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COVID cases rising in about half of states
About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.
Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.
National health officials have said some spots would have a lot of COVID cases.
“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.
“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”
Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.
If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.
The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.
“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.
“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”
A version of this article first appeared on WebMD.com.
About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.
Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.
National health officials have said some spots would have a lot of COVID cases.
“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.
“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”
Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.
If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.
The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.
“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.
“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”
A version of this article first appeared on WebMD.com.
About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.
Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.
National health officials have said some spots would have a lot of COVID cases.
“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.
“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”
Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.
If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.
The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.
“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.
“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”
A version of this article first appeared on WebMD.com.
Study: Physical fitness in children linked with concentration, quality of life
The findings of the German study involving more than 6,500 kids emphasize the importance of cardiorespiratory health in childhood, and support physical fitness initiatives in schools, according to lead author Katharina Köble, MSc, of the Technical University of Munich (Germany), and colleagues.
“Recent studies show that only a few children meet the recommendations of physical activity,” the investigators wrote in Journal of Clinical Medicine.
While the health benefits of physical activity are clearly documented, Ms. Köble and colleagues noted that typical measures of activity, such as accelerometers or self-reported questionnaires, are suboptimal research tools.
“Physical fitness is a more objective parameter to quantify when evaluating health promotion,” the investigators wrote. “Furthermore, cardiorespiratory fitness as part of physical fitness is more strongly related to risk factors of cardiovascular disease than physical activity.”
According to the investigators, physical fitness has also been linked with better concentration and HRQOL, but never in the same population of children.
The new study aimed to address this knowledge gap by assessing 6,533 healthy children aged 6-10 years, approximately half boys and half girls. Associations between physical fitness, concentration, and HRQOL were evaluated using multiple linear regression analysis in participants aged 9-10 years.
Physical fitness was measured using a series of challenges, including curl-ups (pull-ups with palms facing body), push-ups, standing long jump, handgrip strength measurement, and Progressive Aerobic Cardiovascular Endurance Run (PACER). Performing the multistage shuttle run, PACER, “requires participants to maintain the pace set by an audio signal, which progressively increases the intensity every minute.” Results of the PACER test were used to estimate VO2max.
Concentration was measured using the d2-R test, “a paper-pencil cancellation test, where subjects have to cross out all ‘d’ letters with two dashes under a time limit.”
HRQOL was evaluated with the KINDL questionnaire, which covers emotional well-being, physical well-being, everyday functioning (school), friends, family, and self-esteem.
Analysis showed that physical fitness improved with age (P < .001), except for VO2max in girls (P = .129). Concentration also improved with age (P < .001), while HRQOL did not (P = .179).
Among children aged 9-10 years, VO2max scores were strongly associated with both HRQOL (P < .001) and concentration (P < .001).
“VO2max was found to be one of the main factors influencing concentration levels and HRQOL dimensions in primary school children,” the investigators wrote. “Physical fitness, especially cardiorespiratory performance, should therefore be promoted more specifically in school settings to support the promotion of an overall healthy lifestyle in children and adolescents.”
Findings are having a real-word impact, according to researcher
In an interview, Ms. Köble noted that the findings are already having a real-world impact.
“We continued data assessment in the long-term and specifically adapted prevention programs in school to the needs of the school children we identified in our study,” she said. “Schools are partially offering specific movement and nutrition classes now.”
In addition, Ms. Köble and colleagues plan on educating teachers about the “urgent need for sufficient physical activity.”
“Academic performance should be considered as an additional health factor in future studies, as well as screen time and eating patterns, as all those variables showed interactions with physical fitness and concentration. In a subanalysis, we showed that children with better physical fitness and concentration values were those who usually went to higher education secondary schools,” they wrote.
VO2max did not correlate with BMI
Gregory Weaver, MD, a pediatrician at Cleveland Clinic Children’s, voiced some concerns about the reliability of the findings. He noted that VO2max did not correlate with body mass index or other measures of physical fitness, and that using the PACER test to estimate VO2max may have skewed the association between physical fitness and concentration.
“It is quite conceivable that children who can maintain the focus to perform maximally on this test will also do well on other tests of attention/concentration,” Dr. Weaver said. “Most children I know would have a very difficult time performing a physical fitness test which requires them to match a recorded pace that slowly increases overtime. I’m not an expert in the area, but it is my understanding that usually VO2max tests involve a treadmill which allows investigators to have complete control over pace.”
Dr. Weaver concluded that more work is needed to determine if physical fitness interventions can have a positive impact on HRQOL and concentration.
“I think the authors of this study attempted to ask an important question about the possible association between physical fitness and concentration among school aged children,” Dr. Weaver said in an interview. “But what is even more vital are studies demonstrating that a change in modifiable health factors like nutrition, physical fitness, or the built environment can improve quality of life. I was hoping the authors would show that an improvement in VO2max over time resulted in an improvement in concentration. Frustratingly, that is not what this article demonstrates.”
The investigators and Dr. Weaver reported no conflicts of interest.
The findings of the German study involving more than 6,500 kids emphasize the importance of cardiorespiratory health in childhood, and support physical fitness initiatives in schools, according to lead author Katharina Köble, MSc, of the Technical University of Munich (Germany), and colleagues.
“Recent studies show that only a few children meet the recommendations of physical activity,” the investigators wrote in Journal of Clinical Medicine.
While the health benefits of physical activity are clearly documented, Ms. Köble and colleagues noted that typical measures of activity, such as accelerometers or self-reported questionnaires, are suboptimal research tools.
“Physical fitness is a more objective parameter to quantify when evaluating health promotion,” the investigators wrote. “Furthermore, cardiorespiratory fitness as part of physical fitness is more strongly related to risk factors of cardiovascular disease than physical activity.”
According to the investigators, physical fitness has also been linked with better concentration and HRQOL, but never in the same population of children.
The new study aimed to address this knowledge gap by assessing 6,533 healthy children aged 6-10 years, approximately half boys and half girls. Associations between physical fitness, concentration, and HRQOL were evaluated using multiple linear regression analysis in participants aged 9-10 years.
Physical fitness was measured using a series of challenges, including curl-ups (pull-ups with palms facing body), push-ups, standing long jump, handgrip strength measurement, and Progressive Aerobic Cardiovascular Endurance Run (PACER). Performing the multistage shuttle run, PACER, “requires participants to maintain the pace set by an audio signal, which progressively increases the intensity every minute.” Results of the PACER test were used to estimate VO2max.
Concentration was measured using the d2-R test, “a paper-pencil cancellation test, where subjects have to cross out all ‘d’ letters with two dashes under a time limit.”
HRQOL was evaluated with the KINDL questionnaire, which covers emotional well-being, physical well-being, everyday functioning (school), friends, family, and self-esteem.
Analysis showed that physical fitness improved with age (P < .001), except for VO2max in girls (P = .129). Concentration also improved with age (P < .001), while HRQOL did not (P = .179).
Among children aged 9-10 years, VO2max scores were strongly associated with both HRQOL (P < .001) and concentration (P < .001).
“VO2max was found to be one of the main factors influencing concentration levels and HRQOL dimensions in primary school children,” the investigators wrote. “Physical fitness, especially cardiorespiratory performance, should therefore be promoted more specifically in school settings to support the promotion of an overall healthy lifestyle in children and adolescents.”
Findings are having a real-word impact, according to researcher
In an interview, Ms. Köble noted that the findings are already having a real-world impact.
“We continued data assessment in the long-term and specifically adapted prevention programs in school to the needs of the school children we identified in our study,” she said. “Schools are partially offering specific movement and nutrition classes now.”
In addition, Ms. Köble and colleagues plan on educating teachers about the “urgent need for sufficient physical activity.”
“Academic performance should be considered as an additional health factor in future studies, as well as screen time and eating patterns, as all those variables showed interactions with physical fitness and concentration. In a subanalysis, we showed that children with better physical fitness and concentration values were those who usually went to higher education secondary schools,” they wrote.
VO2max did not correlate with BMI
Gregory Weaver, MD, a pediatrician at Cleveland Clinic Children’s, voiced some concerns about the reliability of the findings. He noted that VO2max did not correlate with body mass index or other measures of physical fitness, and that using the PACER test to estimate VO2max may have skewed the association between physical fitness and concentration.
“It is quite conceivable that children who can maintain the focus to perform maximally on this test will also do well on other tests of attention/concentration,” Dr. Weaver said. “Most children I know would have a very difficult time performing a physical fitness test which requires them to match a recorded pace that slowly increases overtime. I’m not an expert in the area, but it is my understanding that usually VO2max tests involve a treadmill which allows investigators to have complete control over pace.”
Dr. Weaver concluded that more work is needed to determine if physical fitness interventions can have a positive impact on HRQOL and concentration.
“I think the authors of this study attempted to ask an important question about the possible association between physical fitness and concentration among school aged children,” Dr. Weaver said in an interview. “But what is even more vital are studies demonstrating that a change in modifiable health factors like nutrition, physical fitness, or the built environment can improve quality of life. I was hoping the authors would show that an improvement in VO2max over time resulted in an improvement in concentration. Frustratingly, that is not what this article demonstrates.”
The investigators and Dr. Weaver reported no conflicts of interest.
The findings of the German study involving more than 6,500 kids emphasize the importance of cardiorespiratory health in childhood, and support physical fitness initiatives in schools, according to lead author Katharina Köble, MSc, of the Technical University of Munich (Germany), and colleagues.
“Recent studies show that only a few children meet the recommendations of physical activity,” the investigators wrote in Journal of Clinical Medicine.
While the health benefits of physical activity are clearly documented, Ms. Köble and colleagues noted that typical measures of activity, such as accelerometers or self-reported questionnaires, are suboptimal research tools.
“Physical fitness is a more objective parameter to quantify when evaluating health promotion,” the investigators wrote. “Furthermore, cardiorespiratory fitness as part of physical fitness is more strongly related to risk factors of cardiovascular disease than physical activity.”
According to the investigators, physical fitness has also been linked with better concentration and HRQOL, but never in the same population of children.
The new study aimed to address this knowledge gap by assessing 6,533 healthy children aged 6-10 years, approximately half boys and half girls. Associations between physical fitness, concentration, and HRQOL were evaluated using multiple linear regression analysis in participants aged 9-10 years.
Physical fitness was measured using a series of challenges, including curl-ups (pull-ups with palms facing body), push-ups, standing long jump, handgrip strength measurement, and Progressive Aerobic Cardiovascular Endurance Run (PACER). Performing the multistage shuttle run, PACER, “requires participants to maintain the pace set by an audio signal, which progressively increases the intensity every minute.” Results of the PACER test were used to estimate VO2max.
Concentration was measured using the d2-R test, “a paper-pencil cancellation test, where subjects have to cross out all ‘d’ letters with two dashes under a time limit.”
HRQOL was evaluated with the KINDL questionnaire, which covers emotional well-being, physical well-being, everyday functioning (school), friends, family, and self-esteem.
Analysis showed that physical fitness improved with age (P < .001), except for VO2max in girls (P = .129). Concentration also improved with age (P < .001), while HRQOL did not (P = .179).
Among children aged 9-10 years, VO2max scores were strongly associated with both HRQOL (P < .001) and concentration (P < .001).
“VO2max was found to be one of the main factors influencing concentration levels and HRQOL dimensions in primary school children,” the investigators wrote. “Physical fitness, especially cardiorespiratory performance, should therefore be promoted more specifically in school settings to support the promotion of an overall healthy lifestyle in children and adolescents.”
Findings are having a real-word impact, according to researcher
In an interview, Ms. Köble noted that the findings are already having a real-world impact.
“We continued data assessment in the long-term and specifically adapted prevention programs in school to the needs of the school children we identified in our study,” she said. “Schools are partially offering specific movement and nutrition classes now.”
In addition, Ms. Köble and colleagues plan on educating teachers about the “urgent need for sufficient physical activity.”
“Academic performance should be considered as an additional health factor in future studies, as well as screen time and eating patterns, as all those variables showed interactions with physical fitness and concentration. In a subanalysis, we showed that children with better physical fitness and concentration values were those who usually went to higher education secondary schools,” they wrote.
VO2max did not correlate with BMI
Gregory Weaver, MD, a pediatrician at Cleveland Clinic Children’s, voiced some concerns about the reliability of the findings. He noted that VO2max did not correlate with body mass index or other measures of physical fitness, and that using the PACER test to estimate VO2max may have skewed the association between physical fitness and concentration.
“It is quite conceivable that children who can maintain the focus to perform maximally on this test will also do well on other tests of attention/concentration,” Dr. Weaver said. “Most children I know would have a very difficult time performing a physical fitness test which requires them to match a recorded pace that slowly increases overtime. I’m not an expert in the area, but it is my understanding that usually VO2max tests involve a treadmill which allows investigators to have complete control over pace.”
Dr. Weaver concluded that more work is needed to determine if physical fitness interventions can have a positive impact on HRQOL and concentration.
“I think the authors of this study attempted to ask an important question about the possible association between physical fitness and concentration among school aged children,” Dr. Weaver said in an interview. “But what is even more vital are studies demonstrating that a change in modifiable health factors like nutrition, physical fitness, or the built environment can improve quality of life. I was hoping the authors would show that an improvement in VO2max over time resulted in an improvement in concentration. Frustratingly, that is not what this article demonstrates.”
The investigators and Dr. Weaver reported no conflicts of interest.
FROM THE JOURNAL OF CLINICAL MEDICINE
Surgeons in China ‘are the executioners,’ procuring organs before brain death
In a deep dive into obscure Chinese language transplant journals, a pair of researchers from Australia and Israel have added a new layer of horror to what’s already known about forced organ harvesting in China.
Searching for documentation that vital organs are being harvested from nonconsenting executed prisoners, a practice that the China Tribunal confirmed “beyond any reasonable doubt” in 2020, Jacob Lavee, MD, an Israeli heart transplant surgeon, and Matthew Roberston, a PhD student at Australian National University, uncovered something even more shocking: that vital organs are being explanted from patients who are still alive.
“We have shown for the first time that the transplant surgeons are the executioners – that the mode of execution is organ procurement. These are self-admissions of executing the patient,” Dr. Lavee told this news organization. “Up until now, there has been what we call circumstantial evidence of this, but our paper is what you’d call the smoking gun, because it’s in the words of the physicians themselves that they are doing it. In the words of these surgeons, intubation was done only after the beginning of surgery, which means the patients were breathing spontaneously up until the moment the operation started ... meaning they were not brain dead.”
The research, published in the American Journal of Transplantation, involved intricate analysis of thousands of Chinese language transplant articles and identified 71 articles in which transplant surgeons describe starting organ procurement surgery before declaring their patients brain dead.
“What we found were improper, illegitimate, nonexistent, or false declarations of brain death,” Mr. Robertson said in an interview. He explained that this violates what’s known as the dead donor rule, which is fundamental in transplant ethics. “The surgeons wrote that the donor was brain dead, but according to everything we know about medical science, they could not possibly have been brain dead because there was no apnea test performed. Brain death is not just something you say, there’s this whole battery of tests, and the key is the apnea test, [in which] the patient is already intubated and ventilated, they turn the machine off, and they’re looking for carbon dioxide in the blood above a certain level.”
Mr. Robertson and Dr. Lavee have painstakingly documented “incriminating sentences” in each of the 71 articles proving that brain death had not occurred before the organ explantation procedure began. “There were two criteria by which we claimed a problematic brain death declaration,” said Mr. Robertson, who translated the Chinese. “One was where the patient was not ventilated and was only intubated after they were declared brain dead; the other was that the intubation took place immediately prior to the surgery beginning.”
“It was mind-boggling,” said Dr. Lavee, from Tel Aviv University. “When I first started reading, my initial reaction is, ‘This can’t be.’ I read it once, and again, and I insisted that Matt get another independent translation of the Chinese just to be sure. I told him, ‘There’s no way a physician, a surgeon could write this – it doesn’t make sense.’ But the more of these papers we read, we saw it was a pattern – and they didn’t come out of a single medical center, they are spread all over China.”
For the analysis, Mr. Robertson wrote code and customized an algorithm to examine 124,770 medical articles from official Chinese databases between 1980 and 2020. The 71 articles revealing cases involving problematic brain death came from 56 hospitals (of which 12 were military) in 33 cities across 15 provinces, they report. In total, 348 surgeons, nurses, anesthesiologists, and other medical workers or researchers were listed as authors of these publications.
