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Doctor faces apparent retaliation after alleging data manipulation in published trial
A rheumatologist was suspended from a professional society and his license to practice medicine was threatened after he raised concerns about data manipulation in a published study for which he recruited patients, according to documents seen by Retraction Watch.
The study, “Added Value of Anti-CD74 Autoantibodies in Axial SpondyloArthritis in a Population With Low HLA-B27 Prevalence,” was published in Frontiers in Immunology in 2019 and has been cited 13 times, according to Clarivate’s Web of Science. In its acknowledgments, it listed Fouad Fayad, PhD, a rheumatologist at the University of Saint Joseph and Hotel-Dieu de France University Medical Center in Beirut, as one of the researchers who recruited patients for the trial.
Dr. Fayad alleged that the researchers tested patient samples multiple times and used a mix of old and new values in their analysis. After he reported his concerns to the journal and then the university, which both concluded that they could not confirm or refute his allegations, he has faced apparent retaliation, including the suspension of his membership in the Lebanese Society of Rheumatology.
In comments to Retraction Watch, the corresponding author for the study noted that the two investigations did not find data manipulation, and said the issue was “based on a background of personal and professional conflicts.”
In an April video recorded with Nassim Nicholas Taleb, PhD, a former quant trader and retired distinguished professor of finance and risk engineering at New York University’s Tandon School of Engineering, Dr. Fayad explained that he was originally an author on the paper, but after expressing concerns about the methodology to the other authors, they didn’t respond to him and his name was dropped from the author list without warning or explanation.
Dr. Taleb also detailed the issues with the study, showing graphs that indicate “very poor correlation” between the old and new test results from participant samples.
In October 2019, Dr. Fayad contacted Frontiers in Immunology with his concerns. But the journal’s investigation was inconclusive, and a staffer on the research integrity team told him in July 2020 to contact his institution to investigate, according to emails seen by Retraction Watch.
Dr. Fayad did so, but the University of Saint Joseph “rushed an incomplete investigation,” he said. It began in September of 2021 and concluded 2 months later that the investigation committee could not confirm or disprove Dr. Fayad’s allegations of data manipulation, according to a copy of the report seen by Retraction Watch. He said that their statistical reviewer did not receive all of the relevant documents, although he had provided them to the university.
A university official sent the findings from the investigation to the Lebanese Order of Physicians – Beirut, which decided to suspend Dr. Fayad’s membership in the Lebanese Society of Rheumatology. It’s “needless to explain the damage resulting from this suspension,” Dr. Fayad said.
The Beirut organization wrote to the Lebanese Order of Physicians – Tripoli, the body with which Dr. Fayad’s license is registered, informing them of the decision. In a copy of the letter seen by Retraction Watch, the Beirut organization cited the university investigation finding Dr. Fayad’s allegations to be invalid, as well as a letter in which he alleged mismanagement of the rheumatology society, as reasons for the decision, and referred the matter to the Tripoli organization for further investigation.
Dr. Fayad told us that the letter asking the Tripoli organization to investigate him could have led to the suspension of his license to practice medicine:
“My license is registered with the Lebanese Order of Physicians – Tripoli. So legally speaking, it is only Tripoli organization that can suspend my license/permit to practice. Beirut Organization has tried to summon me to their investigation committee, but my license (being registered in Tripoli Organization) does not fall under Beirut’s jurisdiction; in other words Beirut Organization violated the law; they can not approach me directly, they have to go through the Tripoli Organization.
“As such, and since Beirut organization could not suspend my license (as they did for my membership in the Lebanese Society of Rheumatology) they sent the letter to Tripoli organization asking them to investigate the matter and take necessary disciplinary action. This was a threat to suspending my license to practice medicine. Should Tripoli Organization have used the [University of Saint Joseph] letter and investigation report without conducting their own international investigation, my permit to practice would have been suspended.”
The Lebanese Order of Physicians – Tripoli conducted its own investigation and confirmed “the existence of manipulation in the study data and failure to respect the data integrity,” according to an official translation of the investigation report seen by Retraction Watch. The Lebanese Order of Physicians – Tripoli decided after its investigation that Dr. Fayad’s suspension from the rheumatology society was invalid.
The lead author of the study in question, Nelly R. Ziade of Saint Joseph University and Hotel-Dieu de France Hospital in Beirut, told Retraction Watch that the investigation by the Lebanese Order of Physicians – Tripoli “cannot be considered as final or official” and that she was “never approached, interviewed, or asked to provide any documents related to this complaint.”
She continued: “I will always be available to give any scientific clarification requested by the Order of Physicians in Beirut where a serious investigation giving equal voice to both parties is currently conducted.
“Kindly note that the concerned journal has already conducted an internal investigation where both parties provided all documents and it was concluded that there was no scientific foundation for the accusations.
“Again, a similar investigation was conducted by the Saint-Joseph University in Beirut (where myself and the other party work). Both parties presented study documents to a committee including the president of the IRB, the vice president of the University, the medical director of the University Hospital, experts in musculoskeletal system and biostatistics. In brief, the case against the authors was dismissed, no data manipulation was found and the colleague from Tripoli also was submitted to University sanctions. The report of the University can be shared with you should you need it.
“I’m afraid that this issue is based on a background of personal and professional conflicts.”
Dr. Fayad added: “The beauty of science is that the truth will always prevail and cannot be obscured for long time.”
A version of this article first appeared on RetractionWatch.com.
A rheumatologist was suspended from a professional society and his license to practice medicine was threatened after he raised concerns about data manipulation in a published study for which he recruited patients, according to documents seen by Retraction Watch.
The study, “Added Value of Anti-CD74 Autoantibodies in Axial SpondyloArthritis in a Population With Low HLA-B27 Prevalence,” was published in Frontiers in Immunology in 2019 and has been cited 13 times, according to Clarivate’s Web of Science. In its acknowledgments, it listed Fouad Fayad, PhD, a rheumatologist at the University of Saint Joseph and Hotel-Dieu de France University Medical Center in Beirut, as one of the researchers who recruited patients for the trial.
Dr. Fayad alleged that the researchers tested patient samples multiple times and used a mix of old and new values in their analysis. After he reported his concerns to the journal and then the university, which both concluded that they could not confirm or refute his allegations, he has faced apparent retaliation, including the suspension of his membership in the Lebanese Society of Rheumatology.
In comments to Retraction Watch, the corresponding author for the study noted that the two investigations did not find data manipulation, and said the issue was “based on a background of personal and professional conflicts.”
In an April video recorded with Nassim Nicholas Taleb, PhD, a former quant trader and retired distinguished professor of finance and risk engineering at New York University’s Tandon School of Engineering, Dr. Fayad explained that he was originally an author on the paper, but after expressing concerns about the methodology to the other authors, they didn’t respond to him and his name was dropped from the author list without warning or explanation.
Dr. Taleb also detailed the issues with the study, showing graphs that indicate “very poor correlation” between the old and new test results from participant samples.
In October 2019, Dr. Fayad contacted Frontiers in Immunology with his concerns. But the journal’s investigation was inconclusive, and a staffer on the research integrity team told him in July 2020 to contact his institution to investigate, according to emails seen by Retraction Watch.
Dr. Fayad did so, but the University of Saint Joseph “rushed an incomplete investigation,” he said. It began in September of 2021 and concluded 2 months later that the investigation committee could not confirm or disprove Dr. Fayad’s allegations of data manipulation, according to a copy of the report seen by Retraction Watch. He said that their statistical reviewer did not receive all of the relevant documents, although he had provided them to the university.
A university official sent the findings from the investigation to the Lebanese Order of Physicians – Beirut, which decided to suspend Dr. Fayad’s membership in the Lebanese Society of Rheumatology. It’s “needless to explain the damage resulting from this suspension,” Dr. Fayad said.
The Beirut organization wrote to the Lebanese Order of Physicians – Tripoli, the body with which Dr. Fayad’s license is registered, informing them of the decision. In a copy of the letter seen by Retraction Watch, the Beirut organization cited the university investigation finding Dr. Fayad’s allegations to be invalid, as well as a letter in which he alleged mismanagement of the rheumatology society, as reasons for the decision, and referred the matter to the Tripoli organization for further investigation.
Dr. Fayad told us that the letter asking the Tripoli organization to investigate him could have led to the suspension of his license to practice medicine:
“My license is registered with the Lebanese Order of Physicians – Tripoli. So legally speaking, it is only Tripoli organization that can suspend my license/permit to practice. Beirut Organization has tried to summon me to their investigation committee, but my license (being registered in Tripoli Organization) does not fall under Beirut’s jurisdiction; in other words Beirut Organization violated the law; they can not approach me directly, they have to go through the Tripoli Organization.
“As such, and since Beirut organization could not suspend my license (as they did for my membership in the Lebanese Society of Rheumatology) they sent the letter to Tripoli organization asking them to investigate the matter and take necessary disciplinary action. This was a threat to suspending my license to practice medicine. Should Tripoli Organization have used the [University of Saint Joseph] letter and investigation report without conducting their own international investigation, my permit to practice would have been suspended.”
The Lebanese Order of Physicians – Tripoli conducted its own investigation and confirmed “the existence of manipulation in the study data and failure to respect the data integrity,” according to an official translation of the investigation report seen by Retraction Watch. The Lebanese Order of Physicians – Tripoli decided after its investigation that Dr. Fayad’s suspension from the rheumatology society was invalid.
The lead author of the study in question, Nelly R. Ziade of Saint Joseph University and Hotel-Dieu de France Hospital in Beirut, told Retraction Watch that the investigation by the Lebanese Order of Physicians – Tripoli “cannot be considered as final or official” and that she was “never approached, interviewed, or asked to provide any documents related to this complaint.”
She continued: “I will always be available to give any scientific clarification requested by the Order of Physicians in Beirut where a serious investigation giving equal voice to both parties is currently conducted.
“Kindly note that the concerned journal has already conducted an internal investigation where both parties provided all documents and it was concluded that there was no scientific foundation for the accusations.
“Again, a similar investigation was conducted by the Saint-Joseph University in Beirut (where myself and the other party work). Both parties presented study documents to a committee including the president of the IRB, the vice president of the University, the medical director of the University Hospital, experts in musculoskeletal system and biostatistics. In brief, the case against the authors was dismissed, no data manipulation was found and the colleague from Tripoli also was submitted to University sanctions. The report of the University can be shared with you should you need it.
“I’m afraid that this issue is based on a background of personal and professional conflicts.”
Dr. Fayad added: “The beauty of science is that the truth will always prevail and cannot be obscured for long time.”
A version of this article first appeared on RetractionWatch.com.
A rheumatologist was suspended from a professional society and his license to practice medicine was threatened after he raised concerns about data manipulation in a published study for which he recruited patients, according to documents seen by Retraction Watch.
The study, “Added Value of Anti-CD74 Autoantibodies in Axial SpondyloArthritis in a Population With Low HLA-B27 Prevalence,” was published in Frontiers in Immunology in 2019 and has been cited 13 times, according to Clarivate’s Web of Science. In its acknowledgments, it listed Fouad Fayad, PhD, a rheumatologist at the University of Saint Joseph and Hotel-Dieu de France University Medical Center in Beirut, as one of the researchers who recruited patients for the trial.
Dr. Fayad alleged that the researchers tested patient samples multiple times and used a mix of old and new values in their analysis. After he reported his concerns to the journal and then the university, which both concluded that they could not confirm or refute his allegations, he has faced apparent retaliation, including the suspension of his membership in the Lebanese Society of Rheumatology.
In comments to Retraction Watch, the corresponding author for the study noted that the two investigations did not find data manipulation, and said the issue was “based on a background of personal and professional conflicts.”
In an April video recorded with Nassim Nicholas Taleb, PhD, a former quant trader and retired distinguished professor of finance and risk engineering at New York University’s Tandon School of Engineering, Dr. Fayad explained that he was originally an author on the paper, but after expressing concerns about the methodology to the other authors, they didn’t respond to him and his name was dropped from the author list without warning or explanation.
Dr. Taleb also detailed the issues with the study, showing graphs that indicate “very poor correlation” between the old and new test results from participant samples.
In October 2019, Dr. Fayad contacted Frontiers in Immunology with his concerns. But the journal’s investigation was inconclusive, and a staffer on the research integrity team told him in July 2020 to contact his institution to investigate, according to emails seen by Retraction Watch.
Dr. Fayad did so, but the University of Saint Joseph “rushed an incomplete investigation,” he said. It began in September of 2021 and concluded 2 months later that the investigation committee could not confirm or disprove Dr. Fayad’s allegations of data manipulation, according to a copy of the report seen by Retraction Watch. He said that their statistical reviewer did not receive all of the relevant documents, although he had provided them to the university.
A university official sent the findings from the investigation to the Lebanese Order of Physicians – Beirut, which decided to suspend Dr. Fayad’s membership in the Lebanese Society of Rheumatology. It’s “needless to explain the damage resulting from this suspension,” Dr. Fayad said.
The Beirut organization wrote to the Lebanese Order of Physicians – Tripoli, the body with which Dr. Fayad’s license is registered, informing them of the decision. In a copy of the letter seen by Retraction Watch, the Beirut organization cited the university investigation finding Dr. Fayad’s allegations to be invalid, as well as a letter in which he alleged mismanagement of the rheumatology society, as reasons for the decision, and referred the matter to the Tripoli organization for further investigation.
Dr. Fayad told us that the letter asking the Tripoli organization to investigate him could have led to the suspension of his license to practice medicine:
“My license is registered with the Lebanese Order of Physicians – Tripoli. So legally speaking, it is only Tripoli organization that can suspend my license/permit to practice. Beirut Organization has tried to summon me to their investigation committee, but my license (being registered in Tripoli Organization) does not fall under Beirut’s jurisdiction; in other words Beirut Organization violated the law; they can not approach me directly, they have to go through the Tripoli Organization.
“As such, and since Beirut organization could not suspend my license (as they did for my membership in the Lebanese Society of Rheumatology) they sent the letter to Tripoli organization asking them to investigate the matter and take necessary disciplinary action. This was a threat to suspending my license to practice medicine. Should Tripoli Organization have used the [University of Saint Joseph] letter and investigation report without conducting their own international investigation, my permit to practice would have been suspended.”
The Lebanese Order of Physicians – Tripoli conducted its own investigation and confirmed “the existence of manipulation in the study data and failure to respect the data integrity,” according to an official translation of the investigation report seen by Retraction Watch. The Lebanese Order of Physicians – Tripoli decided after its investigation that Dr. Fayad’s suspension from the rheumatology society was invalid.
The lead author of the study in question, Nelly R. Ziade of Saint Joseph University and Hotel-Dieu de France Hospital in Beirut, told Retraction Watch that the investigation by the Lebanese Order of Physicians – Tripoli “cannot be considered as final or official” and that she was “never approached, interviewed, or asked to provide any documents related to this complaint.”
She continued: “I will always be available to give any scientific clarification requested by the Order of Physicians in Beirut where a serious investigation giving equal voice to both parties is currently conducted.
“Kindly note that the concerned journal has already conducted an internal investigation where both parties provided all documents and it was concluded that there was no scientific foundation for the accusations.
“Again, a similar investigation was conducted by the Saint-Joseph University in Beirut (where myself and the other party work). Both parties presented study documents to a committee including the president of the IRB, the vice president of the University, the medical director of the University Hospital, experts in musculoskeletal system and biostatistics. In brief, the case against the authors was dismissed, no data manipulation was found and the colleague from Tripoli also was submitted to University sanctions. The report of the University can be shared with you should you need it.
“I’m afraid that this issue is based on a background of personal and professional conflicts.”
Dr. Fayad added: “The beauty of science is that the truth will always prevail and cannot be obscured for long time.”
A version of this article first appeared on RetractionWatch.com.
‘Children are not little adults’ and need special protection during heat waves
After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.
Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.
Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.
“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital.
Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.
Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”
Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.
As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.
More than 9,000 high school athletes are treated for heat-related illnesses every year.
Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.
Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.
Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.
Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.
Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.
They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.
To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.
“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
Warning signs and solutions
Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.
Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.
For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.
Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.
Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.
More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.
The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
A lopsided risk
People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.
A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.
The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.
“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.
Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.
The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.
Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.
“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.
Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.
The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.
But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.
The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.
