Federal Practitioner

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.

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.

Interrogating the cardiac implantable electronic device (CIED) after death can yield important information about critical device malfunction, premortem abnormalities, and the mechanism and timing of death, a new study suggests.

Postmortem CIED interrogation is “richly informative” in assisting both cardiac and forensic investigations and “should be considered for select patients with CIEDs undergoing autopsy,” say Elizabeth Paratz, MBBS, department of cardiology, Baker Heart and Diabetes Institute, Prahran, Australia, and colleagues.

Their study results were published online in JACC: Clinical Electrophysiology. 

Cause of death revealed in half of cases

They reviewed CIED interrogations in 260 deceased individuals undergoing medicolegal investigation of sudden death (162 patients) or unexplained death (98 patients) by the Victorian Institute of Forensic Medicine between 2005 and 2020.

Roughly two-thirds were male (68.8%) and their median age was 72.8 years; 202 patients had pacemakers, 56 had defibrillators, and 2 had loop recorders. The cause of death was cardiac in 79.6% of cases.

Postmortem CIED interrogation was successful in 98.5% cases and directly informed cause of death in 131 cases (50.4%), with fatal ventricular arrhythmias identified in 121 patients.

CIED interrogation assisted in determining the cause of death in 63.6% of cases of sudden death and 28.6% of nonsudden death cases.

In 20 cases (7.7%), CIED interrogation uncovered potential device malfunction. Issues included failure to appropriately treat ventricular arrhythmias in 13 cases; lead issues in 3 cases, including 2 cases resulting in failure to treat ventricular arrhythmias; as well as battery depletion in 6 cases.

In 72 patients (27.7%), the device recorded abnormalities in the 30 days before death. These abnormalities included nonsustained ventricular tachycardia in 26 cases, rapid atrial fibrillation in 17, elective replacement indicator or end-of-life status in 22, intrathoracic impedance alarms or lead issues in 3 each, and therapy delivered in 1 instance.

“In several cases, the absence of an arrhythmia carried medicolegal implications: For example, in eight fatal motor vehicle accident cases, only one patient had a ventricular arrhythmia documented on their CIED,” Dr. Paratz and colleagues report.

And in six cases in which the patient was found dead after a prolonged period, CIED interrogation determined time of death. And in one case, CIED interrogation was the primary means of identifying the patient.

Still, postmortem CIED interrogation remains uncommon, the study team notes.

They point to a 2007 survey of Chicago morticians that found roughly 370 CIEDs were explanted per year prior to cremation, but only 4% of morticians had ever returned a CIED to the manufacturer for analysis.

“Encouraging postmortem interrogation of CIEDs may assist in postmarketing surveillance for critical faults, as well as in providing an electrophysiological appraisal of terminal rhythms and device responses in a variety of physiological scenarios,” the researchers say.

The study had no commercial funding. Dr. Paratz is supported by a National Health and Medical Research Council/National Heart Foundation cofunded Postgraduate Scholarship, Royal Australasian College of Physicians JJ Billings Scholarship, and PSA Insurance Cardiovascular Scholarship. The authors have disclosed no relevant financial relationships.

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

Interrogating the cardiac implantable electronic device (CIED) after death can yield important information about critical device malfunction, premortem abnormalities, and the mechanism and timing of death, a new study suggests.

Postmortem CIED interrogation is “richly informative” in assisting both cardiac and forensic investigations and “should be considered for select patients with CIEDs undergoing autopsy,” say Elizabeth Paratz, MBBS, department of cardiology, Baker Heart and Diabetes Institute, Prahran, Australia, and colleagues.

Their study results were published online in JACC: Clinical Electrophysiology. 

Cause of death revealed in half of cases

They reviewed CIED interrogations in 260 deceased individuals undergoing medicolegal investigation of sudden death (162 patients) or unexplained death (98 patients) by the Victorian Institute of Forensic Medicine between 2005 and 2020.

Roughly two-thirds were male (68.8%) and their median age was 72.8 years; 202 patients had pacemakers, 56 had defibrillators, and 2 had loop recorders. The cause of death was cardiac in 79.6% of cases.

Postmortem CIED interrogation was successful in 98.5% cases and directly informed cause of death in 131 cases (50.4%), with fatal ventricular arrhythmias identified in 121 patients.

CIED interrogation assisted in determining the cause of death in 63.6% of cases of sudden death and 28.6% of nonsudden death cases.

In 20 cases (7.7%), CIED interrogation uncovered potential device malfunction. Issues included failure to appropriately treat ventricular arrhythmias in 13 cases; lead issues in 3 cases, including 2 cases resulting in failure to treat ventricular arrhythmias; as well as battery depletion in 6 cases.

