Clinical Psychiatry News

Not only does the use of e-cigarettes not help cigarette smokers who are unmotivated to quit, it has the opposite effect, according to results from a new study.

6okean/iStock/Getty Images Plus

“In our study, people vaping in addition to smoking actually started smoking more,” said study lead investigator Nancy Anoruo, MD, from the University of Massachusetts Medical School in Worcester.

This is “completely contradictory to what the e-cigarette manufacturers are telling us,” she told this news organization.

In their study, Dr. Anoruo and her colleagues looked at whether people were more likely to quit if they smoked e-cigarettes in addition to conventional cigarettes. The research is a substudy of the ongoing Take a Break project, funded by the National Institutes of Health, which is assessing whether a smoking-cessation motivation app helps smokers quit.

In a cohort of 405 smokers who were unmotivated to quit, 248 were defined as dual smokers after responding “yes” to “ever having used” e-cigarettes, and 157 were defined as traditional smokers who only smoked combustible cigarettes. The majority of participants, 82%, were white; 8.8% were black; and 49% were women.

More dual smokers than traditional smokers were younger than 40 years (27% vs. 16%; (P = .02), Dr. Anoruo reported during her virtual presentation at the American Thoracic Society 2020 International Conference.

The dual smokers reported smoking an average of 16 cigarettes a day, compared with 14 a day for the traditional smokers.

All the smokers were encouraged to consider a 3-week period of abstinence from combustible cigarettes. At the end of that period, the researchers compared outcomes reported by participants.
 

Abstinence challenge

Average abstinence intervals were shorter for dual smokers than for traditional smokers (0.93 vs. 1.8 days; P = .01). And dual smokers reported having a harder time quitting completely (6.3% vs. 13.0%; P = .02).

At 6-month follow-up, dual smokers were smoking more cigarettes than traditional smokers (daily average, 12.0 vs. 9.4; P = .04). And the reduction in cigarette use from baseline was smaller for dual smokers than for traditional smokers (21% vs. 33%; P = .04).

“E-cigarettes are not a special magic bullet to get people to quit smoking,” said Dr. Anoruo.

In this study, smoking cessation was defined as abstinence from combustible cigarettes, but that did not mean participants were abstinent from nicotine.

“If, at the end, they stopped smoking traditional cigarettes, we considered that successful smoking cessation,” Dr. Anoruo explained. This definition is in line with the school of thought that e-cigarettes are a harm-reduction tool.

“But we now know that e-cigarettes are not necessarily safe,” she added.

Still, it might be the lesser evil. “You end up taking in less dangerous chemicals, so we consider it quitting if you get off regular cigarettes,” she said.

“We would like to study the psychology of cigarette smokers to find out if they see e-cigarettes as a smoking-cessation aid,” Dr. Anoruo said, and to see if “their belief is driven by the advertising they see about e-cigarette use.”
 

A meager reduction

Similar results were shown last month in a study by Megan Piper, PhD, of University of Wisconsin–Madison and her colleagues, who reported that dual e-cigarette and combustible cigarette use “did not appear to be an effective path to cessation of combustible cigarettes.”

After 1 year, dual smokers smoked three cigarettes less each day than traditional smokers, which is “a meager reduction,” Dr. Piper said in a news release.

“Typically, you can’t have one foot in both camps. Most can’t be vaping and smoking and hope to quit smoking,” she added. “That sustained pattern is not going to help most people quit.”

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

Not only does the use of e-cigarettes not help cigarette smokers who are unmotivated to quit, it has the opposite effect, according to results from a new study.

6okean/iStock/Getty Images Plus

“In our study, people vaping in addition to smoking actually started smoking more,” said study lead investigator Nancy Anoruo, MD, from the University of Massachusetts Medical School in Worcester.

This is “completely contradictory to what the e-cigarette manufacturers are telling us,” she told this news organization.

In their study, Dr. Anoruo and her colleagues looked at whether people were more likely to quit if they smoked e-cigarettes in addition to conventional cigarettes. The research is a substudy of the ongoing Take a Break project, funded by the National Institutes of Health, which is assessing whether a smoking-cessation motivation app helps smokers quit.

In a cohort of 405 smokers who were unmotivated to quit, 248 were defined as dual smokers after responding “yes” to “ever having used” e-cigarettes, and 157 were defined as traditional smokers who only smoked combustible cigarettes. The majority of participants, 82%, were white; 8.8% were black; and 49% were women.

More dual smokers than traditional smokers were younger than 40 years (27% vs. 16%; (P = .02), Dr. Anoruo reported during her virtual presentation at the American Thoracic Society 2020 International Conference.

The dual smokers reported smoking an average of 16 cigarettes a day, compared with 14 a day for the traditional smokers.

All the smokers were encouraged to consider a 3-week period of abstinence from combustible cigarettes. At the end of that period, the researchers compared outcomes reported by participants.
 

Abstinence challenge

Average abstinence intervals were shorter for dual smokers than for traditional smokers (0.93 vs. 1.8 days; P = .01). And dual smokers reported having a harder time quitting completely (6.3% vs. 13.0%; P = .02).

At 6-month follow-up, dual smokers were smoking more cigarettes than traditional smokers (daily average, 12.0 vs. 9.4; P = .04). And the reduction in cigarette use from baseline was smaller for dual smokers than for traditional smokers (21% vs. 33%; P = .04).

“E-cigarettes are not a special magic bullet to get people to quit smoking,” said Dr. Anoruo.

In this study, smoking cessation was defined as abstinence from combustible cigarettes, but that did not mean participants were abstinent from nicotine.

“If, at the end, they stopped smoking traditional cigarettes, we considered that successful smoking cessation,” Dr. Anoruo explained. This definition is in line with the school of thought that e-cigarettes are a harm-reduction tool.

“But we now know that e-cigarettes are not necessarily safe,” she added.

Still, it might be the lesser evil. “You end up taking in less dangerous chemicals, so we consider it quitting if you get off regular cigarettes,” she said.

“We would like to study the psychology of cigarette smokers to find out if they see e-cigarettes as a smoking-cessation aid,” Dr. Anoruo said, and to see if “their belief is driven by the advertising they see about e-cigarette use.”
 

A meager reduction

Similar results were shown last month in a study by Megan Piper, PhD, of University of Wisconsin–Madison and her colleagues, who reported that dual e-cigarette and combustible cigarette use “did not appear to be an effective path to cessation of combustible cigarettes.”

After 1 year, dual smokers smoked three cigarettes less each day than traditional smokers, which is “a meager reduction,” Dr. Piper said in a news release.

“Typically, you can’t have one foot in both camps. Most can’t be vaping and smoking and hope to quit smoking,” she added. “That sustained pattern is not going to help most people quit.”

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

Not only does the use of e-cigarettes not help cigarette smokers who are unmotivated to quit, it has the opposite effect, according to results from a new study.

6okean/iStock/Getty Images Plus

“In our study, people vaping in addition to smoking actually started smoking more,” said study lead investigator Nancy Anoruo, MD, from the University of Massachusetts Medical School in Worcester.

This is “completely contradictory to what the e-cigarette manufacturers are telling us,” she told this news organization.

In their study, Dr. Anoruo and her colleagues looked at whether people were more likely to quit if they smoked e-cigarettes in addition to conventional cigarettes. The research is a substudy of the ongoing Take a Break project, funded by the National Institutes of Health, which is assessing whether a smoking-cessation motivation app helps smokers quit.

In a cohort of 405 smokers who were unmotivated to quit, 248 were defined as dual smokers after responding “yes” to “ever having used” e-cigarettes, and 157 were defined as traditional smokers who only smoked combustible cigarettes. The majority of participants, 82%, were white; 8.8% were black; and 49% were women.

More dual smokers than traditional smokers were younger than 40 years (27% vs. 16%; (P = .02), Dr. Anoruo reported during her virtual presentation at the American Thoracic Society 2020 International Conference.

The dual smokers reported smoking an average of 16 cigarettes a day, compared with 14 a day for the traditional smokers.

All the smokers were encouraged to consider a 3-week period of abstinence from combustible cigarettes. At the end of that period, the researchers compared outcomes reported by participants.
 

Abstinence challenge

Average abstinence intervals were shorter for dual smokers than for traditional smokers (0.93 vs. 1.8 days; P = .01). And dual smokers reported having a harder time quitting completely (6.3% vs. 13.0%; P = .02).

At 6-month follow-up, dual smokers were smoking more cigarettes than traditional smokers (daily average, 12.0 vs. 9.4; P = .04). And the reduction in cigarette use from baseline was smaller for dual smokers than for traditional smokers (21% vs. 33%; P = .04).

“E-cigarettes are not a special magic bullet to get people to quit smoking,” said Dr. Anoruo.

In this study, smoking cessation was defined as abstinence from combustible cigarettes, but that did not mean participants were abstinent from nicotine.

“If, at the end, they stopped smoking traditional cigarettes, we considered that successful smoking cessation,” Dr. Anoruo explained. This definition is in line with the school of thought that e-cigarettes are a harm-reduction tool.

“But we now know that e-cigarettes are not necessarily safe,” she added.

Still, it might be the lesser evil. “You end up taking in less dangerous chemicals, so we consider it quitting if you get off regular cigarettes,” she said.

“We would like to study the psychology of cigarette smokers to find out if they see e-cigarettes as a smoking-cessation aid,” Dr. Anoruo said, and to see if “their belief is driven by the advertising they see about e-cigarette use.”
 

A meager reduction

Similar results were shown last month in a study by Megan Piper, PhD, of University of Wisconsin–Madison and her colleagues, who reported that dual e-cigarette and combustible cigarette use “did not appear to be an effective path to cessation of combustible cigarettes.”

After 1 year, dual smokers smoked three cigarettes less each day than traditional smokers, which is “a meager reduction,” Dr. Piper said in a news release.

“Typically, you can’t have one foot in both camps. Most can’t be vaping and smoking and hope to quit smoking,” she added. “That sustained pattern is not going to help most people quit.”

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

A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.

The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.

“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.

The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.

The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.

A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).

The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).

Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.

The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.

Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”

The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.

Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.

“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”

Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”

While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”

Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.

SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .

A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.

The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.

“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.

The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.

The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.

A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).

The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).

Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.

The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.

Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”

The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.

Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.

“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”

Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”

While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”

Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.

SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .

A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.

The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.

“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.

The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.

The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.

A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).

The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).

Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.

The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.

Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”

The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.

Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.

“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”

Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”

While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”

Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.

SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .

The Navajo people have dealt with adversity that has tested our strength and resilience since our creation. In Navajo culture, the Holy People or gods challenged us with Naayee (monsters). We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language) is a monster confronting the Navajo today. It has had significant impact on our nation and people.

The Navajo have the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths.¹ The Navajo Nation, which once lagged behind New York, has reported the largest per-capita infection rate in the United States.

These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average numbers of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%.²

Geographical and cultural factors also contribute to the inability to gain a foothold in mitigating the number of cases. The Navajo Nation is the largest tribe in the United States, covering 27,000 square miles over an arid, red rock expanse with canyons and mountains. The population is over 250,000,³ and Navajo have traditionally lived in matrilineal clan units throughout the reservation, the size of West Virginia. The family traditional dwelling, called a “hogan,” often is clustered together. Multiple generations live together in these units. The COVID-19 virus inflicted many Navajo and rapidly spread to the elderly in these close-proximity living quarters.

Most Navajo live away from services and grocery stores and travel back and forth for food and water, which contributes to the virus rapidly being transmitted among the community members. Education aimed at curbing travel and spread of the virus was issued with curfews, commands to stay at home and keep social distance, and protect elders. The Navajo leadership and traditional medicine people, meanwhile, advised the people to follow their cultural values by caring for family and community members and providing a safe environment.
 

