking how much of a substance or behavior they indulge in per week, which can be inaccurate, Dr. Lembke uses a “timeline follow-back” technique — how much yesterday, the day before that, and so on. This can lead to an “aha” moment when they see the week’s true total, she told the ACLM conference.  

She also explored why they do it. Often patients say they are self-medicating or that the substance helps with their anxiety or depression. When people are compulsively continuing to use despite negative consequences, she might recommend a 4-week reset.

Important exceptions: Dr. Lembke did not recommend dopamine fasting to anyone who has repeatedly and unsuccessfully tried to quit a drug on their own nor anyone for whom withdrawal is life-threatening.

For people who can safely try the dopamine fast, she recommended “self-binding” strategies to help them stay the course. Consider the people, places, and things that encourage you to use, and try to avoid them. For example, delete your social media apps if you’re trying to detox from social media. Put physical distance between you and your phone. For foods and substances, keep them out of the house. 

Dr. Lembke also recommended “hormesis,” painful but productive activities like exercise. Your brain’s system for pleasure and pain are closely related, so these activities affect reward circuitry.

“You’re intentionally doing things that are hard, which doesn’t initially release dopamine, in contrast to intoxicants, but you get a gradual increase that remains elevated even after that activity is stopped, which is a nice way to get dopamine indirectly,” she said.

If patients plan to resume their “drug of choice” after the dopamine fast, Dr. Lembke helps them plan how much they will consume and when. For some, this works. Others, unfortunately, go back to using as much or more than they did before. But in many cases, she said, patients feel better and find that their “drug of choice” wasn’t serving them as well as they thought. 

Critiques of Dopamine Fasting

Dopamine fasting isn’t for everyone, and experts debate its safety and effectiveness. Here are some common concerns: 

It’s too simplistic. Peter Grinspoon, MD, a primary care physician at Massachusetts General Hospital and instructor at Harvard Medical School, said dopamine fasting isn’t really fasting — you don’t have a finite store of dopamine to conserve or deplete in a fixed amount of time. Even if you abstain from certain pleasures, your brain will still produce some dopamine.

What makes more sense, he said, is gradual “dopamine retargeting,” seeking rewards from healthy pleasurable activities.

“Addiction is a disease of isolation, and learning to take pleasure in the healthy things in life, like a nice home-cooked meal or a walk in the woods or a hug or a swim in the ocean, is exactly what addiction recovery is about,” he said. “Because once you learn to do that and to be happy, there’s no longer any room for the drug and you’re not nearly as susceptible to relapse.”

A related concern is that the dopamine system isn’t the only part of your brain that matters in addiction. “There are other bits of the brain which are much more important for controlling temptation,” said Trevor W. Robbins, PhD, professor of cognitive neuroscience and director of research at the Behavioural and Clinical Neuroscience Institute at the University of Cambridge. Dopamine plays an important role in addiction and recovery, “but to call this a dopamine fast, it’s just a trendy saying to make it sound exciting,” he said.

Empirical evidence is lacking. Without clinical trials to back it up, dopamine fasting lacks evidence on safety and effectiveness, said David Tzall, PsyD, a psychologist practicing in Brooklyn. “It sounds kind of fun, right? To think like, oh, I’ll just stop doing this for a while, and my body will correct itself,” said Dr. Tzall. “I think that’s a very dangerous thing because we don’t have enough evidence on it to think of how it can be effective or how it can be dangerous.”

Dr. Lembke “would like to see more evidence, too,” beyond clinical observation and expert consensus. Future research could also reveal who is most likely to benefit and how long the fast should last for maximum benefit.

It’s too much a one-size-fits-all approach. “Stopping a drug of choice is going to look different for a lot of people,” said Dr. Tzall. Some people can quit smoking cold turkey; others need to phase it out. Some need nicotine patches; some don’t. Some can do it alone; others need help. 

The individual’s why behind addiction is also crucial. Without their drug or habit, can they “cope with the stressors of life?” Dr. Tzall asked. They may need new strategies. And if they quit before they are ready and fail, they could end up feeling even worse than they did before.