Why would these medical personnel write such self-incriminating evidence? The researchers say it’s unclear. “They don’t think anyone’s reading this stuff,” Mr. Robertson suggests. “Sometimes it’s revealed in just five or six characters in a paper of eight pages.” Dr. Lavee wonders if it’s also ignorance. “If this has been a practice for 20 or 30 years in China, I guess nobody at that time was aware they were doing something wrong, although how to declare brain death is something that is known in China. They’ve published a lot about it.”
The article is “evidence that this barbarity continues and is a very valuable contribution that continues to bring attention to an enormous human rights violation,” said Arthur Caplan, PhD, head of the Division of Medical Ethics at New York University’s Grossman School of Medicine. “What they’ve reported has been going on for many, many years, the data are very clear that China’s doing many more transplants than they have cadaver organ donors,” he said, adding that the country’s well-documented and lucrative involvement in transplant tourism “means you have to have a donor ready when the would-be recipient appears; you have to have a matched organ available, and that’s hard to do waiting on a cadaver donor.”
Although the researchers found no incriminating publications after 2015, they speculate that this is likely due to growing awareness among Chinese surgeons that publishing the information would attract international condemnation. “We think these practices are continuing to go on,” said Dr. Lavee. He acknowledged that a voluntary organ donation program is slowly developing in parallel to this. He said, given China’s place as the world’s second largest transplant country behind the U.S., as well as its low rate of voluntary donation, it’s reasonable to conclude that the main source of organs remains prisoners on death row.
Dr. Caplan and the researchers have called for academic institutions and medical journals to resume their previous boycotts of Chinese transplant publications and speakers, but as long as China denies the practices, economic and political leaders will turn a blind eye. “In the past, I don’t think the question of China’s medical professional involvement in the execution of donors has been taken as seriously as it should have,” said Mr. Robertson. “I certainly hope that with the publication of this paper in the leading journal in the field, this will change.”
The study was supported by the Google Cloud Research Credits program, the Australian Government Research Training Program Scholarship, and the Victims of Communism Memorial Foundation. Mr. Robertson, Dr. Lavee, and Dr. Caplan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a deep dive into obscure Chinese language transplant journals, a pair of researchers from Australia and Israel have added a new layer of horror to what’s already known about forced organ harvesting in China.
Searching for documentation that vital organs are being harvested from nonconsenting executed prisoners, a practice that the China Tribunal confirmed “beyond any reasonable doubt” in 2020, Jacob Lavee, MD, an Israeli heart transplant surgeon, and Matthew Roberston, a PhD student at Australian National University, uncovered something even more shocking: that vital organs are being explanted from patients who are still alive.
“We have shown for the first time that the transplant surgeons are the executioners – that the mode of execution is organ procurement. These are self-admissions of executing the patient,” Dr. Lavee told this news organization. “Up until now, there has been what we call circumstantial evidence of this, but our paper is what you’d call the smoking gun, because it’s in the words of the physicians themselves that they are doing it. In the words of these surgeons, intubation was done only after the beginning of surgery, which means the patients were breathing spontaneously up until the moment the operation started ... meaning they were not brain dead.”
The research, published in the American Journal of Transplantation, involved intricate analysis of thousands of Chinese language transplant articles and identified 71 articles in which transplant surgeons describe starting organ procurement surgery before declaring their patients brain dead.
“What we found were improper, illegitimate, nonexistent, or false declarations of brain death,” Mr. Robertson said in an interview. He explained that this violates what’s known as the dead donor rule, which is fundamental in transplant ethics. “The surgeons wrote that the donor was brain dead, but according to everything we know about medical science, they could not possibly have been brain dead because there was no apnea test performed. Brain death is not just something you say, there’s this whole battery of tests, and the key is the apnea test, [in which] the patient is already intubated and ventilated, they turn the machine off, and they’re looking for carbon dioxide in the blood above a certain level.”
Mr. Robertson and Dr. Lavee have painstakingly documented “incriminating sentences” in each of the 71 articles proving that brain death had not occurred before the organ explantation procedure began. “There were two criteria by which we claimed a problematic brain death declaration,” said Mr. Robertson, who translated the Chinese. “One was where the patient was not ventilated and was only intubated after they were declared brain dead; the other was that the intubation took place immediately prior to the surgery beginning.”
“It was mind-boggling,” said Dr. Lavee, from Tel Aviv University. “When I first started reading, my initial reaction is, ‘This can’t be.’ I read it once, and again, and I insisted that Matt get another independent translation of the Chinese just to be sure. I told him, ‘There’s no way a physician, a surgeon could write this – it doesn’t make sense.’ But the more of these papers we read, we saw it was a pattern – and they didn’t come out of a single medical center, they are spread all over China.”
For the analysis, Mr. Robertson wrote code and customized an algorithm to examine 124,770 medical articles from official Chinese databases between 1980 and 2020. The 71 articles revealing cases involving problematic brain death came from 56 hospitals (of which 12 were military) in 33 cities across 15 provinces, they report. In total, 348 surgeons, nurses, anesthesiologists, and other medical workers or researchers were listed as authors of these publications.
Why would these medical personnel write such self-incriminating evidence? The researchers say it’s unclear. “They don’t think anyone’s reading this stuff,” Mr. Robertson suggests. “Sometimes it’s revealed in just five or six characters in a paper of eight pages.” Dr. Lavee wonders if it’s also ignorance. “If this has been a practice for 20 or 30 years in China, I guess nobody at that time was aware they were doing something wrong, although how to declare brain death is something that is known in China. They’ve published a lot about it.”
The article is “evidence that this barbarity continues and is a very valuable contribution that continues to bring attention to an enormous human rights violation,” said Arthur Caplan, PhD, head of the Division of Medical Ethics at New York University’s Grossman School of Medicine. “What they’ve reported has been going on for many, many years, the data are very clear that China’s doing many more transplants than they have cadaver organ donors,” he said, adding that the country’s well-documented and lucrative involvement in transplant tourism “means you have to have a donor ready when the would-be recipient appears; you have to have a matched organ available, and that’s hard to do waiting on a cadaver donor.”
Although the researchers found no incriminating publications after 2015, they speculate that this is likely due to growing awareness among Chinese surgeons that publishing the information would attract international condemnation. “We think these practices are continuing to go on,” said Dr. Lavee. He acknowledged that a voluntary organ donation program is slowly developing in parallel to this. He said, given China’s place as the world’s second largest transplant country behind the U.S., as well as its low rate of voluntary donation, it’s reasonable to conclude that the main source of organs remains prisoners on death row.
Dr. Caplan and the researchers have called for academic institutions and medical journals to resume their previous boycotts of Chinese transplant publications and speakers, but as long as China denies the practices, economic and political leaders will turn a blind eye. “In the past, I don’t think the question of China’s medical professional involvement in the execution of donors has been taken as seriously as it should have,” said Mr. Robertson. “I certainly hope that with the publication of this paper in the leading journal in the field, this will change.”
The study was supported by the Google Cloud Research Credits program, the Australian Government Research Training Program Scholarship, and the Victims of Communism Memorial Foundation. Mr. Robertson, Dr. Lavee, and Dr. Caplan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a deep dive into obscure Chinese language transplant journals, a pair of researchers from Australia and Israel have added a new layer of horror to what’s already known about forced organ harvesting in China.
Searching for documentation that vital organs are being harvested from nonconsenting executed prisoners, a practice that the China Tribunal confirmed “beyond any reasonable doubt” in 2020, Jacob Lavee, MD, an Israeli heart transplant surgeon, and Matthew Roberston, a PhD student at Australian National University, uncovered something even more shocking: that vital organs are being explanted from patients who are still alive.
“We have shown for the first time that the transplant surgeons are the executioners – that the mode of execution is organ procurement. These are self-admissions of executing the patient,” Dr. Lavee told this news organization. “Up until now, there has been what we call circumstantial evidence of this, but our paper is what you’d call the smoking gun, because it’s in the words of the physicians themselves that they are doing it. In the words of these surgeons, intubation was done only after the beginning of surgery, which means the patients were breathing spontaneously up until the moment the operation started ... meaning they were not brain dead.”
The research, published in the American Journal of Transplantation, involved intricate analysis of thousands of Chinese language transplant articles and identified 71 articles in which transplant surgeons describe starting organ procurement surgery before declaring their patients brain dead.
“What we found were improper, illegitimate, nonexistent, or false declarations of brain death,” Mr. Robertson said in an interview. He explained that this violates what’s known as the dead donor rule, which is fundamental in transplant ethics. “The surgeons wrote that the donor was brain dead, but according to everything we know about medical science, they could not possibly have been brain dead because there was no apnea test performed. Brain death is not just something you say, there’s this whole battery of tests, and the key is the apnea test, [in which] the patient is already intubated and ventilated, they turn the machine off, and they’re looking for carbon dioxide in the blood above a certain level.”
Mr. Robertson and Dr. Lavee have painstakingly documented “incriminating sentences” in each of the 71 articles proving that brain death had not occurred before the organ explantation procedure began. “There were two criteria by which we claimed a problematic brain death declaration,” said Mr. Robertson, who translated the Chinese. “One was where the patient was not ventilated and was only intubated after they were declared brain dead; the other was that the intubation took place immediately prior to the surgery beginning.”
“It was mind-boggling,” said Dr. Lavee, from Tel Aviv University. “When I first started reading, my initial reaction is, ‘This can’t be.’ I read it once, and again, and I insisted that Matt get another independent translation of the Chinese just to be sure. I told him, ‘There’s no way a physician, a surgeon could write this – it doesn’t make sense.’ But the more of these papers we read, we saw it was a pattern – and they didn’t come out of a single medical center, they are spread all over China.”
For the analysis, Mr. Robertson wrote code and customized an algorithm to examine 124,770 medical articles from official Chinese databases between 1980 and 2020. The 71 articles revealing cases involving problematic brain death came from 56 hospitals (of which 12 were military) in 33 cities across 15 provinces, they report. In total, 348 surgeons, nurses, anesthesiologists, and other medical workers or researchers were listed as authors of these publications.
Why would these medical personnel write such self-incriminating evidence? The researchers say it’s unclear. “They don’t think anyone’s reading this stuff,” Mr. Robertson suggests. “Sometimes it’s revealed in just five or six characters in a paper of eight pages.” Dr. Lavee wonders if it’s also ignorance. “If this has been a practice for 20 or 30 years in China, I guess nobody at that time was aware they were doing something wrong, although how to declare brain death is something that is known in China. They’ve published a lot about it.”
The article is “evidence that this barbarity continues and is a very valuable contribution that continues to bring attention to an enormous human rights violation,” said Arthur Caplan, PhD, head of the Division of Medical Ethics at New York University’s Grossman School of Medicine. “What they’ve reported has been going on for many, many years, the data are very clear that China’s doing many more transplants than they have cadaver organ donors,” he said, adding that the country’s well-documented and lucrative involvement in transplant tourism “means you have to have a donor ready when the would-be recipient appears; you have to have a matched organ available, and that’s hard to do waiting on a cadaver donor.”
Although the researchers found no incriminating publications after 2015, they speculate that this is likely due to growing awareness among Chinese surgeons that publishing the information would attract international condemnation. “We think these practices are continuing to go on,” said Dr. Lavee. He acknowledged that a voluntary organ donation program is slowly developing in parallel to this. He said, given China’s place as the world’s second largest transplant country behind the U.S., as well as its low rate of voluntary donation, it’s reasonable to conclude that the main source of organs remains prisoners on death row.
Dr. Caplan and the researchers have called for academic institutions and medical journals to resume their previous boycotts of Chinese transplant publications and speakers, but as long as China denies the practices, economic and political leaders will turn a blind eye. “In the past, I don’t think the question of China’s medical professional involvement in the execution of donors has been taken as seriously as it should have,” said Mr. Robertson. “I certainly hope that with the publication of this paper in the leading journal in the field, this will change.”
The study was supported by the Google Cloud Research Credits program, the Australian Government Research Training Program Scholarship, and the Victims of Communism Memorial Foundation. Mr. Robertson, Dr. Lavee, and Dr. Caplan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DIAMOND: Adding patiromer helps optimize HF meds, foils hyperkalemia
Several of the core medications for patients with heart failure with reduced ejection fraction (HFrEF) come with a well-known risk of causing hyperkalemia, to which many clinicians respond by pulling back on dosing or withdrawing the culprit drug.
But accompanying renin-angiotensin system–inhibiting agents with the potassium-sequestrant patiromer (Veltassa, Vifor Pharma) appears to shield patients against hyperkalemia enough that they can take more RASI medications at higher doses, suggests a randomized, a controlled study.
The DIAMOND trial’s HFrEF patients, who had current or a history of RASI-related hyperkalemia, added either patiromer or placebo to their guideline-directed medical therapy (GDMT), which includes, even emphasizes, the culprit medication. They include ACE inhibitors, angiotensin-receptor blockers (ARBs), angiotensin-receptor/neprilysin inhibitors (ARNIs), and mineralocorticoid receptor antagonists (MRAs).
Those taking patiromer tolerated more intense RASI therapy – including MRAs, which are especially prone to causing hyperkalemia – than the patients assigned to placebo. They also maintained lower potassium concentrations and experienced fewer clinically important hyperkalemia episodes, reported Javed Butler, MD, MPH, MBA, Baylor Scott and White Research Institute, Dallas, at the annual scientific sessions of the American College of Cardiology.
The apparent benefit from patiromer came in part from an advantage for a composite hyperkalemia-event endpoint that included mortality, Dr. Butler noted. That advantage seemed to hold regardless of age, sex, body mass index, HFrEF symptom severity, or initial natriuretic peptide levels.
Patients who took patiromer, compared with those who took placebo, showed a 37% reduction in risk for hyperkalemia (P = .006), defined as potassium levels exceeding 5.5 mEq/L, over a median follow-up of 27 weeks. They were 38% less likely to have their MRA dosage reduced to below target level (P = .006).
More patients in the patiromer group than in the control group attained at least 50% of target dosage for MRAs and ACE inhibitors, ARBs, or ARNIs (92% vs. 87%; P = .015).
Patients with HFrEF are unlikely to achieve best possible outcomes without GDMT optimization, but failure to optimize is often attributed to hyperkalemia concerns. DIAMOND, Dr. Butler said, suggests that, by adding the potassium sequestrant to GDMT, “you can simultaneously control potassium and optimize RASI therapy.” Many clinicians seem to believe they can achieve only one or the other.
DIAMOND was too underpowered to show whether preventing hyperkalemia with patiromer could improve clinical outcomes. But failure to optimize RASI medication in HFrEF can worsen risk for heart failure events and death. So “it stands to reason that optimization of RASI therapy without a concomitant risk of hyperkalemia may, in the long run, lead to better outcomes for these patients,” Dr. Butler said in an interview.
Given the drug’s ability to keep potassium levels in check during RASI therapy, Dr. Butler said, “hypokalemia should not be a reason for suboptimal therapy.”
Patiromer and other potassium sequestrants have been available in the United States and Europe for 4-6 years, but their value as adjuncts to RASI medication in HFrEF or other heart failure has been unclear.
“There’s a good opportunity to expand the use of the drug. The question is, in whom and when?” James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.
Some HFrEF patients on GDMT “should be treated with patiromer. The bigger question is, should we give someone who has a history of hyperkalemia another chance at GDMT before we treat them with patiromer? Because they may not necessarily develop hyperkalemia a second time,” said Dr. Januzzi, who was on the DIAMOND endpoint-adjudication committee.
Among the most notable findings of the trial, he said, is that the number of people who developed hyperkalemia on RASI medication, although significantly elevated, “wasn’t as high as they expected it would be,” he said. “The data from DIAMOND argue that if a really significant majority does not become hyperkalemic on rechallenge, jumping straight to a potassium-binding drug may be premature.”
Physicians across specialties can differ in how they interpret potassium-level elevation and can use various cut points to flag when to stop RASI medication or at least hold back on up-titration, Dr. Butler observed. “Cardiologists have a different threshold of potassium that they tolerate than say, for instance, a nephrologist.”