Resources are spread out

There are only 13 stores in this expansive reservation,⁴ so tribal members rely on traveling to border towns, such as Farmington and Gallup, N.M., Families usually travel to these towns on weekends to replenish food and supplies. There has been a cluster of cases in Gallup, N.M., so to reduce the numbers, the town shut itself off from outsiders – including the Navajo people coming to buy food, do laundry, and get water and feed for livestock. This has affected and stressed the Navajo further in attempting to access necessities.

Access to health care is already challenging because of lack of transportation and distance. This has made it more difficult to access COVID-19 testing and more challenging to get the results back. The Indian Health Service has been the designated health care system for the Navajo since 1955. The Treaty of Bosque Redondo, signed by the Navajo in 1868, included the provision of health care, as well as education in exchange for tracts of land, that included the Navajo homeland or Dinetah.⁵

The Indian Health Service provides care with hospitals and clinics throughout the reservation. Some of the IHS facilities have been taken over by the Navajo, so there are four Navajo tribally controlled hospitals, along with one private hospital. Coordination of care for a pandemic is, therefore, more challenging to coordinate. This contributes to problems with coordination of the health care, establishing alternate care sites, accessing personal protective equipment, and providing testing sites. The Navajo Nation Council is working hard to equitably distribute the $600 million from the CARES Act.⁶

Dealing with the pandemic is compromised by chronic underfunding from the U.S. government. The treaty obligation of the U.S. government is to provide health care to all federally recognized Native Americans. The IHS, which has been designated to provide that care for a tribal person, gets one-third the Medicare dollars for health care provided for a person in the general population.⁷ Health factors have led to the public health issues of poorly controlled diabetes, obesity, and coronary artery disease, which is related to this underfunding and the high rate of COVID-19 cases. Parts of the reservation are also exposed to high levels of pollution from oil and gas wells from the coal-fueled power plants. Those exposed to these high levels of pollutions have a higher than average number of cases of COVID-19, higher than in areas where the pollution is markedly lower.⁸

The Navajo are having to rely on the strength and resilience of traditional Navajo culture and philosophy to confront this monster, Dikos Nitsaa’igii’ 19. We have relied on Western medicine and its limited resources but now need to empower the strength from our traditional ways of knowing. We have used this knowledge in times of adversity for hundreds of years. The Navajo elders and medicine people have reminded us we have dealt with monsters and know how to endure hardship and be resilient. This helps to ameliorate mental health conditions, but there are still issues that remain challenging.

Those having the virus go through times of shortness of breath, which produces anxiety and panic. The risk of death adds further stress, and for a family-oriented culture, the need to isolate from family adds further stress. For the elderly and young people with more serious disease having to go to the hospital alone without family, often far from home, is so challenging. Connecting family by phone or social media with those stricken is essential to decrease anxiety and isolation. Those infected with the virus can learn breathing exercises, which can help the damage from the virus and decrease emotional activation and triggers. Specific breathing techniques can be taught by medical providers. An effective breathing technique to reduce anxiety is coherent breathing, which is done by inhaling 6 seconds and exhaling for 6 seconds without holding your breath. Behavioral health practitioners are available in the tribal and IHS mental health clinics to refer patients to therapy support to manage anxiety and are available by telemedicine. Many of these programs are offering social media informational sessions for the Navajo community. Navajo people often access traditional healing for protection prayers and ceremonies. Some of the tribal and IHS programs provide traditional counselors to talk to. The Navajo access healing that focuses on restoring balance to the body, mind, and spirit.

Taking action against the virus by social distancing, hand washing, and wearing masks can go a long way in reducing anxiety and fear about getting the virus. Resources to help the Navajo Nation are coming from all over the world, from as far as Ireland,⁹ Doctors Without Borders, ¹⁰ and University of San Francisco.¹¹

Two resources that provide relief on the reservation are the Navajo Relief Fund and United Natives.
 

References

1. Navaho Times. 2020 May 27.

2. Ingalls A et al. BMC Obes. 2019 May 6. doi: 10.1186/s40608-019-0233-9.

3. U.S. Census 2010, as reported by discovernavajo.com.

4. Gould C et al. “Addressing food insecurity on the Navajo reservation through sustainable greenhouses.” 2018 Aug.

5. Native Knowledge 360. Smithsonian Institution. “Bosque Redondo.”

6. Personal communication, Carl Roessel Slater, Navajo Nation Council delegate.

7. IHS Profile Fact Sheet.

8. Wu X et al. medRxiv. 2020 Apr 27.

9. Carroll R. ”Irish support for Native American COVID-19 relief highlights historic bond.” The Guardian. 2020 May 9.

10. Capatides C. “Doctors Without Borders dispatches team to the Navajo Nation” CBS News. 2020 May 11.

11. Weiler N. “UCSF sends second wave of health workers to Navajo Nation.” UCSF.edu. 2020 May 21.
 

Dr. Roessel is a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., working with the local indigenous population. She has special expertise in cultural psychiatry; her childhood was spent growing up in the Navajo Nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating indigenous knowledge and principles. Dr. Roessel is a distinguished fellow of the American Psychiatric Association. She has no disclosures.

The Navajo people have dealt with adversity that has tested our strength and resilience since our creation. In Navajo culture, the Holy People or gods challenged us with Naayee (monsters). We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language) is a monster confronting the Navajo today. It has had significant impact on our nation and people.

The Navajo have the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths.¹ The Navajo Nation, which once lagged behind New York, has reported the largest per-capita infection rate in the United States.

These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average numbers of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%.²

Geographical and cultural factors also contribute to the inability to gain a foothold in mitigating the number of cases. The Navajo Nation is the largest tribe in the United States, covering 27,000 square miles over an arid, red rock expanse with canyons and mountains. The population is over 250,000,³ and Navajo have traditionally lived in matrilineal clan units throughout the reservation, the size of West Virginia. The family traditional dwelling, called a “hogan,” often is clustered together. Multiple generations live together in these units. The COVID-19 virus inflicted many Navajo and rapidly spread to the elderly in these close-proximity living quarters.

Most Navajo live away from services and grocery stores and travel back and forth for food and water, which contributes to the virus rapidly being transmitted among the community members. Education aimed at curbing travel and spread of the virus was issued with curfews, commands to stay at home and keep social distance, and protect elders. The Navajo leadership and traditional medicine people, meanwhile, advised the people to follow their cultural values by caring for family and community members and providing a safe environment.
 

Resources are spread out

There are only 13 stores in this expansive reservation,⁴ so tribal members rely on traveling to border towns, such as Farmington and Gallup, N.M., Families usually travel to these towns on weekends to replenish food and supplies. There has been a cluster of cases in Gallup, N.M., so to reduce the numbers, the town shut itself off from outsiders – including the Navajo people coming to buy food, do laundry, and get water and feed for livestock. This has affected and stressed the Navajo further in attempting to access necessities.

Access to health care is already challenging because of lack of transportation and distance. This has made it more difficult to access COVID-19 testing and more challenging to get the results back. The Indian Health Service has been the designated health care system for the Navajo since 1955. The Treaty of Bosque Redondo, signed by the Navajo in 1868, included the provision of health care, as well as education in exchange for tracts of land, that included the Navajo homeland or Dinetah.⁵

The Indian Health Service provides care with hospitals and clinics throughout the reservation. Some of the IHS facilities have been taken over by the Navajo, so there are four Navajo tribally controlled hospitals, along with one private hospital. Coordination of care for a pandemic is, therefore, more challenging to coordinate. This contributes to problems with coordination of the health care, establishing alternate care sites, accessing personal protective equipment, and providing testing sites. The Navajo Nation Council is working hard to equitably distribute the $600 million from the CARES Act.⁶

Dealing with the pandemic is compromised by chronic underfunding from the U.S. government. The treaty obligation of the U.S. government is to provide health care to all federally recognized Native Americans. The IHS, which has been designated to provide that care for a tribal person, gets one-third the Medicare dollars for health care provided for a person in the general population.⁷ Health factors have led to the public health issues of poorly controlled diabetes, obesity, and coronary artery disease, which is related to this underfunding and the high rate of COVID-19 cases. Parts of the reservation are also exposed to high levels of pollution from oil and gas wells from the coal-fueled power plants. Those exposed to these high levels of pollutions have a higher than average number of cases of COVID-19, higher than in areas where the pollution is markedly lower.⁸

The Navajo are having to rely on the strength and resilience of traditional Navajo culture and philosophy to confront this monster, Dikos Nitsaa’igii’ 19. We have relied on Western medicine and its limited resources but now need to empower the strength from our traditional ways of knowing. We have used this knowledge in times of adversity for hundreds of years. The Navajo elders and medicine people have reminded us we have dealt with monsters and know how to endure hardship and be resilient. This helps to ameliorate mental health conditions, but there are still issues that remain challenging.

Those having the virus go through times of shortness of breath, which produces anxiety and panic. The risk of death adds further stress, and for a family-oriented culture, the need to isolate from family adds further stress. For the elderly and young people with more serious disease having to go to the hospital alone without family, often far from home, is so challenging. Connecting family by phone or social media with those stricken is essential to decrease anxiety and isolation. Those infected with the virus can learn breathing exercises, which can help the damage from the virus and decrease emotional activation and triggers. Specific breathing techniques can be taught by medical providers. An effective breathing technique to reduce anxiety is coherent breathing, which is done by inhaling 6 seconds and exhaling for 6 seconds without holding your breath. Behavioral health practitioners are available in the tribal and IHS mental health clinics to refer patients to therapy support to manage anxiety and are available by telemedicine. Many of these programs are offering social media informational sessions for the Navajo community. Navajo people often access traditional healing for protection prayers and ceremonies. Some of the tribal and IHS programs provide traditional counselors to talk to. The Navajo access healing that focuses on restoring balance to the body, mind, and spirit.

Taking action against the virus by social distancing, hand washing, and wearing masks can go a long way in reducing anxiety and fear about getting the virus. Resources to help the Navajo Nation are coming from all over the world, from as far as Ireland,⁹ Doctors Without Borders, ¹⁰ and University of San Francisco.¹¹

Two resources that provide relief on the reservation are the Navajo Relief Fund and United Natives.
 

References

1. Navaho Times. 2020 May 27.

2. Ingalls A et al. BMC Obes. 2019 May 6. doi: 10.1186/s40608-019-0233-9.

3. U.S. Census 2010, as reported by discovernavajo.com.

4. Gould C et al. “Addressing food insecurity on the Navajo reservation through sustainable greenhouses.” 2018 Aug.

5. Native Knowledge 360. Smithsonian Institution. “Bosque Redondo.”

6. Personal communication, Carl Roessel Slater, Navajo Nation Council delegate.

7. IHS Profile Fact Sheet.

8. Wu X et al. medRxiv. 2020 Apr 27.

9. Carroll R. ”Irish support for Native American COVID-19 relief highlights historic bond.” The Guardian. 2020 May 9.

10. Capatides C. “Doctors Without Borders dispatches team to the Navajo Nation” CBS News. 2020 May 11.

11. Weiler N. “UCSF sends second wave of health workers to Navajo Nation.” UCSF.edu. 2020 May 21.
 

Dr. Roessel is a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., working with the local indigenous population. She has special expertise in cultural psychiatry; her childhood was spent growing up in the Navajo Nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating indigenous knowledge and principles. Dr. Roessel is a distinguished fellow of the American Psychiatric Association. She has no disclosures.

The Navajo people have dealt with adversity that has tested our strength and resilience since our creation. In Navajo culture, the Holy People or gods challenged us with Naayee (monsters). We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language) is a monster confronting the Navajo today. It has had significant impact on our nation and people.