Experts do agree on one thing: We can do more to help people who are struggling. “It’s very good that people are having discussions around tempering consumption because we clearly have a serious drug and alcohol addiction, obesity, and digital media problem,” said Dr. Lembke.

A version of this article appeared on Medscape.com.

Nearly 10% of survivors of head, neck, esophageal, and gastric cancers experienced active substance use disorders, based on data from more than 6,000 individuals.

The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.

“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.

In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.

The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.

Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).

Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.

Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).

The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
 

Limitations and Implications

The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.

“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.

“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
 

Integrated care is needed

“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.

Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
 

Recognize risk factors

“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.

The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
 

Individualize risk assessment

“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.

As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.

The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.

Nearly 10% of survivors of head, neck, esophageal, and gastric cancers experienced active substance use disorders, based on data from more than 6,000 individuals.

The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.

“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.

In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.

The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.

Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).

Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.

Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).

The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
 

Limitations and Implications

The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.

“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.

“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
 

Integrated care is needed

“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.

Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
 

Recognize risk factors

“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.

The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
 

Individualize risk assessment

“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.

As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.

The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.

Nearly 10% of survivors of head, neck, esophageal, and gastric cancers experienced active substance use disorders, based on data from more than 6,000 individuals.

The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.

“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.

In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.

The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.

Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).

Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.

Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).

The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
 

Limitations and Implications

The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.

“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.

“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
 

Integrated care is needed

“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.

Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
 

Recognize risk factors

“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.

The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
 

Individualize risk assessment

“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.

As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.

The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.

TOPLINE:

Transcranial alternating current stimulation (tACS), a noninvasive technique that uses low-intensity electrical currents to modulate brain activity, is an effective intervention for treating chronic insomnia, especially in older people, results of a relatively large study suggested.

METHODOLOGY:

• The double-blind study included 124 adults with chronic insomnia (difficulty falling asleep or maintaining sleep and early morning awakening occurring at least three times a week over 3 or more months), mean age about 51 years, from two centers in China who were randomized to receive either tACS (active group) or sham tACS (control group).
• Patients underwent 20 40-minute sessions over 4 weeks; the tACS intervention involved positioning three electrodes on the scalp and applying a current of 15 mA at a frequency of 77.5 Hz, whereas the control group received no stimulation.
• Primary outcome measures included total score on the Chinese version of the self-report Pittsburgh Sleep Quality Index (PSQI), sleep onset latency, total sleep time (TST), sleep efficiency, sleep quality, and daily disturbances (such as fatigue and attention deficits).
• Secondary outcomes included Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and Clinical Global Impression scale (including Clinical Global Impression Severity of Illness [CGI-SI], Clinical Global Impression Global Improvement [CGI-GI], and Clinical Global Impression Efficacy Index [CGI-EI]).
• As rates of chronic insomnia increase with age, researchers explored the influence of age on treatment benefits by dividing participants into two age groups (< 50 years and ≥ 50 years).

TAKEAWAY:

• Among the 120 participants who completed the trial, tACS resulted in a statistically significant decrease in insomnia severity compared with the control group (estimated advantage [number of points on PSQI scale], 2.61; 95% CI, 1.47-3.75; P < .001).
• There were also statistically significant estimated advantages of tACS for TST (−0.65; 95% CI, −1.06 to −0.24; P = .002), sleep efficiency (1.05; 95% CI, 0.48-1.62; P < .001), sleep quality (0.82; 95% CI, 0.29-1.34; P = .003), and daily disturbances (0.91; 95% CI, 0.58-1.25; P < .001).
• tACS exhibited significant effects on CGI-SI (0.84; 95% CI, 0.38-1.30; P < .001), CGI-GI (0.74; 95% CI, 0.42-1.06; P < .001), and CGI-EI (−0.71; 95% CI, −1.02 to −0.39; P < .001) but not on total scores of HAMD and HAMA, possibly because of the relatively low baseline levels of depression and anxiety among study subjects, said the authors.
• In the older, but not younger, group, tACS treatment had a significant benefit in sleep quality, sleep efficiency, PSQI total score, CGI-SI, CGI-GI, and CGI-EI.