The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.
The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.
The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.
Giving people better ways to conceptualize heat is critical, she said.
“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.
Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.
Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.
“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital.
Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.
Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”
Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.
As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.
More than 9,000 high school athletes are treated for heat-related illnesses every year.
Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.
Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.
Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.
Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.
Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.
They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.
To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.
“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
Warning signs and solutions
Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.
Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.
For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.
Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.
Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.
More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.
The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
A lopsided risk
People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.
A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.
The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.
“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.
Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.
The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.
Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.
“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.
Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.
The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.
But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.
The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.
The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.
The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.
The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.
Giving people better ways to conceptualize heat is critical, she said.
“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.
Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.
Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.
“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital.
Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.
Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”
Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.
As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.
More than 9,000 high school athletes are treated for heat-related illnesses every year.
Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.
Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.
Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.
Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.
Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.
They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.
To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.
“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
Warning signs and solutions
Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.
Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.
For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.
Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.
Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.
More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.
The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
A lopsided risk
People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.
A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.
The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.
“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.
Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.
The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.
Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.
“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.
Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.
The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.
But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.
The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.
The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.
The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.
The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.
Giving people better ways to conceptualize heat is critical, she said.
“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Registry launched to reach more patients with PF
The Pulmonary Fibrosis Foundation (PFF) has launched a new initiative in which they hope to capture a far more diverse representation of patients with pulmonary fibrosis (PF) than the current registry allows them to do, a press release from the PFF indicated.
“The existing registry we have – the PFF Patient Registry – is limited to our care centers, which are primarily academic clinical institutions and we have only a few thousand patients within that registry,” Junelle Speller, MBA, vice president of the PFF Registry, told this news organization.
“We wanted to go beyond these care centers and capture patients in community centers, and in rural settings to provide a more complete understanding of patients with this disease and, of course, have a larger sample size,” she added.
“ across all parts of the United States and, most importantly, accelerate the research on PF toward improving earlier diagnosis, treatment, and outcomes for these patients,” Ms. Speller said.
Passive versus active
The PFF Community Registry differs in its structure and purpose from the PFF Patient Registry, as Ms. Speller explained. First, the PFF Patient Registry, established in 2016, is “passive” in its nature in that whatever information is entered into a patient’s electronic medical record or clinical chart on a routine office visit is abstracted and captured in the registry. By contrast, the PFF Community Registry is asking for self-reported data from patients, “so it’s more of an ‘active’ registry and will give us a chance to have a bidirectional connection with participants, provide email updates and newsletters, and give patients an opportunity to participate in future studies within the registry as well as in clinical trials,” she noted.
The two registries still overlap in that both capture demographic data on patients’ medical and family histories as well as any medications patients may be taking, but the Community Registry will also capture information with respect to education, employment, patient-reported outcomes, and quality of life metrics. “It will also let us know how patients feel about continued education on the disease itself and patient participation in support groups,” Ms. Speller observed.
The Community Registry will also collect information from lung transplant recipients who have had PF or any other form of interstitial lung disease (ILD) as well as information from caregivers and family members affected by the patient’s disease. As Ms. Speller noted, both PF and other forms of ILD (of which there are more than 200 types) are all characterized by inflammation or scarring in the lung. “Patients are often misdiagnosed, and it can take months, even years, to identify the disease,” Ms. Speller said.
From there, it can be a very long and difficult road ahead, with no cure in sight, although several antifibrotic drugs do help slow disease progression. Typically, onset is around the age of 60 and symptoms include chronic dry cough, fatigue, shortness of breath, weakness, discomfort in the chest, and sometimes unexplained weight loss. Some patients do have a history of smoking, but not all, Ms. Speller noted. So far, registry data suggest PF largely occurs in White patients.
“We’re very excited about the Community Registry, particularly about reaching into communities that we haven’t been able to reach with our existing registry,” Ms. Speller noted. “The rural population in particular is often underserved, so we are really looking forward to capturing data from these patients as well as those from community centers within smaller and larger cities,” she observed.
“A powerful aspect of the Community Registry is that we can use the information gained from it to understand the experience of individuals living with PF, and how it impacts their lives and those of their families and caregivers,” Kevin Flaherty, MD, steering committee chair, PFF Registry, said in a statement.
“Researchers can also look at the data to better understand fibrotic lung diseases and learn about effective approaches to improve patient care,” he added.
Patients who wish to join the PFF Community Registry can sign up at pffregistry.org. To learn more about PF and its risk factors, readers are invited to visit www.AboutPF.org. More than 250,000 patients in the United States are living with either PF or other types of ILD.
Ms. Speller and Dr. Flaherty disclosed no financial conflicts of interest. The PFF Registry is supported by its founding partner, Genentech, Visionary Partner, United Therapeutics, and its sustaining partner, Boehringer Ingelheim, as well as many donors.
A version of this article first appeared on Medscape.com.
This article was updated 8/8/22.
The Pulmonary Fibrosis Foundation (PFF) has launched a new initiative in which they hope to capture a far more diverse representation of patients with pulmonary fibrosis (PF) than the current registry allows them to do, a press release from the PFF indicated.
“The existing registry we have – the PFF Patient Registry – is limited to our care centers, which are primarily academic clinical institutions and we have only a few thousand patients within that registry,” Junelle Speller, MBA, vice president of the PFF Registry, told this news organization.
“We wanted to go beyond these care centers and capture patients in community centers, and in rural settings to provide a more complete understanding of patients with this disease and, of course, have a larger sample size,” she added.
“ across all parts of the United States and, most importantly, accelerate the research on PF toward improving earlier diagnosis, treatment, and outcomes for these patients,” Ms. Speller said.
Passive versus active
The PFF Community Registry differs in its structure and purpose from the PFF Patient Registry, as Ms. Speller explained. First, the PFF Patient Registry, established in 2016, is “passive” in its nature in that whatever information is entered into a patient’s electronic medical record or clinical chart on a routine office visit is abstracted and captured in the registry. By contrast, the PFF Community Registry is asking for self-reported data from patients, “so it’s more of an ‘active’ registry and will give us a chance to have a bidirectional connection with participants, provide email updates and newsletters, and give patients an opportunity to participate in future studies within the registry as well as in clinical trials,” she noted.
The two registries still overlap in that both capture demographic data on patients’ medical and family histories as well as any medications patients may be taking, but the Community Registry will also capture information with respect to education, employment, patient-reported outcomes, and quality of life metrics. “It will also let us know how patients feel about continued education on the disease itself and patient participation in support groups,” Ms. Speller observed.
The Community Registry will also collect information from lung transplant recipients who have had PF or any other form of interstitial lung disease (ILD) as well as information from caregivers and family members affected by the patient’s disease. As Ms. Speller noted, both PF and other forms of ILD (of which there are more than 200 types) are all characterized by inflammation or scarring in the lung. “Patients are often misdiagnosed, and it can take months, even years, to identify the disease,” Ms. Speller said.
From there, it can be a very long and difficult road ahead, with no cure in sight, although several antifibrotic drugs do help slow disease progression. Typically, onset is around the age of 60 and symptoms include chronic dry cough, fatigue, shortness of breath, weakness, discomfort in the chest, and sometimes unexplained weight loss. Some patients do have a history of smoking, but not all, Ms. Speller noted. So far, registry data suggest PF largely occurs in White patients.
“We’re very excited about the Community Registry, particularly about reaching into communities that we haven’t been able to reach with our existing registry,” Ms. Speller noted. “The rural population in particular is often underserved, so we are really looking forward to capturing data from these patients as well as those from community centers within smaller and larger cities,” she observed.
“A powerful aspect of the Community Registry is that we can use the information gained from it to understand the experience of individuals living with PF, and how it impacts their lives and those of their families and caregivers,” Kevin Flaherty, MD, steering committee chair, PFF Registry, said in a statement.
“Researchers can also look at the data to better understand fibrotic lung diseases and learn about effective approaches to improve patient care,” he added.
Patients who wish to join the PFF Community Registry can sign up at pffregistry.org. To learn more about PF and its risk factors, readers are invited to visit www.AboutPF.org. More than 250,000 patients in the United States are living with either PF or other types of ILD.
Ms. Speller and Dr. Flaherty disclosed no financial conflicts of interest. The PFF Registry is supported by its founding partner, Genentech, Visionary Partner, United Therapeutics, and its sustaining partner, Boehringer Ingelheim, as well as many donors.
A version of this article first appeared on Medscape.com.
This article was updated 8/8/22.
The Pulmonary Fibrosis Foundation (PFF) has launched a new initiative in which they hope to capture a far more diverse representation of patients with pulmonary fibrosis (PF) than the current registry allows them to do, a press release from the PFF indicated.
“The existing registry we have – the PFF Patient Registry – is limited to our care centers, which are primarily academic clinical institutions and we have only a few thousand patients within that registry,” Junelle Speller, MBA, vice president of the PFF Registry, told this news organization.
“We wanted to go beyond these care centers and capture patients in community centers, and in rural settings to provide a more complete understanding of patients with this disease and, of course, have a larger sample size,” she added.
“ across all parts of the United States and, most importantly, accelerate the research on PF toward improving earlier diagnosis, treatment, and outcomes for these patients,” Ms. Speller said.
Passive versus active
The PFF Community Registry differs in its structure and purpose from the PFF Patient Registry, as Ms. Speller explained. First, the PFF Patient Registry, established in 2016, is “passive” in its nature in that whatever information is entered into a patient’s electronic medical record or clinical chart on a routine office visit is abstracted and captured in the registry. By contrast, the PFF Community Registry is asking for self-reported data from patients, “so it’s more of an ‘active’ registry and will give us a chance to have a bidirectional connection with participants, provide email updates and newsletters, and give patients an opportunity to participate in future studies within the registry as well as in clinical trials,” she noted.
The two registries still overlap in that both capture demographic data on patients’ medical and family histories as well as any medications patients may be taking, but the Community Registry will also capture information with respect to education, employment, patient-reported outcomes, and quality of life metrics. “It will also let us know how patients feel about continued education on the disease itself and patient participation in support groups,” Ms. Speller observed.
The Community Registry will also collect information from lung transplant recipients who have had PF or any other form of interstitial lung disease (ILD) as well as information from caregivers and family members affected by the patient’s disease. As Ms. Speller noted, both PF and other forms of ILD (of which there are more than 200 types) are all characterized by inflammation or scarring in the lung. “Patients are often misdiagnosed, and it can take months, even years, to identify the disease,” Ms. Speller said.
From there, it can be a very long and difficult road ahead, with no cure in sight, although several antifibrotic drugs do help slow disease progression. Typically, onset is around the age of 60 and symptoms include chronic dry cough, fatigue, shortness of breath, weakness, discomfort in the chest, and sometimes unexplained weight loss. Some patients do have a history of smoking, but not all, Ms. Speller noted. So far, registry data suggest PF largely occurs in White patients.
“We’re very excited about the Community Registry, particularly about reaching into communities that we haven’t been able to reach with our existing registry,” Ms. Speller noted. “The rural population in particular is often underserved, so we are really looking forward to capturing data from these patients as well as those from community centers within smaller and larger cities,” she observed.
“A powerful aspect of the Community Registry is that we can use the information gained from it to understand the experience of individuals living with PF, and how it impacts their lives and those of their families and caregivers,” Kevin Flaherty, MD, steering committee chair, PFF Registry, said in a statement.
“Researchers can also look at the data to better understand fibrotic lung diseases and learn about effective approaches to improve patient care,” he added.
Patients who wish to join the PFF Community Registry can sign up at pffregistry.org. To learn more about PF and its risk factors, readers are invited to visit www.AboutPF.org. More than 250,000 patients in the United States are living with either PF or other types of ILD.
Ms. Speller and Dr. Flaherty disclosed no financial conflicts of interest. The PFF Registry is supported by its founding partner, Genentech, Visionary Partner, United Therapeutics, and its sustaining partner, Boehringer Ingelheim, as well as many donors.
A version of this article first appeared on Medscape.com.
This article was updated 8/8/22.
New Omicron COVID boosters coming soon: What to know now
– a month ahead of schedule, the Biden administration announced this week.
Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the “bivalent” booster, which includes the original “ancestral” virus strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a $3.2 billion U.S. agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.
About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.
Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines – now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.
For a preview of what to expect from the CDC and FDA, this news organization spoke with Keri Althoff, PhD, an epidemiologist at Johns Hopkins University, Baltimore.
Q: Based on what we know now, who should be getting one of these new bivalent boosters?A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.
Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you’re X amount of months or more from your second booster; or X amount of months or more from your first booster, if you’ve only had one.
Q: What about pregnant women or those being treated for chronic health conditions?A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.
Q: And for children?A: That’s a good question. It’s something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they’re X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].
As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall. But there are questions as to whether or not that is going to happen.
Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?A: I don’t think they will likely make that a requirement – to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.
Q: Are there any new risks associated with these boosters, since they were developed so rapidly?A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.
Q: Some health experts are concerned “vaccine fatigue” will have an impact on the booster campaign. What’s your take?A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we’re doing is really priming the immune system.
We’re trying to expedite the process of getting people’s immune system up to speed so that when the virus comes our way – as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities – we’re able to get the highest level of population immunity, you don’t end up in the hospital.
Q: What other challenges do you see in persuading Americans to get another round of boosters?A: One of the things that I’ve been hearing a lot, which I get very nervous about, is people saying: “Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn’t feel like much to me, and so I’m not going to be boosted anymore.” We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we’re seeing hundreds of deaths every day.
There are consequences, even if it isn’t in severity of disease, meaning hospitalization and death. And let’s not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don’t mistake that for “I don’t need another one.”
Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?A: It’s all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.
Q: There haven’t been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?A: There have been some studies – some great studies – looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say: “Okay, this is what we know about the safety and effectiveness of the prior vaccines ... and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?”
Q: How long will the new boosters’ protections last – do we know yet?A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron specific, and then we have something totally new emerge ... we have to be more nimble because the variants are outpacing what we’re able to do.
This turns out to be a bit of a game of probability – the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.
Q: What about a combined flu-COVID vaccine; is that on the horizon?A: My children, who like most children do not like vaccines, always tell me: “Mom, why can’t they just put the influenza vaccine and the COVID vaccine into the same shot?” And I’m like: “Oh, from your lips to some scientist’s ears.”
At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.
Q: If you’ve received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it’s actually encouraged. So that’s not going to change with the bivalent booster.
Q: Is it okay to get a flu shot and a COVID booster at the same time, as the Centers for Disease Control and Prevention has recommended with past vaccines?A: I don’t anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.
I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.
Q: Once you’re fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission – you know who is ill with COVID in your kids’ schools, you know in your workplace and when people go out – that still signals there’s some increases in the circulation of virus. So, look at that to understand what your risk is.
If you know someone or have a colleague who is currently pregnant or immune suppressed, think about how you can protect them with mask-wearing, even if it’s just when you’re in one-on-one closed-door meetings with that individual.
So, your masking question is an important one, and it’s important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don’t bring anything to here.
The high-level community risk nationwide is high right now. COVID is here.
A version of this article first appeared on WebMd.com.
– a month ahead of schedule, the Biden administration announced this week.
Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the “bivalent” booster, which includes the original “ancestral” virus strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a $3.2 billion U.S. agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.
About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.
Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines – now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.
For a preview of what to expect from the CDC and FDA, this news organization spoke with Keri Althoff, PhD, an epidemiologist at Johns Hopkins University, Baltimore.
Q: Based on what we know now, who should be getting one of these new bivalent boosters?A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.
Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you’re X amount of months or more from your second booster; or X amount of months or more from your first booster, if you’ve only had one.
Q: What about pregnant women or those being treated for chronic health conditions?A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.
Q: And for children?A: That’s a good question. It’s something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they’re X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].
As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall. But there are questions as to whether or not that is going to happen.
Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?A: I don’t think they will likely make that a requirement – to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.
Q: Are there any new risks associated with these boosters, since they were developed so rapidly?A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.
Q: Some health experts are concerned “vaccine fatigue” will have an impact on the booster campaign. What’s your take?A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we’re doing is really priming the immune system.
We’re trying to expedite the process of getting people’s immune system up to speed so that when the virus comes our way – as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities – we’re able to get the highest level of population immunity, you don’t end up in the hospital.
