The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

FROM THE LANCET PSYCHIATRY

Cessation of opioid agonist therapy (OAT) significantly increases the risk of self-harm and death by suicide in the first month after stopping the treatment in new findings that highlight the need for “advanced safety planning” during this critical time.

Investigators found that 4 weeks after stopping OAT, the risk of death by suicide was almost five times higher and the risk of hospital admission for self-harm was almost three times higher during this period, compared with the 4 weeks after initiation of OAT to treatment end.

These results highlight the importance of a “transition” period when stopping OAT and highlight the need for better supports for patients coming off this treatment, study investigator Prianka Padmanathan, MD, PhD candidate, Population Health Sciences, University of Bristol (England), told this news organization.

She noted the study supports previous findings that OAT “has an important role” in suicide prevention.

“Suicide and self-harm risk is greatly increased during treatment cessation, and advanced safety planning and additional psychosocial support during this time may be required,” Dr. Padmanathan said.

The findings were published online Dec. 15 in The Lancet Psychiatry.

Suicide, self-harm risk

Previous research shows an increased risk for overdose deaths and death in general during the first few weeks of starting and stopping treatment for opioid dependence.

“We wanted to see if the risk of dying by suicide was also elevated during these times,” said Dr. Padmanathan. As suicides are relatively rare, the researchers also looked at self-harm, “which is an important risk factor for suicide.”

The investigators used linked health care databases to gather information on mortality and hospital admissions among primary care patients in England prescribed OAT, particularly buprenorphine or methadone.

“We tried to exclude people prescribed these drugs for pain and focused specifically on their prescription for opioid dependence,” Dr. Padmanathan said.

They estimated rates and adjusted risk ratios of hospital admissions for nonfatal self-harm and completed suicide during treatment initiation, maintenance, and cessation.

The study included 8,070 patients (69.3% men; mean baseline age, 33.3 years) who received OAT at least once from January 1998 through November 2018. The median treatment time was 84 days. Most of the participants lived in the most deprived neighborhoods and were White.

There were 807 hospital admissions for self-harm (1.99 per 100 person-years) and 46 suicides (0.11 per 100 person-years).

The investigators examined age, sex, socioeconomic status, number of previous OAT treatment episodes, previous self-harm, previous mental illness, and major chronic illness scores as potential confounders.

Need for psychosocial care

Results showed the risk for self-harm was significantly increased while off OAT (aRR, 1.5; 95% confidence interval, 1.21-1.88).

The overall age- and sex-standardized mortality ratio for suicide was 7.5 times higher (95% CI, 5.5-10) in the study cohort, compared with the general population in England between 1998 and 2017.

There was insufficient evidence to show the risk for suicide was higher off, versus on, treatment, but this may be because suicides are relatively rare, Dr. Padmanathan noted.

“The sample may have been too small to enable a difference to be detected. In contrast, self-harm is more common, so there was power to detect a difference there,” she said.

Risk for self-harm was more than double in the first 4 weeks after stopping OAT versus stable periods on treatment (aRR, 2.60; 95% CI, 1.83-3.7). Risk for suicide more than quadrupled during this period (aRR, 4.68; 95% CI, 1.63-13.42).

These new results suggest additional interventions may be in order, Dr. Padmanathan noted.

“We already knew that extra care – for example, providing naloxone when coming off OAT – was important to prevent overdoses. But this study suggests providing psychosocial care and other extra care may also be important to prevent suicides,” she said.

There was no statistical evidence of difference between buprenorphine and methadone in terms of self-harm and suicide risks. However, this may be because the sample was not large enough to detect a difference, said Dr. Padmanathan.

Although there are currently no guidelines to indicate an ideal OAT period, previous study results have suggested extending treatment to 2 years may be beneficial, perhaps reducing self-harm and, therefore, suicides, she noted.

“We think most of these adverse outcomes likely occur during short treatment episodes with an unplanned ending. Extending OAT sufficiently to enable a planned ending might help to reduce these risks,” she added.

‘A window of vulnerability’

Authors of an accompanying editorial note the study “adds weight” to the evidence that OAT is a “lifesaving” treatment.

“It’s critical to recognize that transitions in and out of care are vulnerable periods” when it comes to suicide, the coauthor of the editorial, Paul S. Nestadt, MD, department of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, told this news organization.

Official suicide statistics may not reflect the entire story, as many deaths that occur because of overdose after treatment cessation are not counted as suicides, he said. “It can be difficult for medical examiners to determine if an overdose was intentional or not,” Dr. Nestadt added.

After treatment has been established, physicians “would be wise to delay treatment cessation” until the patient is in a stable condition and can be closely followed by mental health professionals, the editorialists note.

“We must consider the month following OAT cessation to be a window of vulnerability, not just for relapse but also for suicide,” they write.

The finding that patients prescribed OAT have such a high rate of suicide, compared with the general population, is “troubling” and “highlights the importance of interventions which address both opioid use and suicide risk,” they add.

The editorialists point out the median treatment period of 84 days is less than what is generally recommended, raising the question of whether longer treatment might lower suicide risk after treatment discontinuation.

They also emphasized the need for further study to test potential suicide prevention interventions in the period after treatment cessation.

Dr. Nestadt added the new findings are “quite generalizable outside of the U.K.” and referred to similar studies carried out in Australia and elsewhere.

The study was funded by the Medical Research Council. Dr. Padmanathan was a coapplicant on an a grant awarded to University of Bristol by Bristol and Weston Hospital Charity focusing on suicide prevention for patients presenting to the emergency department with self-harm and harmful substance use. Dr. Nestadt has reported no relevant financial relationships.

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

FROM THE LANCET PSYCHIATRY

Cessation of opioid agonist therapy (OAT) significantly increases the risk of self-harm and death by suicide in the first month after stopping the treatment in new findings that highlight the need for “advanced safety planning” during this critical time.

Investigators found that 4 weeks after stopping OAT, the risk of death by suicide was almost five times higher and the risk of hospital admission for self-harm was almost three times higher during this period, compared with the 4 weeks after initiation of OAT to treatment end.

These results highlight the importance of a “transition” period when stopping OAT and highlight the need for better supports for patients coming off this treatment, study investigator Prianka Padmanathan, MD, PhD candidate, Population Health Sciences, University of Bristol (England), told this news organization.

She noted the study supports previous findings that OAT “has an important role” in suicide prevention.

“Suicide and self-harm risk is greatly increased during treatment cessation, and advanced safety planning and additional psychosocial support during this time may be required,” Dr. Padmanathan said.

The findings were published online Dec. 15 in The Lancet Psychiatry.

Suicide, self-harm risk

Previous research shows an increased risk for overdose deaths and death in general during the first few weeks of starting and stopping treatment for opioid dependence.

“We wanted to see if the risk of dying by suicide was also elevated during these times,” said Dr. Padmanathan. As suicides are relatively rare, the researchers also looked at self-harm, “which is an important risk factor for suicide.”

The investigators used linked health care databases to gather information on mortality and hospital admissions among primary care patients in England prescribed OAT, particularly buprenorphine or methadone.

“We tried to exclude people prescribed these drugs for pain and focused specifically on their prescription for opioid dependence,” Dr. Padmanathan said.

They estimated rates and adjusted risk ratios of hospital admissions for nonfatal self-harm and completed suicide during treatment initiation, maintenance, and cessation.

The study included 8,070 patients (69.3% men; mean baseline age, 33.3 years) who received OAT at least once from January 1998 through November 2018. The median treatment time was 84 days. Most of the participants lived in the most deprived neighborhoods and were White.

There were 807 hospital admissions for self-harm (1.99 per 100 person-years) and 46 suicides (0.11 per 100 person-years).

The investigators examined age, sex, socioeconomic status, number of previous OAT treatment episodes, previous self-harm, previous mental illness, and major chronic illness scores as potential confounders.

Need for psychosocial care

Results showed the risk for self-harm was significantly increased while off OAT (aRR, 1.5; 95% confidence interval, 1.21-1.88).

The overall age- and sex-standardized mortality ratio for suicide was 7.5 times higher (95% CI, 5.5-10) in the study cohort, compared with the general population in England between 1998 and 2017.

There was insufficient evidence to show the risk for suicide was higher off, versus on, treatment, but this may be because suicides are relatively rare, Dr. Padmanathan noted.

“The sample may have been too small to enable a difference to be detected. In contrast, self-harm is more common, so there was power to detect a difference there,” she said.

Risk for self-harm was more than double in the first 4 weeks after stopping OAT versus stable periods on treatment (aRR, 2.60; 95% CI, 1.83-3.7). Risk for suicide more than quadrupled during this period (aRR, 4.68; 95% CI, 1.63-13.42).

These new results suggest additional interventions may be in order, Dr. Padmanathan noted.

“We already knew that extra care – for example, providing naloxone when coming off OAT – was important to prevent overdoses. But this study suggests providing psychosocial care and other extra care may also be important to prevent suicides,” she said.

There was no statistical evidence of difference between buprenorphine and methadone in terms of self-harm and suicide risks. However, this may be because the sample was not large enough to detect a difference, said Dr. Padmanathan.

Although there are currently no guidelines to indicate an ideal OAT period, previous study results have suggested extending treatment to 2 years may be beneficial, perhaps reducing self-harm and, therefore, suicides, she noted.

“We think most of these adverse outcomes likely occur during short treatment episodes with an unplanned ending. Extending OAT sufficiently to enable a planned ending might help to reduce these risks,” she added.

‘A window of vulnerability’

Authors of an accompanying editorial note the study “adds weight” to the evidence that OAT is a “lifesaving” treatment.

“It’s critical to recognize that transitions in and out of care are vulnerable periods” when it comes to suicide, the coauthor of the editorial, Paul S. Nestadt, MD, department of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, told this news organization.

Official suicide statistics may not reflect the entire story, as many deaths that occur because of overdose after treatment cessation are not counted as suicides, he said. “It can be difficult for medical examiners to determine if an overdose was intentional or not,” Dr. Nestadt added.

After treatment has been established, physicians “would be wise to delay treatment cessation” until the patient is in a stable condition and can be closely followed by mental health professionals, the editorialists note.

“We must consider the month following OAT cessation to be a window of vulnerability, not just for relapse but also for suicide,” they write.

The finding that patients prescribed OAT have such a high rate of suicide, compared with the general population, is “troubling” and “highlights the importance of interventions which address both opioid use and suicide risk,” they add.

The editorialists point out the median treatment period of 84 days is less than what is generally recommended, raising the question of whether longer treatment might lower suicide risk after treatment discontinuation.

They also emphasized the need for further study to test potential suicide prevention interventions in the period after treatment cessation.

Dr. Nestadt added the new findings are “quite generalizable outside of the U.K.” and referred to similar studies carried out in Australia and elsewhere.