In 72 patients (27.7%), the device recorded abnormalities in the 30 days before death. These abnormalities included nonsustained ventricular tachycardia in 26 cases, rapid atrial fibrillation in 17, elective replacement indicator or end-of-life status in 22, intrathoracic impedance alarms or lead issues in 3 each, and therapy delivered in 1 instance.

“In several cases, the absence of an arrhythmia carried medicolegal implications: For example, in eight fatal motor vehicle accident cases, only one patient had a ventricular arrhythmia documented on their CIED,” Dr. Paratz and colleagues report.

And in six cases in which the patient was found dead after a prolonged period, CIED interrogation determined time of death. And in one case, CIED interrogation was the primary means of identifying the patient.

Still, postmortem CIED interrogation remains uncommon, the study team notes.

They point to a 2007 survey of Chicago morticians that found roughly 370 CIEDs were explanted per year prior to cremation, but only 4% of morticians had ever returned a CIED to the manufacturer for analysis.

“Encouraging postmortem interrogation of CIEDs may assist in postmarketing surveillance for critical faults, as well as in providing an electrophysiological appraisal of terminal rhythms and device responses in a variety of physiological scenarios,” the researchers say.

The study had no commercial funding. Dr. Paratz is supported by a National Health and Medical Research Council/National Heart Foundation cofunded Postgraduate Scholarship, Royal Australasian College of Physicians JJ Billings Scholarship, and PSA Insurance Cardiovascular Scholarship. The authors have disclosed no relevant financial relationships.

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

Interrogating the cardiac implantable electronic device (CIED) after death can yield important information about critical device malfunction, premortem abnormalities, and the mechanism and timing of death, a new study suggests.

Postmortem CIED interrogation is “richly informative” in assisting both cardiac and forensic investigations and “should be considered for select patients with CIEDs undergoing autopsy,” say Elizabeth Paratz, MBBS, department of cardiology, Baker Heart and Diabetes Institute, Prahran, Australia, and colleagues.

Their study results were published online in JACC: Clinical Electrophysiology. 

Cause of death revealed in half of cases

They reviewed CIED interrogations in 260 deceased individuals undergoing medicolegal investigation of sudden death (162 patients) or unexplained death (98 patients) by the Victorian Institute of Forensic Medicine between 2005 and 2020.

Roughly two-thirds were male (68.8%) and their median age was 72.8 years; 202 patients had pacemakers, 56 had defibrillators, and 2 had loop recorders. The cause of death was cardiac in 79.6% of cases.

Postmortem CIED interrogation was successful in 98.5% cases and directly informed cause of death in 131 cases (50.4%), with fatal ventricular arrhythmias identified in 121 patients.

CIED interrogation assisted in determining the cause of death in 63.6% of cases of sudden death and 28.6% of nonsudden death cases.

In 20 cases (7.7%), CIED interrogation uncovered potential device malfunction. Issues included failure to appropriately treat ventricular arrhythmias in 13 cases; lead issues in 3 cases, including 2 cases resulting in failure to treat ventricular arrhythmias; as well as battery depletion in 6 cases.

In 72 patients (27.7%), the device recorded abnormalities in the 30 days before death. These abnormalities included nonsustained ventricular tachycardia in 26 cases, rapid atrial fibrillation in 17, elective replacement indicator or end-of-life status in 22, intrathoracic impedance alarms or lead issues in 3 each, and therapy delivered in 1 instance.

“In several cases, the absence of an arrhythmia carried medicolegal implications: For example, in eight fatal motor vehicle accident cases, only one patient had a ventricular arrhythmia documented on their CIED,” Dr. Paratz and colleagues report.

And in six cases in which the patient was found dead after a prolonged period, CIED interrogation determined time of death. And in one case, CIED interrogation was the primary means of identifying the patient.

Still, postmortem CIED interrogation remains uncommon, the study team notes.

They point to a 2007 survey of Chicago morticians that found roughly 370 CIEDs were explanted per year prior to cremation, but only 4% of morticians had ever returned a CIED to the manufacturer for analysis.

“Encouraging postmortem interrogation of CIEDs may assist in postmarketing surveillance for critical faults, as well as in providing an electrophysiological appraisal of terminal rhythms and device responses in a variety of physiological scenarios,” the researchers say.

The study had no commercial funding. Dr. Paratz is supported by a National Health and Medical Research Council/National Heart Foundation cofunded Postgraduate Scholarship, Royal Australasian College of Physicians JJ Billings Scholarship, and PSA Insurance Cardiovascular Scholarship. The authors have disclosed no relevant financial relationships.

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

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

Researchers have identified a risk locus on chromosome 7 containing DNA variations that increase the risk that an individual will attempt suicide, even in the absence of a psychiatric disorder.

This finding suggests the genetic underpinnings of suicide attempts are partially shared and partially distinct from those of related psychiatric disorders, the investigators note.

“This study brings us a step closer to understanding the neurobiology of suicidality, with the ultimate goal of developing new treatments and prevention strategies,” Niamh Mullins, PhD, department of psychiatry, department of genetics and genomic sciences, Icahn School of Medicine at Mount Sinai in New York, said in an interview.

The study was published online in Biological Psychiatry.

Largest study to date

In the largest genetic association study of suicide attempt published to date, the researchers conducted a genome-wide association study (GWAS) of 29,782 suicide attempt cases and 519,961 controls in the International Suicide Genetics Consortium (ISGC).

Two loci reached genome-wide significance for suicide attempt – the major histocompatibility complex and an intergenic locus on chromosome 7, the latter of which remained associated with suicide attempt after conditioning on psychiatric disorders and was replicated in an independent cohort of over 14,000 veterans in the Million Veteran Program.

“This is the first replicated genetic locus that contributes more to suicide attempt than related psychiatric disorders,” Dr. Mullins said.

“The study found overlap in the genetic basis of suicide attempt and that of related psychiatric disorders, particularly major depression, but also with that of nonpsychiatric risk factors such as smoking, pain, risk-taking behavior, sleep disturbances, and poorer general health,” Dr. Mullins said.

“These genetic relationships between suicide attempt and nonpsychiatric risk factors were not a by-product of comorbid psychiatric illness, suggesting that there is some shared biological basis between suicide attempt and nonpsychiatric risk factors,” she added.

Dr. Mullins cautioned that the findings do not have any immediate impact on patient care.

“The ultimate goal of this research is to gain insight into the underlying biological pathways involved in suicide attempts or suicidal thoughts, providing potential avenues to treatments and prevention strategies,” she said.

“The study findings also point to the importance of studying the potential direct causal paths between these risk factors and suicide attempt in patients with and without psychiatric illness,” Douglas Ruderfer, PhD, of Vanderbilt University Medical Center, Nashville, Tenn., cofounder and cochair of the consortium and senior author of the paper, added in a news release.

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

Researchers have identified a risk locus on chromosome 7 containing DNA variations that increase the risk that an individual will attempt suicide, even in the absence of a psychiatric disorder.

This finding suggests the genetic underpinnings of suicide attempts are partially shared and partially distinct from those of related psychiatric disorders, the investigators note.

“This study brings us a step closer to understanding the neurobiology of suicidality, with the ultimate goal of developing new treatments and prevention strategies,” Niamh Mullins, PhD, department of psychiatry, department of genetics and genomic sciences, Icahn School of Medicine at Mount Sinai in New York, said in an interview.

The study was published online in Biological Psychiatry.

Largest study to date

In the largest genetic association study of suicide attempt published to date, the researchers conducted a genome-wide association study (GWAS) of 29,782 suicide attempt cases and 519,961 controls in the International Suicide Genetics Consortium (ISGC).

Two loci reached genome-wide significance for suicide attempt – the major histocompatibility complex and an intergenic locus on chromosome 7, the latter of which remained associated with suicide attempt after conditioning on psychiatric disorders and was replicated in an independent cohort of over 14,000 veterans in the Million Veteran Program.

“This is the first replicated genetic locus that contributes more to suicide attempt than related psychiatric disorders,” Dr. Mullins said.

“The study found overlap in the genetic basis of suicide attempt and that of related psychiatric disorders, particularly major depression, but also with that of nonpsychiatric risk factors such as smoking, pain, risk-taking behavior, sleep disturbances, and poorer general health,” Dr. Mullins said.

“These genetic relationships between suicide attempt and nonpsychiatric risk factors were not a by-product of comorbid psychiatric illness, suggesting that there is some shared biological basis between suicide attempt and nonpsychiatric risk factors,” she added.

Dr. Mullins cautioned that the findings do not have any immediate impact on patient care.

“The ultimate goal of this research is to gain insight into the underlying biological pathways involved in suicide attempts or suicidal thoughts, providing potential avenues to treatments and prevention strategies,” she said.

“The study findings also point to the importance of studying the potential direct causal paths between these risk factors and suicide attempt in patients with and without psychiatric illness,” Douglas Ruderfer, PhD, of Vanderbilt University Medical Center, Nashville, Tenn., cofounder and cochair of the consortium and senior author of the paper, added in a news release.

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

Researchers have identified a risk locus on chromosome 7 containing DNA variations that increase the risk that an individual will attempt suicide, even in the absence of a psychiatric disorder.

This finding suggests the genetic underpinnings of suicide attempts are partially shared and partially distinct from those of related psychiatric disorders, the investigators note.

“This study brings us a step closer to understanding the neurobiology of suicidality, with the ultimate goal of developing new treatments and prevention strategies,” Niamh Mullins, PhD, department of psychiatry, department of genetics and genomic sciences, Icahn School of Medicine at Mount Sinai in New York, said in an interview.

The study was published online in Biological Psychiatry.

Largest study to date

In the largest genetic association study of suicide attempt published to date, the researchers conducted a genome-wide association study (GWAS) of 29,782 suicide attempt cases and 519,961 controls in the International Suicide Genetics Consortium (ISGC).

Two loci reached genome-wide significance for suicide attempt – the major histocompatibility complex and an intergenic locus on chromosome 7, the latter of which remained associated with suicide attempt after conditioning on psychiatric disorders and was replicated in an independent cohort of over 14,000 veterans in the Million Veteran Program.

“This is the first replicated genetic locus that contributes more to suicide attempt than related psychiatric disorders,” Dr. Mullins said.

“The study found overlap in the genetic basis of suicide attempt and that of related psychiatric disorders, particularly major depression, but also with that of nonpsychiatric risk factors such as smoking, pain, risk-taking behavior, sleep disturbances, and poorer general health,” Dr. Mullins said.

“These genetic relationships between suicide attempt and nonpsychiatric risk factors were not a by-product of comorbid psychiatric illness, suggesting that there is some shared biological basis between suicide attempt and nonpsychiatric risk factors,” she added.

Dr. Mullins cautioned that the findings do not have any immediate impact on patient care.

“The ultimate goal of this research is to gain insight into the underlying biological pathways involved in suicide attempts or suicidal thoughts, providing potential avenues to treatments and prevention strategies,” she said.

“The study findings also point to the importance of studying the potential direct causal paths between these risk factors and suicide attempt in patients with and without psychiatric illness,” Douglas Ruderfer, PhD, of Vanderbilt University Medical Center, Nashville, Tenn., cofounder and cochair of the consortium and senior author of the paper, added in a news release.

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

With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?

New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.

This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
 

If you have tested positive for COVID-19, what do you do next?

“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)

Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.

Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5  days.

Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.  

According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
 

If you have been exposed to someone with COVID-19, what do you do next?

“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.

For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.

On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.

But if  someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
 

When should the person who has been exposed get tested?

After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”

Testing should be done by those exposed at least once, Dr. Adalja said.

“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
 

At what point can the infected person mingle safely with others?

“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”

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

With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?

New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.

This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
 

If you have tested positive for COVID-19, what do you do next?

“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)

Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.

Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5  days.

Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.  

According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
 

If you have been exposed to someone with COVID-19, what do you do next?

“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.

For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.

On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.

But if  someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
 

When should the person who has been exposed get tested?

After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”

Testing should be done by those exposed at least once, Dr. Adalja said.

“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
 

At what point can the infected person mingle safely with others?

“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”

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

With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?

New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.

This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
 

If you have tested positive for COVID-19, what do you do next?

“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)

Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.

Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5  days.

Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.  

According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
 

If you have been exposed to someone with COVID-19, what do you do next?

“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.

For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.

On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.

But if  someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
 

When should the person who has been exposed get tested?

After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”

Testing should be done by those exposed at least once, Dr. Adalja said.

“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
 

At what point can the infected person mingle safely with others?

“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”

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

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

Extensive efforts have been put forth to evaluate which patients may safely delay, or completely avoid, treatment for prostate cancer. However, identifying who can safely avoid treatment is challenging. Arcot et al. utilized the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry for men to determine whether those with prostate cancer grade group 1 with delayed treatment had increased need for secondary treatments, such as androgen deprivation or radiation therapy, compared with those with upfront surgery. There was a small decrease in the probability of being free from secondary treatment 24 months after diagnosis (96% vs. 93%), suggesting that such an approach is quite reasonable.

These two studies exemplify one of the ongoing points of discussion in treatment of early stage prostate cancer: whether upfront treatments are of net benefit for patients. The study by Wallis et al. further evaluated this point by conducting a prospective cohort study to evaluate the extent of regret of choice of treatment strategy amongst patients with prostate cancer. Out of this cohort of 2,072 men, 16% who underwent surgery, 11% who received radiation, and 7% who chose active surveillance reported regret regarding the treatment choice. However, when controlled for functional outcomes, the differences amongst treatment modalities were not statistically significant. However, perceived treatment efficacy and adverse effects were associated with regret when compared with patient expectations prior to treatment. This suggest that research and focus on shared decision-making in the clinic may be highly beneficial.