Q: What other challenges do you see in persuading Americans to get another round of boosters?A: One of the things that I’ve been hearing a lot, which I get very nervous about, is people saying: “Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn’t feel like much to me, and so I’m not going to be boosted anymore.” We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we’re seeing hundreds of deaths every day.
There are consequences, even if it isn’t in severity of disease, meaning hospitalization and death. And let’s not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don’t mistake that for “I don’t need another one.”
Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?A: It’s all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.
Q: There haven’t been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?A: There have been some studies – some great studies – looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say: “Okay, this is what we know about the safety and effectiveness of the prior vaccines ... and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?”
Q: How long will the new boosters’ protections last – do we know yet?A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron specific, and then we have something totally new emerge ... we have to be more nimble because the variants are outpacing what we’re able to do.
This turns out to be a bit of a game of probability – the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.
Q: What about a combined flu-COVID vaccine; is that on the horizon?A: My children, who like most children do not like vaccines, always tell me: “Mom, why can’t they just put the influenza vaccine and the COVID vaccine into the same shot?” And I’m like: “Oh, from your lips to some scientist’s ears.”
At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.
Q: If you’ve received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it’s actually encouraged. So that’s not going to change with the bivalent booster.
Q: Is it okay to get a flu shot and a COVID booster at the same time, as the Centers for Disease Control and Prevention has recommended with past vaccines?A: I don’t anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.
I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.
Q: Once you’re fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission – you know who is ill with COVID in your kids’ schools, you know in your workplace and when people go out – that still signals there’s some increases in the circulation of virus. So, look at that to understand what your risk is.
If you know someone or have a colleague who is currently pregnant or immune suppressed, think about how you can protect them with mask-wearing, even if it’s just when you’re in one-on-one closed-door meetings with that individual.
So, your masking question is an important one, and it’s important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don’t bring anything to here.
The high-level community risk nationwide is high right now. COVID is here.
A version of this article first appeared on WebMd.com.
– a month ahead of schedule, the Biden administration announced this week.
Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the “bivalent” booster, which includes the original “ancestral” virus strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a $3.2 billion U.S. agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.
About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.
Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines – now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.
For a preview of what to expect from the CDC and FDA, this news organization spoke with Keri Althoff, PhD, an epidemiologist at Johns Hopkins University, Baltimore.
Q: Based on what we know now, who should be getting one of these new bivalent boosters?A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.
Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you’re X amount of months or more from your second booster; or X amount of months or more from your first booster, if you’ve only had one.
Q: What about pregnant women or those being treated for chronic health conditions?A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.
Q: And for children?A: That’s a good question. It’s something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they’re X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].
As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall. But there are questions as to whether or not that is going to happen.
Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?A: I don’t think they will likely make that a requirement – to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.
Q: Are there any new risks associated with these boosters, since they were developed so rapidly?A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.
Q: Some health experts are concerned “vaccine fatigue” will have an impact on the booster campaign. What’s your take?A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we’re doing is really priming the immune system.
We’re trying to expedite the process of getting people’s immune system up to speed so that when the virus comes our way – as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities – we’re able to get the highest level of population immunity, you don’t end up in the hospital.
Q: What other challenges do you see in persuading Americans to get another round of boosters?A: One of the things that I’ve been hearing a lot, which I get very nervous about, is people saying: “Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn’t feel like much to me, and so I’m not going to be boosted anymore.” We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we’re seeing hundreds of deaths every day.
There are consequences, even if it isn’t in severity of disease, meaning hospitalization and death. And let’s not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don’t mistake that for “I don’t need another one.”
Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?A: It’s all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.
Q: There haven’t been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?A: There have been some studies – some great studies – looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say: “Okay, this is what we know about the safety and effectiveness of the prior vaccines ... and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?”
Q: How long will the new boosters’ protections last – do we know yet?A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron specific, and then we have something totally new emerge ... we have to be more nimble because the variants are outpacing what we’re able to do.
This turns out to be a bit of a game of probability – the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.
Q: What about a combined flu-COVID vaccine; is that on the horizon?A: My children, who like most children do not like vaccines, always tell me: “Mom, why can’t they just put the influenza vaccine and the COVID vaccine into the same shot?” And I’m like: “Oh, from your lips to some scientist’s ears.”
At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.
Q: If you’ve received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it’s actually encouraged. So that’s not going to change with the bivalent booster.
Q: Is it okay to get a flu shot and a COVID booster at the same time, as the Centers for Disease Control and Prevention has recommended with past vaccines?A: I don’t anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.
I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.
Q: Once you’re fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission – you know who is ill with COVID in your kids’ schools, you know in your workplace and when people go out – that still signals there’s some increases in the circulation of virus. So, look at that to understand what your risk is.
If you know someone or have a colleague who is currently pregnant or immune suppressed, think about how you can protect them with mask-wearing, even if it’s just when you’re in one-on-one closed-door meetings with that individual.
So, your masking question is an important one, and it’s important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don’t bring anything to here.
The high-level community risk nationwide is high right now. COVID is here.
A version of this article first appeared on WebMd.com.
Topline results for novel drug in ATTR amyloidosis with cardiomyopathy
The RNA interference (RNAi) therapeutic patisiran (Onpattro, Alnylam Pharmaceuticals) led to statistically significant improvement in functional capacity and quality of life in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy in the phase 3 APOLLO-B study, according to topline results released Aug. 3.
“We are thrilled that APOLLO-B successfully met all its major objectives, which we believe for the first time validates the hypothesis that TTR silencing by an RNAi therapeutic can be an effective approach for treating the cardiomyopathy of ATTR amyloidosis,” Pushkal Garg, MD, Alnylam chief medical officer, said in a news release.
The Food and Drug Administration approved patisiran in 2018 for polyneuropathy caused by hereditary ATTR in adults on the basis of results of the APOLLO phase 3 trial, as reported by this news organization.
APOLLO-B enrolled 360 adults with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 centers in 21 countries. Half were randomly allocated to 0.3 mg/kg of patisiran or placebo administered intravenously every 3 weeks for 12 months.
The study met the primary endpoint of a statistically significant improvement from baseline in the 6-minute walk test at 12 months compared with placebo (P = .0162), the company said.
The study also met the first secondary endpoint of a statistically significant improvement from baseline in quality of life compared with placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (P = .0397).
The patisiran and placebo groups had similar frequencies of adverse events (91% and 94%, respectively) and serious adverse events (34% and 35%, respectively).
“ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure, affecting greater than 250,000 patients around the world. These patients have limited treatment options, and disease progression is common. As such, we are encouraged to see the potential of patisiran to improve the functional capacity and quality of life of patients living with this fatal, multisystem disease,” Dr. Garg said in the release.
Full results from APOLLO-B will be presented at a late-breaker session at the 18th International Symposium on Amyloidosis in September in Heidelberg, Germany.
Based on these results, the company plans to file a supplementary new drug application (sNDA) for patisiran for this indication with the FDA later this year, the release noted.
A version of this article first appeared on Medscape.com.
The RNA interference (RNAi) therapeutic patisiran (Onpattro, Alnylam Pharmaceuticals) led to statistically significant improvement in functional capacity and quality of life in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy in the phase 3 APOLLO-B study, according to topline results released Aug. 3.
“We are thrilled that APOLLO-B successfully met all its major objectives, which we believe for the first time validates the hypothesis that TTR silencing by an RNAi therapeutic can be an effective approach for treating the cardiomyopathy of ATTR amyloidosis,” Pushkal Garg, MD, Alnylam chief medical officer, said in a news release.
The Food and Drug Administration approved patisiran in 2018 for polyneuropathy caused by hereditary ATTR in adults on the basis of results of the APOLLO phase 3 trial, as reported by this news organization.
APOLLO-B enrolled 360 adults with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 centers in 21 countries. Half were randomly allocated to 0.3 mg/kg of patisiran or placebo administered intravenously every 3 weeks for 12 months.
The study met the primary endpoint of a statistically significant improvement from baseline in the 6-minute walk test at 12 months compared with placebo (P = .0162), the company said.
The study also met the first secondary endpoint of a statistically significant improvement from baseline in quality of life compared with placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (P = .0397).
The patisiran and placebo groups had similar frequencies of adverse events (91% and 94%, respectively) and serious adverse events (34% and 35%, respectively).
“ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure, affecting greater than 250,000 patients around the world. These patients have limited treatment options, and disease progression is common. As such, we are encouraged to see the potential of patisiran to improve the functional capacity and quality of life of patients living with this fatal, multisystem disease,” Dr. Garg said in the release.
Full results from APOLLO-B will be presented at a late-breaker session at the 18th International Symposium on Amyloidosis in September in Heidelberg, Germany.
Based on these results, the company plans to file a supplementary new drug application (sNDA) for patisiran for this indication with the FDA later this year, the release noted.
A version of this article first appeared on Medscape.com.
The RNA interference (RNAi) therapeutic patisiran (Onpattro, Alnylam Pharmaceuticals) led to statistically significant improvement in functional capacity and quality of life in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy in the phase 3 APOLLO-B study, according to topline results released Aug. 3.
“We are thrilled that APOLLO-B successfully met all its major objectives, which we believe for the first time validates the hypothesis that TTR silencing by an RNAi therapeutic can be an effective approach for treating the cardiomyopathy of ATTR amyloidosis,” Pushkal Garg, MD, Alnylam chief medical officer, said in a news release.
The Food and Drug Administration approved patisiran in 2018 for polyneuropathy caused by hereditary ATTR in adults on the basis of results of the APOLLO phase 3 trial, as reported by this news organization.
APOLLO-B enrolled 360 adults with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 centers in 21 countries. Half were randomly allocated to 0.3 mg/kg of patisiran or placebo administered intravenously every 3 weeks for 12 months.
The study met the primary endpoint of a statistically significant improvement from baseline in the 6-minute walk test at 12 months compared with placebo (P = .0162), the company said.
The study also met the first secondary endpoint of a statistically significant improvement from baseline in quality of life compared with placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (P = .0397).
The patisiran and placebo groups had similar frequencies of adverse events (91% and 94%, respectively) and serious adverse events (34% and 35%, respectively).
“ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure, affecting greater than 250,000 patients around the world. These patients have limited treatment options, and disease progression is common. As such, we are encouraged to see the potential of patisiran to improve the functional capacity and quality of life of patients living with this fatal, multisystem disease,” Dr. Garg said in the release.
Full results from APOLLO-B will be presented at a late-breaker session at the 18th International Symposium on Amyloidosis in September in Heidelberg, Germany.
Based on these results, the company plans to file a supplementary new drug application (sNDA) for patisiran for this indication with the FDA later this year, the release noted.
A version of this article first appeared on Medscape.com.
Why exercise doesn’t help people with long COVID
When Joel Fram woke up on the morning of March 12, 2020, he had a pretty good idea why he felt so lousy.
He lives in New York, where the first wave of the coronavirus was tearing through the city. “I instantly knew,” said the 55-year-old Broadway music director. It was COVID-19.
What started with a general sense of having been hit by a truck soon included a sore throat and such severe fatigue that he once fell asleep in the middle of sending a text to his sister. The final symptoms were chest tightness and trouble breathing.
And then he started to feel better. “By mid-April, my body was feeling essentially back to normal,” he said.
So he did what would have been smart after almost any other illness: He began working out. That didn’t last long. “It felt like someone pulled the carpet out from under me,” he remembered. “I couldn’t walk three blocks without getting breathless and fatigued.”
That was the first indication Mr. Fram had long COVID.
According to the National Center for Health Statistics, at least 7.5% of American adults – close to 20 million people – have symptoms of long COVID.
COVID-19 patients who had the most severe illness will struggle the most with exercise later, according to a review published in June from researchers at the University of California, San Francisco. But even people with mild symptoms can struggle to regain their previous levels of fitness.
“We have participants in our study who had relatively mild acute symptoms and went on to have really profound decreases in their ability to exercise,” said Matthew S. Durstenfeld, MD, a cardiologist at UCSF and principal author of the review.
Most people with long COVID will have lower-than-expected scores on tests of aerobic fitness, as shown by Yale researchers in a study published in August 2021.
“Some amount of that is due to deconditioning,” Dr. Durstenfeld said. “You’re not feeling well, so you’re not exercising to the same degree you might have been before you got infected.”
In a study published in April, people with long COVID told researchers at Britain’s University of Leeds they spent 93% less time in physical activity than they did before their infection.
But multiple studies have found deconditioning is not entirely – or even mostly – to blame.
A 2021 study found that 89% of participants with long COVID had postexertional malaise (PEM), which happens when a patient’s symptoms get worse after they do even minor physical or mental activities. According to the CDC, postexertional malaise can hit as long as 12-48 hours after the activity, and it can take people up to 2 weeks to fully recover.
Unfortunately, the advice patients get from their doctors sometimes makes the problem worse.
How long COVID defies simple solutions
Long COVID is a “dynamic disability” that requires health professionals to go off script when a patient’s symptoms don’t respond in a predictable way to treatment, said David Putrino, PhD, a neuroscientist, physical therapist, and director of rehabilitation innovation for the Mount Sinai Health System in New York.
“We’re not so good at dealing with somebody who, for all intents and purposes, can appear healthy and nondisabled on one day and be completely debilitated the next day,” he said.
Dr. Putrino said more than half of his clinic’s long-COVID patients told his team they had at least one of these persistent problems:
- Fatigue (82%).
- Brain fog (67%).
- Headache (60%).
- Sleep problems (59%).
- Dizziness (54%).
And 86% said exercise worsened their symptoms.
The symptoms are similar to what doctors see with illnesses such as lupus, Lyme disease, and chronic fatigue syndrome – something many experts compare long COVID to. Researchers and medical professionals still don’t know exactly how COVID-19 causes those symptoms. But there are some theories.
Potential causes of long-COVID symptoms
Dr. Putrino said it is possible the virus enters a patient’s cells and hijacks the mitochondria – a part of the cell that provides energy. It can linger there for weeks or months – something known as viral persistence.
“All of a sudden, the body’s getting less energy for itself, even though it’s producing the same amount, or even a little more,” he said. And there is a consequence to this extra stress on the cells. “Creating energy isn’t free. You’re producing more waste products, which puts your body in a state of oxidative stress,” Dr. Putrino said. Oxidative stress damages cells as molecules interact with oxygen in harmful ways.
“The other big mechanism is autonomic dysfunction,” Dr. Putrino said. It’s marked by breathing problems, heart palpitations, and other glitches in areas most healthy people never have to think about. About 70% of long-COVID patients at Mount Sinai’s clinic have some degree of autonomic dysfunction, he said.
For a person with autonomic dysfunction, something as basic as changing posture can trigger a storm of cytokines, a chemical messenger that tells the immune system where and how to respond to challenges like an injury or infection.
“Suddenly, you have this on-off switch,” Dr. Putrino said. “You go straight to ‘fight or flight,’ ” with a surge of adrenaline and a spiking heart rate, “then plunge back to ‘rest or digest.’ You go from fired up to so sleepy, you can’t keep your eyes open.”
A patient with viral persistence and one with autonomic dysfunction may have the same negative reaction to exercise, even though the triggers are completely different.
So how can doctors help long-COVID patients?
The first step, Dr. Putrino said, is to understand the difference between long COVID and a long recovery from COVID-19 infection.
Many of the patients in the latter group still have symptoms 4 weeks after their first infection. “At 4 weeks, yeah, they’re still feeling symptoms, but that’s not long COVID,” he said. “That’s just taking a while to get over a viral infection.”
Fitness advice is simple for those people: Take it easy at first, and gradually increase the amount and intensity of aerobic exercise and strength training.
But that advice would be disastrous for someone who meets Dr. Putrino’s stricter definition of long COVID: “Three to 4 months out from initial infection, they’re experiencing severe fatigue, exertional symptoms, cognitive symptoms, heart palpitations, shortness of breath,” he said.
“Our clinic is extraordinarily cautious with exercise” for those patients, he said.
In Dr. Putrino’s experience, about 20%-30% of patients will make significant progress after 12 weeks. “They’re feeling more or less like they felt pre-COVID,” he said.
The unluckiest 10%-20% won’t make any progress at all. Any type of therapy, even if it’s as simple as moving their legs from a flat position, worsens their symptoms.