The study was funded by the Medical Research Council. Dr. Padmanathan was a coapplicant on an a grant awarded to University of Bristol by Bristol and Weston Hospital Charity focusing on suicide prevention for patients presenting to the emergency department with self-harm and harmful substance use. Dr. Nestadt has reported no relevant financial relationships.

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

FROM THE LANCET PSYCHIATRY

Cessation of opioid agonist therapy (OAT) significantly increases the risk of self-harm and death by suicide in the first month after stopping the treatment in new findings that highlight the need for “advanced safety planning” during this critical time.

Investigators found that 4 weeks after stopping OAT, the risk of death by suicide was almost five times higher and the risk of hospital admission for self-harm was almost three times higher during this period, compared with the 4 weeks after initiation of OAT to treatment end.

These results highlight the importance of a “transition” period when stopping OAT and highlight the need for better supports for patients coming off this treatment, study investigator Prianka Padmanathan, MD, PhD candidate, Population Health Sciences, University of Bristol (England), told this news organization.

She noted the study supports previous findings that OAT “has an important role” in suicide prevention.

“Suicide and self-harm risk is greatly increased during treatment cessation, and advanced safety planning and additional psychosocial support during this time may be required,” Dr. Padmanathan said.

The findings were published online Dec. 15 in The Lancet Psychiatry.

Suicide, self-harm risk

Previous research shows an increased risk for overdose deaths and death in general during the first few weeks of starting and stopping treatment for opioid dependence.

“We wanted to see if the risk of dying by suicide was also elevated during these times,” said Dr. Padmanathan. As suicides are relatively rare, the researchers also looked at self-harm, “which is an important risk factor for suicide.”

The investigators used linked health care databases to gather information on mortality and hospital admissions among primary care patients in England prescribed OAT, particularly buprenorphine or methadone.

“We tried to exclude people prescribed these drugs for pain and focused specifically on their prescription for opioid dependence,” Dr. Padmanathan said.

They estimated rates and adjusted risk ratios of hospital admissions for nonfatal self-harm and completed suicide during treatment initiation, maintenance, and cessation.

The study included 8,070 patients (69.3% men; mean baseline age, 33.3 years) who received OAT at least once from January 1998 through November 2018. The median treatment time was 84 days. Most of the participants lived in the most deprived neighborhoods and were White.

There were 807 hospital admissions for self-harm (1.99 per 100 person-years) and 46 suicides (0.11 per 100 person-years).

The investigators examined age, sex, socioeconomic status, number of previous OAT treatment episodes, previous self-harm, previous mental illness, and major chronic illness scores as potential confounders.

Need for psychosocial care

Results showed the risk for self-harm was significantly increased while off OAT (aRR, 1.5; 95% confidence interval, 1.21-1.88).

The overall age- and sex-standardized mortality ratio for suicide was 7.5 times higher (95% CI, 5.5-10) in the study cohort, compared with the general population in England between 1998 and 2017.

There was insufficient evidence to show the risk for suicide was higher off, versus on, treatment, but this may be because suicides are relatively rare, Dr. Padmanathan noted.

“The sample may have been too small to enable a difference to be detected. In contrast, self-harm is more common, so there was power to detect a difference there,” she said.

Risk for self-harm was more than double in the first 4 weeks after stopping OAT versus stable periods on treatment (aRR, 2.60; 95% CI, 1.83-3.7). Risk for suicide more than quadrupled during this period (aRR, 4.68; 95% CI, 1.63-13.42).

These new results suggest additional interventions may be in order, Dr. Padmanathan noted.

“We already knew that extra care – for example, providing naloxone when coming off OAT – was important to prevent overdoses. But this study suggests providing psychosocial care and other extra care may also be important to prevent suicides,” she said.

There was no statistical evidence of difference between buprenorphine and methadone in terms of self-harm and suicide risks. However, this may be because the sample was not large enough to detect a difference, said Dr. Padmanathan.

Although there are currently no guidelines to indicate an ideal OAT period, previous study results have suggested extending treatment to 2 years may be beneficial, perhaps reducing self-harm and, therefore, suicides, she noted.

“We think most of these adverse outcomes likely occur during short treatment episodes with an unplanned ending. Extending OAT sufficiently to enable a planned ending might help to reduce these risks,” she added.

‘A window of vulnerability’

Authors of an accompanying editorial note the study “adds weight” to the evidence that OAT is a “lifesaving” treatment.

“It’s critical to recognize that transitions in and out of care are vulnerable periods” when it comes to suicide, the coauthor of the editorial, Paul S. Nestadt, MD, department of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, told this news organization.

Official suicide statistics may not reflect the entire story, as many deaths that occur because of overdose after treatment cessation are not counted as suicides, he said. “It can be difficult for medical examiners to determine if an overdose was intentional or not,” Dr. Nestadt added.

After treatment has been established, physicians “would be wise to delay treatment cessation” until the patient is in a stable condition and can be closely followed by mental health professionals, the editorialists note.

“We must consider the month following OAT cessation to be a window of vulnerability, not just for relapse but also for suicide,” they write.

The finding that patients prescribed OAT have such a high rate of suicide, compared with the general population, is “troubling” and “highlights the importance of interventions which address both opioid use and suicide risk,” they add.

The editorialists point out the median treatment period of 84 days is less than what is generally recommended, raising the question of whether longer treatment might lower suicide risk after treatment discontinuation.

They also emphasized the need for further study to test potential suicide prevention interventions in the period after treatment cessation.

Dr. Nestadt added the new findings are “quite generalizable outside of the U.K.” and referred to similar studies carried out in Australia and elsewhere.

The study was funded by the Medical Research Council. Dr. Padmanathan was a coapplicant on an a grant awarded to University of Bristol by Bristol and Weston Hospital Charity focusing on suicide prevention for patients presenting to the emergency department with self-harm and harmful substance use. Dr. Nestadt has reported no relevant financial relationships.

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

Low vitamin D is common in patients with first-episode psychosis (FEP), but supplementation does not appear to improve mental or physical symptoms, new data show.

“Previous work, our own and others, has shown that people with psychosis, even soon after their first diagnosis, have low vitamin D levels, but it was not known whether supplementing with vitamin D in people with early psychosis would improve health outcomes,” study investigator Fiona Gaughran, MD, with the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, told this news organization.

“While we did not demonstrate a benefit of supplementation over 6 months, these very high rates of vitamin deficiency and insufficiency may have longer-term negative health impacts which we have not measured, so raising awareness of the need to optimize vitamin D in people with psychosis is important,” said Dr. Gaughran.

The results of the randomized clinical trial were published online Dec. 28 in JAMA Network Open.

Thoughtful approach, negative result

Participants included 149 adults within 3 years of a first presentation with a functional psychotic disorder. The cohort’s mean age was 28 years, 60% were men, 44% were Black or of other racial and ethnic minority groups, and 56% were White.

Seventy-five participants were randomly assigned to receive 120,000 IU of cholecalciferol or matching placebo administered by the researchers in monthly doses with an oral syringe.

“We chose a dose of 120,000 IU monthly (equivalent to 4,000 IU daily) which was expected to safely increase vitamin D levels. The regimen was discussed with experts with lived experience, and took into account that a daily preparation would add to the significant medication load that people with psychosis already carry,” said Dr. Gaughran.

Vitamin D supplementation as administered in this study was safe and led to a significant increase in 25-hydroxyvitamin D concentrations.

However, there was no significant difference between vitamin D and placebo in the primary outcome of total Positive and Negative Syndrome Scale (PANSS) score at 6 months (mean difference, 3.57; 95% confidence interval, –1.11 to 8.25; P = .13).

There was also no apparent benefit of vitamin D supplementation on any secondary outcome, including the PANSS subscores of global function and depression or cardiometabolic risk factors.

“With respect to clinical practice, we cannot now recommend monthly treatments with 120,000 IU of cholecalciferol in FEP,” the investigators note.

The prevalence of vitamin D insufficiency and deficiency was high in the population – 74.6% overall and 93.4% among ethnic minorities.

“Thus, the sample was well suited to detecting any potential benefits that may have arisen from correcting this. However, even in this subgroup, there was no evidence to support the guiding hypothesis” that vitamin D supplementation would improve outcomes in patients with early psychosis, the researchers note.

They suggest that future studies examine the association of vitamin D with brain-related outcomes based on periods of treatment longer than 6 months and administered as daily rather than bolus treatments.

“Future public health strategies should acknowledge the high prevalence of vitamin D insufficiency and deficiency in people with psychosis and consider any reasonable adjustments which may be needed to address this over and above general population guidance,” said Dr. Gaughran.

The study was funded by the Stanley Medical Research Institute and received support from the National Institute for Health Research Maudsley Biomedical Research Centre, King’s College London, and the NIHR Applied Research Collaboration South London. Dr. Gaughran reported receiving speaking honoraria from Otsuka Lundbeck outside the submitted work. A complete list of author disclosures is available with the original article.

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

Low vitamin D is common in patients with first-episode psychosis (FEP), but supplementation does not appear to improve mental or physical symptoms, new data show.

“Previous work, our own and others, has shown that people with psychosis, even soon after their first diagnosis, have low vitamin D levels, but it was not known whether supplementing with vitamin D in people with early psychosis would improve health outcomes,” study investigator Fiona Gaughran, MD, with the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, told this news organization.

“While we did not demonstrate a benefit of supplementation over 6 months, these very high rates of vitamin deficiency and insufficiency may have longer-term negative health impacts which we have not measured, so raising awareness of the need to optimize vitamin D in people with psychosis is important,” said Dr. Gaughran.

The results of the randomized clinical trial were published online Dec. 28 in JAMA Network Open.

Thoughtful approach, negative result

Participants included 149 adults within 3 years of a first presentation with a functional psychotic disorder. The cohort’s mean age was 28 years, 60% were men, 44% were Black or of other racial and ethnic minority groups, and 56% were White.

Seventy-five participants were randomly assigned to receive 120,000 IU of cholecalciferol or matching placebo administered by the researchers in monthly doses with an oral syringe.

“We chose a dose of 120,000 IU monthly (equivalent to 4,000 IU daily) which was expected to safely increase vitamin D levels. The regimen was discussed with experts with lived experience, and took into account that a daily preparation would add to the significant medication load that people with psychosis already carry,” said Dr. Gaughran.

Vitamin D supplementation as administered in this study was safe and led to a significant increase in 25-hydroxyvitamin D concentrations.

However, there was no significant difference between vitamin D and placebo in the primary outcome of total Positive and Negative Syndrome Scale (PANSS) score at 6 months (mean difference, 3.57; 95% confidence interval, –1.11 to 8.25; P = .13).

There was also no apparent benefit of vitamin D supplementation on any secondary outcome, including the PANSS subscores of global function and depression or cardiometabolic risk factors.