The Navajo have the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths.¹ The Navajo Nation, which once lagged behind New York, has reported the largest per-capita infection rate in the United States.

These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average numbers of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%.²

Geographical and cultural factors also contribute to the inability to gain a foothold in mitigating the number of cases. The Navajo Nation is the largest tribe in the United States, covering 27,000 square miles over an arid, red rock expanse with canyons and mountains. The population is over 250,000,³ and Navajo have traditionally lived in matrilineal clan units throughout the reservation, the size of West Virginia. The family traditional dwelling, called a “hogan,” often is clustered together. Multiple generations live together in these units. The COVID-19 virus inflicted many Navajo and rapidly spread to the elderly in these close-proximity living quarters.

Most Navajo live away from services and grocery stores and travel back and forth for food and water, which contributes to the virus rapidly being transmitted among the community members. Education aimed at curbing travel and spread of the virus was issued with curfews, commands to stay at home and keep social distance, and protect elders. The Navajo leadership and traditional medicine people, meanwhile, advised the people to follow their cultural values by caring for family and community members and providing a safe environment.
 

Resources are spread out

There are only 13 stores in this expansive reservation,⁴ so tribal members rely on traveling to border towns, such as Farmington and Gallup, N.M., Families usually travel to these towns on weekends to replenish food and supplies. There has been a cluster of cases in Gallup, N.M., so to reduce the numbers, the town shut itself off from outsiders – including the Navajo people coming to buy food, do laundry, and get water and feed for livestock. This has affected and stressed the Navajo further in attempting to access necessities.

Access to health care is already challenging because of lack of transportation and distance. This has made it more difficult to access COVID-19 testing and more challenging to get the results back. The Indian Health Service has been the designated health care system for the Navajo since 1955. The Treaty of Bosque Redondo, signed by the Navajo in 1868, included the provision of health care, as well as education in exchange for tracts of land, that included the Navajo homeland or Dinetah.⁵

The Indian Health Service provides care with hospitals and clinics throughout the reservation. Some of the IHS facilities have been taken over by the Navajo, so there are four Navajo tribally controlled hospitals, along with one private hospital. Coordination of care for a pandemic is, therefore, more challenging to coordinate. This contributes to problems with coordination of the health care, establishing alternate care sites, accessing personal protective equipment, and providing testing sites. The Navajo Nation Council is working hard to equitably distribute the $600 million from the CARES Act.⁶

Dealing with the pandemic is compromised by chronic underfunding from the U.S. government. The treaty obligation of the U.S. government is to provide health care to all federally recognized Native Americans. The IHS, which has been designated to provide that care for a tribal person, gets one-third the Medicare dollars for health care provided for a person in the general population.⁷ Health factors have led to the public health issues of poorly controlled diabetes, obesity, and coronary artery disease, which is related to this underfunding and the high rate of COVID-19 cases. Parts of the reservation are also exposed to high levels of pollution from oil and gas wells from the coal-fueled power plants. Those exposed to these high levels of pollutions have a higher than average number of cases of COVID-19, higher than in areas where the pollution is markedly lower.⁸

The Navajo are having to rely on the strength and resilience of traditional Navajo culture and philosophy to confront this monster, Dikos Nitsaa’igii’ 19. We have relied on Western medicine and its limited resources but now need to empower the strength from our traditional ways of knowing. We have used this knowledge in times of adversity for hundreds of years. The Navajo elders and medicine people have reminded us we have dealt with monsters and know how to endure hardship and be resilient. This helps to ameliorate mental health conditions, but there are still issues that remain challenging.

Those having the virus go through times of shortness of breath, which produces anxiety and panic. The risk of death adds further stress, and for a family-oriented culture, the need to isolate from family adds further stress. For the elderly and young people with more serious disease having to go to the hospital alone without family, often far from home, is so challenging. Connecting family by phone or social media with those stricken is essential to decrease anxiety and isolation. Those infected with the virus can learn breathing exercises, which can help the damage from the virus and decrease emotional activation and triggers. Specific breathing techniques can be taught by medical providers. An effective breathing technique to reduce anxiety is coherent breathing, which is done by inhaling 6 seconds and exhaling for 6 seconds without holding your breath. Behavioral health practitioners are available in the tribal and IHS mental health clinics to refer patients to therapy support to manage anxiety and are available by telemedicine. Many of these programs are offering social media informational sessions for the Navajo community. Navajo people often access traditional healing for protection prayers and ceremonies. Some of the tribal and IHS programs provide traditional counselors to talk to. The Navajo access healing that focuses on restoring balance to the body, mind, and spirit.

Taking action against the virus by social distancing, hand washing, and wearing masks can go a long way in reducing anxiety and fear about getting the virus. Resources to help the Navajo Nation are coming from all over the world, from as far as Ireland,⁹ Doctors Without Borders, ¹⁰ and University of San Francisco.¹¹

Two resources that provide relief on the reservation are the Navajo Relief Fund and United Natives.
 

References

1. Navaho Times. 2020 May 27.

2. Ingalls A et al. BMC Obes. 2019 May 6. doi: 10.1186/s40608-019-0233-9.

3. U.S. Census 2010, as reported by discovernavajo.com.

4. Gould C et al. “Addressing food insecurity on the Navajo reservation through sustainable greenhouses.” 2018 Aug.

5. Native Knowledge 360. Smithsonian Institution. “Bosque Redondo.”

6. Personal communication, Carl Roessel Slater, Navajo Nation Council delegate.

7. IHS Profile Fact Sheet.

8. Wu X et al. medRxiv. 2020 Apr 27.

9. Carroll R. ”Irish support for Native American COVID-19 relief highlights historic bond.” The Guardian. 2020 May 9.

10. Capatides C. “Doctors Without Borders dispatches team to the Navajo Nation” CBS News. 2020 May 11.

11. Weiler N. “UCSF sends second wave of health workers to Navajo Nation.” UCSF.edu. 2020 May 21.
 

Dr. Roessel is a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., working with the local indigenous population. She has special expertise in cultural psychiatry; her childhood was spent growing up in the Navajo Nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating indigenous knowledge and principles. Dr. Roessel is a distinguished fellow of the American Psychiatric Association. She has no disclosures.

Here are the stories our MDedge editors across specialties think you need to know about today:

Mass protests could cause COVID-19 outbreaks

As mass protests continue throughout the country, officials expressed concern about a potential spike in coronavirus cases in the coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” Scott Gottlieb, former FDA commissioner, said on the CBS News show “Face the Nation.”

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing six feet apart is impossible. Chanting, singing, and shouting may spread the virus through respiratory droplets.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to The Associated Press. Read More.
 

Diabetes: 1 in 10 hospitalized for COVID-19 die within a week

More than 10% of people with diabetes who are hospitalized for COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO study also revealed that body mass index was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online in Diabetologia.

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview. Read more.
 

Most adult epilepsy-related deaths could be avoided

Almost 80% of epilepsy deaths among adults are potentially avoidable, results of a new study suggest.

The research shows that such avoidable deaths “remain common and have not declined over time, despite advances in treatment,” Gashirai Mbizvo, MBChB, PhD, of the University of Edinburgh, United Kingdom, said during a press briefing. The findings were presented at the virtual/online Congress of the European Academy of Neurology (EAN) 2020.

Dr. Mbizvo investigated adolescents and adults aged 16 years and older who died because of epilepsy from 2009 to 2016. He compared this group to patients of similar age who were living with epilepsy. A total of 2149 epilepsy-related deaths occurred.

The most common cause of death in the 16- to 54-year age group was sudden unexpected death in epilepsy, followed by respiratory disorders, such as aspiration pneumonia. “We think this should be avoidable, in the sense that these are people that could perhaps be targeted early with, for example, antibiotics,” Dr. Mbizvo said.

The next most common cause of death was circulatory disease, largely cardiac arrest.

“The idea is that electroexcitation – an abnormality in the brain – and the heart are related, and maybe that’s translating to a risk of death,” Dr. Mbizvo said. Read More.
 

FDA approves combo treatment for hepatocellular cancer

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

The approval was supported by results from the IMbrave150 trial (N Engl J Med 2020; 382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.

The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib.

The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib. Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Mass protests could cause COVID-19 outbreaks

As mass protests continue throughout the country, officials expressed concern about a potential spike in coronavirus cases in the coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” Scott Gottlieb, former FDA commissioner, said on the CBS News show “Face the Nation.”

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing six feet apart is impossible. Chanting, singing, and shouting may spread the virus through respiratory droplets.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to The Associated Press. Read More.
 

Diabetes: 1 in 10 hospitalized for COVID-19 die within a week

More than 10% of people with diabetes who are hospitalized for COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO study also revealed that body mass index was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online in Diabetologia.

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview. Read more.
 

Most adult epilepsy-related deaths could be avoided

Almost 80% of epilepsy deaths among adults are potentially avoidable, results of a new study suggest.

The research shows that such avoidable deaths “remain common and have not declined over time, despite advances in treatment,” Gashirai Mbizvo, MBChB, PhD, of the University of Edinburgh, United Kingdom, said during a press briefing. The findings were presented at the virtual/online Congress of the European Academy of Neurology (EAN) 2020.

Dr. Mbizvo investigated adolescents and adults aged 16 years and older who died because of epilepsy from 2009 to 2016. He compared this group to patients of similar age who were living with epilepsy. A total of 2149 epilepsy-related deaths occurred.

The most common cause of death in the 16- to 54-year age group was sudden unexpected death in epilepsy, followed by respiratory disorders, such as aspiration pneumonia. “We think this should be avoidable, in the sense that these are people that could perhaps be targeted early with, for example, antibiotics,” Dr. Mbizvo said.

The next most common cause of death was circulatory disease, largely cardiac arrest.

“The idea is that electroexcitation – an abnormality in the brain – and the heart are related, and maybe that’s translating to a risk of death,” Dr. Mbizvo said. Read More.
 

FDA approves combo treatment for hepatocellular cancer

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

The approval was supported by results from the IMbrave150 trial (N Engl J Med 2020; 382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.

The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib.

The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib. Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Mass protests could cause COVID-19 outbreaks

As mass protests continue throughout the country, officials expressed concern about a potential spike in coronavirus cases in the coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” Scott Gottlieb, former FDA commissioner, said on the CBS News show “Face the Nation.”

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing six feet apart is impossible. Chanting, singing, and shouting may spread the virus through respiratory droplets.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to The Associated Press. Read More.
 

Diabetes: 1 in 10 hospitalized for COVID-19 die within a week

More than 10% of people with diabetes who are hospitalized for COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO study also revealed that body mass index was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online in Diabetologia.

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview. Read more.
 

Most adult epilepsy-related deaths could be avoided

Almost 80% of epilepsy deaths among adults are potentially avoidable, results of a new study suggest.

The research shows that such avoidable deaths “remain common and have not declined over time, despite advances in treatment,” Gashirai Mbizvo, MBChB, PhD, of the University of Edinburgh, United Kingdom, said during a press briefing. The findings were presented at the virtual/online Congress of the European Academy of Neurology (EAN) 2020.

Dr. Mbizvo investigated adolescents and adults aged 16 years and older who died because of epilepsy from 2009 to 2016. He compared this group to patients of similar age who were living with epilepsy. A total of 2149 epilepsy-related deaths occurred.

The most common cause of death in the 16- to 54-year age group was sudden unexpected death in epilepsy, followed by respiratory disorders, such as aspiration pneumonia. “We think this should be avoidable, in the sense that these are people that could perhaps be targeted early with, for example, antibiotics,” Dr. Mbizvo said.

The next most common cause of death was circulatory disease, largely cardiac arrest.