IN PRACTICE:

“These significant findings contribute substantially to promoting evidence-based practices and facilitating the development of innovative treatment strategies for chronic insomnia,” the investigators wrote.

SOURCE:

The study was conducted by Xiaolin Zhu, Beijing Huilongguan Hospital, Peking University Huilongguan Clinical Medical School, Beijing, China, and colleagues. It was published online in the Journal of Psychiatric Research.

LIMITATIONS:

The follow-up period was limited to 8 weeks, so longer follow-up studies are needed to explore the sustained effects of tACS on chronic insomnia. Severity of chronic insomnia was limited by using the self-report PSQI, and not objective measures of insomnia such as polysomnography and wrist actigraphy. The age of study subjects ranged from 22 to only 65 years.

DISCLOSURES:

The study was supported by the Beijing Municipal Science and Technology Commission. The authors had no relevant conflicts of interest.

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

TOPLINE:

Transcranial alternating current stimulation (tACS), a noninvasive technique that uses low-intensity electrical currents to modulate brain activity, is an effective intervention for treating chronic insomnia, especially in older people, results of a relatively large study suggested.

METHODOLOGY:

• The double-blind study included 124 adults with chronic insomnia (difficulty falling asleep or maintaining sleep and early morning awakening occurring at least three times a week over 3 or more months), mean age about 51 years, from two centers in China who were randomized to receive either tACS (active group) or sham tACS (control group).
• Patients underwent 20 40-minute sessions over 4 weeks; the tACS intervention involved positioning three electrodes on the scalp and applying a current of 15 mA at a frequency of 77.5 Hz, whereas the control group received no stimulation.
• Primary outcome measures included total score on the Chinese version of the self-report Pittsburgh Sleep Quality Index (PSQI), sleep onset latency, total sleep time (TST), sleep efficiency, sleep quality, and daily disturbances (such as fatigue and attention deficits).
• Secondary outcomes included Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and Clinical Global Impression scale (including Clinical Global Impression Severity of Illness [CGI-SI], Clinical Global Impression Global Improvement [CGI-GI], and Clinical Global Impression Efficacy Index [CGI-EI]).
• As rates of chronic insomnia increase with age, researchers explored the influence of age on treatment benefits by dividing participants into two age groups (< 50 years and ≥ 50 years).

TAKEAWAY:

• Among the 120 participants who completed the trial, tACS resulted in a statistically significant decrease in insomnia severity compared with the control group (estimated advantage [number of points on PSQI scale], 2.61; 95% CI, 1.47-3.75; P < .001).
• There were also statistically significant estimated advantages of tACS for TST (−0.65; 95% CI, −1.06 to −0.24; P = .002), sleep efficiency (1.05; 95% CI, 0.48-1.62; P < .001), sleep quality (0.82; 95% CI, 0.29-1.34; P = .003), and daily disturbances (0.91; 95% CI, 0.58-1.25; P < .001).
• tACS exhibited significant effects on CGI-SI (0.84; 95% CI, 0.38-1.30; P < .001), CGI-GI (0.74; 95% CI, 0.42-1.06; P < .001), and CGI-EI (−0.71; 95% CI, −1.02 to −0.39; P < .001) but not on total scores of HAMD and HAMA, possibly because of the relatively low baseline levels of depression and anxiety among study subjects, said the authors.
• In the older, but not younger, group, tACS treatment had a significant benefit in sleep quality, sleep efficiency, PSQI total score, CGI-SI, CGI-GI, and CGI-EI.

IN PRACTICE:

“These significant findings contribute substantially to promoting evidence-based practices and facilitating the development of innovative treatment strategies for chronic insomnia,” the investigators wrote.

SOURCE:

The study was conducted by Xiaolin Zhu, Beijing Huilongguan Hospital, Peking University Huilongguan Clinical Medical School, Beijing, China, and colleagues. It was published online in the Journal of Psychiatric Research.