Useful, then, might be a way to tell which patients are most likely to develop hyperkalemia with RASI up-titration and so might benefit from a potassium-binding agent right away. But DIAMOND, Dr. Butler said, “does not necessarily define any patient phenotype or any potassium level where we would say that you should use a potassium binder.”
The trial entered 1,642 patients with HFrEF and current or past RASI-related hyperkalemia to a 12-week run-in phase for optimization of GDMT with patiromer. The trial was conducted at nearly 400 centers in 21 countries.
RASI medication could be optimized in 85% of the cohort, from which 878 patients were randomly assigned either to continue optimized GDMT with patiromer or to have the potassium-sequestrant replaced with a placebo.
The patients on patiromer showed a 0.03-mEq/L mean rise in serum potassium levels from randomization to the end of the study, the primary endpoint, compared with a 0.13 mEq/L mean increase for those in the control group (P < .001), Dr. Butler reported.
The win ratio for a RASI-use score hierarchically featuring cardiovascular death and CV hospitalization for hyperkalemia at several levels of severity was 1.25 (95% confidence interval, 1.003-1.564; P = .048), favoring the patiromer group. The win ratio solely for hyperkalemia-related events also favored patients on patiromer, at 1.53 (95% CI, 1.23-1.91; P < .001).
Patiromer also seemed well tolerated, Dr. Butler said.
Hyperkalemia is “one of the most common excuses” from clinicians for failing to up-titrate RASI medicine in patients with heart failure, Dr. Januzzi said. DIAMOND was less about patiromer itself than about ways “to facilitate better GDMT, where we’re really falling short of the mark. During the run-in phase they were able to get the vast majority of individuals to target, which to me is a critically important point, and emblematic of the need for things that facilitate this kind of excellent care.”
DIAMOND was funded by Vifor Pharma. Dr. Butler disclosed receiving consulting fees from Abbott, Adrenomed, Amgen, Applied Therapeutics, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, G3 Pharma, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana Medical, and Vifor Pharma. Dr. Januzzi disclosed receiving consultant fees or honoraria from Abbott Laboratories, Imbria, Jana Care, Novartis, Prevencio, and Roche Diagnostics; serving on a data safety monitoring board for AbbVie, Amgen, Bayer Healthcare Pharmaceuticals, Beyer, CVRx, and Takeda Pharmaceuticals North America; and receiving research grants from Abbott Laboratories, Janssen, and Vifor Pharma.
A version of this article first appeared on Medscape.com.
Several of the core medications for patients with heart failure with reduced ejection fraction (HFrEF) come with a well-known risk of causing hyperkalemia, to which many clinicians respond by pulling back on dosing or withdrawing the culprit drug.
But accompanying renin-angiotensin system–inhibiting agents with the potassium-sequestrant patiromer (Veltassa, Vifor Pharma) appears to shield patients against hyperkalemia enough that they can take more RASI medications at higher doses, suggests a randomized, a controlled study.
The DIAMOND trial’s HFrEF patients, who had current or a history of RASI-related hyperkalemia, added either patiromer or placebo to their guideline-directed medical therapy (GDMT), which includes, even emphasizes, the culprit medication. They include ACE inhibitors, angiotensin-receptor blockers (ARBs), angiotensin-receptor/neprilysin inhibitors (ARNIs), and mineralocorticoid receptor antagonists (MRAs).
Those taking patiromer tolerated more intense RASI therapy – including MRAs, which are especially prone to causing hyperkalemia – than the patients assigned to placebo. They also maintained lower potassium concentrations and experienced fewer clinically important hyperkalemia episodes, reported Javed Butler, MD, MPH, MBA, Baylor Scott and White Research Institute, Dallas, at the annual scientific sessions of the American College of Cardiology.
The apparent benefit from patiromer came in part from an advantage for a composite hyperkalemia-event endpoint that included mortality, Dr. Butler noted. That advantage seemed to hold regardless of age, sex, body mass index, HFrEF symptom severity, or initial natriuretic peptide levels.
Patients who took patiromer, compared with those who took placebo, showed a 37% reduction in risk for hyperkalemia (P = .006), defined as potassium levels exceeding 5.5 mEq/L, over a median follow-up of 27 weeks. They were 38% less likely to have their MRA dosage reduced to below target level (P = .006).
More patients in the patiromer group than in the control group attained at least 50% of target dosage for MRAs and ACE inhibitors, ARBs, or ARNIs (92% vs. 87%; P = .015).
Patients with HFrEF are unlikely to achieve best possible outcomes without GDMT optimization, but failure to optimize is often attributed to hyperkalemia concerns. DIAMOND, Dr. Butler said, suggests that, by adding the potassium sequestrant to GDMT, “you can simultaneously control potassium and optimize RASI therapy.” Many clinicians seem to believe they can achieve only one or the other.
DIAMOND was too underpowered to show whether preventing hyperkalemia with patiromer could improve clinical outcomes. But failure to optimize RASI medication in HFrEF can worsen risk for heart failure events and death. So “it stands to reason that optimization of RASI therapy without a concomitant risk of hyperkalemia may, in the long run, lead to better outcomes for these patients,” Dr. Butler said in an interview.
Given the drug’s ability to keep potassium levels in check during RASI therapy, Dr. Butler said, “hypokalemia should not be a reason for suboptimal therapy.”
Patiromer and other potassium sequestrants have been available in the United States and Europe for 4-6 years, but their value as adjuncts to RASI medication in HFrEF or other heart failure has been unclear.
“There’s a good opportunity to expand the use of the drug. The question is, in whom and when?” James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.
Some HFrEF patients on GDMT “should be treated with patiromer. The bigger question is, should we give someone who has a history of hyperkalemia another chance at GDMT before we treat them with patiromer? Because they may not necessarily develop hyperkalemia a second time,” said Dr. Januzzi, who was on the DIAMOND endpoint-adjudication committee.
Among the most notable findings of the trial, he said, is that the number of people who developed hyperkalemia on RASI medication, although significantly elevated, “wasn’t as high as they expected it would be,” he said. “The data from DIAMOND argue that if a really significant majority does not become hyperkalemic on rechallenge, jumping straight to a potassium-binding drug may be premature.”
Physicians across specialties can differ in how they interpret potassium-level elevation and can use various cut points to flag when to stop RASI medication or at least hold back on up-titration, Dr. Butler observed. “Cardiologists have a different threshold of potassium that they tolerate than say, for instance, a nephrologist.”
Useful, then, might be a way to tell which patients are most likely to develop hyperkalemia with RASI up-titration and so might benefit from a potassium-binding agent right away. But DIAMOND, Dr. Butler said, “does not necessarily define any patient phenotype or any potassium level where we would say that you should use a potassium binder.”
The trial entered 1,642 patients with HFrEF and current or past RASI-related hyperkalemia to a 12-week run-in phase for optimization of GDMT with patiromer. The trial was conducted at nearly 400 centers in 21 countries.
RASI medication could be optimized in 85% of the cohort, from which 878 patients were randomly assigned either to continue optimized GDMT with patiromer or to have the potassium-sequestrant replaced with a placebo.
The patients on patiromer showed a 0.03-mEq/L mean rise in serum potassium levels from randomization to the end of the study, the primary endpoint, compared with a 0.13 mEq/L mean increase for those in the control group (P < .001), Dr. Butler reported.
The win ratio for a RASI-use score hierarchically featuring cardiovascular death and CV hospitalization for hyperkalemia at several levels of severity was 1.25 (95% confidence interval, 1.003-1.564; P = .048), favoring the patiromer group. The win ratio solely for hyperkalemia-related events also favored patients on patiromer, at 1.53 (95% CI, 1.23-1.91; P < .001).
Patiromer also seemed well tolerated, Dr. Butler said.
Hyperkalemia is “one of the most common excuses” from clinicians for failing to up-titrate RASI medicine in patients with heart failure, Dr. Januzzi said. DIAMOND was less about patiromer itself than about ways “to facilitate better GDMT, where we’re really falling short of the mark. During the run-in phase they were able to get the vast majority of individuals to target, which to me is a critically important point, and emblematic of the need for things that facilitate this kind of excellent care.”
DIAMOND was funded by Vifor Pharma. Dr. Butler disclosed receiving consulting fees from Abbott, Adrenomed, Amgen, Applied Therapeutics, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, G3 Pharma, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana Medical, and Vifor Pharma. Dr. Januzzi disclosed receiving consultant fees or honoraria from Abbott Laboratories, Imbria, Jana Care, Novartis, Prevencio, and Roche Diagnostics; serving on a data safety monitoring board for AbbVie, Amgen, Bayer Healthcare Pharmaceuticals, Beyer, CVRx, and Takeda Pharmaceuticals North America; and receiving research grants from Abbott Laboratories, Janssen, and Vifor Pharma.
A version of this article first appeared on Medscape.com.
Several of the core medications for patients with heart failure with reduced ejection fraction (HFrEF) come with a well-known risk of causing hyperkalemia, to which many clinicians respond by pulling back on dosing or withdrawing the culprit drug.
But accompanying renin-angiotensin system–inhibiting agents with the potassium-sequestrant patiromer (Veltassa, Vifor Pharma) appears to shield patients against hyperkalemia enough that they can take more RASI medications at higher doses, suggests a randomized, a controlled study.
The DIAMOND trial’s HFrEF patients, who had current or a history of RASI-related hyperkalemia, added either patiromer or placebo to their guideline-directed medical therapy (GDMT), which includes, even emphasizes, the culprit medication. They include ACE inhibitors, angiotensin-receptor blockers (ARBs), angiotensin-receptor/neprilysin inhibitors (ARNIs), and mineralocorticoid receptor antagonists (MRAs).
Those taking patiromer tolerated more intense RASI therapy – including MRAs, which are especially prone to causing hyperkalemia – than the patients assigned to placebo. They also maintained lower potassium concentrations and experienced fewer clinically important hyperkalemia episodes, reported Javed Butler, MD, MPH, MBA, Baylor Scott and White Research Institute, Dallas, at the annual scientific sessions of the American College of Cardiology.
The apparent benefit from patiromer came in part from an advantage for a composite hyperkalemia-event endpoint that included mortality, Dr. Butler noted. That advantage seemed to hold regardless of age, sex, body mass index, HFrEF symptom severity, or initial natriuretic peptide levels.
Patients who took patiromer, compared with those who took placebo, showed a 37% reduction in risk for hyperkalemia (P = .006), defined as potassium levels exceeding 5.5 mEq/L, over a median follow-up of 27 weeks. They were 38% less likely to have their MRA dosage reduced to below target level (P = .006).
More patients in the patiromer group than in the control group attained at least 50% of target dosage for MRAs and ACE inhibitors, ARBs, or ARNIs (92% vs. 87%; P = .015).
Patients with HFrEF are unlikely to achieve best possible outcomes without GDMT optimization, but failure to optimize is often attributed to hyperkalemia concerns. DIAMOND, Dr. Butler said, suggests that, by adding the potassium sequestrant to GDMT, “you can simultaneously control potassium and optimize RASI therapy.” Many clinicians seem to believe they can achieve only one or the other.
DIAMOND was too underpowered to show whether preventing hyperkalemia with patiromer could improve clinical outcomes. But failure to optimize RASI medication in HFrEF can worsen risk for heart failure events and death. So “it stands to reason that optimization of RASI therapy without a concomitant risk of hyperkalemia may, in the long run, lead to better outcomes for these patients,” Dr. Butler said in an interview.
Given the drug’s ability to keep potassium levels in check during RASI therapy, Dr. Butler said, “hypokalemia should not be a reason for suboptimal therapy.”
Patiromer and other potassium sequestrants have been available in the United States and Europe for 4-6 years, but their value as adjuncts to RASI medication in HFrEF or other heart failure has been unclear.
“There’s a good opportunity to expand the use of the drug. The question is, in whom and when?” James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.
Some HFrEF patients on GDMT “should be treated with patiromer. The bigger question is, should we give someone who has a history of hyperkalemia another chance at GDMT before we treat them with patiromer? Because they may not necessarily develop hyperkalemia a second time,” said Dr. Januzzi, who was on the DIAMOND endpoint-adjudication committee.
Among the most notable findings of the trial, he said, is that the number of people who developed hyperkalemia on RASI medication, although significantly elevated, “wasn’t as high as they expected it would be,” he said. “The data from DIAMOND argue that if a really significant majority does not become hyperkalemic on rechallenge, jumping straight to a potassium-binding drug may be premature.”
Physicians across specialties can differ in how they interpret potassium-level elevation and can use various cut points to flag when to stop RASI medication or at least hold back on up-titration, Dr. Butler observed. “Cardiologists have a different threshold of potassium that they tolerate than say, for instance, a nephrologist.”
Useful, then, might be a way to tell which patients are most likely to develop hyperkalemia with RASI up-titration and so might benefit from a potassium-binding agent right away. But DIAMOND, Dr. Butler said, “does not necessarily define any patient phenotype or any potassium level where we would say that you should use a potassium binder.”
The trial entered 1,642 patients with HFrEF and current or past RASI-related hyperkalemia to a 12-week run-in phase for optimization of GDMT with patiromer. The trial was conducted at nearly 400 centers in 21 countries.
RASI medication could be optimized in 85% of the cohort, from which 878 patients were randomly assigned either to continue optimized GDMT with patiromer or to have the potassium-sequestrant replaced with a placebo.
The patients on patiromer showed a 0.03-mEq/L mean rise in serum potassium levels from randomization to the end of the study, the primary endpoint, compared with a 0.13 mEq/L mean increase for those in the control group (P < .001), Dr. Butler reported.
The win ratio for a RASI-use score hierarchically featuring cardiovascular death and CV hospitalization for hyperkalemia at several levels of severity was 1.25 (95% confidence interval, 1.003-1.564; P = .048), favoring the patiromer group. The win ratio solely for hyperkalemia-related events also favored patients on patiromer, at 1.53 (95% CI, 1.23-1.91; P < .001).
Patiromer also seemed well tolerated, Dr. Butler said.
Hyperkalemia is “one of the most common excuses” from clinicians for failing to up-titrate RASI medicine in patients with heart failure, Dr. Januzzi said. DIAMOND was less about patiromer itself than about ways “to facilitate better GDMT, where we’re really falling short of the mark. During the run-in phase they were able to get the vast majority of individuals to target, which to me is a critically important point, and emblematic of the need for things that facilitate this kind of excellent care.”
DIAMOND was funded by Vifor Pharma. Dr. Butler disclosed receiving consulting fees from Abbott, Adrenomed, Amgen, Applied Therapeutics, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, G3 Pharma, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana Medical, and Vifor Pharma. Dr. Januzzi disclosed receiving consultant fees or honoraria from Abbott Laboratories, Imbria, Jana Care, Novartis, Prevencio, and Roche Diagnostics; serving on a data safety monitoring board for AbbVie, Amgen, Bayer Healthcare Pharmaceuticals, Beyer, CVRx, and Takeda Pharmaceuticals North America; and receiving research grants from Abbott Laboratories, Janssen, and Vifor Pharma.
A version of this article first appeared on Medscape.com.
FROM ACC 2022
Apremilast has neutral effect on vascular inflammation in psoriasis study
BOSTON – Treatment with , and glucose metabolism, in a study presented at the 2022 American Academy of Dermatology annual meeting.
In the phase 4, open-label, single arm trial, participants also lost subcutaneous and visceral fat after 16 weeks on the oral medication, a phosphodiesterase 4 (PDE4) inhibitor, and maintained that loss at 52 weeks.
People with psoriasis have an increased risk of obesity, type 2 diabetes, and cardiovascular events. Patients with more significant psoriasis “tend to die about 5 years younger than they should, based on their risk factors for mortality,” Joel Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania Perelman School of Medicine, Philadelphia, told this news organization.
He led the research and presented the findings at the AAD meeting March 26. “As a result, there has been a keen interest in understanding how psoriasis therapies impact cardiovascular risk, the idea being that by controlling inflammation, you may lower the risk of these patients developing cardiovascular disease over time,” he said.