“The idea is that electroexcitation – an abnormality in the brain – and the heart are related, and maybe that’s translating to a risk of death,” Dr. Mbizvo said. Read More.
 

FDA approves combo treatment for hepatocellular cancer

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) to treat patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

The approval was supported by results from the IMbrave150 trial (N Engl J Med 2020; 382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.

The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib.

The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib. Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

More than 1 in 10 people with diabetes hospitalized with COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
 

First study to examine specific characteristics at time of admission

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.

“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.

Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”

But he urged caution regarding the A_1c finding. “A_1c might be associated with admission to hospital but other factors far beyond A_1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”

And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.

“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
 

_{Yet again, high BMI emerges as a major risk factor}

The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.

Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.

The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).

Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.

On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.

In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m²; P = .0009),

Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.

Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.

Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.

Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.

When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
 

Analysis ongoing, ‘some new messages might pop up’

After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A_1c wasn’t associated with either outcome.

In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.

And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).

In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.

Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”

“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.

But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.

The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.

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

More than 1 in 10 people with diabetes hospitalized with COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
 

First study to examine specific characteristics at time of admission

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.

“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.

Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”

But he urged caution regarding the A_1c finding. “A_1c might be associated with admission to hospital but other factors far beyond A_1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”

And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.

“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
 

_{Yet again, high BMI emerges as a major risk factor}

The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.

Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.

The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).

Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.

On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.

In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m²; P = .0009),

Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.

Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.

Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.

Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.

When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
 

Analysis ongoing, ‘some new messages might pop up’

After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A_1c wasn’t associated with either outcome.

In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.

And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).

In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.

Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”

“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.

But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.

The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.

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

More than 1 in 10 people with diabetes hospitalized with COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
 

First study to examine specific characteristics at time of admission

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.

“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.

Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”

But he urged caution regarding the A_1c finding. “A_1c might be associated with admission to hospital but other factors far beyond A_1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”

And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.

“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
 

_{Yet again, high BMI emerges as a major risk factor}

The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.

Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.

The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).

Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.

On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.

In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m²; P = .0009),

Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.

Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.

Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.

Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.

When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
 

Analysis ongoing, ‘some new messages might pop up’

After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A_1c wasn’t associated with either outcome.

In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.

And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).

In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.

Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”

“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.

But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.

The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.

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

As mass protests continued in large and small cities across the country, officials expressed concerns on Sunday news shows about a potential spike in coronavirus cases in coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” said Scott Gottlieb, former FDA commissioner, on the CBS News show “Face the Nation.”

In Minnesota, he noted, COVID-19 cases and hospitalizations increased in recent days – even before the protests started.

“We still have pockets of spread in communities that aren’t under good control,” he said.

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing 6 feet apart is impossible.

Chanting, singing, and shouting may spread the virus through respiratory droplets. In addition, people who have the virus but don’t show symptoms may infect others without knowing it.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to the Associated Press.

Gottlieb and Bottoms also spoke Sunday about the disproportionate effect of the coronavirus on black and Hispanic people, who are contracting and dying from the virus at higher rates. Socioeconomic factors such as low incomes, limited health care access, underlying conditions and overcrowded housing play a role in the greater risk, Gottlieb said.

“It’s a symptom of broader racial inequities in our country that we need to work to resolve,” he said.

Protests against racial injustice, sparked by the death of George Floyd in Minneapolis last week, could harm those communities experiencing the most severe outcomes of the coronavirus, Bottoms added.

“We know what’s already happening in our community with this virus. We’re going to see the other side of this in a couple of weeks,” Bottoms said on CNN’s “State of the Union.”

The protests may affect the pandemic in other ways. Los Angeles Mayor Eric Garcetti said the city’s coronavirus testing centers were closed on Saturday because of “safety worries across the city,” according to KTLA.

“We need to make sure, especially in communities that have less power, that we are able to make sure people don’t disproportionately die because of the color of their skin,” he said. “We can’t do that when the city breaks down.”

This article first appeared on WebMD.com.

As mass protests continued in large and small cities across the country, officials expressed concerns on Sunday news shows about a potential spike in coronavirus cases in coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” said Scott Gottlieb, former FDA commissioner, on the CBS News show “Face the Nation.”

In Minnesota, he noted, COVID-19 cases and hospitalizations increased in recent days – even before the protests started.

“We still have pockets of spread in communities that aren’t under good control,” he said.

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing 6 feet apart is impossible.

Chanting, singing, and shouting may spread the virus through respiratory droplets. In addition, people who have the virus but don’t show symptoms may infect others without knowing it.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to the Associated Press.

Gottlieb and Bottoms also spoke Sunday about the disproportionate effect of the coronavirus on black and Hispanic people, who are contracting and dying from the virus at higher rates. Socioeconomic factors such as low incomes, limited health care access, underlying conditions and overcrowded housing play a role in the greater risk, Gottlieb said.

“It’s a symptom of broader racial inequities in our country that we need to work to resolve,” he said.

Protests against racial injustice, sparked by the death of George Floyd in Minneapolis last week, could harm those communities experiencing the most severe outcomes of the coronavirus, Bottoms added.

“We know what’s already happening in our community with this virus. We’re going to see the other side of this in a couple of weeks,” Bottoms said on CNN’s “State of the Union.”

The protests may affect the pandemic in other ways. Los Angeles Mayor Eric Garcetti said the city’s coronavirus testing centers were closed on Saturday because of “safety worries across the city,” according to KTLA.

“We need to make sure, especially in communities that have less power, that we are able to make sure people don’t disproportionately die because of the color of their skin,” he said. “We can’t do that when the city breaks down.”

This article first appeared on WebMD.com.

As mass protests continued in large and small cities across the country, officials expressed concerns on Sunday news shows about a potential spike in coronavirus cases in coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” said Scott Gottlieb, former FDA commissioner, on the CBS News show “Face the Nation.”

In Minnesota, he noted, COVID-19 cases and hospitalizations increased in recent days – even before the protests started.

“We still have pockets of spread in communities that aren’t under good control,” he said.

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing 6 feet apart is impossible.

Chanting, singing, and shouting may spread the virus through respiratory droplets. In addition, people who have the virus but don’t show symptoms may infect others without knowing it.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to the Associated Press.

Gottlieb and Bottoms also spoke Sunday about the disproportionate effect of the coronavirus on black and Hispanic people, who are contracting and dying from the virus at higher rates. Socioeconomic factors such as low incomes, limited health care access, underlying conditions and overcrowded housing play a role in the greater risk, Gottlieb said.

“It’s a symptom of broader racial inequities in our country that we need to work to resolve,” he said.

Protests against racial injustice, sparked by the death of George Floyd in Minneapolis last week, could harm those communities experiencing the most severe outcomes of the coronavirus, Bottoms added.

“We know what’s already happening in our community with this virus. We’re going to see the other side of this in a couple of weeks,” Bottoms said on CNN’s “State of the Union.”

The protests may affect the pandemic in other ways. Los Angeles Mayor Eric Garcetti said the city’s coronavirus testing centers were closed on Saturday because of “safety worries across the city,” according to KTLA.

“We need to make sure, especially in communities that have less power, that we are able to make sure people don’t disproportionately die because of the color of their skin,” he said. “We can’t do that when the city breaks down.”

This article first appeared on WebMD.com.

A new placebo-controlled trial has shown no benefit over placebo for three different drugs commonly used to treat fatigue in patients with multiple sclerosis (MS). The TRIUMPHANT study found no difference between the effects of amantadine, modafinil, methylphenidate, and placebo in the Modified Fatigue Impact Scale (MFIS) in a study involving 141 patients with MS.

There was also no difference between any of the drugs and placebo in any of the preplanned subgroups which included different Expanded Disability Status Scale scores, depressive scores, use of disease-modifying therapy, or type of MS (relapsing remitting or progressive).

The research was presented online as part of the 2020 American Academy of Neurology Science Highlights.

“These three drugs are used very commonly used for MS fatigue by neurologists, psychiatrists, and primary care doctors, but they don’t seem to be any better than placebo. They were all associated with increased side effects compared with placebo even with short-term use,” said lead investigator Bardia Nourbakhsh, MD, assistant professor of neurology at Johns Hopkins University, Baltimore.

However, in a post hoc analysis there was an improvement in daytime sleepiness with two of the drugs – methylphenidate and modafinil. “These two agents reduced daytime sleepiness in patients with high daytime sleepiness scores at baseline, with about a 4-point difference versus placebo, which was significant. But as this was not a preplanned analysis, we have to be cautious in its interpretation,” Dr. Nourbakhsh said. “However, this finding may not be too surprising as both these drugs are licensed as stimulants for use in narcolepsy patients with excessive daytime sleepiness.”

“Our recommendations are that as amantadine was not better than placebo in any subgroup its use should be discouraged in MS fatigue,” Dr. Nourbakhsh commented. “Modafinil and methylphenidate may possibly be considered for MS patients with excessive daytime sleepiness, but this should really be confirmed in further studies.”

Fatigue is a common and debilitating symptom of MS, occurring in about 70%-80% of patients with MS. There is no approved drug treatment. However nonpharmacologic therapies have shown some success: studies of exercise and cognitive-behavioral therapy (CBT) have shown these may be effective without causing side effects, Dr. Nourbakhsh noted. “So we should be getting patients to try exercise and CBT before jumping to medication.”

Dr. Nourbakhsh said he was disappointed with the results of the study but not terribly surprised. “We use these three medications frequently in the clinic and we have not been seeing great benefits so we wondered whether they were actually effective.”

He said that the trial was adequately powered and the question has been answered. “These are valuable results – they will hopefully encourage doctors to think twice before prescribing these medications that could be harmful and have no clear benefit,” Dr. Nourbakhsh concluded.

For the randomized, double-blind, placebo-controlled, four-sequence, four-period crossover trial, 141 patients with MS and fatigue received twice-daily oral amantadine (maximum 200 mg/day), modafinil (maximum 200 mg/day), methylphenidate (maximum 20 mg/day), or placebo, each given for up to 6 weeks with a 2-week washout between each medication.

Patients had a mean baseline MFIS score of 51.3 and were randomly assigned to one of four medication administration sequences. Data from 136 participants were available for the analysis of the primary outcome (change in MFIS score), and 111 participants completed all four medication periods.

In the intent-to-treat analysis, the least-squares means of total MFIS scores at the maximally tolerated dose were as follows: 40.7 with placebo, 41.2 with amantadine, 39.0 with modafinil, and 38.7 with methylphenidate (P = .20 for the overall medication effect; P > .05 for all pairwise comparisons). “All medications and placebo reduced the MS fatigue score by 10-12 points from baseline, so there was quite a substantial placebo effect,” Dr. Nourbakhsh noted. There was no statistically significant difference in the physical and cognitive subscales of MFIS and quality of life measures between any of the study medications and placebo. All three drugs were associated with an increase in adverse effects versus placebo.

Dr. Nourbakhsh says he is hopeful that this negative study may stimulate further research into new targets and medications for MS fatigue.

His group has recently conducted a pilot study of intravenous ketamine in MS fatigue with some encouraging results, but he stressed it needs to be tested in a larger study before it can be recommended for use in clinical practice. “While an IV medication is not ideal, the effect did seem to be quite long-lived with a difference still evident at 28 days, so it could perhaps be dosed once a month, which could be feasible,” he said.

Commenting on the TRIUMPHANT study, Jeffrey Cohen, MD, of the Cleveland Clinic, said that “fatigue is a common, often disabling, symptom of MS. It is poorly understood and probably encompasses several mechanisms. There currently is no generally effective treatment for MS-related fatigue.”

“These results are not surprising and confirm previous studies,” Dr. Cohen said. “Despite no benefit from these medicines for patients as a group, they are occasionally helpful for individual patients, so they are frequently tried empirically.