“With respect to clinical practice, we cannot now recommend monthly treatments with 120,000 IU of cholecalciferol in FEP,” the investigators note.

The prevalence of vitamin D insufficiency and deficiency was high in the population – 74.6% overall and 93.4% among ethnic minorities.

“Thus, the sample was well suited to detecting any potential benefits that may have arisen from correcting this. However, even in this subgroup, there was no evidence to support the guiding hypothesis” that vitamin D supplementation would improve outcomes in patients with early psychosis, the researchers note.

They suggest that future studies examine the association of vitamin D with brain-related outcomes based on periods of treatment longer than 6 months and administered as daily rather than bolus treatments.

“Future public health strategies should acknowledge the high prevalence of vitamin D insufficiency and deficiency in people with psychosis and consider any reasonable adjustments which may be needed to address this over and above general population guidance,” said Dr. Gaughran.

The study was funded by the Stanley Medical Research Institute and received support from the National Institute for Health Research Maudsley Biomedical Research Centre, King’s College London, and the NIHR Applied Research Collaboration South London. Dr. Gaughran reported receiving speaking honoraria from Otsuka Lundbeck outside the submitted work. A complete list of author disclosures is available with the original article.

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

Low vitamin D is common in patients with first-episode psychosis (FEP), but supplementation does not appear to improve mental or physical symptoms, new data show.

“Previous work, our own and others, has shown that people with psychosis, even soon after their first diagnosis, have low vitamin D levels, but it was not known whether supplementing with vitamin D in people with early psychosis would improve health outcomes,” study investigator Fiona Gaughran, MD, with the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, told this news organization.

“While we did not demonstrate a benefit of supplementation over 6 months, these very high rates of vitamin deficiency and insufficiency may have longer-term negative health impacts which we have not measured, so raising awareness of the need to optimize vitamin D in people with psychosis is important,” said Dr. Gaughran.

The results of the randomized clinical trial were published online Dec. 28 in JAMA Network Open.

Thoughtful approach, negative result

Participants included 149 adults within 3 years of a first presentation with a functional psychotic disorder. The cohort’s mean age was 28 years, 60% were men, 44% were Black or of other racial and ethnic minority groups, and 56% were White.

Seventy-five participants were randomly assigned to receive 120,000 IU of cholecalciferol or matching placebo administered by the researchers in monthly doses with an oral syringe.

“We chose a dose of 120,000 IU monthly (equivalent to 4,000 IU daily) which was expected to safely increase vitamin D levels. The regimen was discussed with experts with lived experience, and took into account that a daily preparation would add to the significant medication load that people with psychosis already carry,” said Dr. Gaughran.

Vitamin D supplementation as administered in this study was safe and led to a significant increase in 25-hydroxyvitamin D concentrations.

However, there was no significant difference between vitamin D and placebo in the primary outcome of total Positive and Negative Syndrome Scale (PANSS) score at 6 months (mean difference, 3.57; 95% confidence interval, –1.11 to 8.25; P = .13).

There was also no apparent benefit of vitamin D supplementation on any secondary outcome, including the PANSS subscores of global function and depression or cardiometabolic risk factors.

“With respect to clinical practice, we cannot now recommend monthly treatments with 120,000 IU of cholecalciferol in FEP,” the investigators note.

The prevalence of vitamin D insufficiency and deficiency was high in the population – 74.6% overall and 93.4% among ethnic minorities.

“Thus, the sample was well suited to detecting any potential benefits that may have arisen from correcting this. However, even in this subgroup, there was no evidence to support the guiding hypothesis” that vitamin D supplementation would improve outcomes in patients with early psychosis, the researchers note.

They suggest that future studies examine the association of vitamin D with brain-related outcomes based on periods of treatment longer than 6 months and administered as daily rather than bolus treatments.

“Future public health strategies should acknowledge the high prevalence of vitamin D insufficiency and deficiency in people with psychosis and consider any reasonable adjustments which may be needed to address this over and above general population guidance,” said Dr. Gaughran.

The study was funded by the Stanley Medical Research Institute and received support from the National Institute for Health Research Maudsley Biomedical Research Centre, King’s College London, and the NIHR Applied Research Collaboration South London. Dr. Gaughran reported receiving speaking honoraria from Otsuka Lundbeck outside the submitted work. A complete list of author disclosures is available with the original article.

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

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective at improving hepatic steatosis in type 2 diabetes patients, according to a new analysis of a randomized, controlled trial.

Both procedures resulted in near elimination of liver fat 1 year after the surgery, but the effect on liver fibrosis was less clear. The authors called for more research to examine longer-term effects on fibrosis.

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective at improving hepatic steatosis in type 2 diabetes patients, according to a new analysis of a randomized, controlled trial.

Both procedures resulted in near elimination of liver fat 1 year after the surgery, but the effect on liver fibrosis was less clear. The authors called for more research to examine longer-term effects on fibrosis.

Both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective at improving hepatic steatosis in type 2 diabetes patients, according to a new analysis of a randomized, controlled trial.

Both procedures resulted in near elimination of liver fat 1 year after the surgery, but the effect on liver fibrosis was less clear. The authors called for more research to examine longer-term effects on fibrosis.

Two cancer drugs and one drug to treat sickle cell disease will likely reach the European market soon, following approval recommendations from a European Medicines Agency panel.

The drugs are enfortumab vedotin (Padcev, Astellas/Seagen) for urothelial cancer, tepotinib (Tepmetko, Merck) for non–small cell lung cancer (NSCLC), and voxelotor (Oxbryta, Global Blood Therapeutics) for sickle cell hemolytic anemia.

EMA’s Committee for Medicinal Products for Human Use gave the nod for marketing authorization on Dec. 16, 2021, and agency approval generally follows about 6 weeks later. All three products are already approved in the United States.
 

Enfortumab vedotin for urothelial cancer

The recommendation for Astellas’ antibody-drug conjugate infusion was based on the phase 3 EV-301 trial, which found about a 4-month median overall survival benefit with the antibody-drug conjugate versus investigator-chosen chemotherapy across 608 patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based chemotherapy and a programmed death 1 or PD–ligand 1 inhibitor.

The planned European indication is for adults with locally advanced or metastatic disease who met the same criteria – previous platinum-based chemotherapy plus a PD-1 or PD-L1 inhibitor.

The Food and Drug Administration approval came in December 2019, and with the same indication as well as for patients ineligible for cisplatin-containing chemotherapy who have had one or more prior lines of therapy. The U.S. labeling carries a boxed warning of severe and fatal skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
 

Tepotinib for NSCLC

The recommendation for Merck’s tepotinib, a once-daily oral MET inhibitor, followed results from the phase 2 VISION study. The study found an investigator-assessed response rate of 56% across 152 patients with advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation, regardless of previous therapy.

The planned European indication will be for monotherapy in adults with advanced disease harboring the mutation who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The FDA approved the drug in February 2021, and carries the same indication, minus the prior therapy requirement.
 

Voxelotor for sickle cell disease

Voxelotor is an oral hemoglobin S polymerization inhibitor from Global Blood Therapeutics.

The European approval recommendation was based on a phase 3 trial in 274 patients with sickle cell disease that found a greater than 1 g/dL increase in hemoglobin levels at 24 weeks in 51.1% of patients versus 6.5% randomized to placebo, regardless of whether patients were on concomitant hydroxyurea.

The small molecule binds and stabilizes hemoglobin, preventing the hemoglobin polymerization that causes red blood cells to sickle.

“There is a high unmet need for medicines to treat hemolytic anemia” in sickle cell disease because available treatment options are limited to blood transfusions and allogenic hematopoietic stem cell transplantation,” the EMA explained in a press release announcing the approval recommendation.

The planned European indication is for treating hemolytic anemia in sickle cell disease in patients 12 years or older either alone or in combination with hydroxycarbamide (hydroxyurea).

The FDA approved the agent in November 2019 for the same indication, but can be given to children as young as 4 years old.

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

Two cancer drugs and one drug to treat sickle cell disease will likely reach the European market soon, following approval recommendations from a European Medicines Agency panel.

The drugs are enfortumab vedotin (Padcev, Astellas/Seagen) for urothelial cancer, tepotinib (Tepmetko, Merck) for non–small cell lung cancer (NSCLC), and voxelotor (Oxbryta, Global Blood Therapeutics) for sickle cell hemolytic anemia.

EMA’s Committee for Medicinal Products for Human Use gave the nod for marketing authorization on Dec. 16, 2021, and agency approval generally follows about 6 weeks later. All three products are already approved in the United States.
 

Enfortumab vedotin for urothelial cancer

The recommendation for Astellas’ antibody-drug conjugate infusion was based on the phase 3 EV-301 trial, which found about a 4-month median overall survival benefit with the antibody-drug conjugate versus investigator-chosen chemotherapy across 608 patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based chemotherapy and a programmed death 1 or PD–ligand 1 inhibitor.

The planned European indication is for adults with locally advanced or metastatic disease who met the same criteria – previous platinum-based chemotherapy plus a PD-1 or PD-L1 inhibitor.

The Food and Drug Administration approval came in December 2019, and with the same indication as well as for patients ineligible for cisplatin-containing chemotherapy who have had one or more prior lines of therapy. The U.S. labeling carries a boxed warning of severe and fatal skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
 

Tepotinib for NSCLC

The recommendation for Merck’s tepotinib, a once-daily oral MET inhibitor, followed results from the phase 2 VISION study. The study found an investigator-assessed response rate of 56% across 152 patients with advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation, regardless of previous therapy.

The planned European indication will be for monotherapy in adults with advanced disease harboring the mutation who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The FDA approved the drug in February 2021, and carries the same indication, minus the prior therapy requirement.
 

Voxelotor for sickle cell disease

Voxelotor is an oral hemoglobin S polymerization inhibitor from Global Blood Therapeutics.

The European approval recommendation was based on a phase 3 trial in 274 patients with sickle cell disease that found a greater than 1 g/dL increase in hemoglobin levels at 24 weeks in 51.1% of patients versus 6.5% randomized to placebo, regardless of whether patients were on concomitant hydroxyurea.

The small molecule binds and stabilizes hemoglobin, preventing the hemoglobin polymerization that causes red blood cells to sickle.

“There is a high unmet need for medicines to treat hemolytic anemia” in sickle cell disease because available treatment options are limited to blood transfusions and allogenic hematopoietic stem cell transplantation,” the EMA explained in a press release announcing the approval recommendation.

The planned European indication is for treating hemolytic anemia in sickle cell disease in patients 12 years or older either alone or in combination with hydroxycarbamide (hydroxyurea).

The FDA approved the agent in November 2019 for the same indication, but can be given to children as young as 4 years old.

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

Two cancer drugs and one drug to treat sickle cell disease will likely reach the European market soon, following approval recommendations from a European Medicines Agency panel.