The majority – 50%-60% – will have some improvement in their symptoms. But then progress will stop, for reasons researchers are still trying to figure out.
“My sense is that gradually increasing your exercise is still good advice for the vast majority of people,” UCSF’s Dr. Durstenfeld said.
Ideally, that exercise will be supervised by someone trained in cardiac, pulmonary, and/or autonomic rehabilitation – a specialized type of therapy aimed at resyncing the autonomic nervous system that governs breathing and other unconscious functions, he said. But those therapies are rarely covered by insurance, which means most long-COVID patients are on their own.
Dr. Durstenfeld said it’s important that patients keep trying and not give up. “With slow and steady progress, a lot of people can get profoundly better,” he said.
Mr. Fram, who’s worked with careful supervision, says he’s getting closer to something like his pre-COVID-19 life.
But he’s not there yet. Long COVID, he said, “affects my life every single day.”
A version of this article first appeared on WebMD.com.
When Joel Fram woke up on the morning of March 12, 2020, he had a pretty good idea why he felt so lousy.
He lives in New York, where the first wave of the coronavirus was tearing through the city. “I instantly knew,” said the 55-year-old Broadway music director. It was COVID-19.
What started with a general sense of having been hit by a truck soon included a sore throat and such severe fatigue that he once fell asleep in the middle of sending a text to his sister. The final symptoms were chest tightness and trouble breathing.
And then he started to feel better. “By mid-April, my body was feeling essentially back to normal,” he said.
So he did what would have been smart after almost any other illness: He began working out. That didn’t last long. “It felt like someone pulled the carpet out from under me,” he remembered. “I couldn’t walk three blocks without getting breathless and fatigued.”
That was the first indication Mr. Fram had long COVID.
According to the National Center for Health Statistics, at least 7.5% of American adults – close to 20 million people – have symptoms of long COVID.
COVID-19 patients who had the most severe illness will struggle the most with exercise later, according to a review published in June from researchers at the University of California, San Francisco. But even people with mild symptoms can struggle to regain their previous levels of fitness.
“We have participants in our study who had relatively mild acute symptoms and went on to have really profound decreases in their ability to exercise,” said Matthew S. Durstenfeld, MD, a cardiologist at UCSF and principal author of the review.
Most people with long COVID will have lower-than-expected scores on tests of aerobic fitness, as shown by Yale researchers in a study published in August 2021.
“Some amount of that is due to deconditioning,” Dr. Durstenfeld said. “You’re not feeling well, so you’re not exercising to the same degree you might have been before you got infected.”
In a study published in April, people with long COVID told researchers at Britain’s University of Leeds they spent 93% less time in physical activity than they did before their infection.
But multiple studies have found deconditioning is not entirely – or even mostly – to blame.
A 2021 study found that 89% of participants with long COVID had postexertional malaise (PEM), which happens when a patient’s symptoms get worse after they do even minor physical or mental activities. According to the CDC, postexertional malaise can hit as long as 12-48 hours after the activity, and it can take people up to 2 weeks to fully recover.
Unfortunately, the advice patients get from their doctors sometimes makes the problem worse.
How long COVID defies simple solutions
Long COVID is a “dynamic disability” that requires health professionals to go off script when a patient’s symptoms don’t respond in a predictable way to treatment, said David Putrino, PhD, a neuroscientist, physical therapist, and director of rehabilitation innovation for the Mount Sinai Health System in New York.
“We’re not so good at dealing with somebody who, for all intents and purposes, can appear healthy and nondisabled on one day and be completely debilitated the next day,” he said.
Dr. Putrino said more than half of his clinic’s long-COVID patients told his team they had at least one of these persistent problems:
- Fatigue (82%).
- Brain fog (67%).
- Headache (60%).
- Sleep problems (59%).
- Dizziness (54%).
And 86% said exercise worsened their symptoms.
The symptoms are similar to what doctors see with illnesses such as lupus, Lyme disease, and chronic fatigue syndrome – something many experts compare long COVID to. Researchers and medical professionals still don’t know exactly how COVID-19 causes those symptoms. But there are some theories.
Potential causes of long-COVID symptoms
Dr. Putrino said it is possible the virus enters a patient’s cells and hijacks the mitochondria – a part of the cell that provides energy. It can linger there for weeks or months – something known as viral persistence.
“All of a sudden, the body’s getting less energy for itself, even though it’s producing the same amount, or even a little more,” he said. And there is a consequence to this extra stress on the cells. “Creating energy isn’t free. You’re producing more waste products, which puts your body in a state of oxidative stress,” Dr. Putrino said. Oxidative stress damages cells as molecules interact with oxygen in harmful ways.
“The other big mechanism is autonomic dysfunction,” Dr. Putrino said. It’s marked by breathing problems, heart palpitations, and other glitches in areas most healthy people never have to think about. About 70% of long-COVID patients at Mount Sinai’s clinic have some degree of autonomic dysfunction, he said.
For a person with autonomic dysfunction, something as basic as changing posture can trigger a storm of cytokines, a chemical messenger that tells the immune system where and how to respond to challenges like an injury or infection.
“Suddenly, you have this on-off switch,” Dr. Putrino said. “You go straight to ‘fight or flight,’ ” with a surge of adrenaline and a spiking heart rate, “then plunge back to ‘rest or digest.’ You go from fired up to so sleepy, you can’t keep your eyes open.”
A patient with viral persistence and one with autonomic dysfunction may have the same negative reaction to exercise, even though the triggers are completely different.
So how can doctors help long-COVID patients?
The first step, Dr. Putrino said, is to understand the difference between long COVID and a long recovery from COVID-19 infection.
Many of the patients in the latter group still have symptoms 4 weeks after their first infection. “At 4 weeks, yeah, they’re still feeling symptoms, but that’s not long COVID,” he said. “That’s just taking a while to get over a viral infection.”
Fitness advice is simple for those people: Take it easy at first, and gradually increase the amount and intensity of aerobic exercise and strength training.
But that advice would be disastrous for someone who meets Dr. Putrino’s stricter definition of long COVID: “Three to 4 months out from initial infection, they’re experiencing severe fatigue, exertional symptoms, cognitive symptoms, heart palpitations, shortness of breath,” he said.
“Our clinic is extraordinarily cautious with exercise” for those patients, he said.
In Dr. Putrino’s experience, about 20%-30% of patients will make significant progress after 12 weeks. “They’re feeling more or less like they felt pre-COVID,” he said.
The unluckiest 10%-20% won’t make any progress at all. Any type of therapy, even if it’s as simple as moving their legs from a flat position, worsens their symptoms.
The majority – 50%-60% – will have some improvement in their symptoms. But then progress will stop, for reasons researchers are still trying to figure out.
“My sense is that gradually increasing your exercise is still good advice for the vast majority of people,” UCSF’s Dr. Durstenfeld said.
Ideally, that exercise will be supervised by someone trained in cardiac, pulmonary, and/or autonomic rehabilitation – a specialized type of therapy aimed at resyncing the autonomic nervous system that governs breathing and other unconscious functions, he said. But those therapies are rarely covered by insurance, which means most long-COVID patients are on their own.
Dr. Durstenfeld said it’s important that patients keep trying and not give up. “With slow and steady progress, a lot of people can get profoundly better,” he said.
Mr. Fram, who’s worked with careful supervision, says he’s getting closer to something like his pre-COVID-19 life.
But he’s not there yet. Long COVID, he said, “affects my life every single day.”
A version of this article first appeared on WebMD.com.
When Joel Fram woke up on the morning of March 12, 2020, he had a pretty good idea why he felt so lousy.
He lives in New York, where the first wave of the coronavirus was tearing through the city. “I instantly knew,” said the 55-year-old Broadway music director. It was COVID-19.
What started with a general sense of having been hit by a truck soon included a sore throat and such severe fatigue that he once fell asleep in the middle of sending a text to his sister. The final symptoms were chest tightness and trouble breathing.
And then he started to feel better. “By mid-April, my body was feeling essentially back to normal,” he said.
So he did what would have been smart after almost any other illness: He began working out. That didn’t last long. “It felt like someone pulled the carpet out from under me,” he remembered. “I couldn’t walk three blocks without getting breathless and fatigued.”
That was the first indication Mr. Fram had long COVID.
According to the National Center for Health Statistics, at least 7.5% of American adults – close to 20 million people – have symptoms of long COVID.
COVID-19 patients who had the most severe illness will struggle the most with exercise later, according to a review published in June from researchers at the University of California, San Francisco. But even people with mild symptoms can struggle to regain their previous levels of fitness.
“We have participants in our study who had relatively mild acute symptoms and went on to have really profound decreases in their ability to exercise,” said Matthew S. Durstenfeld, MD, a cardiologist at UCSF and principal author of the review.
Most people with long COVID will have lower-than-expected scores on tests of aerobic fitness, as shown by Yale researchers in a study published in August 2021.
“Some amount of that is due to deconditioning,” Dr. Durstenfeld said. “You’re not feeling well, so you’re not exercising to the same degree you might have been before you got infected.”
In a study published in April, people with long COVID told researchers at Britain’s University of Leeds they spent 93% less time in physical activity than they did before their infection.
But multiple studies have found deconditioning is not entirely – or even mostly – to blame.
A 2021 study found that 89% of participants with long COVID had postexertional malaise (PEM), which happens when a patient’s symptoms get worse after they do even minor physical or mental activities. According to the CDC, postexertional malaise can hit as long as 12-48 hours after the activity, and it can take people up to 2 weeks to fully recover.
Unfortunately, the advice patients get from their doctors sometimes makes the problem worse.
How long COVID defies simple solutions
Long COVID is a “dynamic disability” that requires health professionals to go off script when a patient’s symptoms don’t respond in a predictable way to treatment, said David Putrino, PhD, a neuroscientist, physical therapist, and director of rehabilitation innovation for the Mount Sinai Health System in New York.
“We’re not so good at dealing with somebody who, for all intents and purposes, can appear healthy and nondisabled on one day and be completely debilitated the next day,” he said.
Dr. Putrino said more than half of his clinic’s long-COVID patients told his team they had at least one of these persistent problems:
- Fatigue (82%).
- Brain fog (67%).
- Headache (60%).
- Sleep problems (59%).
- Dizziness (54%).
And 86% said exercise worsened their symptoms.
The symptoms are similar to what doctors see with illnesses such as lupus, Lyme disease, and chronic fatigue syndrome – something many experts compare long COVID to. Researchers and medical professionals still don’t know exactly how COVID-19 causes those symptoms. But there are some theories.
Potential causes of long-COVID symptoms
Dr. Putrino said it is possible the virus enters a patient’s cells and hijacks the mitochondria – a part of the cell that provides energy. It can linger there for weeks or months – something known as viral persistence.
“All of a sudden, the body’s getting less energy for itself, even though it’s producing the same amount, or even a little more,” he said. And there is a consequence to this extra stress on the cells. “Creating energy isn’t free. You’re producing more waste products, which puts your body in a state of oxidative stress,” Dr. Putrino said. Oxidative stress damages cells as molecules interact with oxygen in harmful ways.
“The other big mechanism is autonomic dysfunction,” Dr. Putrino said. It’s marked by breathing problems, heart palpitations, and other glitches in areas most healthy people never have to think about. About 70% of long-COVID patients at Mount Sinai’s clinic have some degree of autonomic dysfunction, he said.
For a person with autonomic dysfunction, something as basic as changing posture can trigger a storm of cytokines, a chemical messenger that tells the immune system where and how to respond to challenges like an injury or infection.
“Suddenly, you have this on-off switch,” Dr. Putrino said. “You go straight to ‘fight or flight,’ ” with a surge of adrenaline and a spiking heart rate, “then plunge back to ‘rest or digest.’ You go from fired up to so sleepy, you can’t keep your eyes open.”
A patient with viral persistence and one with autonomic dysfunction may have the same negative reaction to exercise, even though the triggers are completely different.
So how can doctors help long-COVID patients?
The first step, Dr. Putrino said, is to understand the difference between long COVID and a long recovery from COVID-19 infection.
Many of the patients in the latter group still have symptoms 4 weeks after their first infection. “At 4 weeks, yeah, they’re still feeling symptoms, but that’s not long COVID,” he said. “That’s just taking a while to get over a viral infection.”
Fitness advice is simple for those people: Take it easy at first, and gradually increase the amount and intensity of aerobic exercise and strength training.
But that advice would be disastrous for someone who meets Dr. Putrino’s stricter definition of long COVID: “Three to 4 months out from initial infection, they’re experiencing severe fatigue, exertional symptoms, cognitive symptoms, heart palpitations, shortness of breath,” he said.
“Our clinic is extraordinarily cautious with exercise” for those patients, he said.
In Dr. Putrino’s experience, about 20%-30% of patients will make significant progress after 12 weeks. “They’re feeling more or less like they felt pre-COVID,” he said.
The unluckiest 10%-20% won’t make any progress at all. Any type of therapy, even if it’s as simple as moving their legs from a flat position, worsens their symptoms.
The majority – 50%-60% – will have some improvement in their symptoms. But then progress will stop, for reasons researchers are still trying to figure out.
“My sense is that gradually increasing your exercise is still good advice for the vast majority of people,” UCSF’s Dr. Durstenfeld said.
Ideally, that exercise will be supervised by someone trained in cardiac, pulmonary, and/or autonomic rehabilitation – a specialized type of therapy aimed at resyncing the autonomic nervous system that governs breathing and other unconscious functions, he said. But those therapies are rarely covered by insurance, which means most long-COVID patients are on their own.
Dr. Durstenfeld said it’s important that patients keep trying and not give up. “With slow and steady progress, a lot of people can get profoundly better,” he said.
Mr. Fram, who’s worked with careful supervision, says he’s getting closer to something like his pre-COVID-19 life.
But he’s not there yet. Long COVID, he said, “affects my life every single day.”
A version of this article first appeared on WebMD.com.
The gut microbes have spoken: All fiber is good fiber
Finding a fiber of good moral fiber
If you’ve ever wandered into the supplement aisle at your local grocery store, you’ve probably noticed an overabundance of fiber supplements that claim to do this for you and benefit that. Since there’s no Food and Drug Administration regulation on fiber supplements, manufacturers are free to (and do) make whatever wild claims they like. And much like choosing which of 500 shows to watch on Netflix, when you’re spoiled for choice, it can be difficult to pick.
Enter a team of molecular geneticists and microbiologists from Duke University. They can’t tell you what show to watch next, but they can tell you which fiber to choose, thanks to their new study. And the answer? Yes.
Well that’s not very helpful, but let us explain. For their study, a group of 28 received three of the main fiber supplements (inulin, dextrin, and galactooligosaccharides) for a week each, followed by a week off of fibers for their gut to return to baseline until they’d received all three. Those who consumed the least fiber at baseline saw the greatest benefit from fiber supplementation, with no appreciable difference between the three types. It was the same story for study participants who already consumed enough fiber; because their guts already hosted a more-optimal microbiome, the type of supplement didn’t matter. The benefits were the same across the board.
In an additional study, the Duke researchers found that gut microbiomes reacted to new fiber within a day, being primed to consume fiber on the first dose and digesting it more quickly on the second fiber dose.
The results, the researchers pointed out, make sense, since the average American only consumes 20%-40% of their daily recommended supply of fiber. Our digestive systems aren’t picky; they just want more, so go out there and choose whatever fiber you’d like. Do that, and then feel free to eat as many double bacon cheeseburgers as you’d like. That is the pinnacle of diet right there. Dietitians literally could not complain about it.
Jarlsberg vs. Camembert: This time it’s skeletal
Fiber is fabulous, of course, but the road to dietary health and wellness fulfillment takes us to many other, equally wondrous places. Hey, look! This next exit is covered with cheese.
All the cheeses are here, from Abbaye de Belloc to Zwitser, and there, right between the jalapeno cheddar and the Jermi tortes you’ll find Jarlsberg, a mild, semisoft, nutty-flavored cheese that comes from Jarlsberg in eastern Norway. A recent study also suggests that Jarlsberg may help to prevent osteopenia and osteoporosis.
A group of Norwegian investigators gathered together 66 healthy women and gave them a daily portion of either Jarlsberg or Camembert for 6 weeks, at which point the Camembert group was switched to Jarlsberg for another 6 weeks.