“It also is important to address any factors besides MS that may be causing or contributing to fatigue, for example, sleep disruption, medication side effects, depression, other medical conditions such as anemia or hypothyroidism,” he added.

Dr. Nourbakhsh has reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities for Jazz Pharmaceuticals.

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

A new placebo-controlled trial has shown no benefit over placebo for three different drugs commonly used to treat fatigue in patients with multiple sclerosis (MS). The TRIUMPHANT study found no difference between the effects of amantadine, modafinil, methylphenidate, and placebo in the Modified Fatigue Impact Scale (MFIS) in a study involving 141 patients with MS.

There was also no difference between any of the drugs and placebo in any of the preplanned subgroups which included different Expanded Disability Status Scale scores, depressive scores, use of disease-modifying therapy, or type of MS (relapsing remitting or progressive).

The research was presented online as part of the 2020 American Academy of Neurology Science Highlights.

“These three drugs are used very commonly used for MS fatigue by neurologists, psychiatrists, and primary care doctors, but they don’t seem to be any better than placebo. They were all associated with increased side effects compared with placebo even with short-term use,” said lead investigator Bardia Nourbakhsh, MD, assistant professor of neurology at Johns Hopkins University, Baltimore.

However, in a post hoc analysis there was an improvement in daytime sleepiness with two of the drugs – methylphenidate and modafinil. “These two agents reduced daytime sleepiness in patients with high daytime sleepiness scores at baseline, with about a 4-point difference versus placebo, which was significant. But as this was not a preplanned analysis, we have to be cautious in its interpretation,” Dr. Nourbakhsh said. “However, this finding may not be too surprising as both these drugs are licensed as stimulants for use in narcolepsy patients with excessive daytime sleepiness.”

“Our recommendations are that as amantadine was not better than placebo in any subgroup its use should be discouraged in MS fatigue,” Dr. Nourbakhsh commented. “Modafinil and methylphenidate may possibly be considered for MS patients with excessive daytime sleepiness, but this should really be confirmed in further studies.”

Fatigue is a common and debilitating symptom of MS, occurring in about 70%-80% of patients with MS. There is no approved drug treatment. However nonpharmacologic therapies have shown some success: studies of exercise and cognitive-behavioral therapy (CBT) have shown these may be effective without causing side effects, Dr. Nourbakhsh noted. “So we should be getting patients to try exercise and CBT before jumping to medication.”

Dr. Nourbakhsh said he was disappointed with the results of the study but not terribly surprised. “We use these three medications frequently in the clinic and we have not been seeing great benefits so we wondered whether they were actually effective.”

He said that the trial was adequately powered and the question has been answered. “These are valuable results – they will hopefully encourage doctors to think twice before prescribing these medications that could be harmful and have no clear benefit,” Dr. Nourbakhsh concluded.

For the randomized, double-blind, placebo-controlled, four-sequence, four-period crossover trial, 141 patients with MS and fatigue received twice-daily oral amantadine (maximum 200 mg/day), modafinil (maximum 200 mg/day), methylphenidate (maximum 20 mg/day), or placebo, each given for up to 6 weeks with a 2-week washout between each medication.

Patients had a mean baseline MFIS score of 51.3 and were randomly assigned to one of four medication administration sequences. Data from 136 participants were available for the analysis of the primary outcome (change in MFIS score), and 111 participants completed all four medication periods.

In the intent-to-treat analysis, the least-squares means of total MFIS scores at the maximally tolerated dose were as follows: 40.7 with placebo, 41.2 with amantadine, 39.0 with modafinil, and 38.7 with methylphenidate (P = .20 for the overall medication effect; P > .05 for all pairwise comparisons). “All medications and placebo reduced the MS fatigue score by 10-12 points from baseline, so there was quite a substantial placebo effect,” Dr. Nourbakhsh noted. There was no statistically significant difference in the physical and cognitive subscales of MFIS and quality of life measures between any of the study medications and placebo. All three drugs were associated with an increase in adverse effects versus placebo.

Dr. Nourbakhsh says he is hopeful that this negative study may stimulate further research into new targets and medications for MS fatigue.

His group has recently conducted a pilot study of intravenous ketamine in MS fatigue with some encouraging results, but he stressed it needs to be tested in a larger study before it can be recommended for use in clinical practice. “While an IV medication is not ideal, the effect did seem to be quite long-lived with a difference still evident at 28 days, so it could perhaps be dosed once a month, which could be feasible,” he said.

Commenting on the TRIUMPHANT study, Jeffrey Cohen, MD, of the Cleveland Clinic, said that “fatigue is a common, often disabling, symptom of MS. It is poorly understood and probably encompasses several mechanisms. There currently is no generally effective treatment for MS-related fatigue.”

“These results are not surprising and confirm previous studies,” Dr. Cohen said. “Despite no benefit from these medicines for patients as a group, they are occasionally helpful for individual patients, so they are frequently tried empirically.

“It also is important to address any factors besides MS that may be causing or contributing to fatigue, for example, sleep disruption, medication side effects, depression, other medical conditions such as anemia or hypothyroidism,” he added.

Dr. Nourbakhsh has reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities for Jazz Pharmaceuticals.

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

A new placebo-controlled trial has shown no benefit over placebo for three different drugs commonly used to treat fatigue in patients with multiple sclerosis (MS). The TRIUMPHANT study found no difference between the effects of amantadine, modafinil, methylphenidate, and placebo in the Modified Fatigue Impact Scale (MFIS) in a study involving 141 patients with MS.

There was also no difference between any of the drugs and placebo in any of the preplanned subgroups which included different Expanded Disability Status Scale scores, depressive scores, use of disease-modifying therapy, or type of MS (relapsing remitting or progressive).

The research was presented online as part of the 2020 American Academy of Neurology Science Highlights.

“These three drugs are used very commonly used for MS fatigue by neurologists, psychiatrists, and primary care doctors, but they don’t seem to be any better than placebo. They were all associated with increased side effects compared with placebo even with short-term use,” said lead investigator Bardia Nourbakhsh, MD, assistant professor of neurology at Johns Hopkins University, Baltimore.

However, in a post hoc analysis there was an improvement in daytime sleepiness with two of the drugs – methylphenidate and modafinil. “These two agents reduced daytime sleepiness in patients with high daytime sleepiness scores at baseline, with about a 4-point difference versus placebo, which was significant. But as this was not a preplanned analysis, we have to be cautious in its interpretation,” Dr. Nourbakhsh said. “However, this finding may not be too surprising as both these drugs are licensed as stimulants for use in narcolepsy patients with excessive daytime sleepiness.”

“Our recommendations are that as amantadine was not better than placebo in any subgroup its use should be discouraged in MS fatigue,” Dr. Nourbakhsh commented. “Modafinil and methylphenidate may possibly be considered for MS patients with excessive daytime sleepiness, but this should really be confirmed in further studies.”

Fatigue is a common and debilitating symptom of MS, occurring in about 70%-80% of patients with MS. There is no approved drug treatment. However nonpharmacologic therapies have shown some success: studies of exercise and cognitive-behavioral therapy (CBT) have shown these may be effective without causing side effects, Dr. Nourbakhsh noted. “So we should be getting patients to try exercise and CBT before jumping to medication.”

Dr. Nourbakhsh said he was disappointed with the results of the study but not terribly surprised. “We use these three medications frequently in the clinic and we have not been seeing great benefits so we wondered whether they were actually effective.”

He said that the trial was adequately powered and the question has been answered. “These are valuable results – they will hopefully encourage doctors to think twice before prescribing these medications that could be harmful and have no clear benefit,” Dr. Nourbakhsh concluded.

For the randomized, double-blind, placebo-controlled, four-sequence, four-period crossover trial, 141 patients with MS and fatigue received twice-daily oral amantadine (maximum 200 mg/day), modafinil (maximum 200 mg/day), methylphenidate (maximum 20 mg/day), or placebo, each given for up to 6 weeks with a 2-week washout between each medication.

Patients had a mean baseline MFIS score of 51.3 and were randomly assigned to one of four medication administration sequences. Data from 136 participants were available for the analysis of the primary outcome (change in MFIS score), and 111 participants completed all four medication periods.

In the intent-to-treat analysis, the least-squares means of total MFIS scores at the maximally tolerated dose were as follows: 40.7 with placebo, 41.2 with amantadine, 39.0 with modafinil, and 38.7 with methylphenidate (P = .20 for the overall medication effect; P > .05 for all pairwise comparisons). “All medications and placebo reduced the MS fatigue score by 10-12 points from baseline, so there was quite a substantial placebo effect,” Dr. Nourbakhsh noted. There was no statistically significant difference in the physical and cognitive subscales of MFIS and quality of life measures between any of the study medications and placebo. All three drugs were associated with an increase in adverse effects versus placebo.

Dr. Nourbakhsh says he is hopeful that this negative study may stimulate further research into new targets and medications for MS fatigue.

His group has recently conducted a pilot study of intravenous ketamine in MS fatigue with some encouraging results, but he stressed it needs to be tested in a larger study before it can be recommended for use in clinical practice. “While an IV medication is not ideal, the effect did seem to be quite long-lived with a difference still evident at 28 days, so it could perhaps be dosed once a month, which could be feasible,” he said.

Commenting on the TRIUMPHANT study, Jeffrey Cohen, MD, of the Cleveland Clinic, said that “fatigue is a common, often disabling, symptom of MS. It is poorly understood and probably encompasses several mechanisms. There currently is no generally effective treatment for MS-related fatigue.”

“These results are not surprising and confirm previous studies,” Dr. Cohen said. “Despite no benefit from these medicines for patients as a group, they are occasionally helpful for individual patients, so they are frequently tried empirically.

“It also is important to address any factors besides MS that may be causing or contributing to fatigue, for example, sleep disruption, medication side effects, depression, other medical conditions such as anemia or hypothyroidism,” he added.

Dr. Nourbakhsh has reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities for Jazz Pharmaceuticals.

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

While many across the world who have access to Netflix and other streaming services have been on lockdown, the second season of Ricky Gervais’s dark comedy series, “After Life,” was released. The show will also return for a third season.

The setup of the show is that Lisa, the wife of Gervais’s protagonist, Tony, has died of breast cancer. Knowing that he would need help after, she made him a video guide to life without her, ranging from the mundane of a garbage day or house alarm to feeding their dog Brandy, tidying the house, and constantly reminding him to take care of himself.

When we first see Tony, he is not doing great on self-care, and he has turned his grief into a “super power” allowing himself to do or say whatever he wants to – from pretending to reprimand his dog for calling a man (who had just told him his dog should be on a lead) a “fat hairy nosy !#$%&” to getting into a name-calling exchange with a primary school child. He later (jokingly) threatens this same child with a hammer, so that the child will stop bullying his nephew.

Tony works as the head of features for the Tambury Gazette, the free local paper. The comedy is full of the hometown charm with Tony and the photographer, Lenny, visiting the homes of the interesting personalities who have called into the paper with their small-town newsworthy stories.

Colorful characters abound in his town, including Postman Pat, who pops in and helps himself to a bath. Tony develops an unlikely friendship with a sex worker whom he hires to clean his house – since she said that she would do “anything for 50 quid.”

Tony, in the midst of an existential crisis, visits his wife’s grave frequently. While there, he meets an older widow, Anne, who befriends him and offers good advice. (Anne is played by Penelope Wilton of The Best Exotic Marigold Hotel and Downton Abbey.)

Tony also dutifully visits his father daily at the Autumnal Leaves Care Home. His father has dementia and keeps asking about Lisa, forgetting that she is dead. Tony comments that if his father were a dog, he would euthanize him. In actuality, Tony’s dog, Brandy, stops Tony’s potential suicide throughout the series.