The drugs are enfortumab vedotin (Padcev, Astellas/Seagen) for urothelial cancer, tepotinib (Tepmetko, Merck) for non–small cell lung cancer (NSCLC), and voxelotor (Oxbryta, Global Blood Therapeutics) for sickle cell hemolytic anemia.

EMA’s Committee for Medicinal Products for Human Use gave the nod for marketing authorization on Dec. 16, 2021, and agency approval generally follows about 6 weeks later. All three products are already approved in the United States.
 

Enfortumab vedotin for urothelial cancer

The recommendation for Astellas’ antibody-drug conjugate infusion was based on the phase 3 EV-301 trial, which found about a 4-month median overall survival benefit with the antibody-drug conjugate versus investigator-chosen chemotherapy across 608 patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based chemotherapy and a programmed death 1 or PD–ligand 1 inhibitor.

The planned European indication is for adults with locally advanced or metastatic disease who met the same criteria – previous platinum-based chemotherapy plus a PD-1 or PD-L1 inhibitor.

The Food and Drug Administration approval came in December 2019, and with the same indication as well as for patients ineligible for cisplatin-containing chemotherapy who have had one or more prior lines of therapy. The U.S. labeling carries a boxed warning of severe and fatal skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
 

Tepotinib for NSCLC

The recommendation for Merck’s tepotinib, a once-daily oral MET inhibitor, followed results from the phase 2 VISION study. The study found an investigator-assessed response rate of 56% across 152 patients with advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation, regardless of previous therapy.

The planned European indication will be for monotherapy in adults with advanced disease harboring the mutation who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The FDA approved the drug in February 2021, and carries the same indication, minus the prior therapy requirement.
 

Voxelotor for sickle cell disease

Voxelotor is an oral hemoglobin S polymerization inhibitor from Global Blood Therapeutics.

The European approval recommendation was based on a phase 3 trial in 274 patients with sickle cell disease that found a greater than 1 g/dL increase in hemoglobin levels at 24 weeks in 51.1% of patients versus 6.5% randomized to placebo, regardless of whether patients were on concomitant hydroxyurea.

The small molecule binds and stabilizes hemoglobin, preventing the hemoglobin polymerization that causes red blood cells to sickle.

“There is a high unmet need for medicines to treat hemolytic anemia” in sickle cell disease because available treatment options are limited to blood transfusions and allogenic hematopoietic stem cell transplantation,” the EMA explained in a press release announcing the approval recommendation.

The planned European indication is for treating hemolytic anemia in sickle cell disease in patients 12 years or older either alone or in combination with hydroxycarbamide (hydroxyurea).

The FDA approved the agent in November 2019 for the same indication, but can be given to children as young as 4 years old.

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

Dr. A has been treating Ms. W, a graduate student, for depression. Ms. W made subtle comments expressing her interest in pursuing a romantic relationship with her psychiatrist. Dr. A gently redirected her, and she seemed to respond appropriately. However, over the past 2 weeks, Dr. A has seen Ms. W at a local park and at the grocery store. Today, Dr. A is startled to see Ms. W at her weekly yoga class. Dr. A plans to ask her supervisor for advice.

Dr. M is a child psychiatrist who spoke at his local school board meeting in support of masking requirements for students during COVID-19. During the discussion, Dr. M shared that, as a psychiatrist, he does not believe it is especially distressing for students to wear masks, and that doing so is a necessary public health measure. On leaving, other parents shouted, “We know who you are and where you live!” The next day, his integrated clinic started receiving threatening and harassing messages, including threats to kill him or his staff if they take part in vaccinating children against COVID-19.

Because of their work, mental health professionals—like other health care professionals—face an elevated risk of being harassed or stalked. Stalking often includes online harassment and may escalate to serious physical violence. Stalking is criminal behavior by a patient and should not be constructed as a “failure to manage transference.” This article explores basic strategies to reduce the risk of harassment and stalking, describes how to recognize early behaviors, and outlines basic steps health care professionals and their employers can take to respond to stalking and harassing behaviors.

Although this article is intended for psychiatrists, it is important to note that all health professionals have significant risk for experiencing stalking or harassment. This is due in part, but not exclusively, to our clinical work. Estimates of how many health professionals experience stalking vary substantially depending upon the study, and differences in methodologies limit easy comparison or extrapolation. More thorough reviews have reported ranges from 2% to 70% among physicians; psychiatrists and other mental health professionals appear to be at greater risk than those in other specialties and the general population.^1-3 Physicians who are active on social media may also be at elevated risk.⁴ Unexpected communications from patients and their family members—especially those with threatening, harassing, or sexualized tones, or involving contact outside of a work setting—can be distressing. These behaviors represent potential harbingers of more dangerous behavior, including physical assault, sexual assault, or homicide. Despite their elevated risk, many psychiatrists are unaware of how to prevent or respond to stalking or harassment.

Recognizing harassment and stalking

Repeated and unwanted contact or communication, regardless of intent, may constitute stalking. Legal definitions vary by jurisdiction and may not align with subjective experiences or understanding of what constitutes stalking.⁵ At its essence, stalking is repeated harassing behaviors likely to provoke fear in the targeted person. FOUR is a helpful mnemonic when conceptualizing the attributes of stalking: Fixated, Obsessive, Unwanted, and Repetitive.⁶Table 1 lists examples of common stalking behaviors. Stalking and harassing behavior may be from a known source (eg, a patient, coworker, or paramour), a masked source (ie, someone known to the target but who conceals or obscures their identity), or from otherwise unknown persons. Behaviors that persist after the person engaging in the behaviors has clearly been informed that they are unwanted or inappropriate are especially concerning. Stalking may escalate to include physical or sexual assault and, in some cases, homicide.

Stalking duration can vary substantially, as can the factors that lead to the cessation of the behavior. Indicators of increased risk for physical violence include unwanted physical presence/following of the target (“approach behaviors”), having a prior violent intimate relationship, property destruction, explicit threats, and having a prior intimate relationship with the target.⁷

Stalking contact or communication may be unwanted because of the content (eg, sexualized or threatening tone), location (eg, at a professional’s home), or means (eg, through social media). Stalking behaviors are not appropriate in any relationship, including a clinical relationship. They should not be treated as a “failure to manage transference” or in other victim-blaming ways.

There are multiple typologies for stalking behavior. Common motivations for stalking health professionals include resentment or grievance, misjudgment of social boundaries, and delusional fixation, including erotomania.⁸ Associated psychopathologies vary significantly and, while some may be more amenable to psychiatric treatment than others, psychiatrists should not feel compelled to treat patients who repeatedly violate boundaries, regardless of intent or comorbidity.

Patients are not the exclusive perpetrators of stalking; a recent study found that 4% of physicians surveyed reported current or recent stalking by a current or former intimate partner.⁹ When a person who is a victim of intimate partner violence is also stalked as part of the abuse, homicide risk increases.¹⁰ Workplace homicides of health care professionals are most likely to be committed by a current or former partner or other personal acquaintance, not by a patient.¹¹ Workplace harassment and stalking of health care professionals is especially concerning because this behavior can escalate and endanger coworkers or clients.

Continue to: Risk awareness: Recognize your exposure...

Clinicians cannot easily or universally prevent stalking. This is a behavior initiated outside of the clinician’s control and often outside of the clinician’s awareness. However, to some degree, the risk of being stalked can be mitigated. Some basic measures may help reduce unnecessary exposure. In addition to being in a patient-facing role, psychiatrists with gatekeeper functionality (ie, making admission/discharge decisions), visibility in news or social media, or with family or social relations in news or social media may have an increased risk of being stalked.

About 80% of stalking involves some form of technology—often telephone calls but also online or other “cyber” elements.¹² One recent survey found the rate of online harassment, including threats of physical and sexual violence, was >20% among physicians who were active on social media.⁴ Health professionals may be at greater risk of having patients find their personal information simply because patients routinely search online for information about new clinicians. Personal information about a clinician may be readily visible among professional information in search results, or a curious patient may simply scroll further down in the results. For a potential stalker, clicking on a search result linking to a personal social media page may be far easier than finding a home address and going in person—but the action may be just as distressing or risky for the clinician.¹³ Additionally, items visible in a clinician’s office—or visible in the background of those providing telehealth services from their home—may inadvertently reveal personal information about the clinician, their home, or their family.

Psychiatrists are often in a special position in relation to patients and times of crises. They may be involved in involuntary commitment—or declining an admission when a patient or family wishes it. They may be present at the time of the revelation of a serious diagnosis, abuse, injury, or death. They may be a mandated reporter of child or elder abuse.² Additionally, physicians may be engaged in discourse on politically charged public health topics.¹⁴ These factors may increase their risk of being stalked.

Conducting an online visibility self-assessment can be a useful way to learn what information others can find. Table 2 outlines the steps for completing this exercise. Searching multiple iterations of your current and former names (with and without degrees, titles, and cities) will yield differing results in various search engines. After establishing a baseline of what information is available online, it can be helpful to periodically repeat this exercise, and to set up automated alerts for your name, number(s), email(s), and address(es).

Basic mitigation strategies

In the modern era, being invisible online is impractical and likely impossible—especially for a health care professional. Instead, it may be prudent to limit your public visibility to professional portals (eg, LinkedIn or Doximity) and maximize privacy settings on other platforms. Another basic strategy is to avoid providing personal contact information (your home address, phone number, or personal email) for professional purposes, such as licensing and credentialing, conference submissions, or journal publications. Be aware that driving a visually distinct vehicle—one with vanity plates or distinct bumper stickers, or an exotic sportscar—can make it easier to be recognized and located. A personally recorded voicemail greeting (vs one recorded by, for example, an office manager) may be inappropriately reinforcing for some stalkers.

Workplaces should have an established safety policy that addresses stalking and harassment of employees. Similarly, patients and others should receive clear education on how to contact different staff, including physicians, with consideration of how and when to use electronic health information portals, office numbers, and emails. Workplaces should not disclose staff schedules. For example, a receptionist should say “I’ll have Dr. Diaz return your call when she can” instead of “Dr. Diaz is not in until tomorrow.” Avoid unnecessary location/name signals (eg, a parking spot labeled “Dr. Diaz”). Consider creating alert words or phrases for staff to use to signal they are concerned about their immediate safety—and provide education and training, including drills, to test emergency responses when the words/phrases are used. Leaders and managers should nurture a workplace culture where people are comfortable seeking support if they feel they may be the target of harassment or stalking. Many larger health care organizations have threat management programs, which can play a critical role in preventing, investigating, and responding to stalking of employees. Increasingly, threat management teams are being identified as a best practice in health care settings.¹⁵Table 3 summarizes measures to mitigate risk.