The research team choose Camembert because of its similarity to Jarlsberg in fat and protein content. Jarlsberg, however, also is rich in vitamin K2, which is important for bone health, and a substance known as DHNA, which “might combat bone thinning and increase bone tissue formation,” they said in a Eurekalert release.
After the first 6 weeks, blood levels of osteocalcin; vitamin K2; and PINP, a peptide involved in bone turnover, were significantly higher in the Jarlsberg group only. All those measures rose significantly after the switch from Camembert to Jarlsberg, while levels of total and LDL cholesterol “fell significantly in the Camembert group after they switched to Jarlsberg,” the team added.
But wait! There’s more! HbA1c fell significantly among those initially eating the Jarlsberg but rose sharply in those eating Camembert. Do you see where this is going? After the Camembert group made the switch to Jarlsberg, their HbA1c levels fell significantly as well.
So it’s not just a cheese thing: The effects are specific to Jarlsberg. Can you guess what we’re having for lunch? Double bacon and fiber Jarlsbergers. Mmm, Jarlsburgers.
Luck be a lady: The mother of twins
It’s widely believed that women who have twins must be more fertile, giving birth to more than one child at a time. Some studies have supported the idea, but more recent work is refuting that claim. In actuality, it might just be more statistics and luck than fertility after all.
Those earlier studies supporting fertility didn’t specify whether the chances of twin births were based on the ability to produce more than one egg at a time or on the number of births that women had overall. Looking at 100,000 preindustrial European births, before contraception was available, researchers from Norway, Germany, France, and the United Kingdom found that the number of total births, twins included, makes all the difference.
“When a woman gives birth several times, the chances increase that at least one of these births will be a twin birth,” investigator Gine Roll Skjærvø of the Norwegian University of Science and Technology said in a written statement.
Since twins occur in 1%-3% of all births, the more births that a woman has, the better her chances of giving birth to twins. The researchers compared it to playing the lottery. You buy enough tickets, eventually your numbers are going to come up. Despite that, however, they found that women who give birth to twins give birth less often than those who don’t have twins. Which raises the idea of sheer luck.
The researchers said that there’s still a lot to uncover in twin births, noting that “uncritically comparing groups of women with and without twins can trick us into believing the opposite of what is really true. These groupings may either hide the effects of twinning and fertility genes where they exist, or vice versa, create the illusion of these if they do not exist.”
For now, this new research claims that it’s basically a lottery. And women who give birth to twins hit the jackpot.
Those with low wages may be earning future memory loss
Not only are low wages detrimental to our souls, hopes, and dreams, but a new study shows that low wages also are linked to quicker memory decline later in life. Sustained low wages not only cause stress and food insecurity in the lives of many, but they also can cause diseases such as depression, obesity, and high blood pressure, which are risk factors for cognitive aging.
The study was conducted using records from the Health and Retirement Study for the years 1992-2016 and focused on 2,879 adults born between 1936 and 1941. The participants were divided into three groups: those who never earned low wages, those who sometimes did, and those who always did.
The investigators found that workers who earned sustained low wages – defined as an hourly wage lower than two-thirds of the federal median wage for the corresponding year – “experienced significantly faster memory decline in older age” than did those who never earned low wages.
There are signs of inflation everywhere we look these days, but many people are not earning higher wages to compensate for the extra expenses. “Increasing the federal minimum wage, for example to $15 per hour, remains a gridlock issue in Congress,” lead author Katrina Kezios of the Columbia University Mailman School of Public Health, said in a statement released by the university.
If only salaries would rise instead of prices for once.
Finding a fiber of good moral fiber
If you’ve ever wandered into the supplement aisle at your local grocery store, you’ve probably noticed an overabundance of fiber supplements that claim to do this for you and benefit that. Since there’s no Food and Drug Administration regulation on fiber supplements, manufacturers are free to (and do) make whatever wild claims they like. And much like choosing which of 500 shows to watch on Netflix, when you’re spoiled for choice, it can be difficult to pick.
Enter a team of molecular geneticists and microbiologists from Duke University. They can’t tell you what show to watch next, but they can tell you which fiber to choose, thanks to their new study. And the answer? Yes.
Well that’s not very helpful, but let us explain. For their study, a group of 28 received three of the main fiber supplements (inulin, dextrin, and galactooligosaccharides) for a week each, followed by a week off of fibers for their gut to return to baseline until they’d received all three. Those who consumed the least fiber at baseline saw the greatest benefit from fiber supplementation, with no appreciable difference between the three types. It was the same story for study participants who already consumed enough fiber; because their guts already hosted a more-optimal microbiome, the type of supplement didn’t matter. The benefits were the same across the board.
In an additional study, the Duke researchers found that gut microbiomes reacted to new fiber within a day, being primed to consume fiber on the first dose and digesting it more quickly on the second fiber dose.
The results, the researchers pointed out, make sense, since the average American only consumes 20%-40% of their daily recommended supply of fiber. Our digestive systems aren’t picky; they just want more, so go out there and choose whatever fiber you’d like. Do that, and then feel free to eat as many double bacon cheeseburgers as you’d like. That is the pinnacle of diet right there. Dietitians literally could not complain about it.
Jarlsberg vs. Camembert: This time it’s skeletal
Fiber is fabulous, of course, but the road to dietary health and wellness fulfillment takes us to many other, equally wondrous places. Hey, look! This next exit is covered with cheese.
All the cheeses are here, from Abbaye de Belloc to Zwitser, and there, right between the jalapeno cheddar and the Jermi tortes you’ll find Jarlsberg, a mild, semisoft, nutty-flavored cheese that comes from Jarlsberg in eastern Norway. A recent study also suggests that Jarlsberg may help to prevent osteopenia and osteoporosis.
A group of Norwegian investigators gathered together 66 healthy women and gave them a daily portion of either Jarlsberg or Camembert for 6 weeks, at which point the Camembert group was switched to Jarlsberg for another 6 weeks.
The research team choose Camembert because of its similarity to Jarlsberg in fat and protein content. Jarlsberg, however, also is rich in vitamin K2, which is important for bone health, and a substance known as DHNA, which “might combat bone thinning and increase bone tissue formation,” they said in a Eurekalert release.
After the first 6 weeks, blood levels of osteocalcin; vitamin K2; and PINP, a peptide involved in bone turnover, were significantly higher in the Jarlsberg group only. All those measures rose significantly after the switch from Camembert to Jarlsberg, while levels of total and LDL cholesterol “fell significantly in the Camembert group after they switched to Jarlsberg,” the team added.
But wait! There’s more! HbA1c fell significantly among those initially eating the Jarlsberg but rose sharply in those eating Camembert. Do you see where this is going? After the Camembert group made the switch to Jarlsberg, their HbA1c levels fell significantly as well.
So it’s not just a cheese thing: The effects are specific to Jarlsberg. Can you guess what we’re having for lunch? Double bacon and fiber Jarlsbergers. Mmm, Jarlsburgers.
Luck be a lady: The mother of twins
It’s widely believed that women who have twins must be more fertile, giving birth to more than one child at a time. Some studies have supported the idea, but more recent work is refuting that claim. In actuality, it might just be more statistics and luck than fertility after all.
Those earlier studies supporting fertility didn’t specify whether the chances of twin births were based on the ability to produce more than one egg at a time or on the number of births that women had overall. Looking at 100,000 preindustrial European births, before contraception was available, researchers from Norway, Germany, France, and the United Kingdom found that the number of total births, twins included, makes all the difference.
“When a woman gives birth several times, the chances increase that at least one of these births will be a twin birth,” investigator Gine Roll Skjærvø of the Norwegian University of Science and Technology said in a written statement.
Since twins occur in 1%-3% of all births, the more births that a woman has, the better her chances of giving birth to twins. The researchers compared it to playing the lottery. You buy enough tickets, eventually your numbers are going to come up. Despite that, however, they found that women who give birth to twins give birth less often than those who don’t have twins. Which raises the idea of sheer luck.
The researchers said that there’s still a lot to uncover in twin births, noting that “uncritically comparing groups of women with and without twins can trick us into believing the opposite of what is really true. These groupings may either hide the effects of twinning and fertility genes where they exist, or vice versa, create the illusion of these if they do not exist.”
For now, this new research claims that it’s basically a lottery. And women who give birth to twins hit the jackpot.
Those with low wages may be earning future memory loss
Not only are low wages detrimental to our souls, hopes, and dreams, but a new study shows that low wages also are linked to quicker memory decline later in life. Sustained low wages not only cause stress and food insecurity in the lives of many, but they also can cause diseases such as depression, obesity, and high blood pressure, which are risk factors for cognitive aging.
The study was conducted using records from the Health and Retirement Study for the years 1992-2016 and focused on 2,879 adults born between 1936 and 1941. The participants were divided into three groups: those who never earned low wages, those who sometimes did, and those who always did.
The investigators found that workers who earned sustained low wages – defined as an hourly wage lower than two-thirds of the federal median wage for the corresponding year – “experienced significantly faster memory decline in older age” than did those who never earned low wages.
There are signs of inflation everywhere we look these days, but many people are not earning higher wages to compensate for the extra expenses. “Increasing the federal minimum wage, for example to $15 per hour, remains a gridlock issue in Congress,” lead author Katrina Kezios of the Columbia University Mailman School of Public Health, said in a statement released by the university.
If only salaries would rise instead of prices for once.
Finding a fiber of good moral fiber
If you’ve ever wandered into the supplement aisle at your local grocery store, you’ve probably noticed an overabundance of fiber supplements that claim to do this for you and benefit that. Since there’s no Food and Drug Administration regulation on fiber supplements, manufacturers are free to (and do) make whatever wild claims they like. And much like choosing which of 500 shows to watch on Netflix, when you’re spoiled for choice, it can be difficult to pick.
Enter a team of molecular geneticists and microbiologists from Duke University. They can’t tell you what show to watch next, but they can tell you which fiber to choose, thanks to their new study. And the answer? Yes.
Well that’s not very helpful, but let us explain. For their study, a group of 28 received three of the main fiber supplements (inulin, dextrin, and galactooligosaccharides) for a week each, followed by a week off of fibers for their gut to return to baseline until they’d received all three. Those who consumed the least fiber at baseline saw the greatest benefit from fiber supplementation, with no appreciable difference between the three types. It was the same story for study participants who already consumed enough fiber; because their guts already hosted a more-optimal microbiome, the type of supplement didn’t matter. The benefits were the same across the board.
In an additional study, the Duke researchers found that gut microbiomes reacted to new fiber within a day, being primed to consume fiber on the first dose and digesting it more quickly on the second fiber dose.
The results, the researchers pointed out, make sense, since the average American only consumes 20%-40% of their daily recommended supply of fiber. Our digestive systems aren’t picky; they just want more, so go out there and choose whatever fiber you’d like. Do that, and then feel free to eat as many double bacon cheeseburgers as you’d like. That is the pinnacle of diet right there. Dietitians literally could not complain about it.
Jarlsberg vs. Camembert: This time it’s skeletal
Fiber is fabulous, of course, but the road to dietary health and wellness fulfillment takes us to many other, equally wondrous places. Hey, look! This next exit is covered with cheese.
All the cheeses are here, from Abbaye de Belloc to Zwitser, and there, right between the jalapeno cheddar and the Jermi tortes you’ll find Jarlsberg, a mild, semisoft, nutty-flavored cheese that comes from Jarlsberg in eastern Norway. A recent study also suggests that Jarlsberg may help to prevent osteopenia and osteoporosis.
A group of Norwegian investigators gathered together 66 healthy women and gave them a daily portion of either Jarlsberg or Camembert for 6 weeks, at which point the Camembert group was switched to Jarlsberg for another 6 weeks.
The research team choose Camembert because of its similarity to Jarlsberg in fat and protein content. Jarlsberg, however, also is rich in vitamin K2, which is important for bone health, and a substance known as DHNA, which “might combat bone thinning and increase bone tissue formation,” they said in a Eurekalert release.
After the first 6 weeks, blood levels of osteocalcin; vitamin K2; and PINP, a peptide involved in bone turnover, were significantly higher in the Jarlsberg group only. All those measures rose significantly after the switch from Camembert to Jarlsberg, while levels of total and LDL cholesterol “fell significantly in the Camembert group after they switched to Jarlsberg,” the team added.
But wait! There’s more! HbA1c fell significantly among those initially eating the Jarlsberg but rose sharply in those eating Camembert. Do you see where this is going? After the Camembert group made the switch to Jarlsberg, their HbA1c levels fell significantly as well.
So it’s not just a cheese thing: The effects are specific to Jarlsberg. Can you guess what we’re having for lunch? Double bacon and fiber Jarlsbergers. Mmm, Jarlsburgers.
Luck be a lady: The mother of twins
It’s widely believed that women who have twins must be more fertile, giving birth to more than one child at a time. Some studies have supported the idea, but more recent work is refuting that claim. In actuality, it might just be more statistics and luck than fertility after all.
Those earlier studies supporting fertility didn’t specify whether the chances of twin births were based on the ability to produce more than one egg at a time or on the number of births that women had overall. Looking at 100,000 preindustrial European births, before contraception was available, researchers from Norway, Germany, France, and the United Kingdom found that the number of total births, twins included, makes all the difference.
“When a woman gives birth several times, the chances increase that at least one of these births will be a twin birth,” investigator Gine Roll Skjærvø of the Norwegian University of Science and Technology said in a written statement.
Since twins occur in 1%-3% of all births, the more births that a woman has, the better her chances of giving birth to twins. The researchers compared it to playing the lottery. You buy enough tickets, eventually your numbers are going to come up. Despite that, however, they found that women who give birth to twins give birth less often than those who don’t have twins. Which raises the idea of sheer luck.
The researchers said that there’s still a lot to uncover in twin births, noting that “uncritically comparing groups of women with and without twins can trick us into believing the opposite of what is really true. These groupings may either hide the effects of twinning and fertility genes where they exist, or vice versa, create the illusion of these if they do not exist.”
For now, this new research claims that it’s basically a lottery. And women who give birth to twins hit the jackpot.
Those with low wages may be earning future memory loss
Not only are low wages detrimental to our souls, hopes, and dreams, but a new study shows that low wages also are linked to quicker memory decline later in life. Sustained low wages not only cause stress and food insecurity in the lives of many, but they also can cause diseases such as depression, obesity, and high blood pressure, which are risk factors for cognitive aging.
The study was conducted using records from the Health and Retirement Study for the years 1992-2016 and focused on 2,879 adults born between 1936 and 1941. The participants were divided into three groups: those who never earned low wages, those who sometimes did, and those who always did.
The investigators found that workers who earned sustained low wages – defined as an hourly wage lower than two-thirds of the federal median wage for the corresponding year – “experienced significantly faster memory decline in older age” than did those who never earned low wages.
There are signs of inflation everywhere we look these days, but many people are not earning higher wages to compensate for the extra expenses. “Increasing the federal minimum wage, for example to $15 per hour, remains a gridlock issue in Congress,” lead author Katrina Kezios of the Columbia University Mailman School of Public Health, said in a statement released by the university.
If only salaries would rise instead of prices for once.
Researcher revisits ‘03 guidance on monkeypox in pregnant women
In creating a guide about monkeypox for ob.gyns., Denise J. Jamieson, MD, MPH, turned to research she relied on during another outbreak of the disease nearly 20 years ago.
Dr. Jamieson, the James Robert McCord Professor and chair of the department of gynecology and obstetrics at Emory Healthcare, Atlanta, had been working for the Centers for Disease Control and Prevention in 2003 when doctors diagnosed monkeypox in several states.
That year, the virus was mainly transmitted by contact with pet prairie dogs, including in childcare and school settings. Of the approximately 70 suspected and confirmed cases, 55% occurred in female patients, according to one study .
Dr. Jamieson, an obstetrician with a focus on emerging infectious diseases, and colleagues at the agency published a commentary in Obstetrics & Gynecology highlighting the need for physicians to stay up to date with relevant information about the virus.
Fast forward to 2022: Dr. Jamieson – again with coauthors from the CDC – is delivering a similar message in the same journal about the need for clinicians to be prepared for this virus.
“Most ob.gyns. have never seen a case of monkeypox virus infection and may not be aware of testing, treatment, or pre-exposure or postexposure vaccine options,” she and her coauthors wrote in a primer published online.