Matt, who is Tony’s brother-in-law (and boss at the paper) describes Tony as “devastated, suicidal.” Tony explains that he can do and say what he wants, and “then when it all gets too much, I can always kill myself.” By season 2, Matt’s wife has left him, and he, too, needs to see the psychiatrist.

The problem is the Tambury psychiatrist (played by Paul Kaye). General psychiatrists in film have been described in various ways by the late Irving Schneider, MD, including Dr. Evil, Dr. Wonderful, and Dr. Dippy types. “Dr. Dippy’s Sanitarium” was a 1906 silent film in which Dr. Dippy is seen lacking in common sense but being harmless overall. Based on the behaviors displayed in and out of therapy, the Tambury psychiatrist could never be described as Dr. Wonderful, leading to the Dr. Evil or the Dr. Dippy options. He is certainly using patients for his own personal gratification (like a Dr. Evil might) and is certainly lacking in common sense and acting “crazier or more foolish than his patients”¹ (like a Dr. Dippy). However, this psychiatrist may need a category all to himself.

Reference

1. Schneider I. Am J Psychiatry. 1987 Aug;144(8):966-1002.

While many across the world who have access to Netflix and other streaming services have been on lockdown, the second season of Ricky Gervais’s dark comedy series, “After Life,” was released. The show will also return for a third season.

The setup of the show is that Lisa, the wife of Gervais’s protagonist, Tony, has died of breast cancer. Knowing that he would need help after, she made him a video guide to life without her, ranging from the mundane of a garbage day or house alarm to feeding their dog Brandy, tidying the house, and constantly reminding him to take care of himself.

When we first see Tony, he is not doing great on self-care, and he has turned his grief into a “super power” allowing himself to do or say whatever he wants to – from pretending to reprimand his dog for calling a man (who had just told him his dog should be on a lead) a “fat hairy nosy !#$%&” to getting into a name-calling exchange with a primary school child. He later (jokingly) threatens this same child with a hammer, so that the child will stop bullying his nephew.

Tony works as the head of features for the Tambury Gazette, the free local paper. The comedy is full of the hometown charm with Tony and the photographer, Lenny, visiting the homes of the interesting personalities who have called into the paper with their small-town newsworthy stories.

Colorful characters abound in his town, including Postman Pat, who pops in and helps himself to a bath. Tony develops an unlikely friendship with a sex worker whom he hires to clean his house – since she said that she would do “anything for 50 quid.”

Tony, in the midst of an existential crisis, visits his wife’s grave frequently. While there, he meets an older widow, Anne, who befriends him and offers good advice. (Anne is played by Penelope Wilton of The Best Exotic Marigold Hotel and Downton Abbey.)

Tony also dutifully visits his father daily at the Autumnal Leaves Care Home. His father has dementia and keeps asking about Lisa, forgetting that she is dead. Tony comments that if his father were a dog, he would euthanize him. In actuality, Tony’s dog, Brandy, stops Tony’s potential suicide throughout the series.

Matt, who is Tony’s brother-in-law (and boss at the paper) describes Tony as “devastated, suicidal.” Tony explains that he can do and say what he wants, and “then when it all gets too much, I can always kill myself.” By season 2, Matt’s wife has left him, and he, too, needs to see the psychiatrist.

The problem is the Tambury psychiatrist (played by Paul Kaye). General psychiatrists in film have been described in various ways by the late Irving Schneider, MD, including Dr. Evil, Dr. Wonderful, and Dr. Dippy types. “Dr. Dippy’s Sanitarium” was a 1906 silent film in which Dr. Dippy is seen lacking in common sense but being harmless overall. Based on the behaviors displayed in and out of therapy, the Tambury psychiatrist could never be described as Dr. Wonderful, leading to the Dr. Evil or the Dr. Dippy options. He is certainly using patients for his own personal gratification (like a Dr. Evil might) and is certainly lacking in common sense and acting “crazier or more foolish than his patients”¹ (like a Dr. Dippy). However, this psychiatrist may need a category all to himself.

Reference

1. Schneider I. Am J Psychiatry. 1987 Aug;144(8):966-1002.

While many across the world who have access to Netflix and other streaming services have been on lockdown, the second season of Ricky Gervais’s dark comedy series, “After Life,” was released. The show will also return for a third season.

The setup of the show is that Lisa, the wife of Gervais’s protagonist, Tony, has died of breast cancer. Knowing that he would need help after, she made him a video guide to life without her, ranging from the mundane of a garbage day or house alarm to feeding their dog Brandy, tidying the house, and constantly reminding him to take care of himself.

When we first see Tony, he is not doing great on self-care, and he has turned his grief into a “super power” allowing himself to do or say whatever he wants to – from pretending to reprimand his dog for calling a man (who had just told him his dog should be on a lead) a “fat hairy nosy !#$%&” to getting into a name-calling exchange with a primary school child. He later (jokingly) threatens this same child with a hammer, so that the child will stop bullying his nephew.

Tony works as the head of features for the Tambury Gazette, the free local paper. The comedy is full of the hometown charm with Tony and the photographer, Lenny, visiting the homes of the interesting personalities who have called into the paper with their small-town newsworthy stories.

Colorful characters abound in his town, including Postman Pat, who pops in and helps himself to a bath. Tony develops an unlikely friendship with a sex worker whom he hires to clean his house – since she said that she would do “anything for 50 quid.”

Tony, in the midst of an existential crisis, visits his wife’s grave frequently. While there, he meets an older widow, Anne, who befriends him and offers good advice. (Anne is played by Penelope Wilton of The Best Exotic Marigold Hotel and Downton Abbey.)

Tony also dutifully visits his father daily at the Autumnal Leaves Care Home. His father has dementia and keeps asking about Lisa, forgetting that she is dead. Tony comments that if his father were a dog, he would euthanize him. In actuality, Tony’s dog, Brandy, stops Tony’s potential suicide throughout the series.

Matt, who is Tony’s brother-in-law (and boss at the paper) describes Tony as “devastated, suicidal.” Tony explains that he can do and say what he wants, and “then when it all gets too much, I can always kill myself.” By season 2, Matt’s wife has left him, and he, too, needs to see the psychiatrist.

The problem is the Tambury psychiatrist (played by Paul Kaye). General psychiatrists in film have been described in various ways by the late Irving Schneider, MD, including Dr. Evil, Dr. Wonderful, and Dr. Dippy types. “Dr. Dippy’s Sanitarium” was a 1906 silent film in which Dr. Dippy is seen lacking in common sense but being harmless overall. Based on the behaviors displayed in and out of therapy, the Tambury psychiatrist could never be described as Dr. Wonderful, leading to the Dr. Evil or the Dr. Dippy options. He is certainly using patients for his own personal gratification (like a Dr. Evil might) and is certainly lacking in common sense and acting “crazier or more foolish than his patients”¹ (like a Dr. Dippy). However, this psychiatrist may need a category all to himself.

Reference

1. Schneider I. Am J Psychiatry. 1987 Aug;144(8):966-1002.

Prior to the current crisis of COVID-19, I had a critical view of the direction of our psychiatric field. We have given up on complicated psychotherapies in favor of dispensing medications. We have given up on complicated diagnostic assessments in favor of simple self-rated symptoms questionnaires. Many of us even chose to give up on seeing patients face to face in favor of practicing telepsychiatry in the comfort of our homes. Some even promoted a future of psychiatry in which psychiatrists treated patients through large spreadsheets of evidence-based rating tools following evidence-based algorithms without even ever meeting the patients.

I do not view this problem as unique to psychiatry but rather as part of a larger trend in society. For the past couple of years, Vivek Murthy, MD, the former U.S. surgeon general, has popularized the idea that we are in a loneliness epidemic, saying, “We live in the most technologically connected age in the history of civilization, yet rates of loneliness have doubled since the 1980s.” Despite having enumerable means to reach other human beings, so many of us feel distant and out of touch with others. This loneliness has a measurable impact on our well-being with one study that states, “Actual and perceived social isolation are both associated with increased risk for early mortality.”

Then, seemingly out of nowhere, we were confronted with the largest challenge to our sense of connectedness in my lifetime. Throughout the past months, we have been asked to meet each other less frequently, do so through sterile means, and certainly not shake hands, hug, or embrace. The COVID-19 crisis has quickly made us all experts in telepsychiatry, remote work, and doing more with less. The COVID-19 crisis has asked many of us to put aside some of our human rituals like eating together, enjoying artistic experiences as a group, and touching, for the sake of saving lives.

For many, socially distancing has been a considerable added stressor – a stressor that continues to test humanity’s ability to be resilient. I am saddened by prior patients reaching out to seek comfort in these difficult times. I am touched by their desire to reconnect with someone they know, someone who feels familiar. I am surprised by the power of connection through phone and video calls. For some patients, despite the added burden, the current crisis has been an opportunity for their mental health and a reminder of the things that are important, including calling old friends and staying in touch with those who matter the most.

Yet, as the social restrictions continue, the stressors mount and the resilience becomes harder to find. Checking in on others can become a chore. The social norm to partake in fashion, and self-care, become harder to find. In some cases, even hygiene and our health take a side role. The weekly phone visits with a therapist can feel just as mundane and repetitive as life. Sleep becomes harder to find, and food loses its taste. At this point, we realize the humanity that we lost in all this.

In the past couple of months, we have all become much more aware of the fragility of connectedness. However, we should recognize that the impact was well on its way before the COVID-19 crisis. It is my opinion that psychiatry should champion the issue of human relations. I do not think that we need to wait for a new DSM diagnosis, an evidence-based paradigm, or a Food and Drug Administration–approved medication to do so. The COVID-19 crisis has rendered us all cognizant of the importance of relationships.

While it may be that psychiatry continues to foray in electronic means of communication, use of impersonal scales and diagnosis, as well as anonymized algorithmic treatment plans, we should also promote as much humanity as society and public health safety will permit. Getting dressed to see your psychiatrist, face to face, to have an open-ended conversation about the nature of one’s life has clearly become something precious and powerful that should be cherished and protected. My hope is the rules and mandates we are required to use during the pandemic today do not become a continued habit that result in further loneliness and disconnect. If we chose to, the lessons we learn today can, in fact, strengthen our appreciation and pursuit of human connection.
 

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Springer, 2019). He has no disclosures.

Prior to the current crisis of COVID-19, I had a critical view of the direction of our psychiatric field. We have given up on complicated psychotherapies in favor of dispensing medications. We have given up on complicated diagnostic assessments in favor of simple self-rated symptoms questionnaires. Many of us even chose to give up on seeing patients face to face in favor of practicing telepsychiatry in the comfort of our homes. Some even promoted a future of psychiatry in which psychiatrists treated patients through large spreadsheets of evidence-based rating tools following evidence-based algorithms without even ever meeting the patients.

I do not view this problem as unique to psychiatry but rather as part of a larger trend in society. For the past couple of years, Vivek Murthy, MD, the former U.S. surgeon general, has popularized the idea that we are in a loneliness epidemic, saying, “We live in the most technologically connected age in the history of civilization, yet rates of loneliness have doubled since the 1980s.” Despite having enumerable means to reach other human beings, so many of us feel distant and out of touch with others. This loneliness has a measurable impact on our well-being with one study that states, “Actual and perceived social isolation are both associated with increased risk for early mortality.”

Then, seemingly out of nowhere, we were confronted with the largest challenge to our sense of connectedness in my lifetime. Throughout the past months, we have been asked to meet each other less frequently, do so through sterile means, and certainly not shake hands, hug, or embrace. The COVID-19 crisis has quickly made us all experts in telepsychiatry, remote work, and doing more with less. The COVID-19 crisis has asked many of us to put aside some of our human rituals like eating together, enjoying artistic experiences as a group, and touching, for the sake of saving lives.