What to do when harassment or stalking occurs

Consulting with subject matter experts is essential. Approach behaviors, stalking patterns, and immediate circumstances vary highly, and so too must responses. A socially inept approach outside of the work setting by a patient may be effectively responded to with a firm explanation of why the behavior was inappropriate and a reiteration of limits. More persistent or serious threats may require taking actions for immediate safety, calling law enforcement or security (who may have the expertise to assist appropriately), or even run/hide/fight measures. Others to notify early on include human resources, supervisors, front desk staff, and coworkers. Although no single measure is always indicated and no single measure will always be effective, consultation with a specialist is always advisable.

Attempting to assess your own risk may be subject to bias and error, even for an experienced forensic psychiatrist. Risk assessment in stalking and harassment cases is complex, nuanced, and beyond the scope of this article; engagement with specialized threat programs or subject matter experts is advisable.^15,16 If your medical center or area has police or security officers, engage them early. Risk management, insurers, and legal can also be helpful to consult. Attorneys specializing in harassment, stalking, and domestic violence may be helpful in extreme situations.¹⁷Table 4^17,18 highlights steps to take.

Continue to: Clinical documentation and termination of care...

Clinical documentation and termination of care

Repeated and unwanted contact behaviors by a patient may be considered grounds for termination of care by the targeted clinician. Termination may occur through a direct conversation, followed by a mailed letter explaining that the patient’s inappropriate behaviors are the basis for termination. The letter should outline steps for establishing care with another psychiatrist and signing a release to facilitate transfer of records to the next psychiatrist. Ensure that the patient has access to a reasonable supply of medications or refills according to jurisdictional standards for transfer or termination of care.¹⁹ While these are common legal standards for termination of care in the United States, clinicians would be well served by appropriate consultation to verify the most appropriate standards for their location.

Documentation of a patient’s behavior should be factual and clear. Under the 21st Century Cures Act, patients often have access to their own electronic records.²⁰ Therefore, clinicians should avoid documenting personal security measures or other information that is not clinically relevant. Communications with legal or risk management should not be documented unless otherwise advised, because such communications may be privileged and may not be clinically relevant.

In some circumstances, continuing to treat a patient who has stalked a member of the current treatment team may be appropriate or necessary. For example, a patient may respond appropriately to redirection after an initial approach behavior and continue to make clinical progress, or may be in a forensic specialty setting with appropriate operational support to continue with treatment.

Ethical dilemmas may arise in underserved areas where there are limited options for psychiatric care and in communicating the reasons for termination to a new clinician. Consultation may help to address these issues. However, as noted before, clinicians should be permitted to discontinue and transfer treatment and should not be compelled to continue to treat a patient who has threatened or harassed them.

Organizational and employer considerations

Victims of stalking have reported that they appreciated explicit support from their supervisor, regular meetings, and measures to reduce potential stalking or violence in the workplace; unsurprisingly, victim blaming and leaving the employee to address the situation on their own were labeled experienced as negative.² Employers may consider implementing physical security, access controls and panic alarms, and enhancing coworkers’ situational awareness.²¹ Explicit policies about and attention to reducing workplace violence, including stalking, are always beneficial—and in some settings such policies may be a regulatory requirement.²² Large health care organizations may benefit from developing specialized threat management programs to assist with the evaluation and mitigation of stalking and other workplace violence risks.^15,23

Self-care considerations

The impact of stalking can include psychological distress, disruption of work and personal relationships, and false allegations of impropriety. Stalking can make targets feel isolated, violated, and fearful, which makes it challenging to reach out to others for support and safety. It takes time to regain a sense of safety and to find a “new normal,” particularly while experiencing and responding to stalking behavior. Notifying close personal contacts such as family and coworkers about what is occurring (without sharing protected health information) can be helpful for recovery and important for the clinician’s safety. Reaching out for organizational and legal supports is also prudent. It is also important to allow time for, and patience with, a targeted individual’s normal responses, such as decreased work performance, sleep/appetite changes, and hypervigilance, without pathologizing these common stress reactions. Further review of appropriate resources by impacted clinicians is advisable.^24-26

Dr. A has been treating Ms. W, a graduate student, for depression. Ms. W made subtle comments expressing her interest in pursuing a romantic relationship with her psychiatrist. Dr. A gently redirected her, and she seemed to respond appropriately. However, over the past 2 weeks, Dr. A has seen Ms. W at a local park and at the grocery store. Today, Dr. A is startled to see Ms. W at her weekly yoga class. Dr. A plans to ask her supervisor for advice.

Dr. M is a child psychiatrist who spoke at his local school board meeting in support of masking requirements for students during COVID-19. During the discussion, Dr. M shared that, as a psychiatrist, he does not believe it is especially distressing for students to wear masks, and that doing so is a necessary public health measure. On leaving, other parents shouted, “We know who you are and where you live!” The next day, his integrated clinic started receiving threatening and harassing messages, including threats to kill him or his staff if they take part in vaccinating children against COVID-19.

Because of their work, mental health professionals—like other health care professionals—face an elevated risk of being harassed or stalked. Stalking often includes online harassment and may escalate to serious physical violence. Stalking is criminal behavior by a patient and should not be constructed as a “failure to manage transference.” This article explores basic strategies to reduce the risk of harassment and stalking, describes how to recognize early behaviors, and outlines basic steps health care professionals and their employers can take to respond to stalking and harassing behaviors.

Although this article is intended for psychiatrists, it is important to note that all health professionals have significant risk for experiencing stalking or harassment. This is due in part, but not exclusively, to our clinical work. Estimates of how many health professionals experience stalking vary substantially depending upon the study, and differences in methodologies limit easy comparison or extrapolation. More thorough reviews have reported ranges from 2% to 70% among physicians; psychiatrists and other mental health professionals appear to be at greater risk than those in other specialties and the general population.^1-3 Physicians who are active on social media may also be at elevated risk.⁴ Unexpected communications from patients and their family members—especially those with threatening, harassing, or sexualized tones, or involving contact outside of a work setting—can be distressing. These behaviors represent potential harbingers of more dangerous behavior, including physical assault, sexual assault, or homicide. Despite their elevated risk, many psychiatrists are unaware of how to prevent or respond to stalking or harassment.

Recognizing harassment and stalking

Repeated and unwanted contact or communication, regardless of intent, may constitute stalking. Legal definitions vary by jurisdiction and may not align with subjective experiences or understanding of what constitutes stalking.⁵ At its essence, stalking is repeated harassing behaviors likely to provoke fear in the targeted person. FOUR is a helpful mnemonic when conceptualizing the attributes of stalking: Fixated, Obsessive, Unwanted, and Repetitive.⁶Table 1 lists examples of common stalking behaviors. Stalking and harassing behavior may be from a known source (eg, a patient, coworker, or paramour), a masked source (ie, someone known to the target but who conceals or obscures their identity), or from otherwise unknown persons. Behaviors that persist after the person engaging in the behaviors has clearly been informed that they are unwanted or inappropriate are especially concerning. Stalking may escalate to include physical or sexual assault and, in some cases, homicide.

Stalking duration can vary substantially, as can the factors that lead to the cessation of the behavior. Indicators of increased risk for physical violence include unwanted physical presence/following of the target (“approach behaviors”), having a prior violent intimate relationship, property destruction, explicit threats, and having a prior intimate relationship with the target.⁷

Stalking contact or communication may be unwanted because of the content (eg, sexualized or threatening tone), location (eg, at a professional’s home), or means (eg, through social media). Stalking behaviors are not appropriate in any relationship, including a clinical relationship. They should not be treated as a “failure to manage transference” or in other victim-blaming ways.

There are multiple typologies for stalking behavior. Common motivations for stalking health professionals include resentment or grievance, misjudgment of social boundaries, and delusional fixation, including erotomania.⁸ Associated psychopathologies vary significantly and, while some may be more amenable to psychiatric treatment than others, psychiatrists should not feel compelled to treat patients who repeatedly violate boundaries, regardless of intent or comorbidity.

Patients are not the exclusive perpetrators of stalking; a recent study found that 4% of physicians surveyed reported current or recent stalking by a current or former intimate partner.⁹ When a person who is a victim of intimate partner violence is also stalked as part of the abuse, homicide risk increases.¹⁰ Workplace homicides of health care professionals are most likely to be committed by a current or former partner or other personal acquaintance, not by a patient.¹¹ Workplace harassment and stalking of health care professionals is especially concerning because this behavior can escalate and endanger coworkers or clients.

Continue to: Risk awareness: Recognize your exposure...

Clinicians cannot easily or universally prevent stalking. This is a behavior initiated outside of the clinician’s control and often outside of the clinician’s awareness. However, to some degree, the risk of being stalked can be mitigated. Some basic measures may help reduce unnecessary exposure. In addition to being in a patient-facing role, psychiatrists with gatekeeper functionality (ie, making admission/discharge decisions), visibility in news or social media, or with family or social relations in news or social media may have an increased risk of being stalked.

About 80% of stalking involves some form of technology—often telephone calls but also online or other “cyber” elements.¹² One recent survey found the rate of online harassment, including threats of physical and sexual violence, was >20% among physicians who were active on social media.⁴ Health professionals may be at greater risk of having patients find their personal information simply because patients routinely search online for information about new clinicians. Personal information about a clinician may be readily visible among professional information in search results, or a curious patient may simply scroll further down in the results. For a potential stalker, clicking on a search result linking to a personal social media page may be far easier than finding a home address and going in person—but the action may be just as distressing or risky for the clinician.¹³ Additionally, items visible in a clinician’s office—or visible in the background of those providing telehealth services from their home—may inadvertently reveal personal information about the clinician, their home, or their family.

Psychiatrists are often in a special position in relation to patients and times of crises. They may be involved in involuntary commitment—or declining an admission when a patient or family wishes it. They may be present at the time of the revelation of a serious diagnosis, abuse, injury, or death. They may be a mandated reporter of child or elder abuse.² Additionally, physicians may be engaged in discourse on politically charged public health topics.¹⁴ These factors may increase their risk of being stalked.

Conducting an online visibility self-assessment can be a useful way to learn what information others can find. Table 2 outlines the steps for completing this exercise. Searching multiple iterations of your current and former names (with and without degrees, titles, and cities) will yield differing results in various search engines. After establishing a baseline of what information is available online, it can be helpful to periodically repeat this exercise, and to set up automated alerts for your name, number(s), email(s), and address(es).

Basic mitigation strategies

In the modern era, being invisible online is impractical and likely impossible—especially for a health care professional. Instead, it may be prudent to limit your public visibility to professional portals (eg, LinkedIn or Doximity) and maximize privacy settings on other platforms. Another basic strategy is to avoid providing personal contact information (your home address, phone number, or personal email) for professional purposes, such as licensing and credentialing, conference submissions, or journal publications. Be aware that driving a visually distinct vehicle—one with vanity plates or distinct bumper stickers, or an exotic sportscar—can make it easier to be recognized and located. A personally recorded voicemail greeting (vs one recorded by, for example, an office manager) may be inappropriately reinforcing for some stalkers.

