Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

[email protected]

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

[email protected]

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

[email protected]

Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

Obesity interventions would be more effective at preventing premature mortality if they focused less on weight loss and more on increased physical activity and improved cardiorespiratory fitness, a pair of researchers concluded in a recent review.

The authors promote a “weight-neutral approach to treating obesity-related health conditions,” which they say is “as or more effective than a weight-loss centric approach.”

One expert agrees. “The obsession with the bathroom scale as the primary determinant of treatment efficacy when managing obesity is just not right,” Robert Ross, PhD, said in an interview.

“It masks the tremendous health benefits of improved fitness regardless of obesity. If you increase fitness, you improve outcomes even when people don’t lose weight,” noted Dr. Ross, a researcher in the School of Kinesiology and Health Studies at Queen’s University in Kingston, Ontario, Canada.

However, this proposition reprises a long-standing gulf between two schools of thought on obesity intervention.

One indication of the divided sentiment came in another expert review, published just days later, that strongly calls for weight loss of at least 15% of starting body weight as the primary intervention goal for most patients with obesity and type 2 diabetes. (According to 2020 statistics from the U.S. Centers for Disease Control and Prevention, more than 60% of U.S. adults with diabetes are obese.)

However, some question whether it must be all one, or the other, when obesity management could instead combine these approaches and simultaneously promote weight loss, increased activity, and improved fitness.

“It only muddies the water to dichotomize this as either weight management or activity and physical fitness,” observed Scott Kahan, MD, an obesity specialist and director of the National Center for Weight and Wellness in Washington, D.C.
 

Weight-neutral ‘is the way to go’

“The most significant new information [in the review] is the direct comparison of the magnitude of mortality risk reduction associated with weight loss compared with increasing fitness, physical activity, or both,” said Glenn A. Gaesser, PhD, the first author of the new review and professor of exercise physiology at Arizona State University, Phoenix.

“The results are quite clear: Increasing fitness, physical activity, or both are associated with greater mortality reductions than intentional weight loss. We argue that a weight-neutral approach to treating obesity is the way to go.”

The data call “into question the widely perceived notion of ‘lose weight, live longer,’” resulting in a “paradigm shift,” Dr. Gaesser said in an interview.

“There are no downsides to exercise, but there are significant downsides to weight loss, especially when it is inevitably followed by weight regain, which gives rise to the undesirable ‘weight-loss futile cycle’,” he added.
 

No simple, single solutions

Dr. Kahan said, however, that comparison of the effects of weight loss with the effects of increased activity and fitness on mortality is inherently problematic.

“It’s hard to make definitive conclusions from observational studies,” he cautioned, noting that the data cited in the review of activity and fitness compared with weight loss are generally “estimations” that carry a “lot of cloudiness.”

Dr. Kahan also takes issue with the premise detailed in the review that targeting reduced weight and implementing healthful and evidence-based approaches to try to achieve it are bound to fail and have frequent adverse consequences.

“Managing weight in a reasonable, patient-centered, thoughtful way is a standard and central part of long-term health,” he said in an interview.

He did concede, however, that the U.S. weight-loss landscape is awash with hucksterism that takes advantage of many patients, and he cautioned against approaches that focus on weight loss at all costs and as a pathway to selling products.

“But staying focused on activity and not paying attention to healthy eating is extreme,” he said, reemphasizing that obesity management is not a simple intervention with a single solution.
 

Not the first time

This is not the first time that Dr. Gaesser, and others, have published articles promoting a pivot away from weight loss as the primary goal of obesity interventions. In 2015, Dr. Gaesser and colleagues published an evidence review that gave this recommendation for managing people with obesity: “We propose that the proxy for health improvements should not be weight loss but instead improvements in cardiometabolic parameters, functional status, and fitness.”

Dr. Gaesser’s latest review also acknowledges similar recommendations from others, including Dr. Ross, who said it’s nothing new to conclude that increased fitness and activity in the absence of weight loss is not failure.

“It’s something we’ve promoted for decades,” but “it’s not understood and acted on in clinical settings, and that’s unfortunate,” he said.

More than a decade ago, Dr. Ross and his coauthor wrote in a published review that “a monolithic focus on weight loss as the only determinant of success for strategies that aim to reduce obesity is not justified and, more importantly, eliminates opportunities to focus on lifestyle behaviors that are associated with benefit across a wide range of health outcomes.”

And an effective intervention that focuses on activity and fitness means that, at the least, patients should not gain weight, and they may lose weight as a side benefit, he stressed.

“We always advocate a balanced diet, so that people do not gain more weight.”

Dr. Ross also highlighted the usefulness of measuring fitness as an alternative to recording weight to track the response by patients with obesity to various interventions. Dr. Ross recommends nonexercise prediction equations for routine practice to easily estimate cardiorespiratory fitness, an approach detailed in a 2016 statement from the American Heart Association by a writing panel chaired by Dr. Ross.

The AHA statement notes that “not including cardiorespiratory fitness measurement in routine clinical practice fails to provide an optimal approach for stratifying patients according to risk.”

The AHA also advises that “routine estimation of cardiorespiratory fitness in clinical practice is no more difficult than measuring blood pressure,” and details ways of incorporating this into routine clinical assessment.

Dr. Gaesser and Dr. Kahan have reported no relevant financial relationships. Dr. Ross has been an advisor to the Canadian Sugar Institute.

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

Obesity interventions would be more effective at preventing premature mortality if they focused less on weight loss and more on increased physical activity and improved cardiorespiratory fitness, a pair of researchers concluded in a recent review.

The authors promote a “weight-neutral approach to treating obesity-related health conditions,” which they say is “as or more effective than a weight-loss centric approach.”

One expert agrees. “The obsession with the bathroom scale as the primary determinant of treatment efficacy when managing obesity is just not right,” Robert Ross, PhD, said in an interview.

“It masks the tremendous health benefits of improved fitness regardless of obesity. If you increase fitness, you improve outcomes even when people don’t lose weight,” noted Dr. Ross, a researcher in the School of Kinesiology and Health Studies at Queen’s University in Kingston, Ontario, Canada.

