Clinical Psychiatry News

Apologies up front to anyone who spends their weekends bird-watching or doing math for fun. They are among the people expected to be boring, based on stereotypes about what they do for work or how they spend their spare time, new research reveals.

Researchers surveyed more than 500 people across five related experiments to identify what people perceive as the most boring jobs, traits, and hobbies. They also report how we could all be missing out by spending as little time as possible with our tax consultant, accountant, or financial adviser outside of work.

People who work in banking, finance, accounting, data analytics, and cleaning topped the most boring list in the study, published earlier this month in Personality and Social Psychology Bulletin.

Sleeping, religion, watching television, observing animals, and spending spare time on mathematics were the stereotypical most boring hobbies and activities. The “observing animals” group includes people who bird-watch or study ants.

On the flip side, the top five most exciting jobs, in order, were in the performing arts, science, journalism, health professions, and teaching.

The researchers also looked at the how likely people are to avoid spending time with stereotypical dullards.

“Are people who are stereotyped as being boring avoided, if possible? Our current research shows that this is likely,” says Wijnand A.P. Van Tilburg, PhD, one of the researchers who did the study.

Beyond specific traits and stereotypes, Dr. Van Tilburg and colleagues found that boring people are seen as lacking skills and warmth.

“To our surprise, it appears that they are seen as both unfriendly and incompetent,” says Dr. Van Tilburg, an experimental social psychologist at the University of Essex in the United Kingdom.

What qualities do people most often ascribe to boring people? Besides being “dull,” “dry,” “bland,” and “not interesting,” common stereotypes include thinking someone who is likely boring will have no sense of humor, lack opinions, or complain.

The people surveyed also were more likely to place boring people in towns and small cities rather than large metropolitan areas.

A vicious cycle?

What’s the possible harm of relying on boring stereotypes? If people are stereotyped as being boring solely based on professions and hobbies, “then that suggests that they will incur the negative consequences associated with being a stereotypically boring person -- even when others haven’t actually interacted with them,” Dr. Van Tilburg says.

“Having a stereotypically boring profession or hobby may come with the inability to prove the biased perceivers wrong,” he says.

So making distinctions between stereotypes and realities is important, Dr. Van Tilburg says. “Those who have hobbies or occupations that are stereotypically boring do, of course, not actually have to be boring.”

Mark Leary, PhD, a professor in the department of psychology and neuroscience at Duke University in Durham, N.C., agrees. “The research actually dealt with stereotypes about the kinds of people who hold certain jobs, have certain hobbies, and live in certain places -- and not about boring people per se,” he says.

Dr. Leary points out that few people encounter bankers, tax experts, and others perceived as most boring outside a professional setting.

“When we have interactions with data analysts, accountants, insurance agents, and bankers, for example, those interactions are often boring not because the people are boring, but rather because the context is not interesting.”

To get past the preconceptions, “the best advice might be to get people to try to separate people from their roles when forming impressions of them.”

“We need to recognize that many of our interactions with other people are tied up in particular roles and topics and, thus, don’t reveal much about the other people themselves,” Dr. Leary says. “Maybe my accountant is the life of the party in other contexts.”
 

Dollars to avoid the dull?

The researchers also found that as the perception of how boring a person is increased, people were more likely to say they would avoid them.

To find a way to measure this avoidance, they asked people in the study how much money they would have to be paid to pal around with a perceived bore for 1 to 7 days. The payments people said they would need varied by perceptions that their boredom would be low, intermediate, or high.

As an example, they would require an average of $50 to spend one day with a highly boring person. That amount would double to $100 to spend almost 4 days in their company, and up to $230 for the week.

Dr. Leary says boredom happens when people try to pay attention to an experience or event. This means boredom goes beyond simple disinterest or trying to pay attention to someone that is not “intrinsically captivating.” When it takes more brain power to pay attention, you’ll perceive the experience as even more boring.

“Perhaps the best way to see if other people are actually boring is to talk about interesting things and see how they respond,” Dr. Leary says. “But, be careful: The topics you think make interesting conversations may be boring to others.”

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

Apologies up front to anyone who spends their weekends bird-watching or doing math for fun. They are among the people expected to be boring, based on stereotypes about what they do for work or how they spend their spare time, new research reveals.

Researchers surveyed more than 500 people across five related experiments to identify what people perceive as the most boring jobs, traits, and hobbies. They also report how we could all be missing out by spending as little time as possible with our tax consultant, accountant, or financial adviser outside of work.

People who work in banking, finance, accounting, data analytics, and cleaning topped the most boring list in the study, published earlier this month in Personality and Social Psychology Bulletin.

Sleeping, religion, watching television, observing animals, and spending spare time on mathematics were the stereotypical most boring hobbies and activities. The “observing animals” group includes people who bird-watch or study ants.

On the flip side, the top five most exciting jobs, in order, were in the performing arts, science, journalism, health professions, and teaching.

The researchers also looked at the how likely people are to avoid spending time with stereotypical dullards.

“Are people who are stereotyped as being boring avoided, if possible? Our current research shows that this is likely,” says Wijnand A.P. Van Tilburg, PhD, one of the researchers who did the study.

Beyond specific traits and stereotypes, Dr. Van Tilburg and colleagues found that boring people are seen as lacking skills and warmth.

“To our surprise, it appears that they are seen as both unfriendly and incompetent,” says Dr. Van Tilburg, an experimental social psychologist at the University of Essex in the United Kingdom.

What qualities do people most often ascribe to boring people? Besides being “dull,” “dry,” “bland,” and “not interesting,” common stereotypes include thinking someone who is likely boring will have no sense of humor, lack opinions, or complain.

The people surveyed also were more likely to place boring people in towns and small cities rather than large metropolitan areas.

A vicious cycle?

What’s the possible harm of relying on boring stereotypes? If people are stereotyped as being boring solely based on professions and hobbies, “then that suggests that they will incur the negative consequences associated with being a stereotypically boring person -- even when others haven’t actually interacted with them,” Dr. Van Tilburg says.

“Having a stereotypically boring profession or hobby may come with the inability to prove the biased perceivers wrong,” he says.

So making distinctions between stereotypes and realities is important, Dr. Van Tilburg says. “Those who have hobbies or occupations that are stereotypically boring do, of course, not actually have to be boring.”

Mark Leary, PhD, a professor in the department of psychology and neuroscience at Duke University in Durham, N.C., agrees. “The research actually dealt with stereotypes about the kinds of people who hold certain jobs, have certain hobbies, and live in certain places -- and not about boring people per se,” he says.

Dr. Leary points out that few people encounter bankers, tax experts, and others perceived as most boring outside a professional setting.

“When we have interactions with data analysts, accountants, insurance agents, and bankers, for example, those interactions are often boring not because the people are boring, but rather because the context is not interesting.”

To get past the preconceptions, “the best advice might be to get people to try to separate people from their roles when forming impressions of them.”

“We need to recognize that many of our interactions with other people are tied up in particular roles and topics and, thus, don’t reveal much about the other people themselves,” Dr. Leary says. “Maybe my accountant is the life of the party in other contexts.”
 

Dollars to avoid the dull?

The researchers also found that as the perception of how boring a person is increased, people were more likely to say they would avoid them.

To find a way to measure this avoidance, they asked people in the study how much money they would have to be paid to pal around with a perceived bore for 1 to 7 days. The payments people said they would need varied by perceptions that their boredom would be low, intermediate, or high.

As an example, they would require an average of $50 to spend one day with a highly boring person. That amount would double to $100 to spend almost 4 days in their company, and up to $230 for the week.

Dr. Leary says boredom happens when people try to pay attention to an experience or event. This means boredom goes beyond simple disinterest or trying to pay attention to someone that is not “intrinsically captivating.” When it takes more brain power to pay attention, you’ll perceive the experience as even more boring.

“Perhaps the best way to see if other people are actually boring is to talk about interesting things and see how they respond,” Dr. Leary says. “But, be careful: The topics you think make interesting conversations may be boring to others.”

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

Apologies up front to anyone who spends their weekends bird-watching or doing math for fun. They are among the people expected to be boring, based on stereotypes about what they do for work or how they spend their spare time, new research reveals.

Researchers surveyed more than 500 people across five related experiments to identify what people perceive as the most boring jobs, traits, and hobbies. They also report how we could all be missing out by spending as little time as possible with our tax consultant, accountant, or financial adviser outside of work.

People who work in banking, finance, accounting, data analytics, and cleaning topped the most boring list in the study, published earlier this month in Personality and Social Psychology Bulletin.

Sleeping, religion, watching television, observing animals, and spending spare time on mathematics were the stereotypical most boring hobbies and activities. The “observing animals” group includes people who bird-watch or study ants.

On the flip side, the top five most exciting jobs, in order, were in the performing arts, science, journalism, health professions, and teaching.

The researchers also looked at the how likely people are to avoid spending time with stereotypical dullards.

“Are people who are stereotyped as being boring avoided, if possible? Our current research shows that this is likely,” says Wijnand A.P. Van Tilburg, PhD, one of the researchers who did the study.

Beyond specific traits and stereotypes, Dr. Van Tilburg and colleagues found that boring people are seen as lacking skills and warmth.

“To our surprise, it appears that they are seen as both unfriendly and incompetent,” says Dr. Van Tilburg, an experimental social psychologist at the University of Essex in the United Kingdom.

What qualities do people most often ascribe to boring people? Besides being “dull,” “dry,” “bland,” and “not interesting,” common stereotypes include thinking someone who is likely boring will have no sense of humor, lack opinions, or complain.

The people surveyed also were more likely to place boring people in towns and small cities rather than large metropolitan areas.

A vicious cycle?

What’s the possible harm of relying on boring stereotypes? If people are stereotyped as being boring solely based on professions and hobbies, “then that suggests that they will incur the negative consequences associated with being a stereotypically boring person -- even when others haven’t actually interacted with them,” Dr. Van Tilburg says.

“Having a stereotypically boring profession or hobby may come with the inability to prove the biased perceivers wrong,” he says.

So making distinctions between stereotypes and realities is important, Dr. Van Tilburg says. “Those who have hobbies or occupations that are stereotypically boring do, of course, not actually have to be boring.”

Mark Leary, PhD, a professor in the department of psychology and neuroscience at Duke University in Durham, N.C., agrees. “The research actually dealt with stereotypes about the kinds of people who hold certain jobs, have certain hobbies, and live in certain places -- and not about boring people per se,” he says.

Dr. Leary points out that few people encounter bankers, tax experts, and others perceived as most boring outside a professional setting.

“When we have interactions with data analysts, accountants, insurance agents, and bankers, for example, those interactions are often boring not because the people are boring, but rather because the context is not interesting.”

To get past the preconceptions, “the best advice might be to get people to try to separate people from their roles when forming impressions of them.”

“We need to recognize that many of our interactions with other people are tied up in particular roles and topics and, thus, don’t reveal much about the other people themselves,” Dr. Leary says. “Maybe my accountant is the life of the party in other contexts.”
 

Dollars to avoid the dull?

The researchers also found that as the perception of how boring a person is increased, people were more likely to say they would avoid them.

To find a way to measure this avoidance, they asked people in the study how much money they would have to be paid to pal around with a perceived bore for 1 to 7 days. The payments people said they would need varied by perceptions that their boredom would be low, intermediate, or high.

As an example, they would require an average of $50 to spend one day with a highly boring person. That amount would double to $100 to spend almost 4 days in their company, and up to $230 for the week.

Dr. Leary says boredom happens when people try to pay attention to an experience or event. This means boredom goes beyond simple disinterest or trying to pay attention to someone that is not “intrinsically captivating.” When it takes more brain power to pay attention, you’ll perceive the experience as even more boring.

“Perhaps the best way to see if other people are actually boring is to talk about interesting things and see how they respond,” Dr. Leary says. “But, be careful: The topics you think make interesting conversations may be boring to others.”

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

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

DENVER – A first-of-its-kind study evaluating a mindfulness intervention to ease grief unexpectedly showed that the control treatment, progressive muscle relaxation, was more effective.

“Both progressive muscle relaxation and mindfulness training were shown to improve grief severity, yearning, depression symptoms, and stress, [but] the results from this study suggest that progressive muscle relaxation is most effective, compared to a wait-list control condition for improving grief,” study investigator Lindsey Knowles, PhD, senior fellow, MS Center of Excellence, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, told this news organization.

University of Washington School of Medicine

“With replication, progressive muscle relaxation could be a standalone intervention for nondisordered grief or a component of treatment for disordered grief,” Dr. Knowles said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Disordered grief

Approximately 10% of individuals grappling with loss “get stuck” in their grief and develop disordered grief, which is distinguished by repetitive thought processes of yearning and grief rumination, the investigators noted.

The researchers hypothesized that mindfulness training, which has been shown to reduce maladaptive repetitive thought, could be an effective intervention to prevent disordered grief.

To investigate, they enrolled 94 widows and widowers (mean age, 67.5 years) who were experiencing bereavement-related grief and were between 6 months and 4 years post loss.

The researchers compared a 6-week mindfulness intervention (n = 37) with a 6-week progressive muscle relaxation intervention (n = 35), Dr. Knowles said, because there has been speculation that benefits from mindfulness training may be related more to the relaxation response than to the actual mindfulness component.

Both study groups received the intervention in similar settings with matched instructors.

The mindfulness intervention sessions included 10-25 minutes of meditation and mindfulness practices. It also included instructions for home practice.

Participants in the progressive muscle relaxation group were trained to tense and relax the body’s various muscle groups with an end goal of learning to relax four key muscle groups without initial tensing.

A third group of patients were placed on a wait list with no intervention (n = 22).

Measures taken throughout the study interventions and at 1 month postintervention showed reductions in the study’s two primary outcomes of grief severity and yearning for both interventions versus baseline (P = < .003).

However, only the progressive muscle relaxation group had a significantly greater reduction in grief severity vs the wait-list control group (P = .020).

The muscle relaxation group also showed lower grief severity at 1month follow-up versus the wait-list group (P = .049) – with a value at that time falling below an established cutoff for complicated grief, based on the Revised Inventory of Complicated Grief.

All three treatment groups showed a drop in the third primary outcome of grief rumination (P < .001).

Secondary outcomes of depression and stress were reduced in both active study groups versus the wait-list group (P = .028). Sleep quality also improved in both active intervention groups.
 

Simple technique

Dr. Knowles said the study’s findings were unexpected.

“We had hypothesized that mindfulness training would outperform progressive muscle relaxation and wait-list for improving grief outcomes,” she said.

Mindfulness experts underscore that a state of global relaxation is considered integral to the benefits of mindfulness, which could explain the benefits of progressive muscle relaxation, Dr. Knowles noted.

Importantly, progressive muscle relaxation has a key advantage: It is quickly and easily learned, which may partially explain the study’s findings, she added.

“Progressive muscle relaxation is a relatively simple technique, so it is also likely that participants were able to master [the technique] over the 6-week intervention,” Dr. Knowles said. “On the other hand, the mindfulness intervention was an introduction to mindfulness, and mastery was not expected or likely over the 6-week intervention.”

Either way, the results shed important light on a potentially beneficial grief intervention.

“Although mindfulness training and progressive muscle relaxation practices may both be perceived as relaxing, mastering progressive muscle relaxation may in fact enable people to maintain better focus in the present moment and generalize nonreactive awareness to both positively and negatively balanced phenomena,” Dr. Knowles said.

However, “more research is necessary to clarify how progressive muscle relaxation improves grief outcomes in widows and widowers.” 
 

CNS benefits?

Zoe Donaldson, PhD, assistant professor in behavioral neuroscience, department of psychology and neuroscience, University of Colorado, Boulder, said the study is important for ongoing efforts in finding effective therapies for grief.

“We often struggle to try to help those experiencing the pain of loss and this study suggests a discrete set of exercises that may help,” said Dr. Donaldson, who was not involved with the research.

She also described the study results as surprising, and speculated that a combination of factors could explain the findings.

“First, mindfulness is hard to achieve, so the moderate beneficial effects might increase with more substantial mindfulness training. Secondly, it is not clear why progressive muscle relaxation had an effect, but the focus and attention to detail may engage the central nervous system in a beneficial way that we don’t fully understand,” Dr. Donaldson said.

Importantly, it’s key to remember that grief is an individual condition when investigating therapies, Dr. Donaldson noted.

“We likely need to develop multiple interventions to help those who are grieving. Incorporating loss can take many forms,” she said.

The investigators and Dr. Donaldson reported no relevant financial relationships.

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

DENVER – A first-of-its-kind study evaluating a mindfulness intervention to ease grief unexpectedly showed that the control treatment, progressive muscle relaxation, was more effective.

“Both progressive muscle relaxation and mindfulness training were shown to improve grief severity, yearning, depression symptoms, and stress, [but] the results from this study suggest that progressive muscle relaxation is most effective, compared to a wait-list control condition for improving grief,” study investigator Lindsey Knowles, PhD, senior fellow, MS Center of Excellence, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, told this news organization.

University of Washington School of Medicine

“With replication, progressive muscle relaxation could be a standalone intervention for nondisordered grief or a component of treatment for disordered grief,” Dr. Knowles said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Disordered grief

Approximately 10% of individuals grappling with loss “get stuck” in their grief and develop disordered grief, which is distinguished by repetitive thought processes of yearning and grief rumination, the investigators noted.

The researchers hypothesized that mindfulness training, which has been shown to reduce maladaptive repetitive thought, could be an effective intervention to prevent disordered grief.

To investigate, they enrolled 94 widows and widowers (mean age, 67.5 years) who were experiencing bereavement-related grief and were between 6 months and 4 years post loss.

The researchers compared a 6-week mindfulness intervention (n = 37) with a 6-week progressive muscle relaxation intervention (n = 35), Dr. Knowles said, because there has been speculation that benefits from mindfulness training may be related more to the relaxation response than to the actual mindfulness component.

Both study groups received the intervention in similar settings with matched instructors.

The mindfulness intervention sessions included 10-25 minutes of meditation and mindfulness practices. It also included instructions for home practice.

Participants in the progressive muscle relaxation group were trained to tense and relax the body’s various muscle groups with an end goal of learning to relax four key muscle groups without initial tensing.

A third group of patients were placed on a wait list with no intervention (n = 22).

Measures taken throughout the study interventions and at 1 month postintervention showed reductions in the study’s two primary outcomes of grief severity and yearning for both interventions versus baseline (P = < .003).

However, only the progressive muscle relaxation group had a significantly greater reduction in grief severity vs the wait-list control group (P = .020).

The muscle relaxation group also showed lower grief severity at 1month follow-up versus the wait-list group (P = .049) – with a value at that time falling below an established cutoff for complicated grief, based on the Revised Inventory of Complicated Grief.

All three treatment groups showed a drop in the third primary outcome of grief rumination (P < .001).

Secondary outcomes of depression and stress were reduced in both active study groups versus the wait-list group (P = .028). Sleep quality also improved in both active intervention groups.
 

Simple technique

Dr. Knowles said the study’s findings were unexpected.

“We had hypothesized that mindfulness training would outperform progressive muscle relaxation and wait-list for improving grief outcomes,” she said.

Mindfulness experts underscore that a state of global relaxation is considered integral to the benefits of mindfulness, which could explain the benefits of progressive muscle relaxation, Dr. Knowles noted.

Importantly, progressive muscle relaxation has a key advantage: It is quickly and easily learned, which may partially explain the study’s findings, she added.

“Progressive muscle relaxation is a relatively simple technique, so it is also likely that participants were able to master [the technique] over the 6-week intervention,” Dr. Knowles said. “On the other hand, the mindfulness intervention was an introduction to mindfulness, and mastery was not expected or likely over the 6-week intervention.”

Either way, the results shed important light on a potentially beneficial grief intervention.

“Although mindfulness training and progressive muscle relaxation practices may both be perceived as relaxing, mastering progressive muscle relaxation may in fact enable people to maintain better focus in the present moment and generalize nonreactive awareness to both positively and negatively balanced phenomena,” Dr. Knowles said.

However, “more research is necessary to clarify how progressive muscle relaxation improves grief outcomes in widows and widowers.” 
 

CNS benefits?

Zoe Donaldson, PhD, assistant professor in behavioral neuroscience, department of psychology and neuroscience, University of Colorado, Boulder, said the study is important for ongoing efforts in finding effective therapies for grief.

“We often struggle to try to help those experiencing the pain of loss and this study suggests a discrete set of exercises that may help,” said Dr. Donaldson, who was not involved with the research.

She also described the study results as surprising, and speculated that a combination of factors could explain the findings.

“First, mindfulness is hard to achieve, so the moderate beneficial effects might increase with more substantial mindfulness training. Secondly, it is not clear why progressive muscle relaxation had an effect, but the focus and attention to detail may engage the central nervous system in a beneficial way that we don’t fully understand,” Dr. Donaldson said.

Importantly, it’s key to remember that grief is an individual condition when investigating therapies, Dr. Donaldson noted.

“We likely need to develop multiple interventions to help those who are grieving. Incorporating loss can take many forms,” she said.

The investigators and Dr. Donaldson reported no relevant financial relationships.

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

DENVER – A first-of-its-kind study evaluating a mindfulness intervention to ease grief unexpectedly showed that the control treatment, progressive muscle relaxation, was more effective.

“Both progressive muscle relaxation and mindfulness training were shown to improve grief severity, yearning, depression symptoms, and stress, [but] the results from this study suggest that progressive muscle relaxation is most effective, compared to a wait-list control condition for improving grief,” study investigator Lindsey Knowles, PhD, senior fellow, MS Center of Excellence, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, told this news organization.

University of Washington School of Medicine

“With replication, progressive muscle relaxation could be a standalone intervention for nondisordered grief or a component of treatment for disordered grief,” Dr. Knowles said.

The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
 

Disordered grief

Approximately 10% of individuals grappling with loss “get stuck” in their grief and develop disordered grief, which is distinguished by repetitive thought processes of yearning and grief rumination, the investigators noted.

The researchers hypothesized that mindfulness training, which has been shown to reduce maladaptive repetitive thought, could be an effective intervention to prevent disordered grief.

To investigate, they enrolled 94 widows and widowers (mean age, 67.5 years) who were experiencing bereavement-related grief and were between 6 months and 4 years post loss.

The researchers compared a 6-week mindfulness intervention (n = 37) with a 6-week progressive muscle relaxation intervention (n = 35), Dr. Knowles said, because there has been speculation that benefits from mindfulness training may be related more to the relaxation response than to the actual mindfulness component.

Both study groups received the intervention in similar settings with matched instructors.

The mindfulness intervention sessions included 10-25 minutes of meditation and mindfulness practices. It also included instructions for home practice.

Participants in the progressive muscle relaxation group were trained to tense and relax the body’s various muscle groups with an end goal of learning to relax four key muscle groups without initial tensing.

A third group of patients were placed on a wait list with no intervention (n = 22).

Measures taken throughout the study interventions and at 1 month postintervention showed reductions in the study’s two primary outcomes of grief severity and yearning for both interventions versus baseline (P = < .003).

However, only the progressive muscle relaxation group had a significantly greater reduction in grief severity vs the wait-list control group (P = .020).

The muscle relaxation group also showed lower grief severity at 1month follow-up versus the wait-list group (P = .049) – with a value at that time falling below an established cutoff for complicated grief, based on the Revised Inventory of Complicated Grief.

All three treatment groups showed a drop in the third primary outcome of grief rumination (P < .001).

Secondary outcomes of depression and stress were reduced in both active study groups versus the wait-list group (P = .028). Sleep quality also improved in both active intervention groups.
 

Simple technique

Dr. Knowles said the study’s findings were unexpected.

“We had hypothesized that mindfulness training would outperform progressive muscle relaxation and wait-list for improving grief outcomes,” she said.

Mindfulness experts underscore that a state of global relaxation is considered integral to the benefits of mindfulness, which could explain the benefits of progressive muscle relaxation, Dr. Knowles noted.

Importantly, progressive muscle relaxation has a key advantage: It is quickly and easily learned, which may partially explain the study’s findings, she added.

“Progressive muscle relaxation is a relatively simple technique, so it is also likely that participants were able to master [the technique] over the 6-week intervention,” Dr. Knowles said. “On the other hand, the mindfulness intervention was an introduction to mindfulness, and mastery was not expected or likely over the 6-week intervention.”

Either way, the results shed important light on a potentially beneficial grief intervention.

“Although mindfulness training and progressive muscle relaxation practices may both be perceived as relaxing, mastering progressive muscle relaxation may in fact enable people to maintain better focus in the present moment and generalize nonreactive awareness to both positively and negatively balanced phenomena,” Dr. Knowles said.

However, “more research is necessary to clarify how progressive muscle relaxation improves grief outcomes in widows and widowers.” 
 

CNS benefits?

Zoe Donaldson, PhD, assistant professor in behavioral neuroscience, department of psychology and neuroscience, University of Colorado, Boulder, said the study is important for ongoing efforts in finding effective therapies for grief.

“We often struggle to try to help those experiencing the pain of loss and this study suggests a discrete set of exercises that may help,” said Dr. Donaldson, who was not involved with the research.

She also described the study results as surprising, and speculated that a combination of factors could explain the findings.

“First, mindfulness is hard to achieve, so the moderate beneficial effects might increase with more substantial mindfulness training. Secondly, it is not clear why progressive muscle relaxation had an effect, but the focus and attention to detail may engage the central nervous system in a beneficial way that we don’t fully understand,” Dr. Donaldson said.

Importantly, it’s key to remember that grief is an individual condition when investigating therapies, Dr. Donaldson noted.

“We likely need to develop multiple interventions to help those who are grieving. Incorporating loss can take many forms,” she said.

The investigators and Dr. Donaldson reported no relevant financial relationships.

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

Despite a record number of drug overdose deaths in the U.S. and a large body of evidence supporting the efficacy of medications to treat opioid use disorder (OUD) these drugs remain vastly underutilized, new research shows.

Based on data from the National Survey on Drug Use and Health (NSDUH), investigators found only one in four individuals with OUD receive drug treatment.

In addition, receipt of medication for OUD (MOUD) was lowest among women, the uninsured, non-Hispanic Black or Hispanic people, people with low incomes, and those over age 50. Teens with OUD had the lowest rate of medication use among all demographic groups – zero.  

The study is the first to estimate past-year MOUD use in a nationally representative community sample of individuals who may have needed OUD treatment.

“The overdose crisis in the U.S. is continuing unabated, unfortunately, and medication access is an important tool to target and reduce overdose deaths,” lead author Pia Mauro, PhD, assistant professor of epidemiology at Columbia University’s Mailman School of Public Health, New York, told this news organization. “Putting numbers to the distribution of people who are getting medication is important, because it shows that what we’re doing is not enough.”

Columbia University

Overdose deaths at an all-time high

U.S. drug overdose deaths are at a record high, with 100,306 American deaths between April 2020 and April 2021, a nearly 30% increase from the previous year. Nearly three-quarters of those deaths involved opioids.

There are currently three Food and Drug Administration–approved medications to treat OUD: methadone, buprenorphine, or naltrexone, all of which are highly effective. Buprenorphine is the only one approved for use in adolescents, and only in those 16 and older.

Before 2019, information about MOUD treatment use was not collected in the NSDUH, an annual survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA).

Drawing on responses to the newly added MOUD-use question, Dr. Mauro and colleagues identified participants who may have needed MOUD in the previous year, including those who reported having a heroin or opioid use disorder, receiving medication for their disorder, or undergoing a non-medication OUD treatment, including cognitive behavioral therapy and self-help.

Only 27.8% of those eligible for OUD treatment received MOUD in the past year; 57.0% received no treatment; and 15.3% received non-MOUD services.

Individuals aged 18-25 were most likely to receive MOUD, with just 13.2% of those over age 50 and no one under age 18 receiving medication.

“This study points to extremely low medication use for people who may need it, and given the continued increase in drug-related overdose deaths, the majority of which involve opioids, the necessity to increase access to medication is more important than ever,” Dr. Mauro said.

MOUD use was significantly lower in non-Hispanic Black people, (adjusted relative risk ratio, 0.82; 95% confidence interval, 0.27-2.46), Hispanic people (aRRR, 0.57; 95% CI, 0.14-2.28), and in Asian, Native American or Alaska Native, Native Hawaiian, Pacific Islander, or multiracial people (aRRR, 0.28; 95% CI, 0.08-0.92) compared to White people.

Medication use was less likely in women than men (aRRR, 0.52; 95% CI, 0.29-0.95) and more likely in people who had both prescription opioid and heroin use disorder, compared with those who misused just one of the substances (aRRR, 5.07; 95% CI, 1.50-17.12).

MOUD was more common among people with public insurance than those with private or no insurance, but the overall use remained very low regardless of insurance status.

“Public insurance has consistently been positively associated with MOUD access, so our study builds on this showing the importance of public insurance to increase medication access,” Dr. Mauro said. “But even among those with public insurance, only 35% got medication. That’s only one in three.”

About 85% of participants who may have needed treatment for OUD had at least one contact with a health care provider in the past year, and more than half had contact with the criminal legal system. Only about one-third of these individuals received MOUD, which Dr. Mauro lamented as a lost opportunity for treatment.
 

Persistent barriers to treatment

The findings highlight persistent barriers to medication-based therapy for OUD, said Alan Leshner, PhD, chief executive officer emeritus of the American Association for the Advancement of Science and a former director of the National Institute on Drug Abuse.

Courtesy of Dr. Alan Leshner

“These kinds of data are critical to increase our understanding of the nature of the opioid epidemic and what to do about it,” Dr. Leshner said. “It’s particularly important to understand who does, and doesn’t, have access to lifesaving medications, but also where to focus efforts at working on the problem.”

In 2019, Dr. Leshner coauthored a report on the underutilization of medication to treat OUD. As previously reported by this news organization, that report argued that stigma, burdensome regulations, unfounded concerns about diversion of MOUDs, lack of insurance coverage, and inadequate professional training for health care providers, law enforcement, and criminal justice officials all acted as barriers that separate people with a medical disorder from desperately needed – and effective – treatment.

“The barriers are the same and have not been vigorously addressed,” Dr. Leshner said. However, recent moves by government leaders may signal a positive trend toward expanded treatment, he added.

Earlier this month, Dr. Leshner chaired a workshop on ways to improve access to methadone, one of the approved medications to treat OUD. Officials from SAMHSA, the Drug Enforcement Administration, and the FDA participated, as did Rahul Gupta, MD, director of the Office of National Drug Control Policy and the nation’s top drug policy official.

“I am optimistic that there may be a new commitment to working on this epidemic using a health-centered approach that takes into account the array of social issues that surround the problem, as well as the criminal justice issues,” Dr. Leshner said.

The study was funded by the National Institute on Drug Abuse grant. Dr. Mauro and Dr. Leshner reported no conflicts. Full disclosures are reported in the original article.

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

Despite a record number of drug overdose deaths in the U.S. and a large body of evidence supporting the efficacy of medications to treat opioid use disorder (OUD) these drugs remain vastly underutilized, new research shows.

Based on data from the National Survey on Drug Use and Health (NSDUH), investigators found only one in four individuals with OUD receive drug treatment.

In addition, receipt of medication for OUD (MOUD) was lowest among women, the uninsured, non-Hispanic Black or Hispanic people, people with low incomes, and those over age 50. Teens with OUD had the lowest rate of medication use among all demographic groups – zero.  

The study is the first to estimate past-year MOUD use in a nationally representative community sample of individuals who may have needed OUD treatment.

“The overdose crisis in the U.S. is continuing unabated, unfortunately, and medication access is an important tool to target and reduce overdose deaths,” lead author Pia Mauro, PhD, assistant professor of epidemiology at Columbia University’s Mailman School of Public Health, New York, told this news organization. “Putting numbers to the distribution of people who are getting medication is important, because it shows that what we’re doing is not enough.”

Columbia University

Overdose deaths at an all-time high

U.S. drug overdose deaths are at a record high, with 100,306 American deaths between April 2020 and April 2021, a nearly 30% increase from the previous year. Nearly three-quarters of those deaths involved opioids.

There are currently three Food and Drug Administration–approved medications to treat OUD: methadone, buprenorphine, or naltrexone, all of which are highly effective. Buprenorphine is the only one approved for use in adolescents, and only in those 16 and older.

Before 2019, information about MOUD treatment use was not collected in the NSDUH, an annual survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA).

Drawing on responses to the newly added MOUD-use question, Dr. Mauro and colleagues identified participants who may have needed MOUD in the previous year, including those who reported having a heroin or opioid use disorder, receiving medication for their disorder, or undergoing a non-medication OUD treatment, including cognitive behavioral therapy and self-help.

Only 27.8% of those eligible for OUD treatment received MOUD in the past year; 57.0% received no treatment; and 15.3% received non-MOUD services.

Individuals aged 18-25 were most likely to receive MOUD, with just 13.2% of those over age 50 and no one under age 18 receiving medication.

“This study points to extremely low medication use for people who may need it, and given the continued increase in drug-related overdose deaths, the majority of which involve opioids, the necessity to increase access to medication is more important than ever,” Dr. Mauro said.

MOUD use was significantly lower in non-Hispanic Black people, (adjusted relative risk ratio, 0.82; 95% confidence interval, 0.27-2.46), Hispanic people (aRRR, 0.57; 95% CI, 0.14-2.28), and in Asian, Native American or Alaska Native, Native Hawaiian, Pacific Islander, or multiracial people (aRRR, 0.28; 95% CI, 0.08-0.92) compared to White people.

Medication use was less likely in women than men (aRRR, 0.52; 95% CI, 0.29-0.95) and more likely in people who had both prescription opioid and heroin use disorder, compared with those who misused just one of the substances (aRRR, 5.07; 95% CI, 1.50-17.12).

MOUD was more common among people with public insurance than those with private or no insurance, but the overall use remained very low regardless of insurance status.

“Public insurance has consistently been positively associated with MOUD access, so our study builds on this showing the importance of public insurance to increase medication access,” Dr. Mauro said. “But even among those with public insurance, only 35% got medication. That’s only one in three.”

About 85% of participants who may have needed treatment for OUD had at least one contact with a health care provider in the past year, and more than half had contact with the criminal legal system. Only about one-third of these individuals received MOUD, which Dr. Mauro lamented as a lost opportunity for treatment.
 

Persistent barriers to treatment

The findings highlight persistent barriers to medication-based therapy for OUD, said Alan Leshner, PhD, chief executive officer emeritus of the American Association for the Advancement of Science and a former director of the National Institute on Drug Abuse.

Courtesy of Dr. Alan Leshner

“These kinds of data are critical to increase our understanding of the nature of the opioid epidemic and what to do about it,” Dr. Leshner said. “It’s particularly important to understand who does, and doesn’t, have access to lifesaving medications, but also where to focus efforts at working on the problem.”

In 2019, Dr. Leshner coauthored a report on the underutilization of medication to treat OUD. As previously reported by this news organization, that report argued that stigma, burdensome regulations, unfounded concerns about diversion of MOUDs, lack of insurance coverage, and inadequate professional training for health care providers, law enforcement, and criminal justice officials all acted as barriers that separate people with a medical disorder from desperately needed – and effective – treatment.

“The barriers are the same and have not been vigorously addressed,” Dr. Leshner said. However, recent moves by government leaders may signal a positive trend toward expanded treatment, he added.

Earlier this month, Dr. Leshner chaired a workshop on ways to improve access to methadone, one of the approved medications to treat OUD. Officials from SAMHSA, the Drug Enforcement Administration, and the FDA participated, as did Rahul Gupta, MD, director of the Office of National Drug Control Policy and the nation’s top drug policy official.

“I am optimistic that there may be a new commitment to working on this epidemic using a health-centered approach that takes into account the array of social issues that surround the problem, as well as the criminal justice issues,” Dr. Leshner said.

The study was funded by the National Institute on Drug Abuse grant. Dr. Mauro and Dr. Leshner reported no conflicts. Full disclosures are reported in the original article.

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

Despite a record number of drug overdose deaths in the U.S. and a large body of evidence supporting the efficacy of medications to treat opioid use disorder (OUD) these drugs remain vastly underutilized, new research shows.

Based on data from the National Survey on Drug Use and Health (NSDUH), investigators found only one in four individuals with OUD receive drug treatment.

In addition, receipt of medication for OUD (MOUD) was lowest among women, the uninsured, non-Hispanic Black or Hispanic people, people with low incomes, and those over age 50. Teens with OUD had the lowest rate of medication use among all demographic groups – zero.  

The study is the first to estimate past-year MOUD use in a nationally representative community sample of individuals who may have needed OUD treatment.

“The overdose crisis in the U.S. is continuing unabated, unfortunately, and medication access is an important tool to target and reduce overdose deaths,” lead author Pia Mauro, PhD, assistant professor of epidemiology at Columbia University’s Mailman School of Public Health, New York, told this news organization. “Putting numbers to the distribution of people who are getting medication is important, because it shows that what we’re doing is not enough.”

Columbia University

Overdose deaths at an all-time high

U.S. drug overdose deaths are at a record high, with 100,306 American deaths between April 2020 and April 2021, a nearly 30% increase from the previous year. Nearly three-quarters of those deaths involved opioids.

There are currently three Food and Drug Administration–approved medications to treat OUD: methadone, buprenorphine, or naltrexone, all of which are highly effective. Buprenorphine is the only one approved for use in adolescents, and only in those 16 and older.

Before 2019, information about MOUD treatment use was not collected in the NSDUH, an annual survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA).

Drawing on responses to the newly added MOUD-use question, Dr. Mauro and colleagues identified participants who may have needed MOUD in the previous year, including those who reported having a heroin or opioid use disorder, receiving medication for their disorder, or undergoing a non-medication OUD treatment, including cognitive behavioral therapy and self-help.

Only 27.8% of those eligible for OUD treatment received MOUD in the past year; 57.0% received no treatment; and 15.3% received non-MOUD services.

Individuals aged 18-25 were most likely to receive MOUD, with just 13.2% of those over age 50 and no one under age 18 receiving medication.

“This study points to extremely low medication use for people who may need it, and given the continued increase in drug-related overdose deaths, the majority of which involve opioids, the necessity to increase access to medication is more important than ever,” Dr. Mauro said.

MOUD use was significantly lower in non-Hispanic Black people, (adjusted relative risk ratio, 0.82; 95% confidence interval, 0.27-2.46), Hispanic people (aRRR, 0.57; 95% CI, 0.14-2.28), and in Asian, Native American or Alaska Native, Native Hawaiian, Pacific Islander, or multiracial people (aRRR, 0.28; 95% CI, 0.08-0.92) compared to White people.

Medication use was less likely in women than men (aRRR, 0.52; 95% CI, 0.29-0.95) and more likely in people who had both prescription opioid and heroin use disorder, compared with those who misused just one of the substances (aRRR, 5.07; 95% CI, 1.50-17.12).

MOUD was more common among people with public insurance than those with private or no insurance, but the overall use remained very low regardless of insurance status.

“Public insurance has consistently been positively associated with MOUD access, so our study builds on this showing the importance of public insurance to increase medication access,” Dr. Mauro said. “But even among those with public insurance, only 35% got medication. That’s only one in three.”

About 85% of participants who may have needed treatment for OUD had at least one contact with a health care provider in the past year, and more than half had contact with the criminal legal system. Only about one-third of these individuals received MOUD, which Dr. Mauro lamented as a lost opportunity for treatment.
 

Persistent barriers to treatment

The findings highlight persistent barriers to medication-based therapy for OUD, said Alan Leshner, PhD, chief executive officer emeritus of the American Association for the Advancement of Science and a former director of the National Institute on Drug Abuse.

Courtesy of Dr. Alan Leshner

“These kinds of data are critical to increase our understanding of the nature of the opioid epidemic and what to do about it,” Dr. Leshner said. “It’s particularly important to understand who does, and doesn’t, have access to lifesaving medications, but also where to focus efforts at working on the problem.”

In 2019, Dr. Leshner coauthored a report on the underutilization of medication to treat OUD. As previously reported by this news organization, that report argued that stigma, burdensome regulations, unfounded concerns about diversion of MOUDs, lack of insurance coverage, and inadequate professional training for health care providers, law enforcement, and criminal justice officials all acted as barriers that separate people with a medical disorder from desperately needed – and effective – treatment.

“The barriers are the same and have not been vigorously addressed,” Dr. Leshner said. However, recent moves by government leaders may signal a positive trend toward expanded treatment, he added.

Earlier this month, Dr. Leshner chaired a workshop on ways to improve access to methadone, one of the approved medications to treat OUD. Officials from SAMHSA, the Drug Enforcement Administration, and the FDA participated, as did Rahul Gupta, MD, director of the Office of National Drug Control Policy and the nation’s top drug policy official.

“I am optimistic that there may be a new commitment to working on this epidemic using a health-centered approach that takes into account the array of social issues that surround the problem, as well as the criminal justice issues,” Dr. Leshner said.

The study was funded by the National Institute on Drug Abuse grant. Dr. Mauro and Dr. Leshner reported no conflicts. Full disclosures are reported in the original article.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Since it appeared in the first edition of the American Psychiatric Association’s Principles of Medical Ethics in 1973, the “Goldwater rule” – often referred to in terms of where in the APA’s guideline it can be found, Section 7.3 – has placed a stringent prohibition on psychiatrists offering professional opinions about public figures “unless he or she has conducted an examination and has been granted proper authorization for such a statement.”¹

Some psychiatrists experienced the restrictive nature of Section 7.3 more acutely perhaps than ever during the Trump presidency. This spurred numerous articles criticizing the guideline as an outdated “gag rule”² that harms the public image of psychiatry.³ Some psychiatrists violated the rule to warn the public of the dangers of a president with “incipient dementia”⁴ occupying the most powerful position on earth.

Following President Trump’s exit from the White House, the alarm bells surrounding his presidency have quieted. Criticisms of the Goldwater rule, on the other hand, have persisted. Many of these criticisms now call for the rule to be refined, allowing for psychiatrists to give their professional opinions about public figures, but with certain guidelines on how to do so.⁵ Few have yet to make a sober case for the outright abolition of Section 7.3.⁶

Self-regulating and internal policing are important factors in the continued independence of the medical profession, and we should continue to hold each other to high professional standards. That being said, do psychiatrists need training wheels to prevent us from devolving into unprofessional social commentators? Other medical specialties do not see the need to implement a rule preventing their colleagues from expressing expertise in fear of embarrassment. Do we not have faith in our ability to conduct ourselves professionally? Is the Goldwater rule an admission of a juvenile lack of self-control within our field?

Not only do other medical specialties not forcibly handhold their members in public settings, but other “providers” in the realm of mental health likewise do not implement such strict self-restraints. Psychiatry staying silent on the matter of public figures leaves a void filled by other, arguably less qualified, individuals. Subsequently, the public discord risks being flooded with pseudoscientific pontification and distorted views of psychiatric illness. The cycle of speculating on the mental fitness of the president has outlived President Trump, with concerns about Joe Biden’s incoherence and waning cognition.⁷ Therein is an important argument to be made for the public duty of psychiatrists, with their greater expertise and clinical acumen, to weigh in on matters of societal importance in an attempt to dispel dangerous misconceptions.

Practical limitations are often raised and serve as the cornerstone for the Goldwater rule. Specifically, the limitation being that a psychiatrist cannot provide a professional opinion about an individual without a proper in-person evaluation. The psychiatric interview could be considered the most in-depth and comprehensive evaluation in all of medicine. Even so, is a trained psychiatrist presented with grandiosity, flight-of-ideas, and pressured speech unable to comment on the possibility of mania without a lengthy and comprehensive evaluation? How much disorganization of behavior and dialogue does one need to observe to recognize psychosis? For the experienced psychiatrist, many of these behavioral hallmarks are akin to an ST elevation on an EKG representing a heart attack.

When considering less extreme examples of mental affliction, such as depression and anxiety, many signs – including demeanor, motor activity, manner of speaking, and other aspects of behavior – are apparent to the perceptive psychiatrist without needing an extensive interview that dives into the depths of a person’s social history and childhood. After all, our own criteria for depression and mania do not require the presence of social stressors or childhood trauma. Even personality disorders can be reasonably postulated when a person behaves in a particular fashion. The recognition of transitional objects, items used to provide psychological comfort, including the “teddy bear sign” are common and scientifically studied methods to recognize personality disorder.⁸

The necessity for an in-person evaluation has become less compelling over the years. In our modern age, important social moments are memorialized in countless videos that are arguably more relevant, more accurate, and less subjective than a psychiatric interview. Furthermore, forensic psychiatrists routinely comment on individuals they have not examined for a variety of reasons, from postmortem analysis to the refusal of the client to be interviewed. Moreover, and with significant contradiction, many leaders in the field of psychiatry view integrated care, the practice of psychiatrists advising primary care doctors, often without even seeing patients, to be the future of psychiatry.⁹

Some reading this may scoff at the above examples. Perhaps Section 7.3 speaks to an underlying insecurity in our field regarding our ability to accurately diagnose. That insecurity is not unfounded. In terms of the DSM-5, the bar for reliability has been lowered to a kappa of 0.2-0.4, from a previous standard of 0.6, in an attempt to avoid critiques of unreliability.¹⁰ Yet herein lies a powerful recognition of the necessity of the Goldwater rule. If psychiatrists cannot reliably agree on the presence of diagnoses in the controlled setting of scientific study, how can we expect to speak with coherence and consistency on highly mediatized and provoking topics?

The defense – that the difficulty psychiatrists have at providing an accurate diagnosis stems from the immense complexity of the system being evaluated, the human mind – is a valid one. Attempts to force such complex pathology, with all its many variables, into the check-box approach implemented in the DSM inevitably leads to problems with diagnostic reliability. Still, as psychiatrists we retain a level of expertise in assessing and treating complex disorders of the mind that no other field can claim.

The duty physicians have not only to work toward the health of their individual patients, but also to act in service of the public health and well-being of communities in which our patients live, is well established. How ethical is it then for psychiatry to absolve itself from duty when it comes to public figures at the center of shaping public opinion? There are numerous recent, high-profile instances where our expertise may have helped shine light in an otherwise murky public discussion filled with disinformation. The death of George Floyd and the year of turmoil that followed is a salient example. The conservatorship of Britney Spears and the resulting societal outcry is another. Even setting the matter of diagnosis aside, we can help illuminate the societal implications of conservatorship laws,¹¹ in addition to providing input on how to safely and responsibly approach an individual who is in crisis, under the influence of multiple illicit substances, and possibly suffering from excited delirium.

Whether psychiatry has progressed enough as a medical specialty to trust ourselves with the option of providing professional opinions on public figures is an ongoing debate. The persistence of the Goldwater rule is a strong testament to the internal lack of confidence among psychiatrists regarding our ability to provide accurate diagnoses, act with integrity in the public space, and foster a positive public image. That lack of confidence may be well deserved. However, it is possible that our field will never go through the necessary pains of maturing as long as Section 7.3 remains in place.
 

Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research. Dr. Compton has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.

References

1. American Psychiatric Association. The principles of medical ethics with annotations especially applicable to psychiatry. Section 7. American Psychiatric Association; 2013 edition.

2. Glass LL. The Goldwater rule is broken. Here’s how to fix it. STAT News. 2018 June 18.

3. Plymyer D. The Goldwater rule paradox. 2020 Aug 7.

4. Lieberman JA. Trump’s brain and the 25th Amendment. Vice. 2017 Sep 8.

5. Blotcky AD et al. The Goldwater rule is fine, if refined. Here’s how to do it. Psychiatric Times. 2022 Jan 6;39(1).

6. Blotcky AD and Norrholm SD. After Trump, end the Goldwater rule once and for all. New York Daily News. 2020 Dec 22.

7. Stephens B. Biden should not run again – And he should say he won’t. New York Times. 2021 Dec 14.

8. Schmaling KB et al. The positive teddy bear sign: Transitional objects in the medical setting. J Nerv Ment Dis. 1994 Dec;182(12):725.

9. Badre N et al. Psychopharmacologic management in integrated care: Challenges for residency education. Acad Psychiatry. 2015; 39(4):466-9.

10. Kraemer HC et al. DSM-5: How reliable is reliable enough? Am J Psychiatry. 2012 Jan;169(1):13-5.

11. Badre N and Compton C. Britney Spears – Reflections on conservatorship. Clinical Psychiatry News. 2021 Nov 16.

Since it appeared in the first edition of the American Psychiatric Association’s Principles of Medical Ethics in 1973, the “Goldwater rule” – often referred to in terms of where in the APA’s guideline it can be found, Section 7.3 – has placed a stringent prohibition on psychiatrists offering professional opinions about public figures “unless he or she has conducted an examination and has been granted proper authorization for such a statement.”¹

Some psychiatrists experienced the restrictive nature of Section 7.3 more acutely perhaps than ever during the Trump presidency. This spurred numerous articles criticizing the guideline as an outdated “gag rule”² that harms the public image of psychiatry.³ Some psychiatrists violated the rule to warn the public of the dangers of a president with “incipient dementia”⁴ occupying the most powerful position on earth.

Following President Trump’s exit from the White House, the alarm bells surrounding his presidency have quieted. Criticisms of the Goldwater rule, on the other hand, have persisted. Many of these criticisms now call for the rule to be refined, allowing for psychiatrists to give their professional opinions about public figures, but with certain guidelines on how to do so.⁵ Few have yet to make a sober case for the outright abolition of Section 7.3.⁶

Self-regulating and internal policing are important factors in the continued independence of the medical profession, and we should continue to hold each other to high professional standards. That being said, do psychiatrists need training wheels to prevent us from devolving into unprofessional social commentators? Other medical specialties do not see the need to implement a rule preventing their colleagues from expressing expertise in fear of embarrassment. Do we not have faith in our ability to conduct ourselves professionally? Is the Goldwater rule an admission of a juvenile lack of self-control within our field?

Not only do other medical specialties not forcibly handhold their members in public settings, but other “providers” in the realm of mental health likewise do not implement such strict self-restraints. Psychiatry staying silent on the matter of public figures leaves a void filled by other, arguably less qualified, individuals. Subsequently, the public discord risks being flooded with pseudoscientific pontification and distorted views of psychiatric illness. The cycle of speculating on the mental fitness of the president has outlived President Trump, with concerns about Joe Biden’s incoherence and waning cognition.⁷ Therein is an important argument to be made for the public duty of psychiatrists, with their greater expertise and clinical acumen, to weigh in on matters of societal importance in an attempt to dispel dangerous misconceptions.

Practical limitations are often raised and serve as the cornerstone for the Goldwater rule. Specifically, the limitation being that a psychiatrist cannot provide a professional opinion about an individual without a proper in-person evaluation. The psychiatric interview could be considered the most in-depth and comprehensive evaluation in all of medicine. Even so, is a trained psychiatrist presented with grandiosity, flight-of-ideas, and pressured speech unable to comment on the possibility of mania without a lengthy and comprehensive evaluation? How much disorganization of behavior and dialogue does one need to observe to recognize psychosis? For the experienced psychiatrist, many of these behavioral hallmarks are akin to an ST elevation on an EKG representing a heart attack.

When considering less extreme examples of mental affliction, such as depression and anxiety, many signs – including demeanor, motor activity, manner of speaking, and other aspects of behavior – are apparent to the perceptive psychiatrist without needing an extensive interview that dives into the depths of a person’s social history and childhood. After all, our own criteria for depression and mania do not require the presence of social stressors or childhood trauma. Even personality disorders can be reasonably postulated when a person behaves in a particular fashion. The recognition of transitional objects, items used to provide psychological comfort, including the “teddy bear sign” are common and scientifically studied methods to recognize personality disorder.⁸

The necessity for an in-person evaluation has become less compelling over the years. In our modern age, important social moments are memorialized in countless videos that are arguably more relevant, more accurate, and less subjective than a psychiatric interview. Furthermore, forensic psychiatrists routinely comment on individuals they have not examined for a variety of reasons, from postmortem analysis to the refusal of the client to be interviewed. Moreover, and with significant contradiction, many leaders in the field of psychiatry view integrated care, the practice of psychiatrists advising primary care doctors, often without even seeing patients, to be the future of psychiatry.⁹

Some reading this may scoff at the above examples. Perhaps Section 7.3 speaks to an underlying insecurity in our field regarding our ability to accurately diagnose. That insecurity is not unfounded. In terms of the DSM-5, the bar for reliability has been lowered to a kappa of 0.2-0.4, from a previous standard of 0.6, in an attempt to avoid critiques of unreliability.¹⁰ Yet herein lies a powerful recognition of the necessity of the Goldwater rule. If psychiatrists cannot reliably agree on the presence of diagnoses in the controlled setting of scientific study, how can we expect to speak with coherence and consistency on highly mediatized and provoking topics?

The defense – that the difficulty psychiatrists have at providing an accurate diagnosis stems from the immense complexity of the system being evaluated, the human mind – is a valid one. Attempts to force such complex pathology, with all its many variables, into the check-box approach implemented in the DSM inevitably leads to problems with diagnostic reliability. Still, as psychiatrists we retain a level of expertise in assessing and treating complex disorders of the mind that no other field can claim.

The duty physicians have not only to work toward the health of their individual patients, but also to act in service of the public health and well-being of communities in which our patients live, is well established. How ethical is it then for psychiatry to absolve itself from duty when it comes to public figures at the center of shaping public opinion? There are numerous recent, high-profile instances where our expertise may have helped shine light in an otherwise murky public discussion filled with disinformation. The death of George Floyd and the year of turmoil that followed is a salient example. The conservatorship of Britney Spears and the resulting societal outcry is another. Even setting the matter of diagnosis aside, we can help illuminate the societal implications of conservatorship laws,¹¹ in addition to providing input on how to safely and responsibly approach an individual who is in crisis, under the influence of multiple illicit substances, and possibly suffering from excited delirium.

Whether psychiatry has progressed enough as a medical specialty to trust ourselves with the option of providing professional opinions on public figures is an ongoing debate. The persistence of the Goldwater rule is a strong testament to the internal lack of confidence among psychiatrists regarding our ability to provide accurate diagnoses, act with integrity in the public space, and foster a positive public image. That lack of confidence may be well deserved. However, it is possible that our field will never go through the necessary pains of maturing as long as Section 7.3 remains in place.
 

Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research. Dr. Compton has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.

References

1. American Psychiatric Association. The principles of medical ethics with annotations especially applicable to psychiatry. Section 7. American Psychiatric Association; 2013 edition.

2. Glass LL. The Goldwater rule is broken. Here’s how to fix it. STAT News. 2018 June 18.

3. Plymyer D. The Goldwater rule paradox. 2020 Aug 7.

4. Lieberman JA. Trump’s brain and the 25th Amendment. Vice. 2017 Sep 8.

5. Blotcky AD et al. The Goldwater rule is fine, if refined. Here’s how to do it. Psychiatric Times. 2022 Jan 6;39(1).

6. Blotcky AD and Norrholm SD. After Trump, end the Goldwater rule once and for all. New York Daily News. 2020 Dec 22.

7. Stephens B. Biden should not run again – And he should say he won’t. New York Times. 2021 Dec 14.

8. Schmaling KB et al. The positive teddy bear sign: Transitional objects in the medical setting. J Nerv Ment Dis. 1994 Dec;182(12):725.

9. Badre N et al. Psychopharmacologic management in integrated care: Challenges for residency education. Acad Psychiatry. 2015; 39(4):466-9.

10. Kraemer HC et al. DSM-5: How reliable is reliable enough? Am J Psychiatry. 2012 Jan;169(1):13-5.

11. Badre N and Compton C. Britney Spears – Reflections on conservatorship. Clinical Psychiatry News. 2021 Nov 16.

Since it appeared in the first edition of the American Psychiatric Association’s Principles of Medical Ethics in 1973, the “Goldwater rule” – often referred to in terms of where in the APA’s guideline it can be found, Section 7.3 – has placed a stringent prohibition on psychiatrists offering professional opinions about public figures “unless he or she has conducted an examination and has been granted proper authorization for such a statement.”¹

Some psychiatrists experienced the restrictive nature of Section 7.3 more acutely perhaps than ever during the Trump presidency. This spurred numerous articles criticizing the guideline as an outdated “gag rule”² that harms the public image of psychiatry.³ Some psychiatrists violated the rule to warn the public of the dangers of a president with “incipient dementia”⁴ occupying the most powerful position on earth.

Following President Trump’s exit from the White House, the alarm bells surrounding his presidency have quieted. Criticisms of the Goldwater rule, on the other hand, have persisted. Many of these criticisms now call for the rule to be refined, allowing for psychiatrists to give their professional opinions about public figures, but with certain guidelines on how to do so.⁵ Few have yet to make a sober case for the outright abolition of Section 7.3.⁶

Self-regulating and internal policing are important factors in the continued independence of the medical profession, and we should continue to hold each other to high professional standards. That being said, do psychiatrists need training wheels to prevent us from devolving into unprofessional social commentators? Other medical specialties do not see the need to implement a rule preventing their colleagues from expressing expertise in fear of embarrassment. Do we not have faith in our ability to conduct ourselves professionally? Is the Goldwater rule an admission of a juvenile lack of self-control within our field?

Not only do other medical specialties not forcibly handhold their members in public settings, but other “providers” in the realm of mental health likewise do not implement such strict self-restraints. Psychiatry staying silent on the matter of public figures leaves a void filled by other, arguably less qualified, individuals. Subsequently, the public discord risks being flooded with pseudoscientific pontification and distorted views of psychiatric illness. The cycle of speculating on the mental fitness of the president has outlived President Trump, with concerns about Joe Biden’s incoherence and waning cognition.⁷ Therein is an important argument to be made for the public duty of psychiatrists, with their greater expertise and clinical acumen, to weigh in on matters of societal importance in an attempt to dispel dangerous misconceptions.

Practical limitations are often raised and serve as the cornerstone for the Goldwater rule. Specifically, the limitation being that a psychiatrist cannot provide a professional opinion about an individual without a proper in-person evaluation. The psychiatric interview could be considered the most in-depth and comprehensive evaluation in all of medicine. Even so, is a trained psychiatrist presented with grandiosity, flight-of-ideas, and pressured speech unable to comment on the possibility of mania without a lengthy and comprehensive evaluation? How much disorganization of behavior and dialogue does one need to observe to recognize psychosis? For the experienced psychiatrist, many of these behavioral hallmarks are akin to an ST elevation on an EKG representing a heart attack.

When considering less extreme examples of mental affliction, such as depression and anxiety, many signs – including demeanor, motor activity, manner of speaking, and other aspects of behavior – are apparent to the perceptive psychiatrist without needing an extensive interview that dives into the depths of a person’s social history and childhood. After all, our own criteria for depression and mania do not require the presence of social stressors or childhood trauma. Even personality disorders can be reasonably postulated when a person behaves in a particular fashion. The recognition of transitional objects, items used to provide psychological comfort, including the “teddy bear sign” are common and scientifically studied methods to recognize personality disorder.⁸

The necessity for an in-person evaluation has become less compelling over the years. In our modern age, important social moments are memorialized in countless videos that are arguably more relevant, more accurate, and less subjective than a psychiatric interview. Furthermore, forensic psychiatrists routinely comment on individuals they have not examined for a variety of reasons, from postmortem analysis to the refusal of the client to be interviewed. Moreover, and with significant contradiction, many leaders in the field of psychiatry view integrated care, the practice of psychiatrists advising primary care doctors, often without even seeing patients, to be the future of psychiatry.⁹

Some reading this may scoff at the above examples. Perhaps Section 7.3 speaks to an underlying insecurity in our field regarding our ability to accurately diagnose. That insecurity is not unfounded. In terms of the DSM-5, the bar for reliability has been lowered to a kappa of 0.2-0.4, from a previous standard of 0.6, in an attempt to avoid critiques of unreliability.¹⁰ Yet herein lies a powerful recognition of the necessity of the Goldwater rule. If psychiatrists cannot reliably agree on the presence of diagnoses in the controlled setting of scientific study, how can we expect to speak with coherence and consistency on highly mediatized and provoking topics?

The defense – that the difficulty psychiatrists have at providing an accurate diagnosis stems from the immense complexity of the system being evaluated, the human mind – is a valid one. Attempts to force such complex pathology, with all its many variables, into the check-box approach implemented in the DSM inevitably leads to problems with diagnostic reliability. Still, as psychiatrists we retain a level of expertise in assessing and treating complex disorders of the mind that no other field can claim.

The duty physicians have not only to work toward the health of their individual patients, but also to act in service of the public health and well-being of communities in which our patients live, is well established. How ethical is it then for psychiatry to absolve itself from duty when it comes to public figures at the center of shaping public opinion? There are numerous recent, high-profile instances where our expertise may have helped shine light in an otherwise murky public discussion filled with disinformation. The death of George Floyd and the year of turmoil that followed is a salient example. The conservatorship of Britney Spears and the resulting societal outcry is another. Even setting the matter of diagnosis aside, we can help illuminate the societal implications of conservatorship laws,¹¹ in addition to providing input on how to safely and responsibly approach an individual who is in crisis, under the influence of multiple illicit substances, and possibly suffering from excited delirium.

Whether psychiatry has progressed enough as a medical specialty to trust ourselves with the option of providing professional opinions on public figures is an ongoing debate. The persistence of the Goldwater rule is a strong testament to the internal lack of confidence among psychiatrists regarding our ability to provide accurate diagnoses, act with integrity in the public space, and foster a positive public image. That lack of confidence may be well deserved. However, it is possible that our field will never go through the necessary pains of maturing as long as Section 7.3 remains in place.
 

Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research. Dr. Compton has no conflicts of interest. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest.

References

1. American Psychiatric Association. The principles of medical ethics with annotations especially applicable to psychiatry. Section 7. American Psychiatric Association; 2013 edition.

2. Glass LL. The Goldwater rule is broken. Here’s how to fix it. STAT News. 2018 June 18.

3. Plymyer D. The Goldwater rule paradox. 2020 Aug 7.

4. Lieberman JA. Trump’s brain and the 25th Amendment. Vice. 2017 Sep 8.

5. Blotcky AD et al. The Goldwater rule is fine, if refined. Here’s how to do it. Psychiatric Times. 2022 Jan 6;39(1).

6. Blotcky AD and Norrholm SD. After Trump, end the Goldwater rule once and for all. New York Daily News. 2020 Dec 22.

7. Stephens B. Biden should not run again – And he should say he won’t. New York Times. 2021 Dec 14.

8. Schmaling KB et al. The positive teddy bear sign: Transitional objects in the medical setting. J Nerv Ment Dis. 1994 Dec;182(12):725.

9. Badre N et al. Psychopharmacologic management in integrated care: Challenges for residency education. Acad Psychiatry. 2015; 39(4):466-9.

10. Kraemer HC et al. DSM-5: How reliable is reliable enough? Am J Psychiatry. 2012 Jan;169(1):13-5.

11. Badre N and Compton C. Britney Spears – Reflections on conservatorship. Clinical Psychiatry News. 2021 Nov 16.

DENVER – High-intensity exercise may help patients with anxiety quit smoking, new research shows.

Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.

Effective as CBT

Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).

In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.

The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.

Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.

Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.

The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.

All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.

All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).

The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.

“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
 

Abstinence rate doubled

The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.

Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).

“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”

Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.

Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.

In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
 

Real-world evidence

Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.

It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.

He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.

“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.

Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.

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

DENVER – High-intensity exercise may help patients with anxiety quit smoking, new research shows.

Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.

Effective as CBT

Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).

In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.

The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.

Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.

Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.

The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.

All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.

All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).

The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.

“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
 

Abstinence rate doubled

The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.

Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).

“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”

Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.

Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.

In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
 

Real-world evidence

Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.

It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.

He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.

“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.

Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.

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

DENVER – High-intensity exercise may help patients with anxiety quit smoking, new research shows.

Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.

Effective as CBT

Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).

In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.

The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.

Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.

Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.

The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.

All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.

All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).

The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.

“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
 

Abstinence rate doubled

The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.

Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).

“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”

Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.

Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.

In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
 

Real-world evidence

Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.

It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.

He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.

“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.

Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.

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

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

The pandemic not only disrupted sleep but may have also triggered an uptick in the use of wearable tech. Sleep tracking was featured at the Cardiovascular Health Tech virtual conference 2022, sponsored by the Institute of Electrical and Electronics Engineers Engineering in Medicine & Biology Society technical committee on Cardiopulmonary Systems and Physiology-Based Engineering.

This news organization interviewed presenter Kelly Glazer Baron, PhD, MPH, DBSM, an associate professor at the University of Utah, Salt Lake City, and a clinical psychologist specializing in behavioral sleep medicine.

The interview has been edited for length and clarity.
 

Question: Are consumer sleep trackers mainly divided into “nearables” – things that you put at the side of the bed or under the pillow – vs. wearables?

Dr. Baron: There are so many different devices these days. There are things that you put under your mattress or pillow; there are bedside recording devices; then there are headbands, rings, wrist-worn, all kinds of things.

Q: At the conference, Philip de Chazal, PhD, (University of Sydney) described the evidence on sleep tracking smartphone apps as woeful. Would you agree with that?

A: Yes. I would agree if you’re looking at how accurate they are at recording sleep, particularly compared with what we would define as the gold standard, which is a sleep study wherein you have electrodes on the scalp and you’re measuring the electrical activity directly.

Devices that go under the pillow are extremely poor at deciphering sleep from wake time, which is really the main goal. They are best at detecting when you get into the bed and when you get out. But even then, there isn’t good evidence that they do that accurately when there are two people in the bed.

Overall, they may give you a general gist of what’s happening in terms of time in and out of bed, but we’re doubtful on their recording ability to tell sleep from wake time.
 

Q: Are the wrist-worn devices better for sleep tracking?

A: They’re getting better. We’ve used wrist activity monitors in research for years. They use an accelerometer to measure movement, and then an algorithm determines whether an interval of time is called sleep or wake.

Recently, they’ve incorporated more sensors, such as heart rate, and they can more accurately decipher rapid eye movement (REM) sleep from non-REM. They’re still not as good as doing a full sleep study. But they’re getting closer.
 

Q: If asked how you slept, most of us think we can answer without needing to look at a smartphone, but maybe not. Can you explain “paradoxical insomnia”?

A: You can’t really know if you’re sleeping because if you know you’re asleep, then you can’t be asleep because it’s a state of unconsciousness. How people decide whether they had a good night’s sleep probably depends on a lot of things about how they feel when they wake up in the morning or if they remember being up in the night.

Quality of sleep is not really something that people can directly ascertain. There is a selection of people who feel awake all night but they actually are sleeping. They feel that their sleep quality is poor: They’re suffering; they have insomnia, but from the objective data, they are sleeping fine.
 

Q: Is this related to non-REM stage 1 sleep, when you may not be aware that you’re asleep?

A: No. I’m talking about people who come into the sleep lab for an overnight study and get hooked up. And in the morning, they’ll tell the tech I was awake all night, but the tech will see that their sleep was just fine.

There is a disconnect between how people perceive their sleep and how they actually sleep. For most people it’s impossible to be completely accurate to know how much you’re sleeping. Then there are some people who perceive it very differently.

Sleep trackers don’t have the level of detail of sleep studies that use scalp electrodes. When we get into the details of sleep measurement, we’re measuring 30-second epochs (sampling periods), where we look at broad measures of electrical activity. There is even more detail there that can be pulled out using other techniques, such as analyzing the spectrum of the EEG. For example, some studies have found a beta frequency in the EEG of people with insomnia, so even though they are sleeping, they often feel awake.

Basically, the subjective experience of sleep somewhat overlaps with the objective recording of what’s happening on a sleep study, but not completely.
 

Q: You said that first thing in the morning might not be the best time to assess your sleep – if you wake up groggy and are already thinking, “The day is shot.”

A: In general, people really feel worst in the morning. Their circadian drive is low, especially if they’re a little sleep deprived. You shouldn’t judge the day on the first hour after waking – most people are pretty cognitively impaired. I tell people they need some boot-up time.

You feel differently as the day goes on and even at different points of the day. There’s a lull in the early afternoon because of your circadian dip and then we get a second wind in the evening. How you feel isn’t one flat line; it’s really a rhythm throughout the day
 

Q: Would you say that consumer sleep trackers are okay for individuals to use to see a pattern but are maybe not accurate enough to use more globally in research?

A: I think there is a huge opportunity to understand sleep at a population level. For example, if there’s been a hurricane or an earthquake or Superbowl Sunday, companies have an opportunity to look at the impact – say, daylight saving time and how it affects sleep across different countries, or men vs. women, or different age groups.

There was a paper about sleep among hospital workers in Wuhan during the outbreak of the pandemic. That was a creative use of wearable devices to look at sleep in a large population.

Now, of course, the devices are not given out randomly; the people who buy them are probably a little bit healthier, maybe a little bit younger – that sort of thing. It is a biased sample.
 

Q: As you note, mobile health trackers tend to be used by the “worried well.” Can you tell us about your paper that introduced the term “orthosomnia,” or “a perfectionistic quest for the ideal sleep in order to optimize daytime function”?

A: As these devices came out, more people were coming into the clinic and shoving their data in front of us saying, “I don’t feel well, and I don’t sleep 7 hours.” They were focused on this specific number. Back when we wrote this paper, the devices were primarily movement based (now the devices are a bit more accurate). Some would say, “My sleep is light, and it’s not deep.” We’d do a sleep study that showed that they have deep sleep, but they would still believe their device even though the device really wasn’t able to classify sleep accurately.

We even found people making their sleep worse because of the device. For example, trying to get the number higher by spending more time lying in bed trying to sleep which is the opposite of what you want someone with insomnia to do. These people held the data so tight and really felt that it characterized their experience, even though we sleep medicine practitioners didn’t find it very accurate and felt that it was somewhat unhelpful to their treatment.
 

Q: What advice would you give the harried primary care physician presented with a patient’s hypnogram or sleep pattern?

A: As someone once pointed out to me, it’s a conversation opener about their sleep. Did they buy the device because they’re worried about their sleep? It’s unlikely that you can glean anything clinically useful from the data.

I briefly look at it to see the duration of their sleep, the regularity in their sleep pattern – the pattern of awakenings during the night might suggest that they have some insomnia. But it doesn’t take the place of clinical assessment for conditions like sleep apnea: Are they snoring? Are they unrefreshed?

I had a patient in the orthosomnia study who was given a sleep tracker by a family member. He brought the data to his doctor who ordered a sleep study that found he had sleep apnea. He would say, “The device diagnosed my sleep apnea.” But that wasn’t actually the case; it just opened the conversation and the clinician said, “Well, let’s order a sleep study.”
 

Q: The device told him he wasn’t getting much sleep and then the sleep study told him it was apnea.

A: Right. It’s impossible to pick up sleep apnea. Some of the latest devices have some oximetry reading but it is not a clinically validated oximetry that could diagnose sleep apnea.

When these first came out I thought I’d get more referrals. So far, I haven’t had a single person come in and ask if they have sleep apnea. If you have a patient saying, “Hey, I’m worried about my oxygen level and here’s my data,” then the clinician should consider whether they need a sleep study for sleep apnea.
 

Q: You did a survey that suggests that clinicians are less keen on these devices than consumers. Conor Heneghan of Fitbit/Google also mentioned a study using the Fitbit Charge and a SleepLife portal. The patients were very engaged but only one physician (out of 49) logged into the portal to look at the data.

A: Our survey of sleep professionals (which we need to publish) showed that they were wary of the data. They found it frustrating in some ways because it took time out of the clinical encounter.

Some of them said that parents are putting trackers on their children and then catastrophizing their children’s sleep.
 

Q: Is there such a thing as an ideal hypnogram or does it vary by individual?

A: I would say that it depends on a lot of things. If you think about a hypnogram from a sleep study, the patient is not sleeping in their home environment, and it’s only one night. There’s a range of what would be considered normal, and it’s related to your sex and your age.

One night is not going to be sufficient to characterize your percentage in this or that sleep stage. Our patients come in saying, “I’m not getting enough REM.” But there isn’t a sleep disorder called lack of REM; there’s no treatment for that. It’s probably pretty normal for them or maybe they’re taking medications that suppress their REM, such as antidepressants.

The tech world is very interested to sense REM properly and to display it. But on the treatment side of things, there’s not much that we do with that data. We’re more interested in the consolidation of their sleep, the duration of their sleep, breathing-related sleep disorders, those sorts of things.
 

Q: Is there any reason to be concerned about the amount of REM sleep in terms of outcomes? We know that poor sleep can lead to bad cardiovascular outcomes, but has any of that correlated to sleep stage?

A: There are studies where they’ve experimentally deprived people of certain stages of sleep, but they’re not very useful in the real world. We’re looking at sleep holistically: Do you have a good sleep pattern? Any breathing-related sleep disorders? Insomnia? We don’t treat sleep by the stage.

Q: Any concern that people who are focused on a device may be ignoring the basic tenets of good sleep hygiene?

A: If people are doing things that are obviously bad for their sleep, like working too late, not exercising enough, sleeping in on weekends to compensate for being up late during the week, or probably the biggest thing contributing to insomnia – stress. A device itself won’t fix those things but it could show you the evidence.

If somebody really has a sleep disorder, then sleep hygiene alone is probably not going to be enough. They’re going to need to engage in a more extensive program to improve their sleep, such as cognitive-behavioral therapy for insomnia.
 

Q: Is there anything else you want to mention?

A: I don’t want to leave with a reputation of being against sleep trackers. I think they are a great opportunity for people to get excited about and learn about their sleep and try to improve it. We have a lot to learn about what people want from their data and how we can use that data to improve people’s sleep.

As providers, we can engage with our patients – sleep is an automatic process, but improving sleep takes some effort. Buying a device is not going to automatically make you sleep better. It takes work to establish a better sleep pattern; it may require some cognitive-behavioral therapy or treating a sleep disorder. That takes some work.

Dr. Baron reported no conflicts of interest.A version of this article first appeared on Medscape.com.

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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