For many, socially distancing has been a considerable added stressor – a stressor that continues to test humanity’s ability to be resilient. I am saddened by prior patients reaching out to seek comfort in these difficult times. I am touched by their desire to reconnect with someone they know, someone who feels familiar. I am surprised by the power of connection through phone and video calls. For some patients, despite the added burden, the current crisis has been an opportunity for their mental health and a reminder of the things that are important, including calling old friends and staying in touch with those who matter the most.

Yet, as the social restrictions continue, the stressors mount and the resilience becomes harder to find. Checking in on others can become a chore. The social norm to partake in fashion, and self-care, become harder to find. In some cases, even hygiene and our health take a side role. The weekly phone visits with a therapist can feel just as mundane and repetitive as life. Sleep becomes harder to find, and food loses its taste. At this point, we realize the humanity that we lost in all this.

In the past couple of months, we have all become much more aware of the fragility of connectedness. However, we should recognize that the impact was well on its way before the COVID-19 crisis. It is my opinion that psychiatry should champion the issue of human relations. I do not think that we need to wait for a new DSM diagnosis, an evidence-based paradigm, or a Food and Drug Administration–approved medication to do so. The COVID-19 crisis has rendered us all cognizant of the importance of relationships.

While it may be that psychiatry continues to foray in electronic means of communication, use of impersonal scales and diagnosis, as well as anonymized algorithmic treatment plans, we should also promote as much humanity as society and public health safety will permit. Getting dressed to see your psychiatrist, face to face, to have an open-ended conversation about the nature of one’s life has clearly become something precious and powerful that should be cherished and protected. My hope is the rules and mandates we are required to use during the pandemic today do not become a continued habit that result in further loneliness and disconnect. If we chose to, the lessons we learn today can, in fact, strengthen our appreciation and pursuit of human connection.
 

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Springer, 2019). He has no disclosures.

Prior to the current crisis of COVID-19, I had a critical view of the direction of our psychiatric field. We have given up on complicated psychotherapies in favor of dispensing medications. We have given up on complicated diagnostic assessments in favor of simple self-rated symptoms questionnaires. Many of us even chose to give up on seeing patients face to face in favor of practicing telepsychiatry in the comfort of our homes. Some even promoted a future of psychiatry in which psychiatrists treated patients through large spreadsheets of evidence-based rating tools following evidence-based algorithms without even ever meeting the patients.

I do not view this problem as unique to psychiatry but rather as part of a larger trend in society. For the past couple of years, Vivek Murthy, MD, the former U.S. surgeon general, has popularized the idea that we are in a loneliness epidemic, saying, “We live in the most technologically connected age in the history of civilization, yet rates of loneliness have doubled since the 1980s.” Despite having enumerable means to reach other human beings, so many of us feel distant and out of touch with others. This loneliness has a measurable impact on our well-being with one study that states, “Actual and perceived social isolation are both associated with increased risk for early mortality.”

Then, seemingly out of nowhere, we were confronted with the largest challenge to our sense of connectedness in my lifetime. Throughout the past months, we have been asked to meet each other less frequently, do so through sterile means, and certainly not shake hands, hug, or embrace. The COVID-19 crisis has quickly made us all experts in telepsychiatry, remote work, and doing more with less. The COVID-19 crisis has asked many of us to put aside some of our human rituals like eating together, enjoying artistic experiences as a group, and touching, for the sake of saving lives.

For many, socially distancing has been a considerable added stressor – a stressor that continues to test humanity’s ability to be resilient. I am saddened by prior patients reaching out to seek comfort in these difficult times. I am touched by their desire to reconnect with someone they know, someone who feels familiar. I am surprised by the power of connection through phone and video calls. For some patients, despite the added burden, the current crisis has been an opportunity for their mental health and a reminder of the things that are important, including calling old friends and staying in touch with those who matter the most.

Yet, as the social restrictions continue, the stressors mount and the resilience becomes harder to find. Checking in on others can become a chore. The social norm to partake in fashion, and self-care, become harder to find. In some cases, even hygiene and our health take a side role. The weekly phone visits with a therapist can feel just as mundane and repetitive as life. Sleep becomes harder to find, and food loses its taste. At this point, we realize the humanity that we lost in all this.

In the past couple of months, we have all become much more aware of the fragility of connectedness. However, we should recognize that the impact was well on its way before the COVID-19 crisis. It is my opinion that psychiatry should champion the issue of human relations. I do not think that we need to wait for a new DSM diagnosis, an evidence-based paradigm, or a Food and Drug Administration–approved medication to do so. The COVID-19 crisis has rendered us all cognizant of the importance of relationships.

While it may be that psychiatry continues to foray in electronic means of communication, use of impersonal scales and diagnosis, as well as anonymized algorithmic treatment plans, we should also promote as much humanity as society and public health safety will permit. Getting dressed to see your psychiatrist, face to face, to have an open-ended conversation about the nature of one’s life has clearly become something precious and powerful that should be cherished and protected. My hope is the rules and mandates we are required to use during the pandemic today do not become a continued habit that result in further loneliness and disconnect. If we chose to, the lessons we learn today can, in fact, strengthen our appreciation and pursuit of human connection.
 

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Springer, 2019). He has no disclosures.

A new consensus statement recommends monitoring antipsychotic blood levels, also known as therapeutic drug monitoring (TDM), to inform treatment decisions and optimize safety and efficacy.

The statement, jointly authored by experts from the American Society of Clinical Psychopharmacology (ASCP) and the Germany-based Therapeutic Drug Monitoring Task Force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie, recommends antipsychotic TDM, particularly for specific patient groups and for patients with suspected nonadherence.

“This [TDM] is a valuable and reliable instrument for personalizing treatment, which is an increasing focus today – individualizing and tailoring pharmacotherapy,” lead author Georgios Schoretsanitis, MD, PhD, department of psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, and Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, New York, said in an interview.

“I am particularly satisfied to say that this paper adds much knowledge and is a holistic approach, focusing not only on theoretical knowledge but also aiming to make the life of clinicians easier, providing more of an algorithm and decision-making instrument for clinical use in everyday clinical scenarios and problems related to antipsychotic treatment,” he added.

The study was published online May 19 in the Journal of Clinical Psychiatry.

Problem-solving tool

“The therapeutic reference range for antipsychotic levels in blood consists of a lower limit, below which therapeutic response is relatively unlikely, and an upper limit, above which ADRs [adverse drug reactions] … are more likely to occur,” the authors wrote.

TDM can determine whether a patient has a subtherapeutic antipsychotic blood concentration and may explain a lack of response or a supra-therapeutic concentration, which could be associated with adverse drug reactions.

“It is important for clinicians to realize that this type of monitoring is not equally indicated for all antipsychotics and not planned as a way of providing insight if there are no questions. In other words, it is a problem-solving tool for a problem, a complicated situation, or a challenging scenario you’re trying to solve,” Dr. Schoretsanitis said.

The authors divided their recommendations regarding routine TDM for antipsychotics into four categories, based on level of evidence:

Strongly recommended (Level 1)

• Clozapine
• Fluphenazine
• Haloperidol
• Olanzapine
• Perazine
• Perphenazine

Recommended (Level 2)

• Aripiprazole
• Chlorpromazine
• Flupentixol
• Paliperidone
• Quetiapine
• Risperidone
• Sertindole
• Ziprasidone

Useful (Level 3)

• Brexpiprazole
• Cariprazine
• Chlorprothixene
• Iloperidone
• Loxapine
• Lurasidone
• Melperone
• Pimozide

Potentially useful (Level 4)

• Asenapine

“We tried to narrow down specific situations and scenarios in which TDM can be useful and, in fact, has proven benefits,” said Dr. Schoretsanitis.

Patients who have no clinical response, even within established dose ranges, who have a recurrence or relapse during maintenance treatment, or who have ADRs are candidates for TDM.

Patients receiving polypharmacy can benefit from TDM because some coprescribed medications can raise or lower antipsychotic blood levels via overlapping metabolic pathways.

Additional populations requiring TDM are elderly patients, pregnant/lactating women, patients with medical comorbidities such as renal or hepatic disease, children/adolescents, patients with intellectual disabilities, and forensic or court-mandated patients.

Dr. Schoretsanitis noted that switching between formulations – for example from an oral to a long-acting injectable antipsychotic (LAI) – can “easily be guided by regular use of TDM,” as can switching from a brand name drug to a generic.

Patients with acute inflammatory conditions, such as COVID-19, “are good candidates for TDM, even with drugs that were previously well-tolerated, because inflammation affects the way the body metabolizes drugs, leaving patients at high risk for developing toxicity,” he added.

“The most common scenario for using TDM in clinical practice is to measure adherence to antipsychotics, since TDM is one of the most reliable ways to assess adherence and thereby prevent relapse or recurrence of the disease,” said Dr. Schoretsanitis.
 

Long overdue

Sheldon Preskorn, MD, professor of psychiatry, University of Kansas, Wichita, and chief science officer for KUSM-W Clinical Trials Unit, said in an interview that drawing blood 24 hours after taking the drug can help determine the patient’s clearance of the drug.

“If the level is too low, either the patient is not taking the drug at all, or is taking too little, or is a rapid metabolizer, so the dose may have to be adjusted,” said Dr. Preskorn, who was not involved in developing the consensus statement.

This is also an opportunity to initiate a conversation with patients regarding adherence, explaining that a low blood level will not have a therapeutic effect, discussing whether the patient has been taking the medication as prescribed, and addressing reasons for nonadherence, said Dr. Preskorn.

“We want to make it clear that clinicians should treat the patient, not the blood level,” said Dr. Schoretsanitis.

“If a person is tolerating and responding to medications well, but we measure and see something unexpected, such as low levels, this doesn’t mean we need to adjust the dose merely because the levels are low,” he added.

“Timing is very important” when measuring blood levels. For example, if a patient’s blood is usually tested in the morning but then is tested in the afternoon, he or she may exhibit a lower blood level, which may be reflective of the timing of the test rather than drug response.

“This statement is long overdue because TDM is probably the most underutilized tool in psychiatry for individualizing pharmacotherapy,” said Dr. Preskorn.

Also commenting on the consensus statement, Jonathan Meyer, MD, clinical professor of psychiatry, University of California, San Diego, said it brings attention to some of the key issues associated with antipsychotic plasma monitoring and shows TDM is a valuable decision-making tool.

Dr. Meyer, who was not involved in developing the document, pointed out that it may be difficult to obtain levels on newer antipsychotics, which require specialized labs that are not widely available and sometimes take up to 2 weeks to get results.

In such cases, physicians will have to rely on their best clinical judgment to manage an inadequate response until TDM results are available.

No commercial organizations had any role in funding the statement. Dr. Schoretsanitis has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Meyer reports having received speaking or advising fees in the prior 12 months from Acadia Pharmaceuticals, Alkermes, Allergan (now AbbVie), Intra-Cellular Therapies, Janssen Pharmaceutica, Neurocrine, Otsuka America Inc., Sunovion Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. Dr. Preskorn reports having been an investigator and/or a consultant to more than 140 pharmaceutical, biotechnology, diagnostic, and device companies and to the Food and Drug Administration and other federal agencies.
 

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

A new consensus statement recommends monitoring antipsychotic blood levels, also known as therapeutic drug monitoring (TDM), to inform treatment decisions and optimize safety and efficacy.

The statement, jointly authored by experts from the American Society of Clinical Psychopharmacology (ASCP) and the Germany-based Therapeutic Drug Monitoring Task Force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie, recommends antipsychotic TDM, particularly for specific patient groups and for patients with suspected nonadherence.