However, this proposition reprises a long-standing gulf between two schools of thought on obesity intervention.

One indication of the divided sentiment came in another expert review, published just days later, that strongly calls for weight loss of at least 15% of starting body weight as the primary intervention goal for most patients with obesity and type 2 diabetes. (According to 2020 statistics from the U.S. Centers for Disease Control and Prevention, more than 60% of U.S. adults with diabetes are obese.)

However, some question whether it must be all one, or the other, when obesity management could instead combine these approaches and simultaneously promote weight loss, increased activity, and improved fitness.

“It only muddies the water to dichotomize this as either weight management or activity and physical fitness,” observed Scott Kahan, MD, an obesity specialist and director of the National Center for Weight and Wellness in Washington, D.C.
 

Weight-neutral ‘is the way to go’

“The most significant new information [in the review] is the direct comparison of the magnitude of mortality risk reduction associated with weight loss compared with increasing fitness, physical activity, or both,” said Glenn A. Gaesser, PhD, the first author of the new review and professor of exercise physiology at Arizona State University, Phoenix.

“The results are quite clear: Increasing fitness, physical activity, or both are associated with greater mortality reductions than intentional weight loss. We argue that a weight-neutral approach to treating obesity is the way to go.”

The data call “into question the widely perceived notion of ‘lose weight, live longer,’” resulting in a “paradigm shift,” Dr. Gaesser said in an interview.

“There are no downsides to exercise, but there are significant downsides to weight loss, especially when it is inevitably followed by weight regain, which gives rise to the undesirable ‘weight-loss futile cycle’,” he added.
 

No simple, single solutions

Dr. Kahan said, however, that comparison of the effects of weight loss with the effects of increased activity and fitness on mortality is inherently problematic.

“It’s hard to make definitive conclusions from observational studies,” he cautioned, noting that the data cited in the review of activity and fitness compared with weight loss are generally “estimations” that carry a “lot of cloudiness.”

Dr. Kahan also takes issue with the premise detailed in the review that targeting reduced weight and implementing healthful and evidence-based approaches to try to achieve it are bound to fail and have frequent adverse consequences.

“Managing weight in a reasonable, patient-centered, thoughtful way is a standard and central part of long-term health,” he said in an interview.

He did concede, however, that the U.S. weight-loss landscape is awash with hucksterism that takes advantage of many patients, and he cautioned against approaches that focus on weight loss at all costs and as a pathway to selling products.

“But staying focused on activity and not paying attention to healthy eating is extreme,” he said, reemphasizing that obesity management is not a simple intervention with a single solution.
 

Not the first time

This is not the first time that Dr. Gaesser, and others, have published articles promoting a pivot away from weight loss as the primary goal of obesity interventions. In 2015, Dr. Gaesser and colleagues published an evidence review that gave this recommendation for managing people with obesity: “We propose that the proxy for health improvements should not be weight loss but instead improvements in cardiometabolic parameters, functional status, and fitness.”

Dr. Gaesser’s latest review also acknowledges similar recommendations from others, including Dr. Ross, who said it’s nothing new to conclude that increased fitness and activity in the absence of weight loss is not failure.

“It’s something we’ve promoted for decades,” but “it’s not understood and acted on in clinical settings, and that’s unfortunate,” he said.

More than a decade ago, Dr. Ross and his coauthor wrote in a published review that “a monolithic focus on weight loss as the only determinant of success for strategies that aim to reduce obesity is not justified and, more importantly, eliminates opportunities to focus on lifestyle behaviors that are associated with benefit across a wide range of health outcomes.”

And an effective intervention that focuses on activity and fitness means that, at the least, patients should not gain weight, and they may lose weight as a side benefit, he stressed.

“We always advocate a balanced diet, so that people do not gain more weight.”

Dr. Ross also highlighted the usefulness of measuring fitness as an alternative to recording weight to track the response by patients with obesity to various interventions. Dr. Ross recommends nonexercise prediction equations for routine practice to easily estimate cardiorespiratory fitness, an approach detailed in a 2016 statement from the American Heart Association by a writing panel chaired by Dr. Ross.

The AHA statement notes that “not including cardiorespiratory fitness measurement in routine clinical practice fails to provide an optimal approach for stratifying patients according to risk.”

The AHA also advises that “routine estimation of cardiorespiratory fitness in clinical practice is no more difficult than measuring blood pressure,” and details ways of incorporating this into routine clinical assessment.

Dr. Gaesser and Dr. Kahan have reported no relevant financial relationships. Dr. Ross has been an advisor to the Canadian Sugar Institute.

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

Obesity interventions would be more effective at preventing premature mortality if they focused less on weight loss and more on increased physical activity and improved cardiorespiratory fitness, a pair of researchers concluded in a recent review.

The authors promote a “weight-neutral approach to treating obesity-related health conditions,” which they say is “as or more effective than a weight-loss centric approach.”

One expert agrees. “The obsession with the bathroom scale as the primary determinant of treatment efficacy when managing obesity is just not right,” Robert Ross, PhD, said in an interview.

“It masks the tremendous health benefits of improved fitness regardless of obesity. If you increase fitness, you improve outcomes even when people don’t lose weight,” noted Dr. Ross, a researcher in the School of Kinesiology and Health Studies at Queen’s University in Kingston, Ontario, Canada.

However, this proposition reprises a long-standing gulf between two schools of thought on obesity intervention.

One indication of the divided sentiment came in another expert review, published just days later, that strongly calls for weight loss of at least 15% of starting body weight as the primary intervention goal for most patients with obesity and type 2 diabetes. (According to 2020 statistics from the U.S. Centers for Disease Control and Prevention, more than 60% of U.S. adults with diabetes are obese.)

However, some question whether it must be all one, or the other, when obesity management could instead combine these approaches and simultaneously promote weight loss, increased activity, and improved fitness.

“It only muddies the water to dichotomize this as either weight management or activity and physical fitness,” observed Scott Kahan, MD, an obesity specialist and director of the National Center for Weight and Wellness in Washington, D.C.
 

Weight-neutral ‘is the way to go’

“The most significant new information [in the review] is the direct comparison of the magnitude of mortality risk reduction associated with weight loss compared with increasing fitness, physical activity, or both,” said Glenn A. Gaesser, PhD, the first author of the new review and professor of exercise physiology at Arizona State University, Phoenix.

“The results are quite clear: Increasing fitness, physical activity, or both are associated with greater mortality reductions than intentional weight loss. We argue that a weight-neutral approach to treating obesity is the way to go.”

The data call “into question the widely perceived notion of ‘lose weight, live longer,’” resulting in a “paradigm shift,” Dr. Gaesser said in an interview.

“There are no downsides to exercise, but there are significant downsides to weight loss, especially when it is inevitably followed by weight regain, which gives rise to the undesirable ‘weight-loss futile cycle’,” he added.
 

No simple, single solutions

Dr. Kahan said, however, that comparison of the effects of weight loss with the effects of increased activity and fitness on mortality is inherently problematic.

“It’s hard to make definitive conclusions from observational studies,” he cautioned, noting that the data cited in the review of activity and fitness compared with weight loss are generally “estimations” that carry a “lot of cloudiness.”

Dr. Kahan also takes issue with the premise detailed in the review that targeting reduced weight and implementing healthful and evidence-based approaches to try to achieve it are bound to fail and have frequent adverse consequences.

“Managing weight in a reasonable, patient-centered, thoughtful way is a standard and central part of long-term health,” he said in an interview.

He did concede, however, that the U.S. weight-loss landscape is awash with hucksterism that takes advantage of many patients, and he cautioned against approaches that focus on weight loss at all costs and as a pathway to selling products.

“But staying focused on activity and not paying attention to healthy eating is extreme,” he said, reemphasizing that obesity management is not a simple intervention with a single solution.
 

Not the first time

This is not the first time that Dr. Gaesser, and others, have published articles promoting a pivot away from weight loss as the primary goal of obesity interventions. In 2015, Dr. Gaesser and colleagues published an evidence review that gave this recommendation for managing people with obesity: “We propose that the proxy for health improvements should not be weight loss but instead improvements in cardiometabolic parameters, functional status, and fitness.”

Dr. Gaesser’s latest review also acknowledges similar recommendations from others, including Dr. Ross, who said it’s nothing new to conclude that increased fitness and activity in the absence of weight loss is not failure.

“It’s something we’ve promoted for decades,” but “it’s not understood and acted on in clinical settings, and that’s unfortunate,” he said.

More than a decade ago, Dr. Ross and his coauthor wrote in a published review that “a monolithic focus on weight loss as the only determinant of success for strategies that aim to reduce obesity is not justified and, more importantly, eliminates opportunities to focus on lifestyle behaviors that are associated with benefit across a wide range of health outcomes.”

And an effective intervention that focuses on activity and fitness means that, at the least, patients should not gain weight, and they may lose weight as a side benefit, he stressed.

“We always advocate a balanced diet, so that people do not gain more weight.”

Dr. Ross also highlighted the usefulness of measuring fitness as an alternative to recording weight to track the response by patients with obesity to various interventions. Dr. Ross recommends nonexercise prediction equations for routine practice to easily estimate cardiorespiratory fitness, an approach detailed in a 2016 statement from the American Heart Association by a writing panel chaired by Dr. Ross.

The AHA statement notes that “not including cardiorespiratory fitness measurement in routine clinical practice fails to provide an optimal approach for stratifying patients according to risk.”

The AHA also advises that “routine estimation of cardiorespiratory fitness in clinical practice is no more difficult than measuring blood pressure,” and details ways of incorporating this into routine clinical assessment.

Dr. Gaesser and Dr. Kahan have reported no relevant financial relationships. Dr. Ross has been an advisor to the Canadian Sugar Institute.

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

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.

All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.

All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.

All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.

Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.

The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.

Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).

This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.

Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.

The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
 

Social and emotional support

Despite rising mental health care needs, more than 3 in 4 U.S. adults (77.5%) indicated that they always or usually received the social and emotional support they needed during the pandemic period of July to Dec. 2020, also based on NHIS data.

Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.

However, social and emotional support varies by age and race/ethnicity.

Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.

“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.

As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.

The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.

One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.

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

In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.

Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.

The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.

Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).

This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.

Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.

The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
 

Social and emotional support

Despite rising mental health care needs, more than 3 in 4 U.S. adults (77.5%) indicated that they always or usually received the social and emotional support they needed during the pandemic period of July to Dec. 2020, also based on NHIS data.

Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.

However, social and emotional support varies by age and race/ethnicity.

Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.

“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.

As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.

The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.

One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.

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

In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.

Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.

The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.

Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).

This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.

Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.

The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
 

Social and emotional support

Despite rising mental health care needs, more than 3 in 4 U.S. adults (77.5%) indicated that they always or usually received the social and emotional support they needed during the pandemic period of July to Dec. 2020, also based on NHIS data.

Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.

However, social and emotional support varies by age and race/ethnicity.

Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.

“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.

As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.

The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.

One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.

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

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

The recent U.S. Preventive Services Task Force (USPSTF) draft statement on aspirin use is concerning: “The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.” I take no issue with the data and appreciate the efforts of the researchers, but at a minimum the public statement is incomplete. At most, it’s dangerously poor messaging.

As physicians, we understand how best to apply this information, but most laypeople, some at significant cardiovascular risk, closed their medicine cabinets this morning and left their aspirin bottle unopened on the shelf. Some of these patients have never spent an hour in the hospital for cardiac-related issues, but they have mitigated their risk for myocardial infarction by purposely poisoning their platelets daily with 81 mg of aspirin. And they should continue to do so.
 

Don’t forget the calcium score

Take, for instance, my patient Jack, who is typical of many patients I’ve seen throughout the years. Jack is 68 years old and has never had a cardiac event or a gastrointestinal bleed. His daily routine includes a walk, a statin, and a baby aspirin because his CT coronary artery calcium (CAC) score was 10,000 at age 58.

He first visited me 10 years ago because his father died of a myocardial infarction in his late 50s. Jack’s left ventricular ejection fraction is normal and his stress ECG shows 1-mm ST-segment depression at 8 minutes on a Bruce protocol stress test, without angina. Because Jack is well-educated and keeps up with the latest cardiology recommendations, he is precisely the type of patient who may be harmed by this new USPSTF statement by stopping his aspirin.

In October 2020, an analysis from the DALLAS Heart Study showed that persons with a CAC score greater than 100 had a higher cumulative incidence of bleeding and of atherosclerotic cardiovascular disease (ASCVD) events compared with those with no coronary calcium. After adjustment for clinical risk factors, the association between CAC and bleeding was attenuated and no longer statistically significant, whereas the relationship between CAC and ASCVD remained.

I asked one of the investigators, Amit Khera, MD, MSc, from UT Southwestern Medical Center, about the latest recommendations. He emphasized that both the American College of Cardiology/American Heart Association prevention guidelines and the USPSTF statement say that aspirin could still be considered among patients who are at higher risk for cardiovascular events. The USPSTF delineated this as a 10-year ASCVD risk greater than 10%.

Dr. Khera, who was an author of the 2019 guidelines, explained that the guideline committee purposely did not make specific recommendations as to what demarcated higher risk because the data were not clear at that time. Since then, a couple of papers, including the Dallas Heart Study analysis published in JAMA Cardiology, showed that patients at low bleeding risk with a calcium score above 100 may get a net benefit from aspirin. “Thus, in my patients who have a high calcium score and low bleeding risk, I do discuss the option to start or continue aspirin,” he said.
 

One size does not fit all

I watched ABC World News Tonight on Tuesday, October 12, and was immediately troubled about the coverage of the USPSTF statement. With viewership for the “Big Three” networks in the millions, the message to discontinue aspirin may have unintended consequences for many at-risk patients. The blood-thinning effects of a single dose of aspirin last about 10 days; it will be interesting to see if the rates of myocardial infarction increase over time. This could have been avoided with a better-worded statement – I’m concerned that the lack of nuance could spell big trouble for some.

In JAMA Cardiology, Dr. Khera and colleagues wrote that, “Aspirin use is not a one-size-fits-all therapy.” All physicians likely agree with that opinion. The USPSTF statement should have included the point that if you have a high CT coronary artery calcium score and a low bleeding risk, aspirin still fits very well even if you haven’t experienced a cardiac event. At a minimum, the USPSTF statement should have included the suggestion for patients to consult their physician for advice before discontinuing aspirin therapy.

I hope patients like Jack get the right message.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology.

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

The recent U.S. Preventive Services Task Force (USPSTF) draft statement on aspirin use is concerning: “The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.” I take no issue with the data and appreciate the efforts of the researchers, but at a minimum the public statement is incomplete. At most, it’s dangerously poor messaging.

As physicians, we understand how best to apply this information, but most laypeople, some at significant cardiovascular risk, closed their medicine cabinets this morning and left their aspirin bottle unopened on the shelf. Some of these patients have never spent an hour in the hospital for cardiac-related issues, but they have mitigated their risk for myocardial infarction by purposely poisoning their platelets daily with 81 mg of aspirin. And they should continue to do so.
 

Don’t forget the calcium score

Take, for instance, my patient Jack, who is typical of many patients I’ve seen throughout the years. Jack is 68 years old and has never had a cardiac event or a gastrointestinal bleed. His daily routine includes a walk, a statin, and a baby aspirin because his CT coronary artery calcium (CAC) score was 10,000 at age 58.

He first visited me 10 years ago because his father died of a myocardial infarction in his late 50s. Jack’s left ventricular ejection fraction is normal and his stress ECG shows 1-mm ST-segment depression at 8 minutes on a Bruce protocol stress test, without angina. Because Jack is well-educated and keeps up with the latest cardiology recommendations, he is precisely the type of patient who may be harmed by this new USPSTF statement by stopping his aspirin.

In October 2020, an analysis from the DALLAS Heart Study showed that persons with a CAC score greater than 100 had a higher cumulative incidence of bleeding and of atherosclerotic cardiovascular disease (ASCVD) events compared with those with no coronary calcium. After adjustment for clinical risk factors, the association between CAC and bleeding was attenuated and no longer statistically significant, whereas the relationship between CAC and ASCVD remained.

I asked one of the investigators, Amit Khera, MD, MSc, from UT Southwestern Medical Center, about the latest recommendations. He emphasized that both the American College of Cardiology/American Heart Association prevention guidelines and the USPSTF statement say that aspirin could still be considered among patients who are at higher risk for cardiovascular events. The USPSTF delineated this as a 10-year ASCVD risk greater than 10%.

Dr. Khera, who was an author of the 2019 guidelines, explained that the guideline committee purposely did not make specific recommendations as to what demarcated higher risk because the data were not clear at that time. Since then, a couple of papers, including the Dallas Heart Study analysis published in JAMA Cardiology, showed that patients at low bleeding risk with a calcium score above 100 may get a net benefit from aspirin. “Thus, in my patients who have a high calcium score and low bleeding risk, I do discuss the option to start or continue aspirin,” he said.
 

One size does not fit all

I watched ABC World News Tonight on Tuesday, October 12, and was immediately troubled about the coverage of the USPSTF statement. With viewership for the “Big Three” networks in the millions, the message to discontinue aspirin may have unintended consequences for many at-risk patients. The blood-thinning effects of a single dose of aspirin last about 10 days; it will be interesting to see if the rates of myocardial infarction increase over time. This could have been avoided with a better-worded statement – I’m concerned that the lack of nuance could spell big trouble for some.

In JAMA Cardiology, Dr. Khera and colleagues wrote that, “Aspirin use is not a one-size-fits-all therapy.” All physicians likely agree with that opinion. The USPSTF statement should have included the point that if you have a high CT coronary artery calcium score and a low bleeding risk, aspirin still fits very well even if you haven’t experienced a cardiac event. At a minimum, the USPSTF statement should have included the suggestion for patients to consult their physician for advice before discontinuing aspirin therapy.

I hope patients like Jack get the right message.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology.

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

The recent U.S. Preventive Services Task Force (USPSTF) draft statement on aspirin use is concerning: “The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.” I take no issue with the data and appreciate the efforts of the researchers, but at a minimum the public statement is incomplete. At most, it’s dangerously poor messaging.

As physicians, we understand how best to apply this information, but most laypeople, some at significant cardiovascular risk, closed their medicine cabinets this morning and left their aspirin bottle unopened on the shelf. Some of these patients have never spent an hour in the hospital for cardiac-related issues, but they have mitigated their risk for myocardial infarction by purposely poisoning their platelets daily with 81 mg of aspirin. And they should continue to do so.
 

Don’t forget the calcium score

Take, for instance, my patient Jack, who is typical of many patients I’ve seen throughout the years. Jack is 68 years old and has never had a cardiac event or a gastrointestinal bleed. His daily routine includes a walk, a statin, and a baby aspirin because his CT coronary artery calcium (CAC) score was 10,000 at age 58.

He first visited me 10 years ago because his father died of a myocardial infarction in his late 50s. Jack’s left ventricular ejection fraction is normal and his stress ECG shows 1-mm ST-segment depression at 8 minutes on a Bruce protocol stress test, without angina. Because Jack is well-educated and keeps up with the latest cardiology recommendations, he is precisely the type of patient who may be harmed by this new USPSTF statement by stopping his aspirin.

In October 2020, an analysis from the DALLAS Heart Study showed that persons with a CAC score greater than 100 had a higher cumulative incidence of bleeding and of atherosclerotic cardiovascular disease (ASCVD) events compared with those with no coronary calcium. After adjustment for clinical risk factors, the association between CAC and bleeding was attenuated and no longer statistically significant, whereas the relationship between CAC and ASCVD remained.

I asked one of the investigators, Amit Khera, MD, MSc, from UT Southwestern Medical Center, about the latest recommendations. He emphasized that both the American College of Cardiology/American Heart Association prevention guidelines and the USPSTF statement say that aspirin could still be considered among patients who are at higher risk for cardiovascular events. The USPSTF delineated this as a 10-year ASCVD risk greater than 10%.

Dr. Khera, who was an author of the 2019 guidelines, explained that the guideline committee purposely did not make specific recommendations as to what demarcated higher risk because the data were not clear at that time. Since then, a couple of papers, including the Dallas Heart Study analysis published in JAMA Cardiology, showed that patients at low bleeding risk with a calcium score above 100 may get a net benefit from aspirin. “Thus, in my patients who have a high calcium score and low bleeding risk, I do discuss the option to start or continue aspirin,” he said.
 

One size does not fit all

I watched ABC World News Tonight on Tuesday, October 12, and was immediately troubled about the coverage of the USPSTF statement. With viewership for the “Big Three” networks in the millions, the message to discontinue aspirin may have unintended consequences for many at-risk patients. The blood-thinning effects of a single dose of aspirin last about 10 days; it will be interesting to see if the rates of myocardial infarction increase over time. This could have been avoided with a better-worded statement – I’m concerned that the lack of nuance could spell big trouble for some.

In JAMA Cardiology, Dr. Khera and colleagues wrote that, “Aspirin use is not a one-size-fits-all therapy.” All physicians likely agree with that opinion. The USPSTF statement should have included the point that if you have a high CT coronary artery calcium score and a low bleeding risk, aspirin still fits very well even if you haven’t experienced a cardiac event. At a minimum, the USPSTF statement should have included the suggestion for patients to consult their physician for advice before discontinuing aspirin therapy.

I hope patients like Jack get the right message.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology.

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

The words “you have colorectal cancer” can concentrate a patient’s mind, but certainly not in the way that the clinician delivering the bad news intends.

“A lot of my patients, frankly, have told me that on the first visit the only thing they really hear is the diagnosis of cancer, confirming a malignancy, and everything else that follows is what I call the ‘2 minutes of terror.’ Everything else gets drowned out, and they don’t hear my comments on diseases and sometimes my hopefully reassuring comments on prognosis,” said Mark A. Lewis, MD, director of the gastrointestinal oncology program at Intermountain Healthcare in Murray, Utah, who is himself a survivor of a rare cancer.

An estimated 150,000 people hear something like “you have colorectal cancer” in the United States each year, according to American Cancer Society estimates.

Even before the diagnosis, the patient, still groggy from sedation after a colonoscopy, may wake up and be told “we’ve found something; I’ll call you in a few days when we get the pathology results.”

You don’t have to be a psychiatrist to understand that times of great emotional upheaval, stress, or uncertainty are not ideal for decision-making, especially when the person who is asked to decide is facing a challenge that may seem overwhelmingly complex.

Many patients’ first thoughts are to go online for information, but that too can be overwhelming. For example, a Google search for the words “colorectal cancer” turns up roughly 134 million results, in six-tenths of a second, no less.

There are of course solid, reliable sources for information out there, and reliable information is a very good place to start, as noted by the staff at the Mayo Clinic in Rochester, Minn.

The Mayo website offers 11 tips with for coping with a cancer diagnosis. First among the recommendations is “get the facts about your cancer diagnosis,” and that’s the inspiration behind CRC POP.

Text COLON to 484848

“There are 13,000 of us gastroenterologists in the country, and we diagnosis colorectal cancer 150,000 times a year,” said CRC POP program creator Brian Dooreck, MD, from Memorial Healthcare System in Pembroke Pines, Fla.

When the doctor tells patients the results “their world is turned upside down, they’re shocked, and they don’t pick up much after the word ‘cancer’,” Dr. Dooreck said in an interview.

Both Dr. Dooreck and Dr. Lewis noted that, after going home with a diagnosis of colorectal cancer, a large majority of patients will go online to find information about their diagnosis.

“We know from studies and anecdotal experience that the odds that someone will try to research their own diagnosis are in the 97% range, and then they’re going to run into the pluses and minuses of search engine optimization,” Dr. Lewis said.

As even the most casual Internet user can attest, available medical information can range from the practical to the preposterous, from the National Cancer Institute’s Cancer.gov to a Facebook post on Aunt Tillie’s miracle mayonnaise cure. Helping patients to quickly identify which resources are valuable and trustworthy is the overarching goal of CRC POP, Dr. Dooreck explained.

“What we created with the Colorectal Cancer Provider Outreach Program is that it now allows gastroenterologists to have a conversation with a patient – I can say ‘Now listen, take out your phone, and text the world COLON and send it to 484848.”

Doing so returns a text in a few seconds with the words “You are not alone. You have our support. Here. Now,” and a blue heart emoji, followed by a link that takes the user to a web page with a document containing contact information for the ACS, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and Colon Cancer Foundation. Free resources offered by the various organizations include a helpline staffed 24 hours a day (ACS), peer support online or one-to-one and financial assistance (Colorectal Cancer Alliance), access to screening for the under- and uninsured in select areas (Colon Cancer Coalition), and links to a colorectal cancer patient registry (Colon Cancer Foundation).

“I can tell patients ‘Hey listen, go home, call these groups, get on their websites. I’ll call you in a week; call me if you need me. We’re gonna figure this thing out together,’ ” Dr. Dooreck said. “This is a great place to get resources here and now. It’s a very different shift from going home without anything other than a treatment plan.”

No gain – except helping patients

After Dr. Dooreck conceived of CRC POP, in September 2020, he described his plan for consolidating links to free resources in a video conference with the organizations he aimed to include. The organizations immediately agreed, and the text-based service, with technology provided free of charge by the marketing company EZ Texting, went live the following month.

“There’s no hook, there’s no cost, there’s no sale, it’s not monetized. There’s no gain except helping people,” Dr. Dooreck emphasized.

Dr. Lewis agreed: “I think it’s a great initiative, and it helps unify some of the guidance we give these folks.”

Dr. Lewis has the rare perspective of seeing the issue from standpoint of both an oncologist and a patient: Early in his hematology-oncology fellowship at the Mayo Clinic in 2009, he was diagnosed with multiple endocrine neoplasia type 1, and he subsequently underwent surgery to resect pancreatic neuroendocrine tumors.

He says that the buy-in for CRC POP from major support organizations and from gastroenterologists alike is important because most colonoscopies are performed and diagnoses are made in community settings by gastroenterologists who may or may not have formal connections with a cancer center, rather than in large urban or suburban networks affiliated with medical schools.

In most cases, he said, the gastroenterologist makes the CRC diagnosis, and hands the patient off to a surgeon, who may connect with a medical oncologist and/or radiation oncologist depending on the individual patient’s circumstance. This process can take weeks, and in the meantime, patients are left in limbo.

Offering patients multiple trustworthy resources through a simple text message is a particularly appealing part of the CRC POP initiative, and can help patients feel that they are more in control of their care, Dr. Lewis said.

Useful resources, multidisciplinary care

The connection to resources offered by CRC POP is valuable and may be especially helpful for community-based or small gastroenterology practices; on the other hand, large academic medical centers may be able to provide more resources on their own.

“We have home-grown support services that we make available to patients if they either ask for them or if we ascertain that those services would be important components of their care,” Caroline Kuhlman, a nurse practitioner from The Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Cancer Center in Boston, explained in an interview. “Our approach to a newly diagnosed patient happens in the context of a multidisciplinary visit.”

“Newly diagnosed patients meet with a surgeon, a medical oncologist, sometimes a radiation oncologist if that’s going to be a part their care, and whenever possible during the same outpatient visit. Patients are also provided with written information about colon cancer, and we have a patient resource center that has even more information about support from various organizations,” she said.

Patients can also be referred as needed to other resources within the hospital system, including nutritionists, social workers who can help to determine whether patients could benefit from additional social and financial support, and educational resources such as information sessions on what to expect if they receive chemotherapy.

Similarly, Dr. Lewis said that, at Intermountain Health Care, patients newly diagnosed with cancer are contacted within 24 hours by patient navigators who help them manage concerns and expectations about their care and connect them to resources both in the hospital and the community.

Although their own practices differ in size and scope and in the resources they can offer patients, the clinicians interviewed for this article agreed with the central message and purpose of CRC POP: “You are not alone. You have our support.”

Dr. Lewis, Dr. Dooreck, and Ms. Kuhlman reported having no conflicts of interest relevant to the subjects discussed in this article.

The words “you have colorectal cancer” can concentrate a patient’s mind, but certainly not in the way that the clinician delivering the bad news intends.

“A lot of my patients, frankly, have told me that on the first visit the only thing they really hear is the diagnosis of cancer, confirming a malignancy, and everything else that follows is what I call the ‘2 minutes of terror.’ Everything else gets drowned out, and they don’t hear my comments on diseases and sometimes my hopefully reassuring comments on prognosis,” said Mark A. Lewis, MD, director of the gastrointestinal oncology program at Intermountain Healthcare in Murray, Utah, who is himself a survivor of a rare cancer.

An estimated 150,000 people hear something like “you have colorectal cancer” in the United States each year, according to American Cancer Society estimates.

Even before the diagnosis, the patient, still groggy from sedation after a colonoscopy, may wake up and be told “we’ve found something; I’ll call you in a few days when we get the pathology results.”

You don’t have to be a psychiatrist to understand that times of great emotional upheaval, stress, or uncertainty are not ideal for decision-making, especially when the person who is asked to decide is facing a challenge that may seem overwhelmingly complex.

Many patients’ first thoughts are to go online for information, but that too can be overwhelming. For example, a Google search for the words “colorectal cancer” turns up roughly 134 million results, in six-tenths of a second, no less.

There are of course solid, reliable sources for information out there, and reliable information is a very good place to start, as noted by the staff at the Mayo Clinic in Rochester, Minn.

The Mayo website offers 11 tips with for coping with a cancer diagnosis. First among the recommendations is “get the facts about your cancer diagnosis,” and that’s the inspiration behind CRC POP.

Text COLON to 484848

“There are 13,000 of us gastroenterologists in the country, and we diagnosis colorectal cancer 150,000 times a year,” said CRC POP program creator Brian Dooreck, MD, from Memorial Healthcare System in Pembroke Pines, Fla.

When the doctor tells patients the results “their world is turned upside down, they’re shocked, and they don’t pick up much after the word ‘cancer’,” Dr. Dooreck said in an interview.

Both Dr. Dooreck and Dr. Lewis noted that, after going home with a diagnosis of colorectal cancer, a large majority of patients will go online to find information about their diagnosis.

“We know from studies and anecdotal experience that the odds that someone will try to research their own diagnosis are in the 97% range, and then they’re going to run into the pluses and minuses of search engine optimization,” Dr. Lewis said.

As even the most casual Internet user can attest, available medical information can range from the practical to the preposterous, from the National Cancer Institute’s Cancer.gov to a Facebook post on Aunt Tillie’s miracle mayonnaise cure. Helping patients to quickly identify which resources are valuable and trustworthy is the overarching goal of CRC POP, Dr. Dooreck explained.

“What we created with the Colorectal Cancer Provider Outreach Program is that it now allows gastroenterologists to have a conversation with a patient – I can say ‘Now listen, take out your phone, and text the world COLON and send it to 484848.”

Doing so returns a text in a few seconds with the words “You are not alone. You have our support. Here. Now,” and a blue heart emoji, followed by a link that takes the user to a web page with a document containing contact information for the ACS, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and Colon Cancer Foundation. Free resources offered by the various organizations include a helpline staffed 24 hours a day (ACS), peer support online or one-to-one and financial assistance (Colorectal Cancer Alliance), access to screening for the under- and uninsured in select areas (Colon Cancer Coalition), and links to a colorectal cancer patient registry (Colon Cancer Foundation).

“I can tell patients ‘Hey listen, go home, call these groups, get on their websites. I’ll call you in a week; call me if you need me. We’re gonna figure this thing out together,’ ” Dr. Dooreck said. “This is a great place to get resources here and now. It’s a very different shift from going home without anything other than a treatment plan.”

No gain – except helping patients

After Dr. Dooreck conceived of CRC POP, in September 2020, he described his plan for consolidating links to free resources in a video conference with the organizations he aimed to include. The organizations immediately agreed, and the text-based service, with technology provided free of charge by the marketing company EZ Texting, went live the following month.

“There’s no hook, there’s no cost, there’s no sale, it’s not monetized. There’s no gain except helping people,” Dr. Dooreck emphasized.

Dr. Lewis agreed: “I think it’s a great initiative, and it helps unify some of the guidance we give these folks.”

Dr. Lewis has the rare perspective of seeing the issue from standpoint of both an oncologist and a patient: Early in his hematology-oncology fellowship at the Mayo Clinic in 2009, he was diagnosed with multiple endocrine neoplasia type 1, and he subsequently underwent surgery to resect pancreatic neuroendocrine tumors.

He says that the buy-in for CRC POP from major support organizations and from gastroenterologists alike is important because most colonoscopies are performed and diagnoses are made in community settings by gastroenterologists who may or may not have formal connections with a cancer center, rather than in large urban or suburban networks affiliated with medical schools.

In most cases, he said, the gastroenterologist makes the CRC diagnosis, and hands the patient off to a surgeon, who may connect with a medical oncologist and/or radiation oncologist depending on the individual patient’s circumstance. This process can take weeks, and in the meantime, patients are left in limbo.

Offering patients multiple trustworthy resources through a simple text message is a particularly appealing part of the CRC POP initiative, and can help patients feel that they are more in control of their care, Dr. Lewis said.

Useful resources, multidisciplinary care

The connection to resources offered by CRC POP is valuable and may be especially helpful for community-based or small gastroenterology practices; on the other hand, large academic medical centers may be able to provide more resources on their own.

“We have home-grown support services that we make available to patients if they either ask for them or if we ascertain that those services would be important components of their care,” Caroline Kuhlman, a nurse practitioner from The Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Cancer Center in Boston, explained in an interview. “Our approach to a newly diagnosed patient happens in the context of a multidisciplinary visit.”

“Newly diagnosed patients meet with a surgeon, a medical oncologist, sometimes a radiation oncologist if that’s going to be a part their care, and whenever possible during the same outpatient visit. Patients are also provided with written information about colon cancer, and we have a patient resource center that has even more information about support from various organizations,” she said.

Patients can also be referred as needed to other resources within the hospital system, including nutritionists, social workers who can help to determine whether patients could benefit from additional social and financial support, and educational resources such as information sessions on what to expect if they receive chemotherapy.

Similarly, Dr. Lewis said that, at Intermountain Health Care, patients newly diagnosed with cancer are contacted within 24 hours by patient navigators who help them manage concerns and expectations about their care and connect them to resources both in the hospital and the community.

Although their own practices differ in size and scope and in the resources they can offer patients, the clinicians interviewed for this article agreed with the central message and purpose of CRC POP: “You are not alone. You have our support.”

Dr. Lewis, Dr. Dooreck, and Ms. Kuhlman reported having no conflicts of interest relevant to the subjects discussed in this article.

The words “you have colorectal cancer” can concentrate a patient’s mind, but certainly not in the way that the clinician delivering the bad news intends.

“A lot of my patients, frankly, have told me that on the first visit the only thing they really hear is the diagnosis of cancer, confirming a malignancy, and everything else that follows is what I call the ‘2 minutes of terror.’ Everything else gets drowned out, and they don’t hear my comments on diseases and sometimes my hopefully reassuring comments on prognosis,” said Mark A. Lewis, MD, director of the gastrointestinal oncology program at Intermountain Healthcare in Murray, Utah, who is himself a survivor of a rare cancer.

An estimated 150,000 people hear something like “you have colorectal cancer” in the United States each year, according to American Cancer Society estimates.

Even before the diagnosis, the patient, still groggy from sedation after a colonoscopy, may wake up and be told “we’ve found something; I’ll call you in a few days when we get the pathology results.”

You don’t have to be a psychiatrist to understand that times of great emotional upheaval, stress, or uncertainty are not ideal for decision-making, especially when the person who is asked to decide is facing a challenge that may seem overwhelmingly complex.

Many patients’ first thoughts are to go online for information, but that too can be overwhelming. For example, a Google search for the words “colorectal cancer” turns up roughly 134 million results, in six-tenths of a second, no less.

There are of course solid, reliable sources for information out there, and reliable information is a very good place to start, as noted by the staff at the Mayo Clinic in Rochester, Minn.

The Mayo website offers 11 tips with for coping with a cancer diagnosis. First among the recommendations is “get the facts about your cancer diagnosis,” and that’s the inspiration behind CRC POP.

Text COLON to 484848

“There are 13,000 of us gastroenterologists in the country, and we diagnosis colorectal cancer 150,000 times a year,” said CRC POP program creator Brian Dooreck, MD, from Memorial Healthcare System in Pembroke Pines, Fla.

When the doctor tells patients the results “their world is turned upside down, they’re shocked, and they don’t pick up much after the word ‘cancer’,” Dr. Dooreck said in an interview.

Both Dr. Dooreck and Dr. Lewis noted that, after going home with a diagnosis of colorectal cancer, a large majority of patients will go online to find information about their diagnosis.

“We know from studies and anecdotal experience that the odds that someone will try to research their own diagnosis are in the 97% range, and then they’re going to run into the pluses and minuses of search engine optimization,” Dr. Lewis said.

As even the most casual Internet user can attest, available medical information can range from the practical to the preposterous, from the National Cancer Institute’s Cancer.gov to a Facebook post on Aunt Tillie’s miracle mayonnaise cure. Helping patients to quickly identify which resources are valuable and trustworthy is the overarching goal of CRC POP, Dr. Dooreck explained.

“What we created with the Colorectal Cancer Provider Outreach Program is that it now allows gastroenterologists to have a conversation with a patient – I can say ‘Now listen, take out your phone, and text the world COLON and send it to 484848.”

Doing so returns a text in a few seconds with the words “You are not alone. You have our support. Here. Now,” and a blue heart emoji, followed by a link that takes the user to a web page with a document containing contact information for the ACS, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and Colon Cancer Foundation. Free resources offered by the various organizations include a helpline staffed 24 hours a day (ACS), peer support online or one-to-one and financial assistance (Colorectal Cancer Alliance), access to screening for the under- and uninsured in select areas (Colon Cancer Coalition), and links to a colorectal cancer patient registry (Colon Cancer Foundation).

“I can tell patients ‘Hey listen, go home, call these groups, get on their websites. I’ll call you in a week; call me if you need me. We’re gonna figure this thing out together,’ ” Dr. Dooreck said. “This is a great place to get resources here and now. It’s a very different shift from going home without anything other than a treatment plan.”

No gain – except helping patients

After Dr. Dooreck conceived of CRC POP, in September 2020, he described his plan for consolidating links to free resources in a video conference with the organizations he aimed to include. The organizations immediately agreed, and the text-based service, with technology provided free of charge by the marketing company EZ Texting, went live the following month.

“There’s no hook, there’s no cost, there’s no sale, it’s not monetized. There’s no gain except helping people,” Dr. Dooreck emphasized.

Dr. Lewis agreed: “I think it’s a great initiative, and it helps unify some of the guidance we give these folks.”

Dr. Lewis has the rare perspective of seeing the issue from standpoint of both an oncologist and a patient: Early in his hematology-oncology fellowship at the Mayo Clinic in 2009, he was diagnosed with multiple endocrine neoplasia type 1, and he subsequently underwent surgery to resect pancreatic neuroendocrine tumors.

He says that the buy-in for CRC POP from major support organizations and from gastroenterologists alike is important because most colonoscopies are performed and diagnoses are made in community settings by gastroenterologists who may or may not have formal connections with a cancer center, rather than in large urban or suburban networks affiliated with medical schools.

In most cases, he said, the gastroenterologist makes the CRC diagnosis, and hands the patient off to a surgeon, who may connect with a medical oncologist and/or radiation oncologist depending on the individual patient’s circumstance. This process can take weeks, and in the meantime, patients are left in limbo.

Offering patients multiple trustworthy resources through a simple text message is a particularly appealing part of the CRC POP initiative, and can help patients feel that they are more in control of their care, Dr. Lewis said.

Useful resources, multidisciplinary care

The connection to resources offered by CRC POP is valuable and may be especially helpful for community-based or small gastroenterology practices; on the other hand, large academic medical centers may be able to provide more resources on their own.

“We have home-grown support services that we make available to patients if they either ask for them or if we ascertain that those services would be important components of their care,” Caroline Kuhlman, a nurse practitioner from The Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Cancer Center in Boston, explained in an interview. “Our approach to a newly diagnosed patient happens in the context of a multidisciplinary visit.”

“Newly diagnosed patients meet with a surgeon, a medical oncologist, sometimes a radiation oncologist if that’s going to be a part their care, and whenever possible during the same outpatient visit. Patients are also provided with written information about colon cancer, and we have a patient resource center that has even more information about support from various organizations,” she said.

Patients can also be referred as needed to other resources within the hospital system, including nutritionists, social workers who can help to determine whether patients could benefit from additional social and financial support, and educational resources such as information sessions on what to expect if they receive chemotherapy.

Similarly, Dr. Lewis said that, at Intermountain Health Care, patients newly diagnosed with cancer are contacted within 24 hours by patient navigators who help them manage concerns and expectations about their care and connect them to resources both in the hospital and the community.

Although their own practices differ in size and scope and in the resources they can offer patients, the clinicians interviewed for this article agreed with the central message and purpose of CRC POP: “You are not alone. You have our support.”

Dr. Lewis, Dr. Dooreck, and Ms. Kuhlman reported having no conflicts of interest relevant to the subjects discussed in this article.