Workplaces should have an established safety policy that addresses stalking and harassment of employees. Similarly, patients and others should receive clear education on how to contact different staff, including physicians, with consideration of how and when to use electronic health information portals, office numbers, and emails. Workplaces should not disclose staff schedules. For example, a receptionist should say “I’ll have Dr. Diaz return your call when she can” instead of “Dr. Diaz is not in until tomorrow.” Avoid unnecessary location/name signals (eg, a parking spot labeled “Dr. Diaz”). Consider creating alert words or phrases for staff to use to signal they are concerned about their immediate safety—and provide education and training, including drills, to test emergency responses when the words/phrases are used. Leaders and managers should nurture a workplace culture where people are comfortable seeking support if they feel they may be the target of harassment or stalking. Many larger health care organizations have threat management programs, which can play a critical role in preventing, investigating, and responding to stalking of employees. Increasingly, threat management teams are being identified as a best practice in health care settings.¹⁵Table 3 summarizes measures to mitigate risk.

What to do when harassment or stalking occurs

Consulting with subject matter experts is essential. Approach behaviors, stalking patterns, and immediate circumstances vary highly, and so too must responses. A socially inept approach outside of the work setting by a patient may be effectively responded to with a firm explanation of why the behavior was inappropriate and a reiteration of limits. More persistent or serious threats may require taking actions for immediate safety, calling law enforcement or security (who may have the expertise to assist appropriately), or even run/hide/fight measures. Others to notify early on include human resources, supervisors, front desk staff, and coworkers. Although no single measure is always indicated and no single measure will always be effective, consultation with a specialist is always advisable.

Attempting to assess your own risk may be subject to bias and error, even for an experienced forensic psychiatrist. Risk assessment in stalking and harassment cases is complex, nuanced, and beyond the scope of this article; engagement with specialized threat programs or subject matter experts is advisable.^15,16 If your medical center or area has police or security officers, engage them early. Risk management, insurers, and legal can also be helpful to consult. Attorneys specializing in harassment, stalking, and domestic violence may be helpful in extreme situations.¹⁷Table 4^17,18 highlights steps to take.

Continue to: Clinical documentation and termination of care...

Clinical documentation and termination of care

Repeated and unwanted contact behaviors by a patient may be considered grounds for termination of care by the targeted clinician. Termination may occur through a direct conversation, followed by a mailed letter explaining that the patient’s inappropriate behaviors are the basis for termination. The letter should outline steps for establishing care with another psychiatrist and signing a release to facilitate transfer of records to the next psychiatrist. Ensure that the patient has access to a reasonable supply of medications or refills according to jurisdictional standards for transfer or termination of care.¹⁹ While these are common legal standards for termination of care in the United States, clinicians would be well served by appropriate consultation to verify the most appropriate standards for their location.

Documentation of a patient’s behavior should be factual and clear. Under the 21st Century Cures Act, patients often have access to their own electronic records.²⁰ Therefore, clinicians should avoid documenting personal security measures or other information that is not clinically relevant. Communications with legal or risk management should not be documented unless otherwise advised, because such communications may be privileged and may not be clinically relevant.

In some circumstances, continuing to treat a patient who has stalked a member of the current treatment team may be appropriate or necessary. For example, a patient may respond appropriately to redirection after an initial approach behavior and continue to make clinical progress, or may be in a forensic specialty setting with appropriate operational support to continue with treatment.

Ethical dilemmas may arise in underserved areas where there are limited options for psychiatric care and in communicating the reasons for termination to a new clinician. Consultation may help to address these issues. However, as noted before, clinicians should be permitted to discontinue and transfer treatment and should not be compelled to continue to treat a patient who has threatened or harassed them.

Organizational and employer considerations

Victims of stalking have reported that they appreciated explicit support from their supervisor, regular meetings, and measures to reduce potential stalking or violence in the workplace; unsurprisingly, victim blaming and leaving the employee to address the situation on their own were labeled experienced as negative.² Employers may consider implementing physical security, access controls and panic alarms, and enhancing coworkers’ situational awareness.²¹ Explicit policies about and attention to reducing workplace violence, including stalking, are always beneficial—and in some settings such policies may be a regulatory requirement.²² Large health care organizations may benefit from developing specialized threat management programs to assist with the evaluation and mitigation of stalking and other workplace violence risks.^15,23

Self-care considerations

The impact of stalking can include psychological distress, disruption of work and personal relationships, and false allegations of impropriety. Stalking can make targets feel isolated, violated, and fearful, which makes it challenging to reach out to others for support and safety. It takes time to regain a sense of safety and to find a “new normal,” particularly while experiencing and responding to stalking behavior. Notifying close personal contacts such as family and coworkers about what is occurring (without sharing protected health information) can be helpful for recovery and important for the clinician’s safety. Reaching out for organizational and legal supports is also prudent. It is also important to allow time for, and patience with, a targeted individual’s normal responses, such as decreased work performance, sleep/appetite changes, and hypervigilance, without pathologizing these common stress reactions. Further review of appropriate resources by impacted clinicians is advisable.^24-26

Dr. A has been treating Ms. W, a graduate student, for depression. Ms. W made subtle comments expressing her interest in pursuing a romantic relationship with her psychiatrist. Dr. A gently redirected her, and she seemed to respond appropriately. However, over the past 2 weeks, Dr. A has seen Ms. W at a local park and at the grocery store. Today, Dr. A is startled to see Ms. W at her weekly yoga class. Dr. A plans to ask her supervisor for advice.

Dr. M is a child psychiatrist who spoke at his local school board meeting in support of masking requirements for students during COVID-19. During the discussion, Dr. M shared that, as a psychiatrist, he does not believe it is especially distressing for students to wear masks, and that doing so is a necessary public health measure. On leaving, other parents shouted, “We know who you are and where you live!” The next day, his integrated clinic started receiving threatening and harassing messages, including threats to kill him or his staff if they take part in vaccinating children against COVID-19.

Because of their work, mental health professionals—like other health care professionals—face an elevated risk of being harassed or stalked. Stalking often includes online harassment and may escalate to serious physical violence. Stalking is criminal behavior by a patient and should not be constructed as a “failure to manage transference.” This article explores basic strategies to reduce the risk of harassment and stalking, describes how to recognize early behaviors, and outlines basic steps health care professionals and their employers can take to respond to stalking and harassing behaviors.

Although this article is intended for psychiatrists, it is important to note that all health professionals have significant risk for experiencing stalking or harassment. This is due in part, but not exclusively, to our clinical work. Estimates of how many health professionals experience stalking vary substantially depending upon the study, and differences in methodologies limit easy comparison or extrapolation. More thorough reviews have reported ranges from 2% to 70% among physicians; psychiatrists and other mental health professionals appear to be at greater risk than those in other specialties and the general population.^1-3 Physicians who are active on social media may also be at elevated risk.⁴ Unexpected communications from patients and their family members—especially those with threatening, harassing, or sexualized tones, or involving contact outside of a work setting—can be distressing. These behaviors represent potential harbingers of more dangerous behavior, including physical assault, sexual assault, or homicide. Despite their elevated risk, many psychiatrists are unaware of how to prevent or respond to stalking or harassment.

Recognizing harassment and stalking

Repeated and unwanted contact or communication, regardless of intent, may constitute stalking. Legal definitions vary by jurisdiction and may not align with subjective experiences or understanding of what constitutes stalking.⁵ At its essence, stalking is repeated harassing behaviors likely to provoke fear in the targeted person. FOUR is a helpful mnemonic when conceptualizing the attributes of stalking: Fixated, Obsessive, Unwanted, and Repetitive.⁶Table 1 lists examples of common stalking behaviors. Stalking and harassing behavior may be from a known source (eg, a patient, coworker, or paramour), a masked source (ie, someone known to the target but who conceals or obscures their identity), or from otherwise unknown persons. Behaviors that persist after the person engaging in the behaviors has clearly been informed that they are unwanted or inappropriate are especially concerning. Stalking may escalate to include physical or sexual assault and, in some cases, homicide.

Stalking duration can vary substantially, as can the factors that lead to the cessation of the behavior. Indicators of increased risk for physical violence include unwanted physical presence/following of the target (“approach behaviors”), having a prior violent intimate relationship, property destruction, explicit threats, and having a prior intimate relationship with the target.⁷

Stalking contact or communication may be unwanted because of the content (eg, sexualized or threatening tone), location (eg, at a professional’s home), or means (eg, through social media). Stalking behaviors are not appropriate in any relationship, including a clinical relationship. They should not be treated as a “failure to manage transference” or in other victim-blaming ways.

There are multiple typologies for stalking behavior. Common motivations for stalking health professionals include resentment or grievance, misjudgment of social boundaries, and delusional fixation, including erotomania.⁸ Associated psychopathologies vary significantly and, while some may be more amenable to psychiatric treatment than others, psychiatrists should not feel compelled to treat patients who repeatedly violate boundaries, regardless of intent or comorbidity.

Patients are not the exclusive perpetrators of stalking; a recent study found that 4% of physicians surveyed reported current or recent stalking by a current or former intimate partner.⁹ When a person who is a victim of intimate partner violence is also stalked as part of the abuse, homicide risk increases.¹⁰ Workplace homicides of health care professionals are most likely to be committed by a current or former partner or other personal acquaintance, not by a patient.¹¹ Workplace harassment and stalking of health care professionals is especially concerning because this behavior can escalate and endanger coworkers or clients.

Continue to: Risk awareness: Recognize your exposure...

Clinicians cannot easily or universally prevent stalking. This is a behavior initiated outside of the clinician’s control and often outside of the clinician’s awareness. However, to some degree, the risk of being stalked can be mitigated. Some basic measures may help reduce unnecessary exposure. In addition to being in a patient-facing role, psychiatrists with gatekeeper functionality (ie, making admission/discharge decisions), visibility in news or social media, or with family or social relations in news or social media may have an increased risk of being stalked.

About 80% of stalking involves some form of technology—often telephone calls but also online or other “cyber” elements.¹² One recent survey found the rate of online harassment, including threats of physical and sexual violence, was >20% among physicians who were active on social media.⁴ Health professionals may be at greater risk of having patients find their personal information simply because patients routinely search online for information about new clinicians. Personal information about a clinician may be readily visible among professional information in search results, or a curious patient may simply scroll further down in the results. For a potential stalker, clicking on a search result linking to a personal social media page may be far easier than finding a home address and going in person—but the action may be just as distressing or risky for the clinician.¹³ Additionally, items visible in a clinician’s office—or visible in the background of those providing telehealth services from their home—may inadvertently reveal personal information about the clinician, their home, or their family.

