While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

The Department of Labor will likely need to rely on workplace whistleblowers when the Biden administration’s COVID-19 vaccine mandate for large companies goes into effect in January.

The Occupational Safety and Health Administration (OSHA) doesn’t have enough workplace safety inspectors to cover the nation, the Associated Press reported, so the agency will count on people within organizations to identify violations.

“There is no army of OSHA inspectors that is going to be knocking on employers’ doors or even calling them,” Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University, told the news service.

“They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law,” she said.

Last week, OSHA published the details of the Biden administration’s vaccine mandate. Companies with more than 100 employees must require their workers to get vaccinated or undergo weekly testing. Companies that don’t comply could face fines of $14,000 for each “serious” violation. Repeat violators could face 10 times that amount.

Employees who are concerned about workplace safety, unvaccinated co-workers, or people not being tested as required may report their employers, according to Reuters.

Jim Frederick, the acting chief for OSHA, told reporters that the agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”

“That typically comes through in the form of a complaint,” he said.

OSHA has jurisdiction in 29 states, the AP reported. OSHA is tasked with addressing violations of the Occupational Safety and Health Act of 1970, which is meant to create safe workplaces, and the agency has updated its guidance about COVID-19 safety in the workplace throughout this year.

Other states, such as California and Michigan, have their own workplace safety agencies, which will have until February to adopt their own version of a vaccine mandate, according to the AP.

OSHA and state counterparts will be tasked with enforcing the mandate, and their agencies are already short-staffed. About 1,850 inspectors will oversee 130 million workers at 8 million job sites.

OSHA has encouraged workers to first report complaints to employers “if possible.” Otherwise, employees can file a confidential safety complaint with OSHA or file a case through a representative, such as a lawyer or union leader, the AP reported.

But workplace experts have voiced caution about the potential risks of reporting. Whistleblowers tend to face retaliation and OSHA can’t always offer protection in these cases.

“Technically, the law says that companies can’t retaliate against a worker for raising a health and safety issue or filing an OSHA complaint or even reporting an injury,” Ms. Berkowitz said. “But retaliation is rampant.”

OSHA has some jurisdiction to pursue employers who punish workers for reporting unsafe working conditions, the AP reported. Last month, the agency sued a luxury car dealer in Texas for firing an employee who warned co-workers about potential coronavirus hazards.

But at the same time, Ms. Berkowitz and the National Employment Law Project found that OSHA dismissed more than half of the COVID-related complaints of retaliation that it received from whistleblowers. About 2% of complaints were resolved during a 5-month period last year, according to their report.

As the vaccine mandate deadline approaches, most companies are expected to comply, experts told the AP. Some employers wanted to require the shot but didn’t want to create their own rule, and others have said they’ll follow OSHA regulations as they always do.

“Most employers, they’re law abiding,” David Michaels, a former OSHA chief who is a public health professor at George Washington University, told the AP.

“They’re trying to make sure that they meet the requirements of every law and regulation,” he said. “Now OSHA will follow up. They’ll respond to complaints. They’ll do spot checks. They’ll issue citations and fines, and they’ll make a big deal of those.”

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

The Department of Labor will likely need to rely on workplace whistleblowers when the Biden administration’s COVID-19 vaccine mandate for large companies goes into effect in January.

The Occupational Safety and Health Administration (OSHA) doesn’t have enough workplace safety inspectors to cover the nation, the Associated Press reported, so the agency will count on people within organizations to identify violations.

“There is no army of OSHA inspectors that is going to be knocking on employers’ doors or even calling them,” Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University, told the news service.

“They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law,” she said.

Last week, OSHA published the details of the Biden administration’s vaccine mandate. Companies with more than 100 employees must require their workers to get vaccinated or undergo weekly testing. Companies that don’t comply could face fines of $14,000 for each “serious” violation. Repeat violators could face 10 times that amount.

Employees who are concerned about workplace safety, unvaccinated co-workers, or people not being tested as required may report their employers, according to Reuters.

Jim Frederick, the acting chief for OSHA, told reporters that the agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”

“That typically comes through in the form of a complaint,” he said.

OSHA has jurisdiction in 29 states, the AP reported. OSHA is tasked with addressing violations of the Occupational Safety and Health Act of 1970, which is meant to create safe workplaces, and the agency has updated its guidance about COVID-19 safety in the workplace throughout this year.

Other states, such as California and Michigan, have their own workplace safety agencies, which will have until February to adopt their own version of a vaccine mandate, according to the AP.

OSHA and state counterparts will be tasked with enforcing the mandate, and their agencies are already short-staffed. About 1,850 inspectors will oversee 130 million workers at 8 million job sites.

OSHA has encouraged workers to first report complaints to employers “if possible.” Otherwise, employees can file a confidential safety complaint with OSHA or file a case through a representative, such as a lawyer or union leader, the AP reported.

But workplace experts have voiced caution about the potential risks of reporting. Whistleblowers tend to face retaliation and OSHA can’t always offer protection in these cases.

“Technically, the law says that companies can’t retaliate against a worker for raising a health and safety issue or filing an OSHA complaint or even reporting an injury,” Ms. Berkowitz said. “But retaliation is rampant.”

OSHA has some jurisdiction to pursue employers who punish workers for reporting unsafe working conditions, the AP reported. Last month, the agency sued a luxury car dealer in Texas for firing an employee who warned co-workers about potential coronavirus hazards.

But at the same time, Ms. Berkowitz and the National Employment Law Project found that OSHA dismissed more than half of the COVID-related complaints of retaliation that it received from whistleblowers. About 2% of complaints were resolved during a 5-month period last year, according to their report.

As the vaccine mandate deadline approaches, most companies are expected to comply, experts told the AP. Some employers wanted to require the shot but didn’t want to create their own rule, and others have said they’ll follow OSHA regulations as they always do.

“Most employers, they’re law abiding,” David Michaels, a former OSHA chief who is a public health professor at George Washington University, told the AP.

“They’re trying to make sure that they meet the requirements of every law and regulation,” he said. “Now OSHA will follow up. They’ll respond to complaints. They’ll do spot checks. They’ll issue citations and fines, and they’ll make a big deal of those.”

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

The Department of Labor will likely need to rely on workplace whistleblowers when the Biden administration’s COVID-19 vaccine mandate for large companies goes into effect in January.

The Occupational Safety and Health Administration (OSHA) doesn’t have enough workplace safety inspectors to cover the nation, the Associated Press reported, so the agency will count on people within organizations to identify violations.