But if a woman were to contract the virus, her ob.gyn. might well be the first clinician she called. “We are often the first people, the first physicians to see and evaluate women with various symptoms,” Dr. Jamieson said.
To promptly diagnose, treat, and prevent further spread of monkeypox, ob.gyns. need up-to-date information, Dr. Jamieson and colleagues said.
Based on data from related viruses like smallpox, monkeypox may be more severe in pregnant women and entail risk for adverse pregnancy outcomes, Dr. Jamieson said.
Outliers
So far this year, monkeypox has predominantly spread among men who have sex with men. Cases have occurred in women, however, some of whom have required hospitalization.
According to the CDC, as of July 25, 1,373 cases of monkeypox in the United States were in men and 13 in women. The total confirmed case count exceeded 5,800 as of Aug. 1. The agency recently announced that it planned to make the disease a reportable condition.
In the United Kingdom, which has been hit hard by the outbreak, researchers are keeping a close eye on the number of cases in women to assess how the disease is spreading.
At least one case of monkeypox in the United States has occurred in a pregnant woman who delivered. The mother and baby, who received immune globulin as a preventive measure, are doing well, according to health officials.
“We know that infection can occur through placental transfer. In the case that we are aware of presently, it does not appear that the virus was transmitted,” said John T. Brooks, MD, the CDC’s chief medical officer in the division of HIV prevention, on a July 23 call with clinicians.
While monkeypox can be transmitted in utero and during sexual activity, it also can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC.
A preferred vaccine and antiviral in pregnancy
One monkeypox vaccine, Jynneos, is preferred for use during pregnancy, while another, ACAM2000, is contraindicated, the CDC advises.
Jynneos can be offered to people who are pregnant or breastfeeding who are eligible for vaccination based on confirmed or likely contact with cases, ideally within 4 days of exposure. People at high risk for exposure, such as laboratory workers, may receive the vaccine in advance.
Developmental toxicity studies in animals showed no evidence of harm with the Jynneos vaccine, Dr. Jamieson said.
ACAM2000, however, can cause fetal vaccinia and should not be used in people who are pregnant or breastfeeding, according to the CDC.
The Society for Maternal-Fetal Medicine notes that, if treatment for monkeypox is warranted, tecovirimat should be considered the first-line antiviral for pregnant, recently pregnant, and breastfeeding people, in line with CDC guidance.
Current outbreak ‘very different,’ but lessons apply
In 2003, some women exposed to monkeypox through contact with infected prairie dogs were pregnant – which is how Dr. Jamieson came to be involved in responding to the outbreak and studying the effects of the virus in pregnancy.
“When this resurfaced this year, of course it caught my attention,” Dr. Jamieson said. The extensive person-to-person transmission and far greater number of cases today make the current outbreak “very different” from the prior one, she said.
But key principles in managing the disease and understanding its potential risks in pregnancy – despite relatively limited information – remain the same.
“Whenever you are looking at an infectious disease, you want to think about, are pregnant persons more susceptible or more likely to have severe disease,” Dr. Jamieson said. Smallpox, a similar orthopoxvirus, “is more severe during pregnancy with a higher case fatality rate,” which is one reason for concern with monkeypox in this population.
In terms of pregnancy outcomes, researchers have data from only a handful of confirmed cases of monkeypox, which makes it difficult to draw conclusions, Dr. Jamieson said. A review of five cases from outside the United States in prior years found that three resulted in loss of the pregnancy. One resulted in preterm delivery of an infant who subsequently died. One child was apparently healthy and born at term.
Addition to the differential diagnosis
A separate team of researchers has proposed a clinical management algorithm for pregnant women with suspected exposure to monkeypox.
“Clinicians must maintain a high index of suspicion for monkeypox virus in any pregnant woman presenting with lymphadenopathy and vesiculopustular rash – including rash localized to the genital or perianal region – even if there are no apparent epidemiological links,” Pradip Dashraath, MBBS, National University Hospital, Singapore, and coauthors wrote in The Lancet.
Jamieson echoed the call for increased vigilance.
“As ob.gyns., people may present to us with genital lesions concerning for sexually transmitted infection. And it is important to include monkeypox in our differential,” Dr. Jamieson said. “We are trying to get the word out that it needs to be part of what you think about when you see a patient with genital ulcers.”
Health care professionals have acquired monkeypox through contact with patients or fomites, so clinicians should be sure to use appropriate precautions when evaluating patients who might have monkeypox, Dr. Jamieson added. Appropriate protective measures include wearing a gown, gloves, eye protection, and an N95.
A version of this article first appeared on Medscape.com.
In creating a guide about monkeypox for ob.gyns., Denise J. Jamieson, MD, MPH, turned to research she relied on during another outbreak of the disease nearly 20 years ago.
Dr. Jamieson, the James Robert McCord Professor and chair of the department of gynecology and obstetrics at Emory Healthcare, Atlanta, had been working for the Centers for Disease Control and Prevention in 2003 when doctors diagnosed monkeypox in several states.
That year, the virus was mainly transmitted by contact with pet prairie dogs, including in childcare and school settings. Of the approximately 70 suspected and confirmed cases, 55% occurred in female patients, according to one study .
Dr. Jamieson, an obstetrician with a focus on emerging infectious diseases, and colleagues at the agency published a commentary in Obstetrics & Gynecology highlighting the need for physicians to stay up to date with relevant information about the virus.
Fast forward to 2022: Dr. Jamieson – again with coauthors from the CDC – is delivering a similar message in the same journal about the need for clinicians to be prepared for this virus.
“Most ob.gyns. have never seen a case of monkeypox virus infection and may not be aware of testing, treatment, or pre-exposure or postexposure vaccine options,” she and her coauthors wrote in a primer published online.
But if a woman were to contract the virus, her ob.gyn. might well be the first clinician she called. “We are often the first people, the first physicians to see and evaluate women with various symptoms,” Dr. Jamieson said.
To promptly diagnose, treat, and prevent further spread of monkeypox, ob.gyns. need up-to-date information, Dr. Jamieson and colleagues said.
Based on data from related viruses like smallpox, monkeypox may be more severe in pregnant women and entail risk for adverse pregnancy outcomes, Dr. Jamieson said.
Outliers
So far this year, monkeypox has predominantly spread among men who have sex with men. Cases have occurred in women, however, some of whom have required hospitalization.
According to the CDC, as of July 25, 1,373 cases of monkeypox in the United States were in men and 13 in women. The total confirmed case count exceeded 5,800 as of Aug. 1. The agency recently announced that it planned to make the disease a reportable condition.
In the United Kingdom, which has been hit hard by the outbreak, researchers are keeping a close eye on the number of cases in women to assess how the disease is spreading.
At least one case of monkeypox in the United States has occurred in a pregnant woman who delivered. The mother and baby, who received immune globulin as a preventive measure, are doing well, according to health officials.
“We know that infection can occur through placental transfer. In the case that we are aware of presently, it does not appear that the virus was transmitted,” said John T. Brooks, MD, the CDC’s chief medical officer in the division of HIV prevention, on a July 23 call with clinicians.
While monkeypox can be transmitted in utero and during sexual activity, it also can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC.
A preferred vaccine and antiviral in pregnancy
One monkeypox vaccine, Jynneos, is preferred for use during pregnancy, while another, ACAM2000, is contraindicated, the CDC advises.
Jynneos can be offered to people who are pregnant or breastfeeding who are eligible for vaccination based on confirmed or likely contact with cases, ideally within 4 days of exposure. People at high risk for exposure, such as laboratory workers, may receive the vaccine in advance.
Developmental toxicity studies in animals showed no evidence of harm with the Jynneos vaccine, Dr. Jamieson said.
ACAM2000, however, can cause fetal vaccinia and should not be used in people who are pregnant or breastfeeding, according to the CDC.
The Society for Maternal-Fetal Medicine notes that, if treatment for monkeypox is warranted, tecovirimat should be considered the first-line antiviral for pregnant, recently pregnant, and breastfeeding people, in line with CDC guidance.
Current outbreak ‘very different,’ but lessons apply
In 2003, some women exposed to monkeypox through contact with infected prairie dogs were pregnant – which is how Dr. Jamieson came to be involved in responding to the outbreak and studying the effects of the virus in pregnancy.
“When this resurfaced this year, of course it caught my attention,” Dr. Jamieson said. The extensive person-to-person transmission and far greater number of cases today make the current outbreak “very different” from the prior one, she said.
But key principles in managing the disease and understanding its potential risks in pregnancy – despite relatively limited information – remain the same.
“Whenever you are looking at an infectious disease, you want to think about, are pregnant persons more susceptible or more likely to have severe disease,” Dr. Jamieson said. Smallpox, a similar orthopoxvirus, “is more severe during pregnancy with a higher case fatality rate,” which is one reason for concern with monkeypox in this population.
In terms of pregnancy outcomes, researchers have data from only a handful of confirmed cases of monkeypox, which makes it difficult to draw conclusions, Dr. Jamieson said. A review of five cases from outside the United States in prior years found that three resulted in loss of the pregnancy. One resulted in preterm delivery of an infant who subsequently died. One child was apparently healthy and born at term.
Addition to the differential diagnosis
A separate team of researchers has proposed a clinical management algorithm for pregnant women with suspected exposure to monkeypox.
“Clinicians must maintain a high index of suspicion for monkeypox virus in any pregnant woman presenting with lymphadenopathy and vesiculopustular rash – including rash localized to the genital or perianal region – even if there are no apparent epidemiological links,” Pradip Dashraath, MBBS, National University Hospital, Singapore, and coauthors wrote in The Lancet.
Jamieson echoed the call for increased vigilance.
“As ob.gyns., people may present to us with genital lesions concerning for sexually transmitted infection. And it is important to include monkeypox in our differential,” Dr. Jamieson said. “We are trying to get the word out that it needs to be part of what you think about when you see a patient with genital ulcers.”
Health care professionals have acquired monkeypox through contact with patients or fomites, so clinicians should be sure to use appropriate precautions when evaluating patients who might have monkeypox, Dr. Jamieson added. Appropriate protective measures include wearing a gown, gloves, eye protection, and an N95.
A version of this article first appeared on Medscape.com.
In creating a guide about monkeypox for ob.gyns., Denise J. Jamieson, MD, MPH, turned to research she relied on during another outbreak of the disease nearly 20 years ago.
Dr. Jamieson, the James Robert McCord Professor and chair of the department of gynecology and obstetrics at Emory Healthcare, Atlanta, had been working for the Centers for Disease Control and Prevention in 2003 when doctors diagnosed monkeypox in several states.
That year, the virus was mainly transmitted by contact with pet prairie dogs, including in childcare and school settings. Of the approximately 70 suspected and confirmed cases, 55% occurred in female patients, according to one study .
Dr. Jamieson, an obstetrician with a focus on emerging infectious diseases, and colleagues at the agency published a commentary in Obstetrics & Gynecology highlighting the need for physicians to stay up to date with relevant information about the virus.
Fast forward to 2022: Dr. Jamieson – again with coauthors from the CDC – is delivering a similar message in the same journal about the need for clinicians to be prepared for this virus.
“Most ob.gyns. have never seen a case of monkeypox virus infection and may not be aware of testing, treatment, or pre-exposure or postexposure vaccine options,” she and her coauthors wrote in a primer published online.
But if a woman were to contract the virus, her ob.gyn. might well be the first clinician she called. “We are often the first people, the first physicians to see and evaluate women with various symptoms,” Dr. Jamieson said.
To promptly diagnose, treat, and prevent further spread of monkeypox, ob.gyns. need up-to-date information, Dr. Jamieson and colleagues said.
Based on data from related viruses like smallpox, monkeypox may be more severe in pregnant women and entail risk for adverse pregnancy outcomes, Dr. Jamieson said.
Outliers
So far this year, monkeypox has predominantly spread among men who have sex with men. Cases have occurred in women, however, some of whom have required hospitalization.
According to the CDC, as of July 25, 1,373 cases of monkeypox in the United States were in men and 13 in women. The total confirmed case count exceeded 5,800 as of Aug. 1. The agency recently announced that it planned to make the disease a reportable condition.
In the United Kingdom, which has been hit hard by the outbreak, researchers are keeping a close eye on the number of cases in women to assess how the disease is spreading.
At least one case of monkeypox in the United States has occurred in a pregnant woman who delivered. The mother and baby, who received immune globulin as a preventive measure, are doing well, according to health officials.
“We know that infection can occur through placental transfer. In the case that we are aware of presently, it does not appear that the virus was transmitted,” said John T. Brooks, MD, the CDC’s chief medical officer in the division of HIV prevention, on a July 23 call with clinicians.
While monkeypox can be transmitted in utero and during sexual activity, it also can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC.
A preferred vaccine and antiviral in pregnancy
One monkeypox vaccine, Jynneos, is preferred for use during pregnancy, while another, ACAM2000, is contraindicated, the CDC advises.
Jynneos can be offered to people who are pregnant or breastfeeding who are eligible for vaccination based on confirmed or likely contact with cases, ideally within 4 days of exposure. People at high risk for exposure, such as laboratory workers, may receive the vaccine in advance.
Developmental toxicity studies in animals showed no evidence of harm with the Jynneos vaccine, Dr. Jamieson said.
ACAM2000, however, can cause fetal vaccinia and should not be used in people who are pregnant or breastfeeding, according to the CDC.
The Society for Maternal-Fetal Medicine notes that, if treatment for monkeypox is warranted, tecovirimat should be considered the first-line antiviral for pregnant, recently pregnant, and breastfeeding people, in line with CDC guidance.
Current outbreak ‘very different,’ but lessons apply
In 2003, some women exposed to monkeypox through contact with infected prairie dogs were pregnant – which is how Dr. Jamieson came to be involved in responding to the outbreak and studying the effects of the virus in pregnancy.
“When this resurfaced this year, of course it caught my attention,” Dr. Jamieson said. The extensive person-to-person transmission and far greater number of cases today make the current outbreak “very different” from the prior one, she said.
But key principles in managing the disease and understanding its potential risks in pregnancy – despite relatively limited information – remain the same.
“Whenever you are looking at an infectious disease, you want to think about, are pregnant persons more susceptible or more likely to have severe disease,” Dr. Jamieson said. Smallpox, a similar orthopoxvirus, “is more severe during pregnancy with a higher case fatality rate,” which is one reason for concern with monkeypox in this population.
In terms of pregnancy outcomes, researchers have data from only a handful of confirmed cases of monkeypox, which makes it difficult to draw conclusions, Dr. Jamieson said. A review of five cases from outside the United States in prior years found that three resulted in loss of the pregnancy. One resulted in preterm delivery of an infant who subsequently died. One child was apparently healthy and born at term.
Addition to the differential diagnosis
A separate team of researchers has proposed a clinical management algorithm for pregnant women with suspected exposure to monkeypox.
“Clinicians must maintain a high index of suspicion for monkeypox virus in any pregnant woman presenting with lymphadenopathy and vesiculopustular rash – including rash localized to the genital or perianal region – even if there are no apparent epidemiological links,” Pradip Dashraath, MBBS, National University Hospital, Singapore, and coauthors wrote in The Lancet.
Jamieson echoed the call for increased vigilance.
“As ob.gyns., people may present to us with genital lesions concerning for sexually transmitted infection. And it is important to include monkeypox in our differential,” Dr. Jamieson said. “We are trying to get the word out that it needs to be part of what you think about when you see a patient with genital ulcers.”
Health care professionals have acquired monkeypox through contact with patients or fomites, so clinicians should be sure to use appropriate precautions when evaluating patients who might have monkeypox, Dr. Jamieson added. Appropriate protective measures include wearing a gown, gloves, eye protection, and an N95.
A version of this article first appeared on Medscape.com.
FROM OBSTETRICS AND GYNECOLOGY
Comments open for U.K.’s transgender care guideline
Gynecologic and obstetric health care needs of transgender and gender-diverse adults, including fertility preservation, ending masculinizing hormones in pregnancy, and support for “chest-feeding” are proposed in a novel draft guideline issued by the U.K.’s Royal College of Obstetricians and Gynaecologists.