LIMITATIONS:

The follow-up period was limited to 8 weeks, so longer follow-up studies are needed to explore the sustained effects of tACS on chronic insomnia. Severity of chronic insomnia was limited by using the self-report PSQI, and not objective measures of insomnia such as polysomnography and wrist actigraphy. The age of study subjects ranged from 22 to only 65 years.

DISCLOSURES:

The study was supported by the Beijing Municipal Science and Technology Commission. The authors had no relevant conflicts of interest.

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

TOPLINE:

Transcranial alternating current stimulation (tACS), a noninvasive technique that uses low-intensity electrical currents to modulate brain activity, is an effective intervention for treating chronic insomnia, especially in older people, results of a relatively large study suggested.

METHODOLOGY:

• The double-blind study included 124 adults with chronic insomnia (difficulty falling asleep or maintaining sleep and early morning awakening occurring at least three times a week over 3 or more months), mean age about 51 years, from two centers in China who were randomized to receive either tACS (active group) or sham tACS (control group).
• Patients underwent 20 40-minute sessions over 4 weeks; the tACS intervention involved positioning three electrodes on the scalp and applying a current of 15 mA at a frequency of 77.5 Hz, whereas the control group received no stimulation.
• Primary outcome measures included total score on the Chinese version of the self-report Pittsburgh Sleep Quality Index (PSQI), sleep onset latency, total sleep time (TST), sleep efficiency, sleep quality, and daily disturbances (such as fatigue and attention deficits).
• Secondary outcomes included Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and Clinical Global Impression scale (including Clinical Global Impression Severity of Illness [CGI-SI], Clinical Global Impression Global Improvement [CGI-GI], and Clinical Global Impression Efficacy Index [CGI-EI]).
• As rates of chronic insomnia increase with age, researchers explored the influence of age on treatment benefits by dividing participants into two age groups (< 50 years and ≥ 50 years).

TAKEAWAY:

• Among the 120 participants who completed the trial, tACS resulted in a statistically significant decrease in insomnia severity compared with the control group (estimated advantage [number of points on PSQI scale], 2.61; 95% CI, 1.47-3.75; P < .001).
• There were also statistically significant estimated advantages of tACS for TST (−0.65; 95% CI, −1.06 to −0.24; P = .002), sleep efficiency (1.05; 95% CI, 0.48-1.62; P < .001), sleep quality (0.82; 95% CI, 0.29-1.34; P = .003), and daily disturbances (0.91; 95% CI, 0.58-1.25; P < .001).
• tACS exhibited significant effects on CGI-SI (0.84; 95% CI, 0.38-1.30; P < .001), CGI-GI (0.74; 95% CI, 0.42-1.06; P < .001), and CGI-EI (−0.71; 95% CI, −1.02 to −0.39; P < .001) but not on total scores of HAMD and HAMA, possibly because of the relatively low baseline levels of depression and anxiety among study subjects, said the authors.
• In the older, but not younger, group, tACS treatment had a significant benefit in sleep quality, sleep efficiency, PSQI total score, CGI-SI, CGI-GI, and CGI-EI.

IN PRACTICE:

“These significant findings contribute substantially to promoting evidence-based practices and facilitating the development of innovative treatment strategies for chronic insomnia,” the investigators wrote.

SOURCE:

The study was conducted by Xiaolin Zhu, Beijing Huilongguan Hospital, Peking University Huilongguan Clinical Medical School, Beijing, China, and colleagues. It was published online in the Journal of Psychiatric Research.

LIMITATIONS:

The follow-up period was limited to 8 weeks, so longer follow-up studies are needed to explore the sustained effects of tACS on chronic insomnia. Severity of chronic insomnia was limited by using the self-report PSQI, and not objective measures of insomnia such as polysomnography and wrist actigraphy. The age of study subjects ranged from 22 to only 65 years.

DISCLOSURES:

The study was supported by the Beijing Municipal Science and Technology Commission. The authors had no relevant conflicts of interest.

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