“There is no army of OSHA inspectors that is going to be knocking on employers’ doors or even calling them,” Debbie Berkowitz, a former OSHA chief of staff who is a fellow at Georgetown University, told the news service.

“They’re going to rely on workers and their union representatives to file complaints where the company is totally flouting the law,” she said.

Last week, OSHA published the details of the Biden administration’s vaccine mandate. Companies with more than 100 employees must require their workers to get vaccinated or undergo weekly testing. Companies that don’t comply could face fines of $14,000 for each “serious” violation. Repeat violators could face 10 times that amount.

Employees who are concerned about workplace safety, unvaccinated co-workers, or people not being tested as required may report their employers, according to Reuters.

Jim Frederick, the acting chief for OSHA, told reporters that the agency will focus on job sites “where workers need assistance to have a safe and healthy workplace.”

“That typically comes through in the form of a complaint,” he said.

OSHA has jurisdiction in 29 states, the AP reported. OSHA is tasked with addressing violations of the Occupational Safety and Health Act of 1970, which is meant to create safe workplaces, and the agency has updated its guidance about COVID-19 safety in the workplace throughout this year.

Other states, such as California and Michigan, have their own workplace safety agencies, which will have until February to adopt their own version of a vaccine mandate, according to the AP.

OSHA and state counterparts will be tasked with enforcing the mandate, and their agencies are already short-staffed. About 1,850 inspectors will oversee 130 million workers at 8 million job sites.

OSHA has encouraged workers to first report complaints to employers “if possible.” Otherwise, employees can file a confidential safety complaint with OSHA or file a case through a representative, such as a lawyer or union leader, the AP reported.

But workplace experts have voiced caution about the potential risks of reporting. Whistleblowers tend to face retaliation and OSHA can’t always offer protection in these cases.

“Technically, the law says that companies can’t retaliate against a worker for raising a health and safety issue or filing an OSHA complaint or even reporting an injury,” Ms. Berkowitz said. “But retaliation is rampant.”

OSHA has some jurisdiction to pursue employers who punish workers for reporting unsafe working conditions, the AP reported. Last month, the agency sued a luxury car dealer in Texas for firing an employee who warned co-workers about potential coronavirus hazards.

But at the same time, Ms. Berkowitz and the National Employment Law Project found that OSHA dismissed more than half of the COVID-related complaints of retaliation that it received from whistleblowers. About 2% of complaints were resolved during a 5-month period last year, according to their report.

As the vaccine mandate deadline approaches, most companies are expected to comply, experts told the AP. Some employers wanted to require the shot but didn’t want to create their own rule, and others have said they’ll follow OSHA regulations as they always do.

“Most employers, they’re law abiding,” David Michaels, a former OSHA chief who is a public health professor at George Washington University, told the AP.

“They’re trying to make sure that they meet the requirements of every law and regulation,” he said. “Now OSHA will follow up. They’ll respond to complaints. They’ll do spot checks. They’ll issue citations and fines, and they’ll make a big deal of those.”

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

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

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

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

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

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

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

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

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

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

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

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

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

A potential new urine biomarker for prostate cancer not only spots the presence of aggressive tumors, it also indicates the amount of these tumors, according to a recent report.

In a study of biopsy and prostatectomy samples, researchers found that the multigene Prostate Urine Risk-4 (PUR-4) signature was strongly associated with the presence and amount of Gleason pattern 4 tumors, but not tumors of less aggressive histology.

Given that increased Gleason pattern 4 tumor burden is associated with disease progression in men at intermediate risk, the results suggest that “PUR can show us which men at intermediate risk may require treatment and which may instead be managed conservatively with surveillance,” said senior author Jeremy Clark, PhD, of the University of East Anglia, Norwich, England. “PUR will also be useful for monitoring disease in men that do not currently require treatment and flag up the emergence and expansion of aggressive disease.”

The study by Dr. Clark and colleagues was published online on Nov. 3, 2021, in Life.

Tests using the traditional blood-based biomarker for prostate cancer – prostate-specific antigen (PSA) – have limited sensitivity and specificity, leading to unnecessary biopsies and overtreatment.

The PUR biomarker, one of several emerging alternatives to PSA, is a four-group classifier based on 36 genes, Dr. Clark and colleagues explained. Its categories correspond to the probabilities of the presence of normal tissue (PUR-1), and D’Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer.

Dr. Clark’s team found in earlier research that the PUR-4 signature was able to predict disease progression in men on active surveillance for prostate cancer up to 5 years after a single urine sample. For their latest study, they sought to understand the relationship between PUR-4 and the amount and grade of tumor.

On the basis of biopsy samples from 215 men with prostate cancer, the researchers found that PUR-4 signature values correlated significantly with increasing Gleason grade.

There was no significant difference in PSA level by tumor volume for Gleason grade 1, 2, or 3. The same was true for PUR-4 and Gleason grade 1 tumors, which only contain less clinically significant Gleason pattern 3 cancer. However, PUR-4 values in men with Gleason grade 2 tumors larger than the median were significantly greater than for smaller tumors. PUR-4 values for large Gleason grade 3 tumors were also greater than for smaller ones, although the difference did not reach statistical significance.

“Since [Gleason grade] 2 and [Gleason grade] 3 contain both Gleason pattern 3 and 4 cancer these observations suggest that Gleason Pattern 4 cancer may be contributing to PUR-4 status,” the authors wrote.

The researchers also examined radical-prostatectomy specimens from nine men – three with Gleason grade 1, four with Gleason grade 2, and two with Gleason grade 3 tumors, as determined on the basis of presurgical biopsy.

There was no significant correlation between PUR-4 and PSA levels, nor were PUR-4 values linked to total tumor area or Gleason pattern 3 tumor area. But the amount of Gleason pattern 4 tumors showed a strong correlation with PUR-4 values, which did not change after adjusting for total prostate size.

“Our study shows that the PUR test can assess the amount of Gleason pattern 4 without the need for a biopsy,” Dr. Clark said in an interview. “It could therefore be a very useful tool indeed for assessing a man’s risk of dying from prostate cancer.”

Jack Schalken, PhD, a professor of experimental urology at Radboud University Medical Center in Nijmegen, the Netherlands, called PUR “another test” for prostate cancer the performance of which is in the same range as that of existing products.

“In fact, several tests are commercially available, but the clinical use is surprisingly low,” he told this news organization. Dr. Schalken, who was not involved in the new study, has reviewed several biomarkers for prostate cancer.

The PUR test is now undergoing validation in an international study that is expected to last another 2 years, Dr. Clark said. If successful, the test would stand out for several reasons.