The draft Green-top Guideline on Care of Trans and Gender Diverse Adults in Obstetrics and Gynaecology is open for consultation and comment until Sept. 6. It aims to address the specific needs of transgender and gender-diverse individuals that, according to the guideline, are currently not consistently included in specialist training programs or in continuing professional development.
With a rise in the number of people seeking to transition, obstetricians and gynecologists are seeing more transgender and gender-diverse patients. Phil Rolland, MD, consultant gynecological oncologist from Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, and member of the guideline committee, said that, “It is highly likely that if an obstetrician or gynaecologist hasn’t already consulted or treated a trans or gender-diverse patient then it is only a matter of time before they do.”
He stressed the importance of ensuring inclusivity in obstetric and gynecologic care. “We know that trans people are more likely to have poor experiences when accessing health care, and we can do better.”
The U.K.-based guideline follows a similar document from the American College of Obstetricians and Gynecologists, put in place in March 2021, as reported by this news organization. It called for greater “awareness, knowledge, and sensitivity” in caring for these patients and noted that “bias from health care professionals leads to inadequate access to, underuse of, and inequities within the health care system for transgender patients.”
Guideline addresses fertility preservation, obstetric care, and more
Regarding fertility preservation, discussions around protecting future options should be held before endocrine interventions and/or gender-affirming genital or pelvic surgery procedures, says the guideline. In addition, gynecologic problems that can be experienced need to be explained.
The guideline also addresses obstetric care, advising that trans men on long-acting masculinizing hormone therapy should stop therapy 3 months prior to conception. People who conceive while taking masculinizing hormone therapy should discontinue the therapy as soon as possible.
Birth mode should be discussed with all trans men who plan to conceive, ideally at a prepregnancy counseling appointment, but at minimum, before the third trimester. Choice of feeding manner should also be addressed in the antenatal period, with trans men who wish to chest feed offered chest-feeding support, similar to that given to cis women.
The RCOG guideline comes in the wake of the U.K. government’s new Women’s Health Strategy for England, released in July, which notes that trans men (with female reproductive organs) should be able to access screening services for cervical and breast cancer, a position upheld by the RCOG guideline.
Other key recommendations include that obstetricians and gynecologists, when approached by transgender and gender-diverse people to help with identity-related issues, should liaise with gender-identity specialist services to provide appropriate care.
Removing bias, providing affirming care
Asha Kasliwal, MD, consultant in Community Gynaecology and Reproductive Health Care, Manchester, England, and president of the Faculty of Sexual and Reproductive Healthcare, also reflected on how transgender and gender-diverse people often feel uncomfortable accessing care, which could lead to, “many people failing to seek or continue health care because of concerns over how they will be treated,” adding that there were associated reports of poor clinical outcomes.
She highlighted that the draft guideline pointed out the importance of language during consultation with transgender and gender-diverse people, noting that “misuse of language, and particularly deliberate misuse of language associated with the sex assigned at birth (misgendering), may cause profound offence.”
Dr. Kasliwal cited the example of “using the correct pronouns when addressing someone and receiving any information about a person’s gender diversity neutrally and nonjudgementally.”
Edward Morris, MD, president of the Royal College of Obstetricians and Gynaecologists, acknowledged that trans and gender-diverse individuals say they often feel judged and misunderstood by the health service. “This can act as a barrier for them when it comes to accessing vital care, and we as health care professionals have a role to play in making them feel listened to and recognized.”
“This draft guideline is our first attempt to ensure we are providing personalised care for all our patients,” said Dr. Morris. “We welcome feedback on this draft to ensure the guideline is the best as it can be for clinicians and the trans and gender-diverse individuals who use our services.”
The draft guideline as peer-review draft, Care of Trans and Gender Diverse Adults in Obstetrics and Gynaecology is available on the RCOG website. Consultation is open until Sept. 6, 2022.
A version of this article first appeared on Medscape.com.
Gynecologic and obstetric health care needs of transgender and gender-diverse adults, including fertility preservation, ending masculinizing hormones in pregnancy, and support for “chest-feeding” are proposed in a novel draft guideline issued by the U.K.’s Royal College of Obstetricians and Gynaecologists.
The draft Green-top Guideline on Care of Trans and Gender Diverse Adults in Obstetrics and Gynaecology is open for consultation and comment until Sept. 6. It aims to address the specific needs of transgender and gender-diverse individuals that, according to the guideline, are currently not consistently included in specialist training programs or in continuing professional development.
With a rise in the number of people seeking to transition, obstetricians and gynecologists are seeing more transgender and gender-diverse patients. Phil Rolland, MD, consultant gynecological oncologist from Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, and member of the guideline committee, said that, “It is highly likely that if an obstetrician or gynaecologist hasn’t already consulted or treated a trans or gender-diverse patient then it is only a matter of time before they do.”
He stressed the importance of ensuring inclusivity in obstetric and gynecologic care. “We know that trans people are more likely to have poor experiences when accessing health care, and we can do better.”
The U.K.-based guideline follows a similar document from the American College of Obstetricians and Gynecologists, put in place in March 2021, as reported by this news organization. It called for greater “awareness, knowledge, and sensitivity” in caring for these patients and noted that “bias from health care professionals leads to inadequate access to, underuse of, and inequities within the health care system for transgender patients.”
Guideline addresses fertility preservation, obstetric care, and more
Regarding fertility preservation, discussions around protecting future options should be held before endocrine interventions and/or gender-affirming genital or pelvic surgery procedures, says the guideline. In addition, gynecologic problems that can be experienced need to be explained.
The guideline also addresses obstetric care, advising that trans men on long-acting masculinizing hormone therapy should stop therapy 3 months prior to conception. People who conceive while taking masculinizing hormone therapy should discontinue the therapy as soon as possible.
Birth mode should be discussed with all trans men who plan to conceive, ideally at a prepregnancy counseling appointment, but at minimum, before the third trimester. Choice of feeding manner should also be addressed in the antenatal period, with trans men who wish to chest feed offered chest-feeding support, similar to that given to cis women.
The RCOG guideline comes in the wake of the U.K. government’s new Women’s Health Strategy for England, released in July, which notes that trans men (with female reproductive organs) should be able to access screening services for cervical and breast cancer, a position upheld by the RCOG guideline.
Other key recommendations include that obstetricians and gynecologists, when approached by transgender and gender-diverse people to help with identity-related issues, should liaise with gender-identity specialist services to provide appropriate care.
Removing bias, providing affirming care
Asha Kasliwal, MD, consultant in Community Gynaecology and Reproductive Health Care, Manchester, England, and president of the Faculty of Sexual and Reproductive Healthcare, also reflected on how transgender and gender-diverse people often feel uncomfortable accessing care, which could lead to, “many people failing to seek or continue health care because of concerns over how they will be treated,” adding that there were associated reports of poor clinical outcomes.
She highlighted that the draft guideline pointed out the importance of language during consultation with transgender and gender-diverse people, noting that “misuse of language, and particularly deliberate misuse of language associated with the sex assigned at birth (misgendering), may cause profound offence.”
Dr. Kasliwal cited the example of “using the correct pronouns when addressing someone and receiving any information about a person’s gender diversity neutrally and nonjudgementally.”
Edward Morris, MD, president of the Royal College of Obstetricians and Gynaecologists, acknowledged that trans and gender-diverse individuals say they often feel judged and misunderstood by the health service. “This can act as a barrier for them when it comes to accessing vital care, and we as health care professionals have a role to play in making them feel listened to and recognized.”
“This draft guideline is our first attempt to ensure we are providing personalised care for all our patients,” said Dr. Morris. “We welcome feedback on this draft to ensure the guideline is the best as it can be for clinicians and the trans and gender-diverse individuals who use our services.”
The draft guideline as peer-review draft, Care of Trans and Gender Diverse Adults in Obstetrics and Gynaecology is available on the RCOG website. Consultation is open until Sept. 6, 2022.
A version of this article first appeared on Medscape.com.
Gynecologic and obstetric health care needs of transgender and gender-diverse adults, including fertility preservation, ending masculinizing hormones in pregnancy, and support for “chest-feeding” are proposed in a novel draft guideline issued by the U.K.’s Royal College of Obstetricians and Gynaecologists.
The draft Green-top Guideline on Care of Trans and Gender Diverse Adults in Obstetrics and Gynaecology is open for consultation and comment until Sept. 6. It aims to address the specific needs of transgender and gender-diverse individuals that, according to the guideline, are currently not consistently included in specialist training programs or in continuing professional development.
With a rise in the number of people seeking to transition, obstetricians and gynecologists are seeing more transgender and gender-diverse patients. Phil Rolland, MD, consultant gynecological oncologist from Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, and member of the guideline committee, said that, “It is highly likely that if an obstetrician or gynaecologist hasn’t already consulted or treated a trans or gender-diverse patient then it is only a matter of time before they do.”
He stressed the importance of ensuring inclusivity in obstetric and gynecologic care. “We know that trans people are more likely to have poor experiences when accessing health care, and we can do better.”
The U.K.-based guideline follows a similar document from the American College of Obstetricians and Gynecologists, put in place in March 2021, as reported by this news organization. It called for greater “awareness, knowledge, and sensitivity” in caring for these patients and noted that “bias from health care professionals leads to inadequate access to, underuse of, and inequities within the health care system for transgender patients.”
Guideline addresses fertility preservation, obstetric care, and more
Regarding fertility preservation, discussions around protecting future options should be held before endocrine interventions and/or gender-affirming genital or pelvic surgery procedures, says the guideline. In addition, gynecologic problems that can be experienced need to be explained.
The guideline also addresses obstetric care, advising that trans men on long-acting masculinizing hormone therapy should stop therapy 3 months prior to conception. People who conceive while taking masculinizing hormone therapy should discontinue the therapy as soon as possible.
Birth mode should be discussed with all trans men who plan to conceive, ideally at a prepregnancy counseling appointment, but at minimum, before the third trimester. Choice of feeding manner should also be addressed in the antenatal period, with trans men who wish to chest feed offered chest-feeding support, similar to that given to cis women.
The RCOG guideline comes in the wake of the U.K. government’s new Women’s Health Strategy for England, released in July, which notes that trans men (with female reproductive organs) should be able to access screening services for cervical and breast cancer, a position upheld by the RCOG guideline.
Other key recommendations include that obstetricians and gynecologists, when approached by transgender and gender-diverse people to help with identity-related issues, should liaise with gender-identity specialist services to provide appropriate care.
Removing bias, providing affirming care
Asha Kasliwal, MD, consultant in Community Gynaecology and Reproductive Health Care, Manchester, England, and president of the Faculty of Sexual and Reproductive Healthcare, also reflected on how transgender and gender-diverse people often feel uncomfortable accessing care, which could lead to, “many people failing to seek or continue health care because of concerns over how they will be treated,” adding that there were associated reports of poor clinical outcomes.
She highlighted that the draft guideline pointed out the importance of language during consultation with transgender and gender-diverse people, noting that “misuse of language, and particularly deliberate misuse of language associated with the sex assigned at birth (misgendering), may cause profound offence.”
Dr. Kasliwal cited the example of “using the correct pronouns when addressing someone and receiving any information about a person’s gender diversity neutrally and nonjudgementally.”
Edward Morris, MD, president of the Royal College of Obstetricians and Gynaecologists, acknowledged that trans and gender-diverse individuals say they often feel judged and misunderstood by the health service. “This can act as a barrier for them when it comes to accessing vital care, and we as health care professionals have a role to play in making them feel listened to and recognized.”
“This draft guideline is our first attempt to ensure we are providing personalised care for all our patients,” said Dr. Morris. “We welcome feedback on this draft to ensure the guideline is the best as it can be for clinicians and the trans and gender-diverse individuals who use our services.”
The draft guideline as peer-review draft, Care of Trans and Gender Diverse Adults in Obstetrics and Gynaecology is available on the RCOG website. Consultation is open until Sept. 6, 2022.
A version of this article first appeared on Medscape.com.
Summer flu, RSV in July, ‘super colds?’
Richard Martinello, MD, a professor of medicine and pediatric infectious diseases at Yale University, New haven, Conn., doesn’t expect to see a child hospitalized with respiratory syncytial virus (RSV) in the middle of summer. The illness, which can strike infants and older adults especially hard, is known as a “winter virus.”
But not this year. Over the last several weeks, he says, admissions for children with RSV have increased at the Yale New Haven Children’s Hospital. While the numbers aren’t large, they are out of the ordinary, he says, “because usually, at this time of year, we see zero. For lack of a better term, it’s weird.”
Likewise, William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville, says RSV is on the rise there. Tennessee is one of 10 states taking part in a Centers for Disease Control and Prevention surveillance system that tracks influenza, RSV, and COVID-19.
He says RSV cases have risen by at least a third during the past week, including all age ranges. At this time of year, he says, “We aren’t supposed to have any RSV.”
RSV isn’t the only virus thriving out of season or otherwise acting strangely. Since the pandemic began, flu seasons have been out of whack – sometimes nearly nonexistent and other times extending well beyond “normal” seasons. Some experts say one influenza “B” strain may now be extinct, while others say it will be back.
Severe colds – what some call “super colds” – also seem to be on the rise in recent warm-weather months, although that evidence is mostly based on personal experience, not science.
Trying to explain these out-of-season variations has sparked much discussion among epidemiologists and virologists, Dr. Schaffner says, with debates ongoing about whether human behavior and habits or the seasons play a bigger role in the transmission of viral illness.
On top of that, scientists are also looking at the interactions between the SARS-CoV-2 virus that causes COVID-19 and other viruses. When people get hit with COVID-19 and other viruses at the same time, does that make COVID-19 more severe, or less?
Research is conflicting.
Summer of 2022: A repeat of 2021?
RSV. Most children contract the virus by age 2, and while it’s generally mild, about 58,000 children under age 5 years are hospitalized each year. During the pandemic, RSV cases decreased from January to April 2020, the CDC reported, and then remained at “historically low levels”: less than 1% positive RSV results a week, for the next year.
But cases began rising in April 2021.
“Last year, we did have an unusual summer,” Dr. Schaffner says. After lockdown ended, to everyone’s surprise, RSV infections rose.
That increase triggered a CDC health advisory in June 2021, telling doctors and caregivers about the increase in “interseasonal” RSV cases across parts of the Southern United States, recommending broader testing for RSV in patients who had a respiratory illness but tested negative for COVID.
Because of the reduced circulation of RSV during the winter of 2020 to 2021, the CDC warned, older infants and toddlers might have a higher risk of RSV since they weren’t exposed to typical levels of RSV for the previous 15 months.
What about 2022? “At the moment,” Dr. Schaffner says, “it looks like we are having a repeat [of 2021].”
On Twitter, other pediatricians, including those from Maine and Texas, have reported an increase in RSV cases this summer.
Influenza. From October 2020 until May 2021, flu activity was lower than during any previous flu season since at least 1997, according to the CDC.
In late 2021, researchers suggested that one line of influenza known as B/Yamagata may have become extinct.
The 2021-2022 flu season has been mild, the CDC says, but it has come in two waves, with the second wave lingering longer than previous ones. While flu activity is decreasing, last week the CDC said doctors should be alert to flu infections throughout the summer.
Colds. In reports on colds that aren’t based on science, several doctors say they are seeing more colds than usual in the summer, and they’re more severe than usual. According to the CDC, common coronaviruses and respiratory adenoviruses have been increasing since early 2021, and rhinoviruses since June 2020.
Behavior vs. seasons
In explaining the spread of viral respiratory diseases, infectious disease doctors consider two things. “One is that temperature and humidity in the winter favors longer survival of some viruses, leading to longer periods of possible transmission,” says Dean Blumberg, MD, a professor of pediatrics and chief of pediatric infectious disease at University of California Davis Health.
“The other is differences in human behavior, with people spending more time outside in the summer, which results in more distancing and [less] virus concentration due to very large air volume,” he says, and vice versa in winter.
What about the “super colds?” COVID-19 lockdowns and social distancing greatly reduced people’s exposure to common viruses like those that cause colds, says Neil A. Mabbott, PhD, a professor of immunopathology at the University of Edinburgh (Scotland).
“Immunity to these common cold viruses gained through natural infection is considered to last around 8 or 9 months or so,” he says. “Each winter, when we are exposed to the new circulating variants of these viruses, our immunity receives a natural boost.”
That explains why most people get a cold that’s relatively mild. But with all the pandemic lockdowns and the use of hand sanitizers, most people had limited exposure to other viruses, including the common cold. When people emerged from lockdown, the common cold viruses were beginning to circulate again.
“Our immune systems were less able to clear the infection than previously,” Dr. Mabbott says. “As a consequence, some may have experienced increased symptoms, giving the impression of being infected with a ‘super cold.’ ”
“The colds themselves are probably not different to those we got prepandemic,” says Ian Mackay, PhD, a virologist at the University of Queensland, Brisbane, Australia. “But there might be more of them. So I doubt they are ‘super colds’ as much as they are ‘super-perfect circumstances.’ ”
The colds themselves are probably not different to those we got prepandemic. But there might be more of them.
Those super-perfect circumstances, he says, include people gathering after lockdown; a lack of immunity in new babies; viruses that have remained, even if at low levels, but continue to mutate; and our waning immunity to the range of viruses we’d normally encounter.
While lack of exposure may partly explain why some viruses become rampant out of season, it’s likely not the only reason. For example, the reduced circulation of RSV in the population as a whole also may have reduced the transfer of immunity from mothers to infants, some researchers say, making those infants more vulnerable than usual.
Interactions of viruses
Another thing that may be driving the different behavior of viruses is that the SARS-CoV-2 virus could somehow be interacting with other respiratory viruses, Dr. Schaffner says. “And if so, what sort of interactions?”
Many researchers are looking into that, and how coinfections with other respiratory diseases, including the common cold and flu, may affect the course of COVID-19. Some studies have found that the T cells – a source of deeper, cellular immunity in people – generated after a common cold “may also provide cross-protection in some people against COVID-19.”
But another study found immunity against common cold–causing coronaviruses might make COVID-19 more severe.
When researchers in the United Kingdom studied nearly 7,000 patients infected with COVID-19, including 583 also infected with RSV, flu, or adenoviruses (causing flulike or coldlike illness), those with flu or adenovirus, compared with the others, were at higher risk of death.
To be continued …
Exactly how COVID-19 will be changing what we know of other viruses is yet to be determined, too.
Even before the pandemic, Dr. Martinello says, there were already some shifts in RSV. Florida, for instance, has an RSV season longer than the rest of the country, mimicking the pattern in the tropics.
Will the atypical patterns continue? “My guess is that this will settle out,” he says, with some sort of pattern developing. At this point, there are many unknowns. “We still can’t answer whether there will be some seasonality to COVID.”
A version of this article first appeared on WebMD.com.
Richard Martinello, MD, a professor of medicine and pediatric infectious diseases at Yale University, New haven, Conn., doesn’t expect to see a child hospitalized with respiratory syncytial virus (RSV) in the middle of summer. The illness, which can strike infants and older adults especially hard, is known as a “winter virus.”
But not this year. Over the last several weeks, he says, admissions for children with RSV have increased at the Yale New Haven Children’s Hospital. While the numbers aren’t large, they are out of the ordinary, he says, “because usually, at this time of year, we see zero. For lack of a better term, it’s weird.”
Likewise, William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville, says RSV is on the rise there. Tennessee is one of 10 states taking part in a Centers for Disease Control and Prevention surveillance system that tracks influenza, RSV, and COVID-19.
He says RSV cases have risen by at least a third during the past week, including all age ranges. At this time of year, he says, “We aren’t supposed to have any RSV.”
RSV isn’t the only virus thriving out of season or otherwise acting strangely. Since the pandemic began, flu seasons have been out of whack – sometimes nearly nonexistent and other times extending well beyond “normal” seasons. Some experts say one influenza “B” strain may now be extinct, while others say it will be back.
Severe colds – what some call “super colds” – also seem to be on the rise in recent warm-weather months, although that evidence is mostly based on personal experience, not science.
Trying to explain these out-of-season variations has sparked much discussion among epidemiologists and virologists, Dr. Schaffner says, with debates ongoing about whether human behavior and habits or the seasons play a bigger role in the transmission of viral illness.
On top of that, scientists are also looking at the interactions between the SARS-CoV-2 virus that causes COVID-19 and other viruses. When people get hit with COVID-19 and other viruses at the same time, does that make COVID-19 more severe, or less?
Research is conflicting.
Summer of 2022: A repeat of 2021?
RSV. Most children contract the virus by age 2, and while it’s generally mild, about 58,000 children under age 5 years are hospitalized each year. During the pandemic, RSV cases decreased from January to April 2020, the CDC reported, and then remained at “historically low levels”: less than 1% positive RSV results a week, for the next year.
But cases began rising in April 2021.
“Last year, we did have an unusual summer,” Dr. Schaffner says. After lockdown ended, to everyone’s surprise, RSV infections rose.
That increase triggered a CDC health advisory in June 2021, telling doctors and caregivers about the increase in “interseasonal” RSV cases across parts of the Southern United States, recommending broader testing for RSV in patients who had a respiratory illness but tested negative for COVID.
Because of the reduced circulation of RSV during the winter of 2020 to 2021, the CDC warned, older infants and toddlers might have a higher risk of RSV since they weren’t exposed to typical levels of RSV for the previous 15 months.
What about 2022? “At the moment,” Dr. Schaffner says, “it looks like we are having a repeat [of 2021].”
On Twitter, other pediatricians, including those from Maine and Texas, have reported an increase in RSV cases this summer.
Influenza. From October 2020 until May 2021, flu activity was lower than during any previous flu season since at least 1997, according to the CDC.
In late 2021, researchers suggested that one line of influenza known as B/Yamagata may have become extinct.
The 2021-2022 flu season has been mild, the CDC says, but it has come in two waves, with the second wave lingering longer than previous ones. While flu activity is decreasing, last week the CDC said doctors should be alert to flu infections throughout the summer.
Colds. In reports on colds that aren’t based on science, several doctors say they are seeing more colds than usual in the summer, and they’re more severe than usual. According to the CDC, common coronaviruses and respiratory adenoviruses have been increasing since early 2021, and rhinoviruses since June 2020.
Behavior vs. seasons
In explaining the spread of viral respiratory diseases, infectious disease doctors consider two things. “One is that temperature and humidity in the winter favors longer survival of some viruses, leading to longer periods of possible transmission,” says Dean Blumberg, MD, a professor of pediatrics and chief of pediatric infectious disease at University of California Davis Health.
“The other is differences in human behavior, with people spending more time outside in the summer, which results in more distancing and [less] virus concentration due to very large air volume,” he says, and vice versa in winter.
What about the “super colds?” COVID-19 lockdowns and social distancing greatly reduced people’s exposure to common viruses like those that cause colds, says Neil A. Mabbott, PhD, a professor of immunopathology at the University of Edinburgh (Scotland).
“Immunity to these common cold viruses gained through natural infection is considered to last around 8 or 9 months or so,” he says. “Each winter, when we are exposed to the new circulating variants of these viruses, our immunity receives a natural boost.”
That explains why most people get a cold that’s relatively mild. But with all the pandemic lockdowns and the use of hand sanitizers, most people had limited exposure to other viruses, including the common cold. When people emerged from lockdown, the common cold viruses were beginning to circulate again.
“Our immune systems were less able to clear the infection than previously,” Dr. Mabbott says. “As a consequence, some may have experienced increased symptoms, giving the impression of being infected with a ‘super cold.’ ”
“The colds themselves are probably not different to those we got prepandemic,” says Ian Mackay, PhD, a virologist at the University of Queensland, Brisbane, Australia. “But there might be more of them. So I doubt they are ‘super colds’ as much as they are ‘super-perfect circumstances.’ ”
The colds themselves are probably not different to those we got prepandemic. But there might be more of them.
Those super-perfect circumstances, he says, include people gathering after lockdown; a lack of immunity in new babies; viruses that have remained, even if at low levels, but continue to mutate; and our waning immunity to the range of viruses we’d normally encounter.
While lack of exposure may partly explain why some viruses become rampant out of season, it’s likely not the only reason. For example, the reduced circulation of RSV in the population as a whole also may have reduced the transfer of immunity from mothers to infants, some researchers say, making those infants more vulnerable than usual.
Interactions of viruses
Another thing that may be driving the different behavior of viruses is that the SARS-CoV-2 virus could somehow be interacting with other respiratory viruses, Dr. Schaffner says. “And if so, what sort of interactions?”
Many researchers are looking into that, and how coinfections with other respiratory diseases, including the common cold and flu, may affect the course of COVID-19. Some studies have found that the T cells – a source of deeper, cellular immunity in people – generated after a common cold “may also provide cross-protection in some people against COVID-19.”
But another study found immunity against common cold–causing coronaviruses might make COVID-19 more severe.
When researchers in the United Kingdom studied nearly 7,000 patients infected with COVID-19, including 583 also infected with RSV, flu, or adenoviruses (causing flulike or coldlike illness), those with flu or adenovirus, compared with the others, were at higher risk of death.
To be continued …
Exactly how COVID-19 will be changing what we know of other viruses is yet to be determined, too.
Even before the pandemic, Dr. Martinello says, there were already some shifts in RSV. Florida, for instance, has an RSV season longer than the rest of the country, mimicking the pattern in the tropics.
Will the atypical patterns continue? “My guess is that this will settle out,” he says, with some sort of pattern developing. At this point, there are many unknowns. “We still can’t answer whether there will be some seasonality to COVID.”
A version of this article first appeared on WebMD.com.
Richard Martinello, MD, a professor of medicine and pediatric infectious diseases at Yale University, New haven, Conn., doesn’t expect to see a child hospitalized with respiratory syncytial virus (RSV) in the middle of summer. The illness, which can strike infants and older adults especially hard, is known as a “winter virus.”
But not this year. Over the last several weeks, he says, admissions for children with RSV have increased at the Yale New Haven Children’s Hospital. While the numbers aren’t large, they are out of the ordinary, he says, “because usually, at this time of year, we see zero. For lack of a better term, it’s weird.”
Likewise, William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville, says RSV is on the rise there. Tennessee is one of 10 states taking part in a Centers for Disease Control and Prevention surveillance system that tracks influenza, RSV, and COVID-19.
He says RSV cases have risen by at least a third during the past week, including all age ranges. At this time of year, he says, “We aren’t supposed to have any RSV.”
RSV isn’t the only virus thriving out of season or otherwise acting strangely. Since the pandemic began, flu seasons have been out of whack – sometimes nearly nonexistent and other times extending well beyond “normal” seasons. Some experts say one influenza “B” strain may now be extinct, while others say it will be back.
Severe colds – what some call “super colds” – also seem to be on the rise in recent warm-weather months, although that evidence is mostly based on personal experience, not science.
Trying to explain these out-of-season variations has sparked much discussion among epidemiologists and virologists, Dr. Schaffner says, with debates ongoing about whether human behavior and habits or the seasons play a bigger role in the transmission of viral illness.
On top of that, scientists are also looking at the interactions between the SARS-CoV-2 virus that causes COVID-19 and other viruses. When people get hit with COVID-19 and other viruses at the same time, does that make COVID-19 more severe, or less?
Research is conflicting.
Summer of 2022: A repeat of 2021?
RSV. Most children contract the virus by age 2, and while it’s generally mild, about 58,000 children under age 5 years are hospitalized each year. During the pandemic, RSV cases decreased from January to April 2020, the CDC reported, and then remained at “historically low levels”: less than 1% positive RSV results a week, for the next year.
But cases began rising in April 2021.
“Last year, we did have an unusual summer,” Dr. Schaffner says. After lockdown ended, to everyone’s surprise, RSV infections rose.
That increase triggered a CDC health advisory in June 2021, telling doctors and caregivers about the increase in “interseasonal” RSV cases across parts of the Southern United States, recommending broader testing for RSV in patients who had a respiratory illness but tested negative for COVID.
Because of the reduced circulation of RSV during the winter of 2020 to 2021, the CDC warned, older infants and toddlers might have a higher risk of RSV since they weren’t exposed to typical levels of RSV for the previous 15 months.
What about 2022? “At the moment,” Dr. Schaffner says, “it looks like we are having a repeat [of 2021].”
On Twitter, other pediatricians, including those from Maine and Texas, have reported an increase in RSV cases this summer.
Influenza. From October 2020 until May 2021, flu activity was lower than during any previous flu season since at least 1997, according to the CDC.
In late 2021, researchers suggested that one line of influenza known as B/Yamagata may have become extinct.
The 2021-2022 flu season has been mild, the CDC says, but it has come in two waves, with the second wave lingering longer than previous ones. While flu activity is decreasing, last week the CDC said doctors should be alert to flu infections throughout the summer.
Colds. In reports on colds that aren’t based on science, several doctors say they are seeing more colds than usual in the summer, and they’re more severe than usual. According to the CDC, common coronaviruses and respiratory adenoviruses have been increasing since early 2021, and rhinoviruses since June 2020.
Behavior vs. seasons
In explaining the spread of viral respiratory diseases, infectious disease doctors consider two things. “One is that temperature and humidity in the winter favors longer survival of some viruses, leading to longer periods of possible transmission,” says Dean Blumberg, MD, a professor of pediatrics and chief of pediatric infectious disease at University of California Davis Health.
“The other is differences in human behavior, with people spending more time outside in the summer, which results in more distancing and [less] virus concentration due to very large air volume,” he says, and vice versa in winter.
What about the “super colds?” COVID-19 lockdowns and social distancing greatly reduced people’s exposure to common viruses like those that cause colds, says Neil A. Mabbott, PhD, a professor of immunopathology at the University of Edinburgh (Scotland).
“Immunity to these common cold viruses gained through natural infection is considered to last around 8 or 9 months or so,” he says. “Each winter, when we are exposed to the new circulating variants of these viruses, our immunity receives a natural boost.”
That explains why most people get a cold that’s relatively mild. But with all the pandemic lockdowns and the use of hand sanitizers, most people had limited exposure to other viruses, including the common cold. When people emerged from lockdown, the common cold viruses were beginning to circulate again.
“Our immune systems were less able to clear the infection than previously,” Dr. Mabbott says. “As a consequence, some may have experienced increased symptoms, giving the impression of being infected with a ‘super cold.’ ”
“The colds themselves are probably not different to those we got prepandemic,” says Ian Mackay, PhD, a virologist at the University of Queensland, Brisbane, Australia. “But there might be more of them. So I doubt they are ‘super colds’ as much as they are ‘super-perfect circumstances.’ ”
The colds themselves are probably not different to those we got prepandemic. But there might be more of them.
Those super-perfect circumstances, he says, include people gathering after lockdown; a lack of immunity in new babies; viruses that have remained, even if at low levels, but continue to mutate; and our waning immunity to the range of viruses we’d normally encounter.
While lack of exposure may partly explain why some viruses become rampant out of season, it’s likely not the only reason. For example, the reduced circulation of RSV in the population as a whole also may have reduced the transfer of immunity from mothers to infants, some researchers say, making those infants more vulnerable than usual.
Interactions of viruses
Another thing that may be driving the different behavior of viruses is that the SARS-CoV-2 virus could somehow be interacting with other respiratory viruses, Dr. Schaffner says. “And if so, what sort of interactions?”
Many researchers are looking into that, and how coinfections with other respiratory diseases, including the common cold and flu, may affect the course of COVID-19. Some studies have found that the T cells – a source of deeper, cellular immunity in people – generated after a common cold “may also provide cross-protection in some people against COVID-19.”
But another study found immunity against common cold–causing coronaviruses might make COVID-19 more severe.
When researchers in the United Kingdom studied nearly 7,000 patients infected with COVID-19, including 583 also infected with RSV, flu, or adenoviruses (causing flulike or coldlike illness), those with flu or adenovirus, compared with the others, were at higher risk of death.
To be continued …
Exactly how COVID-19 will be changing what we know of other viruses is yet to be determined, too.
Even before the pandemic, Dr. Martinello says, there were already some shifts in RSV. Florida, for instance, has an RSV season longer than the rest of the country, mimicking the pattern in the tropics.
Will the atypical patterns continue? “My guess is that this will settle out,” he says, with some sort of pattern developing. At this point, there are many unknowns. “We still can’t answer whether there will be some seasonality to COVID.”
A version of this article first appeared on WebMD.com.