Cardiology News

New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results were published in Circulation Research.

Morbidity and Mortality

Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain. These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.

Consequences and Pathomechanisms

In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.

The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.

Confirmed Cardiovascular Risk Factor

“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”

Heart Attack Outcomes

Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results were published last year in Cardiovascular Research. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.

The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.

The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.

Clinical Confirmation

These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”

Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; P = .0053).

The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.

Mental Health Effects

Traffic noise also may be associated with an increased risk for depression and anxiety disorders, as reported 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.

Depression Risk Doubled

Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.

Fine Particulate Matter

According to an evaluation of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results were published in Circulation Research.

Morbidity and Mortality

Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain. These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.

Consequences and Pathomechanisms

In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.

The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.

Confirmed Cardiovascular Risk Factor

“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”

Heart Attack Outcomes

Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results were published last year in Cardiovascular Research. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.

The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.

The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.

Clinical Confirmation

These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”

Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; P = .0053).

The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.

Mental Health Effects

Traffic noise also may be associated with an increased risk for depression and anxiety disorders, as reported 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.

Depression Risk Doubled

Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.

Fine Particulate Matter

According to an evaluation of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results were published in Circulation Research.

Morbidity and Mortality

Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain. These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.

Consequences and Pathomechanisms

In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.

The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.

Confirmed Cardiovascular Risk Factor

“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”

Heart Attack Outcomes

Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results were published last year in Cardiovascular Research. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.

The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.

The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.

Clinical Confirmation

These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”

Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; P = .0053).

The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.

Mental Health Effects

Traffic noise also may be associated with an increased risk for depression and anxiety disorders, as reported 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.

Depression Risk Doubled

Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.

Fine Particulate Matter

According to an evaluation of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Observational studies on red meat consumption and lifespan are prime examples of attempts to find signal in a sea of noise. 

Randomized controlled trials are the best way to sort cause from mere correlation. But these are not possible in most matters of food consumption. So, we look back and observe groups with different exposures.

My most frequent complaint about these nonrandom comparison studies has been the chance that the two groups differ in important ways, and it’s these differences — not the food in question — that account for the disparate outcomes.

But selection biases are only one issue. There is also the matter of analytic flexibility. Observational studies are born from large databases. Researchers have many choices in how to analyze all these data.

A few years ago, Brian Nosek, PhD, and colleagues elegantly showed that analytic choices can affect results. His Many Analysts, One Data Set study had little uptake in the medical community, perhaps because he studied a social science question.
 

Multiple Ways to Slice the Data

Recently, a group from McMaster University, led by Dena Zeraatkar, PhD, has confirmed the analytic choices problem, using the question of red meat consumption and mortality. 

Their idea was simple: Because there are many plausible and defensible ways to analyze a dataset, we should not choose one method; rather, we should choose thousands, combine the results, and see where the truth lies. 

You might wonder how there could be thousands of ways to analyze a dataset. I surely did. 

The answer stems from the choices that researchers face. For instance, there is the selection of eligible participants, the choice of analytic model (logistic, Poisson, etc.), and covariates for which to adjust. Think exponents when combining possible choices.

Dr. Zeraatkar and colleagues are research methodologists, so, sadly, they are comfortable with the clunky name of this approach: specification curve analysis. Don’t be deterred. It means that they analyze the data in thousands of ways using computers. Each way is a specification. In the end, the specifications give rise to a curve of hazard ratios for red meat and mortality. Another name for this approach is multiverse analysis.

For their paper in the Journal of Clinical Epidemiology, aptly named “Grilling the Data,” they didn’t just conjure up the many analytic ways to study the red meat–mortality question. Instead, they used a published systematic review of 15 studies on unprocessed red meat and early mortality. The studies included in this review reported 70 unique ways to analyze the association. 
 

Is Red Meat Good or Bad?

Their first finding was that this analysis yielded widely disparate effect estimates, from 0.63 (reduced risk for early death) to 2.31 (a higher risk). The median hazard ratio was 1.14 with an interquartile range (IQR) of 1.02-1.23. One might conclude from this that eating red meat is associated with a slightly higher risk for early mortality. 

Their second step was to calculate how many ways (specifications) there were to analyze the data by totaling all possible combinations of choices in the 70 ways found in the systematic review. 

They calculated a total of 10 quadrillion possible unique analyses. A quadrillion is 1 with 15 zeros. Computing power cannot handle that amount of analyses yet. So, they generated 20 random unique combinations of covariates, which narrowed the number of analyses to about 1400. About 200 of these were excluded due to implausibly wide confidence intervals. 

Voilà. They now had about 1200 different ways to analyze a dataset; they chose an NHANES longitudinal cohort study from 2007-2014. They deemed each of the more than 1200 approaches plausible because they were derived from peer-reviewed papers written by experts in epidemiology. 
 

Specification Curve Analyses Results 

Each analysis (or specification) yielded a hazard ratio for red meat exposure and death.

• The median HR was 0.94 (IQR, 0.83-1.05) for the effect of red meat on all-cause mortality — ie, not significant.
• The range of hazard ratios was large. They went from 0.51 — a 49% reduced risk for early mortality — to 1.75: a 75% increase in early mortality.
• Among all analyses, 36% yielded hazard ratios above 1.0 and 64% less than 1.0.
• As for statistical significance, defined as P ≤.05, only 4% (or 48 specifications) met this threshold. Zeraatkar reminded me that this is what you’d expect if unprocessed red meat has no effect on longevity.
• Of the 48 analyses deemed statistically significant, 40 indicated that red meat consumption reduced early death and eight indicated that eating red meat led to higher mortality.
• Nearly half the analyses yielded unexciting point estimates, with hazard ratios between 0.90 and 1.10.

Paradigm Changing 

As a user of evidence, I find this a potentially paradigm-changing study. Observational studies far outnumber randomized trials. For many medical questions, observational data are all we have. 

Now think about every observational study published. The authors tell you — post hoc — which method they used to analyze the data. The key point is that it is one method. 

Dr. Zeraatkar and colleagues have shown that there are thousands of plausible ways to analyze the data, and this can lead to very different findings. In the specific question of red meat and mortality, their many analyses yielded a null result. 

Now imagine other cases where the researchers did many analyses of a dataset and chose to publish only the significant ones. Observational studies are rarely preregistered, so a reader cannot know how a result would vary depending on analytic choices. A specification curve analysis of a dataset provides a much broader picture. In the case of red meat, you see some significant results, but the vast majority hover around null. 

What about the difficulty in analyzing a dataset 1000 different ways? Dr. Zeraatkar told me that it is harder than just choosing one method, but it’s not impossible. 

The main barrier to adopting this multiverse approach to data, she noted, was not the extra work but the entrenched belief among researchers that there is a best way to analyze data. 

I hope you read this paper and think about it every time you read an observational study that finds a positive or negative association between two things. Ask: What if the researchers were as careful as Dr. Zeraatkar and colleagues and did multiple different analyses? Would the finding hold up to a series of plausible analytic choices? 

Nutritional epidemiology would benefit greatly from this approach. But so would any observational study of an exposure and outcome. I suspect that the number of “positive” associations would diminish. And that would not be a bad thing.

 

Dr. Mandrola, a clinical electrophysiologist at Baptist Medical Associates, Louisville, Kentucky, disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Observational studies on red meat consumption and lifespan are prime examples of attempts to find signal in a sea of noise. 

Randomized controlled trials are the best way to sort cause from mere correlation. But these are not possible in most matters of food consumption. So, we look back and observe groups with different exposures.

My most frequent complaint about these nonrandom comparison studies has been the chance that the two groups differ in important ways, and it’s these differences — not the food in question — that account for the disparate outcomes.

But selection biases are only one issue. There is also the matter of analytic flexibility. Observational studies are born from large databases. Researchers have many choices in how to analyze all these data.

A few years ago, Brian Nosek, PhD, and colleagues elegantly showed that analytic choices can affect results. His Many Analysts, One Data Set study had little uptake in the medical community, perhaps because he studied a social science question.
 

Multiple Ways to Slice the Data

Recently, a group from McMaster University, led by Dena Zeraatkar, PhD, has confirmed the analytic choices problem, using the question of red meat consumption and mortality. 

Their idea was simple: Because there are many plausible and defensible ways to analyze a dataset, we should not choose one method; rather, we should choose thousands, combine the results, and see where the truth lies. 

You might wonder how there could be thousands of ways to analyze a dataset. I surely did. 

The answer stems from the choices that researchers face. For instance, there is the selection of eligible participants, the choice of analytic model (logistic, Poisson, etc.), and covariates for which to adjust. Think exponents when combining possible choices.

Dr. Zeraatkar and colleagues are research methodologists, so, sadly, they are comfortable with the clunky name of this approach: specification curve analysis. Don’t be deterred. It means that they analyze the data in thousands of ways using computers. Each way is a specification. In the end, the specifications give rise to a curve of hazard ratios for red meat and mortality. Another name for this approach is multiverse analysis.

For their paper in the Journal of Clinical Epidemiology, aptly named “Grilling the Data,” they didn’t just conjure up the many analytic ways to study the red meat–mortality question. Instead, they used a published systematic review of 15 studies on unprocessed red meat and early mortality. The studies included in this review reported 70 unique ways to analyze the association. 
 

Is Red Meat Good or Bad?

Their first finding was that this analysis yielded widely disparate effect estimates, from 0.63 (reduced risk for early death) to 2.31 (a higher risk). The median hazard ratio was 1.14 with an interquartile range (IQR) of 1.02-1.23. One might conclude from this that eating red meat is associated with a slightly higher risk for early mortality. 

Their second step was to calculate how many ways (specifications) there were to analyze the data by totaling all possible combinations of choices in the 70 ways found in the systematic review. 

They calculated a total of 10 quadrillion possible unique analyses. A quadrillion is 1 with 15 zeros. Computing power cannot handle that amount of analyses yet. So, they generated 20 random unique combinations of covariates, which narrowed the number of analyses to about 1400. About 200 of these were excluded due to implausibly wide confidence intervals. 

Voilà. They now had about 1200 different ways to analyze a dataset; they chose an NHANES longitudinal cohort study from 2007-2014. They deemed each of the more than 1200 approaches plausible because they were derived from peer-reviewed papers written by experts in epidemiology. 
 

Specification Curve Analyses Results 

Each analysis (or specification) yielded a hazard ratio for red meat exposure and death.

• The median HR was 0.94 (IQR, 0.83-1.05) for the effect of red meat on all-cause mortality — ie, not significant.
• The range of hazard ratios was large. They went from 0.51 — a 49% reduced risk for early mortality — to 1.75: a 75% increase in early mortality.
• Among all analyses, 36% yielded hazard ratios above 1.0 and 64% less than 1.0.
• As for statistical significance, defined as P ≤.05, only 4% (or 48 specifications) met this threshold. Zeraatkar reminded me that this is what you’d expect if unprocessed red meat has no effect on longevity.
• Of the 48 analyses deemed statistically significant, 40 indicated that red meat consumption reduced early death and eight indicated that eating red meat led to higher mortality.
• Nearly half the analyses yielded unexciting point estimates, with hazard ratios between 0.90 and 1.10.

Paradigm Changing 

As a user of evidence, I find this a potentially paradigm-changing study. Observational studies far outnumber randomized trials. For many medical questions, observational data are all we have. 

Now think about every observational study published. The authors tell you — post hoc — which method they used to analyze the data. The key point is that it is one method. 

Dr. Zeraatkar and colleagues have shown that there are thousands of plausible ways to analyze the data, and this can lead to very different findings. In the specific question of red meat and mortality, their many analyses yielded a null result. 

Now imagine other cases where the researchers did many analyses of a dataset and chose to publish only the significant ones. Observational studies are rarely preregistered, so a reader cannot know how a result would vary depending on analytic choices. A specification curve analysis of a dataset provides a much broader picture. In the case of red meat, you see some significant results, but the vast majority hover around null. 

What about the difficulty in analyzing a dataset 1000 different ways? Dr. Zeraatkar told me that it is harder than just choosing one method, but it’s not impossible. 

The main barrier to adopting this multiverse approach to data, she noted, was not the extra work but the entrenched belief among researchers that there is a best way to analyze data. 

I hope you read this paper and think about it every time you read an observational study that finds a positive or negative association between two things. Ask: What if the researchers were as careful as Dr. Zeraatkar and colleagues and did multiple different analyses? Would the finding hold up to a series of plausible analytic choices? 

Nutritional epidemiology would benefit greatly from this approach. But so would any observational study of an exposure and outcome. I suspect that the number of “positive” associations would diminish. And that would not be a bad thing.

 

Dr. Mandrola, a clinical electrophysiologist at Baptist Medical Associates, Louisville, Kentucky, disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Observational studies on red meat consumption and lifespan are prime examples of attempts to find signal in a sea of noise. 

Randomized controlled trials are the best way to sort cause from mere correlation. But these are not possible in most matters of food consumption. So, we look back and observe groups with different exposures.

My most frequent complaint about these nonrandom comparison studies has been the chance that the two groups differ in important ways, and it’s these differences — not the food in question — that account for the disparate outcomes.

But selection biases are only one issue. There is also the matter of analytic flexibility. Observational studies are born from large databases. Researchers have many choices in how to analyze all these data.

A few years ago, Brian Nosek, PhD, and colleagues elegantly showed that analytic choices can affect results. His Many Analysts, One Data Set study had little uptake in the medical community, perhaps because he studied a social science question.
 

Multiple Ways to Slice the Data

Recently, a group from McMaster University, led by Dena Zeraatkar, PhD, has confirmed the analytic choices problem, using the question of red meat consumption and mortality. 

Their idea was simple: Because there are many plausible and defensible ways to analyze a dataset, we should not choose one method; rather, we should choose thousands, combine the results, and see where the truth lies. 

You might wonder how there could be thousands of ways to analyze a dataset. I surely did. 

The answer stems from the choices that researchers face. For instance, there is the selection of eligible participants, the choice of analytic model (logistic, Poisson, etc.), and covariates for which to adjust. Think exponents when combining possible choices.

Dr. Zeraatkar and colleagues are research methodologists, so, sadly, they are comfortable with the clunky name of this approach: specification curve analysis. Don’t be deterred. It means that they analyze the data in thousands of ways using computers. Each way is a specification. In the end, the specifications give rise to a curve of hazard ratios for red meat and mortality. Another name for this approach is multiverse analysis.

For their paper in the Journal of Clinical Epidemiology, aptly named “Grilling the Data,” they didn’t just conjure up the many analytic ways to study the red meat–mortality question. Instead, they used a published systematic review of 15 studies on unprocessed red meat and early mortality. The studies included in this review reported 70 unique ways to analyze the association. 
 

Is Red Meat Good or Bad?

Their first finding was that this analysis yielded widely disparate effect estimates, from 0.63 (reduced risk for early death) to 2.31 (a higher risk). The median hazard ratio was 1.14 with an interquartile range (IQR) of 1.02-1.23. One might conclude from this that eating red meat is associated with a slightly higher risk for early mortality. 

Their second step was to calculate how many ways (specifications) there were to analyze the data by totaling all possible combinations of choices in the 70 ways found in the systematic review. 

They calculated a total of 10 quadrillion possible unique analyses. A quadrillion is 1 with 15 zeros. Computing power cannot handle that amount of analyses yet. So, they generated 20 random unique combinations of covariates, which narrowed the number of analyses to about 1400. About 200 of these were excluded due to implausibly wide confidence intervals. 

Voilà. They now had about 1200 different ways to analyze a dataset; they chose an NHANES longitudinal cohort study from 2007-2014. They deemed each of the more than 1200 approaches plausible because they were derived from peer-reviewed papers written by experts in epidemiology. 
 

Specification Curve Analyses Results 

Each analysis (or specification) yielded a hazard ratio for red meat exposure and death.

• The median HR was 0.94 (IQR, 0.83-1.05) for the effect of red meat on all-cause mortality — ie, not significant.
• The range of hazard ratios was large. They went from 0.51 — a 49% reduced risk for early mortality — to 1.75: a 75% increase in early mortality.
• Among all analyses, 36% yielded hazard ratios above 1.0 and 64% less than 1.0.
• As for statistical significance, defined as P ≤.05, only 4% (or 48 specifications) met this threshold. Zeraatkar reminded me that this is what you’d expect if unprocessed red meat has no effect on longevity.
• Of the 48 analyses deemed statistically significant, 40 indicated that red meat consumption reduced early death and eight indicated that eating red meat led to higher mortality.
• Nearly half the analyses yielded unexciting point estimates, with hazard ratios between 0.90 and 1.10.

Paradigm Changing 

As a user of evidence, I find this a potentially paradigm-changing study. Observational studies far outnumber randomized trials. For many medical questions, observational data are all we have. 

Now think about every observational study published. The authors tell you — post hoc — which method they used to analyze the data. The key point is that it is one method. 

Dr. Zeraatkar and colleagues have shown that there are thousands of plausible ways to analyze the data, and this can lead to very different findings. In the specific question of red meat and mortality, their many analyses yielded a null result. 

Now imagine other cases where the researchers did many analyses of a dataset and chose to publish only the significant ones. Observational studies are rarely preregistered, so a reader cannot know how a result would vary depending on analytic choices. A specification curve analysis of a dataset provides a much broader picture. In the case of red meat, you see some significant results, but the vast majority hover around null. 

What about the difficulty in analyzing a dataset 1000 different ways? Dr. Zeraatkar told me that it is harder than just choosing one method, but it’s not impossible. 

The main barrier to adopting this multiverse approach to data, she noted, was not the extra work but the entrenched belief among researchers that there is a best way to analyze data. 

I hope you read this paper and think about it every time you read an observational study that finds a positive or negative association between two things. Ask: What if the researchers were as careful as Dr. Zeraatkar and colleagues and did multiple different analyses? Would the finding hold up to a series of plausible analytic choices? 

Nutritional epidemiology would benefit greatly from this approach. But so would any observational study of an exposure and outcome. I suspect that the number of “positive” associations would diminish. And that would not be a bad thing.

 

Dr. Mandrola, a clinical electrophysiologist at Baptist Medical Associates, Louisville, Kentucky, disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Physicians are leaving healthcare in droves, “not because they don’t want to practice ... but because the system is making it more and more difficult for them to care for their patients,” Bruce Scott, MD, president-elect of the American Medical Association (AMA), said at a press conference May 9 at the National Rural Health Association’s Annual Conference in New Orleans. 

He said that shrinking reimbursement rates and excessive administrative tasks are pushing doctors out of the workforce, exacerbating physician shortages in rural locations where 46 million Americans live. 

Rural areas have about one tenth of the specialists that urban areas do, and 65% of rural communities do not have enough primary care doctors, according to federal data. A recent Centers for Disease Control and Prevention report found that people living in rural areas are more likely to die early from preventable causes than their urban counterparts, said Dr. Scott. 

He said the AMA wants Congress to pass legislation to incentivize more physicians to work in rural areas and expand the number of rural and primary care residency spots. Historically, 80% of residents practice within 80 miles of where they complete residency, he said. 

Dr. Scott also hopes Congress will revise the J-1 visa rules to allow qualified international medical graduates to continue to practice in the United States. He’d like to see the pandemic telehealth flexibilities made permanent because these loosened guidelines greatly improved care access for rural areas in recent years. 

Lower Pay Affects Care in Rural, Urban Areas

Decreased reimbursements also have hit rural and urban doctors in independent practice particularly hard, Dr. Scott said. When adjusted for inflation, the current Medicare payment rate for physicians has dropped 29% since 2001, he said. Now that commercial payers tie their reimbursement models to the Medicare rate, physicians are experiencing “severe” financial stress amid rising practice costs and student loan debt. 

He shared anecdotes about how these issues have affected his private otolaryngology practice in Louisville, Kentucky, a state where more than 2 million people live in federally designated primary care professional shortage areas. 

“A major insurance company that controls over 60% of the private payer market in rural Kentucky [recently] offered us ... surgical rates less than they paid us 6 years ago,” he said. 

Dr. Scott said physicians must make difficult choices. “Do we not invest in the latest physical equipment? Do we reduce our number of employees? Do we perhaps stop accepting new Medicare patients?”

He noted that physicians now spend twice as much time on prior authorizations and other administrative tasks as they do on direct patient care. According to a 2022 AMA survey, 33% of physicians reported that the cumbersome prior authorization process led to a serious adverse event for a patient. Eighty percent reported it caused their patient to forgo treatment altogether.

Dr. Scott, who will be sworn in as AMA president in June, said he experiences the frustration daily. 

“I have to get on the phone and justify to an insurance person who rarely has gone to medical school, has never seen the patient, and heck, in my case, sometimes they can’t even say otolaryngology, much less tell me what the appropriate care is for my patient,” he said.

When asked about the impact of private equity in healthcare, Dr. Scott said there is room for all different modes of practice, but private equity could bring a unique benefit. 

“They have deeper pockets to potentially invest in telehealth technology, AI, and better computer systems,” he said. 

But, he said, some private equity-owned systems have abandoned rural areas, and in other regions they “push the physicians to move faster, see more patients, and do the things that are profit-driven.

“The key is to continue to provide ... quality medical care that is determined by an individual physician in consultation with the patient.”
 

A version of this article appeared on Medscape.com.

Physicians are leaving healthcare in droves, “not because they don’t want to practice ... but because the system is making it more and more difficult for them to care for their patients,” Bruce Scott, MD, president-elect of the American Medical Association (AMA), said at a press conference May 9 at the National Rural Health Association’s Annual Conference in New Orleans. 

He said that shrinking reimbursement rates and excessive administrative tasks are pushing doctors out of the workforce, exacerbating physician shortages in rural locations where 46 million Americans live. 

Rural areas have about one tenth of the specialists that urban areas do, and 65% of rural communities do not have enough primary care doctors, according to federal data. A recent Centers for Disease Control and Prevention report found that people living in rural areas are more likely to die early from preventable causes than their urban counterparts, said Dr. Scott. 

He said the AMA wants Congress to pass legislation to incentivize more physicians to work in rural areas and expand the number of rural and primary care residency spots. Historically, 80% of residents practice within 80 miles of where they complete residency, he said. 

Dr. Scott also hopes Congress will revise the J-1 visa rules to allow qualified international medical graduates to continue to practice in the United States. He’d like to see the pandemic telehealth flexibilities made permanent because these loosened guidelines greatly improved care access for rural areas in recent years. 

Lower Pay Affects Care in Rural, Urban Areas

Decreased reimbursements also have hit rural and urban doctors in independent practice particularly hard, Dr. Scott said. When adjusted for inflation, the current Medicare payment rate for physicians has dropped 29% since 2001, he said. Now that commercial payers tie their reimbursement models to the Medicare rate, physicians are experiencing “severe” financial stress amid rising practice costs and student loan debt. 

He shared anecdotes about how these issues have affected his private otolaryngology practice in Louisville, Kentucky, a state where more than 2 million people live in federally designated primary care professional shortage areas. 

“A major insurance company that controls over 60% of the private payer market in rural Kentucky [recently] offered us ... surgical rates less than they paid us 6 years ago,” he said. 

Dr. Scott said physicians must make difficult choices. “Do we not invest in the latest physical equipment? Do we reduce our number of employees? Do we perhaps stop accepting new Medicare patients?”

He noted that physicians now spend twice as much time on prior authorizations and other administrative tasks as they do on direct patient care. According to a 2022 AMA survey, 33% of physicians reported that the cumbersome prior authorization process led to a serious adverse event for a patient. Eighty percent reported it caused their patient to forgo treatment altogether.

Dr. Scott, who will be sworn in as AMA president in June, said he experiences the frustration daily. 

“I have to get on the phone and justify to an insurance person who rarely has gone to medical school, has never seen the patient, and heck, in my case, sometimes they can’t even say otolaryngology, much less tell me what the appropriate care is for my patient,” he said.

When asked about the impact of private equity in healthcare, Dr. Scott said there is room for all different modes of practice, but private equity could bring a unique benefit. 

“They have deeper pockets to potentially invest in telehealth technology, AI, and better computer systems,” he said. 

But, he said, some private equity-owned systems have abandoned rural areas, and in other regions they “push the physicians to move faster, see more patients, and do the things that are profit-driven.

“The key is to continue to provide ... quality medical care that is determined by an individual physician in consultation with the patient.”
 

A version of this article appeared on Medscape.com.

Physicians are leaving healthcare in droves, “not because they don’t want to practice ... but because the system is making it more and more difficult for them to care for their patients,” Bruce Scott, MD, president-elect of the American Medical Association (AMA), said at a press conference May 9 at the National Rural Health Association’s Annual Conference in New Orleans. 

He said that shrinking reimbursement rates and excessive administrative tasks are pushing doctors out of the workforce, exacerbating physician shortages in rural locations where 46 million Americans live. 

Rural areas have about one tenth of the specialists that urban areas do, and 65% of rural communities do not have enough primary care doctors, according to federal data. A recent Centers for Disease Control and Prevention report found that people living in rural areas are more likely to die early from preventable causes than their urban counterparts, said Dr. Scott. 

He said the AMA wants Congress to pass legislation to incentivize more physicians to work in rural areas and expand the number of rural and primary care residency spots. Historically, 80% of residents practice within 80 miles of where they complete residency, he said. 

Dr. Scott also hopes Congress will revise the J-1 visa rules to allow qualified international medical graduates to continue to practice in the United States. He’d like to see the pandemic telehealth flexibilities made permanent because these loosened guidelines greatly improved care access for rural areas in recent years. 

Lower Pay Affects Care in Rural, Urban Areas

Decreased reimbursements also have hit rural and urban doctors in independent practice particularly hard, Dr. Scott said. When adjusted for inflation, the current Medicare payment rate for physicians has dropped 29% since 2001, he said. Now that commercial payers tie their reimbursement models to the Medicare rate, physicians are experiencing “severe” financial stress amid rising practice costs and student loan debt. 

He shared anecdotes about how these issues have affected his private otolaryngology practice in Louisville, Kentucky, a state where more than 2 million people live in federally designated primary care professional shortage areas. 

“A major insurance company that controls over 60% of the private payer market in rural Kentucky [recently] offered us ... surgical rates less than they paid us 6 years ago,” he said. 

Dr. Scott said physicians must make difficult choices. “Do we not invest in the latest physical equipment? Do we reduce our number of employees? Do we perhaps stop accepting new Medicare patients?”

He noted that physicians now spend twice as much time on prior authorizations and other administrative tasks as they do on direct patient care. According to a 2022 AMA survey, 33% of physicians reported that the cumbersome prior authorization process led to a serious adverse event for a patient. Eighty percent reported it caused their patient to forgo treatment altogether.

Dr. Scott, who will be sworn in as AMA president in June, said he experiences the frustration daily. 

“I have to get on the phone and justify to an insurance person who rarely has gone to medical school, has never seen the patient, and heck, in my case, sometimes they can’t even say otolaryngology, much less tell me what the appropriate care is for my patient,” he said.

When asked about the impact of private equity in healthcare, Dr. Scott said there is room for all different modes of practice, but private equity could bring a unique benefit. 

“They have deeper pockets to potentially invest in telehealth technology, AI, and better computer systems,” he said. 

But, he said, some private equity-owned systems have abandoned rural areas, and in other regions they “push the physicians to move faster, see more patients, and do the things that are profit-driven.

“The key is to continue to provide ... quality medical care that is determined by an individual physician in consultation with the patient.”
 

A version of this article appeared on Medscape.com.

Like it or not, artificial intelligence (AI) is coming to medicine. For many physicians — maybe you — it’s already here.

More than a third of physicians use AI in their practice. And the vast majority of healthcare companies — 94%, according to Morgan Stanley — use some kind of AI machine learning.

“It’s incumbent on physicians, as well as physicians in training, to become familiar with at least the basics [of AI],” said internist Matthew DeCamp, MD, PhD, an associate professor in the Center for Bioethics and Humanities at the University of Colorado Anschutz Medical Campus, Aurora, Colorado.

Understanding AI can help you leverage it safely and effectively — plus “make better-informed decisions about whether or not to use it in [your] practice,” Dr. DeCamp said.

“Frankly, the people who are deciding whether to implement algorithms in our day-to-day lives are oftentimes not physicians,” noted Ravi B. Parikh, MD, an assistant professor at the University of Pennsylvania and director of augmented and artificial intelligence at the Penn Center for Cancer Care Innovation, Philadelphia. Yet, physicians are most qualified to assess an AI tool’s usefulness in clinical practice.

That brings us to the best starting place for your AI education: Your own institution. Find out what AI tools your organization is implementing — and how you can influence them.

“Getting involved with our hospital data governance is the best way not only to learn practically what these AI tools do but also to influence the development process in positive ways,” Dr. Parikh said.

From there, consider the following resources to enhance your AI knowledge.
 

Get a Lay of the Land: Free Primers

Many clinical societies and interest groups have put out AI primers, an easy way to get a broad overview of the technology. The following were recommended or developed by the experts we spoke to, and all are free:

• The American Medical Association’s (AMA’s) framework for advancing healthcare AI lays out actionable guidance. Ask three key questions, the AMA recommends: Does it work? Does it work for my patients? Does it improve health outcomes?
• The Coalition for Health AI’s Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare provides a high-level summary of how to evaluate AI in healthcare, plus steps for implementing it. AI systems should be useful, safe, accountable, explainable, fair, and secure, the report asserted.
• The National Academy of Medicine’s draft code of conduct for AI in healthcare proposes core principles and commitments. These “reflect simple guideposts to guide and gauge behavior in a complex system and provide a starting point for real-time decision-making,” the report said.
• Health AI Partnership — a collaboration of Duke Health and Microsoft — outlines eight key decision points to consider at any stage of AI implementation, whether you’re still planning how to use it or you’ve started but want to improve it. The site also provides a breakdown of standards by regulatory agencies, organizations, and oversight bodies — so you can make sure your practices align with their guidance.

Make the Most of Conferences

Next time you’re at a conference, check the agenda for sessions on AI. “For someone who’s interested in this, I would be looking for content in my next national meeting because, undoubtedly, it’s going to be there,” said Dr. DeCamp. In a fast-moving field like AI, it’s a great way to get fresh, up-to-the-moment insights.

Listen to This Podcast

The New England Journal of Medicine’s free monthly podcast AI Grand Rounds is made for researchers and clinicians. Available on Apple, Spotify, and YouTube, the pod is good for “someone who’s looking to see both where the field is going [and to hear] a retrospective on big-name papers,” said Dr. Parikh . Episodes run for about an hour.

To learn about the challenges of applying AI to biology: Listen to Daphne Koller, PhD, founder of AI-driven drug discovery and development company insitro. For insights on the potential of AI in medicine, tune into the one with Eric Horvitz, MD, PhD, Microsoft’s chief scientific officer.
 

Consider a Class

Look for courses that focus on AI applications in clinical practice rather than a deep dive into theory. (You need to understand how these tools will influence your work, not the intricacies of large language model development.) Be wary of corporate-funded training that centers on one product , which could present conflicts of interest, said Dr. DeCamp. See the chart for courses that meet these criteria.

A version of this article appeared on Medscape.com.

Like it or not, artificial intelligence (AI) is coming to medicine. For many physicians — maybe you — it’s already here.

More than a third of physicians use AI in their practice. And the vast majority of healthcare companies — 94%, according to Morgan Stanley — use some kind of AI machine learning.

“It’s incumbent on physicians, as well as physicians in training, to become familiar with at least the basics [of AI],” said internist Matthew DeCamp, MD, PhD, an associate professor in the Center for Bioethics and Humanities at the University of Colorado Anschutz Medical Campus, Aurora, Colorado.

Understanding AI can help you leverage it safely and effectively — plus “make better-informed decisions about whether or not to use it in [your] practice,” Dr. DeCamp said.

“Frankly, the people who are deciding whether to implement algorithms in our day-to-day lives are oftentimes not physicians,” noted Ravi B. Parikh, MD, an assistant professor at the University of Pennsylvania and director of augmented and artificial intelligence at the Penn Center for Cancer Care Innovation, Philadelphia. Yet, physicians are most qualified to assess an AI tool’s usefulness in clinical practice.

That brings us to the best starting place for your AI education: Your own institution. Find out what AI tools your organization is implementing — and how you can influence them.

“Getting involved with our hospital data governance is the best way not only to learn practically what these AI tools do but also to influence the development process in positive ways,” Dr. Parikh said.

From there, consider the following resources to enhance your AI knowledge.
 

Get a Lay of the Land: Free Primers

Many clinical societies and interest groups have put out AI primers, an easy way to get a broad overview of the technology. The following were recommended or developed by the experts we spoke to, and all are free:

• The American Medical Association’s (AMA’s) framework for advancing healthcare AI lays out actionable guidance. Ask three key questions, the AMA recommends: Does it work? Does it work for my patients? Does it improve health outcomes?
• The Coalition for Health AI’s Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare provides a high-level summary of how to evaluate AI in healthcare, plus steps for implementing it. AI systems should be useful, safe, accountable, explainable, fair, and secure, the report asserted.
• The National Academy of Medicine’s draft code of conduct for AI in healthcare proposes core principles and commitments. These “reflect simple guideposts to guide and gauge behavior in a complex system and provide a starting point for real-time decision-making,” the report said.
• Health AI Partnership — a collaboration of Duke Health and Microsoft — outlines eight key decision points to consider at any stage of AI implementation, whether you’re still planning how to use it or you’ve started but want to improve it. The site also provides a breakdown of standards by regulatory agencies, organizations, and oversight bodies — so you can make sure your practices align with their guidance.

Make the Most of Conferences

Next time you’re at a conference, check the agenda for sessions on AI. “For someone who’s interested in this, I would be looking for content in my next national meeting because, undoubtedly, it’s going to be there,” said Dr. DeCamp. In a fast-moving field like AI, it’s a great way to get fresh, up-to-the-moment insights.

Listen to This Podcast

The New England Journal of Medicine’s free monthly podcast AI Grand Rounds is made for researchers and clinicians. Available on Apple, Spotify, and YouTube, the pod is good for “someone who’s looking to see both where the field is going [and to hear] a retrospective on big-name papers,” said Dr. Parikh . Episodes run for about an hour.

To learn about the challenges of applying AI to biology: Listen to Daphne Koller, PhD, founder of AI-driven drug discovery and development company insitro. For insights on the potential of AI in medicine, tune into the one with Eric Horvitz, MD, PhD, Microsoft’s chief scientific officer.
 

Consider a Class

Look for courses that focus on AI applications in clinical practice rather than a deep dive into theory. (You need to understand how these tools will influence your work, not the intricacies of large language model development.) Be wary of corporate-funded training that centers on one product , which could present conflicts of interest, said Dr. DeCamp. See the chart for courses that meet these criteria.

A version of this article appeared on Medscape.com.

Like it or not, artificial intelligence (AI) is coming to medicine. For many physicians — maybe you — it’s already here.

More than a third of physicians use AI in their practice. And the vast majority of healthcare companies — 94%, according to Morgan Stanley — use some kind of AI machine learning.

“It’s incumbent on physicians, as well as physicians in training, to become familiar with at least the basics [of AI],” said internist Matthew DeCamp, MD, PhD, an associate professor in the Center for Bioethics and Humanities at the University of Colorado Anschutz Medical Campus, Aurora, Colorado.

Understanding AI can help you leverage it safely and effectively — plus “make better-informed decisions about whether or not to use it in [your] practice,” Dr. DeCamp said.

“Frankly, the people who are deciding whether to implement algorithms in our day-to-day lives are oftentimes not physicians,” noted Ravi B. Parikh, MD, an assistant professor at the University of Pennsylvania and director of augmented and artificial intelligence at the Penn Center for Cancer Care Innovation, Philadelphia. Yet, physicians are most qualified to assess an AI tool’s usefulness in clinical practice.

That brings us to the best starting place for your AI education: Your own institution. Find out what AI tools your organization is implementing — and how you can influence them.

“Getting involved with our hospital data governance is the best way not only to learn practically what these AI tools do but also to influence the development process in positive ways,” Dr. Parikh said.

From there, consider the following resources to enhance your AI knowledge.
 

Get a Lay of the Land: Free Primers

Many clinical societies and interest groups have put out AI primers, an easy way to get a broad overview of the technology. The following were recommended or developed by the experts we spoke to, and all are free:

• The American Medical Association’s (AMA’s) framework for advancing healthcare AI lays out actionable guidance. Ask three key questions, the AMA recommends: Does it work? Does it work for my patients? Does it improve health outcomes?
• The Coalition for Health AI’s Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare provides a high-level summary of how to evaluate AI in healthcare, plus steps for implementing it. AI systems should be useful, safe, accountable, explainable, fair, and secure, the report asserted.
• The National Academy of Medicine’s draft code of conduct for AI in healthcare proposes core principles and commitments. These “reflect simple guideposts to guide and gauge behavior in a complex system and provide a starting point for real-time decision-making,” the report said.
• Health AI Partnership — a collaboration of Duke Health and Microsoft — outlines eight key decision points to consider at any stage of AI implementation, whether you’re still planning how to use it or you’ve started but want to improve it. The site also provides a breakdown of standards by regulatory agencies, organizations, and oversight bodies — so you can make sure your practices align with their guidance.

Make the Most of Conferences

Next time you’re at a conference, check the agenda for sessions on AI. “For someone who’s interested in this, I would be looking for content in my next national meeting because, undoubtedly, it’s going to be there,” said Dr. DeCamp. In a fast-moving field like AI, it’s a great way to get fresh, up-to-the-moment insights.

Listen to This Podcast

The New England Journal of Medicine’s free monthly podcast AI Grand Rounds is made for researchers and clinicians. Available on Apple, Spotify, and YouTube, the pod is good for “someone who’s looking to see both where the field is going [and to hear] a retrospective on big-name papers,” said Dr. Parikh . Episodes run for about an hour.

To learn about the challenges of applying AI to biology: Listen to Daphne Koller, PhD, founder of AI-driven drug discovery and development company insitro. For insights on the potential of AI in medicine, tune into the one with Eric Horvitz, MD, PhD, Microsoft’s chief scientific officer.
 

Consider a Class

Look for courses that focus on AI applications in clinical practice rather than a deep dive into theory. (You need to understand how these tools will influence your work, not the intricacies of large language model development.) Be wary of corporate-funded training that centers on one product , which could present conflicts of interest, said Dr. DeCamp. See the chart for courses that meet these criteria.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 90% of adults were at risk of developing cardiovascular-kidney-metabolic (CKM) syndrome between 2011 and 2020, according to new research published in JAMA.

METHODOLOGY:

• In 2023, the American Heart Association defined  to acknowledge how heart and kidney diseases, diabetes, and obesity interact and are increasingly co-occurring conditions.
• Researchers used data from the National Health and Nutrition Examination Survey between 2011 and 2020.
• More than 10,000 adults over age 20 years were included; all of them received a physical and fasting laboratory measurements and self-reported their cardiovascular disease (CVD) status.
• Researchers created categories for risk, ranging from 0 (no risk factors) to 4, using factors such as kidney disease, obesity, and hypertension.

TAKEAWAY:

• Nearly 90% of participants met the criteria for having a stage of the CKM syndrome, with rates remaining steady throughout the study period.Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
• 14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
• Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.
• Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
   
• 14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
   
• Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.

IN PRACTICE:

“Equitable health care approaches prioritizing CKM health are urgently needed,” the study authors wrote.

SOURCE:

The study was led by Muthiah Vaduganathan, MD, MPH, cardiologist and researcher at Brigham and Women’s Hospital, Harvard Medical School, Boston.

LIMITATIONS: 

Established CVD statuses were self-reported. Some data that would indicate advanced CKM stages were not available (eg, cardiac biomarkers, echocardiography, and coronary angiography), which may have led to an underestimation of rates.

DISCLOSURES:

One author received grants from Bristol Myers Squibb–Pfizer outside the submitted work. Dr. Vaduganathan received grants from and was an adviser and committee trial member for various pharmaceutical companies outside the submitted work. The authors reported no other disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 90% of adults were at risk of developing cardiovascular-kidney-metabolic (CKM) syndrome between 2011 and 2020, according to new research published in JAMA.

METHODOLOGY:

• In 2023, the American Heart Association defined  to acknowledge how heart and kidney diseases, diabetes, and obesity interact and are increasingly co-occurring conditions.
• Researchers used data from the National Health and Nutrition Examination Survey between 2011 and 2020.
• More than 10,000 adults over age 20 years were included; all of them received a physical and fasting laboratory measurements and self-reported their cardiovascular disease (CVD) status.
• Researchers created categories for risk, ranging from 0 (no risk factors) to 4, using factors such as kidney disease, obesity, and hypertension.

TAKEAWAY:

• Nearly 90% of participants met the criteria for having a stage of the CKM syndrome, with rates remaining steady throughout the study period.Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
• 14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
• Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.
• Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
   
• 14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
   
• Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.

IN PRACTICE:

“Equitable health care approaches prioritizing CKM health are urgently needed,” the study authors wrote.

SOURCE:

The study was led by Muthiah Vaduganathan, MD, MPH, cardiologist and researcher at Brigham and Women’s Hospital, Harvard Medical School, Boston.

LIMITATIONS: 

Established CVD statuses were self-reported. Some data that would indicate advanced CKM stages were not available (eg, cardiac biomarkers, echocardiography, and coronary angiography), which may have led to an underestimation of rates.

DISCLOSURES:

One author received grants from Bristol Myers Squibb–Pfizer outside the submitted work. Dr. Vaduganathan received grants from and was an adviser and committee trial member for various pharmaceutical companies outside the submitted work. The authors reported no other disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 90% of adults were at risk of developing cardiovascular-kidney-metabolic (CKM) syndrome between 2011 and 2020, according to new research published in JAMA.

METHODOLOGY:

• In 2023, the American Heart Association defined  to acknowledge how heart and kidney diseases, diabetes, and obesity interact and are increasingly co-occurring conditions.
• Researchers used data from the National Health and Nutrition Examination Survey between 2011 and 2020.
• More than 10,000 adults over age 20 years were included; all of them received a physical and fasting laboratory measurements and self-reported their cardiovascular disease (CVD) status.
• Researchers created categories for risk, ranging from 0 (no risk factors) to 4, using factors such as kidney disease, obesity, and hypertension.

TAKEAWAY:

• Nearly 90% of participants met the criteria for having a stage of the CKM syndrome, with rates remaining steady throughout the study period.Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
• 14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
• Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.
• Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
   
• 14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
   
• Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.

IN PRACTICE:

“Equitable health care approaches prioritizing CKM health are urgently needed,” the study authors wrote.

SOURCE:

The study was led by Muthiah Vaduganathan, MD, MPH, cardiologist and researcher at Brigham and Women’s Hospital, Harvard Medical School, Boston.

LIMITATIONS: 

Established CVD statuses were self-reported. Some data that would indicate advanced CKM stages were not available (eg, cardiac biomarkers, echocardiography, and coronary angiography), which may have led to an underestimation of rates.

DISCLOSURES:

One author received grants from Bristol Myers Squibb–Pfizer outside the submitted work. Dr. Vaduganathan received grants from and was an adviser and committee trial member for various pharmaceutical companies outside the submitted work. The authors reported no other disclosures.

A version of this article appeared on Medscape.com.

A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.

Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses. 

Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial. 

This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response. 

The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal. 

Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson. 

“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents. 

In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records. 

But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.

The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
 

Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says

Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative. 

Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents. 

Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents. 

In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media. 

At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends. 

Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson. 

The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents. 

In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.

All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson. 
 

Surgeon Claims Competitor Behind Allegations 

Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong. 

The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show. 

“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.

The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation. 

Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents. 

The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024. 
 

A version of this article appeared on Medscape.com.

A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.

Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses. 

Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial. 

This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response. 

The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal. 

Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson. 

“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents. 

In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records. 

But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.

The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
 

Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says

Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative. 

Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents. 

Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents. 

In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media. 

At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends. 

Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson. 

The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents. 

In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.

All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson. 
 

Surgeon Claims Competitor Behind Allegations 

Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong. 

The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show. 

“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.

The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation. 

Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents. 

The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024. 
 

A version of this article appeared on Medscape.com.

A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.

Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses. 

Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial. 

This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response. 

The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal. 

Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson. 

“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents. 

In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records. 

But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.

The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
 

Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says

Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative. 

Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents. 

Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents. 

In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media. 

At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends. 

Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson. 

The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents. 

In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.

All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson. 
 

Surgeon Claims Competitor Behind Allegations 

Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong. 

The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show. 

“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.

The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation. 

Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents. 

The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

A large international cohort study identified a higher risk for cardiovascular diseases and mortality in patients with prurigo nodularis (PN), particularly among women and White patients.

METHODOLOGY:

• Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
• In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
• Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.

TAKEAWAY:

• Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
• PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
• White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
• Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.

IN PRACTICE:

“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.

LIMITATIONS:

Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.

SOURCE:

This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.

DISCLOSURES:

The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A large international cohort study identified a higher risk for cardiovascular diseases and mortality in patients with prurigo nodularis (PN), particularly among women and White patients.

METHODOLOGY:

• Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
• In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
• Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.

TAKEAWAY:

• Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
• PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
• White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
• Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.

IN PRACTICE:

“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.

LIMITATIONS:

Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.

SOURCE:

This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.

DISCLOSURES:

The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A large international cohort study identified a higher risk for cardiovascular diseases and mortality in patients with prurigo nodularis (PN), particularly among women and White patients.

METHODOLOGY:

• Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
• In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
• Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.

TAKEAWAY:

• Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
• PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
• White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
• Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.

IN PRACTICE:

“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.

LIMITATIONS:

Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.

SOURCE:

This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.

DISCLOSURES:

The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
 

A version of this article appeared on Medscape.com.

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.

Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.

In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.

“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.

The Inflammatory Pathway

Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.

“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation. 

Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.

“This is where colchicine can potentially play a role,” she said. 

Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.

The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted. 

Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.

Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.

What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.

“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.

“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
 

Slow to Embrace Colchicine

Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.

NYU Langone

“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.

Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.

Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.

Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.

A version of this article appeared on Medscape.com .

NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.

Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.

In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.

“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.

The Inflammatory Pathway

Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.

“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation. 

Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.

“This is where colchicine can potentially play a role,” she said. 

Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.

The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted. 

Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.

Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.

What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.

“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.

“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
 

Slow to Embrace Colchicine

Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.

NYU Langone

“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.

Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.

Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.

Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.

A version of this article appeared on Medscape.com .

NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.

Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.

In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.

“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.

The Inflammatory Pathway

Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.

“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation. 

Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.

“This is where colchicine can potentially play a role,” she said. 

Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.

The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted. 

Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.

Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.

What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.

“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.

“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
 

Slow to Embrace Colchicine

Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.

NYU Langone

“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.

Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.

Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.

Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.

A version of this article appeared on Medscape.com .