First, it is based on many genes, so it is able to spot malignancies that other tests, which rely on just a few genes, may not pick up. In addition, although it is sensitive to the amount of Gleason pattern 4 tumor, it does not seem to detect the clinically less significant Gleason pattern 3 cancers.

“We have an at-home collection kit – the men do not have to come to a hospital to provide a urine sample,” Dr. Clark said.

The study did not receive commercial funding. Dr. Clark and two coauthors have filed a patent application related to their research.
 

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

A potential new urine biomarker for prostate cancer not only spots the presence of aggressive tumors, it also indicates the amount of these tumors, according to a recent report.

In a study of biopsy and prostatectomy samples, researchers found that the multigene Prostate Urine Risk-4 (PUR-4) signature was strongly associated with the presence and amount of Gleason pattern 4 tumors, but not tumors of less aggressive histology.

Given that increased Gleason pattern 4 tumor burden is associated with disease progression in men at intermediate risk, the results suggest that “PUR can show us which men at intermediate risk may require treatment and which may instead be managed conservatively with surveillance,” said senior author Jeremy Clark, PhD, of the University of East Anglia, Norwich, England. “PUR will also be useful for monitoring disease in men that do not currently require treatment and flag up the emergence and expansion of aggressive disease.”

The study by Dr. Clark and colleagues was published online on Nov. 3, 2021, in Life.

Tests using the traditional blood-based biomarker for prostate cancer – prostate-specific antigen (PSA) – have limited sensitivity and specificity, leading to unnecessary biopsies and overtreatment.

The PUR biomarker, one of several emerging alternatives to PSA, is a four-group classifier based on 36 genes, Dr. Clark and colleagues explained. Its categories correspond to the probabilities of the presence of normal tissue (PUR-1), and D’Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer.

Dr. Clark’s team found in earlier research that the PUR-4 signature was able to predict disease progression in men on active surveillance for prostate cancer up to 5 years after a single urine sample. For their latest study, they sought to understand the relationship between PUR-4 and the amount and grade of tumor.

On the basis of biopsy samples from 215 men with prostate cancer, the researchers found that PUR-4 signature values correlated significantly with increasing Gleason grade.

There was no significant difference in PSA level by tumor volume for Gleason grade 1, 2, or 3. The same was true for PUR-4 and Gleason grade 1 tumors, which only contain less clinically significant Gleason pattern 3 cancer. However, PUR-4 values in men with Gleason grade 2 tumors larger than the median were significantly greater than for smaller tumors. PUR-4 values for large Gleason grade 3 tumors were also greater than for smaller ones, although the difference did not reach statistical significance.

“Since [Gleason grade] 2 and [Gleason grade] 3 contain both Gleason pattern 3 and 4 cancer these observations suggest that Gleason Pattern 4 cancer may be contributing to PUR-4 status,” the authors wrote.

The researchers also examined radical-prostatectomy specimens from nine men – three with Gleason grade 1, four with Gleason grade 2, and two with Gleason grade 3 tumors, as determined on the basis of presurgical biopsy.

There was no significant correlation between PUR-4 and PSA levels, nor were PUR-4 values linked to total tumor area or Gleason pattern 3 tumor area. But the amount of Gleason pattern 4 tumors showed a strong correlation with PUR-4 values, which did not change after adjusting for total prostate size.

“Our study shows that the PUR test can assess the amount of Gleason pattern 4 without the need for a biopsy,” Dr. Clark said in an interview. “It could therefore be a very useful tool indeed for assessing a man’s risk of dying from prostate cancer.”

Jack Schalken, PhD, a professor of experimental urology at Radboud University Medical Center in Nijmegen, the Netherlands, called PUR “another test” for prostate cancer the performance of which is in the same range as that of existing products.

“In fact, several tests are commercially available, but the clinical use is surprisingly low,” he told this news organization. Dr. Schalken, who was not involved in the new study, has reviewed several biomarkers for prostate cancer.

The PUR test is now undergoing validation in an international study that is expected to last another 2 years, Dr. Clark said. If successful, the test would stand out for several reasons.

First, it is based on many genes, so it is able to spot malignancies that other tests, which rely on just a few genes, may not pick up. In addition, although it is sensitive to the amount of Gleason pattern 4 tumor, it does not seem to detect the clinically less significant Gleason pattern 3 cancers.

“We have an at-home collection kit – the men do not have to come to a hospital to provide a urine sample,” Dr. Clark said.

The study did not receive commercial funding. Dr. Clark and two coauthors have filed a patent application related to their research.
 

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

A potential new urine biomarker for prostate cancer not only spots the presence of aggressive tumors, it also indicates the amount of these tumors, according to a recent report.

In a study of biopsy and prostatectomy samples, researchers found that the multigene Prostate Urine Risk-4 (PUR-4) signature was strongly associated with the presence and amount of Gleason pattern 4 tumors, but not tumors of less aggressive histology.

Given that increased Gleason pattern 4 tumor burden is associated with disease progression in men at intermediate risk, the results suggest that “PUR can show us which men at intermediate risk may require treatment and which may instead be managed conservatively with surveillance,” said senior author Jeremy Clark, PhD, of the University of East Anglia, Norwich, England. “PUR will also be useful for monitoring disease in men that do not currently require treatment and flag up the emergence and expansion of aggressive disease.”

The study by Dr. Clark and colleagues was published online on Nov. 3, 2021, in Life.

Tests using the traditional blood-based biomarker for prostate cancer – prostate-specific antigen (PSA) – have limited sensitivity and specificity, leading to unnecessary biopsies and overtreatment.

The PUR biomarker, one of several emerging alternatives to PSA, is a four-group classifier based on 36 genes, Dr. Clark and colleagues explained. Its categories correspond to the probabilities of the presence of normal tissue (PUR-1), and D’Amico low-risk (PUR-2), intermediate-risk (PUR-3), and high-risk (PUR-4) prostate cancer.

Dr. Clark’s team found in earlier research that the PUR-4 signature was able to predict disease progression in men on active surveillance for prostate cancer up to 5 years after a single urine sample. For their latest study, they sought to understand the relationship between PUR-4 and the amount and grade of tumor.

On the basis of biopsy samples from 215 men with prostate cancer, the researchers found that PUR-4 signature values correlated significantly with increasing Gleason grade.