“This [TDM] is a valuable and reliable instrument for personalizing treatment, which is an increasing focus today – individualizing and tailoring pharmacotherapy,” lead author Georgios Schoretsanitis, MD, PhD, department of psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, and Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, New York, said in an interview.

“I am particularly satisfied to say that this paper adds much knowledge and is a holistic approach, focusing not only on theoretical knowledge but also aiming to make the life of clinicians easier, providing more of an algorithm and decision-making instrument for clinical use in everyday clinical scenarios and problems related to antipsychotic treatment,” he added.

The study was published online May 19 in the Journal of Clinical Psychiatry.

Problem-solving tool

“The therapeutic reference range for antipsychotic levels in blood consists of a lower limit, below which therapeutic response is relatively unlikely, and an upper limit, above which ADRs [adverse drug reactions] … are more likely to occur,” the authors wrote.

TDM can determine whether a patient has a subtherapeutic antipsychotic blood concentration and may explain a lack of response or a supra-therapeutic concentration, which could be associated with adverse drug reactions.

“It is important for clinicians to realize that this type of monitoring is not equally indicated for all antipsychotics and not planned as a way of providing insight if there are no questions. In other words, it is a problem-solving tool for a problem, a complicated situation, or a challenging scenario you’re trying to solve,” Dr. Schoretsanitis said.

The authors divided their recommendations regarding routine TDM for antipsychotics into four categories, based on level of evidence:

Strongly recommended (Level 1)

• Clozapine
• Fluphenazine
• Haloperidol
• Olanzapine
• Perazine
• Perphenazine

Recommended (Level 2)

• Aripiprazole
• Chlorpromazine
• Flupentixol
• Paliperidone
• Quetiapine
• Risperidone
• Sertindole
• Ziprasidone

Useful (Level 3)

• Brexpiprazole
• Cariprazine
• Chlorprothixene
• Iloperidone
• Loxapine
• Lurasidone
• Melperone
• Pimozide

Potentially useful (Level 4)

• Asenapine

“We tried to narrow down specific situations and scenarios in which TDM can be useful and, in fact, has proven benefits,” said Dr. Schoretsanitis.

Patients who have no clinical response, even within established dose ranges, who have a recurrence or relapse during maintenance treatment, or who have ADRs are candidates for TDM.

Patients receiving polypharmacy can benefit from TDM because some coprescribed medications can raise or lower antipsychotic blood levels via overlapping metabolic pathways.

Additional populations requiring TDM are elderly patients, pregnant/lactating women, patients with medical comorbidities such as renal or hepatic disease, children/adolescents, patients with intellectual disabilities, and forensic or court-mandated patients.

Dr. Schoretsanitis noted that switching between formulations – for example from an oral to a long-acting injectable antipsychotic (LAI) – can “easily be guided by regular use of TDM,” as can switching from a brand name drug to a generic.

Patients with acute inflammatory conditions, such as COVID-19, “are good candidates for TDM, even with drugs that were previously well-tolerated, because inflammation affects the way the body metabolizes drugs, leaving patients at high risk for developing toxicity,” he added.

“The most common scenario for using TDM in clinical practice is to measure adherence to antipsychotics, since TDM is one of the most reliable ways to assess adherence and thereby prevent relapse or recurrence of the disease,” said Dr. Schoretsanitis.
 

Long overdue

Sheldon Preskorn, MD, professor of psychiatry, University of Kansas, Wichita, and chief science officer for KUSM-W Clinical Trials Unit, said in an interview that drawing blood 24 hours after taking the drug can help determine the patient’s clearance of the drug.

“If the level is too low, either the patient is not taking the drug at all, or is taking too little, or is a rapid metabolizer, so the dose may have to be adjusted,” said Dr. Preskorn, who was not involved in developing the consensus statement.

This is also an opportunity to initiate a conversation with patients regarding adherence, explaining that a low blood level will not have a therapeutic effect, discussing whether the patient has been taking the medication as prescribed, and addressing reasons for nonadherence, said Dr. Preskorn.

“We want to make it clear that clinicians should treat the patient, not the blood level,” said Dr. Schoretsanitis.

“If a person is tolerating and responding to medications well, but we measure and see something unexpected, such as low levels, this doesn’t mean we need to adjust the dose merely because the levels are low,” he added.

“Timing is very important” when measuring blood levels. For example, if a patient’s blood is usually tested in the morning but then is tested in the afternoon, he or she may exhibit a lower blood level, which may be reflective of the timing of the test rather than drug response.

“This statement is long overdue because TDM is probably the most underutilized tool in psychiatry for individualizing pharmacotherapy,” said Dr. Preskorn.

Also commenting on the consensus statement, Jonathan Meyer, MD, clinical professor of psychiatry, University of California, San Diego, said it brings attention to some of the key issues associated with antipsychotic plasma monitoring and shows TDM is a valuable decision-making tool.

Dr. Meyer, who was not involved in developing the document, pointed out that it may be difficult to obtain levels on newer antipsychotics, which require specialized labs that are not widely available and sometimes take up to 2 weeks to get results.

In such cases, physicians will have to rely on their best clinical judgment to manage an inadequate response until TDM results are available.

No commercial organizations had any role in funding the statement. Dr. Schoretsanitis has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Meyer reports having received speaking or advising fees in the prior 12 months from Acadia Pharmaceuticals, Alkermes, Allergan (now AbbVie), Intra-Cellular Therapies, Janssen Pharmaceutica, Neurocrine, Otsuka America Inc., Sunovion Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. Dr. Preskorn reports having been an investigator and/or a consultant to more than 140 pharmaceutical, biotechnology, diagnostic, and device companies and to the Food and Drug Administration and other federal agencies.
 

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

A new consensus statement recommends monitoring antipsychotic blood levels, also known as therapeutic drug monitoring (TDM), to inform treatment decisions and optimize safety and efficacy.

The statement, jointly authored by experts from the American Society of Clinical Psychopharmacology (ASCP) and the Germany-based Therapeutic Drug Monitoring Task Force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie, recommends antipsychotic TDM, particularly for specific patient groups and for patients with suspected nonadherence.

“This [TDM] is a valuable and reliable instrument for personalizing treatment, which is an increasing focus today – individualizing and tailoring pharmacotherapy,” lead author Georgios Schoretsanitis, MD, PhD, department of psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, and Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, New York, said in an interview.

“I am particularly satisfied to say that this paper adds much knowledge and is a holistic approach, focusing not only on theoretical knowledge but also aiming to make the life of clinicians easier, providing more of an algorithm and decision-making instrument for clinical use in everyday clinical scenarios and problems related to antipsychotic treatment,” he added.

The study was published online May 19 in the Journal of Clinical Psychiatry.

Problem-solving tool

“The therapeutic reference range for antipsychotic levels in blood consists of a lower limit, below which therapeutic response is relatively unlikely, and an upper limit, above which ADRs [adverse drug reactions] … are more likely to occur,” the authors wrote.

TDM can determine whether a patient has a subtherapeutic antipsychotic blood concentration and may explain a lack of response or a supra-therapeutic concentration, which could be associated with adverse drug reactions.

“It is important for clinicians to realize that this type of monitoring is not equally indicated for all antipsychotics and not planned as a way of providing insight if there are no questions. In other words, it is a problem-solving tool for a problem, a complicated situation, or a challenging scenario you’re trying to solve,” Dr. Schoretsanitis said.

The authors divided their recommendations regarding routine TDM for antipsychotics into four categories, based on level of evidence:

Strongly recommended (Level 1)

• Clozapine
• Fluphenazine
• Haloperidol
• Olanzapine
• Perazine
• Perphenazine

Recommended (Level 2)

• Aripiprazole
• Chlorpromazine
• Flupentixol
• Paliperidone
• Quetiapine
• Risperidone
• Sertindole
• Ziprasidone

Useful (Level 3)

• Brexpiprazole
• Cariprazine
• Chlorprothixene
• Iloperidone
• Loxapine
• Lurasidone
• Melperone
• Pimozide

Potentially useful (Level 4)

• Asenapine

“We tried to narrow down specific situations and scenarios in which TDM can be useful and, in fact, has proven benefits,” said Dr. Schoretsanitis.

Patients who have no clinical response, even within established dose ranges, who have a recurrence or relapse during maintenance treatment, or who have ADRs are candidates for TDM.

Patients receiving polypharmacy can benefit from TDM because some coprescribed medications can raise or lower antipsychotic blood levels via overlapping metabolic pathways.

Additional populations requiring TDM are elderly patients, pregnant/lactating women, patients with medical comorbidities such as renal or hepatic disease, children/adolescents, patients with intellectual disabilities, and forensic or court-mandated patients.

Dr. Schoretsanitis noted that switching between formulations – for example from an oral to a long-acting injectable antipsychotic (LAI) – can “easily be guided by regular use of TDM,” as can switching from a brand name drug to a generic.

Patients with acute inflammatory conditions, such as COVID-19, “are good candidates for TDM, even with drugs that were previously well-tolerated, because inflammation affects the way the body metabolizes drugs, leaving patients at high risk for developing toxicity,” he added.

“The most common scenario for using TDM in clinical practice is to measure adherence to antipsychotics, since TDM is one of the most reliable ways to assess adherence and thereby prevent relapse or recurrence of the disease,” said Dr. Schoretsanitis.
 

Long overdue

Sheldon Preskorn, MD, professor of psychiatry, University of Kansas, Wichita, and chief science officer for KUSM-W Clinical Trials Unit, said in an interview that drawing blood 24 hours after taking the drug can help determine the patient’s clearance of the drug.

“If the level is too low, either the patient is not taking the drug at all, or is taking too little, or is a rapid metabolizer, so the dose may have to be adjusted,” said Dr. Preskorn, who was not involved in developing the consensus statement.

This is also an opportunity to initiate a conversation with patients regarding adherence, explaining that a low blood level will not have a therapeutic effect, discussing whether the patient has been taking the medication as prescribed, and addressing reasons for nonadherence, said Dr. Preskorn.

“We want to make it clear that clinicians should treat the patient, not the blood level,” said Dr. Schoretsanitis.

“If a person is tolerating and responding to medications well, but we measure and see something unexpected, such as low levels, this doesn’t mean we need to adjust the dose merely because the levels are low,” he added.

“Timing is very important” when measuring blood levels. For example, if a patient’s blood is usually tested in the morning but then is tested in the afternoon, he or she may exhibit a lower blood level, which may be reflective of the timing of the test rather than drug response.

“This statement is long overdue because TDM is probably the most underutilized tool in psychiatry for individualizing pharmacotherapy,” said Dr. Preskorn.

Also commenting on the consensus statement, Jonathan Meyer, MD, clinical professor of psychiatry, University of California, San Diego, said it brings attention to some of the key issues associated with antipsychotic plasma monitoring and shows TDM is a valuable decision-making tool.

Dr. Meyer, who was not involved in developing the document, pointed out that it may be difficult to obtain levels on newer antipsychotics, which require specialized labs that are not widely available and sometimes take up to 2 weeks to get results.

In such cases, physicians will have to rely on their best clinical judgment to manage an inadequate response until TDM results are available.

No commercial organizations had any role in funding the statement. Dr. Schoretsanitis has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. Meyer reports having received speaking or advising fees in the prior 12 months from Acadia Pharmaceuticals, Alkermes, Allergan (now AbbVie), Intra-Cellular Therapies, Janssen Pharmaceutica, Neurocrine, Otsuka America Inc., Sunovion Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. Dr. Preskorn reports having been an investigator and/or a consultant to more than 140 pharmaceutical, biotechnology, diagnostic, and device companies and to the Food and Drug Administration and other federal agencies.
 

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