Previous trials looking at the effect of psoriasis therapies on vascular inflammation “have been, for the most part, inconclusive,” Michael Garshick, MD, a cardiologist at NYU Langone Health, told this news organization. Dr. Garshick was not involved with the research. A 2021 systematic review of psoriasis clinicals trials reported that the tumor necrosis factor (TNF) blocker adalimumab (Humira) and phototherapy had the greatest effect on cardiometabolic markers, while ustekinumab (Stelara), an interleukin (IL)-12 and IL-23 antagonist, was the only treatment that improved vascular inflammation. These variable findings make this area “ripe for study,” noted Dr. Garshick.
To observe how apremilast, which is approved by the FDA for treating psoriasis and psoriatic arthritis, affected vascular inflammation, adiposity, and blood-based cardiometabolic markers, Dr. Gelfand organized an open-label study in adults with moderate-to-severe psoriasis. All participants were 18 years or older, had psoriasis for at least 6 months, and were candidates for systemic therapy. All patients underwent FDG PET/CT scans to assess aortic vascular inflammation and had blood work at baseline. Of the 70 patients originally enrolled in the study, 60 remained in the study at week 16, including 57 who underwent imaging for the second time. Thirty-nine participants remained in the study until week 52, and all except one had another scan.
The average age of participants was 47 years, and their mean BMI was 30. More than 80% of participants were White (83%) and 77% were male. The study population had lived with psoriasis for an average of 16 years and 8 patients also had psoriatic arthritis. At baseline, on average, participants had a Psoriasis Area and Severity Index (PASI) score of 18.62, a dermatology life quality index (DLQI) score of 11.60, and 22% of participants’ BSA (body surface area) were affected. The mean TBRmax, the marker for vascular inflammation, was 1.61.
Treatment responses were as expected for apremilast, with 35% of patients achieving PASI 75 and 65% of participants reporting DLQI scores of 5 or less by 16 weeks. At 52 weeks, 31% of the cohort had achieved PASI 75, and 67% reported DLQI score of 5 or higher. All psoriasis endpoints had improved since baseline (P = .001).
Throughout the study period, there was no significant change in TBRmax. However, in a sensitivity analysis, the 16 patients with a baseline TBRmax of 1.6 or higher had an absolute reduction of 0.21 in TBR by week 52. “That suggests that maybe a subset of people who have higher levels of aortic inflammation at baseline may experience some reduction that portend, potentially, some health benefits over time,” Dr. Gelfand said. “Ultimately, I wouldn’t hang my hat on the finding,” he said, noting that additional research comparing the treatment to placebo is necessary.
Both visceral and subcutaneous adipose tissue (VAT and SAT) decreased by week 16, and this reduction was maintained through week 52. In the first 16 weeks of the study, VAT decreased by 5.32% (P = .0009), and SAT decreased by 5.53% (P = .0005). From baseline to 52 weeks, VAT decreased by 5.52% (P = .0148), and SAT decreased by 5.50% (P = .0096). There were no significant differences between week 16 and week 52 in VAT or SAT.
Of the 68 blood biomarkers analyzed, there were significant decreases in the inflammatory markers ferritin (P = .015) and IL-beta (P = .006), the lipid metabolism biomarker HDL-cholesterol efflux (P = .008), and ketone bodies (P = .006). There were also increases in the inflammatory marker IL-8 (P = .003), the lipid metabolism marker ApoA (P = .05), and insulin (P = .05). Ferritin was the only biomarker that was reduced on both week 16 and week 52.
“If you want to be a purist, this was a negative trial,” said Dr. Garshick, because apremilast was not found to decrease vascular inflammation; however, he noted that the biomarker changes “were hopeful secondary endpoints.” It could be, he said, that another outcome measure may be better able to show changes in vascular inflammation compared with FDG. “It’s always hard to figure out what a good surrogate endpoint is in cardiovascular trials,” he noted, “so it may be that FDG/PET is too noisy or not reliable enough to see the outcome that we want to see.”
Dr. Gelfand reports consulting fees/grants from Amgen, AbbVie, BMS, Boehringer Ingelheim, Janssen Biologics, Novartis Corp, Pfizer, and UCB (DSMB). He serves as the Deputy Editor for the Journal of Investigative Dermatology and the Chief Medical Editor at Healio Psoriatic Disease and receives honoraria for both roles. Dr. Garshick has received consulting fees from AbbVie.
A version of this article first appeared on Medscape.com.
BOSTON – Treatment with , and glucose metabolism, in a study presented at the 2022 American Academy of Dermatology annual meeting.
In the phase 4, open-label, single arm trial, participants also lost subcutaneous and visceral fat after 16 weeks on the oral medication, a phosphodiesterase 4 (PDE4) inhibitor, and maintained that loss at 52 weeks.
People with psoriasis have an increased risk of obesity, type 2 diabetes, and cardiovascular events. Patients with more significant psoriasis “tend to die about 5 years younger than they should, based on their risk factors for mortality,” Joel Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania Perelman School of Medicine, Philadelphia, told this news organization.
He led the research and presented the findings at the AAD meeting March 26. “As a result, there has been a keen interest in understanding how psoriasis therapies impact cardiovascular risk, the idea being that by controlling inflammation, you may lower the risk of these patients developing cardiovascular disease over time,” he said.
Previous trials looking at the effect of psoriasis therapies on vascular inflammation “have been, for the most part, inconclusive,” Michael Garshick, MD, a cardiologist at NYU Langone Health, told this news organization. Dr. Garshick was not involved with the research. A 2021 systematic review of psoriasis clinicals trials reported that the tumor necrosis factor (TNF) blocker adalimumab (Humira) and phototherapy had the greatest effect on cardiometabolic markers, while ustekinumab (Stelara), an interleukin (IL)-12 and IL-23 antagonist, was the only treatment that improved vascular inflammation. These variable findings make this area “ripe for study,” noted Dr. Garshick.
To observe how apremilast, which is approved by the FDA for treating psoriasis and psoriatic arthritis, affected vascular inflammation, adiposity, and blood-based cardiometabolic markers, Dr. Gelfand organized an open-label study in adults with moderate-to-severe psoriasis. All participants were 18 years or older, had psoriasis for at least 6 months, and were candidates for systemic therapy. All patients underwent FDG PET/CT scans to assess aortic vascular inflammation and had blood work at baseline. Of the 70 patients originally enrolled in the study, 60 remained in the study at week 16, including 57 who underwent imaging for the second time. Thirty-nine participants remained in the study until week 52, and all except one had another scan.
The average age of participants was 47 years, and their mean BMI was 30. More than 80% of participants were White (83%) and 77% were male. The study population had lived with psoriasis for an average of 16 years and 8 patients also had psoriatic arthritis. At baseline, on average, participants had a Psoriasis Area and Severity Index (PASI) score of 18.62, a dermatology life quality index (DLQI) score of 11.60, and 22% of participants’ BSA (body surface area) were affected. The mean TBRmax, the marker for vascular inflammation, was 1.61.
Treatment responses were as expected for apremilast, with 35% of patients achieving PASI 75 and 65% of participants reporting DLQI scores of 5 or less by 16 weeks. At 52 weeks, 31% of the cohort had achieved PASI 75, and 67% reported DLQI score of 5 or higher. All psoriasis endpoints had improved since baseline (P = .001).
Throughout the study period, there was no significant change in TBRmax. However, in a sensitivity analysis, the 16 patients with a baseline TBRmax of 1.6 or higher had an absolute reduction of 0.21 in TBR by week 52. “That suggests that maybe a subset of people who have higher levels of aortic inflammation at baseline may experience some reduction that portend, potentially, some health benefits over time,” Dr. Gelfand said. “Ultimately, I wouldn’t hang my hat on the finding,” he said, noting that additional research comparing the treatment to placebo is necessary.
Both visceral and subcutaneous adipose tissue (VAT and SAT) decreased by week 16, and this reduction was maintained through week 52. In the first 16 weeks of the study, VAT decreased by 5.32% (P = .0009), and SAT decreased by 5.53% (P = .0005). From baseline to 52 weeks, VAT decreased by 5.52% (P = .0148), and SAT decreased by 5.50% (P = .0096). There were no significant differences between week 16 and week 52 in VAT or SAT.
Of the 68 blood biomarkers analyzed, there were significant decreases in the inflammatory markers ferritin (P = .015) and IL-beta (P = .006), the lipid metabolism biomarker HDL-cholesterol efflux (P = .008), and ketone bodies (P = .006). There were also increases in the inflammatory marker IL-8 (P = .003), the lipid metabolism marker ApoA (P = .05), and insulin (P = .05). Ferritin was the only biomarker that was reduced on both week 16 and week 52.
“If you want to be a purist, this was a negative trial,” said Dr. Garshick, because apremilast was not found to decrease vascular inflammation; however, he noted that the biomarker changes “were hopeful secondary endpoints.” It could be, he said, that another outcome measure may be better able to show changes in vascular inflammation compared with FDG. “It’s always hard to figure out what a good surrogate endpoint is in cardiovascular trials,” he noted, “so it may be that FDG/PET is too noisy or not reliable enough to see the outcome that we want to see.”
Dr. Gelfand reports consulting fees/grants from Amgen, AbbVie, BMS, Boehringer Ingelheim, Janssen Biologics, Novartis Corp, Pfizer, and UCB (DSMB). He serves as the Deputy Editor for the Journal of Investigative Dermatology and the Chief Medical Editor at Healio Psoriatic Disease and receives honoraria for both roles. Dr. Garshick has received consulting fees from AbbVie.
A version of this article first appeared on Medscape.com.
BOSTON – Treatment with , and glucose metabolism, in a study presented at the 2022 American Academy of Dermatology annual meeting.
In the phase 4, open-label, single arm trial, participants also lost subcutaneous and visceral fat after 16 weeks on the oral medication, a phosphodiesterase 4 (PDE4) inhibitor, and maintained that loss at 52 weeks.
People with psoriasis have an increased risk of obesity, type 2 diabetes, and cardiovascular events. Patients with more significant psoriasis “tend to die about 5 years younger than they should, based on their risk factors for mortality,” Joel Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania Perelman School of Medicine, Philadelphia, told this news organization.
He led the research and presented the findings at the AAD meeting March 26. “As a result, there has been a keen interest in understanding how psoriasis therapies impact cardiovascular risk, the idea being that by controlling inflammation, you may lower the risk of these patients developing cardiovascular disease over time,” he said.
Previous trials looking at the effect of psoriasis therapies on vascular inflammation “have been, for the most part, inconclusive,” Michael Garshick, MD, a cardiologist at NYU Langone Health, told this news organization. Dr. Garshick was not involved with the research. A 2021 systematic review of psoriasis clinicals trials reported that the tumor necrosis factor (TNF) blocker adalimumab (Humira) and phototherapy had the greatest effect on cardiometabolic markers, while ustekinumab (Stelara), an interleukin (IL)-12 and IL-23 antagonist, was the only treatment that improved vascular inflammation. These variable findings make this area “ripe for study,” noted Dr. Garshick.
To observe how apremilast, which is approved by the FDA for treating psoriasis and psoriatic arthritis, affected vascular inflammation, adiposity, and blood-based cardiometabolic markers, Dr. Gelfand organized an open-label study in adults with moderate-to-severe psoriasis. All participants were 18 years or older, had psoriasis for at least 6 months, and were candidates for systemic therapy. All patients underwent FDG PET/CT scans to assess aortic vascular inflammation and had blood work at baseline. Of the 70 patients originally enrolled in the study, 60 remained in the study at week 16, including 57 who underwent imaging for the second time. Thirty-nine participants remained in the study until week 52, and all except one had another scan.
The average age of participants was 47 years, and their mean BMI was 30. More than 80% of participants were White (83%) and 77% were male. The study population had lived with psoriasis for an average of 16 years and 8 patients also had psoriatic arthritis. At baseline, on average, participants had a Psoriasis Area and Severity Index (PASI) score of 18.62, a dermatology life quality index (DLQI) score of 11.60, and 22% of participants’ BSA (body surface area) were affected. The mean TBRmax, the marker for vascular inflammation, was 1.61.
Treatment responses were as expected for apremilast, with 35% of patients achieving PASI 75 and 65% of participants reporting DLQI scores of 5 or less by 16 weeks. At 52 weeks, 31% of the cohort had achieved PASI 75, and 67% reported DLQI score of 5 or higher. All psoriasis endpoints had improved since baseline (P = .001).
Throughout the study period, there was no significant change in TBRmax. However, in a sensitivity analysis, the 16 patients with a baseline TBRmax of 1.6 or higher had an absolute reduction of 0.21 in TBR by week 52. “That suggests that maybe a subset of people who have higher levels of aortic inflammation at baseline may experience some reduction that portend, potentially, some health benefits over time,” Dr. Gelfand said. “Ultimately, I wouldn’t hang my hat on the finding,” he said, noting that additional research comparing the treatment to placebo is necessary.
Both visceral and subcutaneous adipose tissue (VAT and SAT) decreased by week 16, and this reduction was maintained through week 52. In the first 16 weeks of the study, VAT decreased by 5.32% (P = .0009), and SAT decreased by 5.53% (P = .0005). From baseline to 52 weeks, VAT decreased by 5.52% (P = .0148), and SAT decreased by 5.50% (P = .0096). There were no significant differences between week 16 and week 52 in VAT or SAT.
Of the 68 blood biomarkers analyzed, there were significant decreases in the inflammatory markers ferritin (P = .015) and IL-beta (P = .006), the lipid metabolism biomarker HDL-cholesterol efflux (P = .008), and ketone bodies (P = .006). There were also increases in the inflammatory marker IL-8 (P = .003), the lipid metabolism marker ApoA (P = .05), and insulin (P = .05). Ferritin was the only biomarker that was reduced on both week 16 and week 52.
“If you want to be a purist, this was a negative trial,” said Dr. Garshick, because apremilast was not found to decrease vascular inflammation; however, he noted that the biomarker changes “were hopeful secondary endpoints.” It could be, he said, that another outcome measure may be better able to show changes in vascular inflammation compared with FDG. “It’s always hard to figure out what a good surrogate endpoint is in cardiovascular trials,” he noted, “so it may be that FDG/PET is too noisy or not reliable enough to see the outcome that we want to see.”
Dr. Gelfand reports consulting fees/grants from Amgen, AbbVie, BMS, Boehringer Ingelheim, Janssen Biologics, Novartis Corp, Pfizer, and UCB (DSMB). He serves as the Deputy Editor for the Journal of Investigative Dermatology and the Chief Medical Editor at Healio Psoriatic Disease and receives honoraria for both roles. Dr. Garshick has received consulting fees from AbbVie.
A version of this article first appeared on Medscape.com.
AT AAD 2022
About 19% of COVID-19 headaches become chronic
Approximately one in five patients who presented with headache during the acute phase of COVID-19 developed chronic daily headache, according to a study published in Cephalalgia. The greater the headache’s intensity during the acute phase, the greater the likelihood that it would persist.
The research, carried out by members of the Headache Study Group of the Spanish Society of Neurology, evaluated the evolution of headache in more than 900 Spanish patients. Because they found that headache intensity during the acute phase was associated with a more prolonged duration of headache, the team stressed the importance of promptly evaluating patients who have had COVID-19 and who then experience persistent headache.
Long-term evolution unknown
Headache is a common symptom of COVID-19, but its long-term evolution remains unknown. The objective of this study was to evaluate the long-term duration of headache in patients who presented with this symptom during the acute phase of the disease.
Recruitment for this multicenter study took place in March and April 2020. The 905 patients who were enrolled came from six level 3 hospitals in Spain. All completed 9 months of neurologic follow-up.
Their median age was 51 years, 66.5% were women, and more than half (52.7%) had a history of primary headache. About half of the patients required hospitalization (50.5%); the rest were treated as outpatients. The most common headache phenotype was holocranial (67.8%) of severe intensity (50.6%).
Persistent headache common
In the 96.6% cases for which data were available, the median duration of headache was 14 days. The headache persisted at 1 month in 31.1% of patients, at 2 months in 21.5%, at 3 months in 19%, at 6 months in 16.8%, and at 9 months in 16.0%.
“The median duration of COVID-19 headache is around 2 weeks,” David García Azorín, MD, PhD, a member of the Spanish Society of Neurology and one of the coauthors of the study, said in an interview. “However, almost 20% of patients experience it for longer than that. When still present at 2 months, the headache is more likely to follow a chronic daily pattern.” Dr. García Azorín is a neurologist and clinical researcher at the headache unit of the Hospital Clínico Universitario in Valladolid, Spain.
“So, if the headache isn’t letting up, it’s important to make the most of that window of opportunity and provide treatment in that period of 6-12 weeks,” he continued. “To do this, the best option is to carry out preventive treatment so that the patient will have a better chance of recovering.”
Study participants whose headache persisted at 9 months were older and were mostly women. They were less likely to have had pneumonia or to have experienced stabbing pain, photophobia, or phonophobia. They reported that the headache got worse when they engaged in physical activity but less frequently manifested as a throbbing headache.
Secondary tension headaches
On the other hand, Jaime Rodríguez Vico, MD, head of the headache unit at the Jiménez Díaz Foundation Hospital in Madrid, said in an interview that, according to his case studies, the most striking characteristics of post–COVID-19 headaches “in general are secondary, with similarities to tension headaches that patients are able to differentiate from other clinical types of headache. In patients with migraine, very often we see that we’re dealing with a trigger. In other words, more migraines – and more intense ones at that – are brought about.”
He added: “Generally, post–COVID-19 headache usually lasts 1-2 weeks, but we have cases of it lasting several months and even over a year with persistent daily headache. These more persistent cases are probably connected to another type of pathology that makes them more susceptible to becoming chronic, something that occurs in another type of primary headache known as new daily persistent headache.”
Primary headache exacerbation
Dr. García Azorín pointed out that it’s not uncommon that among people who already have primary headache, their condition worsens after they become infected with SARS-CoV-2. However, many people differentiate the headache associated with the infection from their usual headache because after becoming infected, their headache is predominantly frontal, oppressive, and chronic.
“Having a prior history of headache is one of the factors that can increase the likelihood that a headache experienced while suffering from COVID-19 will become chronic,” he noted.
This study also found that, more often than not, patients with persistent headache at 9 months had migraine-like pain.
As for headaches in these patients beyond 9 months, “based on our research, the evolution is quite variable,” said Dr. Rodríguez Vico. “Our unit’s numbers are skewed due to the high number of migraine cases that we follow, and therefore our high volume of migraine patients who’ve gotten worse. The same thing happens with COVID-19 vaccines. Migraine is a polygenic disorder with multiple variants and a pathophysiology that we are just beginning to describe. This is why one patient is completely different from another. It’s a real challenge.”
Infections are a common cause of acute and chronic headache. The persistence of a headache after an infection may be caused by the infection becoming chronic, as happens in some types of chronic meningitis, such as tuberculous meningitis. It may also be caused by the persistence of a certain response and activation of the immune system or to the uncovering or worsening of a primary headache coincident with the infection, added Dr. García Azorín.
“Likewise, there are other people who have a biological predisposition to headache as a multifactorial disorder and polygenic disorder, such that a particular stimulus – from trauma or an infection to alcohol consumption – can cause them to develop a headache very similar to a migraine,” he said.
Providing prognosis and treatment
Certain factors can give an idea of how long the headache might last. The study’s univariate analysis showed that age, female sex, headache intensity, pressure-like quality, the presence of photophobia/phonophobia, and worsening with physical activity were associated with headache of longer duration. But in the multivariate analysis, only headache intensity during the acute phase remained statistically significant (hazard ratio, 0.655; 95% confidence interval, 0.582-0.737; P < .001).
When asked whether they planned to continue the study, Dr. García Azorín commented, “The main questions that have arisen from this study have been, above all: ‘Why does this headache happen?’ and ‘How can it be treated or avoided?’ To answer them, we’re looking into pain: which factors could predispose a person to it and which changes may be associated with its presence.”
In addition, different treatments that may improve patient outcomes are being evaluated, because to date, treatment has been empirical and based on the predominant pain phenotype.
In any case, most doctors currently treat post–COVID-19 headache on the basis of how similar the symptoms are to those of other primary headaches. “Given the impact that headache has on patients’ quality of life, there’s a pressing need for controlled studies on possible treatments and their effectiveness,” noted Patricia Pozo Rosich, MD, PhD, one of the coauthors of the study.
“We at the Spanish Society of Neurology truly believe that if these patients were to have this symptom correctly addressed from the start, they could avoid many of the problems that arise in the situation becoming chronic,” she concluded.
Dr. García Azorín and Dr. Rodríguez Vico disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Approximately one in five patients who presented with headache during the acute phase of COVID-19 developed chronic daily headache, according to a study published in Cephalalgia. The greater the headache’s intensity during the acute phase, the greater the likelihood that it would persist.
The research, carried out by members of the Headache Study Group of the Spanish Society of Neurology, evaluated the evolution of headache in more than 900 Spanish patients. Because they found that headache intensity during the acute phase was associated with a more prolonged duration of headache, the team stressed the importance of promptly evaluating patients who have had COVID-19 and who then experience persistent headache.
Long-term evolution unknown
Headache is a common symptom of COVID-19, but its long-term evolution remains unknown. The objective of this study was to evaluate the long-term duration of headache in patients who presented with this symptom during the acute phase of the disease.
Recruitment for this multicenter study took place in March and April 2020. The 905 patients who were enrolled came from six level 3 hospitals in Spain. All completed 9 months of neurologic follow-up.
Their median age was 51 years, 66.5% were women, and more than half (52.7%) had a history of primary headache. About half of the patients required hospitalization (50.5%); the rest were treated as outpatients. The most common headache phenotype was holocranial (67.8%) of severe intensity (50.6%).
Persistent headache common
In the 96.6% cases for which data were available, the median duration of headache was 14 days. The headache persisted at 1 month in 31.1% of patients, at 2 months in 21.5%, at 3 months in 19%, at 6 months in 16.8%, and at 9 months in 16.0%.
“The median duration of COVID-19 headache is around 2 weeks,” David García Azorín, MD, PhD, a member of the Spanish Society of Neurology and one of the coauthors of the study, said in an interview. “However, almost 20% of patients experience it for longer than that. When still present at 2 months, the headache is more likely to follow a chronic daily pattern.” Dr. García Azorín is a neurologist and clinical researcher at the headache unit of the Hospital Clínico Universitario in Valladolid, Spain.
“So, if the headache isn’t letting up, it’s important to make the most of that window of opportunity and provide treatment in that period of 6-12 weeks,” he continued. “To do this, the best option is to carry out preventive treatment so that the patient will have a better chance of recovering.”
Study participants whose headache persisted at 9 months were older and were mostly women. They were less likely to have had pneumonia or to have experienced stabbing pain, photophobia, or phonophobia. They reported that the headache got worse when they engaged in physical activity but less frequently manifested as a throbbing headache.
Secondary tension headaches
On the other hand, Jaime Rodríguez Vico, MD, head of the headache unit at the Jiménez Díaz Foundation Hospital in Madrid, said in an interview that, according to his case studies, the most striking characteristics of post–COVID-19 headaches “in general are secondary, with similarities to tension headaches that patients are able to differentiate from other clinical types of headache. In patients with migraine, very often we see that we’re dealing with a trigger. In other words, more migraines – and more intense ones at that – are brought about.”
He added: “Generally, post–COVID-19 headache usually lasts 1-2 weeks, but we have cases of it lasting several months and even over a year with persistent daily headache. These more persistent cases are probably connected to another type of pathology that makes them more susceptible to becoming chronic, something that occurs in another type of primary headache known as new daily persistent headache.”
Primary headache exacerbation
Dr. García Azorín pointed out that it’s not uncommon that among people who already have primary headache, their condition worsens after they become infected with SARS-CoV-2. However, many people differentiate the headache associated with the infection from their usual headache because after becoming infected, their headache is predominantly frontal, oppressive, and chronic.
“Having a prior history of headache is one of the factors that can increase the likelihood that a headache experienced while suffering from COVID-19 will become chronic,” he noted.
This study also found that, more often than not, patients with persistent headache at 9 months had migraine-like pain.
As for headaches in these patients beyond 9 months, “based on our research, the evolution is quite variable,” said Dr. Rodríguez Vico. “Our unit’s numbers are skewed due to the high number of migraine cases that we follow, and therefore our high volume of migraine patients who’ve gotten worse. The same thing happens with COVID-19 vaccines. Migraine is a polygenic disorder with multiple variants and a pathophysiology that we are just beginning to describe. This is why one patient is completely different from another. It’s a real challenge.”
Infections are a common cause of acute and chronic headache. The persistence of a headache after an infection may be caused by the infection becoming chronic, as happens in some types of chronic meningitis, such as tuberculous meningitis. It may also be caused by the persistence of a certain response and activation of the immune system or to the uncovering or worsening of a primary headache coincident with the infection, added Dr. García Azorín.
“Likewise, there are other people who have a biological predisposition to headache as a multifactorial disorder and polygenic disorder, such that a particular stimulus – from trauma or an infection to alcohol consumption – can cause them to develop a headache very similar to a migraine,” he said.
Providing prognosis and treatment
Certain factors can give an idea of how long the headache might last. The study’s univariate analysis showed that age, female sex, headache intensity, pressure-like quality, the presence of photophobia/phonophobia, and worsening with physical activity were associated with headache of longer duration. But in the multivariate analysis, only headache intensity during the acute phase remained statistically significant (hazard ratio, 0.655; 95% confidence interval, 0.582-0.737; P < .001).
When asked whether they planned to continue the study, Dr. García Azorín commented, “The main questions that have arisen from this study have been, above all: ‘Why does this headache happen?’ and ‘How can it be treated or avoided?’ To answer them, we’re looking into pain: which factors could predispose a person to it and which changes may be associated with its presence.”
In addition, different treatments that may improve patient outcomes are being evaluated, because to date, treatment has been empirical and based on the predominant pain phenotype.
In any case, most doctors currently treat post–COVID-19 headache on the basis of how similar the symptoms are to those of other primary headaches. “Given the impact that headache has on patients’ quality of life, there’s a pressing need for controlled studies on possible treatments and their effectiveness,” noted Patricia Pozo Rosich, MD, PhD, one of the coauthors of the study.
“We at the Spanish Society of Neurology truly believe that if these patients were to have this symptom correctly addressed from the start, they could avoid many of the problems that arise in the situation becoming chronic,” she concluded.
Dr. García Azorín and Dr. Rodríguez Vico disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Approximately one in five patients who presented with headache during the acute phase of COVID-19 developed chronic daily headache, according to a study published in Cephalalgia. The greater the headache’s intensity during the acute phase, the greater the likelihood that it would persist.
The research, carried out by members of the Headache Study Group of the Spanish Society of Neurology, evaluated the evolution of headache in more than 900 Spanish patients. Because they found that headache intensity during the acute phase was associated with a more prolonged duration of headache, the team stressed the importance of promptly evaluating patients who have had COVID-19 and who then experience persistent headache.
Long-term evolution unknown
Headache is a common symptom of COVID-19, but its long-term evolution remains unknown. The objective of this study was to evaluate the long-term duration of headache in patients who presented with this symptom during the acute phase of the disease.
Recruitment for this multicenter study took place in March and April 2020. The 905 patients who were enrolled came from six level 3 hospitals in Spain. All completed 9 months of neurologic follow-up.
Their median age was 51 years, 66.5% were women, and more than half (52.7%) had a history of primary headache. About half of the patients required hospitalization (50.5%); the rest were treated as outpatients. The most common headache phenotype was holocranial (67.8%) of severe intensity (50.6%).
Persistent headache common
In the 96.6% cases for which data were available, the median duration of headache was 14 days. The headache persisted at 1 month in 31.1% of patients, at 2 months in 21.5%, at 3 months in 19%, at 6 months in 16.8%, and at 9 months in 16.0%.
“The median duration of COVID-19 headache is around 2 weeks,” David García Azorín, MD, PhD, a member of the Spanish Society of Neurology and one of the coauthors of the study, said in an interview. “However, almost 20% of patients experience it for longer than that. When still present at 2 months, the headache is more likely to follow a chronic daily pattern.” Dr. García Azorín is a neurologist and clinical researcher at the headache unit of the Hospital Clínico Universitario in Valladolid, Spain.
“So, if the headache isn’t letting up, it’s important to make the most of that window of opportunity and provide treatment in that period of 6-12 weeks,” he continued. “To do this, the best option is to carry out preventive treatment so that the patient will have a better chance of recovering.”
Study participants whose headache persisted at 9 months were older and were mostly women. They were less likely to have had pneumonia or to have experienced stabbing pain, photophobia, or phonophobia. They reported that the headache got worse when they engaged in physical activity but less frequently manifested as a throbbing headache.
Secondary tension headaches
On the other hand, Jaime Rodríguez Vico, MD, head of the headache unit at the Jiménez Díaz Foundation Hospital in Madrid, said in an interview that, according to his case studies, the most striking characteristics of post–COVID-19 headaches “in general are secondary, with similarities to tension headaches that patients are able to differentiate from other clinical types of headache. In patients with migraine, very often we see that we’re dealing with a trigger. In other words, more migraines – and more intense ones at that – are brought about.”
He added: “Generally, post–COVID-19 headache usually lasts 1-2 weeks, but we have cases of it lasting several months and even over a year with persistent daily headache. These more persistent cases are probably connected to another type of pathology that makes them more susceptible to becoming chronic, something that occurs in another type of primary headache known as new daily persistent headache.”
Primary headache exacerbation
Dr. García Azorín pointed out that it’s not uncommon that among people who already have primary headache, their condition worsens after they become infected with SARS-CoV-2. However, many people differentiate the headache associated with the infection from their usual headache because after becoming infected, their headache is predominantly frontal, oppressive, and chronic.
“Having a prior history of headache is one of the factors that can increase the likelihood that a headache experienced while suffering from COVID-19 will become chronic,” he noted.
This study also found that, more often than not, patients with persistent headache at 9 months had migraine-like pain.
As for headaches in these patients beyond 9 months, “based on our research, the evolution is quite variable,” said Dr. Rodríguez Vico. “Our unit’s numbers are skewed due to the high number of migraine cases that we follow, and therefore our high volume of migraine patients who’ve gotten worse. The same thing happens with COVID-19 vaccines. Migraine is a polygenic disorder with multiple variants and a pathophysiology that we are just beginning to describe. This is why one patient is completely different from another. It’s a real challenge.”
Infections are a common cause of acute and chronic headache. The persistence of a headache after an infection may be caused by the infection becoming chronic, as happens in some types of chronic meningitis, such as tuberculous meningitis. It may also be caused by the persistence of a certain response and activation of the immune system or to the uncovering or worsening of a primary headache coincident with the infection, added Dr. García Azorín.
“Likewise, there are other people who have a biological predisposition to headache as a multifactorial disorder and polygenic disorder, such that a particular stimulus – from trauma or an infection to alcohol consumption – can cause them to develop a headache very similar to a migraine,” he said.
Providing prognosis and treatment
Certain factors can give an idea of how long the headache might last. The study’s univariate analysis showed that age, female sex, headache intensity, pressure-like quality, the presence of photophobia/phonophobia, and worsening with physical activity were associated with headache of longer duration. But in the multivariate analysis, only headache intensity during the acute phase remained statistically significant (hazard ratio, 0.655; 95% confidence interval, 0.582-0.737; P < .001).
When asked whether they planned to continue the study, Dr. García Azorín commented, “The main questions that have arisen from this study have been, above all: ‘Why does this headache happen?’ and ‘How can it be treated or avoided?’ To answer them, we’re looking into pain: which factors could predispose a person to it and which changes may be associated with its presence.”
In addition, different treatments that may improve patient outcomes are being evaluated, because to date, treatment has been empirical and based on the predominant pain phenotype.
In any case, most doctors currently treat post–COVID-19 headache on the basis of how similar the symptoms are to those of other primary headaches. “Given the impact that headache has on patients’ quality of life, there’s a pressing need for controlled studies on possible treatments and their effectiveness,” noted Patricia Pozo Rosich, MD, PhD, one of the coauthors of the study.
“We at the Spanish Society of Neurology truly believe that if these patients were to have this symptom correctly addressed from the start, they could avoid many of the problems that arise in the situation becoming chronic,” she concluded.
Dr. García Azorín and Dr. Rodríguez Vico disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CEPHALALGIA
FDA to decide by June on future of COVID vaccines
April 6.
But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.
The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.
“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”
The virus itself will dictate vaccination plans, he said.
The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”
The government should clearly communicate to the public the goals of vaccination, he said.
“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.
The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.
Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.
Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.
“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
Not enough information to make broader plan
The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.
But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.
“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”
Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.
In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.
But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.
It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.
Still, study authors said, any protection against infection itself was “short lived.”
More like flu vaccine?
The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.
The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.
COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.
Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”
“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”
A version of this article first appeared on WebMD.com.
April 6.
But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.
The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.
“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”
The virus itself will dictate vaccination plans, he said.
The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”
The government should clearly communicate to the public the goals of vaccination, he said.
“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.
The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.
Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.
Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.
“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
Not enough information to make broader plan
The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.
But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.
“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”
Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.
In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.
But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.
It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.
Still, study authors said, any protection against infection itself was “short lived.”
More like flu vaccine?
The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.
The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.
COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.
Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”
“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”
A version of this article first appeared on WebMD.com.
April 6.
But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.
The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.
“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”
The virus itself will dictate vaccination plans, he said.
The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”
The government should clearly communicate to the public the goals of vaccination, he said.
“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.
The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.
Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.
Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.
“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
Not enough information to make broader plan
The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.
But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.
“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”
Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.
In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.
But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.
It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.
Still, study authors said, any protection against infection itself was “short lived.”
More like flu vaccine?
The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.
The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.
COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.
Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”
“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”
A version of this article first appeared on WebMD.com.
Type 2 diabetes remission possible for those with lower BMI
A weight-loss program can lead to type 2 diabetes remission, even in individuals with a normal body mass index (BMI), via loss of body fat, particularly in the liver and pancreas, shows a U.K. study.
The ReTUNE trial, funded by Diabetes UK, involved 20 people with type 2 diabetes of less than 6 year’s duration and a BMI of 27 kg/m2 or lower.
After 1 year, participants had lost 9% of their body weight.
Their body fat decreased significantly, to the same level as controls without type 2 diabetes, and they experienced decreases in liver fat, total triglycerides, and pancreatic fat.
The research, presented at the 2022 Diabetes UK Professional Conference, also showed this was accompanied by increases in insulin secretion and reductions in hemoglobin A1c and fasting plasma glucose levels.
Lead author Roy Taylor, MD, PhD, professor of medicine and metabolism, Newcastle University, Newcastle upon Tyne, England, said the findings indicate that the “etiology and pathophysiology of type 2 diabetes is the same whether BMI is normal or raised.”
This information should make a profound difference in what doctors advise their patients, Dr. Taylor added.
“One of the dramatic things about dealing with people in this group,” he said, “is they feel very resentful that healthcare professionals tell them not to lose weight.”
Based on the current results, Dr. Taylor believes this is “inappropriate advice, and it’s that personal advice that I think that this study points a way towards.”
Weight loss ‘first line of treatment’
These findings support the theory of a personal fat threshold, above which “type 2 diabetes occurs,” said Dr. Taylor. “Weight loss is the first-line treatment for all with type 2 diabetes, irrespective of BMI.”
Dr. Taylor already showed in the DiRECT trial that a calorie-restricted liquid diet followed by gradual food reintroduction and a weight-loss maintenance program can achieve and sustain type 2 diabetes remission at 2 years in people who are overweight or obese.
As reported this news organization, 36% of 300 patients enrolled in the trial attained diabetes remission and maintained it out to 24 months, compared with negligible changes in the control group.
Inspired by the results of DiRECT and the DROPLET study, the National Health Service has been rolling out a low calorie–diet treatment program for people who are overweight and living with diabetes.
Asked during the postpresentation discussion whether the current results could have implications for the NHS program, Dr. Taylor said it remains, in effect, a study and will not change things for now.
Chris Askew, chief executive of Diabetes UK, said in a release: “This game-changing study ... advances our understanding of why type 2 diabetes develops and what can be done to treat it.
“Our ambition is for as many people as possible to have the chance to put their type 2 diabetes into remission and live well for longer.”
Mr. Askew continued: “The findings of ReTUNE potentially take us a significant step closer to achieving this goal by showing that remission isn’t only possible for people of certain body weights.”
Weight and body fat decrease led to remission
For ReTUNE, the team recruited 20 individuals with type 2 diabetes of less than 6 year’s duration who had a BMI of 21-27 and compared them with 20 matched controls, with a follow-up of 52 weeks.
Patients were an average age of 59.0 years, 13 were women, mean BMI was 24.8, and average duration of diabetes was 2.8 years. Mean A1c was 54 mmol/mol.
Fourteen of the patients were taking metformin at enrollment and two were being treated with gliclazide. These medications were stopped when the individuals with type 2 diabetes entered a weight-loss program incremented in 5% steps, followed by 6 weeks of weight stability.
Overall, weight decreased by an average of 9%, while body fat decreased from 32% at baseline to 28% at 1 year (P < .001), the same percentage as that seen in the controls.
Liver fats also decreased significantly from baseline (P < .001) down to approximately the same level as controls at 1 year, a pattern also seen with very low-density lipoprotein cholesterol and triglyceride levels.
Pancreatic fat decreased steadily and significantly over the course of the 52-week follow-up (P < .05), although remained above the level seen in controls.
Insulin secretion increased significantly over the course of the study (P = .005) to finish just over the threshold for the lower range of normal at 52 weeks.
This, Dr. Taylor showed, was enough for the 14 patients who achieved type 2 diabetes remission to see their A1c levels fall significantly during follow-up (P < .001), alongside fasting plasma glucose levels (P < .001).
ReTUNE is funded by Diabetes UK. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A weight-loss program can lead to type 2 diabetes remission, even in individuals with a normal body mass index (BMI), via loss of body fat, particularly in the liver and pancreas, shows a U.K. study.
The ReTUNE trial, funded by Diabetes UK, involved 20 people with type 2 diabetes of less than 6 year’s duration and a BMI of 27 kg/m2 or lower.
After 1 year, participants had lost 9% of their body weight.
Their body fat decreased significantly, to the same level as controls without type 2 diabetes, and they experienced decreases in liver fat, total triglycerides, and pancreatic fat.
The research, presented at the 2022 Diabetes UK Professional Conference, also showed this was accompanied by increases in insulin secretion and reductions in hemoglobin A1c and fasting plasma glucose levels.
Lead author Roy Taylor, MD, PhD, professor of medicine and metabolism, Newcastle University, Newcastle upon Tyne, England, said the findings indicate that the “etiology and pathophysiology of type 2 diabetes is the same whether BMI is normal or raised.”
This information should make a profound difference in what doctors advise their patients, Dr. Taylor added.
“One of the dramatic things about dealing with people in this group,” he said, “is they feel very resentful that healthcare professionals tell them not to lose weight.”
Based on the current results, Dr. Taylor believes this is “inappropriate advice, and it’s that personal advice that I think that this study points a way towards.”
Weight loss ‘first line of treatment’
These findings support the theory of a personal fat threshold, above which “type 2 diabetes occurs,” said Dr. Taylor. “Weight loss is the first-line treatment for all with type 2 diabetes, irrespective of BMI.”
Dr. Taylor already showed in the DiRECT trial that a calorie-restricted liquid diet followed by gradual food reintroduction and a weight-loss maintenance program can achieve and sustain type 2 diabetes remission at 2 years in people who are overweight or obese.
As reported this news organization, 36% of 300 patients enrolled in the trial attained diabetes remission and maintained it out to 24 months, compared with negligible changes in the control group.
Inspired by the results of DiRECT and the DROPLET study, the National Health Service has been rolling out a low calorie–diet treatment program for people who are overweight and living with diabetes.
Asked during the postpresentation discussion whether the current results could have implications for the NHS program, Dr. Taylor said it remains, in effect, a study and will not change things for now.
Chris Askew, chief executive of Diabetes UK, said in a release: “This game-changing study ... advances our understanding of why type 2 diabetes develops and what can be done to treat it.
“Our ambition is for as many people as possible to have the chance to put their type 2 diabetes into remission and live well for longer.”
Mr. Askew continued: “The findings of ReTUNE potentially take us a significant step closer to achieving this goal by showing that remission isn’t only possible for people of certain body weights.”
Weight and body fat decrease led to remission
For ReTUNE, the team recruited 20 individuals with type 2 diabetes of less than 6 year’s duration who had a BMI of 21-27 and compared them with 20 matched controls, with a follow-up of 52 weeks.
Patients were an average age of 59.0 years, 13 were women, mean BMI was 24.8, and average duration of diabetes was 2.8 years. Mean A1c was 54 mmol/mol.
Fourteen of the patients were taking metformin at enrollment and two were being treated with gliclazide. These medications were stopped when the individuals with type 2 diabetes entered a weight-loss program incremented in 5% steps, followed by 6 weeks of weight stability.
Overall, weight decreased by an average of 9%, while body fat decreased from 32% at baseline to 28% at 1 year (P < .001), the same percentage as that seen in the controls.
Liver fats also decreased significantly from baseline (P < .001) down to approximately the same level as controls at 1 year, a pattern also seen with very low-density lipoprotein cholesterol and triglyceride levels.
Pancreatic fat decreased steadily and significantly over the course of the 52-week follow-up (P < .05), although remained above the level seen in controls.
Insulin secretion increased significantly over the course of the study (P = .005) to finish just over the threshold for the lower range of normal at 52 weeks.
This, Dr. Taylor showed, was enough for the 14 patients who achieved type 2 diabetes remission to see their A1c levels fall significantly during follow-up (P < .001), alongside fasting plasma glucose levels (P < .001).
ReTUNE is funded by Diabetes UK. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A weight-loss program can lead to type 2 diabetes remission, even in individuals with a normal body mass index (BMI), via loss of body fat, particularly in the liver and pancreas, shows a U.K. study.
The ReTUNE trial, funded by Diabetes UK, involved 20 people with type 2 diabetes of less than 6 year’s duration and a BMI of 27 kg/m2 or lower.
After 1 year, participants had lost 9% of their body weight.
Their body fat decreased significantly, to the same level as controls without type 2 diabetes, and they experienced decreases in liver fat, total triglycerides, and pancreatic fat.
The research, presented at the 2022 Diabetes UK Professional Conference, also showed this was accompanied by increases in insulin secretion and reductions in hemoglobin A1c and fasting plasma glucose levels.
Lead author Roy Taylor, MD, PhD, professor of medicine and metabolism, Newcastle University, Newcastle upon Tyne, England, said the findings indicate that the “etiology and pathophysiology of type 2 diabetes is the same whether BMI is normal or raised.”
This information should make a profound difference in what doctors advise their patients, Dr. Taylor added.
“One of the dramatic things about dealing with people in this group,” he said, “is they feel very resentful that healthcare professionals tell them not to lose weight.”
Based on the current results, Dr. Taylor believes this is “inappropriate advice, and it’s that personal advice that I think that this study points a way towards.”
Weight loss ‘first line of treatment’
These findings support the theory of a personal fat threshold, above which “type 2 diabetes occurs,” said Dr. Taylor. “Weight loss is the first-line treatment for all with type 2 diabetes, irrespective of BMI.”
Dr. Taylor already showed in the DiRECT trial that a calorie-restricted liquid diet followed by gradual food reintroduction and a weight-loss maintenance program can achieve and sustain type 2 diabetes remission at 2 years in people who are overweight or obese.
As reported this news organization, 36% of 300 patients enrolled in the trial attained diabetes remission and maintained it out to 24 months, compared with negligible changes in the control group.
Inspired by the results of DiRECT and the DROPLET study, the National Health Service has been rolling out a low calorie–diet treatment program for people who are overweight and living with diabetes.
Asked during the postpresentation discussion whether the current results could have implications for the NHS program, Dr. Taylor said it remains, in effect, a study and will not change things for now.
Chris Askew, chief executive of Diabetes UK, said in a release: “This game-changing study ... advances our understanding of why type 2 diabetes develops and what can be done to treat it.
“Our ambition is for as many people as possible to have the chance to put their type 2 diabetes into remission and live well for longer.”
Mr. Askew continued: “The findings of ReTUNE potentially take us a significant step closer to achieving this goal by showing that remission isn’t only possible for people of certain body weights.”
Weight and body fat decrease led to remission
For ReTUNE, the team recruited 20 individuals with type 2 diabetes of less than 6 year’s duration who had a BMI of 21-27 and compared them with 20 matched controls, with a follow-up of 52 weeks.
Patients were an average age of 59.0 years, 13 were women, mean BMI was 24.8, and average duration of diabetes was 2.8 years. Mean A1c was 54 mmol/mol.
Fourteen of the patients were taking metformin at enrollment and two were being treated with gliclazide. These medications were stopped when the individuals with type 2 diabetes entered a weight-loss program incremented in 5% steps, followed by 6 weeks of weight stability.
Overall, weight decreased by an average of 9%, while body fat decreased from 32% at baseline to 28% at 1 year (P < .001), the same percentage as that seen in the controls.
Liver fats also decreased significantly from baseline (P < .001) down to approximately the same level as controls at 1 year, a pattern also seen with very low-density lipoprotein cholesterol and triglyceride levels.
Pancreatic fat decreased steadily and significantly over the course of the 52-week follow-up (P < .05), although remained above the level seen in controls.
Insulin secretion increased significantly over the course of the study (P = .005) to finish just over the threshold for the lower range of normal at 52 weeks.
This, Dr. Taylor showed, was enough for the 14 patients who achieved type 2 diabetes remission to see their A1c levels fall significantly during follow-up (P < .001), alongside fasting plasma glucose levels (P < .001).
ReTUNE is funded by Diabetes UK. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Outbid on three houses!’ Doc frustrated by crazy market
After more than a decade of moving because of medical school, residencies, and international fellowships, Abhi Kole, MD, PhD, is ready to put down roots. But he’s learning that buying a house in today’s housing market is easier said than done.
In the past 6 months, Dr. Kole, an internist at Grady Hospital in Atlanta, put in offers on three houses. None resulted in a purchase. Dr. Kole says he’s learned how to be more competitive with each subsequent offer, starting out with a bid significantly above the asking price and waiving his right to an appraisal or financing contingencies.
The experience has been surprising and disappointing.
“I knew the market was bad when I started looking and that home prices had gone up,” Dr. Kole says. “What I didn’t realize was that it would still be so hard for me. I have a good job, no debt, and great credit.”
Another frustration for Dr. Kole: He’s been approved for a physician’s loan (a type of mortgage that requires a lower down payment and does not count student loans in debt-to-income calculations) from a national bank, but sellers seem to prefer buyers who work with local lenders. Dr. Kole has been willing to waive the appraisal and mortgage contingency on the right home, but he draws the line at waiving the inspection, a trend that some other buyers in his area are going along with.
“With each house, I learn more about how this works and what amount of risk I can safely assume,” Dr. Kobe says. “There are certain things I definitely wouldn’t give up.”
“Potential homebuyers are really facing a triple threat right now,” says Clare Losey, an assistant research economist with the Texas Real Estate Research Center. “There’s high home appreciation, high mortgage rates, and low inventory of homes for sale.”
It’s still possible to find — and buy — your dream home, even in today’s market with all its challenges. Here are some important steps that can help you.
1. Do not low ball.
There may be some cases in which you can save money by making an offer significantly below the asking price on a property. However, with most housing areas across the country experiencing a seller’s market, you run the risk of offending the buyer or being dismissed as not having a serious offer.
In today’s market, a better strategy is to go in with close to your best and final offer from the start, realtors say. It can help to waive the appraisal or financing contingency as well, although it’s important to understand the risk associated with doing so. Last month, the average home sold for 103% of the list price, according to data compiled from Statista.
2. Get credit ready.
The better your credit, the easier time you’ll have getting a mortgage — and the lower the rate you’ll pay for the loan. The average first-time homebuyer has a credit score of 746, according to a recent paper by Fannie Mae. If you know you’re going to buy a home in the next few months, you can improve your credit by making sure to pay all your bills on time and by avoiding taking on any new debt.
This is also a good opportunity to check your credit report (get all three reports for free from AnnualCreditReport.com) to see whether there are any mistakes or other problems that you’ll need to clear up before applying for a loan. Also, take a look at your credit-utilization ratio (the amount of credit you use compared to the amount available to you). Experts recommend keeping this number below 30%.
3. Prepare to move quickly.
Among homes that closed in March, the average number of days on the market (the amount of time between listing and closing) was just 38 days, according to Realtor.com. In busy markets, homes are moving even faster, realtors say, with sellers commonly accepting offers within days of listing their house for sale.
“It’s crazy,” says Sarah Scattini, president of the Reno/Sparks Association of Realtors. “The market is moving extremely fast here. If you list your home, your sale is pending within 5 days.”
In addition to moving quickly to make your initial offer, do the same if a buyer counters with a negotiation. A speedy response will show the buyer that you’re very interested — and to beat out any other bidders who may have also received a counteroffer.
4. Shop around for mortgages.
Especially for first-time homebuyers, the process will go much more smoothly if you’ve got a team of professionals to help you. Look for a realtor and a mortgage lender who have experience working with first-time homebuyers and with physicians, if possible.
Since mortgage rates can vary wildly, you’ll want to shop around a bit before settling on a lender. Get quotes from a local lender, an online lender, and, potentially, a credit union or a mortgage broker to get a sense of the types of mortgages and rates available to you.
“With multiple offers on every single listing, you really want to align yourself with a great realtor who can negotiate for you on your behalf and navigate you through this very tricky market,” says Ms. Scattini.
For both your realtor and your lender, you’ll want to know up front how they get paid and how they calculate their fees. Typically, the real estate agents for buyers and sellers split a 6% commission on home sales, meaning that your realtor will likely take home 3% of the purchase price.
5. Get preapproved.
Once you’ve settled on a lender, getting preapproved for a mortgage can make your offer more appealing to potential buyers. Preapproval is an in-depth process in which lenders pull your credit and look at other financial factors, such as your income and assets, to tell you ahead of time how much you could borrow under their standards and how much that might cost you.
These days, a large number of buyers are coming in with a cash offer, which in former times was considered very appealing to sellers. However, preapproval helps equalize buyers, and as one seller noted, “I don’t care if it’s cash or mortgage, as long as I get the money.”
If, like most homebuyers, you need a mortgage to finance the purchase, having preapproval can provide some assurance to sellers that your offer won’t fall through because you can’t qualify for the mortgage you expected. Once you’ve received preapproval, don’t open any new credit accounts. If your credit score goes down, the amount you can borrow could decline as well.
6. Firm up your budget.
While the preapproval process will tell you how much a lender thinks you can afford, it typically makes sense to come up with your own budget as well. That’s because banks and other mortgage lenders may approve you for much more than you want or are able to pay for a home.
You’ll want to factor in future costs of homeowners as well as any other (current or future) expenses for which the lender may not have accounted. For example, if you’re planning to have children soon, you may want to lower your budget to factor in the cost of childcare.
Knowing your budget ahead of time, and looking only at houses that fall within it, will prevent you from falling in love with a house that you really can’t afford.
7. Stick with it.
Buying a house in today’s market is no easy task. The first part of the process requires simply looking at multiple houses to get a sense of how far your budget will go and whether there are homes that meet your requirements.
If you’re sure that purchasing a home is the best financial move for you, don’t give up. Instead, consider whether you can make adjustments that could widen your pool of potential homes. That may mean changing your budget, moving a little further out geographically, or opting for a house that needs a little more work than you expected.
That said, while the pace of price increases will likely moderate, it’s unlikely prices will go down significantly in the future.
“We might see home price appreciation subside to levels close to 10% to 15% [from 20% last year] or even just 5% to 10%,” Ms. Losey says. “When you do the math, home prices just can’t continue to go up 20% year over year.”
Dr. Kobe is planning to keep looking for his home for at least the next several months.
“Prices are still going up, but we are hearing that the inventory will increase over the summer,” he says. “I’m still out looking for the right house, and I’m ready to make an offer.”
A version of this article first appeared on Medscape.com.
After more than a decade of moving because of medical school, residencies, and international fellowships, Abhi Kole, MD, PhD, is ready to put down roots. But he’s learning that buying a house in today’s housing market is easier said than done.
In the past 6 months, Dr. Kole, an internist at Grady Hospital in Atlanta, put in offers on three houses. None resulted in a purchase. Dr. Kole says he’s learned how to be more competitive with each subsequent offer, starting out with a bid significantly above the asking price and waiving his right to an appraisal or financing contingencies.
The experience has been surprising and disappointing.
“I knew the market was bad when I started looking and that home prices had gone up,” Dr. Kole says. “What I didn’t realize was that it would still be so hard for me. I have a good job, no debt, and great credit.”
Another frustration for Dr. Kole: He’s been approved for a physician’s loan (a type of mortgage that requires a lower down payment and does not count student loans in debt-to-income calculations) from a national bank, but sellers seem to prefer buyers who work with local lenders. Dr. Kole has been willing to waive the appraisal and mortgage contingency on the right home, but he draws the line at waiving the inspection, a trend that some other buyers in his area are going along with.
“With each house, I learn more about how this works and what amount of risk I can safely assume,” Dr. Kobe says. “There are certain things I definitely wouldn’t give up.”
“Potential homebuyers are really facing a triple threat right now,” says Clare Losey, an assistant research economist with the Texas Real Estate Research Center. “There’s high home appreciation, high mortgage rates, and low inventory of homes for sale.”
It’s still possible to find — and buy — your dream home, even in today’s market with all its challenges. Here are some important steps that can help you.
1. Do not low ball.
There may be some cases in which you can save money by making an offer significantly below the asking price on a property. However, with most housing areas across the country experiencing a seller’s market, you run the risk of offending the buyer or being dismissed as not having a serious offer.
In today’s market, a better strategy is to go in with close to your best and final offer from the start, realtors say. It can help to waive the appraisal or financing contingency as well, although it’s important to understand the risk associated with doing so. Last month, the average home sold for 103% of the list price, according to data compiled from Statista.
2. Get credit ready.
The better your credit, the easier time you’ll have getting a mortgage — and the lower the rate you’ll pay for the loan. The average first-time homebuyer has a credit score of 746, according to a recent paper by Fannie Mae. If you know you’re going to buy a home in the next few months, you can improve your credit by making sure to pay all your bills on time and by avoiding taking on any new debt.
This is also a good opportunity to check your credit report (get all three reports for free from AnnualCreditReport.com) to see whether there are any mistakes or other problems that you’ll need to clear up before applying for a loan. Also, take a look at your credit-utilization ratio (the amount of credit you use compared to the amount available to you). Experts recommend keeping this number below 30%.
3. Prepare to move quickly.
Among homes that closed in March, the average number of days on the market (the amount of time between listing and closing) was just 38 days, according to Realtor.com. In busy markets, homes are moving even faster, realtors say, with sellers commonly accepting offers within days of listing their house for sale.
“It’s crazy,” says Sarah Scattini, president of the Reno/Sparks Association of Realtors. “The market is moving extremely fast here. If you list your home, your sale is pending within 5 days.”
In addition to moving quickly to make your initial offer, do the same if a buyer counters with a negotiation. A speedy response will show the buyer that you’re very interested — and to beat out any other bidders who may have also received a counteroffer.
4. Shop around for mortgages.
Especially for first-time homebuyers, the process will go much more smoothly if you’ve got a team of professionals to help you. Look for a realtor and a mortgage lender who have experience working with first-time homebuyers and with physicians, if possible.
Since mortgage rates can vary wildly, you’ll want to shop around a bit before settling on a lender. Get quotes from a local lender, an online lender, and, potentially, a credit union or a mortgage broker to get a sense of the types of mortgages and rates available to you.
“With multiple offers on every single listing, you really want to align yourself with a great realtor who can negotiate for you on your behalf and navigate you through this very tricky market,” says Ms. Scattini.
For both your realtor and your lender, you’ll want to know up front how they get paid and how they calculate their fees. Typically, the real estate agents for buyers and sellers split a 6% commission on home sales, meaning that your realtor will likely take home 3% of the purchase price.
5. Get preapproved.
Once you’ve settled on a lender, getting preapproved for a mortgage can make your offer more appealing to potential buyers. Preapproval is an in-depth process in which lenders pull your credit and look at other financial factors, such as your income and assets, to tell you ahead of time how much you could borrow under their standards and how much that might cost you.
These days, a large number of buyers are coming in with a cash offer, which in former times was considered very appealing to sellers. However, preapproval helps equalize buyers, and as one seller noted, “I don’t care if it’s cash or mortgage, as long as I get the money.”
If, like most homebuyers, you need a mortgage to finance the purchase, having preapproval can provide some assurance to sellers that your offer won’t fall through because you can’t qualify for the mortgage you expected. Once you’ve received preapproval, don’t open any new credit accounts. If your credit score goes down, the amount you can borrow could decline as well.
6. Firm up your budget.
While the preapproval process will tell you how much a lender thinks you can afford, it typically makes sense to come up with your own budget as well. That’s because banks and other mortgage lenders may approve you for much more than you want or are able to pay for a home.
You’ll want to factor in future costs of homeowners as well as any other (current or future) expenses for which the lender may not have accounted. For example, if you’re planning to have children soon, you may want to lower your budget to factor in the cost of childcare.
Knowing your budget ahead of time, and looking only at houses that fall within it, will prevent you from falling in love with a house that you really can’t afford.
7. Stick with it.
Buying a house in today’s market is no easy task. The first part of the process requires simply looking at multiple houses to get a sense of how far your budget will go and whether there are homes that meet your requirements.
If you’re sure that purchasing a home is the best financial move for you, don’t give up. Instead, consider whether you can make adjustments that could widen your pool of potential homes. That may mean changing your budget, moving a little further out geographically, or opting for a house that needs a little more work than you expected.
That said, while the pace of price increases will likely moderate, it’s unlikely prices will go down significantly in the future.
“We might see home price appreciation subside to levels close to 10% to 15% [from 20% last year] or even just 5% to 10%,” Ms. Losey says. “When you do the math, home prices just can’t continue to go up 20% year over year.”
Dr. Kobe is planning to keep looking for his home for at least the next several months.
“Prices are still going up, but we are hearing that the inventory will increase over the summer,” he says. “I’m still out looking for the right house, and I’m ready to make an offer.”
A version of this article first appeared on Medscape.com.
After more than a decade of moving because of medical school, residencies, and international fellowships, Abhi Kole, MD, PhD, is ready to put down roots. But he’s learning that buying a house in today’s housing market is easier said than done.
In the past 6 months, Dr. Kole, an internist at Grady Hospital in Atlanta, put in offers on three houses. None resulted in a purchase. Dr. Kole says he’s learned how to be more competitive with each subsequent offer, starting out with a bid significantly above the asking price and waiving his right to an appraisal or financing contingencies.
The experience has been surprising and disappointing.
“I knew the market was bad when I started looking and that home prices had gone up,” Dr. Kole says. “What I didn’t realize was that it would still be so hard for me. I have a good job, no debt, and great credit.”
Another frustration for Dr. Kole: He’s been approved for a physician’s loan (a type of mortgage that requires a lower down payment and does not count student loans in debt-to-income calculations) from a national bank, but sellers seem to prefer buyers who work with local lenders. Dr. Kole has been willing to waive the appraisal and mortgage contingency on the right home, but he draws the line at waiving the inspection, a trend that some other buyers in his area are going along with.
“With each house, I learn more about how this works and what amount of risk I can safely assume,” Dr. Kobe says. “There are certain things I definitely wouldn’t give up.”
“Potential homebuyers are really facing a triple threat right now,” says Clare Losey, an assistant research economist with the Texas Real Estate Research Center. “There’s high home appreciation, high mortgage rates, and low inventory of homes for sale.”
It’s still possible to find — and buy — your dream home, even in today’s market with all its challenges. Here are some important steps that can help you.
1. Do not low ball.
There may be some cases in which you can save money by making an offer significantly below the asking price on a property. However, with most housing areas across the country experiencing a seller’s market, you run the risk of offending the buyer or being dismissed as not having a serious offer.
In today’s market, a better strategy is to go in with close to your best and final offer from the start, realtors say. It can help to waive the appraisal or financing contingency as well, although it’s important to understand the risk associated with doing so. Last month, the average home sold for 103% of the list price, according to data compiled from Statista.
2. Get credit ready.
The better your credit, the easier time you’ll have getting a mortgage — and the lower the rate you’ll pay for the loan. The average first-time homebuyer has a credit score of 746, according to a recent paper by Fannie Mae. If you know you’re going to buy a home in the next few months, you can improve your credit by making sure to pay all your bills on time and by avoiding taking on any new debt.
This is also a good opportunity to check your credit report (get all three reports for free from AnnualCreditReport.com) to see whether there are any mistakes or other problems that you’ll need to clear up before applying for a loan. Also, take a look at your credit-utilization ratio (the amount of credit you use compared to the amount available to you). Experts recommend keeping this number below 30%.
3. Prepare to move quickly.
Among homes that closed in March, the average number of days on the market (the amount of time between listing and closing) was just 38 days, according to Realtor.com. In busy markets, homes are moving even faster, realtors say, with sellers commonly accepting offers within days of listing their house for sale.
“It’s crazy,” says Sarah Scattini, president of the Reno/Sparks Association of Realtors. “The market is moving extremely fast here. If you list your home, your sale is pending within 5 days.”
In addition to moving quickly to make your initial offer, do the same if a buyer counters with a negotiation. A speedy response will show the buyer that you’re very interested — and to beat out any other bidders who may have also received a counteroffer.
4. Shop around for mortgages.
Especially for first-time homebuyers, the process will go much more smoothly if you’ve got a team of professionals to help you. Look for a realtor and a mortgage lender who have experience working with first-time homebuyers and with physicians, if possible.
Since mortgage rates can vary wildly, you’ll want to shop around a bit before settling on a lender. Get quotes from a local lender, an online lender, and, potentially, a credit union or a mortgage broker to get a sense of the types of mortgages and rates available to you.
“With multiple offers on every single listing, you really want to align yourself with a great realtor who can negotiate for you on your behalf and navigate you through this very tricky market,” says Ms. Scattini.
For both your realtor and your lender, you’ll want to know up front how they get paid and how they calculate their fees. Typically, the real estate agents for buyers and sellers split a 6% commission on home sales, meaning that your realtor will likely take home 3% of the purchase price.
5. Get preapproved.
Once you’ve settled on a lender, getting preapproved for a mortgage can make your offer more appealing to potential buyers. Preapproval is an in-depth process in which lenders pull your credit and look at other financial factors, such as your income and assets, to tell you ahead of time how much you could borrow under their standards and how much that might cost you.
These days, a large number of buyers are coming in with a cash offer, which in former times was considered very appealing to sellers. However, preapproval helps equalize buyers, and as one seller noted, “I don’t care if it’s cash or mortgage, as long as I get the money.”
If, like most homebuyers, you need a mortgage to finance the purchase, having preapproval can provide some assurance to sellers that your offer won’t fall through because you can’t qualify for the mortgage you expected. Once you’ve received preapproval, don’t open any new credit accounts. If your credit score goes down, the amount you can borrow could decline as well.
6. Firm up your budget.
While the preapproval process will tell you how much a lender thinks you can afford, it typically makes sense to come up with your own budget as well. That’s because banks and other mortgage lenders may approve you for much more than you want or are able to pay for a home.
You’ll want to factor in future costs of homeowners as well as any other (current or future) expenses for which the lender may not have accounted. For example, if you’re planning to have children soon, you may want to lower your budget to factor in the cost of childcare.
Knowing your budget ahead of time, and looking only at houses that fall within it, will prevent you from falling in love with a house that you really can’t afford.
7. Stick with it.
Buying a house in today’s market is no easy task. The first part of the process requires simply looking at multiple houses to get a sense of how far your budget will go and whether there are homes that meet your requirements.
If you’re sure that purchasing a home is the best financial move for you, don’t give up. Instead, consider whether you can make adjustments that could widen your pool of potential homes. That may mean changing your budget, moving a little further out geographically, or opting for a house that needs a little more work than you expected.
That said, while the pace of price increases will likely moderate, it’s unlikely prices will go down significantly in the future.
“We might see home price appreciation subside to levels close to 10% to 15% [from 20% last year] or even just 5% to 10%,” Ms. Losey says. “When you do the math, home prices just can’t continue to go up 20% year over year.”
Dr. Kobe is planning to keep looking for his home for at least the next several months.
“Prices are still going up, but we are hearing that the inventory will increase over the summer,” he says. “I’m still out looking for the right house, and I’m ready to make an offer.”
A version of this article first appeared on Medscape.com.
Bellies up to the bar, the weight gain is on us
I’d do anything for weight loss (but I won’t do that)
Weight loss isn’t a multibillion-dollar industry for nothing. How many people step onto the scale in the morning and sigh, wishing they could lose that last 10 pounds?
Alcohol also isn’t a multibillion-dollar industry for nothing. If there’s one thing more universal than wishing you could lose weight, it’s drinking to forget your woes about being unable to lose weight.
Naturally, and unfortunately for those of us who rather enjoy a good beer, one of the best ways to lose weight is to stop drinking. Alcohol is almost the definition of empty calories. So, which wins out: The unstoppable force of wanting to lose weight, or the immovable object of alcohol? According to a survey from DrugAbuse.com, it’s alcohol, and it’s not even close.
Even in a state with as health conscious a reputation as California, not only are people not willing to give up alcohol to lose weight, they’re willing to gain a noticeable amount of weight in order to continue drinking. It’s 14 pounds for Californians, which is in the middle of the road for America, which overall averaged 13 pounds to keep drinking. Hawaiians, South Dakotans, Utahns, and Vermonters were at the bottom, willing to add only 8 pounds to keep booze in their diet. At the other end of the scale, willing to add 28 whole pounds to keep the beer flowing, is humble little Rhode Island, followed by Wyoming at 23 pounds, Maryland at 22, and Tennessee at 21.
Obviously, that’s a lot of weight to gain, but to drive home the exact quantity of just how much weight, KRON-TV noted that adding the U.S. average of 13 pounds to your body is the equivalent of strapping 224 slices of bacon to yourself, which, to us, is just the poorest choice of comparison. If there’s one thing we’re less willing to give up than alcohol, it’s probably bacon. Or if you’re feeling especially ambitious, you could go for bacon-scented beer from the Waffle House. Now that’s a drink.
This looks like a job for the ‘magnetic slime robot’
What’s that? While you were in the process of gaining 14 pounds so you could keep drinking alcohol you swallowed something that you shouldn’t have? Did you swallow a lot of aggression?
You swallowed a what? An ear bud? But how did you manage that? No, never mind, we don’t really want to hear about your personal life. Lucky for you, though, today’s LOTME phrase that pays is “magnetic turd” and it’s just the thing for the busy executive/child with a foreign object stuck in their … whatever.
Yes, we said magnetic turd. Or, if you prefer, a “magnetic slime robot.” The black-brown–colored blob/robot/turd in question is an investigational substance that can be controlled magnetically to move through very narrow spaces and encircle small objects that have been accidentally swallowed, its cocreator, Li Zhang of the Chinese University of Hong Kong, told the Guardian.
It’s made by combining the polymer polyvinyl alcohol with borax and particles of neodymium magnet. And since those neodymium particles are not particularly friendly to humans, Dr. Zhang and the research team coated the slime with silica to seal in the toxicity. The slime has the consistency of custard and exhibits “visco-elastic properties,” Dr. Zhang said, meaning that “sometimes it behaves like a solid, sometimes it behaves like a liquid.”
We could go on, telling you about the substance’s self-healing ability and electrical conductivity and how it does look very, very turd-like. Instead, we offer this link to the team’s really freaky video.
We’re going to be seeing that in our nightmares.
Fish: More than meets the fry?
When you think of fish, intelligence isn’t usually the first thing to pop into your head. Their short memory spans, which can be as little as 3 seconds, probably don’t help their cause.
Recently, though, it has become apparent that fish can be trained to do simple math problems like adding and subtracting. Research conducted in Germany has shown that cichlids – tropical fish often found in home aquariums – and stingrays can observe small quantities and know how many things are there without actually counting, kind of like how a human can look at a bowl of apples and know about how many are in it.
Fish, once thought to be not very smart, may be on the same level of intelligence as birds, suggested Vera Schluessel, PhD, of the University of Bonn’s Institute of Zoology, and associates.
“Successful fish showed abilities far above chance level, specifically in the stingrays. Again, this raises the question of what abilities fish may be capable of if being asked the ‘right’ question,” the researchers said in Scientific Reports.
They tried to teach the cichlids and stingrays how to add and subtract by recognizing colors: Blue meant to add one and yellow meant to subtract one. Gates were set up and when the fish chose a correct answer, they were rewarded with food. Although it took many sessions for the fish to completely catch on, they did figure it out eventually.
If fish are smarter than we thought, maybe we can stop paying for math tutors for our kids and just have the family goldfish do it.
For earthworms, not all plastics are created equal
Everything living on the earth has to deal with pollution in some way, including earthworms. Not only have they have adapted to eating plastics found in soil, they have preferences.
The earthworm is a little creature with a big job. The materials and minerals they munch on as they go through the earth get recycled through their tiny bodies to create more fertile soil for things to grow – making them the hidden heroes of every garden. But what about soil that’s full of microscopic plastic pieces? Well, turns out earthworms will eat that too, investigators from Nankai University in Tianjin, China, reported in Environmental Science & Technology.
The researchers looked at how these eating machines were digesting the plastic and found that they actually have preferences. Soils with bio-based polylactic acid (PLA) or petroleum-derived polyethylene terephthalate (PET) particles were a hit. Another test showed that the worms broke the PLA particles down into smaller fragments than the PET ones. So at least the “healthier” option agreed with them more. More work is needed, however, to determine if the worms are being harmed by all the waste they’re digesting.
So what does this mean for the evolution or even survival of this unsung hero of the planet? Scientists still need to dig into that question. No pun intended.
I’d do anything for weight loss (but I won’t do that)
Weight loss isn’t a multibillion-dollar industry for nothing. How many people step onto the scale in the morning and sigh, wishing they could lose that last 10 pounds?
Alcohol also isn’t a multibillion-dollar industry for nothing. If there’s one thing more universal than wishing you could lose weight, it’s drinking to forget your woes about being unable to lose weight.
Naturally, and unfortunately for those of us who rather enjoy a good beer, one of the best ways to lose weight is to stop drinking. Alcohol is almost the definition of empty calories. So, which wins out: The unstoppable force of wanting to lose weight, or the immovable object of alcohol? According to a survey from DrugAbuse.com, it’s alcohol, and it’s not even close.
Even in a state with as health conscious a reputation as California, not only are people not willing to give up alcohol to lose weight, they’re willing to gain a noticeable amount of weight in order to continue drinking. It’s 14 pounds for Californians, which is in the middle of the road for America, which overall averaged 13 pounds to keep drinking. Hawaiians, South Dakotans, Utahns, and Vermonters were at the bottom, willing to add only 8 pounds to keep booze in their diet. At the other end of the scale, willing to add 28 whole pounds to keep the beer flowing, is humble little Rhode Island, followed by Wyoming at 23 pounds, Maryland at 22, and Tennessee at 21.
Obviously, that’s a lot of weight to gain, but to drive home the exact quantity of just how much weight, KRON-TV noted that adding the U.S. average of 13 pounds to your body is the equivalent of strapping 224 slices of bacon to yourself, which, to us, is just the poorest choice of comparison. If there’s one thing we’re less willing to give up than alcohol, it’s probably bacon. Or if you’re feeling especially ambitious, you could go for bacon-scented beer from the Waffle House. Now that’s a drink.
This looks like a job for the ‘magnetic slime robot’
What’s that? While you were in the process of gaining 14 pounds so you could keep drinking alcohol you swallowed something that you shouldn’t have? Did you swallow a lot of aggression?
You swallowed a what? An ear bud? But how did you manage that? No, never mind, we don’t really want to hear about your personal life. Lucky for you, though, today’s LOTME phrase that pays is “magnetic turd” and it’s just the thing for the busy executive/child with a foreign object stuck in their … whatever.
Yes, we said magnetic turd. Or, if you prefer, a “magnetic slime robot.” The black-brown–colored blob/robot/turd in question is an investigational substance that can be controlled magnetically to move through very narrow spaces and encircle small objects that have been accidentally swallowed, its cocreator, Li Zhang of the Chinese University of Hong Kong, told the Guardian.
It’s made by combining the polymer polyvinyl alcohol with borax and particles of neodymium magnet. And since those neodymium particles are not particularly friendly to humans, Dr. Zhang and the research team coated the slime with silica to seal in the toxicity. The slime has the consistency of custard and exhibits “visco-elastic properties,” Dr. Zhang said, meaning that “sometimes it behaves like a solid, sometimes it behaves like a liquid.”
We could go on, telling you about the substance’s self-healing ability and electrical conductivity and how it does look very, very turd-like. Instead, we offer this link to the team’s really freaky video.
We’re going to be seeing that in our nightmares.
Fish: More than meets the fry?
When you think of fish, intelligence isn’t usually the first thing to pop into your head. Their short memory spans, which can be as little as 3 seconds, probably don’t help their cause.
Recently, though, it has become apparent that fish can be trained to do simple math problems like adding and subtracting. Research conducted in Germany has shown that cichlids – tropical fish often found in home aquariums – and stingrays can observe small quantities and know how many things are there without actually counting, kind of like how a human can look at a bowl of apples and know about how many are in it.
Fish, once thought to be not very smart, may be on the same level of intelligence as birds, suggested Vera Schluessel, PhD, of the University of Bonn’s Institute of Zoology, and associates.
“Successful fish showed abilities far above chance level, specifically in the stingrays. Again, this raises the question of what abilities fish may be capable of if being asked the ‘right’ question,” the researchers said in Scientific Reports.
They tried to teach the cichlids and stingrays how to add and subtract by recognizing colors: Blue meant to add one and yellow meant to subtract one. Gates were set up and when the fish chose a correct answer, they were rewarded with food. Although it took many sessions for the fish to completely catch on, they did figure it out eventually.
If fish are smarter than we thought, maybe we can stop paying for math tutors for our kids and just have the family goldfish do it.
For earthworms, not all plastics are created equal
Everything living on the earth has to deal with pollution in some way, including earthworms. Not only have they have adapted to eating plastics found in soil, they have preferences.
The earthworm is a little creature with a big job. The materials and minerals they munch on as they go through the earth get recycled through their tiny bodies to create more fertile soil for things to grow – making them the hidden heroes of every garden. But what about soil that’s full of microscopic plastic pieces? Well, turns out earthworms will eat that too, investigators from Nankai University in Tianjin, China, reported in Environmental Science & Technology.
The researchers looked at how these eating machines were digesting the plastic and found that they actually have preferences. Soils with bio-based polylactic acid (PLA) or petroleum-derived polyethylene terephthalate (PET) particles were a hit. Another test showed that the worms broke the PLA particles down into smaller fragments than the PET ones. So at least the “healthier” option agreed with them more. More work is needed, however, to determine if the worms are being harmed by all the waste they’re digesting.
So what does this mean for the evolution or even survival of this unsung hero of the planet? Scientists still need to dig into that question. No pun intended.
I’d do anything for weight loss (but I won’t do that)
Weight loss isn’t a multibillion-dollar industry for nothing. How many people step onto the scale in the morning and sigh, wishing they could lose that last 10 pounds?
Alcohol also isn’t a multibillion-dollar industry for nothing. If there’s one thing more universal than wishing you could lose weight, it’s drinking to forget your woes about being unable to lose weight.
Naturally, and unfortunately for those of us who rather enjoy a good beer, one of the best ways to lose weight is to stop drinking. Alcohol is almost the definition of empty calories. So, which wins out: The unstoppable force of wanting to lose weight, or the immovable object of alcohol? According to a survey from DrugAbuse.com, it’s alcohol, and it’s not even close.
Even in a state with as health conscious a reputation as California, not only are people not willing to give up alcohol to lose weight, they’re willing to gain a noticeable amount of weight in order to continue drinking. It’s 14 pounds for Californians, which is in the middle of the road for America, which overall averaged 13 pounds to keep drinking. Hawaiians, South Dakotans, Utahns, and Vermonters were at the bottom, willing to add only 8 pounds to keep booze in their diet. At the other end of the scale, willing to add 28 whole pounds to keep the beer flowing, is humble little Rhode Island, followed by Wyoming at 23 pounds, Maryland at 22, and Tennessee at 21.
Obviously, that’s a lot of weight to gain, but to drive home the exact quantity of just how much weight, KRON-TV noted that adding the U.S. average of 13 pounds to your body is the equivalent of strapping 224 slices of bacon to yourself, which, to us, is just the poorest choice of comparison. If there’s one thing we’re less willing to give up than alcohol, it’s probably bacon. Or if you’re feeling especially ambitious, you could go for bacon-scented beer from the Waffle House. Now that’s a drink.
This looks like a job for the ‘magnetic slime robot’
What’s that? While you were in the process of gaining 14 pounds so you could keep drinking alcohol you swallowed something that you shouldn’t have? Did you swallow a lot of aggression?
You swallowed a what? An ear bud? But how did you manage that? No, never mind, we don’t really want to hear about your personal life. Lucky for you, though, today’s LOTME phrase that pays is “magnetic turd” and it’s just the thing for the busy executive/child with a foreign object stuck in their … whatever.
Yes, we said magnetic turd. Or, if you prefer, a “magnetic slime robot.” The black-brown–colored blob/robot/turd in question is an investigational substance that can be controlled magnetically to move through very narrow spaces and encircle small objects that have been accidentally swallowed, its cocreator, Li Zhang of the Chinese University of Hong Kong, told the Guardian.
It’s made by combining the polymer polyvinyl alcohol with borax and particles of neodymium magnet. And since those neodymium particles are not particularly friendly to humans, Dr. Zhang and the research team coated the slime with silica to seal in the toxicity. The slime has the consistency of custard and exhibits “visco-elastic properties,” Dr. Zhang said, meaning that “sometimes it behaves like a solid, sometimes it behaves like a liquid.”
We could go on, telling you about the substance’s self-healing ability and electrical conductivity and how it does look very, very turd-like. Instead, we offer this link to the team’s really freaky video.
We’re going to be seeing that in our nightmares.
Fish: More than meets the fry?
When you think of fish, intelligence isn’t usually the first thing to pop into your head. Their short memory spans, which can be as little as 3 seconds, probably don’t help their cause.
Recently, though, it has become apparent that fish can be trained to do simple math problems like adding and subtracting. Research conducted in Germany has shown that cichlids – tropical fish often found in home aquariums – and stingrays can observe small quantities and know how many things are there without actually counting, kind of like how a human can look at a bowl of apples and know about how many are in it.
Fish, once thought to be not very smart, may be on the same level of intelligence as birds, suggested Vera Schluessel, PhD, of the University of Bonn’s Institute of Zoology, and associates.
“Successful fish showed abilities far above chance level, specifically in the stingrays. Again, this raises the question of what abilities fish may be capable of if being asked the ‘right’ question,” the researchers said in Scientific Reports.
They tried to teach the cichlids and stingrays how to add and subtract by recognizing colors: Blue meant to add one and yellow meant to subtract one. Gates were set up and when the fish chose a correct answer, they were rewarded with food. Although it took many sessions for the fish to completely catch on, they did figure it out eventually.
If fish are smarter than we thought, maybe we can stop paying for math tutors for our kids and just have the family goldfish do it.
For earthworms, not all plastics are created equal
Everything living on the earth has to deal with pollution in some way, including earthworms. Not only have they have adapted to eating plastics found in soil, they have preferences.
The earthworm is a little creature with a big job. The materials and minerals they munch on as they go through the earth get recycled through their tiny bodies to create more fertile soil for things to grow – making them the hidden heroes of every garden. But what about soil that’s full of microscopic plastic pieces? Well, turns out earthworms will eat that too, investigators from Nankai University in Tianjin, China, reported in Environmental Science & Technology.
The researchers looked at how these eating machines were digesting the plastic and found that they actually have preferences. Soils with bio-based polylactic acid (PLA) or petroleum-derived polyethylene terephthalate (PET) particles were a hit. Another test showed that the worms broke the PLA particles down into smaller fragments than the PET ones. So at least the “healthier” option agreed with them more. More work is needed, however, to determine if the worms are being harmed by all the waste they’re digesting.
So what does this mean for the evolution or even survival of this unsung hero of the planet? Scientists still need to dig into that question. No pun intended.