There was no significant difference in PSA level by tumor volume for Gleason grade 1, 2, or 3. The same was true for PUR-4 and Gleason grade 1 tumors, which only contain less clinically significant Gleason pattern 3 cancer. However, PUR-4 values in men with Gleason grade 2 tumors larger than the median were significantly greater than for smaller tumors. PUR-4 values for large Gleason grade 3 tumors were also greater than for smaller ones, although the difference did not reach statistical significance.

“Since [Gleason grade] 2 and [Gleason grade] 3 contain both Gleason pattern 3 and 4 cancer these observations suggest that Gleason Pattern 4 cancer may be contributing to PUR-4 status,” the authors wrote.

The researchers also examined radical-prostatectomy specimens from nine men – three with Gleason grade 1, four with Gleason grade 2, and two with Gleason grade 3 tumors, as determined on the basis of presurgical biopsy.

There was no significant correlation between PUR-4 and PSA levels, nor were PUR-4 values linked to total tumor area or Gleason pattern 3 tumor area. But the amount of Gleason pattern 4 tumors showed a strong correlation with PUR-4 values, which did not change after adjusting for total prostate size.

“Our study shows that the PUR test can assess the amount of Gleason pattern 4 without the need for a biopsy,” Dr. Clark said in an interview. “It could therefore be a very useful tool indeed for assessing a man’s risk of dying from prostate cancer.”

Jack Schalken, PhD, a professor of experimental urology at Radboud University Medical Center in Nijmegen, the Netherlands, called PUR “another test” for prostate cancer the performance of which is in the same range as that of existing products.

“In fact, several tests are commercially available, but the clinical use is surprisingly low,” he told this news organization. Dr. Schalken, who was not involved in the new study, has reviewed several biomarkers for prostate cancer.

The PUR test is now undergoing validation in an international study that is expected to last another 2 years, Dr. Clark said. If successful, the test would stand out for several reasons.

First, it is based on many genes, so it is able to spot malignancies that other tests, which rely on just a few genes, may not pick up. In addition, although it is sensitive to the amount of Gleason pattern 4 tumor, it does not seem to detect the clinically less significant Gleason pattern 3 cancers.

“We have an at-home collection kit – the men do not have to come to a hospital to provide a urine sample,” Dr. Clark said.

The study did not receive commercial funding. Dr. Clark and two coauthors have filed a patent application related to their research.
 

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

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.

Time to relax the age 40 threshold

The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.

“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.

“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.

“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.

“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.

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

Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.

Time to relax the age 40 threshold

The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.

“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.

“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.

“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.

“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.

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

Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.

Time to relax the age 40 threshold

The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.

“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.

“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.

“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.

“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.

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

Telehealth is safe and effective for the treatment of borderline personality disorder (BPD) and may even have an edge over in-person treatment, new research suggests.

Courtesy Dr. Mark Zimmerman

Investigators compared BPD outcomes with therapy delivered in person and via telemedicine and found comparable reductions in depression, anxiety, and anger symptoms as well as improved overall well-being and mental health.

The results also suggest a telehealth advantage with significantly better patient attendance vs. patients treated in-person.

“We found a large effect size of treatment in both groups, as well as comparable levels of satisfaction with treatment, symptom reduction, and improved functioning, coping ability, positive mental health, and general well-being,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., said in an interview.

The study was published online Nov. 8 in the Journal of Personality Disorders.
 

‘No other option’

Most previous research investigating telehealth has occurred in outpatient, individual treatment settings and has not examined telehealth-delivered group therapy or partial hospitalization, the authors noted.

“Until the pandemic, we were delivering care in person, but when the pandemic began, because of public safety recommendations, we knew that we could no longer continue doing so,” said Dr. Zimmerman, director of the outpatient division at the partial hospital program (PHP), Rhode Island Hospital.

“In switching to a telehealth platform, we were concerned about patient safety and acceptability of delivering care in that manner, especially with patients with BPD, which is associated with impulsive behavior, self-harm, and suicidal behavior, among other problems,” he said. However “we had no other option” than to utilize a telehealth delivery mode, since the alternative was to shut down the program.

The investigators were “interested in whether or not virtual treatment in an acute intensive setting, such as a PHP, would be as safe, acceptable, and effective as in-person treatment.”

The study was part of the ongoing work of the Rhode Island Methods to Improve Diagnostic Assessment and Services.
 

Additional safety measures

Treatment, consisting of an Acceptance and Commitment Therapy (ACT) treatment model – including intake assessments, individual therapy, psychiatric visits, and group therapy – was delivered by a multidisciplinary team via Zoom.

Dr. Zimmerman noted that the team implemented additional safety precautions, including having patients check in at the beginning of each day to indicate their location, not seeing patients who were out of state, and making sure all patients had a contact person.

In addition, beyond the therapist leading the group, another therapist was always available, overseeing groups and meeting one-on-one (virtually) with participants if they had been triggered by the group process and were highly distressed.

Patients were asked to complete a number of questionnaires, including the Clinically Useful Patient Satisfaction Scale (CUPSS) at the end of their intake session. The primary outcome measure was the Remission from Depression Questionnaire (RDQ-M).

The study was conducted between May 1 and Dec. 15 of 2020 and included 64 patients with BPD who were treated for the first time in the Rhode Island Hospital PHP. They were compared to 117 patients who participated in the in-person program during the same months in 2019.

Participant characteristics were similar – for example, three-quarters of the participants in both groups were female, and the mean age was 34 years.
 

‘Sea change’

Most patients in the telehealth and in-person groups reported being “very” or “extremely” satisfied with the initial evaluation (90% vs. 85.3%, c² = 0.74) and were hopeful that they would get better (85.8% vs. 82.1%, c² = 0.45).

Upon completion of the program, 100% of the in-person and 95.4% of the telehealth group indicated that they were “very” or “extremely” satisfied (c² = 4.62), and “under both telehealth and in-person treatment conditions, the patients significantly improved from admission to discharge on each of the RDQ-M subscales, with large effect sizes found for most of the subscales,” the authors reported.

There were significant differences between the groups in the average number of days of attendance and number of days missed.

A nonsignificantly higher proportion of patients completed the telehealth program, vs. the in-person program (68.8% vs. 59%, c² = 1.69).

In both programs, transfer to inpatient care and dissatisfaction-related withdrawal from the program were low (both < 2%). Notably, no patients attempted or completed suicide during treatment.

Virtual treatment is more convenient than in-person treatment, Dr. Zimmerman noted. “Some patients – generally those with medical or transportation issues – told us they otherwise would not have been able to participate [in the program] if treatment had been in person.”

He added, “My prediction is that 5 years from now, two-thirds to three-quarters of outpatient visits will be virtual because that is what the patients prefer – and although there will certainly be individuals who prefer in-person care, I think we’ve witnessed a sea change in how behavioral health care will be delivered.”
 

‘Game changer’

In an interview, Monica Carsky, PhD, clinical assistant professor of psychology in psychiatry and a senior fellow at the Personality Disorders Institute, Weill Cornell Medical College, New York, said the study has “a lot of valuable detail about how to set up a virtual PHP, which could guide any group wanting to try this.”

Dr. Carsky, who was not involved with the study, called it “a very important contribution to the research literature on efficacious treatment of BPD,” although it is not a randomized controlled trial.

“Adding more individual attention to the virtual group (e.g., having a co-host in the groups) seems as though it may be an important factor in dealing with the limitations of virtual treatment,” she noted.

However, she continued, “a limitation is that outcome assessment relied on self-administered questionnaires and did not include clinician rating scales, so the response may have been subject to the effects of social desirability bias.”

Courtesy Dr. Donald Black

Donald W. Black, MD, associate chief of staff for mental health at the Iowa City Veterans Administration Hospital, said in an interview that the pandemic has been a “game changer, as we have had to quickly adapt mental health programs to a virtual format.

“For the most part, they have been remarkably successful for a variety of conditions, and Zimmerman and colleagues now show this for BPD families,” said Dr. Black, who was not associated with the research.

No study funding was listed. The study authors, Dr. Carsky, and Dr. Black have disclosed no relevant financial relationships.
 

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

Telehealth is safe and effective for the treatment of borderline personality disorder (BPD) and may even have an edge over in-person treatment, new research suggests.

Courtesy Dr. Mark Zimmerman

Investigators compared BPD outcomes with therapy delivered in person and via telemedicine and found comparable reductions in depression, anxiety, and anger symptoms as well as improved overall well-being and mental health.

The results also suggest a telehealth advantage with significantly better patient attendance vs. patients treated in-person.

“We found a large effect size of treatment in both groups, as well as comparable levels of satisfaction with treatment, symptom reduction, and improved functioning, coping ability, positive mental health, and general well-being,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., said in an interview.

The study was published online Nov. 8 in the Journal of Personality Disorders.
 

‘No other option’

Most previous research investigating telehealth has occurred in outpatient, individual treatment settings and has not examined telehealth-delivered group therapy or partial hospitalization, the authors noted.

“Until the pandemic, we were delivering care in person, but when the pandemic began, because of public safety recommendations, we knew that we could no longer continue doing so,” said Dr. Zimmerman, director of the outpatient division at the partial hospital program (PHP), Rhode Island Hospital.

“In switching to a telehealth platform, we were concerned about patient safety and acceptability of delivering care in that manner, especially with patients with BPD, which is associated with impulsive behavior, self-harm, and suicidal behavior, among other problems,” he said. However “we had no other option” than to utilize a telehealth delivery mode, since the alternative was to shut down the program.

The investigators were “interested in whether or not virtual treatment in an acute intensive setting, such as a PHP, would be as safe, acceptable, and effective as in-person treatment.”

The study was part of the ongoing work of the Rhode Island Methods to Improve Diagnostic Assessment and Services.
 

Additional safety measures

Treatment, consisting of an Acceptance and Commitment Therapy (ACT) treatment model – including intake assessments, individual therapy, psychiatric visits, and group therapy – was delivered by a multidisciplinary team via Zoom.

Dr. Zimmerman noted that the team implemented additional safety precautions, including having patients check in at the beginning of each day to indicate their location, not seeing patients who were out of state, and making sure all patients had a contact person.

In addition, beyond the therapist leading the group, another therapist was always available, overseeing groups and meeting one-on-one (virtually) with participants if they had been triggered by the group process and were highly distressed.

Patients were asked to complete a number of questionnaires, including the Clinically Useful Patient Satisfaction Scale (CUPSS) at the end of their intake session. The primary outcome measure was the Remission from Depression Questionnaire (RDQ-M).

The study was conducted between May 1 and Dec. 15 of 2020 and included 64 patients with BPD who were treated for the first time in the Rhode Island Hospital PHP. They were compared to 117 patients who participated in the in-person program during the same months in 2019.

Participant characteristics were similar – for example, three-quarters of the participants in both groups were female, and the mean age was 34 years.
 

‘Sea change’

Most patients in the telehealth and in-person groups reported being “very” or “extremely” satisfied with the initial evaluation (90% vs. 85.3%, c² = 0.74) and were hopeful that they would get better (85.8% vs. 82.1%, c² = 0.45).

Upon completion of the program, 100% of the in-person and 95.4% of the telehealth group indicated that they were “very” or “extremely” satisfied (c² = 4.62), and “under both telehealth and in-person treatment conditions, the patients significantly improved from admission to discharge on each of the RDQ-M subscales, with large effect sizes found for most of the subscales,” the authors reported.

There were significant differences between the groups in the average number of days of attendance and number of days missed.

A nonsignificantly higher proportion of patients completed the telehealth program, vs. the in-person program (68.8% vs. 59%, c² = 1.69).

In both programs, transfer to inpatient care and dissatisfaction-related withdrawal from the program were low (both < 2%). Notably, no patients attempted or completed suicide during treatment.

Virtual treatment is more convenient than in-person treatment, Dr. Zimmerman noted. “Some patients – generally those with medical or transportation issues – told us they otherwise would not have been able to participate [in the program] if treatment had been in person.”

He added, “My prediction is that 5 years from now, two-thirds to three-quarters of outpatient visits will be virtual because that is what the patients prefer – and although there will certainly be individuals who prefer in-person care, I think we’ve witnessed a sea change in how behavioral health care will be delivered.”
 

‘Game changer’

In an interview, Monica Carsky, PhD, clinical assistant professor of psychology in psychiatry and a senior fellow at the Personality Disorders Institute, Weill Cornell Medical College, New York, said the study has “a lot of valuable detail about how to set up a virtual PHP, which could guide any group wanting to try this.”

Dr. Carsky, who was not involved with the study, called it “a very important contribution to the research literature on efficacious treatment of BPD,” although it is not a randomized controlled trial.

“Adding more individual attention to the virtual group (e.g., having a co-host in the groups) seems as though it may be an important factor in dealing with the limitations of virtual treatment,” she noted.

However, she continued, “a limitation is that outcome assessment relied on self-administered questionnaires and did not include clinician rating scales, so the response may have been subject to the effects of social desirability bias.”