Psychiatrists are often in a special position in relation to patients and times of crises. They may be involved in involuntary commitment—or declining an admission when a patient or family wishes it. They may be present at the time of the revelation of a serious diagnosis, abuse, injury, or death. They may be a mandated reporter of child or elder abuse.² Additionally, physicians may be engaged in discourse on politically charged public health topics.¹⁴ These factors may increase their risk of being stalked.

Conducting an online visibility self-assessment can be a useful way to learn what information others can find. Table 2 outlines the steps for completing this exercise. Searching multiple iterations of your current and former names (with and without degrees, titles, and cities) will yield differing results in various search engines. After establishing a baseline of what information is available online, it can be helpful to periodically repeat this exercise, and to set up automated alerts for your name, number(s), email(s), and address(es).

Basic mitigation strategies

In the modern era, being invisible online is impractical and likely impossible—especially for a health care professional. Instead, it may be prudent to limit your public visibility to professional portals (eg, LinkedIn or Doximity) and maximize privacy settings on other platforms. Another basic strategy is to avoid providing personal contact information (your home address, phone number, or personal email) for professional purposes, such as licensing and credentialing, conference submissions, or journal publications. Be aware that driving a visually distinct vehicle—one with vanity plates or distinct bumper stickers, or an exotic sportscar—can make it easier to be recognized and located. A personally recorded voicemail greeting (vs one recorded by, for example, an office manager) may be inappropriately reinforcing for some stalkers.

Workplaces should have an established safety policy that addresses stalking and harassment of employees. Similarly, patients and others should receive clear education on how to contact different staff, including physicians, with consideration of how and when to use electronic health information portals, office numbers, and emails. Workplaces should not disclose staff schedules. For example, a receptionist should say “I’ll have Dr. Diaz return your call when she can” instead of “Dr. Diaz is not in until tomorrow.” Avoid unnecessary location/name signals (eg, a parking spot labeled “Dr. Diaz”). Consider creating alert words or phrases for staff to use to signal they are concerned about their immediate safety—and provide education and training, including drills, to test emergency responses when the words/phrases are used. Leaders and managers should nurture a workplace culture where people are comfortable seeking support if they feel they may be the target of harassment or stalking. Many larger health care organizations have threat management programs, which can play a critical role in preventing, investigating, and responding to stalking of employees. Increasingly, threat management teams are being identified as a best practice in health care settings.¹⁵Table 3 summarizes measures to mitigate risk.

What to do when harassment or stalking occurs

Consulting with subject matter experts is essential. Approach behaviors, stalking patterns, and immediate circumstances vary highly, and so too must responses. A socially inept approach outside of the work setting by a patient may be effectively responded to with a firm explanation of why the behavior was inappropriate and a reiteration of limits. More persistent or serious threats may require taking actions for immediate safety, calling law enforcement or security (who may have the expertise to assist appropriately), or even run/hide/fight measures. Others to notify early on include human resources, supervisors, front desk staff, and coworkers. Although no single measure is always indicated and no single measure will always be effective, consultation with a specialist is always advisable.

Attempting to assess your own risk may be subject to bias and error, even for an experienced forensic psychiatrist. Risk assessment in stalking and harassment cases is complex, nuanced, and beyond the scope of this article; engagement with specialized threat programs or subject matter experts is advisable.^15,16 If your medical center or area has police or security officers, engage them early. Risk management, insurers, and legal can also be helpful to consult. Attorneys specializing in harassment, stalking, and domestic violence may be helpful in extreme situations.¹⁷Table 4^17,18 highlights steps to take.

Continue to: Clinical documentation and termination of care...

Clinical documentation and termination of care

Repeated and unwanted contact behaviors by a patient may be considered grounds for termination of care by the targeted clinician. Termination may occur through a direct conversation, followed by a mailed letter explaining that the patient’s inappropriate behaviors are the basis for termination. The letter should outline steps for establishing care with another psychiatrist and signing a release to facilitate transfer of records to the next psychiatrist. Ensure that the patient has access to a reasonable supply of medications or refills according to jurisdictional standards for transfer or termination of care.¹⁹ While these are common legal standards for termination of care in the United States, clinicians would be well served by appropriate consultation to verify the most appropriate standards for their location.

Documentation of a patient’s behavior should be factual and clear. Under the 21st Century Cures Act, patients often have access to their own electronic records.²⁰ Therefore, clinicians should avoid documenting personal security measures or other information that is not clinically relevant. Communications with legal or risk management should not be documented unless otherwise advised, because such communications may be privileged and may not be clinically relevant.

In some circumstances, continuing to treat a patient who has stalked a member of the current treatment team may be appropriate or necessary. For example, a patient may respond appropriately to redirection after an initial approach behavior and continue to make clinical progress, or may be in a forensic specialty setting with appropriate operational support to continue with treatment.

Ethical dilemmas may arise in underserved areas where there are limited options for psychiatric care and in communicating the reasons for termination to a new clinician. Consultation may help to address these issues. However, as noted before, clinicians should be permitted to discontinue and transfer treatment and should not be compelled to continue to treat a patient who has threatened or harassed them.

Organizational and employer considerations

Victims of stalking have reported that they appreciated explicit support from their supervisor, regular meetings, and measures to reduce potential stalking or violence in the workplace; unsurprisingly, victim blaming and leaving the employee to address the situation on their own were labeled experienced as negative.² Employers may consider implementing physical security, access controls and panic alarms, and enhancing coworkers’ situational awareness.²¹ Explicit policies about and attention to reducing workplace violence, including stalking, are always beneficial—and in some settings such policies may be a regulatory requirement.²² Large health care organizations may benefit from developing specialized threat management programs to assist with the evaluation and mitigation of stalking and other workplace violence risks.^15,23

Self-care considerations

The impact of stalking can include psychological distress, disruption of work and personal relationships, and false allegations of impropriety. Stalking can make targets feel isolated, violated, and fearful, which makes it challenging to reach out to others for support and safety. It takes time to regain a sense of safety and to find a “new normal,” particularly while experiencing and responding to stalking behavior. Notifying close personal contacts such as family and coworkers about what is occurring (without sharing protected health information) can be helpful for recovery and important for the clinician’s safety. Reaching out for organizational and legal supports is also prudent. It is also important to allow time for, and patience with, a targeted individual’s normal responses, such as decreased work performance, sleep/appetite changes, and hypervigilance, without pathologizing these common stress reactions. Further review of appropriate resources by impacted clinicians is advisable.^24-26

As the United States enters a third year of the COVID-19 pandemic, case numbers are higher than ever and disrupting businesses, travel plans, and school schedules.

The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.

New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.

“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.

“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.

The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.

In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.

About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.

More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.

“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.

The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.

American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.

“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.

K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.

“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.

This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.

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

As the United States enters a third year of the COVID-19 pandemic, case numbers are higher than ever and disrupting businesses, travel plans, and school schedules.

The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.

New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.

“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.

“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.

The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.

In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.

About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.

More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.

“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.

The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.

American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.

“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.

K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.

“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.

This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.

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

As the United States enters a third year of the COVID-19 pandemic, case numbers are higher than ever and disrupting businesses, travel plans, and school schedules.

The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.

New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.

“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.

“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.

The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.

In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.

About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.

More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.

“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.

The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.

American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.

“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.

K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.

“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.

This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.

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

Vedolizumab does not seem to increase the risk of Clostridioides difficile infection (CDI), compared with anti–tumor necrosis factor (TNF) therapies in biologic-naive patients with ulcerative colitis (UC), despite concerns that the gut-selective monoclonal antibody treatment may increase gastrointestinal infections at a greater rate than other biologics in this patient population.

Perturbations of the gut microbiota that occur in IBD predispose patients to CDI. Given that treatment with monoclonal antibody vedolizumab exerts an inhibitory action on lymphocyte trafficking to the intestines, questions have been raised on whether this action could increase the risk of CDI in an already vulnerable population.

In patients with UC, the incidence of CDI typically confers a higher risk of adverse outcomes. Unfortunately, CDI is a common complication associated with inflammatory bowel disease (IBD) that can lead to disease flares, further adding to the physical and psychological burden associated with the condition, according to recent studies.

These concerns, however, may not be warranted in patients with UC, according to findings from a retrospective study presented at the annual Advances in Inflammatory Bowel Diseases conference by Rahul Dalal, MD, a gastroenterology fellow at Brigham and Women’s Hospital in Boston.

In the study, Dr. Dalal and colleagues retrospectively analyzed electronic medical records of adult patients with UC who initiated infliximab, adalimumab, or vedolizumab between June 2014 and December 2020. Patients in this retrospective cohort were followed until there was a documented occurrence of CDI, colectomy, or biologic discontinuation/switch, or until the last recorded gastroenterology encounter.

The researchers analyzed the time from biologic initiation to first CDI, which was characterized by a positive stool for C. difficile toxin or toxigenic C. difficile polymerase chain reaction with CDI-specific antibiotic prescriptions. Additionally, the investigators evaluated rates of CDI-related hospitalization, colectomy, or death within a 30-day period of CDI. The primary analysis compared patients with UC who initiated vedolizumab (n = 195) versus anti-TNF therapy (n = 610).

Compared with those treated with anti-TNF agents, patients who initiated vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months prior to starting biologics.

Over 1,436 patient-years’ worth of follow-up, the investigators observed 43 CDIs. Patients treated with vedolizumab less frequently had CDI (1.0% vs. 6.7%; P =.001) and CDI hospitalization (1.0% vs. 3.8%; P =.042), compared with those treated with anti-TNF therapies. The investigators reported no significant differences in the rates of colectomies or deaths or rates of exposure to antibiotics/corticosteroids during the follow-up period or within 30 days prior to CDI onset.

In the unadjusted Cox model, the researchers reported that vedolizumab featured a lower hazard of CDI, compared with anti-TNF (hazard ratio, 0.17; 95% confidence interval, 0.04-0.71). The multivariable Cox model found no significant difference in hazard of CDI for vedolizumab when compared with anti-TNF therapy (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40). The incidence of CDI prior to biologic initiation was associated with an increased hazard of subsequent CDI (HR, 5.95; 95% CI, 2.93-12.09). In the subgroup of patients who experienced a CDI, approximately 39.5% had CDI before biologic initiation at a median of 227 days preceding the subsequent event.

“Vedolizumab is one of the safest biologics that we have in the clinic,” said Jean-Frederic Colombel, MD, who was asked to comment on the study. Dr. Colombel, who wasn’t involved in the study, is a gastroenterologist and serves as director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai, both in New York. “Findings from this study reinforce the safety profile of vedolizumab” despite the potential concerns regarding gastroenterological infection with the agent, he added.
 

