MDedge Psychiatry

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

Despite the best efforts of my institution’s spam filter, I’ve realized that I spend at least 4 minutes every day of the week removing junk email from my in basket: EMR vendors, predatory journals trying to lure me into paying their outrageous publication fees, people who want to help me with my billing software (evidently that .edu extension hasn’t clicked for them yet), headhunters trying to fill specialty positions in other states, market researchers offering a gift card for 40 minutes filling out a survey.

If you do the math, 4 minutes daily is 1,460 minutes per year. That’s an entire day of my life lost each year to this useless nonsense, which I never agreed to receive in the first place. Now multiply that by the 22 million health care workers in the United States, or even just by the 985,000 licensed physicians in this country. Then factor in the $638 per hour in gross revenue generated by the average primary care physician, as a conservative, well-documented value.

By my reckoning, these bozos owe the United States alone over $15 billion in lost GDP each year.

So why don’t we shut it down!? The CAN-SPAM Act of 2003 attempted to at least mitigate the problem. It applies only to commercial entities (I know, I’d love to report some political groups, too). To avoid violating the law and risking fines of up to $16,000 per individual email, senders must:

• Not use misleading header info (including domain name and email address)
• Not use deceptive subject lines
• Clearly label the email as an ad
• Give an actual physical address of the sender
• Tell recipients how to opt out of future emails
• Honor opt-out requests within 10 business days
• Monitor the activities of any subcontractor sending email on their behalf

I can say with certainty that much of the trash in my inbox violates at least one of these. But that doesn’t matter if there is not an efficient way to report the violators and ensure that they’ll be tracked down. Hard enough if they live here, impossible if the email is routed from overseas, as much of it clearly is.

If you receive email in violation of the act, experts recommend that you write down the email address and the business name of the sender, fill out a complaint form on the Federal Trade Commission website, or send an email to [email protected], then send an email to your Internet service provider’s abuse desk. If you’re not working within a big institution like mine that has hot and cold running IT personnel that operate their own abuse prevention office, the address you’ll need is likely abuse@domain_name or postmaster@domain_name. Just hitting the spam button at the top of your browser/email software may do the trick. There’s more good advice at the FTC’s consumer spam page.

The people not violating the law, though, are wasting my time every bit as flagrantly. How are they getting my email address in the first place?

The answer came, ironically, to my email inbox in the form of one of those emails that did indeed violate the law.

Dr. Hitchcock is assistant professor, department of radiation oncology, at the University of Florida, Gainesville. She reported receiving research grant money from Merck. A version of this article first appeared on Medscape.com.

Despite the best efforts of my institution’s spam filter, I’ve realized that I spend at least 4 minutes every day of the week removing junk email from my in basket: EMR vendors, predatory journals trying to lure me into paying their outrageous publication fees, people who want to help me with my billing software (evidently that .edu extension hasn’t clicked for them yet), headhunters trying to fill specialty positions in other states, market researchers offering a gift card for 40 minutes filling out a survey.

If you do the math, 4 minutes daily is 1,460 minutes per year. That’s an entire day of my life lost each year to this useless nonsense, which I never agreed to receive in the first place. Now multiply that by the 22 million health care workers in the United States, or even just by the 985,000 licensed physicians in this country. Then factor in the $638 per hour in gross revenue generated by the average primary care physician, as a conservative, well-documented value.

By my reckoning, these bozos owe the United States alone over $15 billion in lost GDP each year.

So why don’t we shut it down!? The CAN-SPAM Act of 2003 attempted to at least mitigate the problem. It applies only to commercial entities (I know, I’d love to report some political groups, too). To avoid violating the law and risking fines of up to $16,000 per individual email, senders must:

• Not use misleading header info (including domain name and email address)
• Not use deceptive subject lines
• Clearly label the email as an ad
• Give an actual physical address of the sender
• Tell recipients how to opt out of future emails
• Honor opt-out requests within 10 business days
• Monitor the activities of any subcontractor sending email on their behalf

I can say with certainty that much of the trash in my inbox violates at least one of these. But that doesn’t matter if there is not an efficient way to report the violators and ensure that they’ll be tracked down. Hard enough if they live here, impossible if the email is routed from overseas, as much of it clearly is.

If you receive email in violation of the act, experts recommend that you write down the email address and the business name of the sender, fill out a complaint form on the Federal Trade Commission website, or send an email to [email protected], then send an email to your Internet service provider’s abuse desk. If you’re not working within a big institution like mine that has hot and cold running IT personnel that operate their own abuse prevention office, the address you’ll need is likely abuse@domain_name or postmaster@domain_name. Just hitting the spam button at the top of your browser/email software may do the trick. There’s more good advice at the FTC’s consumer spam page.

The people not violating the law, though, are wasting my time every bit as flagrantly. How are they getting my email address in the first place?

The answer came, ironically, to my email inbox in the form of one of those emails that did indeed violate the law.

Dr. Hitchcock is assistant professor, department of radiation oncology, at the University of Florida, Gainesville. She reported receiving research grant money from Merck. A version of this article first appeared on Medscape.com.

Despite the best efforts of my institution’s spam filter, I’ve realized that I spend at least 4 minutes every day of the week removing junk email from my in basket: EMR vendors, predatory journals trying to lure me into paying their outrageous publication fees, people who want to help me with my billing software (evidently that .edu extension hasn’t clicked for them yet), headhunters trying to fill specialty positions in other states, market researchers offering a gift card for 40 minutes filling out a survey.

If you do the math, 4 minutes daily is 1,460 minutes per year. That’s an entire day of my life lost each year to this useless nonsense, which I never agreed to receive in the first place. Now multiply that by the 22 million health care workers in the United States, or even just by the 985,000 licensed physicians in this country. Then factor in the $638 per hour in gross revenue generated by the average primary care physician, as a conservative, well-documented value.

By my reckoning, these bozos owe the United States alone over $15 billion in lost GDP each year.

So why don’t we shut it down!? The CAN-SPAM Act of 2003 attempted to at least mitigate the problem. It applies only to commercial entities (I know, I’d love to report some political groups, too). To avoid violating the law and risking fines of up to $16,000 per individual email, senders must:

• Not use misleading header info (including domain name and email address)
• Not use deceptive subject lines
• Clearly label the email as an ad
• Give an actual physical address of the sender
• Tell recipients how to opt out of future emails
• Honor opt-out requests within 10 business days
• Monitor the activities of any subcontractor sending email on their behalf

I can say with certainty that much of the trash in my inbox violates at least one of these. But that doesn’t matter if there is not an efficient way to report the violators and ensure that they’ll be tracked down. Hard enough if they live here, impossible if the email is routed from overseas, as much of it clearly is.

If you receive email in violation of the act, experts recommend that you write down the email address and the business name of the sender, fill out a complaint form on the Federal Trade Commission website, or send an email to [email protected], then send an email to your Internet service provider’s abuse desk. If you’re not working within a big institution like mine that has hot and cold running IT personnel that operate their own abuse prevention office, the address you’ll need is likely abuse@domain_name or postmaster@domain_name. Just hitting the spam button at the top of your browser/email software may do the trick. There’s more good advice at the FTC’s consumer spam page.

The people not violating the law, though, are wasting my time every bit as flagrantly. How are they getting my email address in the first place?

The answer came, ironically, to my email inbox in the form of one of those emails that did indeed violate the law.

Dr. Hitchcock is assistant professor, department of radiation oncology, at the University of Florida, Gainesville. She reported receiving research grant money from Merck. A version of this article first appeared on Medscape.com.

Adolescents with psychogenic nonepileptic seizures (PNES) experience severe bullying by fellow students and school staff alike, results of a small study suggest.

The school experience of teens with PNES is overwhelmingly negative, study investigator Andrea Tanner, PhD, a postdoctoral fellow at Indiana University School of Nursing, Indianapolis.

She hopes this research will spur a collaborative effort between students, schools, families, and health care providers “to develop an effective plan to help these adolescents cope, to manage this condition, and hopefully reach seizure freedom.”

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Anxiety, perfectionism

Although psychogenic seizures resemble epileptic seizures, they have a psychological basis and, unlike epilepsy, are not caused by abnormal electrical brain activity.

While the school experience has previously been identified as a source of predisposing, precipitating, and perpetuating factors for PNES, little is known about the school experience of adolescents with the disorder and the role it may play in PNES management, the investigators noted.

During her 20 years as a school nurse, Dr. Tanner saw firsthand how school staff struggled with responding appropriately to teens with PNES. “They wanted to call 911 every time; they wanted to respond as if it [were] an epileptic seizure.”

For the study, she interviewed 10 teens with PNES, aged 12 to 19 years, whom she found mostly through Facebook support groups but also through flyers. All participants had undergone video EEG and been diagnosed with PNES.

From the interviews, Dr. Tanner and colleagues conducted a qualitative content analysis and uncovered “overarching” themes.

A main theme was stress, some of which focused on bullying by peers or harassment by school personnel, much of which was related to accusations of the children “faking” seizures to get attention, said Dr. Tanner.

Some teens reported being banned from school events, such as field trips, out of concern they would be a “distraction,” which led to feelings of isolation and exclusion, said Dr. Tanner.

Research points to a growing incidence of PNES among adolescents. This may be because it is now better recognized, or it may stem from the unique stressors today’s teens face, said Dr. Tanner.

Adolescents discussed the pressures they feel to be the best at everything. “They wanted to be good in athletics; they wanted to be good in academics; they wanted to get into a good college,” said Dr. Tanner.

Some study participants had undergone psychotherapy, including cognitive-behavioral therapy, and others had investigated mindfulness-based therapy. However, not all were receiving treatment. For some, such care was inaccessible, while others had tried a mental health care intervention but had abandoned it.

Although all the study participants were female, Dr. Tanner has interviewed males outside this study and found their experiences are similar.

Her next research step is to try to quantify the findings. “I would like to begin to look at what would be the appropriate outcomes if I were to do an intervention to improve the school experience.”

Her message for doctors is to see school nurses as a “partner” or “liaison” who “can bridge the world of health care and education.”
 

Important, novel research

Commenting on the research, Barbara Dworetzky, MD, Chief, Epilepsy, Brigham and Women’s Hospital, and professor of neurology, Harvard Medical School, said it’s “important and novel.”

The study focuses on the main factors – or themes – that lead to increased stress, such as bullying, isolation, and “not being believed,” that are likely triggers for PNES, said Dr. Dworetzky.

The study is also important because it focuses on factors that help make the girls “feel supported and protected” – for example, having staff “take the episodes seriously,” she said.

The study’s qualitative measures “are a valid way of understanding these girls and giving them a voice,” said Dr. Dworetzky. She added the study provides “practical information” that could help target treatments to improve outcomes in this group.

A limitation of the study was that the very small cohort of teenage girls was selected only through families in Facebook support groups or flyers to school nurses, said Dr. Dworetzky.

“There are likely many other groups who don’t even have families trying to help them. Larger cohorts without this type of bias may be next steps.”

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

Adolescents with psychogenic nonepileptic seizures (PNES) experience severe bullying by fellow students and school staff alike, results of a small study suggest.

The school experience of teens with PNES is overwhelmingly negative, study investigator Andrea Tanner, PhD, a postdoctoral fellow at Indiana University School of Nursing, Indianapolis.

She hopes this research will spur a collaborative effort between students, schools, families, and health care providers “to develop an effective plan to help these adolescents cope, to manage this condition, and hopefully reach seizure freedom.”

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Anxiety, perfectionism

Although psychogenic seizures resemble epileptic seizures, they have a psychological basis and, unlike epilepsy, are not caused by abnormal electrical brain activity.

While the school experience has previously been identified as a source of predisposing, precipitating, and perpetuating factors for PNES, little is known about the school experience of adolescents with the disorder and the role it may play in PNES management, the investigators noted.

During her 20 years as a school nurse, Dr. Tanner saw firsthand how school staff struggled with responding appropriately to teens with PNES. “They wanted to call 911 every time; they wanted to respond as if it [were] an epileptic seizure.”

For the study, she interviewed 10 teens with PNES, aged 12 to 19 years, whom she found mostly through Facebook support groups but also through flyers. All participants had undergone video EEG and been diagnosed with PNES.

From the interviews, Dr. Tanner and colleagues conducted a qualitative content analysis and uncovered “overarching” themes.

A main theme was stress, some of which focused on bullying by peers or harassment by school personnel, much of which was related to accusations of the children “faking” seizures to get attention, said Dr. Tanner.

Some teens reported being banned from school events, such as field trips, out of concern they would be a “distraction,” which led to feelings of isolation and exclusion, said Dr. Tanner.

Research points to a growing incidence of PNES among adolescents. This may be because it is now better recognized, or it may stem from the unique stressors today’s teens face, said Dr. Tanner.

Adolescents discussed the pressures they feel to be the best at everything. “They wanted to be good in athletics; they wanted to be good in academics; they wanted to get into a good college,” said Dr. Tanner.

Some study participants had undergone psychotherapy, including cognitive-behavioral therapy, and others had investigated mindfulness-based therapy. However, not all were receiving treatment. For some, such care was inaccessible, while others had tried a mental health care intervention but had abandoned it.

Although all the study participants were female, Dr. Tanner has interviewed males outside this study and found their experiences are similar.

Her next research step is to try to quantify the findings. “I would like to begin to look at what would be the appropriate outcomes if I were to do an intervention to improve the school experience.”

Her message for doctors is to see school nurses as a “partner” or “liaison” who “can bridge the world of health care and education.”
 

Important, novel research

Commenting on the research, Barbara Dworetzky, MD, Chief, Epilepsy, Brigham and Women’s Hospital, and professor of neurology, Harvard Medical School, said it’s “important and novel.”

The study focuses on the main factors – or themes – that lead to increased stress, such as bullying, isolation, and “not being believed,” that are likely triggers for PNES, said Dr. Dworetzky.

The study is also important because it focuses on factors that help make the girls “feel supported and protected” – for example, having staff “take the episodes seriously,” she said.

The study’s qualitative measures “are a valid way of understanding these girls and giving them a voice,” said Dr. Dworetzky. She added the study provides “practical information” that could help target treatments to improve outcomes in this group.

A limitation of the study was that the very small cohort of teenage girls was selected only through families in Facebook support groups or flyers to school nurses, said Dr. Dworetzky.

“There are likely many other groups who don’t even have families trying to help them. Larger cohorts without this type of bias may be next steps.”

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

Adolescents with psychogenic nonepileptic seizures (PNES) experience severe bullying by fellow students and school staff alike, results of a small study suggest.

The school experience of teens with PNES is overwhelmingly negative, study investigator Andrea Tanner, PhD, a postdoctoral fellow at Indiana University School of Nursing, Indianapolis.

She hopes this research will spur a collaborative effort between students, schools, families, and health care providers “to develop an effective plan to help these adolescents cope, to manage this condition, and hopefully reach seizure freedom.”

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Anxiety, perfectionism

Although psychogenic seizures resemble epileptic seizures, they have a psychological basis and, unlike epilepsy, are not caused by abnormal electrical brain activity.

While the school experience has previously been identified as a source of predisposing, precipitating, and perpetuating factors for PNES, little is known about the school experience of adolescents with the disorder and the role it may play in PNES management, the investigators noted.

During her 20 years as a school nurse, Dr. Tanner saw firsthand how school staff struggled with responding appropriately to teens with PNES. “They wanted to call 911 every time; they wanted to respond as if it [were] an epileptic seizure.”

For the study, she interviewed 10 teens with PNES, aged 12 to 19 years, whom she found mostly through Facebook support groups but also through flyers. All participants had undergone video EEG and been diagnosed with PNES.

From the interviews, Dr. Tanner and colleagues conducted a qualitative content analysis and uncovered “overarching” themes.

A main theme was stress, some of which focused on bullying by peers or harassment by school personnel, much of which was related to accusations of the children “faking” seizures to get attention, said Dr. Tanner.

Some teens reported being banned from school events, such as field trips, out of concern they would be a “distraction,” which led to feelings of isolation and exclusion, said Dr. Tanner.

Research points to a growing incidence of PNES among adolescents. This may be because it is now better recognized, or it may stem from the unique stressors today’s teens face, said Dr. Tanner.

Adolescents discussed the pressures they feel to be the best at everything. “They wanted to be good in athletics; they wanted to be good in academics; they wanted to get into a good college,” said Dr. Tanner.

Some study participants had undergone psychotherapy, including cognitive-behavioral therapy, and others had investigated mindfulness-based therapy. However, not all were receiving treatment. For some, such care was inaccessible, while others had tried a mental health care intervention but had abandoned it.

Although all the study participants were female, Dr. Tanner has interviewed males outside this study and found their experiences are similar.

Her next research step is to try to quantify the findings. “I would like to begin to look at what would be the appropriate outcomes if I were to do an intervention to improve the school experience.”

Her message for doctors is to see school nurses as a “partner” or “liaison” who “can bridge the world of health care and education.”
 

Important, novel research

Commenting on the research, Barbara Dworetzky, MD, Chief, Epilepsy, Brigham and Women’s Hospital, and professor of neurology, Harvard Medical School, said it’s “important and novel.”

The study focuses on the main factors – or themes – that lead to increased stress, such as bullying, isolation, and “not being believed,” that are likely triggers for PNES, said Dr. Dworetzky.

The study is also important because it focuses on factors that help make the girls “feel supported and protected” – for example, having staff “take the episodes seriously,” she said.

The study’s qualitative measures “are a valid way of understanding these girls and giving them a voice,” said Dr. Dworetzky. She added the study provides “practical information” that could help target treatments to improve outcomes in this group.

A limitation of the study was that the very small cohort of teenage girls was selected only through families in Facebook support groups or flyers to school nurses, said Dr. Dworetzky.

“There are likely many other groups who don’t even have families trying to help them. Larger cohorts without this type of bias may be next steps.”

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

Women with epilepsy are more than twice as likely as those without the disorder to report physical, sexual, or emotional abuse during pregnancy, new research shows.

Study investigator Naveed Chaudhry, MD, a recent epilepsy fellow and assistant professor of neurology, University of Colorado School of Medicine, described the finding as “alarming” and called for more support for this patient population.

Investigators found that women with epilepsy are also more likely to report other stressors, including divorce, illness, lost pay, and partner discord, while expecting.

“As epilepsy physicians, it’s important that we ask the right questions and dive a little bit deeper with these patients, even if it’s uncomfortable and not something we’re used to,” said Dr. Chaudhry.

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Cause for concern

Women with epilepsy may be under stress for a variety of social and economic reasons. In some women, stress can trigger seizures, and during pregnancy, this can lead to complications such as preterm labor and low birth weight.

For the study, researchers tapped into the Center for Disease Control and Prevention Pregnancy Risk Assessment and Monitoring System (PRAMS). This database includes information from surveys asking women across the U.S. about their pregnancy and postpartum period.

Thirteen states collected data on stresses in women with and without epilepsy. Respondents were asked about 14 economic and other worries in the year prior to their baby’s birth, including the pregnancy period.

The analysis included 64,951 women, 1,140 of whom had epilepsy, who were included in surveys from 2012-2020. There were no significant demographic differences between those with and those without the disorder.

After adjusting for maternal age, race, ethnicity, marital status, education, and socioeconomic status, the study found that women with epilepsy experienced an average of 2.41 of the stressors compared with 1.72 for women without epilepsy.

Women with epilepsy were more likely to have experienced family illness, divorce, homelessness, partner job loss, reduced work or pay, increased arguments, having a partner in jail, drug use, and the death of someone close to them.

The results showed that unmarried and younger women as well as those with lower incomes were particularly prone to experience stress during pregnancy.

It’s not clear why women with epilepsy report more stressors. “Looking at the literature, no one has really looked at the exact reason for this, but we postulate it could be a lack of supports and support systems,” said Dr. Chaudhry.

Women were asked about physical, sexual, and emotional abuse. Results showed that substantially more women with epilepsy than those without the disorder reported such abuse during pregnancy – 10.6% versus 4.1%. The adjusted odds ratio for women with epilepsy reporting abuse was 2.78 (95% CI, 2.07-3.74).

“That raises our concern and needs to be looked at in more detail,” said Dr. Chaudhry.

It is unclear whether some women might have had psychogenic non-epileptic seizures (PNES), which are linked to a higher rate of abuse, said Dr. Chaudhry. “But the prevalence of PNES in the general population is quite low, so we don’t think it’s contributing to a large extent to this finding.”

The findings highlight the importance of addressing stress in women with epilepsy during pregnancy, he said. “We need to have good support services and we need to counsel women to optimize good outcomes.”

This applies to all women of childbearing age. “We suspect abuse and stressors are going to be going on throughout that period,” said Dr. Chaudhry. “It’s important to ask about it and have appropriate support staff and social work and people available to help when an issue is identified.”
 

Stress a common seizure trigger

Commenting on the research, Kimford Meador, MD, professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, noted the study was well conducted and had a large sample size.

The findings are important, as stress is a common trigger for seizures in people with epilepsy and is associated with mood and anxiety, which can affect quality of life, said Dr. Meador.

Results of his analysis from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, also presented at this year’s AES meeting, showed that women with epilepsy had more depressive symptoms during the postpartum period and more anxiety symptoms during pregnancy and postpartum in comparison with those without epilepsy.

Dr. Meador’s group also recently conducted a study that was published in JAMA Neurology, showing that in women with epilepsy during the postpartum period, anxiety is associated with lower cognitive ability in their children at age 2 years.

“All these findings highlight the importance of assessing and managing stress, anxiety, and mood in women with epilepsy,” said Dr. Meador. “Interventions could impact seizures and quality of life in pregnant women with epilepsy and long-term outcomes in their children.”

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

Women with epilepsy are more than twice as likely as those without the disorder to report physical, sexual, or emotional abuse during pregnancy, new research shows.

Study investigator Naveed Chaudhry, MD, a recent epilepsy fellow and assistant professor of neurology, University of Colorado School of Medicine, described the finding as “alarming” and called for more support for this patient population.

Investigators found that women with epilepsy are also more likely to report other stressors, including divorce, illness, lost pay, and partner discord, while expecting.

“As epilepsy physicians, it’s important that we ask the right questions and dive a little bit deeper with these patients, even if it’s uncomfortable and not something we’re used to,” said Dr. Chaudhry.

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Cause for concern

Women with epilepsy may be under stress for a variety of social and economic reasons. In some women, stress can trigger seizures, and during pregnancy, this can lead to complications such as preterm labor and low birth weight.

For the study, researchers tapped into the Center for Disease Control and Prevention Pregnancy Risk Assessment and Monitoring System (PRAMS). This database includes information from surveys asking women across the U.S. about their pregnancy and postpartum period.

Thirteen states collected data on stresses in women with and without epilepsy. Respondents were asked about 14 economic and other worries in the year prior to their baby’s birth, including the pregnancy period.

The analysis included 64,951 women, 1,140 of whom had epilepsy, who were included in surveys from 2012-2020. There were no significant demographic differences between those with and those without the disorder.

After adjusting for maternal age, race, ethnicity, marital status, education, and socioeconomic status, the study found that women with epilepsy experienced an average of 2.41 of the stressors compared with 1.72 for women without epilepsy.

Women with epilepsy were more likely to have experienced family illness, divorce, homelessness, partner job loss, reduced work or pay, increased arguments, having a partner in jail, drug use, and the death of someone close to them.

The results showed that unmarried and younger women as well as those with lower incomes were particularly prone to experience stress during pregnancy.

It’s not clear why women with epilepsy report more stressors. “Looking at the literature, no one has really looked at the exact reason for this, but we postulate it could be a lack of supports and support systems,” said Dr. Chaudhry.

Women were asked about physical, sexual, and emotional abuse. Results showed that substantially more women with epilepsy than those without the disorder reported such abuse during pregnancy – 10.6% versus 4.1%. The adjusted odds ratio for women with epilepsy reporting abuse was 2.78 (95% CI, 2.07-3.74).

“That raises our concern and needs to be looked at in more detail,” said Dr. Chaudhry.

It is unclear whether some women might have had psychogenic non-epileptic seizures (PNES), which are linked to a higher rate of abuse, said Dr. Chaudhry. “But the prevalence of PNES in the general population is quite low, so we don’t think it’s contributing to a large extent to this finding.”

The findings highlight the importance of addressing stress in women with epilepsy during pregnancy, he said. “We need to have good support services and we need to counsel women to optimize good outcomes.”

This applies to all women of childbearing age. “We suspect abuse and stressors are going to be going on throughout that period,” said Dr. Chaudhry. “It’s important to ask about it and have appropriate support staff and social work and people available to help when an issue is identified.”
 

Stress a common seizure trigger

Commenting on the research, Kimford Meador, MD, professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, noted the study was well conducted and had a large sample size.

The findings are important, as stress is a common trigger for seizures in people with epilepsy and is associated with mood and anxiety, which can affect quality of life, said Dr. Meador.

Results of his analysis from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, also presented at this year’s AES meeting, showed that women with epilepsy had more depressive symptoms during the postpartum period and more anxiety symptoms during pregnancy and postpartum in comparison with those without epilepsy.

Dr. Meador’s group also recently conducted a study that was published in JAMA Neurology, showing that in women with epilepsy during the postpartum period, anxiety is associated with lower cognitive ability in their children at age 2 years.

“All these findings highlight the importance of assessing and managing stress, anxiety, and mood in women with epilepsy,” said Dr. Meador. “Interventions could impact seizures and quality of life in pregnant women with epilepsy and long-term outcomes in their children.”

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

Women with epilepsy are more than twice as likely as those without the disorder to report physical, sexual, or emotional abuse during pregnancy, new research shows.

Study investigator Naveed Chaudhry, MD, a recent epilepsy fellow and assistant professor of neurology, University of Colorado School of Medicine, described the finding as “alarming” and called for more support for this patient population.

Investigators found that women with epilepsy are also more likely to report other stressors, including divorce, illness, lost pay, and partner discord, while expecting.

“As epilepsy physicians, it’s important that we ask the right questions and dive a little bit deeper with these patients, even if it’s uncomfortable and not something we’re used to,” said Dr. Chaudhry.

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Cause for concern

Women with epilepsy may be under stress for a variety of social and economic reasons. In some women, stress can trigger seizures, and during pregnancy, this can lead to complications such as preterm labor and low birth weight.

For the study, researchers tapped into the Center for Disease Control and Prevention Pregnancy Risk Assessment and Monitoring System (PRAMS). This database includes information from surveys asking women across the U.S. about their pregnancy and postpartum period.

Thirteen states collected data on stresses in women with and without epilepsy. Respondents were asked about 14 economic and other worries in the year prior to their baby’s birth, including the pregnancy period.

The analysis included 64,951 women, 1,140 of whom had epilepsy, who were included in surveys from 2012-2020. There were no significant demographic differences between those with and those without the disorder.

After adjusting for maternal age, race, ethnicity, marital status, education, and socioeconomic status, the study found that women with epilepsy experienced an average of 2.41 of the stressors compared with 1.72 for women without epilepsy.

Women with epilepsy were more likely to have experienced family illness, divorce, homelessness, partner job loss, reduced work or pay, increased arguments, having a partner in jail, drug use, and the death of someone close to them.

The results showed that unmarried and younger women as well as those with lower incomes were particularly prone to experience stress during pregnancy.

It’s not clear why women with epilepsy report more stressors. “Looking at the literature, no one has really looked at the exact reason for this, but we postulate it could be a lack of supports and support systems,” said Dr. Chaudhry.

Women were asked about physical, sexual, and emotional abuse. Results showed that substantially more women with epilepsy than those without the disorder reported such abuse during pregnancy – 10.6% versus 4.1%. The adjusted odds ratio for women with epilepsy reporting abuse was 2.78 (95% CI, 2.07-3.74).

“That raises our concern and needs to be looked at in more detail,” said Dr. Chaudhry.

It is unclear whether some women might have had psychogenic non-epileptic seizures (PNES), which are linked to a higher rate of abuse, said Dr. Chaudhry. “But the prevalence of PNES in the general population is quite low, so we don’t think it’s contributing to a large extent to this finding.”

The findings highlight the importance of addressing stress in women with epilepsy during pregnancy, he said. “We need to have good support services and we need to counsel women to optimize good outcomes.”

This applies to all women of childbearing age. “We suspect abuse and stressors are going to be going on throughout that period,” said Dr. Chaudhry. “It’s important to ask about it and have appropriate support staff and social work and people available to help when an issue is identified.”
 

Stress a common seizure trigger

Commenting on the research, Kimford Meador, MD, professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, noted the study was well conducted and had a large sample size.

The findings are important, as stress is a common trigger for seizures in people with epilepsy and is associated with mood and anxiety, which can affect quality of life, said Dr. Meador.

Results of his analysis from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, also presented at this year’s AES meeting, showed that women with epilepsy had more depressive symptoms during the postpartum period and more anxiety symptoms during pregnancy and postpartum in comparison with those without epilepsy.

Dr. Meador’s group also recently conducted a study that was published in JAMA Neurology, showing that in women with epilepsy during the postpartum period, anxiety is associated with lower cognitive ability in their children at age 2 years.

“All these findings highlight the importance of assessing and managing stress, anxiety, and mood in women with epilepsy,” said Dr. Meador. “Interventions could impact seizures and quality of life in pregnant women with epilepsy and long-term outcomes in their children.”

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

A nose for the tooth

Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.

John Oliver/Pixabay

This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.

The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.

This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
 

Lettuce recommend you a sleep aid

Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.

PxHere

Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.

OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?

Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
 

Brains get a rise out of Viagra

A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.

©roberthyrons/thinkstockphotos.com

Omicron is not a social-distancing robot

COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.

neo tam/Pixabay

Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.

The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.

And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.

Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.

“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.

Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”

A nose for the tooth

Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.

John Oliver/Pixabay

This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.

The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.

This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
 

Lettuce recommend you a sleep aid

Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.

PxHere

Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.

OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?

Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
 

Brains get a rise out of Viagra

A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.

©roberthyrons/thinkstockphotos.com

Omicron is not a social-distancing robot

COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.

neo tam/Pixabay

Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.

The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.

And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.

Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.

“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.

Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”

A nose for the tooth

Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.

John Oliver/Pixabay

This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.

The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.

This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
 

Lettuce recommend you a sleep aid

Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.

PxHere

Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.

OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?

Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
 

Brains get a rise out of Viagra

A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.

©roberthyrons/thinkstockphotos.com

Omicron is not a social-distancing robot

COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.

neo tam/Pixabay

Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.

The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.

And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.

Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.

“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.

Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”

A raft of new studies that looked at the ability of Omicron to evade an array of currently available vaccines suggest a substantial loss of protection against the highly mutated variant.

Medscape Illustration/Dreamstime

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

Dr. El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in a press briefing Dec. 8.
 

More research needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing Dec. 8 that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Dr. Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.
 

Retool the vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant. In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending U.S. Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the department of microbiology at the Mount Sinai School of Medicine in New York City.

Dr. Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering. “I am worried.”

Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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

A raft of new studies that looked at the ability of Omicron to evade an array of currently available vaccines suggest a substantial loss of protection against the highly mutated variant.

Medscape Illustration/Dreamstime

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

Dr. El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in a press briefing Dec. 8.
 

More research needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing Dec. 8 that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Dr. Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.
 

Retool the vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant. In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending U.S. Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the department of microbiology at the Mount Sinai School of Medicine in New York City.

Dr. Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering. “I am worried.”

Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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

A raft of new studies that looked at the ability of Omicron to evade an array of currently available vaccines suggest a substantial loss of protection against the highly mutated variant.

Medscape Illustration/Dreamstime

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

Dr. El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in a press briefing Dec. 8.
 

More research needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing Dec. 8 that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Dr. Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.
 

Retool the vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant. In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending U.S. Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the department of microbiology at the Mount Sinai School of Medicine in New York City.

Dr. Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering. “I am worried.”

Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.

The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.

Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.

They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.

Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”

The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”

The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.

“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.

“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”

Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”

Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”

A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.

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

An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.

The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.

Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.

They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.

Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”

The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”

The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.

“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.

“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”

Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”

Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”

A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.

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

An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.

The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.

Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.

They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.

Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”

The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”

The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.

“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.

“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”

Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”

Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”

A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.

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

The erectile dysfunction medication Viagra could potentially be used as a treatment for Alzheimer’s disease, according to a new study published in the journal Nature Aging.

Patients who used the drug sildenafil, the generic name for Viagra, were 69% less likely to develop the disease than were nonusers.

“Sildenafil, which has been shown to significantly improve cognition and memory in preclinical models, presented as the best drug candidate,” Feixiong Cheng, PhD, the lead study author in the Cleveland Clinic’s Genomic Medicine Institute, said in a statement.

“Notably, we found that sildenafil use reduced the likelihood of Alzheimer’s in individuals with coronary artery disease, hypertension, and type 2 diabetes, all of which are comorbidities significantly associated with risk of the disease, as well as in those without,” he said.

Alzheimer’s, which is the most common form of age-related dementia, affects hundreds of millions of people worldwide. The disease is expected to affect nearly 14 million Americans by 2050. There is no approved treatment for it.

Dr. Cheng and colleagues at the Cleveland Clinic used a large gene-mapping network to analyze whether more than 1,600 Food and Drug Administration–approved drugs could work against Alzheimer’s. They gave higher scores to drugs that target both amyloid and tau proteins in the brain, which are two hallmarks of the disease. Sildenafil appeared at the top of the list.

Then the researchers used a database of health insurance claims for more than 7 million people in the U.S. to understand the relationship between sildenafil and Alzheimer’s disease outcomes. They compared sildenafil users to nonusers and found that those who used the drug were 69% less likely to have the neurodegenerative disease, even after 6 years of follow-up.

After that, the research team came up with a lab model that showed the sildenafil increased brain cell growth and targeted tau proteins. The lab model could indicate how the drug influences disease-related brain changes.

But Dr. Cheng cautioned against drawing strong conclusions. The study doesn’t demonstrate a causal relationship between sildenafil and Alzheimer’s disease. Researchers will need to conduct clinical trials with a placebo control to see how well the drug works.

Other researchers said the findings offer a new avenue for research but don’t yet provide solid answers.

“Being able to repurpose a drug already licensed for health conditions could help speed up the drug discovery process and bring about life-changing dementia treatments sooner,” Susan Kohlhaas, PhD, director of research at Alzheimer’s Research UK, told the Science Media Centre.

“Importantly, this research doesn’t prove that sildenafil is responsible for reducing dementia risk, or that it slows or stops the disease,” she continued. “If you want to discuss any treatments you are receiving, the first port of call is to speak to your doctor.”

And doctors won’t likely recommend it as a treatment just yet either.

“While these data are interesting scientifically, based on this study, I would not rush out to start taking sildenafil as a prevention for Alzheimer’s disease,” Tara Spires-Jones, PhD, deputy director of the Centre for Discovery Brain Sciences at the University of Edinburgh, told the Science Media Centre.

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

The erectile dysfunction medication Viagra could potentially be used as a treatment for Alzheimer’s disease, according to a new study published in the journal Nature Aging.

Patients who used the drug sildenafil, the generic name for Viagra, were 69% less likely to develop the disease than were nonusers.

“Sildenafil, which has been shown to significantly improve cognition and memory in preclinical models, presented as the best drug candidate,” Feixiong Cheng, PhD, the lead study author in the Cleveland Clinic’s Genomic Medicine Institute, said in a statement.

“Notably, we found that sildenafil use reduced the likelihood of Alzheimer’s in individuals with coronary artery disease, hypertension, and type 2 diabetes, all of which are comorbidities significantly associated with risk of the disease, as well as in those without,” he said.

Alzheimer’s, which is the most common form of age-related dementia, affects hundreds of millions of people worldwide. The disease is expected to affect nearly 14 million Americans by 2050. There is no approved treatment for it.

Dr. Cheng and colleagues at the Cleveland Clinic used a large gene-mapping network to analyze whether more than 1,600 Food and Drug Administration–approved drugs could work against Alzheimer’s. They gave higher scores to drugs that target both amyloid and tau proteins in the brain, which are two hallmarks of the disease. Sildenafil appeared at the top of the list.

Then the researchers used a database of health insurance claims for more than 7 million people in the U.S. to understand the relationship between sildenafil and Alzheimer’s disease outcomes. They compared sildenafil users to nonusers and found that those who used the drug were 69% less likely to have the neurodegenerative disease, even after 6 years of follow-up.

After that, the research team came up with a lab model that showed the sildenafil increased brain cell growth and targeted tau proteins. The lab model could indicate how the drug influences disease-related brain changes.

But Dr. Cheng cautioned against drawing strong conclusions. The study doesn’t demonstrate a causal relationship between sildenafil and Alzheimer’s disease. Researchers will need to conduct clinical trials with a placebo control to see how well the drug works.

Other researchers said the findings offer a new avenue for research but don’t yet provide solid answers.

“Being able to repurpose a drug already licensed for health conditions could help speed up the drug discovery process and bring about life-changing dementia treatments sooner,” Susan Kohlhaas, PhD, director of research at Alzheimer’s Research UK, told the Science Media Centre.

“Importantly, this research doesn’t prove that sildenafil is responsible for reducing dementia risk, or that it slows or stops the disease,” she continued. “If you want to discuss any treatments you are receiving, the first port of call is to speak to your doctor.”

And doctors won’t likely recommend it as a treatment just yet either.

“While these data are interesting scientifically, based on this study, I would not rush out to start taking sildenafil as a prevention for Alzheimer’s disease,” Tara Spires-Jones, PhD, deputy director of the Centre for Discovery Brain Sciences at the University of Edinburgh, told the Science Media Centre.

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

The erectile dysfunction medication Viagra could potentially be used as a treatment for Alzheimer’s disease, according to a new study published in the journal Nature Aging.

Patients who used the drug sildenafil, the generic name for Viagra, were 69% less likely to develop the disease than were nonusers.

“Sildenafil, which has been shown to significantly improve cognition and memory in preclinical models, presented as the best drug candidate,” Feixiong Cheng, PhD, the lead study author in the Cleveland Clinic’s Genomic Medicine Institute, said in a statement.

“Notably, we found that sildenafil use reduced the likelihood of Alzheimer’s in individuals with coronary artery disease, hypertension, and type 2 diabetes, all of which are comorbidities significantly associated with risk of the disease, as well as in those without,” he said.

Alzheimer’s, which is the most common form of age-related dementia, affects hundreds of millions of people worldwide. The disease is expected to affect nearly 14 million Americans by 2050. There is no approved treatment for it.

Dr. Cheng and colleagues at the Cleveland Clinic used a large gene-mapping network to analyze whether more than 1,600 Food and Drug Administration–approved drugs could work against Alzheimer’s. They gave higher scores to drugs that target both amyloid and tau proteins in the brain, which are two hallmarks of the disease. Sildenafil appeared at the top of the list.

Then the researchers used a database of health insurance claims for more than 7 million people in the U.S. to understand the relationship between sildenafil and Alzheimer’s disease outcomes. They compared sildenafil users to nonusers and found that those who used the drug were 69% less likely to have the neurodegenerative disease, even after 6 years of follow-up.

After that, the research team came up with a lab model that showed the sildenafil increased brain cell growth and targeted tau proteins. The lab model could indicate how the drug influences disease-related brain changes.

But Dr. Cheng cautioned against drawing strong conclusions. The study doesn’t demonstrate a causal relationship between sildenafil and Alzheimer’s disease. Researchers will need to conduct clinical trials with a placebo control to see how well the drug works.

Other researchers said the findings offer a new avenue for research but don’t yet provide solid answers.

“Being able to repurpose a drug already licensed for health conditions could help speed up the drug discovery process and bring about life-changing dementia treatments sooner,” Susan Kohlhaas, PhD, director of research at Alzheimer’s Research UK, told the Science Media Centre.

“Importantly, this research doesn’t prove that sildenafil is responsible for reducing dementia risk, or that it slows or stops the disease,” she continued. “If you want to discuss any treatments you are receiving, the first port of call is to speak to your doctor.”

And doctors won’t likely recommend it as a treatment just yet either.

“While these data are interesting scientifically, based on this study, I would not rush out to start taking sildenafil as a prevention for Alzheimer’s disease,” Tara Spires-Jones, PhD, deputy director of the Centre for Discovery Brain Sciences at the University of Edinburgh, told the Science Media Centre.

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

Motivated, calm, and high-functioning. On the surface, you are the epitome of success. You arrive at work early. You are driven, meet all deadlines and, in fact, excel at tasks. Not only are you successful in your work, but also you appear well put-together – not a single hair out of place. You have a busy social life, always smiling, laughing, or generally in an uplifting mood. On the surface, you have everything together. 

Inside, you’re drowning. You’re in constant survival mode – always overthinking, ruminating, and fearful. Your need for self-preservation is in overdrive. You use your anxiety and fear as motivation. You are a people pleaser, need constant reassurance, and are unable to enjoy the present moment. You have an inability to say no regardless of your overloaded schedule. You are mentally and physically fatigued and overworked beyond the brink of exhaustion. You need to take time off but can’t bring yourself to do so. Others wouldn’t see you in this light because you always appear to be doing well.

The portraits I’ve painted here sound like two different people, but in fact are representative of one. High-functioning anxiety, while not a formal health diagnosis, is a term that broadly encapsulates individuals who experience anxiety but also function well in their day-to-day lives. On the surface, individuals with high-functioning anxiety appear to be “perfect” but in actuality are under constant stress and anxiety in fear of disappointing others. They are perceived as overachievers, but this perception fails to recognize and acknowledge the mental health toll required to achieve at such a high level.

I came across this concept when a friend sent me a post on social media. It was a completely new but oddly familiar concept when I first read about high-functioning anxiety. In fact, I related to this concept almost immediately based on interactions with friends and colleagues, and their recollection of stressors over the years in high-stress, high-functioning environments. 

In addition to personal interactions, I’ve seen anxiety and mental health at large become more “normalized” on various platforms (e.g., Instagram, TikTok) over the years. Interestingly, normalizing these concepts could be beneficial. For example, they increase awareness, encourage conversations (e.g., creating communities), and minimize the barriers toward understanding and respecting individuals who experience high-functioning anxiety. However, social media also has the potential to be harmful (e.g., “humorizing” the concept or turning it into memes, diminishing the experience).

However, the question that nagged at my mind even further was: What reasons are there, if any, for why high-functioning anxiety is not recognized as a formal diagnosis? Is this concept too new? Difficult to diagnose? Anecdotal evidence seems to suggest that high-functioning anxiety is debilitating and impairs one’s quality of life. There appears to be a need to formally recognize this subtype of anxiety and invest more time and research. Increasing the sphere of knowledge may bring more good than harm, as a way to let others know that it’s okay.

Ms. Lui is an MSc candidate at the University of Toronto and is with the mood disorders psychopharmacology unit, Toronto Western Hospital, University Health Network, also in Toronto. She reported receiving income from Braxia Scientific.

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

Motivated, calm, and high-functioning. On the surface, you are the epitome of success. You arrive at work early. You are driven, meet all deadlines and, in fact, excel at tasks. Not only are you successful in your work, but also you appear well put-together – not a single hair out of place. You have a busy social life, always smiling, laughing, or generally in an uplifting mood. On the surface, you have everything together. 

Inside, you’re drowning. You’re in constant survival mode – always overthinking, ruminating, and fearful. Your need for self-preservation is in overdrive. You use your anxiety and fear as motivation. You are a people pleaser, need constant reassurance, and are unable to enjoy the present moment. You have an inability to say no regardless of your overloaded schedule. You are mentally and physically fatigued and overworked beyond the brink of exhaustion. You need to take time off but can’t bring yourself to do so. Others wouldn’t see you in this light because you always appear to be doing well.

The portraits I’ve painted here sound like two different people, but in fact are representative of one. High-functioning anxiety, while not a formal health diagnosis, is a term that broadly encapsulates individuals who experience anxiety but also function well in their day-to-day lives. On the surface, individuals with high-functioning anxiety appear to be “perfect” but in actuality are under constant stress and anxiety in fear of disappointing others. They are perceived as overachievers, but this perception fails to recognize and acknowledge the mental health toll required to achieve at such a high level.

I came across this concept when a friend sent me a post on social media. It was a completely new but oddly familiar concept when I first read about high-functioning anxiety. In fact, I related to this concept almost immediately based on interactions with friends and colleagues, and their recollection of stressors over the years in high-stress, high-functioning environments. 

In addition to personal interactions, I’ve seen anxiety and mental health at large become more “normalized” on various platforms (e.g., Instagram, TikTok) over the years. Interestingly, normalizing these concepts could be beneficial. For example, they increase awareness, encourage conversations (e.g., creating communities), and minimize the barriers toward understanding and respecting individuals who experience high-functioning anxiety. However, social media also has the potential to be harmful (e.g., “humorizing” the concept or turning it into memes, diminishing the experience).

However, the question that nagged at my mind even further was: What reasons are there, if any, for why high-functioning anxiety is not recognized as a formal diagnosis? Is this concept too new? Difficult to diagnose? Anecdotal evidence seems to suggest that high-functioning anxiety is debilitating and impairs one’s quality of life. There appears to be a need to formally recognize this subtype of anxiety and invest more time and research. Increasing the sphere of knowledge may bring more good than harm, as a way to let others know that it’s okay.

Ms. Lui is an MSc candidate at the University of Toronto and is with the mood disorders psychopharmacology unit, Toronto Western Hospital, University Health Network, also in Toronto. She reported receiving income from Braxia Scientific.

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

Motivated, calm, and high-functioning. On the surface, you are the epitome of success. You arrive at work early. You are driven, meet all deadlines and, in fact, excel at tasks. Not only are you successful in your work, but also you appear well put-together – not a single hair out of place. You have a busy social life, always smiling, laughing, or generally in an uplifting mood. On the surface, you have everything together. 

Inside, you’re drowning. You’re in constant survival mode – always overthinking, ruminating, and fearful. Your need for self-preservation is in overdrive. You use your anxiety and fear as motivation. You are a people pleaser, need constant reassurance, and are unable to enjoy the present moment. You have an inability to say no regardless of your overloaded schedule. You are mentally and physically fatigued and overworked beyond the brink of exhaustion. You need to take time off but can’t bring yourself to do so. Others wouldn’t see you in this light because you always appear to be doing well.

The portraits I’ve painted here sound like two different people, but in fact are representative of one. High-functioning anxiety, while not a formal health diagnosis, is a term that broadly encapsulates individuals who experience anxiety but also function well in their day-to-day lives. On the surface, individuals with high-functioning anxiety appear to be “perfect” but in actuality are under constant stress and anxiety in fear of disappointing others. They are perceived as overachievers, but this perception fails to recognize and acknowledge the mental health toll required to achieve at such a high level.

I came across this concept when a friend sent me a post on social media. It was a completely new but oddly familiar concept when I first read about high-functioning anxiety. In fact, I related to this concept almost immediately based on interactions with friends and colleagues, and their recollection of stressors over the years in high-stress, high-functioning environments. 

In addition to personal interactions, I’ve seen anxiety and mental health at large become more “normalized” on various platforms (e.g., Instagram, TikTok) over the years. Interestingly, normalizing these concepts could be beneficial. For example, they increase awareness, encourage conversations (e.g., creating communities), and minimize the barriers toward understanding and respecting individuals who experience high-functioning anxiety. However, social media also has the potential to be harmful (e.g., “humorizing” the concept or turning it into memes, diminishing the experience).

However, the question that nagged at my mind even further was: What reasons are there, if any, for why high-functioning anxiety is not recognized as a formal diagnosis? Is this concept too new? Difficult to diagnose? Anecdotal evidence seems to suggest that high-functioning anxiety is debilitating and impairs one’s quality of life. There appears to be a need to formally recognize this subtype of anxiety and invest more time and research. Increasing the sphere of knowledge may bring more good than harm, as a way to let others know that it’s okay.

Ms. Lui is an MSc candidate at the University of Toronto and is with the mood disorders psychopharmacology unit, Toronto Western Hospital, University Health Network, also in Toronto. She reported receiving income from Braxia Scientific.

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