Courtesy Dr. Donald Black

Donald W. Black, MD, associate chief of staff for mental health at the Iowa City Veterans Administration Hospital, said in an interview that the pandemic has been a “game changer, as we have had to quickly adapt mental health programs to a virtual format.

“For the most part, they have been remarkably successful for a variety of conditions, and Zimmerman and colleagues now show this for BPD families,” said Dr. Black, who was not associated with the research.

No study funding was listed. The study authors, Dr. Carsky, and Dr. Black have disclosed no relevant financial relationships.
 

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

Telehealth is safe and effective for the treatment of borderline personality disorder (BPD) and may even have an edge over in-person treatment, new research suggests.

Courtesy Dr. Mark Zimmerman

Investigators compared BPD outcomes with therapy delivered in person and via telemedicine and found comparable reductions in depression, anxiety, and anger symptoms as well as improved overall well-being and mental health.

The results also suggest a telehealth advantage with significantly better patient attendance vs. patients treated in-person.

“We found a large effect size of treatment in both groups, as well as comparable levels of satisfaction with treatment, symptom reduction, and improved functioning, coping ability, positive mental health, and general well-being,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., said in an interview.

The study was published online Nov. 8 in the Journal of Personality Disorders.
 

‘No other option’

Most previous research investigating telehealth has occurred in outpatient, individual treatment settings and has not examined telehealth-delivered group therapy or partial hospitalization, the authors noted.

“Until the pandemic, we were delivering care in person, but when the pandemic began, because of public safety recommendations, we knew that we could no longer continue doing so,” said Dr. Zimmerman, director of the outpatient division at the partial hospital program (PHP), Rhode Island Hospital.

“In switching to a telehealth platform, we were concerned about patient safety and acceptability of delivering care in that manner, especially with patients with BPD, which is associated with impulsive behavior, self-harm, and suicidal behavior, among other problems,” he said. However “we had no other option” than to utilize a telehealth delivery mode, since the alternative was to shut down the program.

The investigators were “interested in whether or not virtual treatment in an acute intensive setting, such as a PHP, would be as safe, acceptable, and effective as in-person treatment.”

The study was part of the ongoing work of the Rhode Island Methods to Improve Diagnostic Assessment and Services.
 

Additional safety measures

Treatment, consisting of an Acceptance and Commitment Therapy (ACT) treatment model – including intake assessments, individual therapy, psychiatric visits, and group therapy – was delivered by a multidisciplinary team via Zoom.

Dr. Zimmerman noted that the team implemented additional safety precautions, including having patients check in at the beginning of each day to indicate their location, not seeing patients who were out of state, and making sure all patients had a contact person.

In addition, beyond the therapist leading the group, another therapist was always available, overseeing groups and meeting one-on-one (virtually) with participants if they had been triggered by the group process and were highly distressed.

Patients were asked to complete a number of questionnaires, including the Clinically Useful Patient Satisfaction Scale (CUPSS) at the end of their intake session. The primary outcome measure was the Remission from Depression Questionnaire (RDQ-M).

The study was conducted between May 1 and Dec. 15 of 2020 and included 64 patients with BPD who were treated for the first time in the Rhode Island Hospital PHP. They were compared to 117 patients who participated in the in-person program during the same months in 2019.

Participant characteristics were similar – for example, three-quarters of the participants in both groups were female, and the mean age was 34 years.
 

‘Sea change’

Most patients in the telehealth and in-person groups reported being “very” or “extremely” satisfied with the initial evaluation (90% vs. 85.3%, c² = 0.74) and were hopeful that they would get better (85.8% vs. 82.1%, c² = 0.45).

Upon completion of the program, 100% of the in-person and 95.4% of the telehealth group indicated that they were “very” or “extremely” satisfied (c² = 4.62), and “under both telehealth and in-person treatment conditions, the patients significantly improved from admission to discharge on each of the RDQ-M subscales, with large effect sizes found for most of the subscales,” the authors reported.

There were significant differences between the groups in the average number of days of attendance and number of days missed.

A nonsignificantly higher proportion of patients completed the telehealth program, vs. the in-person program (68.8% vs. 59%, c² = 1.69).

In both programs, transfer to inpatient care and dissatisfaction-related withdrawal from the program were low (both < 2%). Notably, no patients attempted or completed suicide during treatment.

Virtual treatment is more convenient than in-person treatment, Dr. Zimmerman noted. “Some patients – generally those with medical or transportation issues – told us they otherwise would not have been able to participate [in the program] if treatment had been in person.”

He added, “My prediction is that 5 years from now, two-thirds to three-quarters of outpatient visits will be virtual because that is what the patients prefer – and although there will certainly be individuals who prefer in-person care, I think we’ve witnessed a sea change in how behavioral health care will be delivered.”
 

‘Game changer’

In an interview, Monica Carsky, PhD, clinical assistant professor of psychology in psychiatry and a senior fellow at the Personality Disorders Institute, Weill Cornell Medical College, New York, said the study has “a lot of valuable detail about how to set up a virtual PHP, which could guide any group wanting to try this.”

Dr. Carsky, who was not involved with the study, called it “a very important contribution to the research literature on efficacious treatment of BPD,” although it is not a randomized controlled trial.

“Adding more individual attention to the virtual group (e.g., having a co-host in the groups) seems as though it may be an important factor in dealing with the limitations of virtual treatment,” she noted.

However, she continued, “a limitation is that outcome assessment relied on self-administered questionnaires and did not include clinician rating scales, so the response may have been subject to the effects of social desirability bias.”

Courtesy Dr. Donald Black

Donald W. Black, MD, associate chief of staff for mental health at the Iowa City Veterans Administration Hospital, said in an interview that the pandemic has been a “game changer, as we have had to quickly adapt mental health programs to a virtual format.

“For the most part, they have been remarkably successful for a variety of conditions, and Zimmerman and colleagues now show this for BPD families,” said Dr. Black, who was not associated with the research.

No study funding was listed. The study authors, Dr. Carsky, and Dr. Black have disclosed no relevant financial relationships.
 

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

Brain beta rhythm predicts early and robust response to deep brain stimulation (DBS) for severe depression in new findings that could help optimize and personalize DBS treatment protocols, early research suggests.

In a small study, investigators found brief stimulation at the time of implantation of DBS leads induced a rapid and consistent decrease in beta power measured at the site of stimulation, which correlated with significant and sustained decrease in depressive symptoms.

“Patient by patient, the magnitude of the decrease in the left beta power could predict how well they were doing a week later,” study investigator Helen Mayberg, MD, founding director of the Nash Family Center for Advanced Circuit Therapeutics at Mount Sinai in New York, told this news organization.

The study was published online Nov. 3 in Translational Psychiatry.
 

Optimal targets identified

Eight adults with treatment-resistant depression underwent intraoperative electrophysiological recording at the time that bilateral DBS leads were implanted in the subcallosal cingulate (SCC).

Using patient-specific tractography models prior to surgery, the investigators identified the optimal target within the SCC for lead placement.

During surgery, 20 minutes of stimulation in the optimal tractography-defined targets was delivered, with no stimulation in the 4 weeks after surgery. Local field potentials (LFPs) – electrical signals between neurons deep in the brain – were simultaneously recorded during intraoperative stimulation.

One week after brief intraoperative stimulation, patient depression scores had declined by 45.6% on the 17-item Hamilton Depression Rating Scale (HDRS-17).

This early antidepressant response correlated with a decrease in the beta power recorded from the left hemisphere SCC. The correlation of symptom improvement with reduction in SCC beta power suggests that this electrophysiological finding is a “biomarker for treatment optimization,” the investigators note.

“This study shows reproducible and consistent changes in a brain readout over the first minutes of optimized stimulation in the operating room in individual patients,” Dr. Mayberg said in a press release.

“Within minutes of stimulation inside the operating room, there was a change in the beta brain rhythm. Patients who showed larger changes then experienced greater relief from their depression in the week after surgery,” added Allison Waters, PhD, a co–first author on the study and electrophysiology core leader at Mount Sinai’s Nash Center.

It appears that the early decline in depressive symptoms is “partially but not completely lost” during a postoperative, one-month washout period, the researchers note.

In addition, it remains unknown whether intraoperative stimulation-induced changes in beta power are predictive of eventual sustained clinical response to chronic therapeutic SCC DBS for treatment-resistant depression.

To this point, however, chronic SCC DBS at the tractography-defined “optimal” locations led to a response rate of 88% (7 of 8) after 6 months of treatment, they report.
 

One step closer to precision psychiatry

“This line of work is moving the field one step closer to precision psychiatry,” Shaheen E. Lakhan, MD, PhD, a neurologist in Newton, Massachusetts, said in an interview.

“Outside of psychiatry, many diseases have measurable biomarkers that correlate with whether the disease is present or its severity. For example, for diabetes there is hemoglobin A1c, and for multiple sclerosis, brain lesions on MRI are both diagnostic and prognostic. Sadly, within psychiatry, biomarkers are few and far between,” said Dr. Lakhan, who wasn’t involved in this study.

“Over the last decades, an interesting phenomenon occurs with DBS for patients with advanced Parkinson’s – often their depression abates and mood improves. Several lines of studies have tried to tease apart whether this was primarily from alleviating the motor symptoms of Parkinson’s or [if] DBS is directly implicated in mood enhancement. Lo and behold a subset of patients with treatment-resistant depression demonstrate improvement on standardized depression testing,” Dr. Lakhan added.

This study now shows that beta rhythm – a signal deep in the brain that traditional EEG can’t pick up – “predicted who would later benefit from DBS right at the time of implantation,” Dr. Lakhan said.

“This is incredibly important for not only predicting response to DBS for depression, but specifically targeting this potential biomarker (deep beta rhythm) in and outside of brain surgery,” he told this news organization.

“Other therapy trials, for instance, with drugs or non-invasive, digital neuroactivation and modulation (DiNaMo), may use this key biomarker to optimize its development and maximize effect, one day, for a given individual,” Dr. Lakhan predicted.

“The challenge remains that these signals are deep in the brain and currently require surgical implantation of electrodes for recordings. However, technologies such as magnetoencephalography (MEG) that use powerful external magnetics may substitute,” he added.

Funding support was provided by the National Institutes of Health, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and the Hope for Depression Research Foundation. Implanted devices used in this research were donated by Medtronic. Dr. Mayberg receives consulting and licensing fees from Abbott Labs. Dr. Lakhan has disclosed no relevant financial relationships.

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

Brain beta rhythm predicts early and robust response to deep brain stimulation (DBS) for severe depression in new findings that could help optimize and personalize DBS treatment protocols, early research suggests.

In a small study, investigators found brief stimulation at the time of implantation of DBS leads induced a rapid and consistent decrease in beta power measured at the site of stimulation, which correlated with significant and sustained decrease in depressive symptoms.

“Patient by patient, the magnitude of the decrease in the left beta power could predict how well they were doing a week later,” study investigator Helen Mayberg, MD, founding director of the Nash Family Center for Advanced Circuit Therapeutics at Mount Sinai in New York, told this news organization.

The study was published online Nov. 3 in Translational Psychiatry.
 

Optimal targets identified

Eight adults with treatment-resistant depression underwent intraoperative electrophysiological recording at the time that bilateral DBS leads were implanted in the subcallosal cingulate (SCC).

Using patient-specific tractography models prior to surgery, the investigators identified the optimal target within the SCC for lead placement.

During surgery, 20 minutes of stimulation in the optimal tractography-defined targets was delivered, with no stimulation in the 4 weeks after surgery. Local field potentials (LFPs) – electrical signals between neurons deep in the brain – were simultaneously recorded during intraoperative stimulation.

One week after brief intraoperative stimulation, patient depression scores had declined by 45.6% on the 17-item Hamilton Depression Rating Scale (HDRS-17).

This early antidepressant response correlated with a decrease in the beta power recorded from the left hemisphere SCC. The correlation of symptom improvement with reduction in SCC beta power suggests that this electrophysiological finding is a “biomarker for treatment optimization,” the investigators note.

“This study shows reproducible and consistent changes in a brain readout over the first minutes of optimized stimulation in the operating room in individual patients,” Dr. Mayberg said in a press release.

“Within minutes of stimulation inside the operating room, there was a change in the beta brain rhythm. Patients who showed larger changes then experienced greater relief from their depression in the week after surgery,” added Allison Waters, PhD, a co–first author on the study and electrophysiology core leader at Mount Sinai’s Nash Center.

It appears that the early decline in depressive symptoms is “partially but not completely lost” during a postoperative, one-month washout period, the researchers note.

In addition, it remains unknown whether intraoperative stimulation-induced changes in beta power are predictive of eventual sustained clinical response to chronic therapeutic SCC DBS for treatment-resistant depression.

To this point, however, chronic SCC DBS at the tractography-defined “optimal” locations led to a response rate of 88% (7 of 8) after 6 months of treatment, they report.
 

One step closer to precision psychiatry

“This line of work is moving the field one step closer to precision psychiatry,” Shaheen E. Lakhan, MD, PhD, a neurologist in Newton, Massachusetts, said in an interview.

“Outside of psychiatry, many diseases have measurable biomarkers that correlate with whether the disease is present or its severity. For example, for diabetes there is hemoglobin A1c, and for multiple sclerosis, brain lesions on MRI are both diagnostic and prognostic. Sadly, within psychiatry, biomarkers are few and far between,” said Dr. Lakhan, who wasn’t involved in this study.

“Over the last decades, an interesting phenomenon occurs with DBS for patients with advanced Parkinson’s – often their depression abates and mood improves. Several lines of studies have tried to tease apart whether this was primarily from alleviating the motor symptoms of Parkinson’s or [if] DBS is directly implicated in mood enhancement. Lo and behold a subset of patients with treatment-resistant depression demonstrate improvement on standardized depression testing,” Dr. Lakhan added.

This study now shows that beta rhythm – a signal deep in the brain that traditional EEG can’t pick up – “predicted who would later benefit from DBS right at the time of implantation,” Dr. Lakhan said.

“This is incredibly important for not only predicting response to DBS for depression, but specifically targeting this potential biomarker (deep beta rhythm) in and outside of brain surgery,” he told this news organization.

“Other therapy trials, for instance, with drugs or non-invasive, digital neuroactivation and modulation (DiNaMo), may use this key biomarker to optimize its development and maximize effect, one day, for a given individual,” Dr. Lakhan predicted.

“The challenge remains that these signals are deep in the brain and currently require surgical implantation of electrodes for recordings. However, technologies such as magnetoencephalography (MEG) that use powerful external magnetics may substitute,” he added.

Funding support was provided by the National Institutes of Health, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and the Hope for Depression Research Foundation. Implanted devices used in this research were donated by Medtronic. Dr. Mayberg receives consulting and licensing fees from Abbott Labs. Dr. Lakhan has disclosed no relevant financial relationships.

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

Brain beta rhythm predicts early and robust response to deep brain stimulation (DBS) for severe depression in new findings that could help optimize and personalize DBS treatment protocols, early research suggests.

In a small study, investigators found brief stimulation at the time of implantation of DBS leads induced a rapid and consistent decrease in beta power measured at the site of stimulation, which correlated with significant and sustained decrease in depressive symptoms.

“Patient by patient, the magnitude of the decrease in the left beta power could predict how well they were doing a week later,” study investigator Helen Mayberg, MD, founding director of the Nash Family Center for Advanced Circuit Therapeutics at Mount Sinai in New York, told this news organization.

The study was published online Nov. 3 in Translational Psychiatry.
 

Optimal targets identified

Eight adults with treatment-resistant depression underwent intraoperative electrophysiological recording at the time that bilateral DBS leads were implanted in the subcallosal cingulate (SCC).

Using patient-specific tractography models prior to surgery, the investigators identified the optimal target within the SCC for lead placement.

During surgery, 20 minutes of stimulation in the optimal tractography-defined targets was delivered, with no stimulation in the 4 weeks after surgery. Local field potentials (LFPs) – electrical signals between neurons deep in the brain – were simultaneously recorded during intraoperative stimulation.

One week after brief intraoperative stimulation, patient depression scores had declined by 45.6% on the 17-item Hamilton Depression Rating Scale (HDRS-17).

This early antidepressant response correlated with a decrease in the beta power recorded from the left hemisphere SCC. The correlation of symptom improvement with reduction in SCC beta power suggests that this electrophysiological finding is a “biomarker for treatment optimization,” the investigators note.

“This study shows reproducible and consistent changes in a brain readout over the first minutes of optimized stimulation in the operating room in individual patients,” Dr. Mayberg said in a press release.

“Within minutes of stimulation inside the operating room, there was a change in the beta brain rhythm. Patients who showed larger changes then experienced greater relief from their depression in the week after surgery,” added Allison Waters, PhD, a co–first author on the study and electrophysiology core leader at Mount Sinai’s Nash Center.

It appears that the early decline in depressive symptoms is “partially but not completely lost” during a postoperative, one-month washout period, the researchers note.

In addition, it remains unknown whether intraoperative stimulation-induced changes in beta power are predictive of eventual sustained clinical response to chronic therapeutic SCC DBS for treatment-resistant depression.

To this point, however, chronic SCC DBS at the tractography-defined “optimal” locations led to a response rate of 88% (7 of 8) after 6 months of treatment, they report.
 

One step closer to precision psychiatry

“This line of work is moving the field one step closer to precision psychiatry,” Shaheen E. Lakhan, MD, PhD, a neurologist in Newton, Massachusetts, said in an interview.

“Outside of psychiatry, many diseases have measurable biomarkers that correlate with whether the disease is present or its severity. For example, for diabetes there is hemoglobin A1c, and for multiple sclerosis, brain lesions on MRI are both diagnostic and prognostic. Sadly, within psychiatry, biomarkers are few and far between,” said Dr. Lakhan, who wasn’t involved in this study.

“Over the last decades, an interesting phenomenon occurs with DBS for patients with advanced Parkinson’s – often their depression abates and mood improves. Several lines of studies have tried to tease apart whether this was primarily from alleviating the motor symptoms of Parkinson’s or [if] DBS is directly implicated in mood enhancement. Lo and behold a subset of patients with treatment-resistant depression demonstrate improvement on standardized depression testing,” Dr. Lakhan added.

This study now shows that beta rhythm – a signal deep in the brain that traditional EEG can’t pick up – “predicted who would later benefit from DBS right at the time of implantation,” Dr. Lakhan said.

“This is incredibly important for not only predicting response to DBS for depression, but specifically targeting this potential biomarker (deep beta rhythm) in and outside of brain surgery,” he told this news organization.

“Other therapy trials, for instance, with drugs or non-invasive, digital neuroactivation and modulation (DiNaMo), may use this key biomarker to optimize its development and maximize effect, one day, for a given individual,” Dr. Lakhan predicted.

“The challenge remains that these signals are deep in the brain and currently require surgical implantation of electrodes for recordings. However, technologies such as magnetoencephalography (MEG) that use powerful external magnetics may substitute,” he added.

Funding support was provided by the National Institutes of Health, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and the Hope for Depression Research Foundation. Implanted devices used in this research were donated by Medtronic. Dr. Mayberg receives consulting and licensing fees from Abbott Labs. Dr. Lakhan has disclosed no relevant financial relationships.

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

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.

Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

[email protected]

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.

Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

[email protected]

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.

Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

[email protected]