Recurrence worries

Recurrent CDI is an issue in patients with IBD, many of whom are considered at high risk for initial and recurrent infection. During a session on CDI and recurrence at the AIBD meeting, Sahil Khanna, MBBS, of the Mayo Clinic, explained that there are three different treatment guidelines to manage initial CDI in patients with IBD.

Predominantly, these guidelines also suggest human monoclonal antibody bezlotoxumab could be used for prevention of CDI recurrence in patients at high risk of recurrence, including those who had experienced severe CDI. “One can argue that anyone with IBD who has C. difficile can be a severe CDI patient because of the bad outcomes we can see,” he explained.

“We do know that IBD is a state of chronic microbial dysbiosis compared to our patients without IBD who get C. difficile because of antibiotic exposure, and that’s why these patients have a high risk of recurrence, compared with non-IBD patients,” said Dr. Khanna. He noted that the bezlotoxumab studies showed numerically lower CDI recurrence rates compared with other treatments in patients with IBD who were initially treated with the monoclonal antibody, but this difference was not statistically significant. “But again, this agent has been shown to be safe in this patient population.”

Dr. Dalal reported having no relevant conflicts of interest. Dr. Colombel has consulted for Takeda, which markets Entyvio for UC. Dr. Khanna has research grants from Rebiotix, as well as consulting fees from Shire Plc, Premier, Facile Therapeutics, and ProbioTech.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff .

Vedolizumab does not seem to increase the risk of Clostridioides difficile infection (CDI), compared with anti–tumor necrosis factor (TNF) therapies in biologic-naive patients with ulcerative colitis (UC), despite concerns that the gut-selective monoclonal antibody treatment may increase gastrointestinal infections at a greater rate than other biologics in this patient population.

Perturbations of the gut microbiota that occur in IBD predispose patients to CDI. Given that treatment with monoclonal antibody vedolizumab exerts an inhibitory action on lymphocyte trafficking to the intestines, questions have been raised on whether this action could increase the risk of CDI in an already vulnerable population.

In patients with UC, the incidence of CDI typically confers a higher risk of adverse outcomes. Unfortunately, CDI is a common complication associated with inflammatory bowel disease (IBD) that can lead to disease flares, further adding to the physical and psychological burden associated with the condition, according to recent studies.

These concerns, however, may not be warranted in patients with UC, according to findings from a retrospective study presented at the annual Advances in Inflammatory Bowel Diseases conference by Rahul Dalal, MD, a gastroenterology fellow at Brigham and Women’s Hospital in Boston.

In the study, Dr. Dalal and colleagues retrospectively analyzed electronic medical records of adult patients with UC who initiated infliximab, adalimumab, or vedolizumab between June 2014 and December 2020. Patients in this retrospective cohort were followed until there was a documented occurrence of CDI, colectomy, or biologic discontinuation/switch, or until the last recorded gastroenterology encounter.

The researchers analyzed the time from biologic initiation to first CDI, which was characterized by a positive stool for C. difficile toxin or toxigenic C. difficile polymerase chain reaction with CDI-specific antibiotic prescriptions. Additionally, the investigators evaluated rates of CDI-related hospitalization, colectomy, or death within a 30-day period of CDI. The primary analysis compared patients with UC who initiated vedolizumab (n = 195) versus anti-TNF therapy (n = 610).

Compared with those treated with anti-TNF agents, patients who initiated vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months prior to starting biologics.

Over 1,436 patient-years’ worth of follow-up, the investigators observed 43 CDIs. Patients treated with vedolizumab less frequently had CDI (1.0% vs. 6.7%; P =.001) and CDI hospitalization (1.0% vs. 3.8%; P =.042), compared with those treated with anti-TNF therapies. The investigators reported no significant differences in the rates of colectomies or deaths or rates of exposure to antibiotics/corticosteroids during the follow-up period or within 30 days prior to CDI onset.

In the unadjusted Cox model, the researchers reported that vedolizumab featured a lower hazard of CDI, compared with anti-TNF (hazard ratio, 0.17; 95% confidence interval, 0.04-0.71). The multivariable Cox model found no significant difference in hazard of CDI for vedolizumab when compared with anti-TNF therapy (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40). The incidence of CDI prior to biologic initiation was associated with an increased hazard of subsequent CDI (HR, 5.95; 95% CI, 2.93-12.09). In the subgroup of patients who experienced a CDI, approximately 39.5% had CDI before biologic initiation at a median of 227 days preceding the subsequent event.

“Vedolizumab is one of the safest biologics that we have in the clinic,” said Jean-Frederic Colombel, MD, who was asked to comment on the study. Dr. Colombel, who wasn’t involved in the study, is a gastroenterologist and serves as director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai, both in New York. “Findings from this study reinforce the safety profile of vedolizumab” despite the potential concerns regarding gastroenterological infection with the agent, he added.
 

Recurrence worries

Recurrent CDI is an issue in patients with IBD, many of whom are considered at high risk for initial and recurrent infection. During a session on CDI and recurrence at the AIBD meeting, Sahil Khanna, MBBS, of the Mayo Clinic, explained that there are three different treatment guidelines to manage initial CDI in patients with IBD.

Predominantly, these guidelines also suggest human monoclonal antibody bezlotoxumab could be used for prevention of CDI recurrence in patients at high risk of recurrence, including those who had experienced severe CDI. “One can argue that anyone with IBD who has C. difficile can be a severe CDI patient because of the bad outcomes we can see,” he explained.

“We do know that IBD is a state of chronic microbial dysbiosis compared to our patients without IBD who get C. difficile because of antibiotic exposure, and that’s why these patients have a high risk of recurrence, compared with non-IBD patients,” said Dr. Khanna. He noted that the bezlotoxumab studies showed numerically lower CDI recurrence rates compared with other treatments in patients with IBD who were initially treated with the monoclonal antibody, but this difference was not statistically significant. “But again, this agent has been shown to be safe in this patient population.”

Dr. Dalal reported having no relevant conflicts of interest. Dr. Colombel has consulted for Takeda, which markets Entyvio for UC. Dr. Khanna has research grants from Rebiotix, as well as consulting fees from Shire Plc, Premier, Facile Therapeutics, and ProbioTech.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff .

Vedolizumab does not seem to increase the risk of Clostridioides difficile infection (CDI), compared with anti–tumor necrosis factor (TNF) therapies in biologic-naive patients with ulcerative colitis (UC), despite concerns that the gut-selective monoclonal antibody treatment may increase gastrointestinal infections at a greater rate than other biologics in this patient population.

Perturbations of the gut microbiota that occur in IBD predispose patients to CDI. Given that treatment with monoclonal antibody vedolizumab exerts an inhibitory action on lymphocyte trafficking to the intestines, questions have been raised on whether this action could increase the risk of CDI in an already vulnerable population.

In patients with UC, the incidence of CDI typically confers a higher risk of adverse outcomes. Unfortunately, CDI is a common complication associated with inflammatory bowel disease (IBD) that can lead to disease flares, further adding to the physical and psychological burden associated with the condition, according to recent studies.

These concerns, however, may not be warranted in patients with UC, according to findings from a retrospective study presented at the annual Advances in Inflammatory Bowel Diseases conference by Rahul Dalal, MD, a gastroenterology fellow at Brigham and Women’s Hospital in Boston.

In the study, Dr. Dalal and colleagues retrospectively analyzed electronic medical records of adult patients with UC who initiated infliximab, adalimumab, or vedolizumab between June 2014 and December 2020. Patients in this retrospective cohort were followed until there was a documented occurrence of CDI, colectomy, or biologic discontinuation/switch, or until the last recorded gastroenterology encounter.

The researchers analyzed the time from biologic initiation to first CDI, which was characterized by a positive stool for C. difficile toxin or toxigenic C. difficile polymerase chain reaction with CDI-specific antibiotic prescriptions. Additionally, the investigators evaluated rates of CDI-related hospitalization, colectomy, or death within a 30-day period of CDI. The primary analysis compared patients with UC who initiated vedolizumab (n = 195) versus anti-TNF therapy (n = 610).

Compared with those treated with anti-TNF agents, patients who initiated vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months prior to starting biologics.

Over 1,436 patient-years’ worth of follow-up, the investigators observed 43 CDIs. Patients treated with vedolizumab less frequently had CDI (1.0% vs. 6.7%; P =.001) and CDI hospitalization (1.0% vs. 3.8%; P =.042), compared with those treated with anti-TNF therapies. The investigators reported no significant differences in the rates of colectomies or deaths or rates of exposure to antibiotics/corticosteroids during the follow-up period or within 30 days prior to CDI onset.

In the unadjusted Cox model, the researchers reported that vedolizumab featured a lower hazard of CDI, compared with anti-TNF (hazard ratio, 0.17; 95% confidence interval, 0.04-0.71). The multivariable Cox model found no significant difference in hazard of CDI for vedolizumab when compared with anti-TNF therapy (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40). The incidence of CDI prior to biologic initiation was associated with an increased hazard of subsequent CDI (HR, 5.95; 95% CI, 2.93-12.09). In the subgroup of patients who experienced a CDI, approximately 39.5% had CDI before biologic initiation at a median of 227 days preceding the subsequent event.

“Vedolizumab is one of the safest biologics that we have in the clinic,” said Jean-Frederic Colombel, MD, who was asked to comment on the study. Dr. Colombel, who wasn’t involved in the study, is a gastroenterologist and serves as director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai, both in New York. “Findings from this study reinforce the safety profile of vedolizumab” despite the potential concerns regarding gastroenterological infection with the agent, he added.
 

Recurrence worries

Recurrent CDI is an issue in patients with IBD, many of whom are considered at high risk for initial and recurrent infection. During a session on CDI and recurrence at the AIBD meeting, Sahil Khanna, MBBS, of the Mayo Clinic, explained that there are three different treatment guidelines to manage initial CDI in patients with IBD.

Predominantly, these guidelines also suggest human monoclonal antibody bezlotoxumab could be used for prevention of CDI recurrence in patients at high risk of recurrence, including those who had experienced severe CDI. “One can argue that anyone with IBD who has C. difficile can be a severe CDI patient because of the bad outcomes we can see,” he explained.

“We do know that IBD is a state of chronic microbial dysbiosis compared to our patients without IBD who get C. difficile because of antibiotic exposure, and that’s why these patients have a high risk of recurrence, compared with non-IBD patients,” said Dr. Khanna. He noted that the bezlotoxumab studies showed numerically lower CDI recurrence rates compared with other treatments in patients with IBD who were initially treated with the monoclonal antibody, but this difference was not statistically significant. “But again, this agent has been shown to be safe in this patient population.”

Dr. Dalal reported having no relevant conflicts of interest. Dr. Colombel has consulted for Takeda, which markets Entyvio for UC. Dr. Khanna has research grants from Rebiotix, as well as consulting fees from Shire Plc, Premier, Facile Therapeutics, and ProbioTech.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff .